bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled study to evaluate the effect of
      tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28
      days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder
      therapy.
    

Detailed description: 
      The study consists of a Screening visit; a Run-in Period of at least 2 weeks and up to 4
      weeks, where existing phosphate binder treatment is maintained; and a 4-week Double-Blind
      Treatment Period.

      At Screening, a subject must be on thrice daily phosphate binder therapy and have a serum
      phosphate (s-P) level ≥5.5 and ≤10.0 mg/dL to qualify for entering the study. s-P will be
      measured at each visit during the run-in period to enable the evaluation of the s-P
      randomization criteria.

      Subjects who qualify to enroll in the study will be randomized in a 1:1 ratio to receive
      tenapanor or placebo while continuing their existing phosphate binder treatment.

      During the Double-Blind Treatment Period, subjects will receive tenapanor or placebo starting
      at a dose of 30 mg bid
    

Intervention name(s): Tenapanor; Placebo; Phosphate Binder Agents
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active Drug; Inactive Drug; standard of care phosphate binder use at study entry was maintained throughout the entire study
Other intervention name(s): sevelamer carbonate; ferric citrate; calcium carbonate; calcium acetate; sucroferric oxyhydroxide
Intervention MeSH terms: Calcium, Dietary; Calcium Carbonate; Calcium; Sevelamer; Calcium acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Opioid-induced Hyperalgesia After Remifentanil Infusion
Condition: Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Remifentanil is a rapid-acting opioid which has been widely used in pain treatment during
      surgery for the last 15 years 1. Remifentanil is rapidly eliminated (minutes) from the body
      after end of infusion, and this makes it easily manageable compared to other opioids.
      However, there are both experimental and clinical studies indicating that remifentanil, after
      end of infusion, triggers increased pain sensation and increased opioid consumption
      post-operatively. Increased post-operative opioid consumption should be avoided due to the
      adverse effects of these drugs (nausea/vomiting, pruritus, dizziness, fatigue and reduced
      respiratory rate). Thus, it's important to investigate relevant strategies to avoid the
      increased pain sensation (opioid-induced hyperalgesia = hypersensitivity to pain stimuli)
      after end of infusion of remifentanil after surgery. Several experimental and clinical trials
      have been conducted in this field. Ketamine has been shown to block this effect, but its
      adverse effect profile (i.a. hallucinations) makes it not suitable in normal clinical use. In
      a study of healthy volunteers, it has been demonstrated that parecoxib (a COX-2 selective
      NSAID) can prevent remifentanil-induced hyperalgesia. Our group has previously shown that a
      relatively COX-1 selective NSAID (ketorolac) can prevent hyperalgesia in an experimental pain
      model.

      This is of interest since NSAIDs are frequently administered as premedication before surgery.
      There are several disadvantages associated with the use of COX-2 inhibitors, e.g. the risk of
      myocardial infarction after long-term use (> 1 year), and potentially reduced bone healing
      after orthopedic surgery. However, this has not been shown with short-term use (days/week).
      The disadvantages associated with the use of e.g. ketorolac (a COX-1 inhibitor) are i.a.
      increased bleeding tendency, which is unfavourable for the surgeon, and increased risk of
      gastric ulcer. Therefore, it is of interest to investigate other ways of preventing
      opioid-induced hyperalgesia. In a recent animal study it has been shown that gradual dose
      reduction of remifentanil (vs. abrupt withdrawal of a relatively high remifentanil dose) can
      prevent the development of hyperalgesia after end of infusion. In this study we will i.a.
      investigate whether this is also the case in humans. In this new model, the study
      participants will get remifentanil infusion with two different dose reduction regimes:
      gradual reduction or abrupt withdrawal.
    


Intervention name(s): Remifentanil
Intervention type(s): Drug
Other intervention name(s): Ultiva
Intervention MeSH terms: Remifentanil
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: opioid induced hyperalgesia; Pain; Postoperative pain; Hyperalgesia
Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a phase 1, double-blind, 4-way crossover study in healthy male and female
      volunteers. Subjects received 4 formulations of intranasal ketorolac tromethamine 30 mg.
      There was a wash-out period of 3-7 days between each dose. On Day 1 of each period subjects
      were randomised to receive either a single intranasal dose of 30 mg ketorolac tromethamine
      alone or single intranasal dose of 30 mg ketorolac tromethamine with 4%, 5% or 6% lidocaine
      hydrochloride. At the end of the study each subject had received all 4 treatments.

      The primary objective of this study in healthy volunteers was to compare the safety,
      tolerability, and pharmacokinetics of 4 formulations of ketorolac tromethamine. A secondary
      objective was to monitor lidocaine hydrochloride plasma levels.
    


Intervention name(s): Ketorolac Tromethamine; Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl); Ketorolac Tromethamine with 5% Lidocaine HCl; 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 30 mg Ketorolac Tromethamine intranasal (IN); 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN; 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN; 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Arm Function After Stroke
Condition: Stroke; Cerebrovascular Accident (CVA); Hemiparesis
MeSH terms: Stroke; Paresis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate if multiple therapy sessions of Transcutaneous Vagus
      Nerve Stimulation (tVNS) combined with robotic arm therapy lead to a greater functional
      recovery in upper limb mobility after stroke than that provided by robotic arm therapy in a
      sham stimulation condition.
    

Detailed description: 
      Promising new animal research suggests that vagus nerve stimulation paired with motor
      intervention induces movement-specific plasticity in the motor cortex and improves limb
      function after stroke. These results were recently extended to the first clinical trial, in
      which patients with stroke demonstrated significant improvements in upper limb function
      following rehabilitation paired with implanted VNS. Currently, vagus nerve stimulation is
      being used clinically to treat a number of human diseases including migraine headaches,
      epilepsy, and depression, and these investigations are expanding to deliver stimulation via a
      transcutaneous route to potentially improve intervention efficacy and decrease side effects.
      This pilot study will combine non-invasive transcutaneous stimulation of the vagus nerve with
      upper limb robotic therapy to investigate the potential of tVNS to augment improvements
      gained with robotic therapy in patients with chronic hemiparesis after stroke.
    

Intervention name(s): Transcutaneous Vagus Nerve Stimulation (tVNS); Sham Transcutaneous Vagus Nerve Stimulation (tVNS)
Intervention type(s): Device; Device
Intervention description(s): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear.; tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control.
Other intervention name(s): Transauricular Vagus Nerve Stimulation; Sham Transauricular Vagus Nerve Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double-blind, sham controlled treatment study in which patients will have a 50/50 chance of receiving robotic arm therapy with either active transcutaneous vagus nerve stimulation (tVNS) or sham tVNS (placebo).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcutaneous vagus nerve stimulation (tVNS); VNS; robotic therapy; occupational therapy; motor rehabilitation
Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia
Condition: Schizophrenia; Recovery; Medication Adherence
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Meeting people's needs is positively correlated with their recovery. However, recovery
      services rarely include nurse-led programs tailored to the needs of these people. This study
      aimed to evaluate the effectiveness of a new needs-tailored recovery program by using a
      cluster-randomized controlled trial design.
    

Detailed description: 
      First year, investigators used the pilot study to test the needs tailored recovery program
      feasibility, acceptability and preliminary usefulness of the needs-tailored nurse-led
      recovery program. In the second year, based on the findings of the pilot study, a cluster
      randomized controlled trial was conducted to assess the effectiveness of the needs-tailored
      nurse-led recovery program in two psychiatric centers in northern Taiwan. The treatment group
      receive the needs-tailored nurse-led recovery program by their home-care nurses over 6
      months. The control group receive the usual community psychiatric care only. Data were
      collected before the intervention, after the intervention, and at a follow-up session three
      months after the end of the intervention period. The outcomes were recovery, needs, hope,
      empowerment, psychotic symptoms, and medication adherence. The investigators used repeated
      measures ANOVA tests to examine the effect of the group × time interaction.
    

Intervention name(s): needs-tailored nurse-led recovery program
Intervention type(s): Behavioral
Intervention description(s): The needs-tailored nurse-led recovery program were divided into five major stages of care, which were build partnership, conduct integrated needs assessment, set needs-based recovery goals and provide empowerment-oriented care, conduct continuous monitoring of goals, and conduct effectiveness evaluations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Needs-tailored; Recovery; Empowerment; Hope; Medication Adherence; Cluster-randomized controlled trial
Dexmedetomidine Sedation and Cardiopulmonary Bypass
Condition: Coronary Artery Bypass Grafting
Study type: Interventional
Phase: Phase 2

Summary: 
      Dexmedetomidine is a unique sedative anesthetic agent that allows accurate control of the
      depth of sedation and provides analgesia, cardio protection, renal protection, and
      neuroprotection without causing respiratory depression. It is an alpha 2-adrenoreceptor
      agonist that modulates the release of catecholamines from the central and autonomic nervous
      systems. When patients sedated by dexmedetomidine are allowed to become responsive, they are
      calm and cooperative (1). No other sedative agent has this feature, and sedated patients
      frequently awaken in a confused state. Investigators are conducting this study project to
      compare between dexmedetomidine based and propofol based anesthetic techniques with regard to
      hemodynamic changes, stress hormone release as well as cytokines in patients undergoing CPB
      for coronary revascularization.
    

Detailed description: 
      100 patients undergoing elective CPB for coronary revascularization surgery. On the morning
      of operation the patients were randomized to receive one of two anesthetic techniques
      dependent on the type of sedation used. Standard anesthetic technique will be used for all
      patients except for using dexmedetomidine sedation in one group and propofol sedation in the
      other group.
    

Intervention name(s): Dexmedetomidine; propofol
Intervention type(s): Drug; Drug
Intervention description(s): Anesthesia will be maintained with continuous infusion of dexmedetomidine 0.5-0.7 µg/kg/h in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.; Anesthesia will be maintained with continuous infusion of propofol 50-100 µg/kg/min in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.
Other intervention name(s): precedex; diprivan
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexmedetomidine; Cardiac; Coronary Artery Bypass Grapht; Sedation; Propofol; Intravenous Anesthetics
Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions
Condition: Hypertension
MeSH terms: Hypertension; Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under
      fed conditions.
    


Intervention name(s): Ramipril
Intervention type(s): Drug
Intervention description(s): 10 mg capsule
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules
Condition: Diphtheria; Acellular Pertussis; Tetanus; Haemophilus Influenzae Type b; Hepatitis B; Poliomyelitis
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will
      be randomly allocated into two groups:

        -  one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B
           virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at
           6-10-14 weeks of age

        -  the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of
           age
    

Detailed description: 
      DTPa-HBV-IPV/Hib vaccine will be administered at two schedules (i.e. 6-10-14 weeks of age OR
      2-4-6 months of age) in infants who were previously vaccinated with hepatitis B vaccine at
      birth. The duration of the study will be approximately 3 months for each subject who will
      receive vaccination at 6-10-14 weeks of age and approximately 5 months for each subject who
      will receive vaccination at 2-4-6 months of age. Intervention name: Diphteria, tetanus,
      acellular pertussis, hepatitis B, poliovirus types 1, 2, 3 & Haemophilus influenzae type b
      vaccine
    

Intervention name(s): DTPa-HBV-IPV/Hib vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diphtheria; tetanus; poliomyelitis; pertussis; hepatitis B; Prophylaxis; Haemophilus influenza type b diseases
Effect of Irvingia Gabonensis (Bush Mango)on Parameters Associated With Metabolic Syndrome
Condition: Metabolic Syndrome; Obesity; Dyslipidemia
MeSH terms: Obesity; Metabolic Syndrome; Dyslipidemias; Syndrome
Study type: Interventional

Summary: 
      The study investigated the use and efficacy of the seeds of African bush mango (Irvingia
      gabonensis)to control body weight, blood lipids and hormones in overweight and obese people.
    

Detailed description: 
      To assess the effects of seeds of Irvingia gabonensis on body weight, fasting blood glucose,
      plasma total and LDL cholesterol in 102 overweight and obese participants.

      The study was a 10 week randomized, double blind, placebo controlled design. participants
      were randomly divided into 2 groups of 51 participants each. Group 1 was the placebo group,
      while Group 2 was the active group. Each group received 2 daily doses of 125 mg (before
      meals) of either placebo or Irvingia gabonensis.

      Weight as well as fasting blood was taken at baseline and at 4, 8 and 10 weeks. No major
      detary changes or exercises were suggested during the study period.
    

Intervention name(s): IGOB131
Intervention type(s): Dietary Supplement
Intervention description(s): Comparison of 250 mg per day of Irvingia gabonensis to placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight loss; Antiobesity; Metabolic syndrome; Leptin
Immune Fitness Prediction
Condition: Healthy Adults
Study type: Observational

Summary: 
      The overall objective of the study is to determine whether self-rated, perceived immune
      fitness (using questionnaire) is associated with biological assessment of immune fitness
      (immune signatures in the blood).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults
      
Biospecimen description: 
      blood
Effect of Thoracic Manipulation on Latent Trigger Point
Condition: Trigger Points
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of one session thoracic manipulation on
      pressure pain threshold and rhomboid muscle strength in healthy individuals with latent
      trigger point.
    

Detailed description: 
      Within the scope of the study, all individuals studying at Sarayköy Vocational School and
      volunteering to participate in the study will be screened.Immediately after determining the
      latent trigger points in the rhomboid muscles, the participants will be randomized by
      computer method and divided into 2 groups. Participants who underwent thrust thoracic
      manipulation will form the study group, and participants who received sham thrust thoracic
      manipulation will form the control group.Pressure pain threshold will be evaluated with an
      algometer and rhomboid muscle strength will be evaluated with a hand dynamometer.
    

Intervention name(s): Thrust manipulation; Sham thrust manipulation
Intervention type(s): Other; Other
Intervention description(s): Participants will be positioned prone and the clinician will perform a high-speed, low-amplitude thrust into the most symptomatic segment of the thoracic spine. TM type, thrust direction, and number of thrusts will be at the clinician's discretion and will be based on the individualized assessment of the patient.; The same protocol will be applied as the push thoracic manipulation application, but no push will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised sham controlled study involving 2 parallel groups
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: latent trigger point; thorasic manipulation; muscle strength; pressure pain threshold
The Effect of Dietary Fat Modification on Risk Factors Associated With the Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The LIPGENE Human Dietary Intervention Study, multi-centre, trans -European, single-blinded,
      randomised, controlled trial with two principal aims. Firstly to determine the relative
      efficacy of reducing dietary SFA consumption, by altering quality of dietary fat and reducing
      the quantity of dietary fat, on metabolic and molecular risk factors of the metabolic
      syndrome. Secondly to determine if common genetic polymorphisms affect an individual's
      responsiveness to dietary therapy.
    

Detailed description: 
      521 free-living subjects with the metabolic syndrome received one of four dietary treatments
      for 12 weeks: (1) High-fat (38% energy) SFA-rich diet; (2) High-fat (38% energy), MUFA-rich
      diet; (3) Isocaloric low-fat (28% energy), high-complex carbohydrate diet and (4) Isocaloric
      low-fat (28% energy), high-complex carbohydrate diet, with 1 g/d LC n-3 PUFA. A 3-day weighed
      food intake assessed dietary compliance pre-, mid- and post- intervention. An IVGTT,
      lipoprotein analysis, cytokine, adhesion molecule, coagulation factor and isoprostane levels
      were determined pre- and post-intervention. DNA, adipose and skeletal muscle biopsies, and
      PBMC were isolated to characterise nutrient sensitive molecular markers of insulin
      sensitivity.
    

Intervention name(s): Dietary Fatty Acid Modification
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: LIPGENE; Fatty acid; Dietary intervention; Metabolic syndrome; Insulin resistance