bioihbjkbjnl/mcl2 huggingface dataset:
Satiety Effects of Protein and Fiber Added to Pasta
Condition: Food Selection
Study type: Interventional

Summary: 
      The combination of fiber and protein added to pasta will enhance satiety.
    

Detailed description: 
      Subjects will consume 3 different pasta lunches and satiety will be measured by visual
      analogue scales. They will consume an ad lib snack after 3 hours and food intake will be
      measured.
    

Intervention name(s): Pasta with protein; Pasta with Fiber; Pasta
Intervention type(s): Other; Other; Other
Intervention description(s): Pasta with Protein; Pasta with Fiber; Pasta
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Efficacy and Safety of the CollaRx Bupivacaine Implant Compared to the ON-Q Painbuster Following Abdominal Hysterectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the CollaRx Bupivacaine Implant is safe and
      effective in reducing the amount of narcotic pain medication needed to control pain during
      the first 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster Post-op
      Pain Relief System.
    

Detailed description: 
      Hysterectomy is the second most common surgery among women in the United States (US).
      Abdominal hysterectomy surgery may be performed to treat benign tumors, such as fibroids,
      heavy periods, painful periods and chronic pelvic pain. The most common route for performing
      hysterectomy is through an incision in the abdominal wall; however, about 20% are performed
      vaginally.Laparoscopic assisted vaginal hysterectomy is performed when warranted.

      Bupivacaine is a local anesthetic (pain medication) that has an established safety profile.
      Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin
      flat sponge made out of collagen that comes from cattle tendons and contains bupivacaine.
      When inserted into a surgical site, the collagen breaks down and bupivacaine is released at
      the site but very little is absorbed into the blood stream. The high levels of bupivacaine at
      the surgical site may result in less pain for several days after surgery.

      The ON Q system consists of 1 elastometric pump with a fill volume of 270 mL containing 0.25%
      bupivacaine; 1 soaker catheter measuring 12.5 cm in size; and a fill port, tubing, clamp,
      filter and flow restrictor. The pump provides positive pressure and is portable. It may be
      attached to the patient's dressing or placed in a carrying pouch. The catheter is inserted
      directly into the surgical wound providing a continuous flow of bupivacaine into the wound. A
      capillary flow restricting orifice located at the end of the tubing controls the flow rate.

      This study will compare the total narcotic use in patients with the CollaRx Bupivacaine
      Implant with the total narcotic use in patients with the ON Q PainBuster Post op Pain Relief
      System after abdominal hysterectomy.
    

Intervention name(s): Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant); ON-Q PainBuster Post-op Pain relief System
Intervention type(s): Drug; Drug
Intervention description(s): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride; 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL [900 mg])
Other intervention name(s): CollRx Bupivacaine Implant
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Abdominal Hysterectomy; Postoperative pain
Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K
Condition: Vascular Calcification; Systemic and Arterial Stiffness; Complication of Hemodialysis; Deficiency of Vitamin K2
MeSH terms: Vitamin K Deficiency; Calcinosis; Vascular Calcification
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study will seek to evaluate the prevalence and the progression of vascular
      calcification in a cohort of maintenance hemodialysis patients in Asian population. It will
      also evaluate the efficacy of vitamin K 2 supplementation in reducing the progression of
      vascular calcification in this group of patients.

      This will be a single-center randomized, prospective and open-label interventional clinical
      trial of end stage renal failure patients on hemodialysis.Primary outcome will be absolute
      difference in coronary artery calcium (CAC) score at 18-month between control and
      intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve
      calcification, percentage of patients with regression of coronary artery calcification of at
      least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any
      cause and major adverse cardiovascular events (MACE) over the same period.
    


Intervention name(s): menaquinone-7
Intervention type(s): Drug
Intervention description(s): Oral supplement given post dialysis 3x/week
Intervention MeSH terms: Vitamin K 2; Vitamin K; Menaquinone 7
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interactive Effects of Mindfulness and Slow-paced Breathing
Condition: Stress; Stress, Psychological; Stress Physiology; Sleep; Slow Breathing
MeSH terms: Respiratory Aspiration; Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to better understand specific stress-management practices on
      mood, sleep, and physiology. Participants will be assigned to one of three interventions
      (they all active interventions - none are a "wait-list"). Each intervention asks participants
      to engage in a daily practice of 20 minutes per day for 8 weeks. Questionnaires and measures
      of heart rate and blood pressure will be collected at the start and end of the 8 weeks,
      including a virtual laboratory visit.
    

