bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Portion-control Training on Food Intake
Condition: Feeding Behaviors
Study type: Interventional

Summary: 
      The purpose of this study is to test whether food intake in response to large portion sizes
      differs between women who have received portion-control training and women who have not
      received such training. In a crossover design, women come to the laboratory on four occasions
      to eat a lunch of seven foods varying in energy density. Across meals, all foods are varied
      in portion size (100%, 125%, 150%, or 175% of baseline amounts). Food and energy intake is
      determined for each meal. Participants are from two groups: women who completed a one-year
      weight-loss trial in which they were trained in portion-control strategies, and women who had
      not received such training (community controls).
    


Intervention name(s): Meal portion size
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Portion Size
A Study of the Safety, Tolerability, Pharmacokinetics (What the Body Does to the Drug), and Pharmacodynamics (What the Drug Does to the Body) of CNTO 1959 Following a Single Subcutaneous (Under the Skin) Administration in Japanese Participants With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of CNTO 1959 following a
      single subcutaneous (SC, under the skin) dose administered to Japanese participants with
      moderate to severe plaque psoriasis.
    

Detailed description: 
      This is a randomized (participants are assigned to treatment groups by chance), double-blind
      (participants and study personnel know what study agents are given), placebo-controlled (a
      placebo is a treatment identical in appearance to CNTO 1959 but does not contain active
      drug), single-dose study. The study will include 24 participants: 4 groups of at least 6
      participants each. If it is decided that additional data are needed to define the safety and
      tolerability of CNTO 1959, an additional group may be enrolled. A given dose level may be
      repeated in newly enrolled participants, or a lower or intermediate dose may be administered
      based on preliminary data. The total duration of participation will be approximately 30
      weeks, which includes a screening period of up to 6 weeks before the administration of study
      agent. Participant safety will be monitored. Ascending doses of 10, 30, 100, and 300 mg dose
      of CNTO 1959 and placebo will be administered as single SC injections; however, 2 SC
      injections may be required for the 300 mg dose level. Dosing will be performed for 24 weeks.
    

Intervention name(s): CNTO 1959; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CNTO 1959: type=range, unit=mg, number=10, 30, 100, 300, form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks; Placebo: form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Moderate to Severe Plaque-Type Psoriasis; Psoriasis; Plaque-type psoriasis; CNTO 1959; Japanese participants
Role of Ultrasound in Diagnosis of Placenta Previa and MAP
Condition: Morbidly Adherent Placenta
MeSH terms: Placenta Previa
Study type: Observational

Summary: 
      Placenta accreta occurs when the placental implantation is abnormal. The marked rise in
      incidence has been assumed the increasing prevalence of cesarean delivery in recent years.
    

Detailed description: 
      The most accepted theory is that abnormal placentation . The most important risk factor for
      placenta accreta is placenta previa after a prior cesarean delivery. The first clinical
      manifestation of placenta accreta is usually severe , life-threatening hemorrhage. The
      recommended intervention of suspected placenta accreta is planned preterm cesarean
      hysterectomy with the placenta left in situ.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pregnant females with previous cs will be subjected to US to assess placental location and
        MAP
      
Biospecimen description: 
      uterus in case of hysterectomy after cesarean hysterectomy
Effectiveness and Safety of Yiqitongluo Granule for Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the prospective study is to evaluate the effectiveness and safety of
      Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more
      than sixy hospitals all over China.
    


Intervention name(s): Yiqitongluo granule
Intervention type(s): Drug
Intervention description(s): administered after dissolved
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of Diet on the Tolerability of FOS in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      The primary objective of this study is to determine the 5-day tolerability of one
      commercially available prebiotic food ingredient, FOS, in healthy human subjects with and
      without diet control.
    


Intervention name(s): FOS
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Prebiotic; FOS; fructooligosaccharide; polyglycan; microbiome; microbiota; Healthy Volunteers
Transarterial Chemoembolization (TACE) Therapy of Hepatocellular Carcinoma (HCC) With Blocking Tumor Blood Temporarily and Enhancing Perfusion
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      According to radiology imaging, the patients of HCC are divided into two groups(hypovascular
      tumor group and moderately vascular tumor group). Every group is divided into TACE therapy
      with balloon catheter subgroup and regular TACE therapy subgroup. Patients take the TACE
      therapy each 45 days, and have MRI diffusion examine or CT one week before next therapy. All
      objects are observed until the end event happening or in the group for 6 months.
    


Intervention name(s): balloon catheter
Intervention type(s): Procedure
Intervention description(s): transcatheter arterial chemoembolization therapy with balloon catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; transcatheter arterial chemoembolization; overall survival
A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the potential pharmacodynamic and potential pharmacokinetic
      interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not
      adequately controlled with glyburide as standard prescribed therapy. Patients will enter the
      study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK
      Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK
      Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and
      glyburide treatment re-started. The anticipated time on study treatment is <3 months, and the
      target sample size is <100 individuals.
    


Intervention name(s): GK Activator (2); Glyburide
Intervention type(s): Drug; Drug
Intervention description(s): 100mg po bid; 10-20mg po daily
Intervention MeSH terms: Glyburide
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Smartphone Technology: Young Adult Drinking
Condition: Alcohol Use; Alcohol Drinking; Drinking Behavior
MeSH terms: Alcohol Drinking; Drinking Behavior
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Exploring technology based tools to reduce drinking is important. The purpose of this
      research study is to compare different BAC monitoring apps for their effects on alcohol
      drinking and ratings of usability among young adults.This study will be conducted in six
      phases: a web-based and in-person screening assessment; brief counseling session on the day
      before the alcohol drinking session; brief appointment on the day of the alcohol drinking
      session; alcohol drinking session; two-week field period; and a follow-up appointment.
      Participation in this study will last approximately two months.
    


Intervention name(s): Smartphone breathalyzer device/app use; BAC estimator app use; Text messaging procedure
Intervention type(s): Other; Other; Other
Intervention description(s): Participants randomized to this condition will be able to blow into the smartphone breathalyzer after consuming each alcoholic drink, which produces an accurate breath alcohol reading on the app. These breath alcohol readings may inform participants' subsequent decisions regarding drinking.; Participants randomized to this condition will be able to make an entry into the BAC estimator app after consuming each alcoholic drink, which produces an estimated blood alcohol concentration based on the individual's sex, weight, number of alcoholic drinks and time spent drinking alcohol. These estimated blood alcohol concentrations may inform participants' subsequent decisions regarding drinking.; Participants randomized to this condition will be instructed to send a text to a smartphone they will use for the study after each alcoholic drink. A consideration of the number of texts sent may inform participants' subsequent decisions regarding drinking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Brief intervention; Harm reduction; Young adult; College Student
Target Validation and Discovery in Idiopathic Bronchiectasis
Condition: Bronchiectasis; Idiopathic Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Observational

Summary: 
      Bronchiectasis is a long-term lung condition where the airways become abnormally enlarged,
      leading to a build-up of mucus and inflammation that makes the lungs more susceptible to
      recurrent infection. Patients with bronchiectasis have subtle abnormalities in the way their
      airway cells respond to infection that are, in part, responsible for the development of their
      condition. At present there are no licensed treatments for bronchiectasis.

      This study will aim to characterise in depth some of these abnormalities with a view to
      future studies that will try to develop treatments that can directly target those
      abnormalities at a molecular level.

      Patients known to have bronchiectasis who have provided written informed consent will be
      enrolled alongside healthy volunteers and patients with chronic obstructive pulmonary disease
      and cystic fibrosis, for comparison. Participants will give a blood sample and have a
      bronchoscopy. This is a thin telescopic tube, passed through the nose or mouth, under
      sedation, into the airways that will allow a sample of bronchial epithelial cells to be
      taken.

      The main objective of the study is to achieve a greater understanding of some of the key
      biological processes/pathways and disease marker genes that play a role in the development of
      bronchiectasis. This is important because, at present, little is known about the underlying
      disease mechanisms and there are no licensed treatments for bronchiectasis.

      The investigator's hope this in-depth characterisation of specific bronchial epithelial cell
      abnormalities in bronchiectasis will shed light on novel targets for future drug discovery.
    


Intervention name(s): Bronchoscopy; Blood test
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Flexible bronchoscopy will be performed under sedation (typically a sedative such as intravenous midazolam and/or fentanyl) with local anaesthetic to the throat and vocal cords. Bronchial epithelial tissue (via bronchial brushing and biopsy forceps) and bronchial lavage samples will be taken for analysis.; Peripheral blood will be taken to collect peripheral blood monocytes, which will then allow the production of induced pluripotent stem cell derived bronchial epithelial tissues.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Secondary care respiratory clinics
      
Biospecimen description: 
      Whole blood, bronchial biopsy, bronchial brushings, bronchoalveolar lavage
Silk'n HST for Wrinkle Reduction - Clinical Study Protocol
Condition: Wrinkles
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the safety, efficacy and usage compliance of the
      home-use device Silk'n HST for self-treatment of periorbital wrinkles and skin laxity and
      improvement of skin appearance.
    

Detailed description: 
      This is a single arm prospective study of 18 weeks aimed to evaluate the safety and
      efficiency of Silk'n HST treatment on the periorbital areas. 30 subjects will be enrolled by
      a single USA clinical site. Throughout the trial there will be 3 pre-scheduled face to face
      treatment visits, as well as additional 18 independent treatments at home. 2 additional
      follow-up visits will be conducted 1 and 3 months following treatment end. In addition, 2
      maintenance treatment will be conducted independently at home once a month following
      treatment end.
    

Intervention name(s): Silk'n HST
Intervention type(s): Device
Intervention description(s): Treatment with Silk'n HST on the periorbital area as instructed in the user's manual
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and tolerability of a 6-week Inspiratory
      Muscle Training and cardiovascular exercise training program in children and adolescents with
      asthma.

      To also determine the efficacy of inspiratory muscle training and exercise in increasing
      respiratory muscle strength and endurance, and to explore relationships between fitness
      interventions (inspiratory muscle training and exercise), exercise tolerance, airway closure
      and dyspnea scores.
    


Intervention name(s): Inspiratory muscle training (IMT); Exercise alone; IMT and Exercise
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): IMT exercises at home will gradually ramp up; Subjects will be asked to exercise 2x/week for 6 weeks in person at the Duke research facility and again 2x/week at home for 30 minutes.; Combining IMT training and exercise
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Asthma
Assessing Symptomatic Clinical Episodes in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
    

Detailed description: 
      This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind,
      active-controlled study in patients diagnosed with major depressive disorder (MDD)
      experiencing an acute episode.
    

Intervention name(s): AXS-05; Bupropion
Intervention type(s): Drug; Drug
Intervention description(s): AXS-05 taken twice daily for 6 weeks.; Bupropion taken twice daily for 6 weeks.
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AXS-05; Major Depressive Disorder; MDD; Axsome; Depression; Dextromethorphan; Bupropion; Sigma-1; NDMA; ASCEND
Intervention in the Surgical Treatment of Obesity
Condition: Obesity, Morbid
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The worldwide prevalence of obesity reaching epidemic levels, and directly associated with
      several non-communicable chronic diseases, being considered the sixth leading cause of death
      in the world. In Brazil, estimated that one third of the population is overweight. Currently,
      bariatric surgery the fastest and most effective method to control the disease. However, most
      patients do not follow the postoperative follow-up protocol, causing weight regain.
      Intervention in the literature that goes beyond multidisciplinary and can prevent weight
      relapse. The develop and apply an interdisciplinary manual, based on the guidelines of the
      Food Guide for the Brazilian Population, as a support in the prophylactic treatment of weight
      relapse patients and bariatric surgery
    

Detailed description: 
      The objective of this randomized clinical study is to compare the eating behavior of obese
      participants who underwent the dietary guide after bariatric surgery treatment. The main
      questions are:

        -  Can an interdisciplinary intervention through a dietary guide promote a change in eating
           behavior in participants undergoing surgical treatment for obesity?

        -  Participants will participate in consultations and receive a food guidance guide and
           lectures with guidance.

        -  Researchers will compare intervention and control groups to see if there will be changes
           in eating behavior
    

Intervention name(s): multidisciplinary guide
Intervention type(s): Behavioral
Intervention description(s): use of the food guide for education, clarification of doubts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: obesity; bariatric surgery; food guide; interdisciplinarity
Sleep Disturbances as a Non-traditional Risk Factor in CKD-Actigraphy
Condition: Chronic Kidney Disease; Sleep Loss
MeSH terms: Dyssomnias; Parasomnias; Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      To test if usual at home night time sleep duration as measured with activity monitors and
      questionnaires will predict changes in kidney function as measured by kidney filtration rate
      and of cardiovascular function as measured by C-reactive protein in the blood. The study will
      explore the role of decreased sleep time or decreased sleep quality as a non-traditional risk
      factor for the progression of CKD and for the development of cardiovascular disease in CKD.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        CKD subjects; healthy volunteers
      
Keywords: CKD; Kidney Disease; poor sleep; CKD progression
Self-Myofascial Release in the Posterior Myofascial Chain
Condition: Fasciae (Anatomy)--Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The study investigates the relation between different segments of the posterior myofascial
      chain of the human body.

      The intervention consists on apply self-myofascial release with a foam roller in one of the
      segments of the posterior myofascial chain of the participants, and then see if the treatment
      has produced any changes in the hamstrings, gastrocnemius and soleus flexibility.
    

Detailed description: 
      The study investigates the relation between different segments of the posterior myofascial
      chain of the human body.

      The intervention consists on apply self-myofascial release with a foam roller in one of the
      segments of the posterior myofascial chain, and then see if the treatment has produced any
      changes in the hamstrings, gastrocnemius and soleus flexibility.
    

Intervention name(s): Self-myofascial release
Intervention type(s): Other
Intervention description(s): The subjects roll a foam roller under a determinated part of the body to self-massage that area.
Other intervention name(s): Foam rolling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability Study of rBet v1 SLIT Tablets
Condition: Birch Pollen-Related Rhinoconjunctivitis; Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of several doses of r
      Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.
    


Intervention name(s): rBet v 1; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 12.5 to 100 µg rBet v 1.; Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
Other intervention name(s): rBet v 1.0101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rBet v 1; Birch pollen allergy; Sublingual Immunotherapy