bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Milk Proteins on Blood Pressure
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The primary purpose of the study is to demonstrate a blood pressure lowering effect of
      CasiGold and CasiMax in subjects with high-normal blood pressure or mild hypertension. The
      secondary purpose is to collect human safety data after treatment with CasiGold and CasiMax,
      to gain insight into potential mechanisms by measurement of renin and angiotensin I and II,
      and to evaluate the genetic determinants of the individual BP lowering response by
      measurement of specific genetic polymorphisms.
    

Detailed description: 
      Rationale: Hypertension is the major controllable risk factor associated with cardiovascular
      disease. The risk of developing CVD is directly related to blood pressure (BP) level.
      Tripeptides IPP and VPP obtained from milk proteins were shown to have potential blood
      lowering effects. The renin-angiotensin system is one of the major pathways of BP regulation,
      and ACE inhibition is an important target for BP control. CasiGold and CasiMax are hydrolysed
      casein preparations consisting of relatively high concentrations tripeptides which have ACE
      inhibitory properties in vitro and which may have beneficial effects on blood pressure.

      Study population: 84 female and male Caucasians with a high-normal blood pressure or mild
      hypertension, aged 30 - 70 years at Day 01 of the study and with a BMI 18 - 32 kg/m2, will
      participate in the study.

      Intervention: All subjects receive all treatments, but in a different order. One of the
      treatments consists of daily consumption of two capsules Casigold containing IPP during a
      period of 4 weeks. One of the treatments consists of daily consumption of two capsules
      Casimax containing a mixture of tripeptides during a period of 4 weeks. And one of the
      treatments consists of daily consumption of two capsules placebo during a period of 4 weeks.
      One capsule will be taken upon completion of breakfast and one capsule will be taken upon
      completion of dinner.

      Main study parameters: The main study parameter is the blood pressure after 4 weeks of each
      treatment. Blood pressure will be measured at the study site on the two last days of each
      treatment period. Other study parameters include evaluation of safety at the end of each
      treatment period, and determination of genetic polymorphisms. Analysis of renin and
      angiotensin I and II will only be done in case a change in BP is found.
    

Intervention name(s): Casigold; Casimax; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
In-hospital Initiation of PCSK9 Inhibitor in Patients With Acute Myocardial Infarction
Condition: Coronary Disease
MeSH terms: Myocardial Infarction; Coronary Disease; Infarction
Study type: Observational

Summary: 
      Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to improve
      cardiovascular outcomes when added to conventional statin therapy. This study aims to
      investigate the efficacy and safety of in-hospital initiation of PCSK9 inhibitor among
      patients with acute myocardial infarction(AMI) based on real-world experience.

      A total of 7556 AMI patients from the biobank database between January 2016 and December 2020
      were screened for eligibility. After excluding those without revascularization or Statin
      based therapy, the remaining 5802 Statin users, 801 Statin plus Ezetimibe users and 170
      Statin plus Evolocumab users (including 95 users without and 75 users with Ezetimibe), were
      selected for this study. Then, 1st and 3rd-month follow-up data were collected and analysed,
      including in-hospital mortality, readmission rate and lipid profiles
    


Intervention name(s): Evolocumab 140 MG/ML
Intervention type(s): Drug
Intervention description(s): 140 mg per two weeks, subcutaneous injection
Intervention MeSH terms: Evolocumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        7556 consecutive patients admitted to the cardiology department of the First Affiliated
        Hospital of Xi'an Jiaotong University for AMI between January 2016 and December 2020 were
        enrolled.
Telecoaching of People With Type 2 Diabetes in Primary Care
Condition: Type 2 Diabetes Mellitus; Telenursing
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objective of the study is to analyze the effectiveness and the cost-effectiveness of
      telecoching in improving glyceamic control and other modifiable risk factors in patients with
      type 2 diabetes compared to usual care only.
    


Intervention name(s): telecoaching
Intervention type(s): Behavioral
Intervention description(s): The COACH program trains patients to 'drive' the process of achieving and maintaining the target levels for their risk factors while working in association with their GP. The telephone coaching is aimed at improving self-efficacy by adhering to the prescribed therapy and making relevant behavior changes.
The coaching model is a continuous five-stage coaching cycle: Stage 1. Finding out what the patient knows; Stage 2. Telling the patient what they should know; Stage 3. Assertiveness training; Stage 4. Setting an action plan; Stage 5. Reassessment at the next coaching session (monitoring).
The coach monitors and registers: the biomedical risk factors, the lifestyle/behavioral risk factors and use of the recommended medications. Coaching is focused on eliminating the knowledge gap and motivating the patient to apply the appropriate lifestyle and medical therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: type 2 Diabetes Mellitus; telenursing; RCT; economic analysis
Flecainide in Treating Patients With Chronic Neuropathic Pain
Condition: Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably.

      PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with
      chronic neuropathic pain from cancer or AIDS.
    

Detailed description: 
      OBJECTIVES:

        -  Investigate the effectiveness of flecainide in the management of neuropathic pain.

      OUTLINE: Patients are given a brief pain inventory (BPI) form to assess their pain upon
      enrollment in the study. Following a 7 day stabilization period, flecainide is administered.
      One capsule of flecainide is given twice a day on days 8-10, two capsules are given twice a
      day on days 11-14 and three capsules are given twice a day on days 15-21. BPI forms are
      completed on days 8, 15 and 22 to assess neuropathic pain.

      PROJECTED ACCRUAL: A total of 7-20 patients will be accrued for this study.
    

Intervention name(s): flecainide acetate
Intervention type(s): Drug
Intervention MeSH terms: Flecainide
Primary purpose: Supportive Care
Keywords: pain
Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study
Condition: Methamphetamine Dependence; Methamphetamine Withdrawal
Study type: Observational

Summary: 
      Methamphetamine use has escalated in recent years. Methamphetamine use has also spread
      throughout the country. Although much information has been gathered on the treatment of
      cocaine abuse, very little information has been obtained on the treatment of methamphetamine
      abuse. One of the first steps in developing appropriate treatment is to examine the effects
      of stopping a particular substance's use on individuals abusing that substance. To date this
      has not been well studied for people abusing methamphetamine. The purpose of this study is to
      better understand and develop accurate ways of measuring symptoms associated with stopping
      the use of methamphetamine in people that are abusing methamphetamine. If the withdrawal
      symptoms are able to be effectively measured, this will help to develop treatments targeted
      at alleviating these symptoms. These symptoms are often associated with relapse to use of
      that substance.
    

Detailed description: 
      The primary aim of this 4 week observational study is to examine and characterize the
      withdrawal symptoms experienced by methamphetamine abusers who are recently abstinent from
      methamphetamine. The period of drug or substance withdrawal is often cited as the time during
      which risk of relapse use of that substance is very high. Therefore it is highly important to
      characterize specifically the withdrawal syndrome associated with cessation of
      methamphetamine use. This study will demonstrate our ability to recruit and work with this
      methamphetamine dependent population. In addition it will allow for the collection of pilot
      data to assist in selecting appropriate assessment tools in a submission of an RO1 grant for
      well-controlled studies characterizing methamphetamine withdrawal.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will enroll 20 methamphetamine dependent individuals ages 18-65 recruited from those
        admitted to the Recovery Centers of Arkansas in North Little Rock.
      
Keywords: methamphetamine; drug abuse; withdrawal
Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain
Condition: Postoperative Pain, Acute
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional

Summary: 
      Postoperative pain is generally caused by inflammation and oedema related to tissue trauma.
      Surgical tissue trauma is caused by many factors such as cotery-related burns, surgical
      incisions, dissections, and instrumental procedures like cutting, stretching, or compression.

      The pain stimulus is triggered by mediators released by the traumatic tissue and transmitted
      to the spinal cord and then to the upper centres of the brain. Tenoxicam is an analgesic,
      anti-inflammatory, and antipyretic drug with a long duration of action, included in the
      oxicam subgroup of NSAIDs. Tenoxicam has been studied and found effective for many rheumatic
      diseases such as rheumatoid arthritis, ankylosing spondylitis, gout, extra-articular
      disorders, bursitis, tendonitis, and osteoarthritis. The primary aim of this study was to
      compare the effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination
      analgesic applications on the postoperative VAS score of double-jaw surgery patients. The
      secondary aim was to investigate the effects of these interventions on the number of both
      opioid and rescue analgesic drug consumption postoperatively.
    


Intervention name(s): Double jaw surgery
Intervention type(s): Procedure
Intervention description(s): A type of orthognathic surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Maxillofacial Orthognathic Surgery; Pain management; Postoperative pain; Tenoxicam
Capillary Refill Time Measurement Utilizing Mobile Application in Children
Condition: Healthy Children (1 Month to 17 Years Old)
Study type: Observational

Summary: 
      To determine the accuracy and precision of capillary refill time measurement using a mobile
      health application (Cap App) in a healthy pediatric population. This will be a
      cross-sectional study measuring the capillary refill time in a healthy pediatric population
      using both the Cap App and two additional manual methods which will serve as the comparison.
    


Intervention name(s): Mobile Health application (CapApp)
Intervention type(s): Device
Intervention description(s): Mobile Health application (CapApp) will be used to measure capillary refill time in a healthy pediatric population and compared to two additional manual methods to include both human and computer annotation and mobile health application (Cap App).
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy children age 1 month to 17 years
      
Keywords: Capillary Refill; Mobile Health Application; Pediatrics
Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
Condition: Atrial Flutter
MeSH terms: Atrial Flutter
Study type: Interventional

Summary: 
      Study to determine the feasibility of the Acutus Medical System in obtaining data to create
      Dipole Density Maps of electrical activation in the right atrium in patients with typical
      atrial flutter.
    


Intervention name(s): Acutus Medical System Mapping
Intervention type(s): Device
Intervention description(s): Mapping with the Acutus Medical System followed by intracardiac ablation of typical atrial flutter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of ISIS 449884 (ISIS-GCGRRX) on Hepatic
      Lipid and Glycogen Content in patients with Type 2 Diabetes being treated with Metformin.
    


Intervention name(s): ISIS-GCGRRx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): once weekly dosing for 13 weeks; once weekly dosing for 13 weeks
Other intervention name(s): ISIS 449884
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was to evaluate the safety and and immune response of each of three lots of
      Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy
      Toddlers.
    


Intervention name(s): MenC-CRM LIQ; MenC-CRM ROS; MenC-CRM EMV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One dose of MenC-CRM vaccine, liquid formulation; One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.; One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Meningococcal disease; vaccines; toddlers; prevention; Meningitis
Intervention Study of Depression in Breast Cancer Patients
Condition: Breast Cancer; Depression; Anxiety
MeSH terms: Breast Neoplasms; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on
      depression and anxiety in breast cancer patients.
    

Detailed description: 
      Comprehensive intervention on depression and anxiety in breast cancer patients is a 24-week,
      multicenter, randomized, blinded controlled clinical study, which uses cognitive-behavioral
      therapy. This study tries to evaluate the efficacy of sequential therapy on breast cancer
      patients' depression and its improvement on breast cancer patients' life quality, pain and
      sleeping.
    

Intervention name(s): CBT; Clinical Management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention.; Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.
Following are major elements:
Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.
Other intervention name(s): cognitive-behavioral intervention; psychological intervention; Placebo of Cognitive-Behavioral therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Breast Cancer; Depression; Anxiety; Cognitive-Behavioral Therapy
Scapula Retraction Exercises in Subacromial Pain Syndrome
Condition: Rotator Cuff Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome
Study type: Interventional

Summary: 
      Scapula retraction exercises are often recommended as a part of the exercise programs. The
      primary aim of this study is to investigate the initial effect of the scapula retraction
      exercises on acromiohumeral distance (AHD) at varying shoulder abduction angles and to
      compare asymptomatic subjects. The secondary aim of this study is to investigate the effect
      of scapula retraction exercises on AHD values and symptoms (pain and disability) in patients
      with SPS.
    

Detailed description: 
      Subacmial pain syndrome (SPS) is a common cause of shoulder pain and dysfunction in the
      general population. Exercise interventions is thought as a primary choice in clinical
      settings. Scapula retraction exercises are commonly recommended as a part of the exercise
      programs. Applying scapula retraction exercises at varying shoulder abduction angles could
      restore balance between the scapulothoracic muscles. Since the scapulothoracic muscles
      dynamically control subacromial space, scapula retraction exercises could further help to
      maintain AHD during arm elevation.

      The primary aim of this study is to investigate the initial effect of the scapula retraction
      exercises on acromiohumeral distance (AHD) at varying shoulder abduction angles and to
      compare asymptomatic subjects. The secondary aim of this study is to investigate the effect
      of scapula retraction exercises on AHD values and symptoms (pain and disability) in patients
      with SPS.
    

Intervention name(s): Exercise Intervention
Intervention type(s): Other
Intervention description(s): Scapula retraction exercises at varying shoulder abduction angles will be applied
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain severity; functional status; acromiohumeral distance; shoulder pain
Evaluation of Arginine in Periodontal and Cardiovascular Disease
Condition: Metabolic Disorder; Arginine; Hyperaminoaciduria
MeSH terms: Cardiovascular Diseases; Metabolic Diseases
Study type: Observational

Summary: 
      Asymmetric dimethylarginine (ADMA) plays a key role in endothelial function and may be a link
      for the known interaction of periodontitis and coronary heart disease (CHD). The
      investigators compared the impact of gingival health, periodontitis (CP), CHD or of both
      diseases (CP+CHD) on saliva and serum ADMA levels.
    

Detailed description: 
      The aim of this study was to evaluate a possible association between both saliva and serum
      ADMA levels in patients with CP and with CHD and if the serum ADMA levels are mediated by
      serum CRP.
    

Intervention name(s): Evaluation of arginine serum level
Intervention type(s): Other
Intervention description(s): correlation of serum arginine level with periodontal and cardiovascular disease
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Thus, for this study, 35 patients with CP, 36 patients with CHD, 35 patients with CP+CHD,
        and 35 healthy subjects will finally enrolled.
Safety and Efficacy Study of RTS,S AS02A/AS01B Vaccine to Prevent Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a double blinded study where 2 test vaccines will be evaluated to see if they protect
      persons who have never had malaria against malaria infection when bitten by mosquitoes.
    


Intervention name(s): RTS,S with AS02A/AS01B adjuvant
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: malaria
A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in Healthy Adults
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate adverse events and tolerability of single and
      multiple doses of ABBV-903, and to assess how the drug moves through the body in healthy
      adult volunteers.
    


Intervention name(s): ABBV-903; Placebo for ABBV-903; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsule; oral; Capsule; oral; Capsule; oral
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ABBV-903
To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
Condition: Keratoconjunctivitis Sicca
MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are
      safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.
    


Intervention name(s): R348 Ophthalmic Solution, 0.2%; R348 Ophthalmic Solution, 0.5%; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.; R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.; Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.
Other intervention name(s): R932348; R932348
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment