bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia
Condition: Community Acquired Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy, safety and tolerance of 2 different
      dose levels of oral NXL103 with oral comparator in the treatment of community acquired
      pneumonia in adults
    


Intervention name(s): NXL103; comparator; NXL103
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 600mg orally twice daily; comparator twice daily; 500mg orally twice daily
Intervention MeSH terms: Streptogramin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CAP; community acquired pneumonia
Stress Reduction in the Prevention of Left Ventricular Hypertrophy
Condition: Left Ventricular Hypertrophy; High Blood Pressure
MeSH terms: Hypertension; Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional

Summary: 
      This study evaluated the effect of stress reduction by Transcendental Meditation (TM) on left
      ventricular mass compared to a health education control group in pre-hypertensive or
      hypertensive African-American adults over a six-month intervention period.
    

Detailed description: 
      Left ventricular hypertrophy (LVH) is an independent risk factor for cardiovascular disease
      (CVD). African Americans have higher rates of LVH and CVD than whites. Substantial evidence
      indicates that psychological stress contributes to LVH. This randomized controlled trial
      evaluated the effect of stress reduction with the Transcendental Meditation (TM) technique on
      left ventricular mass (LVM) in hypertensive African-Americans.

      Hypertensive African American men and women were tested at baseline for left ventricular mass
      index (LVMI) by M-mode echocardiography, blood pressure, lifestyle and behavioral factors.
      Subjects were randomly assigned to either TM or health education (HE) control. After six
      months intervention, 86 subjects were posttested on all outcomes. Data were analyzed for
      between-group and within-group differences.
    

Intervention name(s): meditation; Health education control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): meditation practice 20 minutes twice a day at home and attending classes at the clinic.; didactic based classes in CVD risk factor reduction and prevention
Other intervention name(s): stress reduction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, controlled, single-blinded, clinical trial was conducted to compare the effect of Transcendental Meditation (TM) and health education (HE) on left ventricular mass in adult hypertensive African-Americans
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: left ventricular mass; meditation; stress reduction
Single Oral Dose Escalation Study of DNDI-0690 in Healthy Subjects
Condition: Visceral Leishmaniasis; Cutaneous Leishmaniases
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate how the test medicine DNDI-0690 is taken up and broken down by the
      body and will also look at the safety and tolerability of the test medicine after a single
      dose. This is the first time the test medicine DNDI-0690 will be administered to humans.
    

Detailed description: 
      DNDI-0690 is intended to be used as oral treatment for Visceral Leishmaniasis with potential
      for the cutaneous form of the disease, Cutaneous Leishmaniasis. The present protocol
      describes the first-in-human (FIH) study with DNDI-0690.
    

Intervention name(s): DNDI-0690; Placebo of DNDI-0690
Intervention type(s): Drug; Drug
Intervention description(s): capsules of 10, 100 and 200 mg; capsules of matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single Ascending Dose
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: First-in-human; single ascending dose; healthy volunteer
Peri Implant Marginal Bone Height and Bone Density
Condition: Implant Site Reaction
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of mandibular implant supported removable overdenture
      on bone height and density and compare it with implant supported fixed overdenture in single
      mandibular overdenture.
    

Detailed description: 
      In this study 10 patients will be selected following inclusion and exclusion criteria. In
      each group 5 patients (each patient will receive 6 implants) will be divided randomly into
      two groups.

      Group I patients will receive mandibular implant supported removable overdenture, while Group
      II will receive mandibular implant supported fixed overdenture.

      All patients will be given the usual home care instructions about wearing and caring of
      dentures and opposing arch. Regarding dentures, removal of them at night and cleaning with
      denture brush and mild soap will be required. Measurements of Bone height and Bone density
      will be obtained by using Cone Beam Computed Tomography (CBCT).

      Measurements will be obtained at denture insertion, after 1 month and after 3 months.
    

Intervention name(s): assessment of change in bone height by cone beam computed tomography
Intervention type(s): Device
Intervention description(s): bone height was measured at 1 ,30 ,90 days after denture insertion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: group 1 mandibular implant supported overdenture group 2 mandibular implant supported fixed overdenture
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bone height; Bone density; Implant supported
Evaluate the Efficacy of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps
Condition: Sleep-related Leg Cramps
MeSH terms: Muscle Cramp
Study type: Interventional

Summary: 
      Sleep-related leg cramps (SRLCs) are a sleep-related movement disorder whereby painful
      contractions of the calf or foot muscles arise at sleep onset and during sleep and awaken the
      patient, interrupting sleep. Application of oral administration with Chinese herbal medicine
      can enhance the effectiveness and efficacy in treatment of SRLCs.This study will using
      Shaoyao Gancao Prescription Jiawei by adding Pueraria montana, Salvia Miltiorrhiza, into
      Shaoyao Gancao. The study aims to evaluate the effectiveness of a Shaoyao Gancao Prescription
      Jiawei in relieving leg cramps.
    

Detailed description: 
      The study will be conducted in Yan Oi Tong Mrs Shirley W K Siu Medical Centre. All
      participants diagnosed with sleep-related leg cramp will be screened for eligibility criteria
      from the general public or referred patients via daily outpatient services. This will be a
      prospective trial in patients with sleep-related leg cramps (SRLCs). 30 subjects will be
      recruited from Yan Oi Tong Mrs Shirley W K Siu Medical Centre. The medication will be taken
      twice daily for 28 consecutive days. Each prescription will consist of 4 herbal granules.
      Study follow up will be offered every 7 days till 56th day after enrolment. Daily leg cramps
      log will be filled in by each individual everyday from day 0 to day 56.
    

Intervention name(s): Shaoyao Gancao Decoction Jiawei
Intervention type(s): Drug
Intervention description(s): Study herb will be prescribed for 28 consecutive days. Study follow up will be offered every 7 days till 56th day after enrolment.
Daily leg cramps log will be filled in by each individual everyday from day 0 to day 56.
Other intervention name(s): Nong's Concentrated Chinese Medicine Granules
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Omegia Softgel Clinical Research Program
Condition: Skin Manifestations; Antioxidative Stress; Eye Strain; Vaginal Disease
MeSH terms: Asthenopia; Vaginal Diseases; Skin Manifestations
Study type: Interventional

Summary: 
      Evaluate the improvement of regulation of skin and blood index composition after consumption
      of Omegia® Softgel
    

Detailed description: 
      The blood biochemical analysis at Weeks 0 and 12, including Catalase, Tumor necrosis
      factor-α, Cholesterol, Triglyceride, High-density lipoprotein-Cholesterol and Low-density
      lipoprotein- Cholesterol.

      The Skin assessment at Weeks 0, 4 and 12, including Skin brightness, Skin redness sensitivity
      index, Skin moisture, Skin elasticity, Facial skin pores, Facial skin texture and Skin
      collagen content.
    

Intervention name(s): Omegia® Softgel -B; Omegia® Softgel -A
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): How to use: Take once a day for 12 weeks Subject precautions: If the health products and cosmetic care products used contain sea buckthorn ingredients, stop using them.; How to use: Take once a day for 12 weeks Subject precautions: If the health products and cosmetic care products used contain sea buckthorn ingredients, stop using them.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
The Activity School in Finnmark for Overweight Children
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of a life style counseling
      programme designed for overweight and obese children and their parents in groups compared to
      traditional individual counseling in the pediatric outpatient clinic and the community. The
      two interventions are both hospital and community based.
    

Detailed description: 
      Randomized study design with two parallel groups.Active intervention in two years, last
      follow-up after 3 years.
    

Intervention name(s): Lifestyle counseling in groups; Individual intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The activity school in Finnmark. Lifestyle counseling (physical activity and dietary modification) in groups both at the hospital and in their own municipality.
They meet a multidisciplinary team, receive organized physical activity in the municipality and are invited to a 3 days camp after 4-6 months.; Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: childhood; therapy; life style; motor activity; obesity; overweight; body mass index; treatment
Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine
Condition: Meningitis
MeSH terms: Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this double-blind study is to evaluate the safety, reactogenicity and
      immunogenicity of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine in 2 to 30
      years-old Children and Adults. All subjects will receive 1 dose of Group A,C,Y and W135
      Meningococcal Polysaccharide Vaccine.
    


Intervention name(s): Group T; Group C
Intervention type(s): Biological; Biological
Intervention description(s): 0.5ml, Intramuscular; 0.5ml, Intramuscular
Other intervention name(s): vaccine made by Beijing Minhai Biotechnology Co., Ltd; vaccine made by Hualan Biological Engineering, INC
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: safety, immunogenicity, Meningococcal Polysaccharide Vaccine
Sensory Analysis and Taste Modulation of Ketone Esters
Condition: Flavor Perception in Normal, Healthy Adults
Study type: Interventional

Summary: 
      Ketone ester (KE) drinks are sold commercially in the USA and elsewhere (the FDA has accepted
      a GRAS (generally regarded as safe) notification on the KEs we propose to study). KE drinks
      can have beneficial effects on metabolism. Unfortunately, KE drinks have a strongly
      unpleasant flavor which can trigger rejection. The current study will generate data to help
      inform KE drink formulations with improved flavor. First stage, trained subjects will rate
      the intensity of various sensation qualities (e.g., bitter, sour, metallic, and astringent)
      from KE drinks to help understand the nature of the unpleasant flavor and the particular
      sensory systems involved (e.g., taste vs. smell). Then, subjects will taste KE drinks with
      and without various flavor modifiers. Subjects will be healthy adults (aged 21-45) without
      known food allergies.
    


Intervention name(s): Flavor additive
Intervention type(s): Other
Intervention description(s): Various flavor additives will be tested (vs. no added flavor) to determine which show promise for making KE drinks taste less unpleasant
Intervention model: Single Group Assignment
Intervention model description: Within-subjects design (the same group of subjects will taste model KE drinks with vs. without added flavors), with order counter-balanced.
Masking: None (Open Label)
Primary purpose: Other
Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes
Condition: Diabetes; Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 4

Summary: 
      Long-standing diabetes is often complicated by retinopathy. The mechanisms that induce the
      development of diabetic retinopathy are incompletely understood and include alterations in
      bone marrow derived vasculogenic cells called "endothelial progenitor cells".

      Fenofibrate is a PPAR-alpha agonist used for the treatment of mixed dislipidemia and
      hypertriglyceridemia. In a trial conducted in type 2 diabetic patients, the drug fenofibrate
      has reduced retinopathy-related endpoints suggesting a direct effect of the drug on the
      mechanisms that drive the development of this complication.

      Herein, the investigators hypothesize that fenofibrate treatment can increase circulating EPC
      levels in diabetic patients with retinopathy, compared to placebo.
    

Detailed description: 
      Long-standing diabetes is often complicated by retinopathy. The mechanisms that induce the
      development of diabetic retinopathy are incompletely understood and include alterations in
      bone marrow derived vasculogenic cells called "endothelial progenitor cells".

      Fenofibrate is a PPAR-alpha agonist used for the treatment of mixed dislipidemia and
      hypertriglyceridemia. In addition to lowering triglyceride-rich lipoproteins, PPAR-alpha
      agonism with fenofibrate has several additional molecular benefit on the vessel wall, such as
      reduction of inflammation. In a trial conducted in type 2 diabetic patients, the drug
      fenofibrate has reduced retinopathy-related endpoints suggesting a direct effect of the drug
      on the mechanisms that drive the development of this complication.

      Preliminary data of ours on the effects of fenofibrate on cultured EPC show that this drug
      has the potential to improve EPC and, consequently, may benefit patients with retinopathy.

      Herein, the investigators hypothesize that fenofibrate treatment can increase circulating EPC
      levels in diabetic patients with retinopathy, compared to placebo.
    

Intervention name(s): Fenofibrate 145 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets of Fulcrosupra 145 mg to be taken at 8.00 am daily for 12 weeks.; Oral Placebo tablets once daily
Other intervention name(s): Fulcrosupra 145 mg; Placebo control
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Stem cells; Regeneration; Angiogenesis; Prevention
Study of Efficacy and Safety of MEXIDOL®
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter, prospective, randomized, double-blind, placebo-controlled, parallel group
      study in patients with stroke
    


Intervention name(s): MEXIDOL® (ethylmethylhydroxypyridine succinate); Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Emoxypine succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of High Oleic Palm Olein, Virgin Olive Oil and Coconut Oil Diets on Markers Selected in Malaysian
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study will be comparing human body responses by the effects of diets cooked with
      NoveLin, virgin olive oil and RBD coconut oil.
    

Detailed description: 
      NoveLin has high content of monounsaturate fatty acids - oleic acid (C18:1) which is the
      predominant fatty acid and in this study NoveLin is used as cooking fat in compare with olive
      oil. Olive oil is the world's most commonly eaten monounsaturated oil which contains 55 - 83%
      oleic acid. Consumption of olive oil gives numerous health benefits on lowering total and LDL
      cholesterol, reducing LDL cholesterol's, lowering blood clotting factors, and lowering blood
      pressure. Coconut oil is the richest source of medium chain fatty acid and it has greater
      than 90% of saturated fatty acid with dominant fatty acid of lauric acid (C12:0). RBD coconut
      oil is used as positive control in this study.
    

Intervention name(s): diets
Intervention type(s): Other
Intervention description(s): Feeding trial for 6 weeks (week 0 - baseline). The experimental diets are comprised of 30% kcal fat, 15% kcal protein and 55% kcal carbohydrate. Each of the test fat contributes to two-thirds of total dietary fat will be compared.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacodynamic and safety of MBA-P01 in Healthy Male Volunteers
    


Intervention name(s): MBA-P01; BOTOX
Intervention type(s): Drug; Drug
Intervention description(s): injection of MBA-P01 into the muscle of each contralateral foot in equal doses; injection of BOTOX into the muscle of each contralateral foot in equal doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Hemodynamic Effects on Cerebral Autoregulation in Acute Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational

Summary: 
      This study investigates if there are hemodynamic alterations in acute stroke that predispose
      patients to impaired perfusion and regulation of cerebral blood flow. To test this, we will
      target recruitment of acute ischemic stroke patients who present to the ED within 12 hours of
      symptoms onset. Enrolled subjects will receive continuous noninvasive hemodynamic monitoring
      contemporaneous with measurements of cerebral blood flow velocities and cerebral oximetry.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Acute (< 12 hours) ischemic stroke patients presenting to the Emergency Department
      
Keywords: stroke; transcranial doppler; cerebral blood flow; cardiac output; non-invasive hemodynamic monitoring
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept
      relative to Process C belatacept in Healthy subjects
    


Intervention name(s): Process E Belatacept; Process C Belatacept
Intervention type(s): Biological; Biological
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 or A*02-positive Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, the investigators examine using a combination of two types of HLA-A*2402 (or
      HLA-A*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the
      safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor
      patients who are refractory to standard therapy.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability, immune response and
      clinical efficacies of HLA-A*2402 or HLA-A*0201 restricted epitope peptides (VEGF-R1 and
      VEGF-R2) emulsified with Montanide ISA 51 for advanced solid tumors.

      In this phase I/II trial, the investigators examine using a combination of the two peptides
      the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402 or
      HLA-A*0201-positive advanced solid tumor patients who are refractory to standard therapy.
    

Intervention name(s): HLA-A*2402 or A*0201 restricted peptides
Intervention type(s): Biological
Intervention description(s): Open Label, Non-Randomized, Safety/Efficacy study:
HLA-A*2402-positive patients will be vaccinated subcutaneously once a week with HLA-A*2402 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.
HLA-A*0201-positive patients will be vaccinated subcutaneously once a week with HLA-A*0201 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment