bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Comparison of the cardioprotective effects and safety of two cardioplegic solutions
      (solutions used during a cardiac arrest in the heart surgery) in patients undergoing
      cardiopulmonary bypass for coronary artery bypass surgery.
    

Detailed description: 
      The objective of this investigation is to compare the cardioprotective effects and safety of
      two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients
      undergoing cardiopulmonary bypass for coronary artery bypass surgery. The study design is a
      prospective, double blind, multicenter, randomized, Phase III comparison study intended to
      demonstrate non-inferiority in surgical outcome between Custodiol and Custodiol-N as
      determined by CK-MB area under the curve (primary endpoint), catecholamine
      requirement(cumulative dose) and cardiac Troponin T, occurrence of comorbid events
      postoperatively (e.g., myocardial infarction).
    

Intervention name(s): Custodiol-N; Custodiol
Intervention type(s): Drug; Drug
Intervention description(s): Route of administration: by infusion Dosage: will be infused antegrade into the root of the aorta until 1500-2000 mL of solution have been infused Duration: infusion technique will be continued for seven minutes; Route of administration: by infusion duration: infusion technique will be continued for seven minutes dosage: until 1500-2000 mL of solution have been infused
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CAD, ACVB
Mothers With a History of Depression and Their 10-14 Year Old Daughters
Condition: Depression; Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      The purpose of this study is to investigate risk factors associated with depression and how
      such factors might be transmitted cross-generationally. The investigators are conducting an
      integrative assessment of emotion regulation and stress reactivity in a group of mothers with
      and without a history of depression and their daughters.
    

Detailed description: 
      The purpose of this study is to investigate risk factors associated with depression and how
      such factors might be transmitted cross-generationally. We are conducting an integrative
      assessment of emotion regulation and stress reactivity in a group of mothers with and without
      a history of depression and their daughters. We use a range of methodologies to evaluate
      these processes, including self-report measures, information-processing performance, HPA-axis
      functioning and reactivity, and neural responses to emotional stimuli following exposure to
      stressful experiences.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): there is no intervention for this study
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible mothers must read and speak English fluently and have a child between the ages of
        9 and 15 years old. Mothers must either have no history of psychopathology or have a
        history of depression during their child's lifetime.
      
Biospecimen description: 
      All participants are asked to submit saliva samples during their second session using sterile
      salivette containers in order to assess cortisol levels. There is no risk involved in giving
      these samples.
Hemodynamic Effects of Spironolactone in Patients With Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      To determine if the beneficial effect of spironolactone in patients with congestive heart
      failure is in part due to its intrinsic inotropic action.

      Randomized, two group placebo controlled, single blind study.
    


Intervention name(s): Spironolactone
Intervention type(s): Drug
Intervention description(s): 100 mg tablet of Spironolactone (Aldactone) by mouth with half a glass of water.
Intervention MeSH terms: Spironolactone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Congestive Heart Failure; Hemodynamics; Echocardiographs
The Affecting Factors on Airway Temperature and Moisture
Condition: General Anesthesia
Study type: Observational

Summary: 
      There is no literature information about the flow rate of fresh gas mixture (air+O2) in the
      patients who underwent general anesthesia. Different flow rates of fresh gas mixture are used
      in both the investigator's hospital and the experiences of the anesthesiologists. It is aimed
      to study the effects of different fresh gas flow rates on the rate of temperature and
      moisture of the airway of patients who underwent general anesthesia.
    

Detailed description: 
      Under physiological conditions, inhaled air is heated and humidified as it passes through the
      nose and upper airways until reaching the alveoli. This mechanism is bypassed by endotracheal
      intubation. Ventilation with dry and cold compressed gases leads to loss of water and heat
      from the respiratory tract. Drying of the respiratory tract can lead to destruction of the
      cilia and mucous membranes, resulting in decreased mucociliary transport and increased
      concentration of secretions.There is no definitive literature on fresh gas mix (oxygen + air)
      flow rates in patients under general anesthesia. This study aimed to investigate whether two
      fresh gas flow rates routinely employed in the authors' practice affected airway temperature
      and humidity.
    

Intervention name(s): We will observe and evaluate the temperature and moisture in the respiratory circuit by a thermo-hygrometer.
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were aged between 18-65 years and underwent surgery with general anesthesia.
      
Keywords: general anesthesia; fresh gas; moisture; temperature; respiratory circuit
Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis
Condition: Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Lou Gehrig's Disease
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to find out if supervised exercise training using a treadmill
      with partial weight support is safe and has an impact on gait and function of persons with
      Amyotrophic lateral sclerosis.
    

Detailed description: 
      Twenty ALS patients who are independent in their transfer with assistive devise such as
      walker, cane, or AFO will be offered the opportunity to participate in this study. 20
      subjects will be enrolled at Carolinas ALS/Neuromuscular Center at the Carolinas HealthCare
      System. Eligible subjects will return for 26 sessions, each lasting between 1-2 hours. At
      Session 1 (4 weeks pre-treatment), assessments of muscle strength, spasticity, gait, and
      balance will be performed, which will take between 30-60 minutes. At Sessions 2-25, patients
      will do supported treadmill ambulation training at a very low speed 3 times a week for 6
      weeks under the supervision of the physical therapist. Each session will have 30 minutes of
      direct ambulation with the suspension system and treadmill over a 60 minute period of time.
      Additionally, at sessions 13 and 26 (4 and 8 weeks post-treatment), the assessments of muscle
      strength, spasticity, gait, and balance will be repeated. Needle EMG to assess denervation
      potential will be performed at base line and at the conclusion of the study. The study will
      last a total of 26 weeks for each patient.
    

Intervention name(s): Treadmill Exercise
Intervention type(s): Behavioral
Intervention description(s): The intervention will consist of 30 minutes of exercise, performed 3 times per week for 8 weeks (24 sessions). Patient will walk on a treadmill with up to 40% of their body weight supported by a body weight support system with an overhead harness. The training session duration will be 60 minutes consisting of six intervals of 5 minutes exercise, interspersed with 6 intervals of 5 minutes rest to avoid overwork weakness and fatigue. Five minute exercise intervals should be sufficient for patients to reach a steady state. Patients will build up their endurance to this training level at their own pace as tolerated. Walking speed will be determined as tolerated by each patient. Exercise intensity will be guided by each patient's own perception of exertion, but not to exceed level 12-13 (mild to moderate) on the modified Borg perceived exertion scale, and by oxygen saturation (Sa O2) ≥ 90% monitor by handheld pulse Oximeter.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise for Amyotrophic lateral sclerosis
Effect of Sacral Nerve Stimulation on Enteric Nervous System
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Observational

Summary: 
      Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence,
      although its mecanims of action remains poorly understood. The investigators hypothtized that
      SNS could act on enteric nervous system (ENS). To verify this hypothesis, the investigators
      will collect biopsy samples from patients implanted for SNS, and assess whether SNS induces
      changes in ENS.
    

Detailed description: 
      Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence. Its
      efficacy yields 80% approximately, but its mecanims of action remains poorly understood. In
      particular, SNS does not restore anal squeezing contraction nor it increase anal tone.
      Recently, using a porcine model, it was shown that SNS changed colonic permeability,
      suggesting that SNS may activate the enteric nervous system (ENS).

      The investigators hypothtized therefore that SNS could act on enteric nervous system (ENS).

      To verify this hypothesis, the investigators will collect biopsy samples from patients before
      and after implantation for SNS. The investigators will assess whether SNS induces changes in
      ENS, and if this is correlated to SNS efficacy.
    

Intervention name(s): Sacral nerve stimulation
Intervention type(s): Procedure
Intervention description(s): implantation of a stimulation electrode in one of the S2-S3-S4 sacral hole then connected to a subcutaneous stimulator for permanent stimulation of the sacral nerve
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with fecal incontience refractory to standard medical treatment
      
Biospecimen description: 
      colonic biopsies
    
Keywords: Fecal incontinence, sacral nerve stimulation
The Effect of Feeding Infant Formula With Enriched Protein Fractions
Condition: Cognitive Ability, General
Study type: Interventional

Summary: 
      This study is intended to evaluate the nutritive effects of study formulas on growth and
      cognitive outcomes.
    

Detailed description: 
      To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
    

Intervention name(s): Enriched Protein Fractions; Protein Fractions
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Enriched protein fractions; Protein fractions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study of Mirikizumab in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to compare the amount of mirikizumab that gets into the
      blood stream and how long it takes the body to get rid of it, when given as a solution
      formulation via manual prefilled syringe or autoinjector. The information about any adverse
      effects experienced will be collected and the tolerability of mirikizumab will also be
      evaluated.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be about 17 weeks, including screening.
    


Intervention name(s): Mirikizumab Prefilled Syringe; Mirikizumab Autoinjector
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC by prefilled syringe; Administered SC by autoinjector
Other intervention name(s): LY3074828; LY3074828
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Promoting Behavioral Change for Oral Health in American Indian Mothers and Children
Condition: Early Childhood Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      A program of motivational interviewing plus enhanced community services in prevention of
      early childhood caries vs. enhanced community services alone for American Indian mothers and
      their children will reduce the childrens' decayed, missing, and filled tooth surfaces measure
      over a 3-year period.
    

Detailed description: 
      This is a randomized, controlled clinical trial. Six hundred mothers and their children will
      be randomized over a 2-year period to motivational interviewing (MI) plus enhanced community
      services vs. enhanced community services alone in equal numbers in the 2 groups. The MI
      sessions will involve home visits concentrating on the mitigation of behavioral risk factors
      for early childhood caries (ECC), shortly after childbirth and at 6, 12, and 18 months. The
      enhanced community services will involve development of culturally appropriate messages
      related to the mitigation of risk factors for ECC through public announcements and simple
      brochures. The primary outcome measure will be decayed, missing, and filled tooth surfaces
      (dmfs) of the children at ages 1, 2, and 3. Secondary outcomes will include children's ds, %
      with dmfs and ds >0, mother's dental knowledge, attitudes, and behaviors, caries patterns,
      and costs.
    

Intervention name(s): Motivational interviewing; Enhanced community services
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MI sessions will involve home visits concentrating on the mitigation of behavioral risk factors for early childhood caries. These will take place shortly after childbirth and at months 6, 12, and 18.; Enhanced community services will involve the development of culturally appropriate messages related to the mitigation of behavioral risk factors for early childhood caries through public service announcements and brochures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Study of a Screening Blood Test to Determine Patients' Potential Risk of Adenomatous or Advanced Colon Polyps (ACPs)
Condition: Colonic Polyp
MeSH terms: Polyps; Colonic Polyps
Study type: Observational

Summary: 
      The aim of this study is to develop a blood test to determine which patients are at risk for
      pre-cancerous colon polyps (ACPs: Advanced Colon Polyps). The telomere length of peripheral
      blood lymphocytes (PBLs) can be measured from a blood sample. Mechanistic pathways and the
      investigator's preliminary data support PBL telomere length as a biomarker for ACPs. The
      long-term goal of this project is to decrease deaths from colon cancer by using a blood test
      to target colonoscopy for those patients who are at high risk for pre-cancerous polyps.
    

Detailed description: 
      Telomeres are the repetitive DNA sequences that cap both ends of chromosomes. Shortening of
      peripheral blood lymphocyte (PBL) telomeres has been associated with renal and other cancers.
      The investigators' preliminary data shows an association between shorter PBL telomere length
      and ACPs.

      I. Specific Aims

        1. Develop a DNA and data repository from individuals with advanced colon polyps (ACPs) and
           controls

        2. Confirm that individuals 50 to 60 years of age with ACPs tend to have shorter peripheral
           blood lymphocyte (PBL) telomeres than those without ACPs

        3. Identify a potential optimal PBL telomere length cut-off to differentiate between
           individuals with ACPs and those without for evaluation in a larger scale study

      The over reaching long term goal is to decrease disease and death from colorectal cancer
      (CRC) using a biomarker strategy to target colonoscopy to those at higher risk.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Most subjects will be recruited at the time of a clinic visit in primary care, community
        internal medicine, executive international physicals, and/or during a pre-colonoscopy visit
        in the GI Department or GI Laboratory. The ACP subjects will be identified primarily from
        those referred for ACP removal (EMR) and secondarily from those having screening
        colonoscopy.
      
Biospecimen description: 
      The only specimens obtained will be blood for PBL DNA. For all subjects two 10 cc EDTA tubes
      will be obtained and processed into DNA.
    
Keywords: Advanced colon polyp; Adenomatous colon polyp; Adenoma, villous colon polyp; Advanced colorectal adenomas; Colonic neoplasms; High grade dysplasia; Telomere blood testing
A Trial of Telmisartan Prevention of Cardiovascular Disease
Condition: Hypertension
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The present research is conducted as a randomized, parallel-group, controlled, open study
      (using the PROBE method) to primarily verify the effects on various biomarkers in high-risk
      hypertensive patients treated with ARB (telmisartan, ARB group) as compared with those in
      patients receiving ordinary therapy (non-ARB group (ordinary therapy group)). In addition,
      onset of cardiovascular events and levels of markers that are associated with cardiovascular
      events are observed over time to examine the significance of each marker. The biomarkers will
      be obtained at the start of the study (at registration), after 6, 12, 24 and 36 months from
      the start of the study.
    

Detailed description: 
      Events are defined as follows; Cerebrovascular events: Stroke (cerebral infarction, cerebral
      hemorrhage, subarachnoid hemorrhage, unknown type of stroke), transient ischemic attack
      Coronary events: Myocardial infarction, angina pectoris, asymptomatic myocardial ischemia
      Cardiac events: Myocardial infarction, angina pectoris, asymptomatic myocardial ischemia,
      heart failure Aortic/peripheral arterial events: Aortic aneurysm, aortic dissection,
      arteriosclerotic disease (aorta, carotid artery, renal artery, mesenteric artery, peripheral
      artery, etc.) Complications of diabetes: Diabetic nephropathy*, diabetic retinopathy*,
      diabetic neuropathy* Aggravation of renal function: Doubling of serum creatinine level, ESRD
      (initiation of dialysis, renal transplantation)

      *Newly occurred or aggravated

      The followings will be measured as biomarkers; urinary albumin creatinine rates (UACR),
      plasma brain natriuretic peptide (BNP), urinary 8-hydroxy-deoxy-guanosine (8-OHdG), serum
      adiponectin, serum high-molecular weight adiponectin, high sensitivity c-reactive protein
      (hsCRP), estimated glomerular filtration rate (eGFR)
    

Intervention name(s): Non-ARB (standard therapy); ARB (Telmisartan)
Intervention type(s): Drug; Drug
Intervention description(s): Blood pressure lowering therapy except ARB; Telmisartan 20-80 mg/day
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Cerebrovascular disease; Coronary Artery Disease; Chronic Kidney Disease; Peripheral Artery Disease
A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study of the pharmacokinetics of ustekinumab in Chinese male subjects.
    

Detailed description: 
      This is a randomized (study medication assigned by chance), open-label (both the physician
      and subject know the assigned study medication) study to assess the safety, tolerability,
      immune response, pharmacokinetics (what the body does to the drug), of ustekinumab (Stelara).
      The study population will consist of 24 healthy male participants in China. Participants will
      receive a single dose of either 45mg or 90 mg ustekinumab. Participants will be in the study
      for up to 16 weeks. Safety assessments will be performed throughout the study and include
      obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the
      occurrence and severity of adverse events. A single dose of 45 mg or 90 mg ustekinumab.
    

Intervention name(s): ustekinumab; ustekinumab
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 45 mg subcutaneous injection; Single dose of 90 mg subcutaneous injection
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteer; Chinese male; Stelara