bioihbjkbjnl/mcl2 huggingface dataset:
Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain
Condition: Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is premedication efficacy of analgesics on post endodontic pain.
      Sixty-six healthy adult volunteers including criteria, are participating. The patients will
      be divided into 3 groups and will be randomly given one of pre medications including 1) 10 mg
      Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before
      applying the injection. All patients will receive standard root canal treatment. Patients
      will record their post treatment pain using a Heft parker Visual Analog Scale(VAS). Success
      will be considered as no or mild pain (VAS≤54)with no need to take analgesic. Data will be
      analysed using Mann-U-Whitney and Kruskal-wallis tests.
    

Detailed description: 
      The aim of this study is premedication efficacy of analgesics on post endodontic pain.
      Sixty-six healthy adult volunteers with age ranged 18-65, non smoking or any medicine
      consumption, non pregnant or break feeding who haven't received any analgesic during 24 hours
      before the treatment, are participating. The patients will be divided into 3 groups and will
      be randomly given one of premedications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus
      1000mg Acetaminophen, and 3)Placebo, 45 minutes before the treatment. All patients will
      receive a standard root canal treatment. Patients will record their post treatment pain using
      a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain
      (VAS≤54) with no need to take analgesic during 6, 12, 24 and 48 hours intervals following the
      treatment. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.
    

Intervention name(s): Ketorolac tromethamine; Acetaminophen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment; 1000 mg oral Acetaminophen along with10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment.; placebo 45 minutes before root canal treatment
Other intervention name(s): Toradol; Tylenol; disambiguation
Intervention MeSH terms: Acetaminophen; Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Endodontic treatment; non steroid; pain; pre medication
Efficacy of Jobelyn™ Consumption on Hemoglobin Levels in a Borderline Anemic Population
Condition: Anemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the timing and magnitude of improvements to red
      blood cell health associated with consumption of Jobelyn™.
    

Detailed description: 
      From past history, case studies in Nigeria, as well as testimonials from all over the world,
      have shown a robust increase in hemoglobin within a few weeks in people with serious cases of
      anemia present under disease conditions such as sickle cell, Malaria, HIV, or cancer. In
      parallel, improvements in red blood cell health were also seen in many healthy people with
      general low blood counts due to undetermined factors.

      A clinical study on anemia is currently ongoing in Nigeria. The study population is focused
      on women and aims at evaluating whether Jobelyn™ consumption can help increase hemoglobin and
      thus reduce risk factors associated with gynecological surgery in a Nigerian cohort of
      gynecological patients (ClinicalTrials.gov Identifier: NCT01670955).

      As a parallel to the ongoing study in Nigeria, this study protocol will help to
      systematically examine the effects of Jobelyn™ on anemic conditions in an otherwise healthy
      North American population, and help document the speed and magnitude of improvements in a
      population without concomitant infections or sickle cell anemia.

      Twenty-four human subjects of both genders will be tested over a period of 8 weeks. Both
      genders may enroll in the study, but we expect more women to be eligible, due to effects of
      menses and prolonged consumption of birth control pills. Recruiting of volunteers will happen
      via NIS Labs. A screening blood draw will be used for CBC/differential and the hemoglobin
      level help determine eligibility.

      Enrolled subjects will randomized to consume placebo or Jobelyn™ for 8 weeks, during which
      time subjects are monitored at baseline, and after 3 days, 7 days, and 2, 4, and 8 weeks. A
      fasting blood sample will be taken at each visit, and used for hemoglobin and fasting glucose
      measurements.
    

Intervention name(s): Jobelyn™; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Sorghum bicolor leaf sheath extract; Placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia
Condition: Balance
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily
      (QD), compared to placebo with Zopiclone in adults with chronic insomnia
    

Detailed description: 
      A vast majority of people are affected by chronic insomnia in the western world. Several
      studies have looked at this and have estimated that 30% to 48% of the general population is
      affected at some time in their life with a form of insomnia that goes on for several months,
      and about one third of those are described as severely affected. Daytime symptoms of insomnia
      include tiredness, lack of energy, difficulty concentrating, and irritability. Recent
      epidemiologic research focusing on the quality of life has identified significant
      insomnia-related conditions that relate to work productivity, health care utilization, and
      risk of depression. Insomnia is associated with diminished work output, absenteeism, and
      greater rates of accidents.

      This study will examine the effect of ramelteon on balance/postural stability on Night 14 at
      peak plasma concentration levels, compared with placebo and using zopiclone as the reference
      arm.
    

Intervention name(s): Ramelteon; Zopiclone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ramelteon 8 mg, tablets, orally, once daily for up to 28 nights.; Zopiclone 7.5 mg, tablets, orally, once daily for up to 28 nights.; Placebo-matching tablets, orally, once daily for up to 28 nights.
Other intervention name(s): Rozerem; TAK-375; Zimovane; Imovane; Rovane
Intervention MeSH terms: Zopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Center of Pressure; Postural Sway; Drug Therapy; Balance and Stability
Back to the Future: Bridging the Hospital to Home Continuum After Hip Fracture
Condition: Hip Fracture
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether is is feasible and acceptable to deliver a
      telephone based coaching intervention compared with education alone in community dwelling
      older adults (age 60 and older) after a fall related hip fracture.
    

Detailed description: 
      The investigators propose a randomized controlled trial design to inform the development of a
      larger scale study to test effectiveness of a clinician supported telephonic self management
      intervention for older adults after hip fracture. The primary aim is to determine feasibility
      and acceptability of the intervention, and the secondary aim is to measure statistical trends
      on quality of life at 4 months after fracture in community dwelling older adults. In
      parallel, we will conduct a process evaluation to ascertain key features of the intervention
      via qualitative interviews of participants and health care professionals involved in delivery
      of the intervention.
    

Intervention name(s): Telephone Support and Coaching; Education Only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The participants will receive up to 5 telephone calls of 30-45 minutes each after hospital discharge to provide support and education for the transition from acute to community care. The first call will be made within 48-72 hours of hospital discharge and will have the following elements:
Health Status
Medication Management
Activity/Exercise Prescription and Goal-Setting
Falls Prevention
Clarification of Appointments
Coordination of Post-Discharge Home Services
What To Do If a Problem Arises; An educational toolkit will be provided, with materials to self manage at home after hospital discharge following a fall related hip fracture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Femoral Fractures; Hip Fractures; Frail older adults; Quality of Life; Feasibility Studies
Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the safety and efficacy of oral PF-00299804 in patients who have
      not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck
      squamous cell cancer.
    


Intervention name(s): PF-00299804
Intervention type(s): Drug
Intervention description(s): 45 mg by continuous oral dosing
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent or metastatic squamous cell cancer of the Head and Neck; no prior systemic therapy for recurrence
Liver-enriched Antimicrobial Peptide 2
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators aim to investigate the physiological importance of LEAP-2 in healthy
      volunteers focusing on its potential insulinotropic effects.
    

Detailed description: 
      The dramatic and almost immediate effects of Roux-en-Y gastric bypass (RYGB) surgery on type
      2 diabetes (T2D) can only in part be explained by alterations in the plasma concentrations of
      known peptides. Thus, other - yet unknown - signals or hormones elicited from the endocrine
      cells of the small intestine may play an important role for the remission of T2D observed
      following RYGB. In a recent study, a predicted sequence of liver-enriched antimicrobial
      peptide 2 (LEAP-2) was shown to induce a glucose-stimulated insulin secretion in isolated
      human pancreatic islets. The fragment was subsequently identified to be circulating in human
      plasma in concentrations comparable to the circulating levels of other known gut secreted
      hormones, hereby validating that LEAP-2 is an endogenous circulating peptide.

      The investigators hypothesise that LEAP-2 increases insulin secretion during a graded glucose
      infusion as assessed by plasma insulin and C-peptide compared with saline (placebo) in
      healthy subjects. The study is designed as a clinical, placebo-controlled, double-blinded
      cross-over study involving two experimental study days and ten young healthy male
      participants. The co-primary endpoints are the difference in plasma insulin levels during a
      graded glucose infusion and beta-cell secretion assessed by plasma C-peptide concentration
      relative to plasma glucose concentration between the two study days with either saline
      (placebo) or LEAP-2 infusion.
    

Intervention name(s): Liver-enriched antimicrobial peptide 2; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Infusion of LEAP-2 during a 180 min grated glucose infusion.; Saline
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is designed as a clinical, placebo-controlled, double-blinded cross-over study involving two experimental study days.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Routine Ultrasound Screening in the Third Trimester
Condition: Fetal Growth Retardation; High-Risk Pregnancy
MeSH terms: Fetal Growth Retardation
Study type: Interventional

Summary: 
      Late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity of
      40 % in low-risk pregnancies. In addition, late intrauterine growth restriction may be
      associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and
      hospitalization in intensive care unit. The investigators hypothesis that a later third
      trimester routine ultrasound may be more accurate to diagnose late intrauterine growth
      restriction.
    


Intervention name(s): ultrasound examination; ultrasound examination
Intervention type(s): Other; Other
Intervention description(s): ultrasound examination between week 30+1 weeks to 31+6 weeks; ultrasound examination between 34+1 weeks to 35+6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Intrauterine growth restriction; Screening; Ultrasound; Perinatal morbidity; Maternal complications
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel,
      225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy
      (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
    


Intervention name(s): Rapastinel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rapastinel pre-filled syringes for weekly IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      Children (Exclusively breast fed: 6mo - 3yrs, and who are not exclusively breast fed 3mo to 3
      yrs) with infantile cholestasis syndrome will be randomized to either recieve indigenously
      prepared oral nutritional supplement (energy dense supplement appox. 2 kcal/mL, prepared from
      locally available, affordable, socially acceptable food items - milk, sugar, edible coconut
      oil, egg and custard powder as base) in addition to standard nutritional counseling by a
      trained dietician (Group A). The control group (Group B) in comparison will receive standard
      nutritional counseling from a trained dietician but will not receive any additional
      nutritional supplement. All the children will be followed up at 1 month, 3 months, 6 months,
      9 months and 1 year after inclusion. Clinical, nutritional assessment and laboratory data
      will be collected at each visit. Additionally IL-6 levels will be done at each visit in
      children of both arms of the intervention group.

      The outcomes of interest will be growth and improvement of nutritional status parameters,
      hepatic morbidity (ascites, gastrointestinal bleeding, encephalopathy, {SBP (Spontaneous
      Bacterial Peritonitis), HRS (Hepatorenal Syndrome), etc and outcome (improvement, death or
      Liver Transplantation}.

      All children will receive individualized standard treatment for infantile cholestasis
      syndrome including vitamin supplements/endotherapy/ beta blockers/ prophylaxis for SBP
      (Spontaneous Bacterial Peritonitis)/cholangitis (to at risk children) and drug therapy
      wherever indicated (steroids/ copper chelation/ UDCA).
    


Intervention name(s): Nutritional Supplement; Standard Nutritional Treatment
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Energy dense supplement appox. 2 kcal/mL, prepared from locally available, affordable, socially acceptable food items - milk, sugar, edible coconut oil, egg and custard powder as base) in addition to standard nutritional counseling by a trained dietician as per the recommended daily allowance according to gender and age.; Standard nutritional counseling by a trained dietician as per the recommended daily allowance according to gender and age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae
Condition: Arteriovenous Fistula
MeSH terms: Central Nervous System Vascular Malformations; Arteriovenous Fistula; Fistula
Study type: Observational [Patient Registry]

Summary: 
      The objective of this study is to evaluate the safety and performance post last embolization
      with Onyx
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients presenting at the participating centers for whom an intracranial dAVF (not
        previosly treated) needs to be treated (unrelated to the planned treatment) and who agree
        to the collection and transmission of related data.
      
Keywords: dAVF; Arteriovenous fistula; ONYX
Structured Gym Activities and Aerobic Activities in People With Cardiac Conditions
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      To compare the effect of structured gym activities and traditional aerobic activities on
      cardiorespiratory endurance in people with cardiac conditions To compare the effect of
      structured gym activities and traditional aerobic activities on quality of life in people
      with cardiac conditions
    


Intervention name(s): Structured gym activities; Traditional aerobic activities
Intervention type(s): Other; Other
Intervention description(s): Planned and structured activities such as Strength training
Dumbbell Exercises (1kg with 2 sets of 10 repetitions)
Sit-ups (2 sets of 10 repetitions)
Stair climbing, (2 sets of 10 stairs up and down)
Squat (2 sets of 10 repetitions) Flexibility training • Tai chi (Peng. Lu, chi, an Tsai, lieh, chou, Kao (Hold each posture for 20 seconds)) • Pilates (Breathing., Shoulder bridge, Leg lifts (Hold each pose for 20 seconds)) • Stretching techniques (Neck stretch, Shoulder stretch, Side stretch Hold each stretch for 20 seconds)).; Activities performed such as
Treadmill Time: 10 minutes Intensity: 60 to 80% of target heart rate
Cycle ergometer Time: 10 minutes Intensity: 60 to 80% of target heart rate
Elliptical exercises Time: 10 minutes Intensity: 60 to 80% of target heart rate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Gym Activities; Aerobic Exercises
TART - Troglitazone Atherosclerosis Regression Trial
Condition: Atherosclerosis; Diabetes Mellitus
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine if troglitazone reduces the progression of early
      preintrusive carotid atherosclerosis in insulin-requiring diabetes patients.
    

Detailed description: 
      Insulin resistance and hyperinsulinism appear to be important risk factors for the
      development of atherosclerosis in diabetes patients. The atherogenic potential of insulin has
      been shown to improve cholesterol and may have an effect on the thickness and structure of
      the arterial wall. Troglitazone is an oral diabetic agent that treats insulin resistance.
      Based on the initial data available, it would appear that troglitazone may be effective in
      both glycemic control and improved atherosclerosis risk in diabetes patients. This study will
      compare the effects of troglitazone to placebo in insulin-requiring diabetes patients on both
      glycemic control and progression of atherosclerosis.

      A total of 288 men and women 30 to 70 years of age with insulin-treated diabetes were
      recruited and entered an 8 week run-in phase to stabilize diet, exercise, insulin dose and
      glucose levels. Upon successful completion of the run-in phase, all patients were randomized
      into one of two groups to receive either troglitazone 400mg/day or a matching placebo while
      continuing with diet and exercise regimens and insulin dose to maintain pre-meal glucose
      levels between 100 to 150 mg/dL.

      Follow up visits occurred every 2 weeks for 2 months, every 4 weeks for 2 months, then every
      8 weeks for the remainder of the 2-year trial. The progression of atherosclerosis was
      measured by ultrasonography at baseline and every 6 months throughout the 2 years of
      randomized treatment.
    

Intervention name(s): troglitazone
Intervention type(s): Drug
Intervention MeSH terms: Troglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: IDDM; Insulin; cardiovascular disease
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC
Condition: Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate the tolerability, safety and efficacy of SHR-1210 in
      combination with Apatinib and Fluzoparib in subjects with recurrent and metastatic triple
      negative breast cancer
    

Detailed description: 
      Drug: SHR-1210 + Apatinib +Fluzoparib SHR-1210 will be administered as an intravenous
      infusion, Apatinib tablets will be given orally, Fluzoparib capsule will be given orally 28
      days per cycle, until disease progression or unacceptable toxicity.

      Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparib
    

Intervention name(s): SHR-1210 + Apatinib +Fluzoparib
Intervention type(s): Drug
Intervention description(s): SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity.
Other intervention name(s): Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparib
Intervention MeSH terms: Apatinib; Fluzoparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment