bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when
      given as single oral ascending doses to healthy volunters. This will be done by comparing the
      effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution
      and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017
      vs time after dose intake will also be collected. The future indication for AZD4017 is
      planned to be Type 2 Diabetes Mellitus.
    


Intervention name(s): AZD4017; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ascending single doses (start dose 2 mg), oral suspension; Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Safety and Tolerability
Effect of Distress Tolerance Training on Problematic Internet Use and Psychological Wellbeing Among Faculty Nursing Students
Condition: Nurse's Role
Study type: Interventional

Summary: 
      The Internet is a social environment as well as a tool. In this digital environment, where
      students interact with each other, live, and generally comprehend their cultures, college
      students learn information. The Internet has become essential to college students' daily
      lives and education. The World Health Organization (WHO) has cautioned that increased screen
      usage and gaming may occur during the COVID-19 pandemic. Due to this, there is an increased
      chance of Internet and gaming addiction, leading to more distress and concern for students'
      psychological well-being. Therefore, university students needed an intervention program to
      overcome these problems. The researchers in the present study will use distress tolerance.
      Distress tolerance (DT) is defined as one's ability to continue engaging in goal-directed
      behavior in the face of emotional, cognitive, or physical discomfort. Eventually, the present
      study aimed to The present study aims to:

      Assess the impact of distress tolerance training on problematic internet use and
      psychological wellbeing among university nursing students.

      Research Hypothesis:

      Nursing students who receive distress tolerance training will exhibit lower problematic
      internet use and better psychological wellbeing than those who didn't receive it
    


Intervention name(s): Distress tolerance training
Intervention type(s): Behavioral
Intervention description(s): It consisted of seven sessions. A 90-minute session will be conducted twice a week for four weeks. The first introductory session will be concerned with helping the student learn how to engage in distress tolerance training and define goals of distress tolerance. At the end of the 1st session, a written plan for every session (time, duration and setting) will be scheduled individually with each student.The next six training sessions will cover three core skills which comprised three sets: Crisis Survival Skills, the skills of Reality Acceptance; and the Skills When the Crisis Is Addiction. The distress tolerance training methods will include individualized interactions, demonstration, and rehearsal, psychoeducation, practice exercises and homework assignments. Follow up between sessions will done using telephone calling and messaging in order to encourage performance homework assignments, and provide help and support when needed particularly at the time of stress. .
Other intervention name(s): dialectical behavioral therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Distress Tolerance; Problematic Internet Use; Psychological well being; Nursing
Nutritional Supplement Impact on Metabolic Parameters
Condition: Other Endocrine/Nutritional/Metabolic Disorder
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      This open label study seeks to study the effects of a nutritional supplement on inflammatory
      markers, metabolic parameters, and safety in subjects compared to baseline after taking
      supplement for 2 and 4 months.
    

Detailed description: 
      Primary endpoint will be to determine if nutritional supplement decreases the metabolic
      parameter of triglycerides. Numerous studies have demonstrated the efficacy of fish oil on
      reducing triglycerides in subjects taking fish oil at similar doses provided in our product
      (see references).

      Additional metabolic parameters will be measured as secondary endpoints, including abdominal
      obesity, HDL cholesterol, blood pressure, fasting glucose, haemoglobin A1c, skin glycation
      (AGEs), pulse wave velocity, skin carotenoids, serum 25(OH)D concentrations, weight, and LDL
      density, particle size and number. The novel nutritional supplement contains many nutrients
      that have been shown to improve metabolic parameters.
    

Intervention name(s): Nutritional Supplement Blend
Intervention type(s): Dietary Supplement
Intervention description(s): It is to be taken orally at a dose of 4 capsules per day, 2 capsules with breakfast and 2 capsules with dinner.
Intervention model: Single Group Assignment
Masking: None (Open Label)
SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia
Condition: Schizophrenic Disorder
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained
      Release (SR) is more effective than placebo in the treatment of acute schizophrenia.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Seroquel Sustained Release (SR); Seroquel Immediate Release (IR); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenic disorder
Effects of Resistance Exercise During Pregnancy
Condition: Pregnancy
Study type: Interventional

Summary: 
      Pregnant women at increased risk for back pain were studied during the second trimester and
      randomized to12-weeks of resistance exercise, education or waitlist. Several outcomes were
      assessed including physical function, quality of life and mood.
    

Detailed description: 
      A parallel group trial was completed at a single site. Second trimester women (n=134) were
      randomly assigned (in blocks of 3) to 12-weeks of wait list, bi-monthly pregnancy education
      classes or twice weekly low-to-moderate intensity resistance training. Resistance training
      involved one abdominal exercise with no external load and five exercises with an external
      load that gradually progressed (leg extension, leg press, arm lat pull, leg curl, and lumbar
      extension). Several outcomes were assessed including physical function, quality of life and
      mood.
    

Intervention name(s): Resistance exercise; Education; Wait list
Intervention type(s): Behavioral; Other; Other
Intervention description(s): Resistance exercise involved 12-weeks of strength training twice per week; Bimonthly pregnancy education classes; Wait list participants were tested on the outcomes during their pregnancy and were eligible to participate in a post-partum supervised exercise program. The wait list participants formed a no treatment control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Effect of Selenium Supplementation on Influenza Vaccination
Condition: Selenium Supplementation; Influenza Vaccination
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      The study is designed to assess whether selenium supplementation can boost the immunity
      response to influenza vaccination in healthy adults. This is a randomized, prospective study
      enrolling a total of 60 healthy subjects, 18-55 years old.
    

Detailed description: 
      Background: Selenium is an essential trace element required for human health and wellbeing.
      Despite mouse studies and human clinical trial suggest selenium supplementation might enhance
      immunity, little is known for the effects of selenium supplementation on humoral immunity.
      Vaccination is the most effective medical intervention to prevent infections and to reduce
      disability and mortality associated with infectious disease. However, some individuals, in
      healthy or disease conditions, mount less effective humoral immune responses to vaccination.
      Therefore, new strategy to enhance humoral immunity upon vaccination is highly sought after.
      Using mouse models, we have observed that selenium supplementation significantly increased
      antigen-specific antibody responses. Thus, we hypothesize that selenium supplementation may
      be beneficial in enhancing humoral immunity in humans.

      Objectives: To investigate whether selenium supplementation will boost the humoral response
      to influenza vaccination in healthy adults.

      Design and trial size: This is a randomized prospective study. A total of 60 healthy
      subjects, 18-55 years old, will be enrolled in this study.

      Intervention and duration: The enrolled subjects will be randomized into selenium
      supplementation and control group. The selenium supplementation group will receive 200 μg
      selenium daily by taking two selenium-enriched yeast tablets (SelenoPrecise®, Pharma Nord)
      once daily for 60 days. The control group will not receive selenium supplementation. Thirty
      days after allocation, both groups will receive standard seasonal influenza vaccination for
      the 2019-2020 season. Peripheral blood samples will be collected at baseline (day 0, prior to
      treatment), day 30, day 37 (7 days after vaccination) and day 60 (30 days after vaccination).
    

Intervention name(s): Selenium Supplementation; Influenza vaccination
Intervention type(s): Dietary Supplement; Biological
Intervention description(s): The selenium supplementation group will receive 200 μg selenium daily by taking two selenium-enriched yeast tablets (SelenoPrecise®, Pharma Nord) once daily for 60 days.; Subjects will receive standard seasonal influenza vaccination for the 2019-2020 season.
Intervention MeSH terms: Selenium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain
Condition: Moderate-to-severe Chronic Noncancer Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of Egalet-002 in
      opioid-experienced patients with moderate-to-severe chronic noncancer pain.
    


Intervention name(s): Oxycodone extended-release
Intervention type(s): Drug
Intervention MeSH terms: Oxycodone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pain; opioid; oxycodone; non cancer pain; moderate to severe
Exercise and Respiratory Training as Supportive Treatments for Patients With Chronic Pulmonary Hypertension
Condition: Chronic Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Background

      -Pulmonary hypertension (PH) is associated with restricted physical capacity, limited quality
      of life, and a poor prognosis because of right heart failure. The present study is the first
      prospective randomized study to evaluate the effects of exercise and respiratory training in
      patients with severe symptomatic PH.

      Methods

      -Patients with PH on stable disease-targeted medication will be randomly assigned to a
      control and a primary training group. Medication will remain unchanged during the study
      period. Primary end points will be the changes from baseline to week 15 in the distance
      walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life
      questionnaire. Changes in WHO functional class, Borg scale, and parameters of
      echocardiography and gas exchange also will be assessed.

      Prospects

      -We hope this study will indicate that respiratory and physical training are a promising
      adjunct to medical treatment in severe PH.
    


Intervention name(s): Exercise and Respiratory Training
Intervention type(s): Behavioral
Intervention description(s): Patients in the interventional group will participate in an exercise program 7 days a week at low workloads (10 to 60 W) that will be supervised by physical therapists and physicians.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Medifast's 5 & 1 Plan to a Food-based Plan of Equal Calories
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Portion-controlled meal replacements have been shown to be an effective weight control
      strategy in overweight and obese individuals. Thus, the investigators plan to evaluate the
      effect of Medifast's 5 & 1 program compared to an food-based diet plan of equal calories on
      the following indices: weight loss and maintenance of weight loss, satiety during weight
      loss, changes in biochemical markers of inflammation and oxidative stress following weight
      loss, and compliance and retention rates.
    


Intervention name(s): Medifast 5 & 1 Plan for weight loss and weight maintenance; Food-based diet plan for weight loss and weight maintenance
Intervention type(s): Other; Other
Intervention description(s): Medifast's 5 & 1 Plan is a meal replacement program for weight loss that uses 5 Medifast meals and 1 self-prepared meal. The weight maintenance plan incorporates 3-5 Medifast meals as well as a certain amount of food from all other food groups.; The food-based group was provided a meal plan for weight loss based on the guidelines of the USDA Food Guide Pyramid providing the same number of calories as the Medifast 5 & 1 Plan. Weight maintenance calories were calculated and participants were provided meal plans from the USDA Food Guide Pyramid.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Weight loss; meal replacements; inflammation; oxidative stress; visceral fat
A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adolescent Subjects
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy of BLI400 laxative in
      constipated adolescent subjects.
    


Intervention name(s): BLI400 Laxative
Intervention type(s): Drug
Intervention MeSH terms: Laxatives
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate Whether Acetyl Salicylic Acid (Aspirin), the Combination of Aspirin and Clopidogrel and Darexaban (YM150) Interact in Their Effects
Condition: Pharmacodynamic Interaction; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate whether ASA, the combination of ASA and
      clopidogrel, and darexaban, which have different effects on blood coagulation, influence each
      other in their effects. Also it will be investigated whether the blood levels of either drug
      are influenced by the presence of the other drug. In addition, the safety and tolerability of
      each drug and the combination of the drugs will be investigated.
    


Intervention name(s): darexaban; darexaban (double dose); Acetyl Salicylic Acid; clopidogrel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral; oral; oral; oral
Other intervention name(s): YM150; YM150; Aspirin; Plavix
Intervention MeSH terms: Aspirin; Salicylic Acid; Salicylates; Darexaban; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacodynamics; darexaban; Acetyl Salicylic Acid; clopidogrel; YM150; Phase 1
A Study Comparing The Amounts of Tafamidis In The Blood With Or Without Food
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Each subject will be given tafamidis after either a high fat meal or while fasted. After
      swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one
      week. After about 14 days, subjects will take either a different dose of tafamidis or the
      same dose under the opposite meal condition. Tafamidis concentrations from the three
      different conditions will be compared to determine if they are approximately the same.
    


Intervention name(s): tafamidis; tafamidis; tafamidis
Intervention type(s): Drug; Drug; Drug
Intervention description(s): fasted; high fat meal
Other intervention name(s): fasted
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Use of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke Patients
Condition: Stroke; Virtual Reality; Physical Therapy
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Randomized clinical trial based on the application of virtual reality and video games
      together with physiotherapy treatment in stroke patients, with the main objective of
      determining their beneficial effects.
    

Detailed description: 
      21 participants who will be divided by randomization between a control group and an
      experimental group. The results will be quantified with the following scales: Modified
      Asworth (spasticity). Daniels et al (muscle strength) Tinetti (balance and gait) Berg
      (balance) Joint range
    

Intervention name(s): Virtual reality and video games; Neurological physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Use of a software in stroke patients' rehabilitation.; Application of conventional physical therapy techniques.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two randomized groups. A control group and an experimental group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      The purpose of this pilot study is to investigate the relationship between attention and
      emotional function post-Traumatic Brain Injury (TBI) in an effort to better understand the
      cognitive mechanisms of emotional processing in patients with TBI, and explore novel
      treatment strategies to improve emotional regulation using with transcranial direct current
      stimulation (tDCS) to modulate activity in the dysfunctional prefrontal-limbic circuits.
    

Detailed description: 
      Thirty (30) individuals status post TBI with complaints of emotional dysfunction 6 months
      post-brain injury and Fifteen (15) healthy controls will participate in the study. The
      experimental group will receive active tDCS for 20 minutes and computerized cognitive
      training twice a week for 30-45 minutes for 6 weeks as described below. The control group
      will receive sham-tDCS 20 minutes and computerized cognitive training for 30-45 minutes twice
      a week for 6 weeks (12 training sessions). The sham group will not receive real tDCS after
      completion of the study.
    

Intervention name(s): Transcranial Direct Current Stimulator (TDCS); Control Group; Healthy Control Group
Intervention type(s): Device; Device; Other
Intervention description(s): Group will receive active TDCS; This group will receive Sham TDCS; Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.
Other intervention name(s): Fisher Wallace Cranial Stimulator; The Fisher Wallace Stimulator, Model FW-100; FDA 510 (K)Cleared number K903654
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TBI; Traumatic Brain Injury; Rehabilitation; Therapy
Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth
Condition: Self Harm; Depression; Emotion Dysregulation; Behavior Problem
MeSH terms: Self-Injurious Behavior; Problem Behavior
Study type: Interventional

Summary: 
      This study is designed to refine and test the efficacy of a computer assisted culturally
      informed and flexible/adaptive intervention for Latino adolescents for whom self-harm
      behaviors are a health disparity-specifically, Latinas and sexual/gender minority youth.
    

Detailed description: 
      This study enhances an original Computer Assisted Culturally Informed and Flexible
      Family-Based Treatment for Adolescents (CA CIFFTA) to directly address key targets related to
      self-harm behavior (e.g., depression, emotion dysregulation, LGBT, culture-related stressors,
      and trauma-related stressors); (b) refines the technological aspects of CA CIFFTA for
      web-based delivery; and (c) tests the preliminary efficacy of the new intervention and its
      delivery system in a randomized trial of 100 Hispanic adolescents and their parents. The
      investigators seek to reduce risk for repeated self-harm by showing treatment effects on
      depression, emotion regulation, substance use, and family functioning. Participants are
      randomly assigned to CA CIFFTA or Treatment-As-Usual and treatment covers a four month
      period.
    

Intervention name(s): Computer Assisted CIFFTA; Behavioral: Traditional face-to-face treatment-no technology
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.; Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
Other intervention name(s): Behavioral: Family Therapy; Behavioral: Individual Therapy; Behavioral: Technology delivered psycho-educational modules; Behavioral: Individual Therapy; Behavioral: Family Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization will be stratified by gender, type of self-harm, trauma exposure and LGBT status. The investigators will attempt to match overall contact hours (in the experimental condition some of these hours will be with technology). During the "continuing care" phase the CIFFTA families will interact with the therapist via the website for a period of 8 additional weeks. To match dosage time during aftercare, Treatment As Usual (TAU) will receive "check-in" telephone calls with the therapist.
Masking: None (Open Label)
Primary purpose: Treatment