bioihbjkbjnl/mcl2 huggingface dataset:
Investigating the Effects of a High GI Versus a Low GI Diet on Hepatic Metabolism and Satiety Levels in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of a one week high versus low glycaemic
      index dietary intervention on hepatic glycogen and lipid levels and blood hormone levels in a
      two way cross overs study and to see if there is any correlation between this and satiety or
      appetite.
    

Detailed description: 
      8 Healthy subject will be scanned the start and end of a 7 day high versus low glycaemic in
      diet with a 4 week washout between arms. During scan days the hepatic glycogen response to a
      corresponding high versus low glycaemic index test meal will be measured using 13C Magnetic
      resonance spectroscopy (MRS) to explore any acute changes in metabolic response. Baseline
      liver lipid levels will be measured using 1H MRS to explore any long term changes in liver
      lipid levels.

      Blood samples will also be obtained throughout the test day to measure for blood glucose,
      insulin and blood hormone response. Satiety surveys will also be taken throughout the test
      day and during the diet week.

      The main hypothesis is that a one week calorie matched Glycaemic index varied diet will
      result in an altered response of liver glycogen levels acutely following a meal and also
      longer term hepatic liver lipid levels. A secondary hypothesis is that there will also be
      associated changes in blood sugar and hormone levels and that all these changes will have an
      effect on satiety levels in subjects.
    

Intervention name(s): High/Low Glycaemic index test breakfast
Intervention type(s): Other
Intervention description(s): High/Low Glycaemic index test breakfast on test days for a High/Low Glycaemic index 7-day diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Glycaemic Index; NAFLD; Glycogen; Liver; Diet
A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786
      (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy
      volunteers.
    


Intervention name(s): AVP-786; AVP-923
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; Healthy Volunteers; deuterated dextromethorphan; deuterated dextromethorphan with quinidine
Comparison of Catheterized and Clean Catch Urine Specimens for Protein/Creatinine Ratio in Preeclampsia Evaluation
Condition: Preeclampsia; Proteinuria; Hypertension; Pregnancy
MeSH terms: Pre-Eclampsia; Proteinuria
Study type: Observational

Summary: 
      The purpose of this prospective study was to examine whether protein/creatinine ratios in
      catheterized urine specimens correlate to clean catch specimens in pregnant patients being
      evaluated for preeclampsia.
    

Detailed description: 
      Preeclampsia is the new onset of hypertension and proteinuria after twenty weeks of gestation
      in pregnant women. The gold standard for evaluation of proteinuria in the diagnosis of
      preeclampsia is a twenty-four hour urine collection. However, single-specimen
      protein/creatinine ratios have been used to detect preeclampsia without the delay and
      inconvenience that a twenty-four hour urine collection would entail. At our institution,
      women are routinely catheterized for urine collection of protein/creatinine ratios because of
      concerns that vaginal contaminants would falsely elevate protein measurement in urine.
      However, no studies have specifically evaluated whether catheterized urine specimens
      correlate to clean catch urine specimens in protein estimation. Thus, the purpose of this
      prospective study was to examine whether protein/creatinine ratios in catheterized urine
      specimens correlate to clean catch specimens in pregnant patients being evaluated for
      preeclampsia.
    

Intervention name(s): urine collection
Intervention type(s): Other
Intervention description(s): clean catch urine collection and catheterized urine collection
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any pregnant woman between the ages of 14 - 50 who is being evaluated for preeclampsia is
        eligible for this study.
      
Keywords: protein/creatinine ratio; clean catch urine; catheterized urine
Paravertebral Block for Breast Surgery
Condition: Breast Cancer
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of paravertebral block in combination with general anaesthesia is studied in a
      double blind fashion.
    

Detailed description: 
      Patients having surgery for breast cancer receive a paravertebral blockade at C8-Th4 with
      either Naropin 0.5% or saline. General anaesthesia is then provided with laryngeal mask
      intubation, propofol infusion and fentanyl i.v. as needed. The effect on postoperative pain
      ([VAS] and fentanyl PCA doses taken) and postoperative nausea and vomiting is recorded.
    

Intervention name(s): paravertebral block
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Sugar Sweetened Beverages (SSB)- Effects on Metabolism
Condition: Metabolism
Study type: Interventional

Summary: 
      The objective of this study is to investigate the impact of sugar sweetened beverages on the
      fat metabolism of healthy young men. It is well known that consumption of beverages sweetened
      with fructose is associated with different health risks such as type 2 diabetes. The present
      study has been designed to dissect differences in the metabolic pathways of fructose and
      glucose, but also metabolic adaptations during fructose, glucose and sucrose diets. During a
      period of seven weeks subjects will consume either fructose, glucose or sucrose sweetened
      beverages or continue their usual drinking habits. During these seven weeks there will be
      different metabolic investigations using stable isotope tracers. First, the rate of lipolysis
      and beta-oxidation will be determined. Second, the rates of fatty acid synthesis will be
      measured. During all examinations there will also be substrate- and energy-utilization
      measurements by indirect calorimetry, blood analysis and morphometric measurements. Based on
      the literature main hypotheses are: Fructose enhances de novo lipogenesis postprandially and
      also in the fasting state significantly more than glucose by enhanced expression of lipogenic
      enzymes. Fructose decreases beta oxidation via downregulation of oxidative enzymes.
    


Intervention name(s): Soft drink consumption
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: sugar sweetened beverages; fructose; lipogenesis; beta-oxidation
A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the efficacy of a range of preladenant doses compared with placebo
      in participants with moderate to severe Parkinson's disease (PD) experiencing motor
      fluctuations and receiving a stable dose of levodopa (L-dopa), as measured by "off" time.
      Participants will continue to receive their stable regimen of L-dopa plus any adjunct
      medications during the study as prescribed by their physician. Several classes of adjunct
      medications may be used, including Amantadine, anticholinergics, dopa decarboxylase
      inhibitors, and dopamine agonists.

      Primary Hypothesis: At least the 10 mg twice daily dose of preladenant is superior to placebo
      as measured by the change from Baseline to Week 12 in the mean "off" time.
    


Intervention name(s): Preladenant; Placebo tablet to match Preladenant
Intervention type(s): Drug; Drug
Intervention description(s): 2, 5, or 10 mg tablets taken orally twice daily (BID); tablets taken orally BID
Other intervention name(s): SCH 420814; MK-3814
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease
A Study to Evaluate the Pharmacokinetics of a Single Dose of Tafenoquine Co-administered With Either Artemether + Lumefantrine or Dihydroartemisinin + Piperaquine Tetraphosphate
Condition: Malaria, Vivax
MeSH terms: Malaria; Malaria, Vivax
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single-centre, 5-cohort, randomized open-label, parallel-group study in
      healthy volunteer subjects. This study aims to provide sufficient pharmacokinetic (PK)
      evidence to support the safe usage of Tafenoquine (TQ) in studies and markets where the
      Artemisinin-based Combination Therapies (ACTs) are the standard of care for patients with
      Plasmodium vivax malaria (i.e., co administration with TQ). The objective of this study is to
      assess the pharmacokinetics, safety and tolerability of TQ when co-administered with the
      chosen ACTs (AL and DHA + PQP), administered concomitantly in healthy subjects. Specifically,
      the study will evaluate whether there are drug-drug interactions between TQ and each of the
      ACTs and if these interactions are considered to be clinically significant. The co-primary
      objectives of this study are to characterize both the effects of a 300 milligram (mg) single
      dose of TQ on the pharmacokinetics; changes in (area under the concentration-time curve from
      0 to time t) AUC (0-t), AUC (0-infinity), and maximum observed concentration (Cmax) of each
      of the two Artemisinin-based Combination Therapies (ACT) according to their prescribed dose
      when co-administered as well as the effects of the ACTs on the PK of TQ.

      A total of 120 subjects (24 subjects in each of 5 cohorts) are planned to be enrolled in
      order to ensure a target sample size of at least 22 subjects completing the study per cohort.
      All subjects will arrive in the unit at least 24 hours prior to dosing and be discharged
      after 72-hour post first dose assessments have been completed. Subjects will return for
      outpatient visits on Days 7, 14, 21, 28, and 56 after first dose.
    


Intervention name(s): Tafenoquine; Dihydroartemisinin + Piperaquine tetraphosphate; Artemether + Lumefantrine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A dark pink, capsule-shaped, film-coated tablet containing 150mg tafenoquine. To be administered orally; White, oblong, biconvex, film-coated tablet with a break-line and marked on one side with two "σ" letters containing 320 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 40 mg dihydroartemisinin (DHA). To be administered orally; Light yellow, round tablet with "NC" debossed on one side and "CG" on the other, containing 20 mg artemether and 120 mg lumefantrine. To be administered orally
Intervention MeSH terms: Lumefantrine; Artemether; Piperaquine; Artenimol; Tafenoquine; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria; Artemisinin-based Combination Therapies (ACT)
Time and Dose Evaluation of Stearidonic Acid (SDA) to Eicosapentaenoic Acid (EPA) in Red Blood Cells
Condition: Sudden Cardiac Death; Sudden Cardiac Arrest; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Death, Sudden, Cardiac; Death
Study type: Interventional

Summary: 
      The purpose of this study is to assess the relationships between dose and time of consumption
      of stearidonic acid (SDA) and eicosapentaenoic acid (EPA) on EPA enrichment of red blood cell
      (RBC) membranes in men and women.
    


Intervention name(s): Safflower Oil; EPA; SDA
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): One softgel consumed daily with food; Three different doses of EPA (0.5, 1.5 and 3.0 g/d) consumed with food daily.Subjects consuming more than 1 softgel/day (as in the groups with 1.5 and 3.0 g/d) are instructed to consume the softgels in 2 or 3 separate servings.; Four different doses of SDA (0.5, 1.5, 3.0 and 6.0 g/d) consumed with food daily.Subjects consuming more than 1 softgel/day (as in the groups with 1.5 and 3.0 g/d) are instructed to consume the softgels in 2 or 3 separate servings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Omega 3 fatty acids; Omega 3 Index; Stearidonic acid (SDA); Eicosapentaenoic acid (EPA); Red blood cells; Lipids; Inflammation markers
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease
Condition: Meniere Disease
MeSH terms: Meniere Disease
Study type: Interventional

Summary: 
      Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the
      patients Meniere disease.

      Methods: We accrued 25 patients at Beijing TongRen Hospital. All treatments were
      self-administered by the patients at home after training at the hospital. Patients completed
      questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks.

      Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry,
      visual scale of ear stuffiness and SF-36 were performed to evaluate the therapeutic effects.

      A difference of P < 0.05 was considered statistically significant.
    


Intervention name(s): taVNS
Intervention type(s): Device
Intervention description(s): taVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 20 Hz with pulse duration ≤ 1 ms, for 30min,administered twice daily.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transcutaneous auricular vagus nerve stimulation
Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain
Condition: Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      In our daily clinical practice, one of the most frequent reasons for consultation
      physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the
      approach from physiotherapy contemplates the reduction of pain through different procedures,
      including neuromodulation.

      In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is
      defined as the application through a needle with ultrasound guidance of an electrical current
      at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve
      in some point of its trajectory, or of a muscle in a motor point, with a therapeutic
      objective. The objective of this study is to analyze that the effect of PNM on the sciatic
      nerve produces statistically significant changes in pain, joint range and functionality in
      patients with chronic LBP. Thirty subjects will be recruited, which will be divided into 3
      groups: group 1 to which PNM will be applied to the sciatic nerve in the gluteus region;
      group 2 to which PNM will be applied to the sciatic nerve in the middle of the thigh; and
      group 3 to which PNM will be applied to the sciatic nerve before popliteus region. The PNM
      intervention with NMP will consist in the single application of an asymmetric rectangular
      biphasic current (250 microseconds, 3 Hz) during 90 seconds
    


Intervention name(s): NMP
Intervention type(s): Other
Intervention description(s): Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Beta Blocker Treatment on Endothelial Function in Patients With Type 2 Diabetes or Chronic Heart Failure
Condition: Endothelial Function; Beta Blocker
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the effect of the two different beta blockers metoprolol
      and carvedilol on endothelial function in patients with either type two diabetes or chronic
      heart failure.

      Hypothesis: 1* Carvedilol compared to metoprolol has a favourable effect on endothelial
      function.

      2* Carvedilol compared to metoprolol has a favourable effect on insulin stimulated
      endothelial function.

      The study is conducted as an open parallel group study. Endothelial function and insulin
      stimulated endothelial function was evaluated before and after a two months treatment period
      with either of the two beta blockers.
    

Detailed description: 
      Endothelial function is deteriorated in patients with type 2 diabetes and in patients with
      chronic heart failure. Treatment with carvedilol improves survival in patients with chronic
      heart failure compared to treatment with metoprolol. Carvedilol improves metabolic glucose
      control in patients with diabetes compared to metoprolol.Carvedilol compared to metoprolol
      also decreases the number of patients with new onset diabetes among patients with chronic
      heart failure. The mechanism behind these findings has not been fully understood.

      The purpose of this study is to investigate if carvedilol compared to metoprolol has a
      favourable effect on endothelial function and insulin stimulated endothelial function, in
      groups of patients with either diabetes or chronic heart failure.
    

Intervention name(s): Treatment with either metoprolol or carvedilol
Intervention type(s): Drug
Intervention MeSH terms: Metoprolol; Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Endothelial function; Beta blocker; Type 2 diabetes; Chronic heart failure
Early Viscosupplementation After Partial Meniscectomy: a Randomized Controlled Trial
Condition: Meniscus Lesion
Study type: Interventional
Phase: Phase 4

Summary: 
      The rational of intra-articular viscosupplementation is based on both the biological and
      mechanical properties of HA, which exerts positive effects on the modulation of the entire
      joint environment.

      The aim of the present double blind controlled study was to evaluate the effects in terms of
      pain control and functional recovery provided by a single intra-operative injection of HA
      performed at the end of arthroscopic partial meniscectomy.

      Patients included in this trial were randomized in two treatment groups: the first one
      received a single injection of HA (Hymovis 24 mg/3ml, Fidia Farmaceutici Spa, Padova, Italy)
      at the end of the arthroscopic meniscectomy, whereas the second group was treated by surgery
      alone.

      All patients were evaluated basally, at 15, 30, 60, and 180 days after surgery by the
      following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS
      (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and
      Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and
      at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the
      operated and contralateral knee were documented; also in addition, the trans-patellar
      circumference of both knees was registered to assess the trend of knee swelling over time.
    


Intervention name(s): hyaluronic acid; meniscectomy alone
Intervention type(s): Biological; Procedure
Intervention description(s): A single injection of 3 ml hyaluronic acid to be performed under arthroscopic view at the end of meniscectomy; The patients randomized in this group will receive arthroscopic meniscectomy alone
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: meniscectomy; hyaluronic acid; intra-op injection; randomized controlled trial; placebo
Acute Effect of Static Stretching and Muscle Warming on the Functional Performance of College Volleyball Athletes
Condition: Neuromuscular Manifestations
MeSH terms: Neuromuscular Manifestations
Study type: Interventional

Summary: 
      The purpose of this study is analyze the effects of static stretching and active warm up,
      isolated and associated, in functional performance of the lower limbs in college volleyball
      athletes.

      Study hypothesis:

      H0: The stretching and / or warm up, alone or in combination, do not alter the functional
      performance of volleyball players.

      H1: The stretching and / or warm up, alone or in combination, alter the functional
      performance of volleyball players.
    

Detailed description: 
      This is a cross-over study containing 11 volleyball athletes randomly divided into 5 groups:
      control (C), warming-up (gAQ), stretching (gAL), warming-up and stretching (gAQAL),
      stretching and warming-up (gALAQ). All subjects underwent the evaluation measures of
      functional performance that were conducted pre and post intervention.
    

Intervention name(s): Static Stretching; warm up; static stretching + warm up; warm up+static stretching; Control
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): 3 sets of 30-second self static hamstring stretch (IT), quadriceps (QD) and sural triceps (TS) of both lower limbs, with an interval of 30 seconds of rest between sets; Warm-up for 10 minutes at 70-80% of maximum heart rate.; 3 sets of 30-second self static hamstring stretch (IT), quadriceps (QD) and sural triceps (TS) of both lower limbs, with an interval of 30 seconds of rest between sets + Warm-up for 10 minutes at 70-80% of maximum heart rate.; Warm-up for 10 minutes at 70-80% of maximum heart rate + 3 sets of 30-second self static hamstring stretch (IT), quadriceps (QD) and sural triceps (TS) of both lower limbs, with an interval of 30 seconds of rest between sets; No intervention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: exercise muscle stretching; electromyography