bioihbjkbjnl/mcl2 huggingface dataset:
Investigation of the Effects of Different Exercise Programs in Patients With Restless Legs Syndrome.
Condition: Restless Legs Syndrome; Anxiety; Sleep
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional

Summary: 
      Restless leg syndrome (RLS) is a very common neurological condition characterized by an
      uncontrollable desire to move the legs. Due to the traumatic effect of RLS on morbidity, the
      patient is negatively affected in many different directions. The duration and quality of
      sleep of the patients decrease, and their cognitive functions change. The prevalence or risk
      of anxiety and depression increases in this population. At the same time, the quality of life
      of patients is significantly reduced. Among the different pharmacological agents used in RLS,
      dopamine agonists are the most widely used. However, the reporting of serious and common side
      effects related to this treatment has led to non-pharmacological approaches in the treatment
      of RLS and the effectiveness of many different approaches has been investigated. The exercise
      approach, which is determined to be effective in the treatment of the disease, is a subject
      that has been little studied. The type, duration and frequency of optimal exercise could not
      be standardized. In addition, the effect of exercise on RLS patients has been investigated in
      limited subjects. For this reason, the aim of our study is to examine the effect of different
      exercise programs on symptoms, sleep, cognitive functions, quality of life, psychological
      status and fatigue in patients with RLS.
    


Intervention name(s): Aerobic exercise; Stretchin exercise
Intervention type(s): Other; Other
Intervention description(s): Patients will do aerobic exercise three days a week for 40 minutes during 8 weeks. Aerobic exercise protocol will consist of warm up, loading and cooling periods. . Exercise prescription will be prepared in line with the recommendations of "The American College of Sports Medicine".; Patients will do stretching exercise three days a week for 40 minutes during 8 weeks. Stretching exercises will start with active warm-up activities. Static stretching method will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Impact of Comprehensive Education Before Gastroscopy on Improving the Tolerance of Patients
Condition: Comprehensive Education
Study type: Interventional

Summary: 
      This clinical trial is being conducted to assess whether the comprehensive education before
      gastroscopy could reduce the adverse reactions, such as nausea, vomiting and improve patient
      satisfaction.
    


Intervention name(s): Comprehensive education group
Intervention type(s): Other
Intervention description(s): The details of Comprehensive education are as follows:
introduce the purpose, method and function of breathing training and the whole process of gastroscopy;
instruct patients to take deep breath training, inhaling with his/her nose and exhaling with his/her mouth,
provide patients with a disposable dental biting device and repeat exercising deep breathing again until he/she is fully mastered,
inform patients to cooperate with the instructions issued by endoscopist and endoscopy nurse during the whole process of gastroscopy,
inform patients to inhale with nose and exhale with mouth when the gastroscope passes through the throat, then he/she should perform inhaling and exhaling with his/her nose until the end of the gastroscopy when the endoscopist ask to adjust the breathing method,
inform patients that there would be some normal physiological reaction when gastroscopy, such as throat discomfort and nausea/vomiting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Diagnostic
Sucrosomal Iron Supplementation in Blood Donors
Condition: Iron-deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this descriptive/explorative pilot study is to examine the effects of
      supplementing a sucrosomal iron preparation in whole blood donors with iron deficiency for
      three months.
    

Detailed description: 
      In this academic, monocentric interventional pilot study with one cohorte, otherwise healthy
      blood donors who have been rejected from blood donation due to low hemoglobin (females <12.5
      g/dl, males <13.5 g/dl) and low ferritin levels (<30 ng/ml) receive an iron-containing
      dietary supplement (sucrosomal iron) for three months with a daily intake of 30 g iron.

      Fifty donors will be included in the study. The study population will consist of two
      sub-groups (premenopausal women and postmenopausal women plus men).

      Our aim is to

        -  gain first findings concerning the extent of the change primarily in hemoglobin and
           secondly in ferritin concentrations

        -  observe acceptance and tolerance after intake of the test product for several months

        -  create pilot data for a following randomized controlled study.

      In addition, possible clinical symptoms associated with iron deficiency will be recorded by
      using appropriate questionnaires (Questionnaire on the assessment of health-related quality
      of life [WHOQOL-Bref], Fatigue questionnaire [FAQ], questionnaire on psychic symptoms of
      insomnia [RIS] and Restless Legs Syndrome).
    

Intervention name(s): sucrosomal iron
Intervention type(s): Dietary Supplement
Intervention description(s): oral intake of iron as sachets or capsules
Other intervention name(s): OLEOvital(R) EISEN FORTE
Intervention model: Single Group Assignment
Intervention model description: This monocentric study (single cohort study design) is classified as a food study (application of the commercially available supplement OLEOvital® EISEN FORTE) in an interventional setting (study-related measures: additional blood tests and oral intake of OLEOvital® EISEN FORTE).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: blood donors; donor rejection; sucrosomal iron; dietary supplements
SeRenade Parent-Child Music Class Program
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This pilot study examines the impact of the SeRenade Parent-Child Music Class Program, which
      emphasizes parent training, peer inclusion, and musical play combined with established
      behavioral techniques, on the development of child social engagement, positive behavior, and
      parental well-being.
    

Detailed description: 
      This pilot study evaluates the impact of the SeRenade Parent-Child Music Class Program on
      families of children with and without autism spectrum disorders (ASD). This study examines
      the impact of this program on social development in children with ASD, parental stress and
      efficacy, and parent-child relationships. A primary goal of this study is to examine multiple
      levels of analysis including families' experience within and outside of the music class
      program.
    

Intervention name(s): SeRenade Parent-Child Music Class; Delayed Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parent-Child Music Class involving parent training, peer inclusion, and musical play; Participants receive intervention after delay
Intervention MeSH terms: Nitrazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Seborrheic Dermatitis
Condition: Seborrheic Dermatitis
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a Phase II, single center, randomized, double-blind, placebo-controlled study
      in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of
      the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle
      for up to 4 weeks.
    


Intervention name(s): PAC-14028 cream 0.3%; PAC-14028 cream 1.0%; PAC-14028 cream vehicle
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical application; Topical application; Topical application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the
      oral doses of the extended-release test- and reference formulations of AZD0837 in healthy
      volunteers both in fasting and fed conditions.
    


Intervention name(s): AZD0837; AZD0837
Intervention type(s): Drug; Drug
Intervention description(s): Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days; Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers
Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine
Condition: Procedural Sedation
Study type: Interventional
Phase: Phase 1

Summary: 
      A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability
      Study of MELT-100, IV Midazolam, and IV Ketamine under Fasted Conditions in Healthy
      Volunteers
    

Detailed description: 
      A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability
      Study of 2 doses of 3.5mgMELT-100, IV Midazolam, and IV Ketamine 18mg under Fasted Conditions
      in Healthy Volunteers
    

Intervention name(s): midazolam / ketamine sublingual tablet
Intervention type(s): Drug
Intervention description(s): sublingual tablet
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4-period 4-arm crossover relative bioavailability
Masking: None (Open Label)
Primary purpose: Treatment
Peer-Presented Versus Mental Health Service Provider-Presented Mental Health Outreach Programs for University Students
Condition: Stress; Self Efficacy; Social Support; Social Connectedness; Mindfulness; Quality of Life
Study type: Interventional

Summary: 
      The overarching goal of the present study was to evaluate a MHSP-presented versus
      peer-presented mental health resilience skills-building online video outreach program against
      a wait-list comparison group.
    

Detailed description: 
      Participants were recruited using a study flyer distributed to students in-person on campus
      and online through email listservs, social media platforms, and from an existing database of
      university students who participated in previous studies and agreed to be followed-up with.
      Given the self-paced nature of the program, a staggered recruitment approach was used wherein
      new participants completed the online baseline questionnaires between January 2020 until
      early March 2020.

      Participants were randomly assigned to one of the three groups (MHSP-presented,
      peer-presented, or a wait-list comparison group), while counterbalancing the three groups
      based on gender and preference for seeking help from MHSPs or peers (i.e., using results from
      the General Help-seeking Questionnaire). Two weeks after the baseline questionnaire was sent,
      participants in the intervention groups received either the MHSP-presented video or the
      peer-presented video (video 1) depending on which group they were randomly assigned to, as
      well as a link for access to the resource library. The following two videos were sent two
      weeks apart. Participants were encouraged to access the resource library over the duration of
      the program and were reminded with each video link sent. All participants then received post
      (T2) and follow-up measures (T3) 6 and 10 weeks following the baseline completion
      respectively. Participants in the wait-list comparison group were only asked to complete
      evaluation measures at the three time points (they only received the videos and resource
      library at the end of the study). Following completion of the study, students received an
      e-mail with a personalized profile indicating their individual scores on various measures and
      all participants received full access to the program resources (videos and resource library).
    

Intervention name(s): Stress and Coping Online Outreach Program
Intervention type(s): Behavioral
Intervention description(s): 3 videos and a resource library disseminated over the course of 9 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor
      and cause less damage to normal tissue.

      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic
      radiation therapy in treating patients with advanced liver cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the safety of hypofractionated stereotactic radiotherapy (SRT) in patients
           with advanced hepatocellular carcinoma.

      Secondary

        -  To determine the maximum tolerated dose of SRT in these patients.

        -  To determine the objective tumor response rate in terms of the percentage of tumor size
           change on CT, percentage of intensity change on MRI, and the percentage of change in
           alfa fetoprotein in patients treated with this therapy.

        -  To determine the value of 4-dimensional CT in liver cancer planning in terms of the
           extent of liver motion (three dimensionally) and the percentage of patients requiring
           breath gating due to the amplitude of organ motion exceeding 1 cm in any dimension.

        -  To determine the value of breath gating in liver cancer SRT in terms of the success rate
           of breath gating and the percentage of treatment time prolongation secondary to the
           gating.

      OUTLINE: Patients undergo hypofractionated stereotactic radiotherapy once daily on days 1-5.

      After completion of study therapy, patients are followed at 1 and 3 months.
    

Intervention name(s): stereotactic body radiation therapy
Intervention type(s): Radiation
Intervention description(s): Undergo radiotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult primary hepatocellular carcinoma; advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer
A Study of HS-10353 in Chinese Participants.
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the safety and tolerability of single and
      multiple oral administered doses of HS-10353 separately in Chinese healthy and major
      depressive disorder subjects.
    

Detailed description: 
      This is a phase I, randomized, double-blinded, placebo-controlled, both single ascending
      doses (SAD) study and multiple ascending dose (MAD) clinical trial to assess the safety,
      tolerability, and pharmacokinetics of HS-10353 tablet(s) separately in Chinese healthy and
      major depressive disorder (MDD) subjects.

      Approximately six sequential dose cohorts will be evaluated in SAD study. Sentinel dosing
      will be employed for the first SAD cohort to protect the subjects' safety. Escalation to the
      next dose cohort will be undertaken only after safety and PK data are reviewed by the Safety
      Review Committee (SRC) and agreement reach that it is safe to increase the dose. Each SAD
      cohort is dosed at approximately weekly intervals to allow adequate time for collection and
      review of safety and PK data.

      Approximately three sequential dose cohorts will be evaluated in MAD study. The total daily
      dose for each MAD cohort will be based on information obtained from the SAD study. Each
      subject will receive only one dose regimen in this study.

      Safety data up to Day14 (±1) in SAD and up to Day20 (±1) in MAD will be reviewed prior to the
      next dose level. The number of Cohorts in SAD and MAD would be adjusted based on the
      assessment of SRC.
    

Intervention name(s): HS-10353; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single or multiple dose(s) of HS-10353; Single or multiple dose(s) of placebo
Other intervention name(s): HS-10353 capsules; HS-10353 placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase I; major depressive disorder; healthy subject; SAD; MAD
Exercise Training in Obesity-prone Black and White Women
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Overweight premenopausal Black and White women are randomized to either diet-only,
      diet+aerobic or diet+resistance exercise training. Diet/behavior intervention, with or
      without the aerobic or resistance exercise training, will be provided throughout the 18
      months of study. Major outcomes will include measures of perceived and physiologic difficulty
      of exercise (cardiac, ventilatory, electromyographic responses to standardized exercise
      tasks); aerobic fitness; strength fitness; and spontaneous free-living energy expenditure
      (all derived from doubly labeled water). The results will provide insight into the
      effectiveness of, and the mechanisms by which, different types of exercise training can
      improve physical fitness, spontaneous engagement in physical activities of daily living and,
      in turn, weight-loss maintenance.
    

Detailed description: 
      Overweight premenopausal Black and White women are randomized to either diet-only,
      diet+aerobic or diet+resistance exercise training. Diet/behavior intervention, with or
      without the aerobic or resistance exercise training, will be provided throughout the 18
      months of study. Major outcomes will include measures of perceived and physiologic difficulty
      of exercise (cardiac, ventilatory, electromyographic responses to standardized exercise
      tasks); aerobic fitness; strength fitness; and spontaneous free-living energy expenditure
      (all derived from doubly labeled water). The results will provide insight into the
      effectiveness of, and the mechanisms by which, different types of exercise training can
      improve physical fitness, spontaneous engagement in physical activities of daily living and,
      in turn, weight-loss maintenance.

      Time of initial weight loss was defined as the time needed to reach the goal of 25 kg/m2 BMI.
      The women will then be evaluated one year after this time and the amount of weight gain will
      be determined.
    

Intervention name(s): Diet; Aerobic exercise; Resistance exercise
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Medicinal Cannabis for Painful HIV Neuropathy
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if medicinal cannabis (marijuana) is safe and
      effective for treating pain in individuals with HIV-associated distal, sensory-predominant
      polyneuropathy (DSPN).
    

Detailed description: 
      Peripheral neuropathy occurs in over 30% of patients with HIV infection, making it among the
      most common neurological complications of HIV infection. Nucleoside analogues such as ddI and
      d4T, key components of modern, potent, combination antiretroviral therapies (ART), are also
      neurotoxic and contribute to the frequent occurence of painful neuropathy. By using treatment
      with available non-narcotic analgesic and adjunctive pain medications, approximately half of
      patients with painful HIV neuropathy obtain sufficient pain control.

      On the first day each study week (active or placebo), participants will follow a specific
      titration procedure to achieve the optimal dose. This optimal dose will then be continued for
      the duration of the treatment week. Participants will undergo a 2-week washout period, after
      which they crossover to the other arm (active or placebo) and will again repeat the dose
      titration and dose maintenance procedures.

      Comparison: Active cannabis doses ranging from 2-8% THC will be compared to placebo for the
      reduction of neuropathic pain.
    

Intervention name(s): Smoked cannabis
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neuropathy; cannabis; marijuana; HIV; DSPN
Memory for Flu Facts and Myths and Effects on Vaccine Intentions
Condition: Influenza Vaccines
Study type: Interventional

Summary: 
      Objectives: To determine whether people systematically misremember the "myths" (false
      information) as true, and to assess effects on perceptions of risk and behavioral intentions.
    

Detailed description: 
      Public information campaigns often warn people about false and unreliable medical claims by
      juxtaposing "myths" and "facts." The effectiveness of such communications has rarely been
      assessed. We assessed whether people systematically misremember the "myths" (false
      information) as true, and to assess effects on perceptions of risk and behavioral intentions.

      In an experimental study, participants read either a published CDC flyer on "Facts and Myths"
      about the flu vaccine, or a "Facts Only" version; a separate control group read no flyer.
      Participants completed the outcome measures either immediately or after 30 minutes.

      Primary measures were memory for information about the flu presented in the flyer, ratings of
      perceived risks associated with the flu, and personal intentions to get vaccinated in the
      upcoming season.

      After a delay of 30 minutes, participants who read the "Facts and Myths" flyer systematically
      misremembered myths as facts. Both versions of the flyer had the immediate effect of
      increasing intentions to get a flu vaccine, compared to the control group. After 30 minutes,
      however, participants who read the "Facts and Myths" flyer reported lower intentions to get
      vaccinated, compared to those who read the same flyer with no delay, and compared to all
      participants who read the "Facts Only" flyer.

      In sum, people show a bias to think that incompletely remembered information is true, turning
      "myths" into "facts." Hence public information campaigns should emphasize information that is
      true. Repeating false information, even as a warning, can create the unintended consequence
      of belief in the information.
    

Intervention name(s): Memory for truth
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Educational/Counseling/Training