bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Sedative on the Fluid Responsiveness in Critically Ill Patients
Condition: Shock; Sepsis
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 1

Summary: 
      Hypotension and bradycardia are often observed following induction of dexmedetomidine or
      propofol sedation.Cardiac preload decrease by sedative agents was often considered as one of
      main causes for this hypotension.The investigators hypothesized that hypotension after
      induction of sedation is caused by decrease of preload by sedative agents,and passive leg
      raising (PLR)test could predict this event.Dexmedetomidine or propofol infusion in patients
      with circulatory failure decrease cardiac preload and enhance preload-dependency and fluid
      responsiveness.
    

Detailed description: 
      In this clinical trial,the investigators hypothesized dexmedetomidine or propofol infusion in
      patients with circulatory failure decrease cardiac preload and enhanced preload-dependency
      and fluid responsiveness,and PLR induced pulse pressure variation (PLR-ΔPP) could predict the
      hypotension during dexmedetomidine induction in critically ill patients.Before
      dexmedetomidine or propofol infusion, the investigators will conduct passive leg raising
      test. At first, the patient's trunk was elevated 45 degrees for the first set of
      measurements. Then, the lower limbs were raised to a 45° angle while the patient's trunk was
      lowered to a supine position to measure peak BP (usually within 30-90 s). Hemodynamic
      profiles planned to be measured are SBP, DBP, CVP and HR.Sedation was induced with a
      dexmedetomidine 0.5μg/kg over 10 min loading, followed by a maintenance infusion of 0.2-0.7
      μg/kg/h for one hour. The dose of propofol was titrated targeting the Richmond agitation
      sedation scale (RASS) ranged from -2 to -1 (bispectral index: 60-75).Hypotension was defined
      as a SBP less than 80 mmHg or DBP was less than 50 mmHg, or greater than 30% decrease from
      baseline for longer than 60 s. Bradycardia was defined a HR 50 /min or greater than 30%
      change from baseline for longer than 60 s. Receiver operator characteristic curve analysis
      was performed to evaluate sensitivity and specificity of the value PLR-ΔPP to detect patients
      at high risk of hypotension.
    

Intervention name(s): Passive Leg Raising; propofol or mexmedetomidine
Intervention type(s): Other; Drug
Intervention description(s): elevation of both legs to a 45 degrees for about 1-2 minute before sedation
Other intervention name(s): Passive Leg Raising testing
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Ketamine Effects as Preemptive Analgesia
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of this randomized controlled trial is to compare the effect of preemptive ketamine
      administration to placebo administration in patients underwent hysterectomy surgery. The main
      questions it aims to answer are:

        1. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on
           the duration of analgesia after hysterectomy surgery

        2. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on
           the need for fentanyl after hysterectomy surgery
    


Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The intervention was prepared by the research team (anesthesia resident) in the form of ketamine which had been diluted to a dosage of 10 mg/cc, taken according to the required dose based on actual body weight then diluted with 0.9% NaCl to 10 cc. Then the two solutions were given to researchers without knowing the contents of the drugs that had been prepared by the resident who assisted in this research.; While the 0.9% NaCl solution was used as placebo was prepared in a 10 cc syringe
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Ketamine; Preemptive Analgesia
Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children
Condition: HIV-1 Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai
      children.
    

Detailed description: 
      This is an open-label, single arm study to compare standard dose with a new tablet
      formulation of a lower dose of lopinavir/ritonavir in HIV-1 infected children.
    

Intervention name(s): lopinavir/ritonavir
Intervention type(s): Other
Intervention description(s): standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour.
Intervention MeSH terms: Ritonavir; Lopinavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Lopinavir/ritonavir; pharmacokinetic; low dose; HIV-infected children; pharmacokinetics of low-dose lopinavir/ritonavir in HIV-1 infected Thai children.
Effect of SLC30A8 rs13266634 Genetic Polymorphism on Zinc Supplementation and Glycemic Control in Egyptian Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Study whether SLC30A8 rs13266634 polymorphism is associated with type 2 diabetes mellitus
      (T2DM) susceptibility in Egyptian patients and study effect of Zn supplementation on glycemic
      control in patients with type 2 diabetes
    


Intervention name(s): zinc supplement plus vitamin A and E; vitamin A and E
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vitamins; Vitamin A; Retinol palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Efficacy and Tolerability of Xalatan in Patients
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Observational

Summary: 
      Efficacy data was not collected or analyzed. This study did assess safety and tolerability of
      Xalatan.
    

Detailed description: 
      -  Efficacy data not collected or analyzed

        -  Safety and tolerability of Xalatan assessed NA
    

Intervention name(s): Xalatan 0.005% eye drops
Intervention type(s): Drug
Intervention description(s): ophthalmic solution dosed once daily for 3 months
Other intervention name(s): latanoprost
Intervention MeSH terms: Ophthalmic Solutions; Latanoprost
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adults with glauocma or ocular hypertension
      
Keywords: observational safety study
Connected Ovulation Test Efficacy Study
Condition: Pregnancy
Study type: Interventional

Summary: 
      Clearblue Connected Ovulation Test System (COTS) has been designed for home use by women who
      are either planning or trying for a pregnancy. This study will determine the difference in
      pregnancy rate of female volunteers seeking to get pregnant who use COTS in comparison to
      those not using an ovulation product to assist with conception.
    


Intervention name(s): Clearblue Connected Ovulation Test System
Intervention type(s): Device
Intervention description(s): Urinary LH test to predict ovulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Argus II Retinal Prosthesis System Dry AMD Feasibility Study Protocol
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      The purpose of this study is to test the Argus II Retinal Prosthesis System in patients with
      severe age-related macular degeneration (AMD). The Argus II System has already been studied
      in completely blind patients with retinitis pigmentosa (RP). In RP patients, some cells of
      the retina are irrevocably damaged and the Argus II System has been found to restore some
      basic visual function. On these grounds, the device has received authorization for use on the
      European market (the CE certification) in 2011.
    

Detailed description: 
      In this study, 5 subjects with severe dry AMD who are legally blind will be implanted with
      the Argus II System. The study will evaluate the safety of the device and surgery, as well as
      functioning of the system and the extent of any restored vision. Each subject will be
      followed for 3 years, with their eye health and visual function tested at multiple time
      points.
    

Intervention name(s): Effect of Argus II on Functional Vision
Intervention type(s): Device
Intervention description(s): To evaluate the safety and effectiveness of the Argus II Retinal Prosthesis in subjects with AMD.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bone Marrow Aspirate Concentrate in Treating Mandibular Cystic Defects
Condition: Mandible Cyst
Study type: Interventional

Summary: 
      Mandibular cystic defect healing is a complex process. Various methods have been developed to
      shorten the bone regeneration time and improve its quality. Autogenous grafting is the gold
      standard for filling cystic defects due to the osteogenesis property provided by the viable
      cells but is related to donor site morbidity. Allografts and Xenografts are used for the same
      purpose. However, the increased cost is their main disadvantage. Bone marrow aspirate
      concentrate is now used to enhance the healing and regeneration process in many areas of the
      body with no morbidity and low cost.
    


Intervention name(s): Enucleation and filling by Bone marrow aspirate; Conventional enucleation only
Intervention type(s): Other; Other
Intervention description(s): The iliac crest is palpated along its widest part forming the iliac tubercle ( 5-6 cm posterior to the anterior superior iliac spine), then a 5 mm incision is made 3-4 cm posterior to the ASIS directly on the crest.
The needle is advanced between the outer and inner plates of the ileum for a 4-6 cm into the cancellous bone and 10 ml of bone marrow is aspirated.
Bone marrow aspirate is processed by a dual centrifugation technique.; patients were treated conventionally by enucleation and plain collagen sponge only.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adjunctive Glycine for Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether individuals with obsessive compulsive
      disorder who will take a preparation of the amino acid glycine in addition to their current
      treatment, may experience improvement in their symptoms.
    

Detailed description: 
      Individuals with obsessive compulsive disorder (OCD) often find inadequate relief, even with
      the best of currently available treatments. Some evidence suggests the the neurotransmitter
      glutamate may be a useful target for new treatments for OCD. The amino acid glycine, if given
      orally in adequate dosages, can have specific effects on one particular glutamate receptor
      molecule in the brain, that might be helpful with OC symptoms. This randomized, double-blind
      protocol will have study participants who suffer with OCD take either a glycine preparation
      or placebo for 12 weeks. Clinical measures (e.g., Y-BOCS, NIMH-OC) will be recorded at each
      visit to determine whether those taking the glycine experience clinical benefit.
    

Intervention name(s): glycine; placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OCD; Obsessive Compulsive Disorder; Glycine
Ready Meal Consumption, Appetite and Food Intake in Females
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Overweight and obesity are public health concerns and there is a forecast rise in the
      consumption of ready meals that are generally high in saturated fat and low in fibre.
      Slimming World, a commercial weight management organisation has designed a range of ready
      meals in line with their weight management programme, which advocates an unrestricted intake
      of low energy dense food in order to aid in weight loss. Hence, it is valuable to understand
      the satiating properties of ready meals in order to establish if specific ready meals can
      enhance satiety and contribute to reducing subsequent energy intake. This study aims to
      explore the effect of ready meals on short-term satiety and food intake among females with a
      BMI ≥ 25 kg/m2.
    

Detailed description: 
      A total of 26 female participants aged between 18-65 years attended Oxford Brookes Centre for
      Nutrition and Health for two separate testing days. The study aimed to investigate the
      effects of energy matched ready meals (calorie-matched but differing quantities of protein
      and fat) on appetite and subsequent energy and macronutrient intake. The ready meals (Control
      = supermarket brand and Test = Slimming World) differed in energy density and macronutrient
      composition, with satiety responses investigated in the studies. The participants consumed a
      standard breakfast and four hours later consumed either a test ready meal (lasagne, higher
      energy density) or the control ready meal (lower energy density). Four hours after lunch
      participants food intake was measured during an ad libitum buffet tea. Additionally, satiety
      measurements were recorded using visual analogue scales throughout and participants completed
      a weighed food diary for the remainder of the test day.
    

Intervention name(s): Control ready meal; Test ready meal
Intervention type(s): Other; Other
Intervention description(s): Supermarket brand lasagne ready meal; The Slimming World lasagne ready meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir
Condition: Healthy Participant
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug-drug interaction study to assess the effects of a single dose of
      PF-07321332/ritonavir after multiple dose administrations of carbamazepine. Pharmacokinetic
      (PK) will be evaluated for PF-07321332 and ritonavir. Carbamazepine is being utilized as a
      cytochrome P450 3A4 (CYP3A4) inducer.
    


Intervention name(s): PF-07321332/ritonavir; Carbamazepine; PF 07321332/ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PF-07321332/ritonavir administered orally as a single dose on Day 1, Period 1; In Period 2, Days 1-3, participants will receive low-dose of carbamazepine twice daily (BID), then a titrated mid-dose of carbamazepine BID on Days 4-7, and finally maintaining carbamazepine at the high-dose on Days 8-15.; In Period 2, Day 14, participants will receive a single dose of PF-07321332/ritonavir orally.
Intervention MeSH terms: Ritonavir; Nirmatrelvir; Carbamazepine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase 1, fixed sequence, 2-period study to estimate the effect of a strong CYP3A4 inducer, carbamazepine, on the PK of PF-07321332 and ritonavir in healthy participants. A total of approximately 12 healthy male and/or female participants will be enrolled into the study.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-drug interaction; Carbamazepine; CYP3A4 inducer
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Greece
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a National, Multicentre, Observational Registry to study adherence and long term
      outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth
      hormone treatment from hospitals in Greece and to assess the level of adherence of subjects
      receiving SAIZEN® via Easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter, longitudinal observational registry.
      Parents/subjects will provide their Informed Consent/assent to upload their data for
      populationbased analyses and optionally to adhere to a patient adherence support program
      designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will
      be primarily derived from the Easypod™ device combined with physician data entry of outcome
      measures. Data will be collected retrospectively and prospectively. This will allow the
      establishment of adherence profiles and explore the hypothesis that patient adherence support
      programs improve adherence and subsequent clinical outcomes. Collected data will be also
      analyzed in a multinational pooled analysis of comparable national studies.

      Primary Objective:

      - To assess the level of adherence of subjects receiving SAIZEN® via Easypod™

      Secondary Objectives:

        -  To identify adherence subject profiling

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via Easypod™

        -  To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above,
           below or within normal ranges)

        -  To assess/describe the impact of the Greek Scientific Service (Patient Support Program)
    

Intervention name(s): Easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) as per Summary of Product Characteristics administered by Easypod™
Other intervention name(s): Saizen; Somatotropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        Easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
Project ACTIVE a Clinical Intervention
Condition: Alcohol Abuse; Obesity
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      This is a clinical Randomized Controlled Trial where the study personnel will run a
      personalized prevention clinic with patients in attempts to improve their preventive health
      outcomes and compare their health outcomes with a matched control sample of patients who do
      not receive the clinical intervention.
    

Detailed description: 
      The Project ACTIVE intervention was constructed around the following framework, and then
      adapted to suit workflow demands of a busy inner-city clinic: (1) identify patients who could
      most benefit from improvements in adherence to evidence-based preventive care, (2) use a
      validated mathematical model that was published in Annals of Internal Medicine to quantify
      and rank the estimated amount of health benefit that would arise from improved adherence to
      each USPSTF preventive care guideline, with estimates personalized based on that patient's
      risk factors and medical history, (3) communicate this information in a manner informed by
      risk communication studies relevant to patients from disparate cultural groups and with low
      literacy and numeracy, (4) engage the patient in a shared decision making process in which
      the patient identified which preventive health goals patient aimed to achieve, and (5) set
      particular action steps for the next visit that were congruent with these goals. The program
      supplements rather than substitutes for normally scheduled primary care visits, and is
      coordinated with these visits whenever possible.
    

Intervention name(s): ACTIVE intervention
Intervention type(s): Behavioral
Intervention description(s): The Project ACTIVE intervention was adapted to suit workflow demands of our busy inner-city clinic: (1) identify patients who could most benefit from improvements in adherence to evidence-based preventive care, (2) use a validated mathematical model to quantify and rank the estimated amount of health benefit that would arise from improved adherence to each USPSTF preventive care guideline, (3) communicate this information in a manner informed by risk communication studies relevant to patients from disparate cultural groups and with low literacy and numeracy, (4) engage the patient in a shared decision making process in which the patient identified which preventive health goals aimed to achieve, and (5) set particular action steps for the next visit that were congruent with these goals .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention