bioihbjkbjnl/mcl2 huggingface dataset:
Study Testing Ketamine Sublingual Wafer After Wisdom Tooth Extraction
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to test two different doses of ketamine sub-lingual (under the
      tongue) wafer against placebo to see how effective the medication is to treat moderate to
      severe pain after wisdom tooth extraction.
    

Detailed description: 
      This is a Phase 2, randomized, double-blind, parallel group, dose-ranging placebo-controlled
      evaluation of the analgesic efficacy, safety and pharmacokinetics of ketamine sublingual
      wafer in adult subjects who experience post-operative pain after undergoing third molar
      extraction.

      The study will enroll approximately 80 subjects at a single site. Subjects will be at least
      18 years to 38 years of age. Subjects will receive a single dose of 70 mg or 100 mg
      sublingual ketamine wafer or placebo.

      Efficacy assessment will include pain intensity, use of rescue medication, and Patient Global
      Assessment (PGA) of pain control. Safety assessments will include monitoring of AEs and SAEs,
      clinical laboratory tests, vital sign measurements, oral assessments, and ECGs.

      A maximum of eight 4ml blood samples will be taken from each participant up to 8 hours after
      study drug administration for plasma analysis.
    

Intervention name(s): Ketamine; Placebo (for Ketamine)
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of sublingual investigational medication administered when subjects develop moderate to severe pain after third molar extraction.; Sublingual sugar pill developed to mimic ketamine sublingual dose.
Other intervention name(s): Sugar pill
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Third molar extraction; Wisdom tooth extraction
ToleroMune Grass Follow on Study
Condition: Grass Allergy; Rhinoconjunctivitis
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Grass pollen allergens are recognised as a major cause of allergic diseases in humans and
      animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen
      allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass
      pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising
      vaccine, currently being developed for the treatment of grass allergy.

      The purpose of this optional observational follow-on study is to further evaluate
      rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all
      dosing visits in study TG002 approximately one year after the start of treatment.
    

Detailed description: 
      Subjects who completed all dosing visits and the post treatment challenge (PTC) in study
      TG002 will be invited to attend the Screening Visit for TG002a. Subjects will attend for 4
      visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be
      performed 3-10 days later.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subject previously randomised in study TG002 and completed all dosing visits and the PTC
      
Keywords: Grass allergy; Rhinoconjunctivitis; Environmental Exposure Unit; Immunotherapy; ToleroMune Grass
Right Ventricular Function in Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to determine the structural and functional cardiac alterations
      in obstructive sleep apne (OSA) independent from systemic and pulmonary arterial hypertension
      and their correlation to the severity of OSA.
    

Detailed description: 
      Many risk factors for OSA, such as male gender, obesity, and increasing age are the same as
      for cardiovascular diseases. This fact makes it more difficult to establish a causal
      relationship between OSA and cardiovascular diseases. The relationship between OSA and right
      ventricular (RV) function is controversial. RV dysfunction may be a result of chronic
      intermittent hypoxia and hypercapnia during apneic episodes. It may also occur secondary to
      left ventricular dysfunction as a result of increased afterload and sympathetic activity
      which causes secondary hypertension. As systemic hypertension is one of the most accompanying
      and contributing factors in OSA along with obesity, we tried to compare the effects of newly
      diagnosed OSA on RV function with an age and body mass index- matched control group.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Tertiary care clinic, obstructive sleep apnea patients
A Comparison of microRNA Samples in Patients With Nasal Polyps and Aspirin Exacerbated Respiratory Disease and Those With Nasal Polyps Only
Condition: Aspirin-exacerbated Respiratory Disease; Nasal Polyp
MeSH terms: Respiratory Tract Diseases; Respiration Disorders; Nasal Polyps; Polyps
Study type: Observational

Summary: 
      We hypothesize that the miRNA expression in subjects with nasal polyps and
      Aspirin-exacerbated respiratory disease (AERD) differs from the miRNA expressed in subjects
      with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD).
    