Detailed description: 
      Slow-paced breathing (SPB), mindfulness (M), and their combination (SPB+M) in the form of
      yoga, yogic breathing, Tai Chi, Qigong, and other practices are considered distinct forms of
      intervention, yet are often considered inextricably linked and overlapping in their effects
      on the autonomic nervous system. Although the scientific community continues to build
      understanding of autonomic mechanisms that might be unique to SPB, M, and their interaction
      (SPB+M), no studies we are aware of have attempted to directly compare these three forms of
      intervention in a controlled fashion that enables a 'dismantling' framework of
      interpretation.

      The goal of this pilot project is to compare the separate and combined effects of SPB and M
      on autonomic function. We will test the feasibility of a three-arm intervention trial (N=5
      per group), involving 20-min daily practice for 8 weeks, with multimodal ambulatory autonomic
      measurement before and after intervention. We will first focus on a healthy young adult
      population to then inform translation to hypertension, insomnia, and other clinical groups.

      Aim 1: Distinguish SPB, M, and SPB+M training in terms of breathing rate and subjective
      mindfulness.

      Aim 2: Obtain pilot data comparing the three interventions in terms of autonomic regulation
      using both conventional metrics and non-linear dynamics.

      Aim 3: Develop methods to examine relationships across domains of autonomic regulation,
      stress, and sleep for the three interventions.
    

Intervention name(s): Slow-Paced Breathing (SPB); Mindfulness (M); Yogic Breathing (SPB+M)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): see arm description; see arm description; see arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: stress; slow-paced breathing; breath training; mindfulness; yogic breathing; wellness; stress-management
A Relative BioavailabilityStudy Of Ibuprofen 40mg/ml (laboratórios Pfizer Ltda) In The Oral Suspension Form.
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      A PHASE IV, OPEN LABEL, RANDOMIZED, TWO-WAY CROSSOVER, SINGLE DOSE STUDY TO DETERMINE THE
      RELATIVE BIOAVAILABILITY OF IBUPIRAC 40MG/ML (LABORATÓRIOS PFIZER LTDA) ORAL SUSPENSION FORM
      VERSUS ALIVIUM® 50MG/ML (MANTECORP INDÚSTRIA QUÍMICA E FARMACÊUTICA LTDA.) ORAL SUSPENSION
      FORM, UNDER FASTED CONDITIONS IN HEALTHY VOLUNTEERS.
    


Intervention name(s): Alivium®; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): 400mg of Ibuprofen equivalent to 8mL (50mg/mL) oral suspension of the Reference Drug; 400mg of Ibuprofen equivalent to 10mL (40mg/mL) oral suspension of the Test Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Relative Bioavailability Study; Ibuprofen; Alivium
Feasibility Study of the Taïso Practice in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This is a pilot study of descriptive and analytical, prospective feasibility, monocentric,
      longitudinal with 6 months of bi-weekly practice of Taïso in patients with Parkinson's
      disease with mild to moderate postural instability.

      The intervention is planned over 6 months (25 consecutive weeks) for the whole project of the
      patient group. Patients are included in the month before the start of the treatment of the
      intervention. Four standardized evaluation sessions are conducted: a first evaluation during
      the first week of Taiso and then every 8 weeks (2 months, 4 months and 6 months). Incident
      collection and fitness assessment tests are performed by the physical trainer while the
      balance and are performed by a physiotherapist. The quality of life assessment and the
      MDS-UPDRS II rating are performed during the inclusion visit and then the final study visit
      (within 2 weeks) after 6 months of practice) with the coordinating neurologist. An evaluation
      of incidents is also carried out during this end-of-study visit.
    


Intervention name(s): Taïso
Intervention type(s): Other
Intervention description(s): Taiso is a physical preparation practice of which the French Judo Federation is a state delegate. It is practiced in most French dojos. During each course, Taiso's practice works the fundamental motor skills (coordination, static and dynamic balance, locomotion and grip), muscle strengthening, target work by simulated attacks-defenses exercises without blows or projections, relaxation and the specific work of knowledge to fall and rise with graduation and progressivity in the intensity and complexity of the exercises as and when practiced.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Taïso; Physical therapy; Exercice therapy; Parkinson disease
Omega-3 Fatty Acids in Adolescent Depression
Condition: Adolescent Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of
      adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of
      omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1)
      change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the
      end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end
      of 10-week treatment.

      Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant
      reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at
      the end of treatment compared to placebo.
    

Detailed description: 
      Title: Omega-3 Fatty Acids in Adolescents with Depression

      NOTE: No individual will be advised to terminate ongoing treatment. If adolescents have been
      in psychotherapy prior to their entry in the study, they will be allowed to continue with the
      treatment. However, psychotherapy cannot be initiated at the time of entry into the study.

      Aim: To provide preliminary clinical data about the efficacy of omega-3FA (derived from fish
      oil) in the treatment of adolescent MDD. A NCCAM/NIH-funded study.

      Summary: Informed consent will be obtained from parent/guardian and assent obtained from
      participant. Interested participants will have a free diagnostic evaluation by study
      psychiatrist to determine eligibility. Routine blood tests and a urine pregnancy test will be
      obtained. Eligible participants will be randomized to receive either omega-3FA or matching
      placebo (corn oil) for 10 weeks. Patients will be seen weekly throughout the trial. Dosage
      will be titrated based on clinical response and side effects. At end of double-blind phase,
      participants will be referred to a clinician who will be informed of subjects' treatment.
      Depending on treatment received during double-blind phase, post-study treatment options will
      include treatment with omega-3 fatty acids or an SSRI.
    

Intervention name(s): Omega-3 Fatty Acids; corn oil
Intervention type(s): Drug; Drug
Intervention description(s): 10 wk treatment period; placebo comparator
Other intervention name(s): fish oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescents; Depression; Fish Oil; Omega-3 Fatty Acids; Psychiatry
Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The aims this study is to explore the effect of a GLP-1 receptor agonist on the degree of
      brain activation and connectivity obtained by functional magnetic resonance imaging in lean
      and obese type 2 diabetes
    

Detailed description: 
      Fifteen lean [BMI(body mass index) less than 23 kg/m2] type 2 diabetes subjects and fifteen
      obese (BMI more than 26 kg/m2) subjects with type 2 diabetes treated by diet and/or
      metformin, SU(sulfonylurea), DPP4-inhibitors(Dipeptidyl peptidase-4 inhibitor) will be
      recruited. Every subject will be studied on 2 separate days in random order with 1-2 week
      intervals. These participants will be injected either normal saline or 10 mcg of lixisenatide
      in a cross-over fashion. Neuroimaging composed with resting-12-min, visual stimulation
      task-12-min, T1-5-min, and diffusion tensor image-12-min will be proceeded. Ad lib buffet
      will be provided to every participant and the intake will be measured. Surveys about appetite
      and mood will be done before and after neuroimaging test and buffet eating.
    

Intervention name(s): Lixisenatide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Colorless, transparent liquid contained in a glass prefilled syringe pen-like injection (GLP-1 receptor agonist); Normal saline injection before performing fMRI
Other intervention name(s): Lyxumia® pen injection; Normal saline injection
Intervention MeSH terms: Lixisenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: lean/obese diabetes mellitus; functional MRI; GLP-1; appetite; activation of brain; connectivity
Bedrest, Feeding Pattern, and Insulin Sensitivity
Condition: Atrophy, Disuse; Insulin Resistance
MeSH terms: Muscular Disorders, Atrophic; Insulin Resistance
Study type: Interventional

Summary: 
      In the present study, the investigators will assess the impact of two different feeding
      patterns (continuous vs intermittent) on insulin sensitivity and muscle mass following
      bedrest.
    

Detailed description: 
      In the present study, the investigators will assess the impact of two different feeding
      patterns on insulin sensitivity and muscle mass following bedrest. Healthy, young males will
      be fed in a continuous (no breaks in food supply) or intermittent (in boluses throughout the
      day) manner.
    

Intervention name(s): Intermittent feeding pattern; Continuous feeding pattern
Intervention type(s): Other; Other
Intervention description(s): Intermittent feeding; Continuous feeding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study To Examine Effect Of CP-866,087 On Consumption And Craving Of Alcohol In Alcohol Dependent Subjects.
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      Test the hypothesis that increasing doses of CP-866,087 will decrease the total number of
      drinks consumed during a 2 hour acute alcohol consumption assessment and to determine the
      safety and tolerability of multiple doses of CP-866,087 in alcohol dependent subjects
      compared to placebo.
    


Intervention name(s): CP-866,087
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of 60-days Saccharomyces Boulardii and Superoxide Dismutase Supplementation in Obese Adults
Condition: Obesity; Superoxide Dismutase
Study type: Interventional

Summary: 
      In animals it has been demonstrated that Saccharomyces boulardii decrease low-grade
      inflammation and fat mass; also Superoxide Dismutase (SOD) decrease low-grade inflammation.
      Therefore, the aim of this double-blind, placebo-controlled clinical trial was to assess the
      effect of a 60-days S. boulardii and SOD supplementation on circulating markers of
      inflammation, body composition, hunger sensation, pro/antioxidant ratio, hormonal, lipid
      profile, glucose, insulin and HOMA-IR, in obese adults (BMI 30-35 kg/m2).
    


Intervention name(s): Saccharomyces boulardii and SOD; Placebo
Intervention type(s): Dietary Supplement; Combination Product
Intervention description(s): A complex of 250 mg of Saccharomyces boulardii and 500 IU SOD to be assumed twice/day for 8 weeks at mealtimes; A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bringing Relief to Adolescents Naturally Using Melatonin for Migraine
Condition: Migraine in Adolescents
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Migraine in adolescents is common and effective and safe preventive treatments are needed.
      This is a pilot randomized controlled trial of melatonin versus placebo for migraine
      prevention in adolescents 12-17 years old.
    

Detailed description: 
      This is a pilot randomized controlled trial of melatonin vs. placebo for migraine prevention
      in adolescents 12-17 years old. The main goal of this pilot study is to estimate variance in
      the outcome measures to help with planning the future fully powered study. Participants will
      have an in person enrollment visit, followed by phone follow up visits and headache diary
      data collection via smart phone or internet.
    

Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Taken at 9 PM or 1 hour before bedtime, whichever is earlier; Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier
Other intervention name(s): Rugby melatonin
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic Fibrosis
Condition: Healthy Volunteers
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and
      digestive system, significantly impairing the quality of life, with those affected having a
      median age of death at 40. The main objectives of this study are to assess the safety and
      pharmacokinetics of the combination therapy of galicaftor/navocaftor/ABBV-576.
    


Intervention name(s): Galicaftor; ABBV-576; Navocaftor; Midazolam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral; Oral; Oral; Oral
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Galicaftor; Navocaftor; ABBV-576; Cystic Fibrosis
Anesthetic Efficacy of PECS II Block and Parasternal Block
Condition: Anesthesia, Local
Study type: Interventional

Summary: 
      The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during
      quadrantectomy with or without axillary dissection, in breast cancer surgery
    

Detailed description: 
      All patients receive Pecs II block and parasternal block, under ultrasound guidance. Pecs II
      block, performed at the 4th rib level, and parasternal block performed at the level of the
      2nd and 4th intercostal space level. Data on the anesthesia, side effects and pain, will be
      recorded
    

Intervention name(s): Pecs II block and parasternal block
Intervention type(s): Procedure
Intervention description(s): The Pecs II block will be performed under ultrasound guidance, at fourth rib level, on the axillary line, into the fascial plane between pectoralis minor muscle and serratus muscle. The parasternal block will be performed under ultrasound guidance, at the second and fourth intercostal space, between the pectoralis major muscle and the intercostal muscles, near to the external intercostal membrane.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment