bioihbjkbjnl/mcl2 huggingface dataset:
Pivot Breath Sensor Performance Study
Condition: Smoking Cessation; Smoking, Tobacco
Study type: Interventional

Summary: 
      A clinical study enrolling 70 subjects to:

        -  evaluate the user performance of the Pivot Breath Sensor

        -  compare measurements from the Pivot Breath Sensor to a similar device

        -  assess user documentation comprehension

        -  obtain feedback on the Pivot Breath Sensor via rating scales. No medical decisions will
           be made related to test results.
    

Detailed description: 
      The objectives of this performance study are to:

        -  Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study
           subjects using two different types of measurement devices.

        -  We will assess the correlation between the measured CO levels (in parts per million, or
           ppm) of the study CO breath sensor (Carrot Inc.) and a similar device.

        -  assess user documentation comprehension

        -  obtain feedback on the Pivot Breath Sensor via rating scales.
    

Intervention name(s): Pivot Breath Sensor System; Similar Carbon Monoxide breath sensor system
Intervention type(s): Device; Device
Intervention description(s): Collect breath sample from the Pivot Breath Sensor to measure the carbon monoxide in the participant's exhaled breath, along with recording responses to user documentation questions and rating scales.; Collect breath sample from a similar breath sensor to measure the carbon monoxide in the participant's exhaled breath.
Intervention MeSH terms: Carbon Monoxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Reinforcing Value of Added Sugars
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine how daily diet relates to eating choices.
    

Detailed description: 
      Despite the long-term emphasis on reducing intake of and added sugar, this behavioral change
      has been hard to instill amongst most of the population. Foods with added sugars are highly
      reinforcing and, as such, reducing their consumption in order to adhere to the dietary
      guidelines (DGA) may be difficult to maintain. Sugar produces effects similar to some drugs
      of abuse such as increased extracellular dopamine release in the nucleus accumbens shell
      resulting in a reinforcing effect. Reducing any reinforcing behavior can be challenging, but
      in terms of food, it is not known whether the reinforcing value of foods high in added sugar
      increases when access to these foods is reduced. If so, this would present a mechanistic
      barrier to meeting the DGA and making dietary changes in general. That the reinforcing value
      of a behavior (e.g., eating sugar) will be increased when the rate of that behavior is
      decreased has strong theoretical underpinnings in the "Disequilibrium Approach". This theory
      predicts that the circumstances of reinforcement are created or limited by changing baseline
      access. According to the Disequilibrium Approach, a response deficit will result in an
      increase in reinforcement. Applied to the proposed study, the Disequilibrium Approach would
      predict that lowering the consumption of dietary added sugar would increase the reinforcing
      value of foods high in added sugar. The Disequilibrium Approach has accurately predicted an
      increase in the relative reinforcing value (RRV) of snack foods among children. However,
      dietary changes would need to occur at the whole diet level for adults and children to meet
      the DGA for reducing added sugar intake. It is important to know if reducing added sugars at
      the whole-diet level results in increases in the reinforcing value of foods high in added
      sugars.
    

Intervention name(s): Low Added Sugar Diet
Intervention type(s): Other
Intervention description(s): 1-week intake of Low Added Sugar Diet 3 day rotating menu
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Cytokines of Patients With Transversus Abdominis Plane Block After Laparoscopic Colonic Surgery
Condition: Laparoscopic Colonic Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators designed a study to determine whether with combined general-transversus
      abdominis plane block anesthesia or standard general anaesthetic would provide same level of
      cytokines in patients undergoing Laparoscopic Colonic Surgery.
    

Detailed description: 
      The investigators designed a study to determine whether combined general-transversus
      abdominis plane block anesthesia or standard general anaesthetic would provide same level of
      cytokine in patients undergoing Laparoscopic Colonic Surgery.
    

Intervention name(s): transversus abdominis plane block; transversus abdominis plane block
Intervention type(s): Drug; Drug
Intervention description(s): transversus abdominis plane block with 20 mL saline; transversus abdominis plane block with 20 mL 0.25% ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cytokine Transversus Abdominis Plane Block
Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes
Condition: Patellofemoral Disorder; Anterior Knee Pain
MeSH terms: Patellofemoral Pain Syndrome
Study type: Interventional

Summary: 
      This study aims to investigate the effects of electromyography biofeedback (EMG-BF) guided
      isometric quadriceps strengthening with patellar taping and isometric exercise alone in young
      adult male athletes with patellofemoral pain syndrome (PFPS).
    

Detailed description: 
      A total of 60 adult male athletes aged 18 to 45 years will be recruited from two cities
      (Majmaah and Riyadh) of Saudi Arabia. Subjects will be included with the history of knee pain
      during activities such as descending and ascending stairs, squatting, and running, had
      positive J sign (lateral tilt of patella), and a sign of patellar malalignment on the
      radiograph. Individuals with the history of fracture around knee, patella dislocation, knee
      deformity (e.g., genu varum), flexion contracture, ligaments/meniscal injuries, and
      osteoarthritis of knee will be excluded from the study. The protocol was submitted to and
      approved by the ethical sub-committee of College of applied medical science, Majmaah, Saudi
      Arabia (Ethics number: MUREC-Nov./COM-2O20/11-2). Participants will be requested to sign a
      written informed consent form approved by the institution ethics committee.

      Participants will be randomly assigned to Group A (experimental group): electromyography
      biofeedback (EMG-BF) guided maximum voluntary isometric contraction exercise with patellar
      taping; Group B (control group): sham EMG-BF guided maximum voluntary isometric contraction
      without patellar taping. The outcome measure for this study will be the mean changes in
      maximum voluntary isometric contraction (MVIC) of the quadriceps muscle, pain intensity, and
      functional status up to 6 weeks.
    

Intervention name(s): Electromyography biofeedback (EMG-BF); Sham electromyography biofeedback (EMG-BF)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training with patellar taping; Participants in this group will receive Sham electromyography biofeedback (EMG-BF) guided strength training without patellar taping
Other intervention name(s): Patellar Taping
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental: Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training along with patellar taping
No Intervention: Control: Participants in this group will receive Sham EMG-BF guided strength training without patellar taping
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Strength; Function; PFPS; Athletes; Young adults
Glycemic Response in Persons With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This will be a randomized crossover design. The subjects will be randomized to one of six
      interventions on six separate study days, one week apart.
    


Intervention name(s): Oral Nutrition Supplement
Intervention type(s): Other
Intervention description(s): Product intake of oral nutrition supplement provided
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
Masking: Single (Participant)
Primary purpose: Supportive Care
Trident® X3 Polyethylene Insert Study
Condition: Arthroplasty, Replacement, Hip
Study type: Interventional

Summary: 
      The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3
      polyethylene insert are superior to a polyethylene control group wear rate at 5 years
      postoperative. This measurement will be evaluated by comparing digitized images of serial
      radiographs obtained over a follow-up period of 5-years.
    

Detailed description: 
      The study is a prospective, multi-center, historical-controlled clinical evaluation of the
      Trident® X3 Polyethylene insert. The device is commercially available in the United States
      where the study is being conducted. The study device, the Stryker Orthopaedics Trident® X3
      polyethylene insert, is used for the replacement of the bearing surface of the acetabulum to
      relieve pain, instability, and the restriction of motion due to degenerative bone disease,
      including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. The
      control device, the Stryker Orthopaedics N2VAC polyethylene insert, is also used for the
      replacement of the bearing surface of the acetabulum to relieve pain, instability, and the
      restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid
      arthritis, trauma, or failure of other devices.
    

Intervention name(s): Trident® X3 Polyethylene Insert
Intervention type(s): Device
Intervention description(s): Trident® X3 Polyethylene Insert
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of TAK-831 versus placebo on upper
      extremity (arm and hands) motor function and manual dexterity. This study will also evaluate
      the efficacy of TAK-831 versus placebo on activities of daily living (ADL) and other
      secondary assessments.
    

Detailed description: 
      The drug being tested in this study is called TAK-831. TAK-831 is being tested to treat
      people who have Friedreich ataxia. This study will look at upper extremity (arms and hands)
      motor function and manual dexterity of people who take TAK-831. Efficacy evaluations also
      include other neurological, functional, and patient performance assessments.

      The study will enroll approximately 65 participants. Participants will be randomly assigned
      in a 2:1:2 ratio to one of the three treatment groups-which will remain undisclosed to the
      participant and study doctor during the study (unless there is an urgent medical need):

        -  TAK-831 High dose

        -  TAK-831 Low dose

        -  Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
           no active ingredient

      All participants will be asked to take three tablets of high dose, low dose, or placebo twice
      a day for 12 weeks.

      This multi-center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 13 weeks. Participants will make 5 visits to the
      clinic, and will be contacted by telephone for an exit interview no later than 7 days after
      their final visit or termination. Participants will also receive a safety follow-up phone
      call 7 to 17 days after receiving their last dose of TAK-831.
    

Intervention name(s): TAK-831; TAK-831 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-831 tablets; TAK-831 placebo matching tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy
Home-based Proprioceptive Neuromuscular Facilitation for Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus; Exercise
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In this research work, the concept of strengthening technique of proprioceptive neuromuscular
      facilitation (PNF) incorporated with tendon gliding exercise (TGE) will be used to improve
      neuromuscular function of upper extremity of patients with diabetes mellitus. The first
      specific aim of the study is to examine the effects of home-based PNF exercise on the motor,
      sensation and functional performance parameters of upper extremity of the patients with
      diabetes mellitus. In addition, whether adding a tendon gliding exercise (TGE) to the
      home-based PNF exercises can provide better treatment effects for the patients with diabetes
      mellitus will also been investigated in this study. One of the hypothesis of this study is
      the prescribing home-based PNF exercise program has a positive treatment effect on
      neuromuscular function of the upper extremity of patients with diabetes mellitus. And,the
      other is home-based PNF in conjunction with TGE provides better benefits for neuromuscular
      function of the upper extremity of patients with diabetes mellitus.
    


Intervention name(s): lifestyle changes
Intervention type(s): Behavioral
Intervention description(s): Providing a home-based exercise program supervised by therapists can be an acceptable strategy with the characteristics of convenience and inexpensiveness to promote neuromuscular and functional component for the patients with diabetes mellitus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Biological Standardization of Platanus Acerifolia Allergen Extract
Condition: Allergy to Platanus Acerifolia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the biologic activity of a Platanus acerifolia
      allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house
      reference preparation (IHRP).
    

Detailed description: 
      This is an open, unblinded and non-randomized biological assay. The study design is a slight
      modification of the recommendations proposed by the Nordic Guidelines.

      Four concentrations of Platanus acerifolia allergen extract, together with a positive and
      negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol
      saline solution, respectively, will be tested in every patient in duplicate on the volar
      surface of the forearm.
    

Intervention name(s): Prick test Platanus acerifolia allergen extract
Intervention type(s): Biological
Intervention description(s): This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.
Four concentrations of Platanus acerifolia allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test.
Other intervention name(s): Platanus acerifolia allergen extract.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: skin prick test; inmunotherapy; standarization
Caudal Block Versus Local Wound Infiltration for Inguinal Procedures
Condition: Anesthesia, Caudal
Study type: Observational

Summary: 
      Single-centre observational study to analyse whether there is a difference in post-operative
      pain scores and set up time when comparing caudal block with local wound infiltration
    

Detailed description: 
      Inguinal procedures in children are surgical frequently performed in an outpatient setting.
      This study analyzed regional analgesia for inguinal procedures in toddlers comparing caudal
      block with local wound infiltration and assessed post-operative pain scores as well as
      process times.A number of documents were compiled to inform and record data: a standard
      anaesthesia protocol, a documentation sheet for intraoperative recording, an information
      leaflet for the parents and a documentation sheet for the post-operative course of 24 hours .

      Caudal anaesthesia was performed after induction of anaesthesia. In patients getting wound
      infiltration ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the
      fascia transversalis.

      Parents were informed about the study and invited to participate upon arriving on the
      outpatient ward if the patient fulfilled the following inclusion criteria: scheduled for
      elective inguinal procedure, age three to 72 months, no contraindication for either local or
      caudal analgesia, no comorbidities. If parents agreed to participate, written informed
      consent was obtained. Pain score and administration of analgesics, vomiting, interval until
      micturition and interval until mobilization as well as sleep quality during the first
      post-operative night were documented by the parents in the provided booklet.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        outpatient setting

        paediatric inguinal procedures classifeind ASA 1 or 2 perfomed from the department of
        paediatric surgery
      
Keywords: caudal block; wound infiltration; postoperative pain; outpatient surgery
Effects of Tart Cherry Juice on the Body
Condition: Cardiovascular Risk Factors; Age-Related Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Tart cherries are a rich source of antioxidants. Studies have shown that tart cherries exert
      anti-oxidative and anti-inflammatory properties. The purpose of this study is to learn about
      the effects of drinking tart cherry juice on cardiovascular and cognitive health.
    

Detailed description: 
      Thirty-seven older adults were randomly assigned to drink 16 oz per day of either tart cherry
      juice or placebo drink for 12 weeks. Blood and urine samples were collected at baseline and
      12 weeks to assess biomarkers. Physical activity and 3-day diet records were also collected
      throughout the study.
    

Intervention name(s): Tart cherry juice; Placebo
Intervention type(s): Other; Other
Intervention description(s): 16 fl. oz of tart cherry juice; 16 fl. oz of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Regular Swimming, Vascular Function, and Arthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Hypothesis #1: The investigators hypothesize that both swimming training and cycling training
      will demonstrate significant improvements in endothelium-mediated vasodilation and central
      artery compliance in this population and that there will be no difference in the magnitude of
      increases between the water-based and land-based exercise interventions.

      Hypothesis #2: The investigators hypothesize that the improvements in endothelium-dependent
      vasodilation and arterial compliance in response to exercise training interventions will be
      related to the corresponding reductions in inflammatory biomarkers.

      Hypothesis #3: The investigators hypothesize that both swimming exercise and cycling exercise
      will improve functional capacities and disease progression in middle-aged and older adults
      with osteoarthritis.
    

Detailed description: 
      Middle-aged and older men and women (40-90 years old) of all races and ethnic backgrounds
      will serve as subjects after obtaining their written, informed consent. All the subjects will
      have a radiological diagnosis of osteoarthritis according to American College of Rheumatology
      criteria.
    

Intervention name(s): Exercise Training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
Condition: Insomnia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether dexmedetomidine can be used to induce
      normal physiological sleep in humans.
    


Intervention name(s): Dexmedetomidine; Zolpidem
Intervention type(s): Drug; Drug
Intervention description(s): A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).; 12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine; Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients will receive both interventions in a randomized order.
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The investigators aimed to study the effect of supplementation with species of Lactobacillus
      on anthropometric measurements, body composition, appetite and serum lipid profile in
      overweight and obese adults
    

Detailed description: 
      The Objective of This Study was Evaluating the Effect of supplementation with Species of
      Lactobacillus on anthropometric measurements include weight, waist and hip circumference ,
      body composition include body fat and muscle percent, appetite measured by visual analogues
      scale and serum lipid profile in overweight and obese adults.
    

Intervention name(s): Species of Lactobacillus; lactose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsule a day Lactofem probiotics containing Species of Lactobacillus; 2 capsule a day containing lactose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: probiotics; Lactobacillus; obesity; body composition