bioihbjkbjnl/mcl2 huggingface dataset:
Ketamine for the Treatment of Opioid Use Disorder and Depression
Condition: Depression; Opioid-use Disorder; Opioid Abuse
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to examine whether an investigational medication called ketamine
      is able to improve treatment outcomes for concurrent opioid addiction and depression when
      used in conjunction with buprenorphine treatment. Study medications will be delivered twice
      per week for four weeks. If you are eligible and you decide to enroll in the study, your
      participation will last approximately 8 weeks, or 2 months.
    


Intervention name(s): Ketamine Hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants receiving the active study medication will receive 60 mg ketamine twice per week for four weeks under clinical supervision.; Participants receiving the placebo study medication will receive saline twice per week for four weeks under clinical supervision.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ketamine
Microcirculation in Cardiac Surgery
Condition: Cardiac Disorder
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether cardiopulmonary bypass affects mesenteric
      microcirculatory function, using sublingual evaluation, in cardiac surgery.
    


Intervention name(s): sublingual microcirculatory evaluation
Intervention type(s): Other
Intervention description(s): TNF, ICAM, syndecan-1, heparan sulfate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cardiopulmonary bypass; mesenteric; microcirculatory function
A Study to Evaluate the Safety and Tolerability of the Administration of MEDI-528 When Administered in Multiple Doses to Adults With Mild Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of escalating
      multiple SC doses of MEDI-528 in adult patients with mild persistent asthma.
    

Detailed description: 
      The secondary objectives of this study are to:

        1. Assess the PK of MEDI-528; and

        2. Assess the IM of MEDI-528 in this patient population.
    

Intervention name(s): MEDI528 0.3 mg/kg; MEDI528 1 mg/kg; MEDI528 3 mg/kg; PLACEBO
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks; MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks; MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks; Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion
Condition: Otitis Media With Effusion; Probiotics; Adenoid Vegetations
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether the microbiota in the upper respiratory tract
      (nasopharynx, adenoids and middle ear fluid) of otitis media with effusion (OME) patients is
      changed after 4 weeks of probiotic product intake. Therefore, bacterial DNA from swabs, fluid
      and tissue will be isolated via commercially available DNA extraction kits, followed by
      Illumina MiSeq sequencing in order to identify the bacterial species present in these
      samples. Furthermore, the concentration of specific pathogens will be monitored via qPCR.
    


Intervention name(s): Probactiol Mini
Intervention type(s): Dietary Supplement
Intervention description(s): 6 droplets of Probactiol Mini contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Community Based Management of Diabetes in Nepal
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Type 2 diabetes is the largest growing concern across the globe, and this is particularly
      apparent in developing countries, including Nepal. Despite the growing burden and chronic
      nature of diabetes, prevention and control of this disease is far from adequate setting in
      Nepal. Moreover, there is lack of evidence on effectiveness and affordability of a population
      approach on reducing blood glucose level among diabetes persons. The main aim of this study
      is to determine the effect of Female Community Health Volunteers' (FCHVs)-led family-based
      health education and screening on blood sugar level in adults at community level in Nepal.
      This is a community-based cluster randomized controlled trial involving family based health
      education through FCHVs in Nepal. People ≥25 years of age listed in the Community-Based
      Management of Hypertension (COBIN) study and who were diabetics are eligible for eligible for
      participation in the study. FCHVs will conduct family based health education and fasting
      blood glucose measurements in the treatment arm vs not any interventions in the control arm.
      Independent assessors will conduct the baseline and end line assessment of the intervention.
      Intention to treat analysis and per protocol analysis will be used in analysis to detect
      significant differences between treatment and control group participants at baseline and
      follow up. For individual outcomes, proportions will be compared using Chi-square test and
      continuous measures will be compared using t-tests. Random effect mixed regression analysis
      will be adjusted for age and sex. Since randomisation will be at the cluster level in the
      study, a random-effect model will be used to account for clustering effect. Effectiveness of
      the intervention will be tested by analysis of covariance, which will allow us to adjust for
      baseline differences between groups. It is anticipated that the study can give valuable
      information regarding effectiveness, acceptability, and feasibility of an innovative way to
      improve diabetes management. Assessing the FCHVs' ability to address diabetes may contribute
      to develop a policy that can be scaled-up to a national level.
    


Intervention name(s): FCHV visit
Intervention type(s): Behavioral
Intervention description(s): FCHVs will visit selected households 3 times a year for providing health promotion messages and measure the blood glucose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes; Non-communicable disease; Primary health care; Nepal
To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to
      Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and
      EU-approved Humira) in Healthy Subjects
    


Intervention name(s): CT-P17; US-licensed Humira; EU-approved Humira
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS; 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS; 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Study of Human Central Nervous System (CNS) Stem Cells Transplantation in Pelizaeus-Merzbacher Disease (PMD) Subjects
Condition: Pelizaeus-Merzbacher Disease
MeSH terms: Pelizaeus-Merzbacher Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and preliminary effectiveness of human
      central nervous system stem cells (HuCNS-SC®) transplantation in patients with Connatal
      Pelizaeus-Merzbacher Disease (PMD).
    

Detailed description: 
      Enrolled subjects will be transplanted with HuCNS-SC cells into the brain and will receive
      immunosuppression for nine months. The study observation period is for one year after
      transplant surgery. Thereafter, subjects will be enrolled in a long-term observational
      follow-up study for four years.
    

Intervention name(s): HuCNS-SC cells
Intervention type(s): Biological
Intervention description(s): intracerebral transplantation
Other intervention name(s): Human central nervous system stem cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: PMD; stem cells; Pelizaeus-Merzbacher Disease; human stem cells; central nervous system stem cells
Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
Condition: Colonoscopy; Bowel Preparation; Predictive Model
Study type: Observational

Summary: 
      The rate of adequate bowel preparation is one of important quality indicators of colonoscopy.
      Inadeqaute bowel preparation negatively affects the outcomes of colonoscopy. If patients with
      inadequate bowel preparation were identified before the procedure, enhanced strategy could be
      offerred to achieve better bowel cleasing. Currently, there were three predicting models of
      inadequate bowel preparation eatablished based on patient-related factors. It remains unclear
      which model perfroms better in predicting bowel preparation quality. Futhermore, althought
      those predicting models only composing of patients-related factors are useful for identifing
      high-risk patients, the preparation-related factors may also be valuable for prediciting
      inadeqaute bowel preparation before the procedure of colonoscopy.

      This study aimed: 1) to compare the values of three availlable models (based on
      patient-related factors) in predicting inadeqaute bowel preparation in a prospective,
      multicentered cohort of patients undergoing colonoscopy; 2) to investigate whether a new
      model based on preparation-related or a combined model based on patient-related and
      preparation-related factors is comparable to previous models based on patient-related
      factors.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Using PEG for bowel preparation before colonoscopy
      
Keywords: factors;bowel preparation;colonoscopy
Effects of Platelet Rich Plasma on Endometrium
Condition: Asherman Syndrome
MeSH terms: Gynatresia
Study type: Interventional

Summary: 
      Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal
      route after the cessation of menstrual period. The endometrial thickness will be assessed
      under ultrasound and hormone replacement will be started. As the endometrial thickness
      reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed.
    

Detailed description: 
      Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal
      route after the cessation of menstrual period. In the second menstrual period following the
      PRP injection, the endometrial thickness will be assessed under ultrasound and hormone
      replacement will be started. As the endometrial thickness reaches adequate thickness during
      ultrasound follow-up, embryo transfer will be performed. Pregnancy test results will be
      recorded and followed.
    

Intervention name(s): PRP injection in the endometrium
Intervention type(s): Biological
Intervention description(s): Within 5 days after the cessation of menstrual period, endometrial PRP procedure will be planned. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into the endometrial region of the endometrium in several positions.On the same day after the procedure, the patient will be observed in the outpatient room and will be discharged on the same day.
Intervention model: Single Group Assignment
Intervention model description: Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into the endometrial region of the endometrium in several positions.On the same day after the procedure, the patient will be observed in the outpatient room and will be discharged on the same day. On the second menstrual cycle after the procedure, the patients will be checked under ultrasound and will be started hormone replacement therapy for embryo transfer.
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe LUTS Due to BPH
Condition: Prostatic Neoplasms; Prostate Disease; Prostate Obstruction; Prostate Hypertrophy
MeSH terms: Prostatic Neoplasms; Prostatic Diseases; Prostatic Hyperplasia; Hypertrophy
Study type: Interventional

Summary: 
      Single dose versus double dose tamsulosin in Management of Moderate and severe lower urinary
      tract symptoms due to benign prostatic hyperplasia
    


Intervention name(s): Single dose tamsulosin 0.4mg; Double dose tamsulosin 0.4mg
Intervention type(s): Drug; Drug
Intervention description(s): Single dose tamsulosin 0.4mg; Double dose tamsulosin 0.4mg
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Tamsulosin; Prostate
Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing Endoscopic Retrograde Cholangiopancreatogram (ERCP)
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Observational

Summary: 
      Patients with primary sclerosing cholangitis (PSC) are affected by an inflammatory condition
      of the bile ducts. Unfortunately, patients with PSC have a 10 to 15 percent lifetime risk of
      developing gallbladder and bile duct cancers. Gallbladder and bile duct cancers have a
      five-year survival of only 5 to 10 percent. Surgery to provide a cure must remove all cancer
      confined to one area.

      In order to increase survival rates there is a need to identify cancer and pre-cancer early.
      This has been difficult to do.

      Patients who have lab tests, positive imaging tests or obstructions will usually have a test
      called ERCP (Endoscopic Retrograde Cholangiopancreatogram) to take biopsies and enlarge bile
      ducts or opening bile ducts with stents. Patients usually have cells in the bile ducts
      removed and analyzed, but there are not studies to show how sensitive this may be to
      determine if the cells are cancer or pre-cancerous. A new scope with a system using light
      filters called Narrow Band Imaging (NBI) may help detect cancer and pre-cancer more often and
      at an earlier stage.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting for ERCP with history of Primary Sclerosing Cholangitis
      
Keywords: Primary sclerosing cholangitis
Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
Condition: Anaplastic Astrocytoma
MeSH terms: Astrocytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Current therapies for adults with anaplastic astrocytomas that have not responded
      to standard therapy provide very limited benefit to the patient. The anti-cancer properties
      of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults
      with anaplastic astrocytomas that have not responded to standard therapy.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on adults with anaplastic astrocytomas that have not responded to
      standard therapy.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in patients with anaplastic
           astrocytomas that have not responded to standard therapy, as measured by an objective
           response to therapy (complete response, partial response or stable disease).

        -  To determine the safety and tolerance of Antineoplaston therapy in patients with a
           anaplastic astrocytoma

      OVERVIEW: This is a single arm, open-label study in which adults withanaplastic astrocytomas
      that have not responded to standard therapy receive gradually escalating doses of intravenous
      Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.
      Treatment continues for at least 12 months in the absence of disease progression or
      unacceptable toxicity. After 12 months, patients with a complete or partial response or with
      stable disease may continue treatment.

      To determine objective response, tumor size is measured utilizing MRI scans, which are
      performed every 8 weeks for the first two years, every 3 months for the third and fourth
      years, every 6 months for the 5th and sixth years, and annually thereafter.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study
    

Intervention name(s): Antineoplaston therapy (Atengenal + Astugenal)
Intervention type(s): Drug
Intervention description(s): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Other intervention name(s): A10 (Atengenal); AS2-1 (Astugenal)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: persistent anaplastic astrocytoma; recurrent anaplastic astrocytoma; adult anaplastic astrocytoma
OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the comparative effectiveness of insulin pump
      therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are
      sub optimally controlled with multiple daily injections (MDI).
    

Detailed description: 
      The type of study is interventional post-market release. All the devices under investigation
      have CE mark, and are used within intended use.

      This study has been designed to be prospective randomized controlled with a single-arm
      cross-over in the continuation phase.

      Four hundred type 2 Multiple Daily Injections (MDI) treated patients will undergo a screening
      (run-in) phase of 8 weeks. The aim of the screening phase is to eliminate the study effect
      that might result in a decrease of HbA1c and to make sure that patients, who are failing
      current MDI therapy, are selected.

      After this screening phase, eligible patients will be randomised to receive either Continuous
      Subcutaneous Insulin Infusion (CSII) treatment or continue MDI treatment. The study phase is
      a 6-months phase with 2-arms parallel design.
    

Intervention name(s): Insulin Pump (Medtronic Minimed Paradigm® VEO)
Intervention type(s): Device
Intervention description(s): The pump delivers insulin as specified by the patient
Other intervention name(s): Medtronic MiniMed Paradigm® VEO system (MMT-554/754
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; MDI; pump therapy
Comparison of Modified Broselow Tape and Cole Formula
Condition: Predicting Uncuffed Endotracheal Tube Size in Pediatric Anesthesia
Study type: Interventional

Summary: 
      This study aimed to determine the accuracy of modified Broselow tape measurements compared to
      Cole formula in predicting the size of uncuffed endotracheal tubes in Indonesian pediatrics
    

Detailed description: 
      110 subjects were given informed consent before enrolling the study and randomized into two
      groups, modified Broselow Tape and Cole formula. Preoperatively, prediction of suitable ETT
      size was performed based on Cole formula and Modified Broselow Tape. In the operating
      theatre, general anesthesia induction was performed with sevoflurane 4-8 vol%, fentanyl 2
      μcg/kg BW, and atracurium 0.5 mg/kg BW. Laryngoscopy was performed, and an uncuffed polyvinyl
      chloride endotracheal tubes, whose size was based on the Cole formula, was inserted. An
      appropriate size of the endotracheal tube was confirmed if the endotracheal tube could go
      through the cricoid ring smoothly, and no air leakage found when ventilating with an
      inspiratory pressure of 15-20 cmH2O. The surgery and anesthesia would proceed if the correct
      size of the endotracheal tube were successfully inserted. If the tube couldn't pass the
      cricoid smoothly or air leakage was found when ventilated with an inspiratory pressure of
      15-20 cmH2O, the endotracheal tube should be replaced with a bigger or smaller size.
    

Intervention name(s): Modification Broselow Tape; Cole Formula
Intervention type(s): Procedure; Procedure
Intervention description(s): Intubation using modified Broselow Tape prediction for predicting ETT size; Intubation using Cole Formula prediction for predicting ETT size
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Uncuffed endotracheal tube; Pediatric; Cole Formula; Broselow Tape
A Single and Multiple Dose Study of Lemborexant in Healthy Chinese Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the pharmacokinetics (PK) of lemborexant and
      metabolites (M4, M9, and M10) in plasma in healthy Chinese participants following single and
      multiple oral doses of lemborexant.
    


Intervention name(s): Lemborexant
Intervention type(s): Drug
Intervention description(s): Lemborexant oral tablets.
Other intervention name(s): E2006; Dayvigo
Intervention MeSH terms: Lemborexant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Phase 1; E2006; Healthy Participants