bioihbjkbjnl/mcl2 huggingface dataset:
Myocardial Protection and Anesthetic Agents
Condition: Myocardial Ischemic Reperfusion Injury
MeSH terms: Reperfusion Injury; Myocardial Reperfusion Injury
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to investigate the myocardial protective effects of remifentanil
      and dexmedetomidine in cardiac surgery.
    

Detailed description: 
      Fifty patients is included in this study. Routine monitorization included a 5-lead
      electrocardiogram (ECG), invasive arterial monitoring, pulse oximetry, capnography,
      temperature monitoring. Invasive arterial catheter were inserted under local anesthesia.
      Central venous catheter (jugular or subclavian) and esophageal heat probe were inserted after
      tracheal intubation.

      Anesthesia induction was standardized in all patients and included 1 mg/kg propofol, 1 μg/kg
      fentanyl and 0.1 mg/kg vecuronium bromus to facilitate endotracheal intubation. The patients
      were divided into two groups by computer randomization method. Group R (n=25), remifentanil
      group and Group D (n=25) dexmedetomidine group. In the remifentanil group, anesthesia was
      maintained with 0.5-1.5% sevoflurane and 0.125-0.25 μg/kg/min remifentanil infusion. In the
      dexmedetomidine group anesthesia was maintained with 0.5-1.5% sevoflurane and 0.5 μg/kg
      dexmedetomidine loading dose during 10 minute and 0.3-0.9 μg/kg/min infusion.

      Cardiopulmonary bypass (CPB) period was started after aort and venous cannulae were inserted.
      Mean arterial pressure, central venous pressure, venous oxygen saturation (SVO2) and arterial
      blood gase analysis were recorded. All blood samples include laktat, pyruvate, CKMB and
      Troponin-T were taken via the coronary sinus catheter at specific time intervals
      (precardiopulmonary bypass, 20 minutes after cross clamp, 20 minutes after removal cross
      clamp and 10 minutes after cardiopulmonary bypass).

      Cardiopulmonary bypass time, aortic cross clamping time, the need of
      defibrillation/intraaortic balloon pumping (IABP)/extracorporeal membrane oxygenator (ECMO),
      urine output, positive inotropic agents requirement were recorded. At the end of surgery, the
      patients were transferred intensive care unit intubated and full monitorized.
    

Intervention name(s): Remifentanil; Dexmedetomidine; Sevoflurane
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Dexmedetomidine; Remifentanil; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC74647 in HCV-infected Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to assess the tolerability, pharmacokinetics and antiviral activity
      of HEC74647 in HCV treatment naïve subjects with genotypes 1-6.
    

Detailed description: 
      All subjects will be receive QD doses of HEC74647 or the matching placebo for 3 days to
      assess the the tolerability, pharmacokinetics and antiviral activity at specified time-points
      during the study.All subjects also will be monitored for up to 8 days post-dose to determine
      the persistence of viral mutations.
    

Intervention name(s): HEC74647PA capsule; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule administered orally once daily; HEC74647PA capsule matching placebo administered orally once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia
Condition: Schizophrenia; Negative Symptoms; Cognitive Dysfunction
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      Negative symptoms and cognitive dysfunction in schizophrenia (CDS) are core features of
      schizophrenia. These negative symptoms and cognitive deficits have a devastating impact on
      the function, employment, and social interactions of patients with schizophrenia. Medications
      used to treat schizophrenia (e.g. atypical antipsychotics) do not improve negative symptoms
      or CDS. TC-5619 is being developed for use as an add-on therapy in combination with atypical
      antipsychotics to treat patients with negative symptoms and CDS.
    


Intervention name(s): TC-5619; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine
    


Intervention name(s): BMS-986165; Pyrimethamine
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of tablet BMS- 986165; Oral administration of Pyrimethamine in combination with BMS-986185
Intervention MeSH terms: Pyrimethamine; Deucravacitinib
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of YH14617 in Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to assess the safety, efficacy and pharmacokinetic of YH14617
      after once weekly or biweekly injection in patients with type 2 Diabetes Mellitus to
      investigate the optimal recommended dosage. Study period is 20 weeks including 12 weeks of
      treatment period and 8weeks of follow-up period without treatment.
    


Intervention name(s): YH14617; YH14617; YH14617; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1mg once weekly; 1.6mg once weekly; 2mg once biweekly; Once weekly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; YH14617; Exenatide; Yuhan
Effect of Motor Cortex Versus Sacral Magnetic Stimulation in Multiple Sclerosis Patients With Urinary Tract Dysfunction
Condition: Multiple Sclerosis; Lower Urinary Tract Symptoms
MeSH terms: Multiple Sclerosis; Sclerosis; Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      This work is intended to assess the effect of repetitive magnetic stimulation on the sacral
      roots versus repetitive magnetic stimulation on motor cortex in multiple sclerosis patients
      with the lower urinary tract dysfunction.
    

Detailed description: 
      Twenty Multiple sclerosis patients with lower urinary tract symptoms will be receiving
      repetitive magnetic stimulation on sacral roots. Another twenty Multiple sclerosis patient
      with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on motor
      cortex. Treatment outcome will be assessed and compared between the two groups.

      Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second
      pause were delivered for a total of 1000 pulses (total duration: 16 minutes) once a day for
      four consecutive days for two weeks.
    

Intervention name(s): magnetic stimulation
Intervention type(s): Other
Intervention description(s): Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: magnetic stimulation, multiple sclerosis
Safety and Efficacy Evaluation of IM19 CAR-T Cells (IM19CAR-T)
Condition: Leukemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19
      Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia.
    

Detailed description: 
      Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19
      Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia and determine the best
      dosage.
    

Intervention name(s): IM19 CAR-T; fludarabine and cyclophosphamide
Intervention type(s): Biological; Drug
Intervention description(s): T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor; Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days
Other intervention name(s): IM19; FC
Intervention MeSH terms: Cyclophosphamide; Fludarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Children Immune Functions(2)
Condition: Diarrhea; Upper Respiratory Infections
MeSH terms: Infections; Respiratory Tract Infections; Diarrhea
Study type: Interventional

Summary: 
      To investigate the effect of milk-based formulas on infections and immune functions in
      healthy children.
    

Detailed description: 
      Particular attention was paid to the role played by nutrition in supporting the gut
      ecosystem, balancing microbiota and promoting health status. In that respect, the beneficial
      effects of probiotics were demonstrated for different infectious diseases, GII and URI.

      The beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly
      documented.
    

Intervention name(s): Milk with Bifidobacteria; Milk with non replicating lactobacilli; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.; A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.; A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Diarrhea; Children; Lactobacilli
High-activity Natural Killer Immunotherapy for Small Metastases of Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of high-activity natural killer
      immunotherapy to small metastases of pancreatic cancer.
    

Detailed description: 
      By enrolling patients with small metastases of pancreatic cancer adapted to enrolled
      criteria, this study will document for the first time the safety and the short and long term
      efficacy of high-activity natural killer cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): High-activity natural killer
Intervention type(s): Drug
Intervention description(s): Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
Other intervention name(s): HANK cell
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic pancreatic cancer; High-activity natural killer Immunotherapy
Effect of Botox and Vibration on Bone in Children With Cerebral Palsy
Condition: Cerebral Palsy; Muscle Spasticity
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy (CP) is a neuromuscular disorder that affects approximately 800,000
      individuals in the U.S. An estimated 70-80% of these individuals have spasticity which
      affects ambulation and requires management. Therefore, the treatment of spasticity is a
      primary goal of interventions for children with CP. One treatment widely used to reduce
      spasticity is Botox because of its ability to temporarily paralyze a muscle. However, no
      studies have determined the effect of Botox treatment on bone in humans. Also, a low
      magnitude vibration treatment has been shown to improve bone structure in the lower extremity
      bones of children with CP. The aims of this study are: 1) to determine the effect of Botox
      treatment in conjunction with a daily vibration treatment on bone mass and bone structure in
      children with spastic CP, and 2) to identify the mechanism that underlies the effect of Botox
      and vibration on bone.
    

Detailed description: 
      The investigators have been working with children diagnosed with cerebral palsy (CP) for the
      past 10 years. The investigators have found that bone structure is markedly underdeveloped
      and bone strength is severely compromised in children with CP. Also, an increased fracture
      rate has been observed in the lower extremity bones of children with CP. There is evidence
      that Botox, which is used to treat spasticity in CP, can improve motor function; however the
      effect of Botox on human bone is unknown. There is also evidence that low magnitude vibration
      treatment can improve bone mass and bone structure. The overall goal of this current research
      study is to investigate the effect and mechanism of action of Botox and vibration on bone in
      children with CP. The investigators will also examine the effect of Botox on muscle volume.

      A total of 36 participants will participate in this study. The investigators will assess bone
      structure and muscle volume using MRI. The investigators will assess bone mass using
      dual-energy X-ray absorptiometry (DXA).
    

Intervention name(s): Low-magnitude vibration; Botox
Intervention type(s): Device; Drug
Intervention description(s): Children will receive a daily low-magnitude vibration treatment.; Children who are candidates to receive Botox as part of their standard of care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Botox; Muscle strength
Maintaining the Head Extension by an Assistant Decreases Dental Contact
Condition: Dental Contact During Direct Laryngoscopy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the head extension by an assistant
      decreases dental contact between laryngoscope blade and maxillary incisors during direct
      laryngoscopy
    


Intervention name(s): with assistant; without assistant
Intervention type(s): Procedure; Procedure
Intervention description(s): head extension by an assistant during direct laryngoscopy; without head extension by an assistant during direct laryngoscopy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Enhanced Implementation of Low Back Pain Guidelines in General Practice
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The aim of this study is to evaluate whether an enhanced strategy of implementation of the
      new guideline will lower the number of patients getting referred to secondary care spine
      centres compared to a normal implementation strategy.
    

Detailed description: 
      Introduction:

      There is a need for more knowledge on how to introduce new guidelines effectively in general
      practice. A new low back pain treatment guideline is implemented in Denmark. This guideline
      demands that patients with low back pain who have not improved after eight weeks of primary
      care treatment should be referred to a secondary care spine centre.

      Methods:

      This is a cluster randomized trial. One hundred general practices define clusters and are
      randomly allocated to enhanced or usual implementation of the new guideline. The practices
      are all situated in the North Denmark Region and count two hundred general practitioners
      (GPs).

      General practices in the control group will receive normal implementation of the new
      guideline, which include newsletters and briefings. In contrast the intervention group will
      receive an enhanced implementation strategy, adding visits from a consultant, two different
      stratification tools and feedback on guideline compliance. The two stratification tools: The
      STarT back screening tool (STarT) and a "Social and Occupational Screening" tool (SOS). The
      two screening tools subgroups patients and aids the clinicians in their choice of treatment.

      Discussion:

      To evaluate how change in behaviour may improve guideline adherence and patient treatment we
      plan two Ph.d. studies in relation to this study; one focusing on the clinical and an one on
      the economic aspects of the study. In addition a qualitative study is planned for patients
      refered to specialists in social medicine.
    

Intervention name(s): Guideline implementation as usual; Enhanced guideline implementation strategy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Newsletters and Invitation to Meetings; Enhanced guideline implementation strategy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: General Practice; Low Back Pain; Guideline; Health Plan Implementation; Referral and Consultation
Bioavailability of Technosphere® Insulin Versus Subcutaneous Regular Human Insulin in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the kinetics and biodynamics of inhaled Technosphere
      Insulin with those of subcutaneous (SC) regular human insulin.
    


Intervention name(s): Technosphere Insulin; Actrapid
Intervention type(s): Drug; Drug
Intervention description(s): 48U; 24IU
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Protein and Ultrasound Indicators of Preterm Birth
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Women are being asked to participate in a research study that is looking for new methods to
      understand and predict premature birth (birth before 37 weeks of pregnancy-full term
      pregnancy is 40 weeks). In this study the investigators will be looking at proteins in
      vaginal fluid, tissue from the placenta after the baby is born (fetal membranes), and a new
      form of ultrasound of the mouth of the womb (cervix) that measures its length, volume, and
      stiffness, in order to try to know who will have a preterm birth and who will reach full
      term. The investigators will collect the vaginal fluid samples and perform ultrasounds both
      in the clinic throughout pregnancy in normal women, and from women admitted to the hospital
      because they are in early labor. The investigators will collect the placental tissue after
      the baby is born (this is normally discarded). This study will help us to understand the
      process of preterm birth and the investigators hope that this will eventually allow us to
      develop better methods to treat preterm labor and prevent the birth of premature babies.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women with a single intrauterine pregnancy with good gestational age dating, and
        live fetus with no indications for preterm delivery will be enrolled. Three groups of
        subjects will be recruited: a) 50 women with uncomplicated pregnancies and no history of
        preterm birth, b) 50 multiparous women with history of spontaneous preterm labor or preterm
        premature rupture of membranes (PPROM) c) 20 women evaluated on the labor and delivery unit
        because they are deemed to be at high risk for preterm birth. Pregnant women of all races
        and ethnicities will be recruited into the study.
      
Biospecimen description: 
      Cervicovaginal fluid and placental membranes will be retained for study.
A Study of Bedaquiline 100 Milligram (mg) Tablets Administered as Different Test Formulations Compared to the Commercial Tablet Formulation (F001) in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the rate and extent of absorption of bedaquiline
      following administration of a single oral dose of 100 milligram (mg) equivalent (1*100 mg)
      given as different test tablet formulations compared to the administration of a single oral
      dose of 100 mg equivalent (1*100 mg) formulated as SIRTURO commercial tablet (formulation
      F001), under fasted conditions in healthy adult participants. Also, to assess the effect of a
      standardized breakfast on the rate and extent of absorption of bedaquiline compared to fasted
      conditions following administration of a single oral dose of 100 mg equivalent (1*100 mg) for
      each of the different test tablet formulations.
    


Intervention name(s): Bedaquiline (Test formulation); Bedaquiline (Reference formulation)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive bedaquiline orally.; Participants will receive bedaquiline orally.
Other intervention name(s): JNJ-16175328; SIRTURO, TMC207
Intervention MeSH terms: Bedaquiline; Diarylquinolines
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other