bioihbjkbjnl/mcl2 huggingface dataset:
diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study aims to randomly assign individuals with type 2 diabetes into the ENHANCED
      randomized control trial. The study is being conducted by the Minneapolis Heart Institute
      Foundation (MHIF) and will have two study sites 1) Hutchinson Health and 2) New Ulm Medical
      Center. The study is primarily funded through the Academy of Nutrition and Dietetics (AND).

      The study will examine the impact of a registered dietitian-led, primary care integrated,
      telemedicine program on diabetes care measures (the 'D5') over one year as compared to usual
      care. The D5 goals include: blood pressure <140/90 mmHg, taking a statin as appropriate, A1c
      <8%, not using tobacco and taking an aspirin as appropriate.
    

Detailed description: 
      Individuals will be invited to attend a baseline visit where they will have lab work done,
      anthropometrics (height, weight, waist circumference) and complete a lifestyle assessment.
      They will formally consent to participation by signing a study consent form. The same
      measures will be collected after completion of the one year study.

      Study participants will receive two sessions of free lab work, a diabetes education book, and
      brief coaching with a registered dietitian/certified diabetes educator. In addition, those
      randomized to the phone coaching will have access to a registered dietitian/certified
      diabetes educator on a monthly basis for one year of personalized health coaching for free.
      The intent of this coaching is to help individuals achieve diabetes "optimal" care or meeting
      all 5 Diabetes Care measures (blood glucose, blood pressure, tobacco use, statin and aspirin
      use).

      This program is designed to complement usual clinic-based primary care, with coaches
      documenting lab, biometrics and medication adjustments in the EHR, along with documenting
      phone encounters and communicating directly with patients' PCPs as needed. Documentation in
      the EHR uses an order created specifically for the study indicating the patient's research
      status.

      Lab work required as part of this research study at baseline and 12 months is covered by the
      study. Any lab work and/or medication co-pays or fees outside of the baseline and 12 month
      study visits are the responsibility of the patient and/or their insurance
    

Intervention name(s): Coaching
Intervention type(s): Behavioral
Intervention description(s): Focus on nutrition, activity and appropriate medication use and adherence
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The North American Pancreatitis Study
Condition: Pancreatitis
MeSH terms: Pancreatitis
Study type: Observational

Summary: 
      This study will investigate several genes and other factors measured in the blood that may
      cause recurrent acute pancreatitis and chronic pancreatitis. No treatment is offered as part
      of this study. Subjects have one single visit to provide a blood sample for genetic testing
      and to answer a questionnaire. Subjects are not given results of genetic testing. The study
      is currently enrolling African American subjects and controls only.
    

Detailed description: 
      This study seeks to enroll African American people with and without pancreatitis. There is
      only one study visit to obtain consent, a blood sample and complete a questionnaire. Subjects
      must be patients of a participating center; controls must present to a participating center
      for enrollment.
    

Intervention name(s): blood sampling
Intervention type(s): Genetic
Intervention description(s): blood samples obtained to extract biomarkers and dna for analysis, questionnaires
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        people with and without pancreatitis
      
Biospecimen description: 
      Blood samples and extracted biomarkers and genetic material.
    
Keywords: African Americans; pancreatitis; controls
Effects of Muscle Fatigue and Kinesio Taping on Shoulder Position Sense
Condition: Fatigue; Proprioception
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of Kinesio Taping on the position
      sense of shoulder after muscle fatigue.
    


Intervention name(s): Kinesio taping with tension; Kinesio taping without tension; Fatigue protocol
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Fatigue; Proprioception; Shoulder
Comparison of Analgesic Efficacy of PENB Block With FICB in Post Operative Hip Fracture Patients
Condition: Post-operative Pain Management; Hip Fracture Surgery
MeSH terms: Pain, Postoperative; Fractures, Bone; Hip Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was done to evaluate two different interventions for postoperative pain control in
      patients undergoing hip surgeries. Fifty patients, divided in two equal groups, were included
      in the study. Patients in Group P were given pericapsular nerve group (PENG) block while
      those in Group F were given fascia iliaca compartment block (FICB). Pain score, using Numeric
      Rating scale as a measurement tool, was assessed at one, six, eighteen and twenty fours after
      the procedure as a primary outcome. Total tramadol consumption in milligrams was recorded as
      a secondary outcome.
    


Intervention name(s): PENG block; FICB Block
Intervention type(s): Drug; Drug
Intervention description(s): 10ml of 0.125% isobaric bupivacaine injected; 20ml of 0.125% isobaric bupivacaine injected
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the influence of
      oral semaglutide (NNC0113-0217) on the pharmacokinetics of lisinopril and warfarin in healthy
      subjects.
    


Intervention name(s): semaglutide; lisinopril; warfarin; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): For oral administration once daily. Doses of 5 mg and 10 mg, respectively, will be given for 7 days followed by 20 mg administered on days 43-84.; For oral administration. A single dose of 20 mg is administered three times either alone or conconmitantly with a perpetrator compound (days 1, 15 and 71).; For oral administration. A single dose of 5 mg is administered three times either alone or conconmitantly with a perpetrator compound (days 8, 22 and 78).; A single dose of SNAC is administered conconmitantly with victim compounds (days 15 and 22).
Intervention MeSH terms: Lisinopril; Warfarin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Application of IV 99mTc-tilmanocept for Imaging of Macrophage-specific Inflammation
Condition: HIV
MeSH terms: Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to evaluate uptake of intravenously administered
      99mTc-tilmanocept using single photon emission computed tomography (SPECT/CT) scanning in
      individuals with HIV and individuals without HIV.
    

Detailed description: 
      People living with HIV (PLWH) have an increased risk of cardiovascular disease (CVD) compared
      to individuals without HIV. Increased systemic immune activation and arterial inflammation
      are thought to contribute to this increased risk by affecting the highly inflammatory process
      of atherosclerotic plaque formation and progression. This study will evaluate whether
      intravenous administration of a macrophage-specific imaging agent, 99mTc-tilmanocept,
      followed by SPECT/CT scanning can permit quantification of aortic 99mTc-tilmanocept uptake,
      reflective of aortic macrophage-specific inflammation among participants with HIV. We will
      also compare aortic 99mTc-tilmanocept uptake in participants with HIV to participants without
      HIV. Immunology parameters such as markers of immune activation and traditional CVD
      parameters will be assessed in relation to imaging assessments.
    

Intervention name(s): Imaging
Intervention type(s): Diagnostic Test
Intervention description(s): Macrophage-specific inflammation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HIV-infected participants and non-HIV-infected participants
      
Keywords: Macrophage-specific inflammation; Arterial inflammation; Neuroinflammation; SPECT/CT; Tilmanocept
Liraglutide as Add on Therapy on Metformin in Women With Polycystic Ovary Syndrome
Condition: PCOS; Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine whether combined treatment with liraglutide and
      metformin is more effective than metformin as monotherapy in the treatment of obese women
      with polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in
      patients on combined treatment than in those on monotherapy.
    


Intervention name(s): Metformin; Glucophage tablets and Victoza
Intervention type(s): Drug; Drug
Other intervention name(s): Glucophage tablets; Glucophage tablets and Victoza 6 mg/ml solution for injection in pre-filled pen
Intervention MeSH terms: Metformin; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: response to therapy
The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder
Condition: Alcohol Use Disorder; Mild Cognitive Impairment
MeSH terms: Alcoholism; Cognitive Dysfunction; Alcohol Drinking
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is an open label feasibility trial to learn whether the combination of donepezil and
      cognitive remediation therapy (Donepezil + CRT) may improve neurocognitive functioning and
      decreasing alcohol use in Veterans with alcohol use disorder who have mild cognitive
      impairment (AUD-MCI). The study will determine the acceptability and adherence to treatment
      and preliminary evidence for efficacy. The study will recruit 15 newly recovering Veterans
      individuals with AUD-MCI for a 13-week, open-label, single-arm pilot study with sobriety and
      cognitive assessments at baseline and at 13-week follow-up.
    

Detailed description: 
      Donepezil is FDA approved for treatment of dementia and recent animal studies have suggested
      that it may reduce craving in rat models of alcohol use disorder. Investigators' previous
      studies of cognitive remediation therapy (CRT) with work therapy have shown efficacy with
      newly recovering Veterans with AUD compared with work therapy alone. The current study
      combines Donepezil and CRT in an open-label trial to learn whether the combination of
      Donepezil + CRT may improve neurocognitive functioning and decrease alcohol use in Veterans
      with alcohol use disorder who have mild cognitive impairment (AUD-MCI). The study will
      determine the acceptability and adherence to treatment and provide preliminary evidence for
      efficacy. The study will recruit 15 newly recovering Veterans individuals with AUD-MCI for a
      13-week, open-label, single-arm pilot study with sobriety and cognitive assessments at
      baseline and at 13-week follow-up. Primary outcome variables will be a Clinical Global Index
      of AUD recovery and a Global Cognitive Composite of MCI related neurocognitive assessment.
    

Intervention name(s): Donepazil
Intervention type(s): Combination Product
Intervention description(s): Donepezil: Subjects will take 5 mg/day of donepezil in the evening for first 4 weeks, then 10 mg/day of donepezil in the evening until week 13.
Cognitive remediation therapy (CRT): This study employs a computerized program (BrainHQ) for cognitive enhancement. Participants use their program for one hour per session, up to five sessions per week, over 13 weeks (maximum of 65 sessions). They may training on site or at another quiet location of their choice.
Other intervention name(s): Cognitive Remediation Therapy
Intervention model: Single Group Assignment
Intervention model description: Open-label single group design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcohol Use Disorder; Mild Cognitive Impairment; Cognitive Remediation Therapy; Donepezil; Recovery
Intensity of Task-Oriented Exercises
Condition: Stroke
MeSH terms: Stroke
Study type: Observational [Patient Registry]

Summary: 
      In an observational study, the energy consumption of stroke individuals during performing the
      structured, progressive task-oriented exercise program for walking rehabilitation will be
      measured in order to confirm the intensity demand in the range of moderate to vigorous.
    

Detailed description: 
      Community reintegration is often significantly affected in the majority of stroke
      individuals. To fulfill the requirements of a proper home exercise program in walking
      rehabilitation for stroke victims, investigators structured the task-oriented exercise
      program with minimal supervision. This exercise program is structured with challenging
      walking-related activities based on motor learning principle and Gentile's progression of the
      motor task. The strengthening and balance components, aerobic conditioning and walking
      adaptability are composed of an exercise program to optimize walking ability. There are sixty
      minutes last ten exercises in each three progression steps of this exercise program. For the
      training effect to occur, each step of exercise program is designed by increasing demand of
      intensity in the range from moderate to vigorous. To confirming progressive energy demand,
      the purpose of this study is to investigate the intensity demand of three steps task-
      oriented home exercise program on walking competency in individual post stroke.
    

Intervention name(s): Structured, Progressive, Task-oriented exercise program
Intervention type(s): Procedure
Intervention description(s): The intervention is walking related task-oriented exercise program with three progressive steps at moderate to high intensity. Each step consists of 60 minutes last ten tasks to optimize walking function of stroke individuals.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Stroke individuals who able to walk without physical assistance.
      
Keywords: Stroke; walking competency; Task-oriented exercise program; Exercise intensity
Serum Exosomal Long Noncoding RNAs as Potential Biomarkers for Lung Cancer Diagnosis
Condition: Lung Cancer (Diagnosis)
MeSH terms: Lung Neoplasms; Neoplasms; Disease
Study type: Observational

Summary: 
      The study is to investigate the sensitivity and specificity of serum exosome noncoding RNA as
      a biomarker for the diagnosis of lung cancer
    

Detailed description: 
      Conventional tumor markers for non-invasive diagnosis of Lung cancer (LC) exhibit
      insufficient sensitivity and specificity to facilitate detection of early lung cancer (ELC).
      The investigators aimed to identify ELC-specific exosomal lncRNA biomarkers that are highly
      sensitive and stable for the non-invasive diagnosis of ELC.Hence, in the present study,
      exosomes from the plasma of five healthy individuals and 30 LC patients and from culture
      media of four human bronchial epithelial cells and four cancer cells were isolated. Exosomal
      RNA profiling was performed using RNA sequencing to identify LC specific exosomal lncRNAs.
    

Intervention name(s): collect samples
Intervention type(s): Diagnostic Test
Intervention description(s): collect serum samples and clinical features
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed as lung cancer by histopathology or cytopathology in union hospital.
      
Keywords: exosomes；lncRNA； lung cancer；
Effectiveness of Black Tea Mouthwash on Plaque Formation
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study was conducted to measure the effectiveness of Black Tea in reducing the deposits on
      teeth. It also compares the effect between use of black tea mouthwash and green tea mouthwash
      to that of chlorhexidine in reducing plaque deposition on teeth in a two weeks long clinical
      trial among adults of 18-40 years of age.
    

Detailed description: 
      The study titled "Effectiveness of Black Tea Mouthwash on Plaque formation: A Randomized
      Controlled Clinical Trial" conducted at Department of Periodontics,during February 2015 till
      July 2015 included three interventional arms with 15 subjects each who had chronic
      generalized plaque-induced gingivitis. All subjects underwent scaling and randomly allocated
      into three groups as Black tea,Green tea and Chlorhexidine. Those in black tea, green tea and
      Chlorhexidine groups advised to rinse with 0.5% Black tea, 0.5% green tea and 0.12%
      Chlorhexidine aqueous based solutions for 30 seconds twice daily half an hour after brushing
      teeth respectively. Gingival Index (Loe and Silness 1963) and Plaque Index (Silness and Loe,
      1964) recorded at baseline and 2 weeks after intervention in all subjects. Results were
      analyzed using SPSS Statistical software version 20.
    

Intervention name(s): Black Tea; Green Tea; 0.12% Chlorhexidine Mouthwash.
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): 0.5% Black Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.; 0.5% Green Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.; 5mL of 0.12% Chlorhexidine used as mouthwash twice daily for two weeks after scaling of teeth.
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Gingivitis, Black Tea, Green Tea,Chlorhexidine, Biofilm,
Attention and Social Behavior in Children
Condition: Anxiety
Study type: Interventional

Summary: 
      This study examines the way attention may be linked to temperamental risk for anxiety, social
      behavior and brain processes. The study aims to see if temperamentally at risk youth display
      an attention bias towards threat, and if anxiety symptoms can be reduced through attentional
      bias modification training.
    


Intervention name(s): Attention Bias Modification; Dot-probe task
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This is a modification of the dot-probe task (placebo task) designed to train attention away from threat; This is the active control placebo condition that simply measures levels of attention to threat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer
Condition: Colorectal Cancer; Colon Rectal Resection; Oxidative Stress
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups
      for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine for
      RNA peroxidation)in patients with colorectal cancer undergo surgical treatment
      (preoperatively during the intervention and postoperatively) and controls.
    

Detailed description: 
      Study of the impact of surgery on Lipid peroxidation, Protein peroxidation, damage by
      nitrogens, and RNA peroxidation, in patients undergo surgical resection for colorectal cancer
      and compared with controls, and validation of the responsiveness of oxidative stress markers
      on surgery
    

Intervention name(s): Surgery for colorectal cancer
Intervention type(s): Procedure
Intervention description(s): Surgical resection of colorectal cancer
Other intervention name(s): Open or Laparoscopic resection for colorectal cancer; Low anterior resection; Sigmoidectomy; Left colectomy; Trasverse colectomy; Right colectomy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Colorectal cancer; Surgical resection; Oxidative Stress Markers; Controls
CX-8998 for Absence Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures; Epilepsy, Absence
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a
      4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998,
      followed by a 1-week safety follow-up period after the last dose of study medication.
    

Detailed description: 
      This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a
      4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998,
      followed by a 1-week safety follow-up period after the last dose of study medication.

      Subjects will participate for a total of up to 9 weeks, including screening, the 4-week
      treatment period and follow-up.
    

Intervention name(s): CX-8998
Intervention type(s): Drug
Intervention description(s): T-type calcium channel blocker
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy, Idiopathic Generalized Epilepsy, Absence Seizures
Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effectiveness and safety of the investigational drug 683699 in
      treating subjects with moderately to severely active CD (Crohn's Disease).
    


Intervention name(s): 683699
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: CD; Crohn's Disease