Detailed description: 
      Nasal epithelial tissue will be collected from the inferior nasal turbinates of ten subjects
      with nasal polyps and AERD disease and from the inferior turbinates of ten subjects with
      nasal polyps but without AERD. A rhinoprobe™ will be used to collect this epithelial tissue.
      These samples will be analyzed by miRNA assay to determine if there is a difference in
      mircroRNA expression between the two subject groups.
    

Intervention name(s): microRNA
Intervention type(s): Genetic
Intervention description(s): Biological samples will be taken from subjects w/ Nasal polyps & AERD disease and subjects w/ nasal polyps without AERD. MicroRNA will be analyzed to compare genetic similarities and differences between the two study groups.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will be a prospective study design with a target sample size of 20. The
        objective of conducting it as a prospective study is to confirm that the sampling
        procedures and analysis methodology work as expected before attempting a larger study. We
        propose to have 10 study participants with nasal polyps but without AERD and 10 study
        participants with nasal polyps and AERD. If the results of this study are promising, larger
        studies with sufficient power for statistical analysis will be considered.
      
Biospecimen description: 
      Nasal epithelial tissue will be collected from the inferior nasal turbinates of ten subjects
      with nasal polyps and AERD disease and from the inferior turbinates of ten subjects with
      nasal polyps but without AERD. A rhinoprobe™ will be used to collect this epithelial tissue.
      These samples will be analyzed by miRNA assay to determine if there is a difference in
      mircroRNA expression between the two subject groups.
    
Keywords: Aspirin-exacerbated respiratory disease; Nasal polyp
Clinical Relevance of Different Training Intensities in Chronic Heart Failure.
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      To determine the efficacy of different aerobic exercise training intensities in patients with
      chronic heart failure.Forty five eligible male patients with chronic heart failure were
      randomly assigned into three groups( High intensity , moderate intensity and low
      intensity)groups .
    

Detailed description: 
      Forty five eligible male patients with chronic heart failure secondary to ischemic heart
      disease were selected from National Heart Institute heart failure outpatient clinic , their
      ages ranged from 50-60 years old and their ejection fraction ranged from 30-40% ,they were
      randomly assigned into three groups :HIT Group: received High Intensity aerobic Training in
      the form of bicycle ergometer exercise for the lower limbs three times /week for three
      months.(n=15) MIT Group: received moderate Intensity aerobic Training in the form of bicycle
      ergometer exercise for the lower limbs three times /week for three months. .(n=15) LIT Group:
      received low Intensity aerobic Training in the form of bicycle ergometer exercise for the
      lower limbs three times /week for three months, Before and after intervention, the following
      measures were obtained: Echocardiograph parameter (EF%, and left ventricular internal
      dimension ) , prognostic biomarkers (proBNP), and quality of life .
    

Intervention name(s): Aerobic exercise training
Intervention type(s): Other
Intervention description(s): bicycle ergometer exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Preoperative Preparation for Children
Condition: Elective Surgery; Anxiety
Study type: Interventional

Summary: 
      Children scheduled for elective surgery are randomized into a control and intervention group.
      Children in the intervention group receive a CD and booklet of relaxation and distraction
      stories to listen to/read during the preoperative period. Preoperative anxiety is assessed by
      the child life specialist in the preoperative holding area. Ease of induction and emergence
      from anesthesia are rated by the anesthesia care provider. Post-hospital behaviors are
      reported by the parents one week after discharge. It is hypothesized that children receiving
      the intervention will have less anxiety, easier induction and emergence from anesthesia, and
      fewer changes in post-hospital behaviors than children in the control group.
    


Intervention name(s): Healing images, relaxation and distraction materials
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of TG103 in Chinese Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purposes of this study are to determine:

        1. To assess the safety and tolerability of a single subcutaneous injection of different
           doses of TG103 in healthy Chinese adult subjects.

        2. The pharmacokinetic and pharmacodynamic characteristics of a single subcutaneous
           injection of different doses of TG103 in healthy Chinese adult subjects were assessed.
    


Intervention name(s): TG103; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: TG103; Pharmacokinetic; Pharmacodynamic; Safety; Tolerability
CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the safety and efficacy of the CLiRpath®
      Photoablation Atherectomy System consisting of the Bias Sheath guiding catheter, in
      combination with the available CLiRpath® Excimer Laser Catheters ≤ 2.0 mm, to create larger
      lumens for treatment within the superficial femoral and popliteal arteries above the knee.
    


Intervention name(s): CLiRpath Photoablation System
Intervention type(s): Device
Intervention description(s): Use of CLiRpath Laser Catheter to improve vessel lumen diameter.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Virtual Reality for Phantom Limb Pain
Condition: Phantom Limb Pain
MeSH terms: Phantom Limb
Study type: Interventional

Summary: 
      This study will develop a virtual reality-based treatment for phantom limb pain among
      Veterans and test it against the most established behavioral therapy for phantom limb pain,
      mirror therapy.
    

Detailed description: 
      The VA system performs more than 10% of all amputations in the U.S., a percentage translating
      into more than 50,000 upper and lower extremity amputations in the past decade. Among
      Veterans with amputations, research suggests that upwards of 70% experience phantom limb pain
      (PLP), an often chronic and debilitating condition with adverse effects on quality of life
      and poor responsiveness to conventional pain treatments. The use of virtual reality
      technology for chronic pain management is a novel and rapidly advancing area of study, with
      existing research suggesting that virtual reality treatments are effective for acute pain
      management, promising for chronic pain management, and as yet untested for PLP. In the
      current study, the investigators will develop a virtual reality environment that simulates
      mirror therapy - the gold standard behavioral treatment for PLP - comparing the efficacy of
      this modality in a population of Veterans with PLP against a standard mirror therapy
      treatment validated by this research team in a previously supported clinical trial.
    

Intervention name(s): Virtual Reality
Intervention type(s): Other
Intervention description(s): Using a VR headset, motion sensors, and VR software, the investigators will create a customized VR treatment for each participant that engages them in movements and exercises involving their missing limb in a game-like environment. For example, participants may use the headset to engage in activities such as driving a race car around a course requiring both arms, ski down simulated slopes, or manipulate objects.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Legume Intake on Cardiovascular Risk Factors Among Adults at Risk for Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This randomized cross-over study was designed to investigate the effects of legume enriched
      diet consumption on cardiovascular risk factors among first degree relatives of diabetic
      patients.
    


Intervention name(s): nutritional intervention; life style modification
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A 2-Part Trial of CVL-751 in Subjects With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will be a 2-part, adaptive, open label, single and/or multiple oral dose, safety,
      tolerability, food effect trial of CVL-751 in subjects with Parkinson's disease. Part 1 is a
      placebo-controlled, single dose cohort intended for assessment of safety and tolerability. In
      case of intolerable AEs, Part 2 would proceed as a multiple dose titration trial to achieve a
      15 mg once daily dose while maintaining L-Dopa treatment (Part 2A). In case of a favorable
      tolerability profile in Part 1, Part 2B would proceed as a single dose trial (similar to Part
      1), with discontinuation of L-Dopa for 24 hours (12 hours pre-Day 1 dose and 12 hours
      post-Day 1 dose).
    


Intervention name(s): CVL-751
Intervention type(s): Drug
Intervention description(s): Oral tablet
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
Condition: Uncomplicated Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      The World Health Organization recommends regular surveillance of antimalarial efficacy to
      monitor the performance of different drugs. The Tanzanian National Malaria Control Programme
      (NMCP) in collaboration with its partners have been implementing therapeutic efficacy studies
      (TES) to monitor the performance of different antimalarials in the country. Most of the
      studies conducted in recent years focused on artemether-lumefantrine which is the first line
      antimalarial for the treatment of uncomplicated malaria in Mainland Tanzania. However, data
      on the performance of other artemisinin based combination therapy (ACTs) is urgently needed
      to support timely review and changes of treatment guidelines in case of drug resistance to
      current regimen. This study was undertaken in the same NMCP framework to assess the efficacy
      and safety of alternative ACTs used or with potential use in Tanzania. The study assessed the
      efficacy and safety of artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP)
      for the treatment of uncomplicated malaria in Tanzania. The study was undertaken at two NMCP
      sentinel sites of Kibaha and Ujiji from July to December 2017.
    


Intervention name(s): Artesunate amodiaquine
Intervention type(s): Drug
Intervention description(s): Drugs were administered under observation of the study nurse for three days
Other intervention name(s): dihydroartemisinin piperaquine
Intervention MeSH terms: Artesunate; Piperaquine; Amodiaquine; Artenimol
Intervention model: Single Group Assignment
Intervention model description: The first group of 88 children were recruited first and given dihydroartemisinin- piperaquine, once the sample size was attained, the second group for artesunate amodiaquine followed and the follow-up for the two groups were running concurrently
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Additional Physician's Consultations and Short Message Service (SMS) Reminders to Patient Compliance
Condition: Lipid Metabolism Disorders
MeSH terms: Metabolic Diseases; Lipid Metabolism Disorders
Study type: Observational

Summary: 
      A systematic collection of retrospective and prospective data based on non-interventional
      patient observation, aimed to assess the risks, course and outcomes of a disease or a group
      of diseases:

        -  the retrospective part: database of patients with cardiovascular risks;

        -  the prospective part: observation of patients in the real world medical practice.
    

Detailed description: 
      The research program will have two parts:

      Stage 1: identification of patients with moderate, high and very high cardiovascular risk,
      not having diseases of atherosclerotic genesis and requiring lipid-lowering drugs.

      Stage 2: a prospective observation of patients receiving primary medical prophylaxis of CVD
      with atorvastatin.
    

Intervention name(s): atorvastatin
Intervention type(s): Drug
Intervention description(s): Profound patients' consultations (different from standard practice) on the importance of primary prevention of cardiovascular diseases, including preventive administration of statins.
Subjects in profound consultation group will receive regular reminders (2 times a month) via SMS and phone calls to check following the doctor's recommendations and remind about follow-up visit to study centre.
Other intervention name(s): SMS and phone call reminders; Patients' consultations
Intervention MeSH terms: Atorvastatin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The total population of patients (2912 people) will be divided into three strata:

        patients with moderate risk of CVD (1242 patients) patients with high risk of CVD (1044
        patients) patients with very high risk of CVD (626 patients). The subjects are randomized
        to a study or control group in each stratum in the ratio of 1: 1
      
Keywords: prevention of cardiovascular diseases; atorvastatin
Monitored vs Standard Supplementation of Vitamin D in Preterm Infants
Condition: Vitamin D Deficiency; Osteopenia; Nephrolithiasis; Drug Overdose
MeSH terms: Bone Diseases, Metabolic; Nephrolithiasis; Kidney Calculi; Vitamin D Deficiency; Drug Overdose
Study type: Interventional

Summary: 
      The purpose of this study is to determine wheather the monitored vitamin D (vit D) therapy is
      safer and more effective than standard therapy in pretrem infants.
    

Detailed description: 
      Vitamin D (vit D) deficiency is a risk factor of osteopenia of prematurity, which leads to
      rickets or decreased bone mass mineral density. Recently multiple studies have been published
      on vit D adjust biological functions. Dosage, safety and effectiveness of vitD
      supplementation in preterm infants still remains a controversial topic. We hypothesize that
      monitored supplementation of vit D is more effective and safer than standard therapy 500IU in
      preterm infants. The study will be carried out in 138 preterm infants, born at 24-32 week of
      gestational age (GA) at the Princess Anne's Hospital in Warsaw, Poland. We will determine if
      monitored supplementation of vit D decreases the incidence of vit D deficiency and/or
      overdosing at 40 week (GA). For secondary objective we shall assess if monitored therapy
      reduces the incidence of vit D deficiency and/or overdosing at 35, 52 week (GA), prevalence
      of osteopenia, low bone mass, nephrocalcinosis and nephrolithiasis.
    

Intervention name(s): monitored vit D supplementation; standard vit D supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The vit D supplementation dose start from dose 500IU from 7th day of age and is modified based on vit D measurement at 4 week of age for infants born <30 GA, at 8 week of age for infants born <26 GA at 35+/-2 weeks PMA(postmenstrual age), +/-at 40+/-2 weeks PMA according to the protocol.; The vitamin D supplementation dose is 500IU from 7th day of age.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vitamin D; supplementation; hydroxyvitamin D; pretrem infants; osteopenia