bioihbjkbjnl/mcl2 huggingface dataset:
NAC-003 P.L.U.S. Program (Progress Through Learning Understanding & Support)
Condition: Early Memory Loss; Mild Cognitive Impairment; Alzheimer's Disease; Vascular Dementia
MeSH terms: Alzheimer Disease; Dementia, Vascular; Memory Disorders; Amnesia; Cognitive Dysfunction
Study type: Observational

Summary: 
      This study will be an observational study in which patients who have been prescribed
      CerefolinNAC® are invited to participate in surveys regarding their experiences with
      CerefolinNAC®. CerefolinNAC® is a medical food indicated for the distinct nutritional
      requirements of individuals under treatment for early memory loss with particular emphasis
      for those individuals diagnosed with or at risk for neurovascular oxidative stress and/or
      hyperhomocysteinemia; mild to moderate cognitive impairment with or without vitamin B12
      deficiency, vascular dementia or Alzheimer's disease. The purpose of this study is to
      increase the understanding of the role of CerefolinNAC® in managing proper neuronal function
      in the brain, provide patients with personalized education and support, and contribute to the
      overall understanding of the needs and concerns of patients being treated for early memory
      loss.
    

Detailed description: 
      Surveys used to conduct this study will be administered via telephone by InfoMedics, Inc., a
      company with an established system for developing such patient-physician feedback programs.
      Participating physicians will ask their patients to participate in the program after
      CerefolinNAC® has been prescribed and provide them with a brochure containing an introduction
      to the program and instructions on how to enroll. Patients self-enroll, take a brief survey
      before starting their CerefolinNAC® prescription, and then two brief follow-up surveys at 6
      weeks and 12 weeks. As patients complete surveys within the study, their physician will
      receive individualized feedback reports outlining their patient's treatment experience and
      progress. Patients will also receive a copy of their own reports, to help encourage them to
      continue taking CerefolinNAC® as directed. Patients will also receive educational materials
      about managing their early memory loss.
    

Intervention name(s): CerefolinNAC®
Intervention type(s): Other
Intervention description(s): CerefolinNAC® is an orally-administered medical food, and each caplet contains 2 mg Methylcobalamin, 600 mg N-acetylcysteine, and 6 mg of L-methylfolate Calcium (as Metafolin®), which is the primary biologically active and immediately bioavailable form of folate. Dosage will be 1 caplet QD.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Early Memory Loss Who Have Been Prescribed CerefolinNAC®
      
Keywords: CerefolinNAC; early memory loss; pre-alzheimer's disease; cognitive function; folic acid; folate; L-methylfolate; vitamin B12; methylcobalamin; N-acetylcysteine; NAC; oxidative stress; memory deficit; antioxidant
A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of 100 mg DRBP108 tablets in the treatment
      of type 2 diabetes mellitus. A total of 750 subjects will be randomly allocated to three
      groups: DRBP108, active comparator and placebo comparator, in a 3:1:1 ratio. The purpose of
      this study is to evaluate whether 24 weeks of DRBP108 treatment will adequately reduce
      hemoglobin A1C levels in T2DM subjects.
    


Intervention name(s): DBPR108; Placebo matching sitagliptin; Placebo matching DBPR108; Sitagliptin; DBPR108; Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Phase A (Weeks 1-24): DBPR108 100 mg once daily under fasted conditions for 24 weeks; Placebo matching sitagliptin 100 mg once daily under fasted conditions for 24 weeks.
Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks.; Phase A (Weeks 1-24): Placebo matching DBPR108 100mg once daily under fasted conditions for 24 weeks; Sitagliptin 100 mg once daily under fasted conditions for 24 weeks.
Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks.; Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg once daily under fasted conditions for 24 weeks; Placebo matching sitagliptin 100 mg once daily under fasted conditions for 24 weeks.
Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks.
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DBPR108; Type 2 diabetes mellitus; DPP4 inhibitor
Oculomotor Assessment of Traumatic Brain Injury (TBI)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of the proposed study is to compare the sensitivity and specificity of three
      oculomotor test devices in normal subjects versus subjects with history of TBI. The study is
      designed as a prospective research project in which a group of 120 normal controls without a
      history of TBI will be compared to another group of 120 participants (total of 240) who have
      a confirmed history of TBI. Each participant will complete the TBI assessment protocol for
      each of three separate devices (Neuro Kinetics, SyncThink, and Oculogica). The order of the
      devices will be counter-balanced across participants. Participants will also be screened for
      vestibular migraine and visual vertigo, which are two conditions that influence
      oculo-vestibular perception in normal and TBI patients and might influence the results from
      the three oculomotor devices. Data from each device will be utilized to perform AUC analyses
      to determine the respective sensitivity and specificity for each.
    


Intervention name(s): Neuro Kinetics IPAS; Oculogica EyeBox; SyncThink EyeSync Device
Intervention type(s): Device; Device; Device
Intervention description(s): Testing with PAS device; Testing with Oculogica EyeBox device; Testing with SyncThink EyeSync device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants undergo testing with the same three devices. The order of devices will be semi-randomized to eliminate order effects.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: oculomotor testing
Effects of Dexmedetomidine on Modulation of Perioperative Blood Glucose and Related Hormones
Condition: Dexmedetomidine; Blood Glucose
Study type: Interventional

Summary: 
      The investigators aimed to explore effects of dexmedetomidine on modulation of perioperative
      blood glucose and relevant hormone during the general anesthesia with surgery time ≥ 4 hours,
      and the effects on postoperative complications. 75 participants (American Society of
      Anesthesiologists grades I or II, of both sexes,aged 40-80 yr,with BMI of 18.5-27 kg/m2)
      scheduled for elective surgery under general anesthesia with surgery time ≥ 4 hours were
      enrolled in this study. The participants were divided into four groups: group C (control
      saline group, no dexmedetomidine use), group D1 (dexmedetomidine loading dose 1 mcg/kg,
      maintenance dose 0.25 mcg/kg/h), group D2 (dexmedetomidine loading dose 1 mcg/kg, maintenance
      dose 0.5 mcg/kg/h).10 minutes before anesthesia induction, all participants were
      administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine
      was changed to corresponding maintenance dose in each group. Blood samples were taken at the
      beginning of dexmedetomidine (T0), the beginning of skin incision (T1), 1 h after skin
      incision (T2), the end of the surgery (T3) and 1 h after patient transfer to PACU (T4) for
      the value of blood glucose,lactate and relevant hormones. Also, investigators also record the
      total amount of propofol and sufentanil at the end of surgery,and the complications within 24
      h after the surgery.
    


Intervention name(s): dexmedetomidine
Intervention type(s): Drug
Intervention description(s): 10 minutes before anesthesia induction, all patients were administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine was changed to corresponding maintenance dose in each group.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will look at whether this new drug is effective in the treatment of rheumatoid
      arthritis, and at whether it is safe and well-tolerated by participants with the disease.
    


Intervention name(s): MK-0873; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-0873 1.25 mg twice daily for 12 weeks; Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks
Intervention MeSH terms: MK 0873
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of EVP-6124 (Alpha-7 nAChR) as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy
Condition: Schizophrenia; Impaired Cognition
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the
      cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic
      therapy.
    


Intervention name(s): EVP-6124; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Arms 1, 2; Arm 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognition; Cognition Impairment; Alpha-7 nAChR
Three-Factor Eating Questionnaire in Measuring Eating Behavior in Adolescent and Young Adult Survivors of CNS Tumors
Condition: Cancer Survivor
MeSH terms: Central Nervous System Neoplasms
Study type: Observational

Summary: 
      This trial studies how the Three-Factor Eating Questionnaire works in measuring eating
      behavior in adolescent and young adult survivors of central nervous system (CNS) tumors. The
      Three-Factor Eating Questionnaire is comprised of three factors, including cognitive
      restraint, uncontrolled eating, and emotion eating. The Eating Questionnaire - Ecological
      Momentary Assessment method measures a patient's recent experiences and behavior, such as
      eating behavior, as they continue their daily living. Giving the Three-Factor Eating
      Questionnaire and the Eating Questionnaire - Ecological Momentary Assessment may help
      researchers measure eating behaviors more effectively in adolescent and young adult survivors
      of CNS tumors.
    

Detailed description: 
      PRIMARY OBJECTIVES I. Evaluate whether the factor structure of the adapted Eating
      Questionnaire-Ecological Momentary Assessment (EQ-EMA), which has been modified for real time
      assessment, will be similar to the factor structures for cognitive restraint (CR) and
      uncontrollable eating (UE) factors assessed by the Three Factor Eating Questionnaire-R18v2
      (TFEQ-R18v2) in a sample of adolescent and young adult (AYA) survivors of childhood central
      nervous system (CNS) tumors in the United States (US).

      SECONDARY OBJECTIVES I. To validate the original TFEQ-R18v2 in a sample of AYA survivors of
      childhood CNS tumors in the US.

      II. To determine the association of the original TFEQ-R18v2 with self-reported body mass
      index (BMI).

      III. To determine the association of the original TFEQ-R18v2 with fruits and vegetables,
      fiber, and fat intake.

      IV. To determine the association of EQ-EMA with self-reported BMI. V. To determine the
      association of EQ-EMA with fruits and vegetables, fiber, and fat intake.

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP I: Patients complete the TFEQ-R18v2 questionnaire, a dietary intake assessment, and the
      EQ-EMA questionnaire online.

      GROUP II: Patients complete the EQ-EMA questionnaire, a dietary intake assessment and the
      TFEQ-R18v2 questionnaire.
    

Intervention name(s): Nutritional Assessment; Questionnaire Administration; Questionnaire Administration
Intervention type(s): Other; Other; Other
Intervention description(s): Complete dietary intake assessment; Complete TFEQ-R18v2 questionnaire; Complete EQ-EMA questionnaire
Other intervention name(s): Dietary Assessment; dietary counseling; nutritional counseling
Sampling method: Non-Probability Sample
Study population: 
        MDACC participants
"Effect of Scaling and Root Planing on Liver Function Test (Alanine Aminotransferase and Aspartate Aminotransferase) in Systemically Healthy - Chronic Periodontitis Subjects: a Clinical Trial."
Condition: Chronic Periodontitis (CP) Subjects.
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim:

      To evaluate effect of non- surgical periodontal therapy on liver function in systemically
      healthy chronic periodontitis (CP) subjects.

      Materials and methods:

      The study is non surgical interventional trial, includes 50 CP subjects in the age group of
      35- 60 years selected from the OPD (Out Patient Department) of department of periodontology
      Tatyasaheb Kore Dental College and Research center (TKDC and RC), Kolhapur. CP subjects were
      equally divided into test group and control group. Liver function test- aspartate
      aminotransferase (AST), alanine aminotransferase (ALT) were checked at baseline and at 1
      month after treatment. Clinical examination includes plaque index, gingival index, sulcus
      bleeding index, probing depth, clinical attachment loss.
    


Intervention name(s): Scaling and root planing
Intervention type(s): Procedure
Intervention description(s): scaling and root planing as an intervention was done in patients of the test group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Duration of Vitamin D Stores After Prolonged Vitamin D Substitution
Condition: Obesity
Study type: Observational

Summary: 
      Ingested or skin produced vitamin D is either hydroxylated in the liver to 25-hydroxyvitamin
      D (25(OH)D), metabolized and excreted in the urine, or stored in adipose and other tissues.
      The capacity for vitamin D storage in adipose tissue is not known, nor the importance of such
      storage which may potentially be of vital importance when intake or solar exposure is
      limited. In the present study we will include 76 subjects who have participated in an
      intervention study with vitamin D (20.000 IU per week) versus placebo for the prevention of
      type 2 diabetes, and who have completed the study after 5 years or who have been excluded
      because of diagnosed type 2 diabetes or for other reasons. If vitamin D is stored to any
      extent in the body the subjects given 20.000 IU vitamin D per week for 2-5 years will have a
      considerable amount of stored vitamin D and accordingly, a slow decline in serum 25(OH)D
      during the following year without vitamin D substitution, which will be measured in the
      present study. If our hypothesis is correct, that vitamin D can be stored in significant
      amounts when the supply is abundant; current advice on vitamin D supplementation mainly
      during winter should be changed to "year around" in order to build up sufficient stores for
      the months without sufficient sun light.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who have previously participated in a vitamin D study
      
Biospecimen description: 
      blood samples and fat biopsy
    
Keywords: vitamin D; fat; biopsy
Assessing the Team SA Instrument in Measuring the Effectiveness of Communication Across Disciplines During ICU Rounds
Condition: Personal Communication
Study type: Observational

Summary: 
      Assessing the utility of the Team SA instrument in measuring the effectiveness of
      communication across disciplines during ICU rounds.
    

Detailed description: 
      Multidisciplinary rounds are events that occur daily in Intensive care units. During these
      events, practitioners from multiple disciplines meet at a pre-specified time to discuss
      current medical condition and plans of care. At the conclusion of these discussions, all
      practitioners are expected to understand the plan of care well enough to execute defined
      tasks, but also coordinate as circumstances change. In order to coordinate under changing
      circumstances practitioners must have a broader understanding of the current state of the
      patient and how likely certain deteriorations are. This synthetic understanding of patient
      risks across multi-provider groups has been described as anticipatory team situational
      awareness (Team SA). One instrument has been validated in the ICU as feasible and
      informative. This Team SA survey successfully identified that the time spent in "training"
      discussions improved Team SA across physician groups. The investigators' goal is to implement
      this survey across the investigators' medical ICU service to obtain a baseline estimate of
      how effective current communication patterns are for achieving concordant Team SA. If gaps in
      communication are encountered future interventions will be developed
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Daily census rosters of the MICU and 8ICU nursing units will be reviewed for occupancy. At
        8am on survey days occupied beds will be tallied (up to 39 beds). Beds occupied by a
        non-MICU service patient and those with active DNR-CC orders will be excluded. From the
        remaining patients, ten bed numbers will be randomly selected for review. Randomization
        will be stratified by MICU service sub-unit (MICU 40, MICU 90, 8ICU). If fewer than ten
        patients are eligible on an assigned survey day, all patients in the ICU on that day will
        be surveyed.
Effects of Muscle Flossing on Quadriceps Muscle Potentiation
Condition: Ischemia; Placebo - Control
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      Tissue flossing involves wrapping a thick rubber band around a joint or muscle, which can
      partially occlude blood flow. In practice, it is often used while concomitantly performing a
      range of motion exercises (ROM) for 1 to 3 minutes in duration. The mechanisms involved in
      tissue flossing with a floss band may be similar to those involved in ischemic
      preconditioning. Previous results would support the use of tissue flossing on ROM, while
      there are no clear conclusions on post-activation effects on sports-related performance and
      muscle contractile properties. This may be attributed to the different methodologies used in
      the studies. Therefore, the time course associated with tissue flossing benefits remains to
      be investigated.
    

Detailed description: 
      Nowadays, various methods are used for acute performance enhancement. The most recent of
      these is tissue flossing, which is becoming increasingly popular for both performance
      enhancement and rehabilitation. However, the effects of flossing on athletic performance have
      not been clearly demonstrated, which could be due to differences in the methodology used. In
      particular, the rest periods between the end of the preconditioning activity and the
      performance of the criterion task or assessment tools varied considerably in the published
      literature. Therefore, the present study aimed to investigate the effects of applying tissue
      flossing to the thigh on bilateral countermovement jump performance and contractile
      properties of vastus lateralis (VL) muscle. Nineteen recreational athletes (11 males; aged
      23.1 ± 2.7 years) were randomly assigned to days of flossing application (3 sets for 2 min of
      flossing with 2 min rest between sets) with preset experimental pressure (EXP = 95 ± 17.4
      mmHg) or control condition (CON = 18.9 ± 3.5 mmHg). The first part of the measurements was
      performed before and after warm-up consisting of 5 min of cycling followed by dynamic
      stretching and specific jumping exercises, while the second part consisted of six measurement
      points after flossing application (0.5, 3, 6, 9, 12, 15 min).
    

Intervention name(s): Flossing experimental group; Low wrapping pressure
Intervention type(s): Other; Other
Intervention description(s): Flossing of the tight muscles with medium wrapping pressure, which is individualized in based on the tight circumference of the participant.; Control group where flossing wrapping pressure is between 20 and 30 mmHg
Other intervention name(s): Muscle flossing; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: tissue flossing
Pilot Study of Minocycline (NPL-2003) in Adults With Obsessive-Compulsive Disorder (OCD)
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3%
      of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as
      obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only
      medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with
      SRI treatment, most patients continue to experience significant OCD symptoms, impaired
      functioning, and diminished quality of life. Recent evidence suggest that a different
      neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target
      glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from
      OCD. In this study we are recruiting patients to receive the drug NPL-2003, which is thought
      to modulate the neurotransmitter glutamate, added to whatever other OCD medications they are
      taking in a 12-week open label study.
    


Intervention name(s): NPL-2003
Intervention type(s): Drug
Intervention description(s): Minocycline (NPL-2003) daily for 12 weeks
Other intervention name(s): 5707 (Insitution Code name)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OCD