bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period
Condition: Dexmedetomidine; General Anesthesia; Cardiac Electrophysiology; Cardiac Function
Study type: Interventional

Summary: 
      Perioperative stress may increase the incidence of adverse events in the cardiovascular
      system and lead to poor prognosis. Dexmedetomidine is a highly selective α2 adrenergic
      receptor agonist, which can inhibit stress response and reduce hemodynamic fluctuations. In
      different usage plans, dexmedetomidine can have different effects on hemodynamics, myocardial
      electrical activity, cardiac function. The main purpose was to observe its effects on
      myocardial electrophysiology and cardiac function during perioperative period. The secondary
      purpose was to explore the optimal dose of dexmedetomidine that has the least adverse effects
      on perioperative electrocardia action and cardiac function
    


Intervention name(s): Dexmedetomidine; Dexmedetomidine; Dexmedetomidine; Normal saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts; The loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts; The loading dose with 1 μg/kg, maintenance dose with 1 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts; Normal saline is used to observe the effect on the electrophysiology of the patients' hearts
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture.
Condition: Cesarean Section
Study type: Interventional

Summary: 
      A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical
      outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the
      suturing time during C-Section.
    

Detailed description: 
      A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical
      outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the
      suturing time during C-Section. In addition, the need of additional sutures to control
      bleeding after the 2- layer closure will be estimated.These will be the primary outcome
      measures. The secondary outcome measures will be factors related to the blood loss at the
      time of the uterine closure, surgical complications, duration of hospital stay, postoperative
      infection (endometritis) and wound infection..
    

Intervention name(s): Stratafix suture; Vicryl suture
Intervention type(s): Device; Device
Intervention description(s): Stratafix barbed sutures during C-Sections.; Standart Vicryl suture during C- Sections.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Device Feasibility
Keywords: Cesarean section; C- section; Suture
Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      assess the safety and tolerability of single doses of NNC9204-1706 administered
      subcutaneously in male subjects being overweight or with obesity.
    


Intervention name(s): NNC9204-1706 A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated.; Administered subcutaneously (s.c., under the skin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Two Different Preparations of Sevoflurane in Induction
Condition: Coughing on Induction; Vapors; Inhalation
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 4

Summary: 
      In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity
      rapid inhalation induction.
    


Intervention name(s): Sevoflurane; Sevoflurane
Intervention type(s): Drug; Drug
Other intervention name(s): Sevorane, Abbott Laboratories; Sojourn, Adeka IS A.S
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of Galcanezumab in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are:

        -  To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A)

        -  To measure how much of the Galcanezumab lyophilized (freeze dried) injectable
           formulation is absorbed into the blood stream and how long it takes the body to get rid
           of it compared to the Galcanezumab solution injectable formulation after a single
           injection under the skin (subcutaneous [SC]) (Part B).

      Information about any side effects that may occur will also be collected. Each part of the
      study will last about six months. Participants may only enroll in one part.
    


Intervention name(s): Galcanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Microtransplantation in Older Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see whether HLA-mismatched donor cells infusion with
      chemotherapy (microtransplantation，MST) could increase complete remission (CR) and improve
      survival in older patients with acute myeloid leukemia (AML)，the investigators conducted a
      prospective, multicenter clinical trial of HLA-mismatched MST to estimate outcomes and
      toxicities.
    


Intervention name(s): microtransplantation
Intervention type(s): Biological
Intervention description(s): HLA mismatched donor mobilized prepheral stem cell infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis
Condition: Osteoarthritis in the Carpometacarpal (CMC) Joint
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of the study is to investigate if occupational therapy may delay or prevent the
      need for surgery in patients with carpometacarpal(CMC) osteoarthritis (OA) who are scheduled
      for surgery in the CMC-joint.

      Our study hypothesis is that compared to participants in the intervention group,
      significantly more participants in the control group have received CMC-surgery after two
      years.
    

Detailed description: 
      Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult
      population, and approximately 68% of people between the ages of 71 and 80 years have
      radiographic OA in the carpometacarpal (CMC) joint.

      Currently, there is no cure for hand OA. However, several studies have demonstrated that hand
      exercises and CMC-orthoses may reduce pain and improve grip strength, and in a recent study,
      assistive devices improved activity performance and satisfaction with performance in people
      with hand-OA. Still, most people do not receive any such treatment, but those with severe
      CMC-OA are often referred for surgery in this joint. The effect of occupational therapy to
      prevent or delay need for surgery CMC-OA has been investigated in a small study with 33
      participants, but randomised controlled trails (RCT) of good quality are needed.
    

Intervention name(s): Care as usual; Occupational therapy
Intervention type(s): Other; Other
Intervention description(s): Occupational therapy in the waiting period before surgery. Occupational therapy comprises orthoses for the CMC-joint, hand exercises, and use of alternative working methods and assistive devices. The participants are encouraged to perform hand exercises three times a week for the first 12 weeks, and to use orthosis as much as possible, both during daytime (day orthosis) and night time (night orthosis).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Hand osteoarthritis; CMC1-joint; surgery; occupational therapy; hand exercises; assistive devices; orthoses
Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Cardiotoxicity
Study type: Observational

Summary: 
      In the proposed project the investigators will asses whether changes in expression of
      selected circulating microRNAs in serum could comprise a sensitive and specific biomarker of
      cardiotoxicity in cancer patients treated with anthracyclines based chemotherapy.
    

Detailed description: 
      Blood will be taken

        1. before anthracycline based chemotherapy administration

        2. at the middle of anthracycline treatment (before 3rd and/or 5th cycle of drugs infusion)

        3. after anthracycline chemotherapy cessation

        4. 6 months after chemotherapy cessation if an end point occurs

        5. 12 months after chemotherapy cessation if an end point occurs

      Echocardiography will be performed

        1. before anthracycline based chemotherapy administration

        2. after anthracycline based chemotherapy cessation

        3. 6 months after anthracycline based chemotherapy cessation

        4. 12 months after anthracycline based chemotherapy cessation if no end point was observed
           earlier The investigators will perform high-throughput miRNA(microRNA) expression
           profiling of serum samples - called training set.

      Training set will consist of sera of 30 patients who has reached an end point. Training set
      will be sequenced using next generation sequencing.

      Training set will be used to derive a miRNA signature capable of separating early
      cardiotoxicity patients from healthy ones. MiRNA signature will be validated using validation
      set.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with newly diagnosed breast cancer that will be treated with anthracyclines will be
        recruited.
      
Biospecimen description: 
      5 ml of blood will be collected, 2ml of serum will be isolated from the blood and stored
      below -80C till completion of the study.
    
Keywords: breast cancer; anthracyclines; cardiotoxicity; circulating microRNA; biomarker; serum; anthracyclines based chemotherapy
Salivary TAS, TOS, LL-37 and Dental Status in Passive Smoking Children
Condition: Passive Smoking; Oxidative Stress; Dental Caries; Children
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      The aim of the present study was to determine the effect of passive smoking on the levels of
      salivary TAS, TOS, LL-37 and dental status in children.In the study the parents of children
      were asked to fill out a complete survey about smoking habits. After filling out the
      questionnaire, according to the survey results, a total of 180 children were included to the
      study as follows; 90 children exposed to passive smoking, and 90 children in the control
      group (unexposed controls). Also demographic data were recorded (age, gender, parental
      education levels, child's tooth-brushing habit and child's daily dietary sugar exposure,
      family income). Dental examination of children were performed and caries prevalance of the
      patients were recorded. Unstimulated saliva samples were collected from children. Saliva
      'cotinine levels' which are expected to increase in passive smoking group; 'antimicrobial
      peptide LL-37' and oxidative stress markers 'total antioxidant status' (TAS), and' total
      oxidant status' (TOS) were evaluated by using Enzyme-linked immunosorbent assay (ELISA). The
      obtained data parameters of the two groups were evaluated and comparison was performed.
    


Intervention name(s): taking saliva samples to determine TAS, TOS and LL-37
Intervention type(s): Diagnostic Test
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children, referring for dental examination to the Department of Pediatric Dentistry of
        Kirikkale University, were selected.
This is a Study to Determine the Antidepressant Effects of AZD6765
Condition: Treatment Resistant Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the antidepressant effects of AZD6765 compared to
      placebo.
    


Intervention name(s): AZD6765; Placebo to AZD6765
Intervention type(s): Drug; Drug
Intervention description(s): Single IV infusion of 150 mg AZD6765.; Single IV infusion of Placebo to AZD6765
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patients
Reactive Neuromuscular Training Effects on Side Bridge Endurance Test
Condition: Balance
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of reactive neuromuscular training on
      muscular endurance test.
    


Intervention name(s): Rehabilitation device
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Rehabilitation, Side Bridge test, Muscular endurance
Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin
      glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week
      24 (visit 10).

      Secondary Objectives:

        1. Percentage of patients with HbA1c < 7% at week 24.

        2. Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event
           at week 24.

        3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week
           0, week 12 and week 24.

        4. Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose /
           kg (U/kg) will be calculated at week 24.

        5. Systolic and diastolic blood pressure, heart rate, weight change will be measured at
           week 0, week 12 and week 24.

        6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal
           symptomatic, severe and nocturnal severe) will be evaluated during the treatment period.
           7-Adverse events.
    

Detailed description: 
      The study is divided in 3 periods:

        1. a 2-week run-in period,

        2. a 12-week treatment period 1

        3. a 12-week treatment period 2 study treatment duration per patient: 24 weeks study
           duration per patient: 26 weeks
    

Intervention name(s): INSULIN GLARGINE; INSULIN GLULISINE
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day in the evening at bedtime; Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day, 0 to 15 minutes before the main meal
Other intervention name(s): Lantus SoloStar; Apidra SoloStar
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome
Condition: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases
MeSH terms: Leukemia; Preleukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of
      immune cells found in bone marrow or peripheral blood.

      PURPOSE: Phase II trial to study the effectiveness of sargramostim after bone marrow
      transplantation in treating patients who have myelodysplastic syndrome.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the effect of sargramostim (GM-CSF) on the progression-free 1-year survival of
           patients with myelodysplastic syndrome who have undergone T-cell-depleted CD34+
           augmented allogeneic bone marrow transplantation.

      OUTLINE: All patients receive elutriated, CD34+ stem cell augmented donor bone marrow
      according to another protocol on day 0.

      Patients receive sargramostim (GM-CSF) subcutaneously on days 5-60.

      Patients are followed on days 120, 180, 360 and periodically thereafter.

      PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 3-4 years.
    

Intervention name(s): sargramostim
Intervention type(s): Biological
Intervention MeSH terms: Sargramostim
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; refractory cytopenia with multilineage dysplasia; atypical chronic myeloid leukemia; myelodysplastic/myeloproliferative disease, unclassifiable
Mesenchymal Stem Cells After Renal or Liver Transplantation
Condition: Liver Failure; Kidney Failure
MeSH terms: Liver Failure; Renal Insufficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The immune system of a patient can attack the liver or the kidney received from a donor
      (organ rejection). This can be prevented by treating these patients long-life with
      immunosuppressive drugs. Unfortunately, these drugs lead to numerous side effects and fail to
      prevent the rejection occurring months later after the transplantation (chronic rejection).
      Recently, it has been shown that a particular type of cells present in the bone marrow,
      namely Mesenchymal Stem Cells (MSC), when injected to a patient, suppress its immune system
      and increase success rates of blood cells transplantation. This outcome opens doors to
      investigate the potential of these cells to provide a valuable tool for improving solid organ
      transplantation without the need of high concentration of immunosuppressive drugs. The
      present project aims at evaluating the safety and tolerability of MSC administration after
      liver or kidney transplantation.
    

Detailed description: 
      The present project aims at evaluating the safety and tolerability of third party MSC
      administration after liver or kidney organ transplantation. Ten patients undergoing liver
      transplantation and 10 patients undergoing kidney transplantation will be included in the
      experimental arm to receive a single infusion of MSC. The outcome of each of these 2
      subgroups will be compared with that of similar control patients undergoing liver or kidney
      transplantation but who will not receive MSC.

      Liver and kidney transplanted patients will receive standard immunosuppressive therapy,
      TAC-MMF-steroïds and TAC-MMF-steroïds plus an IL-2-R antibody respectively. Patients enrolled
      in the experimental arms will be infused with a single dose of 1,5-3,0 10E6 MSC/kg, 3(+/-2)
      days after the transplantation.

      Weaning of immunosuppression will be attempted from month 6 in liver transplant patients who
      did not present a rejection episode and show normal graft function and graft biopsy.

      Kidney transplant patients will continue standard immunosuppressive therapy indefinitely.

      Male or female (>18 years) individuals unrelated to the recipient or the graft donor will be
      MSC donors. MSC donors need to fulfill generally accepted criteria for allogeneic HSC
      donation.
    

Intervention name(s): Mesenchymal Stem Cells
Intervention type(s): Biological
Intervention description(s): Third party MSC 1,5-3,010E6/kg. No HLA matching between MSC donor and the recipient or the liver/kidney donor. One infusion at day 3+/-2.
Other intervention name(s): MSC
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: end-stage; liver diseases; cirrhosis; cancer; fulminant hepatic failure; metabolic hepatic diseases; congenital hepatic diseases; renal diseases
Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls
Condition: Mental Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Adolescent girls in developing countries face high rates of adversity and are at an elevated
      risk of depression and other forms of psychological distress. Untreated depression can have
      negative consequences on life outcomes such as early pregnancies, social exclusion and school
      dropout. These can result in a cycle of poverty for young women and their families. Despite
      this being a very pressing problem there is little evidence on what types of interventions
      can help break the vicious cycle of poor mental health and poverty.

      This research program aims to evaluate, through the use of a cluster-Randomized Control Trial
      (cluster- RCT), the effect of group-based interpersonal psychotherapy (IPT-G) and
      unconditional cash transfers on adolescent girls' mental health and social functioning.
      Working with Strong Minds Uganda in collaboration with BRAC Uganda's Empowerment and
      Livelihood for Adolescents (ELA) clubs, the evidence generated from this research will create
      a better understanding of whether adolescent mental health improves through this
      cost-effective approach, and whether improved mental health impacts other outcomes of
      interest.
    


Intervention name(s): IPT-G; Unconditional Cash Transfer
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 14 weeks of group-based interpersonal therapy (IPT-G); Lump sum cash transfer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment