bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Routine Physical Therapy With and Without Thoracic Mobility Exercises in Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      There is a limited data available on the effectiveness of thoracic mobility exercises in
      chronic neck pain and there is a need to determine these exercises in chronic neck pain
      because chronic neck pain has significant effects on the surrounding muscles of the neck and
      cervical spine and along with the muscles of shoulder and arm. So the mobility exercises of
      any region around the neck area can reduce neck pain because these structures are interlinked
      anatomically and functionally aspects.
    


Intervention name(s): Routine Physical Therapy with Thoracic mobility exercise; Routıne Physıcal therapy
Intervention type(s): Other; Other
Intervention description(s): Combınatıon of routıne Routine Physical Therapy with Thoracic mobility exercise; Exercise for Chronic Neck Pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: THORACIC MOBILITY EXERCISES; Chronic Neck Pain
Antibiotics After Breast Reduction:Clinical Trial With Randomization
Condition: Surgical Site Infection
MeSH terms: Surgical Wound Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to determine the role of antibiotics reduction mammaplasty influence
      surgical site infections rates.
    

Detailed description: 
      Prevention of SSI is important due to its morbidity, longer hospital stays and higher costs.
      In many surgical procedures where the risk of infection is relatively low and the
      postoperative infection can be treated properly, the role of antibiotics is not clear.

      Despite the lack of evidence from prospective randomized controlled trials of evaluation, the
      use of antibiotics in plastic surgery is widespread in order to offer the highest safety
      standards patients.

      The breast reduction is defined as "clean surgery" with a lower infection rate to 3.4%. Thus,
      the antibiotic is not recommended. However, studies have shown a real rate of infection
      associated with procedures ranging from 4-36%.

      Thus, this trial was designed to verify the role of antibiotics in reduction mammaplasty.
    

Intervention name(s): Cephalexin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules containing cephalexin/500mg; Capsules containing placebo/500mg
Intervention MeSH terms: Cephalexin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: plastic surgery; mammaplasty; wound infection; prophylaxis
Evaluation of Effects of Exercise Training and ARB in DM Patients
Condition: Vascular Function; Exercise Training
Study type: Observational

Summary: 
      The aims of this clinical trial are to assess the impacts on vascular function tests and
      circulating biomarkers of a short-term (12-week) low-to-median intensity exercise training or
      ARBs treatment in patients with DM and hypertension.
    

Detailed description: 
      Inclusion criteria: type II diabetic and hypertensive patients who are aged 30 to 70 year-old
      with HbA1c ≤ 8.0 % and systolic blood pressure ≥ 140 mmHg. Neither ACEI nor ARB is
      administrated in recent 6 months. None has significant concomitant systemic diseases such as
      active infection, malignancy, hepatic or significant renal dysfunction at the time of
      enrollment (i.e. total bilirubin > 3 mg/dl，ALT > 2.5 times the upper limit of normal range
      and creatinine > 3 mg/dl in our hospital). Information regarding smoking, hypertension,
      hyperlipidemia as well as history of cardiovascular disease is obtained from all subjects. No
      other medication will be modified during the study period. After enrollment, patients are
      assessed to (1) olmesartan (20 mg per day, with titration), (2) life modification/exercise
      training for 12 weeks. Vascular function and exercise capacity studies, and peripheral blood
      testing are performed at baseline and at 12- week follow-up. Data are collected as mean ± SD
      showing comparison between groups by use of 2-sample t test and chi-square analysis for
      continuous and categorical variables, respectively. Adjust for the HbA1c level will be
      adjusted using simple adjustment method (ANCOVA or equivalent regression analysis) while
      doing the data analysis. Changes between baseline and follow-up measurements are assessed by
      paired t test. The frequencies of adverse effects between groups will also be comparing by
      2-sample t test. A p value <0.05 is defined as statistically significant.
    

Intervention name(s): olmesartan
Intervention type(s): Drug
Intervention description(s): (1) Olmesartan treatment or (2) Life modification and exercise training
Intervention MeSH terms: Olmesartan
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with diabetes melitus and hypertension
      
Biospecimen description: 
      serum
    
Keywords: Angiotensin receptor II antagonist
The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial
Condition: Plaque, Dental
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      Objectives:

      to evaluate the effect of brushing with Salvadora persica (Miswak) on streptococcus mutants
      compared to brushing with fluoridated tooth paste (FTP) in children.

      Methods:

      A total of 94 healthy children (8 years old) from an elementary governmental school in
      Jeddah, Saudi Arabia were grouped to Miswak and FTP groups. They were assessed for their
      salivary level of mutans streptococci species, and lactobacillus at the baseline and three
      weeks after brushing. Caries level using DMFT/dmft, and plaque amount using Greene Vermillion
      simplified oral hygiene index were recorded.
    


Intervention name(s): brushing
Intervention type(s): Combination Product
Intervention description(s): mechanical and chemical plaque removal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effectiveness of Telescopic Magnification in the Treatment of Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Amblyopia is a visual impairment of one eye that results from disuse of that eye during early
      brain development. The standard treatment for amblyopia consists of patching or
      pharmacological penalization of the sound eye. Unfortunately, approximately 50% of amblyopic
      children do not respond to these therapies, with poor compliance being a major factor in
      treatment failure. One new treatment strategy involves patching the sound eye while using a
      telescopic device on the amblyopic eye to magnify the images formed in the amblyopic eye.
      Children were randomized to receive either daily patching of the sound eye for 30 minutes
      only (patching only group), or daily patching of the sound eye for 30 minutes plus
      simultaneous use of a telescopic device by the amblyopic eye during patching (patching plus
      telescope group).
    

Detailed description: 
      The goal of the present investigation was to conduct a prospective randomized clinical study
      to further evaluate the effectiveness of telescopic magnification plus patching vs patching
      alone on different types of amblyopia in patients who had failed previous treatment.
    

Intervention name(s): Patching; Telescopic magnification
Intervention type(s): Other; Other
Intervention description(s): Patching of the sound eye for 30 minutes a day for 17 weeks.; Patching of the sound eye plus simultaneous use of a telescopic device by the amblyopic eye for 30 minutes a day for 17 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amblyopia; Telescopic magnification; Patching
Effect of Antenatal Education on Fear of ChildBirth
Condition: Fear of Childbirth; Stress
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of antenatal education on birth fear,
      depression, anxiety, stress, maternal self-efficacy, and mode of delivery in primiparous
      pregnant women
    

Detailed description: 
      There is still a lack of evidence regarding the effects of antenatal education on birth fear,
      maternal self-efficacy, anxiety, stress, depression, and mode of delivery. Therefore, this
      study aimed to investigate the effects of antenatal education on birth fear, anxiety, stress,
      depression, maternal self-efficacy, and mode of delivery
    

Intervention name(s): Education
Intervention type(s): Other
Intervention description(s): education
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: antenatal education; fear of childbirth; depression, anxiety; stress; maternal self-efficacy; mode of delivery
Hostile Interpretation Bias Training to Treat Irritability
Condition: Irritable Mood; Mood Disorders
MeSH terms: Mood Disorders
Study type: Interventional

Summary: 
      Hostile interpretation bias may be a feature of severe, chronic irritability in children, one
      of the most common psychiatric symptoms of childhood. Interpretation bias training (IBT) is a
      computer-based training program that may reduce irritability in youths. This trial lays the
      groundwork for a test IBT on irritability.
    

Detailed description: 
      This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by
      establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response
      in the neural threat-learning system.

      The design is a single-blinded, randomized controlled trial of IBT on its targets. The study
      will have four arms, with 25 participants in each arm for all four conditions of training
      (active versus sham) and scanning (in MRI or out of MRI scanner). During IBT, participants
      judge as happy or angry facial expressions which are on a continuum between happy and angry.
      The point at which judgments shift from predominantly happy to angry on this continuum is the
      indifference point. During training feedback encourages no change in the indifference point
      or a change in the indifference point towards more happy judgments of ambiguous faces. A
      shift in indifference point towards more benign judgments is interpreted as a reduction in
      hostile interpretation.

      The design will test whether active relative to sham IBT shifts the indifference point
      towards more benign judgments. Neural response to active versus sham IBT will be measured in
      half the sample.
    

Intervention name(s): IBT
Intervention type(s): Device
Intervention description(s): Interpretation bias training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia
Condition: Insomnia
MeSH terms: HIV Seropositivity; Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test two study drugs, one of which is temazepam (15mg) and
      one of which is a placebo (an inactive substance that looks just like the temazepam), to see
      if insomnia (trouble sleeping) can be reduced in patients with HIV infection. Placebos are
      given in research studies to try and make sure that subjects are responding to the effects of
      the study drug and not to other factors, like the attention they are receiving. If you decide
      to take part in this study, you will take 1 capsule of study drug every night approximately
      30 minutes before bedtime for approximately 12 weeks.

      This study is to test the study drug called temazepam for the treatment of insomnia (trouble
      sleeping) in patients with HIV infection. Temazepam has been approved by the FDA for the
      treatment of insomnia. However, because this study requires treatment for 12 weeks instead of
      the 7 to 10 days approved by the FDA, the use of temazepam is considered to be
      investigational in this study.
    


Intervention name(s): Temazepam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Temazepam 15 mg orally at bedtime
Intervention MeSH terms: Temazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; HIV
2-part Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of CC-220 & Effect of Food on CC-220 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral
      dose of CC-220 and to explore the effect of food on the bioavailability of CC-220 in healthy
      subjects
    

Detailed description: 
      This is a 2-part study to be conducted at a single study center. Part 1 is a randomized,
      double-blind, placebo-controlled, ascending-dose study. During the course of Part 1, each
      subject will participate in a screening phase, a baseline phase, a treatment phase and a
      follow-up visit. There will be a total of 7 cohorts, each of which consists of a different
      dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of
      CC-220 and 2 subjects will receive placebo depending on the randomization schedule. A single
      dose will be administered to each subject. This study design allows safety and tolerability
      data to be gathered in a stepwise fashion. Administration of study drug at the next higher
      dose level will not begin until the safety and tolerability of the preceding dose have been
      evaluated and deemed acceptable by the investigator and sponsor's medical monitor. Part 2 is
      an open-label, randomized, 2-period, 2-way crossover study. During the course of Part 2, each
      subject will participate in a screening phase, a baseline phase in each study period, a
      treatment phase in each study period and a follow-up visit. A total of 10 subjects will
      receive a single dose of 1 mg CC-220 in each of 2 study periods, once without food and once
      with food, depending on the treatment sequence to which they are randomized. The CC-220 dose
      in each study period will be separated by a washout of 11 to 14 days.
    

Intervention name(s): CC-220 0.03 mg; CC-220 0.1 mg; CC-220 0.3 mg; CC-220 1 mg; CC-220 2 mg; Placebo; CC-220; CC-220; CC-220
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A single dose of CC-220 0.03 mg will be administered orally once a day.; A single dose of CC-220 0.1 mg will be administered orally once a day.; A single dose of CC-220 0.3 mg will be administered orally once a day.; A single dose of CC-220 1 mg will be administered orally once a day.; A single dose of CC-220 2 mg will be administered orally once a day.; A single dose of placebo will be administered orally once a day.; CC-220 4 mg will be administered orally once a day; CC-220 6 mg will be administered orally once a day; CC-220 1 mg will be administered orally once a day in each of 2 study periods - once with food and once without food
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Safety; Pharmacokinetics; Food effect; Healthy subjects
Efficacy and Safety of Buspirone, Sustained-release Tablets, 15 mg in Patients With Autonomic Dysfunction Syndrome Accompanied by Vertigo
Condition: Vertigo; Autonomic Dysfunction
MeSH terms: Vertigo; Autonomic Nervous System Diseases; Primary Dysautonomias; Dizziness
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to evaluate the efficacy and safety of Buspirone, sustained-release tablets, 15 mg in
      patients with autonomic dysfunction syndrome accompanied by vertigo
    


Intervention name(s): Buspirone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet (15 mg) once per day for 28 days; 1 placebo tablet once per day for 28 days
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate the Effect of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of Mitapivat Sulfate (AG-348) in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1 of this study will determine the effect of multiple-dose itraconazole, a strong
      cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) inhibitor, on the single-dose
      pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants. Part 2 of this
      study will determine the effect of multiple-dose rifampin, a strong CYP3A4 and P-gp inducer,
      on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult
      participants.
    

Detailed description: 
      This study consists of 2 periods and 2 parts. Participants will be placed in Part 1 or Part
      2, and cannot participate in both:

      Part 1, Period 1 includes a screening period up to 28 days prior to dosing and treatment on
      Day 1.

      Part 1, Period 2 includes a treatment period from Day 1 to Day 9 and a possible follow-up, up
      to 28 days after the last dose of study drug.

      Part 2, Period 1 includes a screening period up to 28 days prior to dosing and treatment on
      Day 1.

      Part 2, Period 2 includes a treatment period from Day 1 to Day 12 and a possible follow-up,
      up to 28 days after the last dose of study drug.
    

Intervention name(s): itraconazole; rifampin; mitapivat sulfate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive an oral solution as described in the arm description.; Participants will receive oral capsule(s) as described in the arm description.; Participants will receive an oral tablet as described in the arm description.
Other intervention name(s): AG348
Intervention MeSH terms: Itraconazole; Rifampin; Mitapivat
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to test safety tolerability and PK of single oral ascending doses of
      PF-06305591,
    


Intervention name(s): PF-06305591; Placebo; PF-06305591; Placebo; PF-06305591; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose, solution; matching placebo; single dose, solution; matching placebo; single dose, solution; matching placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Improvement of STI Detection in Adolescent Emergency Department Patients
Condition: Sexually Transmitted Infections
MeSH terms: Sexually Transmitted Diseases; Emergencies
Study type: Interventional

Summary: 
      The goal of this trial is to test a novel means of collecting patient-entered sexual health
      information for the provision of clinical decision support to increase the testing and
      detection of sexually transmitted infections (STI) in adolescent emergency department (ED)
      patients at high risk for STIs.
    

Detailed description: 
      The investigators have developed a novel means of collecting sexual health information from
      adolescents in the emergency department (ED) through the use of an audio-computer assisted
      self-interview (ACASI). This information can then be used to provide clinical decision
      support to clinicians for targeted sexually transmitted infection (STI) screening in the ED
      for adolescents. This randomized trial randomizes patients to whether or not the clinician
      receives the decision support and tests whether provision of decision support results in
      increased STI screening for patients who report high risk sexual activity. Secondary outcomes
      include evaluation of whether the clinical decision support results in increased STI
      detection, and identifying factors associated with adapting the clinical decision support.
    

Intervention name(s): Sexual health screen (SHS)
Intervention type(s): Behavioral
Intervention description(s): Decision support for STI screening through a novel sexual health screen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension
Condition: Uncontrolled Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized,
      controlled study of the safety and effectiveness of renal denervation in subjects with
      uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity
      Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal
      surface of the renal artery.
    

Detailed description: 
      The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized,
      controlled study of the safety and effectiveness of renal denervation in subjects with
      uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity
      Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal
      surface of the renal artery.
    

Intervention name(s): Renal denervation (Symplicity Catheter System); Renal angiogram
Intervention type(s): Device; Diagnostic Test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: uncontrolled hypertension; renal denervation