bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
Condition: Obesity; Weight Gain
MeSH terms: Body Weight; Weight Gain
Study type: Interventional

Summary: 
      This randomized controlled trial is designed to test the feasibility and efficacy of a novel
      10-week mindfulness-based intervention (MBI) on weight maintenance as well as behavioral and
      psychosocial outcomes in patients who have undergone bariatric surgery.

      Primary hypothesis:

      Bariatric patients who have stopped losing weight (< 5 lbs weight loss in past month) 1-5
      years post-surgery will be willing to participate in this 10-week intervention. The
      investigators expect a high adherence rate (>70%) and no issues with meeting recruitment
      goals.

      Secondary hypotheses:

      Patients assigned to the MBI will show greater improvement in a) weight control (defined by
      differences in body weight between baseline and follow-up); b) eating behaviors (binge
      eating, emotional eating); and c) psychosocial measures (quality of life, depression,
      perceived stress, eating self-efficacy, coping ability) than a standard lifestyle
      intervention (1 hr lifestyle counseling).

      Patients assigned to the MBI intervention will show greater improvement in biomarkers of
      stress and inflammation [salivary cortisol, high sensitivity C-reactive protein (hs-CRP),
      interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha)] as compared with a
      standard lifestyle intervention.

      Food-related attentional bias as measured by the food-related Stroop task will be
      differentially affected among patients assigned to the MBI as compared with the intensive
      lifestyle intervention and standard lifestyle intervention.
    


Intervention name(s): Mind-body lifestyle intervention; Standard lifestyle intervention
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Randomized controlled trial; Mindfulness; Obesity
An Exploratory Investigation of a Supplement to Promote Gut Health
Condition: Gastrointestinal Symptoms; Exercise Performance
Study type: Interventional

Summary: 
      Bovine colostrum is a dairy food and the first milk produced by the mother cow. Abundant
      research exists revealing the valuable health benefits it confers due to its unique
      nutritional properties., including benefits to gastrointestinal health, fitness, and overall
      well-being.This study aims to test a specific food-grade supplement, ARMRA Colostrum Immune
      Revival, over a 12-week trial to better understand the well-being, fitness, and gut benefits.
      This trial will use two groups, one that suffers from gastrointestinal complaints frequently
      and another that exercises at least three days a week.
    


Intervention name(s): ARMRA™ Bovine Colostrum
Intervention type(s): Drug
Intervention description(s): Participants have the option to choose between unflavoured ARMRA™ Bovine Colostrum or blood orange flavoured ARMRA™ Bovine Colostrum.
Participants took 2 sachets (1g each) of the product mixed with a cold drink daily for 12 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Multiarm study, both arms receiving the same intervention drug.
Masking: None (Open Label)
Primary purpose: Other
Mifepristone Treatment of Alcohol Use Disorder
Condition: Alcohol Dependence; Alcohol Use Disorders; Alcohol Abuse; Alcoholism
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups,
      study of 1-week of treatment with mifepristone (0, 1200 mg/d) given in conjunction with 8
      weeks of manual-guided counseling, and a follow-up visit at Week 12.
    


Intervention name(s): Mifepristone 1200 mg daily; Standardized behavioral therapy; Placebo
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.; Standardized behavioral therapy 1 time per week for 8 week duration.; Placebo tablets, Four tablets daily/am for 1-week duration.
Other intervention name(s): Korlym; Manually-guided therapy; Placebo Comparator
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol-Related Disorders; Substance-Related Disorders; Mental Disorders; Mifepristone; Glucocorticoid Antagonists; Alcohol Treatment; Alcohol
Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis
Condition: Progressive Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional

Summary: 
      To date, no drug therapy has been approved for primary (PPMS) & secondary (SPMS) progressive
      multiple sclerosis. The urgent need to find new therapies - if possible with minimal side
      effects - led us to the search for the potential therapeutic effects of early harvest olive
      oil. The positive effect of phenol-rich, flavonoid and lignin-based olive oil on the
      modification of intestinal microbe populations and their by-products of metabolism is well
      known, such as the extent of gut-associated lymphoid tissue immune-stimulation due to
      antioxidants, anti-inflammatory and immunoregulatory properties. The aim of this Greek,
      Randomized Clinical Trial, is to evaluate the effect of Early Harvest Extra Virgin Olive Oil
      on cognition and mental health of patients diagnosed with PPMS or SPMS. The patients will be
      evaluated once at the beginning of treatment, after 6 months of treatment and after twelve
      months of treatment, in order to specify the eficacy of extra virgin olive oil in holistic
      treatments for SPMS and PPMS
    

Detailed description: 
      Study Type: Randomized Clinical Trial. Primary Purpose: Prevention OBJECTIVES OF THE TRIAL
      The objectives of this study are:To investigate the efficacy of Early Harvest EVOO as a
      disease course modifying treatment for primary (PPMS) or secondary (SPMS) progressive
      multiple sclerosis in a phase III randomized controlled clinical trial study in objective
      measurements in patients with primary (PPMS) or secondary (SPMS) progressive multiple
      sclerosis.

      STUDY DESIGN This is a Greek, randomized controlled study group of Early Harvest EVOO to a
      control group, in which the patients will receive only their symptomatic medication.
      Qualifying patients will be randomly assigned to receive 50mL of Early Harvest EVOO or not on
      a daily basis for 24 months. Patients undergo assessments at baseline, 6 and 12 months +/- 7
      days after beginning treatment.

      Duration: The total study duration will be 12 months. Patients will receive study
      interventions for 12 months.

      Number of Subjects 30 subjects total will be enrolled; 20 in the experimental group (Early
      Harvest EVOO); 10 in the Control group
    

Intervention name(s): Early Harvest Extra Virgin Olive Oil
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will take 3 tablespoons on a daily basis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: extra virgin olive oil; cognition; mental health; multiple sclerosis
Clinical Condition and Sleep Quality Factors Associated With Sleep Bruxism in Adults.
Condition: Sleep Bruxism, Adult
MeSH terms: Bruxism; Sleep Bruxism
Study type: Observational

Summary: 
      This cross-sectional study will evaluate the association between sociodemographic,
      occupational, clinical conditions, psychological (sense of coherence), sleep quality
      variables and SB diagnosed by PSG, the gold standard exam with audio-visual resources
      obtained at Pelotas Sleep Institute.
    

Detailed description: 
      Sleep bruxism is defined as a masticatory muscle activity during sleep that is characterised
      as rhythmic (phasic) or non-rhythmic (tonic) and should be considered a risk factor rather
      than a disorder in otherwise healthy individuals.

      The diagnosis of sleep bruxism often is challenging and despite the use of questionnaires,
      clinical exams and portable devices, based on current knowledge, the polysomnography with
      audio-video recordings emerges as the gold-standard criteria for a definite sleep bruxism
      diagnosis.

      Included on the questionnaire there is a registration form, which contains: included: age at
      time of data collection , gender, marital status , and education level ; Occupational:
      individuals were asked about work outside home, and working hours; Clinical condition: body
      mass index, smoking; alcohol consumption; use of sleeping pills; respiratory allergy and
      Psychological: sense of coherence .
    

Intervention name(s): Polysomnography
Intervention type(s): Diagnostic Test
Intervention description(s): The polysomnography (referred to as type I) allows assessing several sleep physiologic parameters (eg, EEG, electrooculogram, electromyogram, electrocardiogram, airflow, respiratory effort, oxygen saturation), whereas audio-video recording enables documenting tooth-grinding sounds and distinguishing between rhythmic masticatory muscle activity (RMMA) and orofacial (eg, swallowing) and other muscular activity (eg, head movements) during sleep. Based on the RMMA index (number of episodes per hour of sleep), sleep bruxism is diagnosed when RMMA episodes are greater than or equal to 2 (low-frequency SB, mild bruxism) or RMMA episodes are greater than or equal to 4 (high-frequency SB, severe bruxism)
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All records obtained from adults (aged 20 to 60 years) and elderly (aged >60 years) who had
        undergone PSG at a private medical outpatients clinic from July 2017 to February 2018 were
        reviewed.
      
Keywords: grind; polysomnography; rhythmic masticatory muscle activity; sleep bruxism
Evaluating the Impact of Reining in Anxiety
Condition: Anxiety; Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this pilot study is to evaluate the impact of Reining in Anxiety for children
      with anxiety and their caregivers. A total of up to 80 child/caregiver dyads will be enrolled
      in the study, anticipating that 40 dyads will complete the 10 week intervention. The
      intervention will be delivered at Fieldstone Farm Therapeutic Riding Center, which is one of
      the largest therapeutic riding centers in the US.
    

Detailed description: 
      Reining in Anxiety is a manualized equine assisted therapy (EAT) for childhood anxiety. The
      manual and associated materials are being tested in this pilot study, and, if found to be
      successful, will be available for public consumption. This EAT, which is delivered in a group
      setting, combines therapeutic horseback riding with cognitive behavioral strategies for
      anxiety. The group meets weekly over the course of ten weeks, with each session lasting 45
      minutes. Each session is delivered in a group format with up to four children between 6 and
      17 years of age.
    

Intervention name(s): Manualized equine assisted therapy
Intervention type(s): Behavioral
Intervention description(s): This equine assisted therapy (EAT), which is delivered in a group setting, combines therapeutic horseback riding with cognitive behavioral strategies for anxiety. Each 45 minute session is delivered in a group format with up to four children between 6 and 17 years of age. Each session follows the same structure: (1) weekly review; (2) groom and connect; (3) warm-up period; (4) session activity; (5) cool down; (6) parent/caregiver psychoeducation, during which the instructor facilitates psychoeducation; and (7) homework instruction.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aripiprazole in Adolescents With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent
      patients with schizophrenia for a period of at least 6 weeks.
    


Intervention name(s): Aripiprazole tablet, 10 mg; Aripiprazole tablet, 30 mg; Placebo tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Aripiprazole tablet 10 mg po qd x 42 days; Aripiprazole tablet 30 mg po qd x 42 days; Placebo tablet po qd x 42 days
Other intervention name(s): OPC-14597; OPC-14597
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Aripiprazole
BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934)
      will be asked to participate in this long term extension study with BAY63-2521.
    


Intervention name(s): Riociguat (BAY63-2521)
Intervention type(s): Drug
Intervention description(s): BAY63-2521: 1mg tid -2.5 mg tid oral until end of study
Intervention MeSH terms: Riociguat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary arterial hypertension; PH; Stimulator
Combined Effects of Nutritional and Exercise Countermeasures
Condition: Muscular Atrophy; Muscle Weakness
MeSH terms: Muscle Weakness; Muscular Atrophy
Study type: Interventional

Summary: 
      The purpose of this study is to see if a combination of resistance exercises and amino acid
      capsules can reduce muscle loss and maintain muscle function during bedrest. This experiment
      will imitate many of the physical conditions experienced by astronauts during space flight by
      examining the effects of resistance exercise or nutrition on muscle during 2 days of bedrest.
      The diet of astronauts will also be imitated by providing diets in the General Clinic
      Research Center.
    


Intervention name(s): Resistance Exercise; diet orange soda; essential amino acids
Intervention type(s): Behavioral; Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will lift weights with their legs.; Subjects drink diet orange soda 3x day for 2 days.; Subjects drink 15 grams of EAA mixed into diet orange soda 3x day for 2 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Muscle loss and Maintenance of Muscle function
The Effectiveness of the "MINDLiNG" Digital Mental Health Intervention
Condition: Mental Health Services; Personality
MeSH terms: Personality Disorders
Study type: Interventional

Summary: 
      A study in South Korea assessed the effectiveness of the "MINDLiNG" digital mental healthcare
      program, targeting maladaptive personality traits, and found significant improvements in
      reducing stress, perfectionism, loneliness, and anxiety, while increasing self-esteem among
      participants. The study highlights the potential of digital solutions to address the high
      demand for mental healthcare services in South Korea.
    

Detailed description: 
      This study conducted a randomized controlled trial to evaluate the effectiveness of a digital
      intervention program called "MINDLiNG" designed to target maladaptive personality traits,
      with four subprograms addressing perfectionism, low self-esteem, social isolation, and
      anxiety. Participants were assigned to one of these programs, and primary outcome measures
      varied accordingly, including the Perceived Stress Scale, Hewitt Multidimensional
      Perfectionism Scale, State Self-Esteem Scale, UCLA Loneliness Scale, and Beck Anxiety
      Inventory. The study anticipated treatment effects in both primary and secondary outcome
      measures for the treatment group compared to the waitlist group after 5 and 10 weeks of
      intervention.
    

Intervention name(s): "MINDLiNG" Digital Mental Health Intervention
Intervention type(s): Device
Intervention description(s): The intervention was delivered on an online platform set up separately for the study, which was accessible via the web browser and application. The psychological intervention program for maladaptive personality traits (Mindling) is based on the principles of CBT, psychological schema therapy, acceptance-commitment therapy, and mindfulness-based cognitive therapy, and is aimed primarily at adults to prevent and overcome psychological difficulties
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: digital mental health service; intervention; randomized controlled trial; Personality Focused
Lifestyle Intervention for Toddlers Pilot Study
Condition: Obesity
Study type: Interventional

Summary: 
      Study aims to pilot a family-centred tailored nutrition intervention at child welfare
      clinics, targeting the previously observed dietary defaults of Finnish children.
    

Detailed description: 
      Eating habits can predict diet-related health problems and obesity. The defaults observed
      previously in the diet of Finnish children include low consumption of vegetables, fruits and
      vegetable oil-based fats, high consumption of sucrose, poor quality of drinks and low
      frequency of family meals. Child welfare clinic is the place to promote healthy lifestyles
      because most Finnish families visit there at regular intervals.
    

Intervention name(s): Intensified dietary counseling at child wellfare clinics.
Intervention type(s): Behavioral
Intervention description(s): The intervention is completed by public health nurses who receive updating education in nutrition. A special training in a family-centred lifestyle counseling method in implemented. The nutrition intervention consists of tailored dietary counseling, information leaflets and self-evaluation card given to the families in the intervention arm. In the control clinics, public health nurses continue their usual dietary counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55375515 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of
      JNJ-55375515 in healthy participants after administration of single and multiple oral doses.
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), double-blind
      (neither the investigator nor the participants know what treatment the participant is
      receiving), placebo-controlled (an inactive comparator treatment that has no study drug in
      it), single center study in healthy male participants and female participants of
      non-childbearing potential (surgically sterile or post menopausal), aged 18 to 58 years
      inclusive. This study will consist of two parts; a Single Ascending Dose (SAD) part and a
      Multiple Ascending Dose (MAD) part. The SAD will consist of 6 escalating dose cohorts.
      Participants in each cohort will be randomized to receive a single oral administration of
      JNJ-55375515 or placebo after an overnight fast. The planned doses of JNJ-55375515 range from
      0.75 to 100 milligrams (mg). Participants in an additional cohort will be dosed in the fed
      state to determine the effects of food on the safety, tolerability and pharmacokinetics of
      JNJ-55375515. An additional optional cohort may be evaluated to further explore the safety,
      tolerability, pharmacokinetics, and pharmacodynamics of JNJ-55375515, with the maximal dose
      not exceeding 200 mg. The study duration for participants in the SAD part of the study will
      be approximately 2 to 5.5 weeks, including eligibility Screening. The MAD will consist of 3
      cohorts of 9 participants. Participants will receive once daily oral doses of JNJ-55375515 or
      placebo for 10 consecutive days. The study duration for participants in the MAD part of this
      study will be approximately 3 to 7 weeks including the eligibility Screening. The Safety of
      Participants will be monitored throughout the study.
    

Intervention name(s): JNJ-55375515; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-55375515 at a starting dose of 0.75 milligrams (mg) and maximum escalated dose will be 200 mg.; Participants will receive matching placebo.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: JNJ-55375515; Healthy; Placebo
Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      In this multicenter study, patients with dark skin and acne vulgaris will be included. The
      patients will receive treatment with MAL PDT and placebo PDT.
    

Detailed description: 
      The treatment period started within 2 weeks of the study screen. Patients received two
      treatments (MAL PDT and vehicle PDT) to each of the treatment areas, 2 weeks apart, and were
      followed-up 4 weeks after last treatment. The total duration of the study was 6-8 weeks.

      Methyl aminolevulinate 80 mg/g cream (MAL cream 8%)and vehicle was applied for 1.5 hours
      before illumination (Aktilite® CL128), total light dose 37 J/cm2
    

Intervention name(s): Methyl aminolevulinate (MAL) PDT
Intervention type(s): Drug
Intervention description(s): Cream application followed by illumination with red light
Intervention MeSH terms: Aminolevulinic Acid; Methyl 5-aminolevulinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down
      and removed from the body when given as an oral capsule, a radiolabelled oral suspension and
      a radiolabelled intravenous injection.
    


Intervention name(s): IV PBT2 microtracer and oral PBT2 single dose; oral 14C-PBT2
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science