bioihbjkbjnl/mcl2 huggingface dataset:
Serrated Lesions Detection With Endocuff-assisted Colonoscopy
Condition: Serrated Lesion; Adenoma; Colorectal Cancer
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Colorectal cancer (CRC) is a leading cause of morbidity and mortality worldwide, especially
      in Western countries. CRC is currently considered a preventable disease and screening has
      been endorsed by several societies, since it has been shown that screening and surveillance
      are effective in reducing both CRC incidence and mortality. However, recently, concern has
      risen regarding colonoscopy effectiveness, especially in the right colon. The most accepted
      explanation for this effectiveness variability is attributed to sessile serrated lesions
      (SSL), which are more frequent in the proximal colon, more difficult to detect because of
      their flat morphology and associated with interval CRC, which is the occurrence of CRC after
      screening colonoscopy and before the next scheduled procedure. Several techniques are
      emerging to increase the sensitivity of colonoscopy for pre-cancerous lesions, especially
      adenomas. Recently an endoscopic cap, the Endocuff, was developed to improve adenoma
      detection. Several studies demonstrated improved adenoma detection with Endocuff-assisted
      colonoscopy when compared with conventional colonoscopy. Still, the available data for its'
      role in detecting SSL is very limited. The aim of this randomized controlled trial is to
      evaluate the effectiveness of Endocuff-assisted colonoscopy in detection of colorectal SSL.
    


Intervention name(s): Endocuff colonoscopy; control
Intervention type(s): Device; Device
Intervention description(s): Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).; colonoscopy without endocuff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Serrated Lesion; Endocuff; Detection
Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a the first in human study to evaluate the safety, tolerability, PK and PD of single
      subcutaneous or intravenous dose of IBI112 in healthy subjects
    

Detailed description: 
      In this first in human, phase 1, randomized, double-blind, placebo-controlled study, a single
      subcutaneous or intravenous dose of IBI112 will be administered to 46 healthy subjects.
    

Intervention name(s): IBI112 dose1; IBI112 dose2; IBI112 dose3; IBI112 dose4; IBI112 dose5; IBI112 dose6; IBI112 dose7
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug: IBI112 SC dose1 Drug:placebo; Drug: IBI112 SC dose2 Drug:placebo; Drug: IBI112 SC dose3 Drug:placebo; Drug: IBI112 SC dose4 Drug:placebo; Drug: IBI112 IV dose5 Drug:placebo; Drug: IBI112 SC dose6 Drug:placebo; Drug: IBI112 IV dose7 Drug:placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Music Therapy on Neutrophyl Lymphocytes Ratio, Interleukin 6 and Interleukin 10 Levels of Burnout Syndrome
Condition: Burnout Syndrome; Neutrophil-Lymphocyte Ratio; Interleukin-6; Interleukin-10
MeSH terms: Syndrome; Burnout, Psychological
Study type: Interventional

Summary: 
      Burnout Syndrome (BOS) can be defined as a state of stress both physically and psychically
      due to the burden and stressor of high work. The prevalence of BOS in health workers varies
      between 25-75% globally. Studies have shown that the presence of Burnout syndrome will
      meaningfully reduce the quality of services related to patient safety and cause immune system
      disorders that act as the body's defense against viral, bacterial, protozoal and fungal
      infections. Many strategies have been researched to help prevent and reduce the occurrence of
      Burnout syndrome, one of which is music therapy. The purpose of this study was to determine
      the effect of music therapy on the immune response in health workers with Burnout Syndrome.

      This study is a randomized clinical trial with a pre and post test control group design for
      health workers at Dr Kariadi General Hospital and Dr. Cipto Mangunkusumo General Hospital.
      Subjects will be provided with information prior to the study and asked to sign an informed
      consent sheet if they agree to be involved in the study. Subjects will be divided into
      control groups and treatment groups with matching age, gender and type of work. In the
      treatment group, music therapy will be given as much as 3 times a week for 4 weeks. Data were
      taken on both groups before and after the intervention. This study used the Maslach Burnout
      Inventory Human Service Survey (MBI-HSS) and blood laboratory examination to determine the
      value of the Neutrophyl Lymphocyte Ratio, Interleukin 6 and Interleukin 10 levels.
    


Intervention name(s): music therapy
Intervention type(s): Other
Intervention description(s): Music therapy that have been made by Music Therapist after Focus Group discussion, given three times a week for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke
Condition: Tobacco-Use Disorder; Schizophrenia; Psychotic Disorders
MeSH terms: Tobacco Use Disorder; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic
      population often find it difficult to quit smoking. The purpose of this trial is to determine
      the safety and effectiveness of bupropion in treating individuals with schizophrenia who
      smoke.
    

Detailed description: 
      Schizophrenia affects 1 % of the population. Among individuals with schizophrenia, between 74
      and 92 % smoke cigarettes regularly. Heavy smoking represents a significant and neglected
      public health problem for people with schizophrenia; smoking cessation treatment is often
      overlooked as part of the psychiatric care for such individuals.

      The most effective treatment for smoking cessation described to date is sustained release
      (SR) bupropion. Past research suggests that SR bupropion may be especially effective in
      individuals with depressive symptoms, including individuals with schizophrenia. The purpose
      of this trial is to evaluate the safety and efficacy of SR bupropion, when combined with
      cognitive behavioral therapy (CBT), in individuals with schizophrenia.

      This trial will last 12 weeks. Participants will be randomly assigned to receive SR bupropion
      or placebo. All participants will receive weekly CBT. Participants will be followed for 3
      months following completion of the 12-week treatment session.
    

Intervention name(s): bupropion SR; Cognitive Behavioral Group Therapy; nicotine replacement therapy
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.; Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week.; Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.
Other intervention name(s): Zyban, Wellbutrin; CBT; nicotine patch; nicotine gum
Intervention MeSH terms: Bupropion; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bupropion; Zyban; Wellbutrin; Smoking cessation; Schizophrenia; Schizoaffective disorder; Cognitive Behavioral Therapy
Water Flosser vs String Floss vs Manual Toothbrush Safety
Condition: Soft Tissue Injuries
MeSH terms: Soft Tissue Injuries
Study type: Interventional

Summary: 
      Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different
      Pressure Settings
    

Detailed description: 
      This study is designed to add to the safety data by measuring, Oral Soft tissue, Clinical
      Attachment Levels and Probing Pocket Depths on different pressure settings at different time
      points over a 6 week period. Data will be collected at Baseline, 2 week, 4 week and 6 week
      time frames.
    

Intervention name(s): Water Flosser; String Floss; Manual Toothbrush
Intervention type(s): Device; Device; Device
Intervention description(s): Power interdental cleaner; Mechanical interdental cleaner; ADA standard soft bristle toothbrush
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a examiner-masked, 3-treatment, randomized clinical trial comparing the safety of different oral hygiene regimens.
Masking: Single (Investigator)
Primary purpose: Other
Impact of Nutrition Education on Knowledge and Beliefs About Dietary Supplements/Herbal Foods
Condition: Knowledge, Attitudes, Practice
Study type: Interventional

Summary: 
      A two session nutrition education intervention was administered to health professionals and
      non-health professionals in separate sessions. Nutrition knowledge status was evaluated with
      comparing the pre-test and post-test values.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy of nutrition education intervention of
      health professionals and non-health professionals about the effectiveness of dietary
      supplements/herbal foods (DS/HF) in COVID-19. Study design is a cross-sectional study with an
      education intervention. This study was conducted through online video communication
      application. Overall, 106 health professionals and 110 non-health professionals completed the
      study. The education intervention was administered in two sessions, one week apart for both
      health professionals and non-health professionals separately. Knowledge level of nutrition
      and COVID-19 and beliefs about DS/HF in the prevention/treatment of COVID-19 were evaluated
      with a pre-test and post-test setting. Comparison of the groups before and after the
      intervention was implemented with the McNemar's test.
    

Intervention name(s): Education
Intervention type(s): Other
Intervention description(s): All participants attended to a two-part nutrition education program. The education intervention program was administered in two sessions, one week apart. Before the intervention, a pre-test was administered to determine the knowledge and beliefs attitudes of participants. After the pre-test each session consisted of a PowerPoint presentation of about 20 minutes. Education topics included components of adequate-balanced nutrition and its relationship with COVID-19, introduction of food groups, the association between COVID-19 and dietary supplements, herbal foods in the prevention/treatment of COVID-19, considerations regarding DS/HF, food-drug interactions, and COVID-19 drugs and food interactions. The presentation was concluded with the nutritional recommendations for COVID-19. The post-tests were shared with the participants at the end of the second session of the education intervention.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: nutrition education; dietary supplements; herbal supplements
Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the effect of abrilumab on induction of
      remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as
      assessed by a total Mayo Score ≤ 2 points, with no individual subscore > 1 point.
    

Detailed description: 
      The study consisted of a 24-week double-blind, placebo-controlled treatment period followed
      by an open-label period of approximately 108 weeks. Participants were eligible to enter the
      open-label period of the study early if they did not achieve a response at week 8 and had an
      inadequate response at week 12 or later or if they experienced disease worsening after
      achieving response and/or remission at week 8. Failure to achieve response at week 8 was
      defined as failure to achieve a decrease from baseline in total Mayo Score ≥ 3 points and ≥
      30% decrease from baseline. Inadequate response at week 12 or later was defined as failure to
      achieve a 2-point decrease and 25% improvement in partial Mayo Score compared with screening
      and minimum partial Mayo Score ≥ 5 points. Disease worsening was defined as an increase in
      partial Mayo Score ≥ 3 points from the week 8 value and minimum partial Mayo Score ≥ 5 points
      with recto-sigmoidoscopy sub-score ≥ 2.

      Participants were planned to be randomized in a 2:1:2:2:2 ratio to placebo or abrilumab at 7
      mg, 21 mg, 70 mg (on day 1, week 2, week 4, and every 4 weeks thereafter until week 24), or
      210 mg (on day 1 followed by placebo in weeks 2 and 4 and every 4 weeks thereafter until week
      24), respectively. Due to a consistent discrepancy between the investigational product (IP)
      instruction manual (IPIM) description of vial positions and the actual vial positions in the
      IP package participants were initially randomized to 3 arms (placebo, 70 mg, and 210 mg) with
      a randomization ratio of 4:3:2. The study was temporarily paused while this issue was
      investigated. Once the discrepancy was corrected, Protocol Amendment 3 implemented, and
      affected participants completed their double-blind treatment period, the study resumed
      enrollment and randomization per protocol. Neither the randomization nor study blind was
      compromised and therefore the intent-to-treat principle was maintained.
    

Intervention name(s): Abrilumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered by subcutaneous injection.; Placebo matching to abrilumab administered by subcutaneous injection
Other intervention name(s): AMG 181
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ulcerative Colitis, IBD
Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Gynecomastia
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to investigate the efficacy of different dosing and scheduling of
      Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in
      patients with prostate cancer.
    


Intervention name(s): Bicalutamide; Tamoxifen
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tamoxifen; Bicalutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Casodex monotherapy
A Study of LY3015014 in Healthy Participants With High Cholesterol
Condition: Healthy Volunteers; Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study in healthy participants with high levels of "bad" cholesterol who are already
      taking a popular type of cholesterol-lowering medication called statins. Following multiple
      doses of LY3015014, investigators will study the safety and tolerability of the drug, how the
      body handles the drug, and the drug's effect on the body. Participants will remain in the
      study for about 3 months, not including screening. Screening is required within 28 days
      before the study starts.
    


Intervention name(s): LY3015014; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SQ; Administered SQ
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in Operations
Condition: General Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an
      intravenous general anaesthetic drug in operations and to determine its efficacy and safety
      profile comparing to propofol.
    

Detailed description: 
      This is an multi-center，double-blinded，parallel and control study using Remimazolam or
      propofol for anesthesia in operations.Subjects are randomized to different treatment groups
      (including 3 for Remimazolam Tosilate and 1 for propofol) and anaesthetics are pumped
      contimuously into bodies.Analgesics and muscle relaxants are permitted during
      operations.Efficacy，safety and pharmacokinetic/pharmacodynamic profiles of Remimazolam
      Tosilate are to be evaluated.
    

Intervention name(s): Remimazolam Tosilate; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): IV pumping for anesthesia; IV bolus for anesthesia
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Decreasing Narcotics in Advanced Pelvic Surgery
Condition: Narcotic Use; Pain; Constipation; Nausea
MeSH terms: Nausea; Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      In recent years, there has been an emphasis on the creation of "enhanced-recovery",
      "fast-track" or "multi-modal" pathways to improve perioperative care (1-4). The goal of these
      programs is to reduce the length of hospital stay, decrease narcotic usage while improving
      pain control, accelerate post-operative recovery, and expedite return to baseline functional
      status. Pathways often are developed by a team of surgeons, nurses, pain specialists,
      anesthesiologists and other support staff. Postoperative components often involve multi-modal
      analgesia, early return to activity and early return to a regular diet. The goal of this
      study is to evaluate the efficacy of a multi-modal pain regimen in advanced pelvic surgery
      with a primary goal of decreasing narcotic usage.
    


Intervention name(s): Celebrex; Gabapentin; IV acetaminophen; oral acetaminophen; oral ibuprofen; percocet; vicodin; Oxycodone; dilaudid; Dexamethasone; zofran
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Acetaminophen; Dexamethasone; Ibuprofen; Celecoxib; Acetaminophen, hydrocodone drug combination; Oxycodone; Gabapentin; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: narcotic use; pain; constipation; nausea
Effect of Low-level Laser Therapy (808nm) on Marker of Muscle Damage
Condition: Healthy
Study type: Interventional

Summary: 
      The study hypothesis is a decreased muscle damage induced by exercises when low-level laser
      therapy is applied on body muscles before exercises.
    

Detailed description: 
      The study assessed males submitted to exercise to induce muscle damage. Creatine kinase
      levels in blood was quantified in order to identify the magnitude of muscle damage.
    

Intervention name(s): Low-level laser therapy (808nm) and exercise
Intervention type(s): Device
Intervention description(s): Use of low-level laser therapy(LLLT)or placebo-LLLT applied on biceps brachii for muscle damage recovery
Other intervention name(s): Laser device (808nm; 100mW; DMC®, Brazil); Low-level laser therapy; Muscle damage; Muscle recovery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low-level laser therapy; muscle damage
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function
Condition: Heart Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the safety, tolerability, and pharmacokinetics of AMG 986 given orally as a
      single dose to healthy participants and participants with severely impaired kidney function.
    


Intervention name(s): AMG 986
Intervention type(s): Drug
Intervention description(s): tablets for oral administration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multisite (approximately 3 sites), open-label, non-randomized, single-dose study in participants with severely impaired kidney function and healthy participants. About 12 participants will be assigned to two groups: Group 1: 6 with severely impaired kidney function , and Group 2: 6 with normal kidney function.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular Diseases; Renal Impairment; Heart Diseases
Evaluation of the Efficacy and Safety of MV140
Condition: Urinary Tract Infection Bacterial
MeSH terms: Urinary Tract Infections; Bacterial Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of a biological vaccine
      (MV140) in women with Recurrent Urinary Tract Infections (RUTI) compared with a placebo
      group.
    

Detailed description: 
      Double blind parallel placebo controlled study. The subjects will receive medication during
      three or six months and will be followed up during another twelve months.
    

Intervention name(s): MV140; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): The subjects will receive daily dose of MV140 during 3 or 6 months; The subjects will receive daily dose of placebo during 3 or 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vaccine; Recurrent Urinary Tract Infections (RUTI)