bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's Syndrome
Condition: Sjögren's Syndrome Patients With Severe Dry Eye
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the therapeutic effect and safety of therapeutic
      bandage contact lenses treating dry eye caused by Sjögren's syndrome.
    

Detailed description: 
      Comparisons were made between Sjögren's syndrome patients with severe dry eye on the
      subjective and objective therapeutic effects of the overnight therapeutic bandage contact
      lenses at different period (i.e. before wearing, after wearing 3 weeks, after another 3 weeks
      with new lens and after 6 weeks without wearing ) based on the results of examinations.
    

Intervention name(s): 0.02% Fm, SH; 0.02% Fm, SH, 0.05% CsA; 0.02% Fm, SH, tBCL; 0.02% Fm, SH, AS
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): Sjogren's Syndrome patients with severe dry eye; Sjogren's Syndrome patients with severe dry eye; Sjogren's Syndrome patients with severe dry eye; Sjogren's Syndrome patients with severe dry eye
Other intervention name(s): baseline treatment; immunosuppression treatment; BCL treatment; Autologous Serum Treatment
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dry eye; Therapeutic bandage contact lenses; The quality of life
Vestibular Stimulation Therapy for Rhythmic Movement Disorder
Condition: Sleep Related Rhythmic Movement Disorder (Disorder)
MeSH terms: Movement Disorders
Study type: Interventional

Summary: 
      This study aims to a) investigate the feasibility of the detection of episodes of RMD using
      contactless 3D video analysis and customised analysis software and b) the use of vestibular
      stimulation as a therapy for childhood rhythmic movement disorder.
    

Detailed description: 
      Rhythmic movement disorder (RMD) is a childhood onset sleep disorder that is characterised by
      repetitive movements that involve large muscle groups, such as body rocking, rolling and head
      banging. These rhythmic movements are performed prior to and during sleep and as such can
      disturb sleep with clinical consequences. There is no standard measure to quantify the
      severity of rhythmic movements. 3D video offers a contactless method of achieving this
      without disrupting the child's sleep. Vestibular stimulation has a soothing effect and might
      be effective in promoting sleep. Furthermore, mild vestibular stimulation in the form of
      gentle rocking movements generated by the Somnomat device might function as a stimulation
      substitute for the child's RMD with therapeutic potential.

      This study aims to a) investigate the feasibility of the detection of episodes of RMD using
      contactless 3D video analysis and customised analysis software and b) the use of vestibular
      stimulation as a therapy for childhood rhythmic movement disorder.
    

Intervention name(s): Somnomat B; Sound
Intervention type(s): Device; Other
Intervention description(s): Vestibular stimulation is provided using an innervated bed platform. This robotic device consists of a standard single bed, mounted on a moving mechanism. It was developed and produced by the ETH Zürich and approved for use in this study by Swissmedic.; Sound of the moving bed was recorded and played back during the baseline night.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Endothelial Dysfunction (BMS vs SES) in the Same Patient With Multiple Coronary Artery Lesions
Condition: Endothelial Dysfunction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a prospective, randomised study to compare the endothelial dysfunction of BMS vs SES,
      both implanted in the same patient with multiple de novo coronary artery lesions undergoing
      elective PCI. The primary end point will be the evaluation of endothelial dysfunction at 6
      months follow-up by measuring the change in vessel diameter in 5 points of the stent and
      peri-stent site after infusion of acetylcholine.
    

Detailed description: 
      This prospective, randomised study compares the endothelial dysfunction of BMS vs SES, both
      implanted in the same patient with multiple de novo coronary artery lesions undergoing
      elective PCI. From february 2009 to may 2009 we aim to enroll 20 patients with at least two
      de novo significant angiographic stenoses in different coronary segments who will have
      similar diameter and length. The primary end point will be the evaluation of endothelial
      dysfunction at 6 months follow-up by measuring the change in vessel diameter in 5 points of
      the stent and peri-stent site after infusion of acetylcholine.
    

Intervention name(s): intracoronary infusion of acetylcholine
Intervention type(s): Drug
Intervention description(s): Acetylcholine will be infused at a concentration of 140 microg/minute, over a period of 2 minutes, yielding estimated intracoronary concentrations of 10(-5)mol/L, with the assumption of a flow rate of 80mL/min). All infusions will be delivered at a constant rate using an infusion pump. Subsequently, in order to evaluate the endothelium-independent vasomotor response, 2mg of isosorbide dinitrate or bolus 250microg of nitroglycerine will be infused by intracoronary bolus in all subjects. The response to nitrate will be recorded 1 minute after the bolus. A 3-min period will be allowed to elapse between each drug infusion.
Other intervention name(s): cypher coroflex
Intervention MeSH terms: Acetylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endothelial dysfunction acetylcholine bms ses
Respiratory Rate Validation Study - ChroniSense Polso
Condition: Respiratory Rate
Study type: Interventional

Summary: 
      20 volunteer test subjects entered into an accuracy study that is designed to validate
      accuracy of the respiratory rate of the ChroniSense Polso
    

Detailed description: 
      20 volunteer test subjects entered into an accuracy study that is designed to validate
      accuracy of the respiratory rate of the ChroniSense Polso.

      A range of stable respiratory rates were elicited from each volunteer test subject. The rates
      will be approximately 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with some
      natural variation from these exact numbers.

      Each subject was instrumented with an open system mask that allows for measurement of the end
      tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor was used as
      the Accuracy Reference Device (Reference) in this study.
    

Intervention name(s): ChoniSense Polso
Intervention type(s): Device
Intervention description(s): A range of stable respiratory rates was elicited from each volunteer test subject. The rates were 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with some natural variation from these exact numbers.
Each subject was instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor was used as the Accuracy Reference Device (Reference) in this study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Ginseng HRG80 in Stress and Fatigue
Condition: Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the effects of a specific herbal preparation of Panax ginseng in
      preventing symptoms of stress in healthy individuals.
    

Detailed description: 
      HRG80 is an herbal preparation of Panax ginseng with a higher concentration of bioavailable
      ginsenosides than typical Korean ginseng. This study will test whether HRG80 is effective at
      preventing symptoms of stress, such as fatigue, impaired memory, difficulty in concentration,
      attention deficit, restlessness, and irritation related to daily work situations of healthy
      individuals in comparison to placebo and a standard Pananx ginseng with a lower concentration
      of ginsenosides.
    

Intervention name(s): HRG80 Panax ginseng; Panax ginseng; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Panax ginseng containing 63.4 mg ginsenosides; Panax ginseng containing 19.6 mg ginsenosides; 800 mg excipient
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Panax ginseng; Red ginseng; Korean ginseng; Adaptogen
Prevention Program Promoting Self Resilience, Positive Self-Image and Body Image Among Adolescents
Condition: Primary Prevention
Study type: Interventional

Summary: 
      The study is a group randomized controlled trial. High school classes were allocated by
      randomization to the intervention or control group by a Randomization function in Excel
      computer program. Outcomes were measured by questionnaire at pre-intervention,
      post-intervention and 3-months follow-up. The study protocol was approved by Tel Hai College
      institutional review board. Parents of all participants, in the intervention and in the
      control group, received information about the program and the study and were asked to provide
      informed consent.
    

Detailed description: 
      The study is a group randomized controlled trial. High school classes were allocated by
      randomization to the intervention or control group by a Randomization function in Excel
      computer program. Outcomes were measured by questionnaire at pre-intervention,
      post-intervention and 3-month follow-up. The study protocol was approved by Tel Hai College
      institutional review board. Parents of all participants, in the intervention and in the
      control group, shall receive information about the program and the study and shall be asked
      to provide informed consent.

      Participants and setting: A high school in the northern region of Israel was recruited for
      the study. 9th and 10th grade classes were chosen to participate in the study, all mixed
      gender classes. All data will be collected within the school setting.

      Program description: "In Favor of a Resilient Self" is an interactive, cognitive behavior
      program aiming to address low resilience, low self-esteem and body dissatisfaction. This
      program is part of a series of intervention programs named "In Favor of Myself" which has
      been in development since 2008. This resilience-based program contains a range of coping
      strategies to help adolescents improve resilience, self-esteem and body image. The program
      consists of nine 90-min sessions delivered by one group leader in the presence of the
      classes' teachers. Participants in the control group shall receive one session of 90 minutes
      of health nutrition education.
    

Intervention name(s): Prevention program: "In Favor of Resilient Self"
Intervention type(s): Behavioral
Intervention description(s): Prevention program: "In Favor of Resilient Self"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: resilience; prevention program; body-image; self-esteem
A Multiple Ascending High Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, randomized, double-blinded, placebo parallel controlled phase 1 study to
      evaluate the safety and pharmacokinetics/pharmacodynamics of multiple (7 days) ascending dose
      (60mg QD, 80mg QD, 100mg Qd) administrationof Anaprazole in healthy Chinese subjects. 45
      subjects, 15 subjects for each dose group. In each dose group, 10 subjects take
      investigational drug (anaprazole), 2 subjects take active comparatory drug (rabeprazole), 3
      subjects take placebo.
    


Intervention name(s): Anaprazole Sodium enteric-coated tablet; Placebo; Active controlled (rabeprazole)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Multiple ascendinng dose, anaprazole 60mg QD(60mg QD group), 80mg QD(80mg QD group), 100mg QD(100mg QD group) , 7 days, fasting oral administration.; Multiple dose, 1 tablet QD (60mg QD,80mg QD and 100mg QD group), 7 days, fasting oral administration.; Multiple dose, rabeprazole 20mg QD (60mg QD,80mg QD and 100mg QD group), 7 days, fasting oral administration.
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mediterranean Diet and Postprandial Lipemia
Condition: Postprandial Lipemia; Type 2 Diabetes
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      The aim of this intervention study was to evaluate in type 2 diabetic patients the effects on
      postprandial lipemia and other metabolic parameters (in both everyday life conditions and
      after a standard test meal) of two diets, one moderately rich in CHO, rich in fibre and with
      a low glycemic index (Mediterranean diet), and the other low in CHO and rich in MUFA (Low-CHO
      diet).Since adipose tissue, mainly through its lipolytic activities, is considered as having
      a pivotal role in the regulation of postprandial lipid metabolism, a further aim of our study
      was to clarify the role of adipose tissue in modulating the postprandial lipid response
      induced by the two dietary approaches by evaluating the activities of lipoprotein lipase
      (LPL) and hormone-sensitive lipase (HSL).
    


Intervention name(s): Mediterranean diet and Low-Carbohydrates diet
Intervention type(s): Other
Intervention description(s): The Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%) versus Low-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%)for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mediterranean diet; Postprandial lipids; Postprandial glucose; High fibre diet; Low- CHO diet; High MUFA diet; Dietary approach
Role of Folinic Acid in Improving the Adaptive Skills and Language Impairment in Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Language Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      No such study has been conducted in Pakistan so the primary objective of this study was to
      determine the role of folinic acid in improving the speech and adaptive skills while
      secondary objective was improvement of stereotype movements and hyperactivity in ASD among
      children aged 3 to 14 years.
    


Intervention name(s): Folinic Acid
Intervention type(s): Drug
Intervention description(s): Folinic Acid was given at the dose of 2mg/kg per day in two divide doses( maximum 50 mg per day) given for 12 weeks
Intervention MeSH terms: Leucovorin; Folic Acid; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Amnion Wound Covering for Enhanced Wound Healing
Condition: Burns; Wound of Skin; Skin Wound
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this research study is to find our if human amnion membrane powder can be
      safely used as a covering for wounds and can improve the condition of skin graft donor sites.
      The amnion powder product is composed of "lyophilized" (freeze-dried), "gamma irradiation
      sterilized" (exposed to bacteria killing radiation) fragments of amniotic membrane.
    

Detailed description: 
      Extensive burns and full thickness skin wounds can be devastating to patients, even when
      treated with our current standard of care. There are an estimated 500,000 burns treated in
      the United States each year. Moreover, in the military environment, soldiers who suffer from
      extensive burn injuries on the battlefield may benefit from rapid treatments that result in
      complete closure and protection of the wounds. As such, there is a need for mobile platform
      technologies that allow fast treatment at the site where the injury occurred, or at the very
      least at the forward operating sites. This safety investigation of a human amnion membrane
      powder product for wound healing is a with-in patient-controlled study, enrolling 10 subjects
      undergoing donor skin graft harvest. The single-center study will include patients undergoing
      donor skin harvest such that two regions, of at least 25 cm2 and separated by at least a 5 cm
      gap, of donor site wounds in comparable skin locations, are available for covering with the
      amnion membrane product and the current institutional standard of care (SOC) covering. The
      proposed sterilized product is composed of lyophilized, gamma-irradiated powder made from
      amniotic membrane for topical application with the purpose of enhanced wound healing.

      The primary objective of the study is to evaluate the safety of a human amnion membrane
      product intended for enhanced wound healing. The secondary objective is efficacy as evidenced
      by complete wound closure relative to standard of care (SOC) treatment in a similar wound on
      the same subject at donor sites created for skin grafts at 14 days and 28 days
      postoperatively.
    

Intervention name(s): Amnion Membrane Powder; SOC Wound Covering
Intervention type(s): Drug; Procedure
Intervention description(s): This sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.; Institutional standard of care wound covering.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human amnion membrane; Autologous skin graft; Scar Formation
Relapse Prevention Study in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Recurrence; Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Iloperidone is effective in the prevention
      of relapse in patients with schizophrenia
    


Intervention name(s): Iloperidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Over-encapsulated iloperidone tablets were administered orally using a bid schedule; the strengths used include 1, 2, 4, 6, 8, 10, and 12 mg.; Matching placebo capsules were administered orally using a bid schedule during the double-blind period.
Other intervention name(s): Fanapt®
Intervention MeSH terms: Iloperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Mental Disorders; Antipsychotic Agents; Iloperidone; Relapse Prevention
To Evaluate the Efficacy of a Nutraceutical in Reducing Cardiovascular Risk in Healthy Subjects
Condition: Cardiovascular Risk
Study type: Interventional

Summary: 
      Single-blind, double-blind, controlled, randomized clinical trial of two parallel branches
      depending on the product consumed (experimental product and placebo product) and
      single-center with the objective of evaluating the effect of the investigational product on
      cardiovascular risk reduction.
    

Detailed description: 
      Subjects who meet the selection criteria will make a total of two visits to the research
      laboratory and will carry out the tests established in the protocol. Subsequently, a
      statistical analysis will be performed with the variables measured in the study to obtain
      results.
    

Intervention name(s): Dietary supplement consumption
Intervention type(s): Dietary Supplement
Intervention description(s): The consumption time was 56 days. Consumed 100 grams daily to consume during the day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Immunogenicity of COVID-19 Vaccine, Inactivated in Healthy Population Aged From 3 to 11 Years
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-labelled, bridging phase Ⅲ clinical trial of COVID-19 Vaccine manufactured by
      Sinovac Research & Development Co., Ltd. The main purpose of this study is to evaluate the
      superiority of the COVID-19 Vaccine in healthy population aged from 3 to 11 years against
      that in adults aged 18-26 years.
    

Detailed description: 
      This study is a single-center, open-labelled, bridging phase Ⅲ clinical trial of COVID-19
      Vaccine.The main purpose of this study is to evaluate the superiority of the COVID-19 Vaccine
      in healthy population aged from 3 to 11 years against that in adults aged 18-26 years.This
      study (PRO-nCOV-3002-1) will be used as a sub-trial of the Phase Ⅲ global multi-center
      clinical trial in children and adolescents(PRO-nCOV-3002) to provide safety and
      immunogenicity data.A total of 1000 healthy children aged 3-11 years will be enrolled
      ,including 500 children aged 3-5 years and 500 children aged 6-11 years.All subjects will
      receive 2 doses of experimental vaccine (600SU) with an interval of 28 days,and adverse
      reactions/events will be collected from all subjects after each dose and SAE and AESI
      monitoring will be completed from the beginning of vaccination to 6 and 12 months after full
      vaccination to evaluate the safety of the vaccine.About 3.0-3.5ml of venous blood will be
      collected from all subjects before immunization, 28 days after the whole immunization, 6
      months after the whole immunization and 12 months after the whole immunization. Neutralizing
      antibody and S antibody will be detected to evaluate the immunogenicity and immune
      persistence of the vaccine.
    

Intervention name(s): COVID-19 Vaccine,Inactivated
Intervention type(s): Biological
Intervention description(s): The COVID-19 vaccine,inactivated was manufactured by Sinovac Research& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection
Other intervention name(s): CoronaVac
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 250 mg/5
      ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.
    


Intervention name(s): Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH); Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cefprozil; Cephalosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotic