bioihbjkbjnl/mcl2 huggingface dataset:
Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention
Condition: Acute Anterior Myocardial Infarction
MeSH terms: Myocardial Infarction; Anterior Wall Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Rapid MI-ICE-Pilot is designed to demonstrate the safety and efficacy of the Celsius Control™
      System (CCS) endovascular catheter to reduce the infarct size resulting from acute anterior
      myocardial infarction when used in combination with cold saline as an adjunct to immediate
      percutaneous coronary intervention (PCI) in patients with an occluded infarct-related artery.
    

Detailed description: 
      The CCS is an endovascular thermal control system that circulates cooled saline through an
      indwelling central venous catheter in a closed-loop manner. The system has received 510(k)
      approval from the FDA for use in temperature management in neuro-surgical and cardiac
      patients during surgery and in recovery/intensive care. It has also received European CE mark
      and Australian TGA approval. Animal data in a model of acute myocardial infraction support
      the hypothesis that rapid cooling, prior to acute PCI, may reduce infarct size. Meta-analysis
      of the previous acute MI trials ICE-IT (N = 228; 1:1 randomization, hypothermia : control,
      Innercool Therapies, Inc.) and COOL MI-I (Radiant Medical, Inc) suggests there is a reduction
      in infarct size as measured by 30-day SPECT in the population of patients with anterior MIs
      who were cooled below 35 C prior to PCI.

      This study is designed to investigate the safety, feasibility and efficacy of rapid
      endovascular cooling in the setting of acute PCI in patients with anterior infarctions.
    

Intervention name(s): Endovascular cooling by the Celsius Control System; Standard of care
Intervention type(s): Device; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myocardial infarction; acute intervention; percutaneous intervention; endovascular cooling; endovascular rewarming
Safety Study of Tecadenoson to Treat Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      Assess the tolerability and safety of a rapid bolus of tecadenoson at different dose levels
      when given alone and in combination with a beta-blocker (esmolol) in patients with atrial
      fibrillation to control rapid heart rate. Explore the pharmacokinetic and pharmacodynamic
      effects when given alone and in combination with beta-blocker (esmolol).
    


Intervention name(s): Tecadenoson; Esmolol
Intervention type(s): Drug; Drug
Intervention description(s): Tecadenoson administered intravenously (i.v.); Esmolol low dose infusion according to manufacturer's instructions
Other intervention name(s): CVT-510; Brevibloc®
Intervention MeSH terms: Esmolol; Tecadenoson
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diacerein as Adjuvant to Diclofenac Sodium in Indian Patients of Osteoarthritis (OA) Knee
Condition: Osteoarthritis; Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate clinical effectiveness of diacerein as add on
      therapy to diclofenac sodium in Indian patients of osteoarthritis (OA) knee.
    

Detailed description: 
      Currently symptomatic relief is provided by the use of nonsteroidal anti-inflammatory drugs
      (NSAIDs) but they do not reverse the basic pathology of disease, rather may accelerate it,
      like degeneration of cartilage, inhibition of chondroitin synthesis and suppression of
      proteoglycans synthesis by the chondrocyte.

      Research shows that IL-1β plays a fundamental role in osteoarthritis pathophysiology and
      cartilage destruction. Diacerein, a purified compound with anthraquinonic structure, inhibits
      IL-1β, retarding all pathological processes initiated in OA. Also, Diacerein has proven
      analgesic efficacy comparable to that of diclofenac in patients of osteoarthritis knee12.
      Because of these factors, the present study has been planned to evaluate the clinical
      effectiveness of diacerein as add on therapy to diclofenac sodium in Indian patients of
      symptomatic OA knee.
    

Intervention name(s): diacerein
Intervention type(s): Drug
Intervention description(s): Diclofenac sodium 75mg sustained release tablet once daily was given to both groups for 3 months. Capsule diacerein 50mg in study group and matched placebo in control group were given once daily for first month and twice daily for next two months with the main meals.
Intervention MeSH terms: Diacerein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: OA; knee
A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06372865 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate safety, toleration and time course of plasma
      concentration of multiple oral doses of PF-06372865 for 14 days in healthy subjects of two
      age groups, 18-55 years (Group 1) and 56-75 years (Group 2).
    


Intervention name(s): PF-06372865; Placebo; PF-06372865; Placebo; PF-06372865; Placebo; PF-06372865; Placebo; PF-06372865; Placebo; PF-06372865
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, 2.5 mg BID, 14 days; Tablets, BID, 14 days; Tablets, to be decided dose, BID or titration, 14 days; Tablets, BID or titration, 14 days; Tablets, to be decided dose, BID or titration, 14 days; Tablets, BID or titration, 14 days; Tablets, to be decided dose, BID or titration, 14 days; Tablets, BID or titration, 14 days; Tablets, to be decided dose, BID or titration, 14 days; Tablets, BID or titration, 14 days; Tablets, to be decided dose, BID or titration, 14 days
Intervention MeSH terms: PF-06372865
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Multiple dose; safety; tolerability; PK
Acute Effect of Crocus Sativus on Postprandial Glycemia
Condition: Potential Abnormality of Glucose Tolerance; Appetitive Behavior; Blood Pressure
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      This study investigated the effects of two different doses of Crocus Sativus in glucose
      beverages on glycemic responses.
    

Detailed description: 
      This study examined the short-term effects of two different doses (15 mg and 30 mg) of Crocus
      Sativus in glucose beverages on postprandial glycemic responses in healthy young adults.
    

Intervention name(s): D-Glucose beverage as reference food; 15mg of Crocus Sativus as beverage; 30mg of Crocus Sativus as beverage
Intervention type(s): Other; Other; Other
Intervention description(s): Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.; Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.; Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover, double blind, randomized clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Crocus sativus; Blood glucose responses; blood pressure; subjective appetite; blood glucose concentrations
Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers
Condition: Short Bowel Syndrome; Malabsorption; Malnutrition
MeSH terms: Short Bowel Syndrome; Malabsorption Syndromes; Malnutrition
Study type: Interventional

Summary: 
      12 month study testing mobile delivery of health information and connections to professionals
      and peers to improve health of teen/young adult HPN users.
    

Detailed description: 
      This research study will test the effect of in-home/mobile HPN support delivered to teen and
      young adult home parenteral nutrition (HPN) patients and family members over handheld
      personal computers. Effects on health status, QoL, and fatigue will be assessed over time
      between groups of study subjects from the ages of 13 through 30 randomized to one of two
      groups. Group One (intervention group) will receive mConnect, integrated evidence-based
      interventions (skill-building games, restorative naps & peer support) via mobile iPad and
      Internet delivery plus two real-time audiovisual encrypted connections with multidisciplinary
      professionals and peers. Group Two (control group) will receive healthy activity information
      via mobile iPad and Internet delivery plus one real-time audiovisual encrypted connection
      with professionals and peers.
    

Intervention name(s): mConnect plus mobile connections to multidisciplinary professionals & peers; iPad use plus one mobile connections to multidisciplinary professionals & peers
Intervention type(s): Behavioral; Behavioral
Intervention description(s): mConnect is the integration of evidence-based HPN interventions delivered via professionally moderated iPad visual meetings with peers, and reinforced by HPN related skill-building games (apps) and iPad music guided short naps.; iPad with a data plan and one professionally moderated iPad visual meeting with peers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Home Parenteral Nutrition; HPN; Total Parenteral Nutrition; TPN; mConnect; SBS; short bowel disorder; telehealth; telemedicine
Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts
Condition: Deep Partial Thickness Burn; Full Thickness Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 4

Summary: 
      This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5
      centres in the US with deep-partial of full thickness burns in need of skin grafts will be
      enrolled.The subjects will be equally randomised to either treatment with Mepitel One or
      bridal veil together with staples.

      The primary objective is to compare pain at the time of dressing change for the use of
      Mepitel One versus bridal veil together with staples on deep partial or full thickness burns
      requiring skin grafts.
    

Detailed description: 
      Skin grafts are placed over excised areas of full thickness injuries and usually attached
      with sutures or staples. While useful in anchoring the graft in place, subjects often
      complain of pain from the staples as wound healing progresses.Pulling and sticking are common
      complaints.There is also a possibility that staples become embedded in the graft which leads
      to disruption of otherwise healed area, increased pain and anxiety for the subject as well as
      anxiety for the staff.

      Graft take can be optimized with appropriate medical management. Use of non-adherent
      dressings to protect the graft is customary. Various types of netting-style are used, such as
      Bridal veil, a sterile product which is fixed over the graft with staples.

      Silicone net dressings have also been used successfully to prevent lifting and adherence of
      skin grafts to the dressings, prevent pain and promote healing. Mepitel One is a sterile,
      transparent, and flexible wound contact layer consisting of perforated polyurethane film
      coated with Safetac soft silicone adhesive on one side. Mepitel One is available in various
      sizes and can be left in place for several days depending on the wound/skin condition.

      Evaluation of burns will be performed at Baseline. Skin graft assessment will be performed at
      Day 7 and Day 14. End of study will be considered the time that graft is considered to have
      >95% take.
    

Intervention name(s): Mepitel One
Intervention type(s): Device
Intervention description(s): Dressing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Split thickness skin grafts; Mepitel One; Bridal Veil and staples; Pain
Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306
      tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in
      the study protocol.
    


Intervention name(s): BI 409306; BI 409306; BI 409306; BI 409306; placebo; placebo; BI 409306
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablet; tablet; tablet; tablet; placebo tablet; placebo tablet; tablet
Intervention MeSH terms: BI 409306
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)
Condition: Atherosclerotic Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a))
      levels among participants with a history of ASCVD as defined by their medical history and is
      2-fold:

        -  Evaluate the distribution of Lp(a) value in the overall participants with documented
           history of ASCVD

        -  Evaluate the distribution of Lp(a) value in participants with documented history of
           ASCVD by demographics and regions
    


Intervention name(s): Lp(a) Screening
Intervention type(s): Other
Intervention description(s): Participants will provide demographic information and have a blood draw for Lp(a) levels if they are unknown.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Atherosclerotic Cardiovascular Disease; Lipoprotein(a)
The Difference Between Acupuncture and Far-infrared Ray Illumination at CV12 Acupoint
Condition: Reaction of Autonomic Nervous System; Reaction of Acupuncture; Reaction of Far Infrared Ray
Study type: Interventional

Summary: 
      The purpose of the study was to investigate the changes of Ryodoraku value at 12 source
      acupoints, and heart rate viability (HRV) when acupuncture or far-infrared ray illumination
      applied to CV12 acupoint.
    

Detailed description: 
      Acupuncture and far-infrared ray illumination at CV12 acupoint have been widely used to treat
      many diseases in clinic. To our knowledge, the report is about the different reaction on
      autonomic nervous system between acupuncture and far-infrared illumination is very rare until
      now.Therefore,the study was to investigate the different changes on autonomic nervous system
      from Ryodoraku value at 12 source acupoints and heart rate viability (HRV) when acupuncture
      or far-infrared ray illumination applied to CV12 acupoint.
    

Intervention name(s): acupuncture and far-infrared ray
Intervention type(s): Procedure
Intervention description(s): During experimental phase,inserting the needle of acupuncture into CV12 acupoint or using far-infrared ray to illuminate on CV12 20 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Ryodoraku; Heart Rate Variability; Traditional medicine; Autonomic Nervous System; Acupuncture; Far Infrared Ray; CV12 Acupoint
Allogenic Cord Blood Transfusion in Patients With Autism
Condition: Autism Spectrum Disorder; Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by
      social interaction abnormalities, impaired verbal and non-verbal communication, and
      repetitive, obsessive behavior, while the therapeutic effect of current treatments remains
      limited progress.

      The possible reason for ASD is neural hypoperfusion and immune deregulation. The Human
      Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to
      modulate the immune response and enhance angiogenesis, suggesting the novel and promising
      therapeutic strategy. In this study, the safety and efficacy of hUCB-MNCs infusion will be
      evaluated in patients with Autism.
    

Detailed description: 
      Autism Spectrum Disorders (ASD) are heterogeneous neuro-developed disorders. Autism is the
      most common disorder of the diseases characterized by dysfunctions in response social
      interaction and communication, as well as the presence of repetitive and stereotyped
      behaviors. Recent reports of a sharp increase in the number of children with autism. The
      exact etiology of autism remains unclear. Compliance, the definition of effective treatments
      for autism is particularly difficult.

      Although it has been understood, it can be a question of immune dysregulation. Examination of
      the inflammatory cytokines, dysfunction of the immune system and the immune system. The Human
      Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to
      modulate the immune response and enhance angiogenesis, suggesting the novel and promising
      therapeutic strategy. The Our study suggest that infusion of cord blood mononuclear cells
      will affect Autism.
    

Intervention name(s): ASD CB-MNC injection.; Standard therapy.
Intervention type(s): Biological; Other
Intervention description(s): CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.; The standard therapy can include drugs, special psychology training etc.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is prospective, non-randomized (open label) with control group study. The total 20 patient will be enrolled in this study. In 10 patient with ASD will be infused with umbilical corb blood. Other 10 patient with ASD will be treated with standard therapy (control group).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism, ASD, Cord blood
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of IBI362 in Chinese
      patients with Type 2 Diabetes.
    


Intervention name(s): IBI362; placebo; Dulaglutide
Intervention type(s): Drug; Other; Other
Intervention description(s): IBI362 administered subcutaneously (SC) once a week.; placebo administered subcutaneously (SC) once a week.; Dulaglutide administered subcutaneously (SC) once a week.
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery
Condition: Ambulatory Surgical Procedures
MeSH terms: Emergence Delirium
Study type: Interventional

Summary: 
      Emergence agitation/delirium (EA/ED) is a common complication in pediatric surgery patients,
      which increases the risk of developing postoperative airway obstruction and respiratory
      depression. In infants, there is a high incidence of emergence agitation (EA) after
      desoflurane anesthesia. The aim of the present preliminary study was to determine the safety
      and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent
      postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia
    

Detailed description: 
      subjects who underwent day surgery were stratified into two age groups as follows: low to 3
      years group, and 3-12 years group. Then they were randomly assigned to receive one of six
      doses of intravenous dexmedetomidine: 0, 0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.
    

Intervention name(s): 0.2ug/kg dexmedetomidine; 0.4ug/kg dexmedetomidine; 0.6ug/kg dexmedetomidine; 0.8ug/kg dexmedetomidine; 1.0ug/kg dexmedetomidine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision; subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision; subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision; subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision; subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
Other intervention name(s): Age; Age; Age; Age; Age
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The aim of the present preliminary study was to determine the safety and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia. Subjects who underwent day surgery were stratified into two age groups as follows: low to 3 years, and 3-9 years. Then they were randomly assigned to receive one of six doses of intravenous dexmedetomidine: 0,0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Emergence Delirium; desoflurane; general anesthesia