bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fasted Conditions
Condition: Breast Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to prove the bioequivalence of Letrozole Tablet under fasted
      conditions.
    


Intervention name(s): Letrozole; Letrozole
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 mg tablet; 2.5 mg Tablet
Other intervention name(s): Femara; Femara
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pecan Consumption and Cognitive Function
Condition: Healthy
Study type: Interventional

Summary: 
      Human cognitive function is affected by age-related changes, with some areas beginning to
      decline in mid-adulthood and worsening with age. However, there is evidence that dietary
      interventions or the incorporation of certain healthy foods or nutrients, into the diet can
      have protective effects against cognitive decline. These foods include nutrients such as
      polyunsaturated fats, vitamins E and C, and polyphenols. Pecans are a rich source of
      polyunsaturated fatty acids, antioxidants (including polyphenols), and vitamin E. Pecans
      contain more total phenols than any other tree nut suggesting that they may be an ideal
      bioactive food to enhance cognitive performance; however, the relationship between pecan
      consumption and cognitive functioning has never been assessed. The overall goal behind this
      research is to determine the relationship between antioxidant-rich pecans and cognitive
      functioning in a postprandial state.
    

Detailed description: 
      This trial will be a double-blinded, randomized, cross-over design in humans. There will be
      two study visits for two different test meals administered in random order. The two testing
      visits (v1 and v2) include blood draws and repetitions of the cognitive battery after
      consuming one of the two different test meals containing 1% milk, Nesquik, and either: 1)
      pecans, or 2) heavy whipping cream. There will be a 6-8 day washout period between each study
      visit.

      Hypothesis: Investigators hypothesize that the pecan-enriched meal will 1.) improve
      performance on select measures of postprandial cognitive functioning (such as executive
      functioning, memory, learning, attention, and processing speed) 2.) improve postprandial
      markers of glycemic control, inflammation, antioxidant capacity, coagulation potential, and
      3.) present a similar suppression of subjective appetite compared to the isocaloric, control
      meal that does not contain pecans.
    

Intervention name(s): Pecan Breakfast Shake; Cream Breakfast Shake
Intervention type(s): Other; Other
Intervention description(s): The pecan breakfast shake contains 68 grams of blended raw pecans. Participants will consume this shake at either visit 1 or visit 2 depending on randomization procedures.; The cream breakfast shake contains 138 grams of heavy whipping cream. Participants will consume this shake at either visit 1 or visit 2 depending on randomization procedures.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This trial will be a double-blinded, randomized, cross-over design. There will be 2 testing visits in which each participant will be randomized to receive either the control (cream) shake or the pecan shake at visit 1; they will receive the opposing shake at visit 2. There will be a 6-8 day washout period between visit 1 and visit 2.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse
      Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial
      is designed to test the clinical and functional effects of the two different laparoscopic
      procedures in terms of anatomical correction of the prolapse, post-operative and long term
      morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a
      quality of life questionnaire.
    


Intervention name(s): Laparoscopic procedure
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of Carbon Dioxide Insufflation During Endoscopy
Condition: Carbon Dioxide Insufflation During Colonoscopy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the differences of safety and efficacy of carbon
      dioxide insufflation instead of air during sedated or unsedated endoscopy.
    

Detailed description: 
      Total 640 participants who are indicated to accept endoscopic examinations or procedures will
      be enrolled in this study. The participants will be divided into 2 groups according to the
      examination field, esophagogastroduodenoscopy group (320 participants) and colonoscope group
      (320 participants). The participants in each group will be divided into sedated endoscope
      subgroup and sedated and unsedated endoscope subgroup (each subgroup is inclusive of 160
      participants). Carbon dioxide (CO2) or room air will be used randomly to insufflate the bowel
      lumen during the procedure in each subgroup.
    

Intervention name(s): carbon dioxide insufflation during endoscopy; Room air insufflation during endoscopy (Placebo)
Intervention type(s): Procedure; Procedure
Intervention description(s): Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy; Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: CO2 insufflation
Support Activities for the Reduction of Distress and Pain in Children During Venipuncture
Condition: Venipuncture
Study type: Observational

Summary: 
      To evaluate the efficacy of Health Support Activities (Animal Assisted Intervention, Clows,
      Musicians) in the reduction of pain and distress in children undergoing venipuncture.

      Hypothesis: the investigators expect a reduction in in pain and distress.
    

Detailed description: 
      Venipuncture is one of the most unpleasant procedures for children. Previous studies
      demonstrated the effectiveness of distraction techniques in reducing anxiety and pain but no
      one compares the specific activities of animals assisted intervention (AAI), clowns and
      musicians for this procedure.

      In the Hospital involved in the present study, venipuncture service has a week schedule for
      Health Support Activities. In specific days children can benefit of Health Support Activities
      as part of routine care.

      Aims of the present study are: evaluate efficacy of AAI, clowns and musicians in the
      reduction of childrens' distress and pain during venipuncture with respect of a control group
      undergoing venipuncture in the days where Health Support Activities are not scheduled;
      compare distress and pain levels between groups; evaluate caregiver's anxiety and its
      influence on child pain and distress; explore parents' and staff opinion.
    

Intervention name(s): Animal Assisted Intervention; Clowns; Musicians
Intervention type(s): Other; Other; Other
Intervention description(s): Operators of AAI and their dog meet the child and his/her parent in the waiting room and facilitates interaction using their professional characteristics. The interaction continue in the venipuncture room during the procedure and at its conclusion; in fact, the operators accompany the child and his/her parent outside the venipuncture room, to not abruptly interrupt the interaction.; Hospital clowns meet the child and his/her parent in the waiting room and facilitates interaction using their professional characteristics. The interaction continue in the venipuncture room during the procedure and at its conclusion; in fact, the operators accompany the child and his/her parent outside the venipuncture room, to not abruptly interrupt the interaction.; Musicians meet the child and his/her parent in the waiting room and facilitates interaction using their professional characteristics. The interaction continue in the venipuncture room during the procedure and at its conclusion; in fact, the operators accompany the child and his/her parent outside the venipuncture room, to not abruptly interrupt the interaction.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Outpatiens reffering to hospital for venipuncture
      
Keywords: pain, procedural; child; anxiety
Oral Health Status of Asthmatic Children
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study aimed to investigate the dental caries experience, periodontal health and salivary
      properties of asthmatic and non-asthmatic children ⁄ adolescents.
    

Detailed description: 
      A total of 108 children aged from 7 to 16 years old were included in this study and equally
      divided into two groups: Group I (asthmatic children) and Group II (healthy control). All the
      children were clinically examined to assess their dental caries experience and periodontal
      health condition. A trained and calibrated examiner (kappa = 0.95) performed the dental
      caries examination according to World Health Organization (WHO) criteria. Dental caries
      status was recorded using the number of decayed, missing or filled teeth (dmft/DMFT) and
      decayed, missing or filled surface (dmfs/DMFS) indices. Periodontal health was assessed by
      gingival index [GI] and plaque index(PI). An interview was conducted with parents/guardians
      and a structured questionnaire was employed to parents in addition to medical records.
      Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH
      and buffering capacity.
    

Intervention name(s): Diagnosis of caries experience and periodontal health
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A total of 108 children aged from 7 to 16 years old were included in this study and equally
        divided into two groups: Group I (asthmatic children) and Group II (healthy control).
      
Keywords: asthma; children; oral health
The Socket Shield Technique, a Prospective Cohort Study of 20 Patients
Condition: Peri-implant Health
Study type: Interventional

Summary: 
      23 implants with socket shield were followed for 18 months. buccal bone thickness and
      survival rates registered.
    

Detailed description: 
      Aims: This study aims to collect data on implant survival, bone volume maintenance, and
      complications associated with the socket shield technique.

      Materials & methods: The study involved the placement of 23 implants using the socket shield
      technique in 20 patients. AstraTech EV implants were used, and no bone substitutes or
      connective tissue grafts were applied. Patients were monitored for 18 months, recording
      implant survival, volumetric bone analysis on CBCT scans, interproximal bone levels, bone
      sounding, pink esthetic scores, and complications. Prosthetic procedures were also described,
      including temporary and final restorations.
    

Intervention name(s): oral implant placement with socket shield technique
Intervention type(s): Device
Intervention description(s): tooth is split in socket shield configuration, implant is immediately placed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence
Condition: Alcohol Dependence; PTSD
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the effect of propranolol versus placebo on craving,
      distress and cue reactivity to trauma and alcohol cues.
    

Detailed description: 
      Summary and Synthesis: Epidemiological studies have established the occurrence of high rates
      of AD in persons with PTSD. Likewise, studies of alcohol/drug abuse treatment seekers have
      documented high rates of trauma exposure and PTSD. The high prevalence of PTSD/AD comorbidity
      is the cause of enormous human suffering, most of which either goes untreated or is resistant
      to treatment efforts. Both theory and research concerning the interface between these two
      disorders suggests that PTSD is associated with the initiation of excessive alcohol use
      and/or the development of AD by way of an escape/avoidance behavioral mechanism wherein
      escalating alcohol use is reinforced by its ability to dampen the negative emotions and
      arousal associated with PTSD. If PTSD is often a primary cause of the initiation and
      maintenance of AD, then clinical interventions that primarily impact PTSD should lead to
      significant improvements in craving for, and use of, alcohol. The findings of two recent
      treatment studies offer especially compelling support for this expectation. Drawing on both
      basic neuroscience research and a developing body of suggestive clinical/applied research, we
      were led to consider if the putative memory modulating properties of the adrenergic
      antagonist propranolol might have therapeutic benefits for PTSD/AD comorbid individuals.
      Thus, the proposed study will test the hypothesis that the strategic administration of
      propranolol coupled with the elicitation/retrieval of trauma-related memories will dampen
      emotional distress, alcohol craving and cue reactivity during subsequent exposure to trauma-
      and alcohol-related cues. A two-week follow-up laboratory session and clinical assessment
      will permit us to evaluate whether treatment benefits are maintained over time and if there
      are any changes in alcohol use and PTSD symptomatology.
    

Intervention name(s): Propranolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg; Single Administration.; 40 mg; Single Dose.
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol dependence; PTSD; propanolol; craving; beta-block; cue exposure; addiction; memory; trauma; addictive behavior
Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up
Condition: Bipolar Disorder; Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Observational

Summary: 
      This study aims to study prospectively for 8 months a sample of bipolar patients with acute
      depressive episode in order to identify that factors associated with functional impairment,
      with especial attention to the presence of subsyndromal symptoms beyond the acute phase.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Outpatients from Mental Health Centres or Psychiatric Offices, diagnosed with bipolar I or
        II disorder experiencing an acute depressive episode.
      
Keywords: Bipolar depression; subsyndromal symptoms; functioning; cognitive function
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
Condition: Agammaglobulinemia; IgG Deficiency; Common Variable Immunodeficiency
MeSH terms: Agammaglobulinemia; IgG Deficiency; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients
      with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety,
      the number of infusions temporally associated with AEs, the rate, severity and relationship
      of all AEs and the vital sign changes during each infusion will be evaluated.
    


Intervention name(s): Immunoglobulins Intravenous (Human)
Intervention type(s): Drug
Intervention description(s): Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunoglobulin Intravenous; Agammaglobulinemia; Hypogammaglobulinemia; Common variable immunodeficiency; Immunoglobulin G; Children
Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) for Colorectal Cancer in China
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      S-1 is an oral fluoropyrimidine with demonstrated efficacy on gastric cancer and colorectal
      cancer. The new regimen with Oxaliplatin and leucovorin is expected to achieve more
      encouraging efficacy on colorectal cancer. This study is to explore the feasibility of the
      SOL regimen on efficacy and tolerability on Chinese colorectal cancer patients.
    

Detailed description: 
      -  Endpoints:

        -  Primary endpoints: adverse drug reaction

        -  Secondary endpoints:

             -  Overall Response Rate：ORR

             -  Progress Free Survival: PFS

             -  Time to Treatment Failure：TTF
    

Intervention name(s): S-1, leucovorin, oxaliplatin
Intervention type(s): Drug
Intervention description(s): S-1(20mg、25mg), capsule, 40~60mg, Bid,p.o., day1~7； LV (25 mg), tablet, 25mg,Bid,p.o., day1~7； L-OHP (50 mg),injection 85mg/m2, day1. repeated at every 2 weeks cycle till disease progression.
Other intervention name(s): S-1(20mg、25mg)--Taiho Pharmaceutical Co., Ltd.；; LV (25 mg)；; L-OHP (50 mg)--Sanofi Aventis Co., Ltd.
Intervention MeSH terms: Leucovorin; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: S-1; leucovorin; oxaliplatin; colorectal cancer; SOL; unresectable or recurrent colorectal cancer
Biodiversity in the Diet in Vietnam
Condition: Biodiversity; Food Intake; Nutritional Status
Study type: Interventional

Summary: 
      Agricultural biodiversity can have an important role in improving diet diversity, quality and
      nutrition and can be seen as the foundation of the food and nutrition value chain. Increasing
      the availability and access to local agricultural and/or wild biodiversity genetic resources
      has the potential to increase production, making more food available for consumption as long
      as entitlements to access it exist. However, as the history of food security interventions
      has shown, increasing the production and supply of staple crops alone is not enough to
      improve food security or nutritional status. However, while agricultural diversification is
      an important component, it is not alone sufficient to improve diet diversity. Other system
      elements including women's education and knowledge, intra-household dynamics and women's
      status and cultural beliefs and practices that improves children's health and nutrition are
      important to ensure biodiversity has a successful role in improving dietary diversity and
      quality.
    


Intervention name(s): Promotion of a biodiverse diet
Intervention type(s): Behavioral
Intervention description(s): Component 1 - Participatory Identification of Intervention Approach (PIIA) Component 2. Local stakeholder consultation Component 3. Sensitisation of community Diversity club will receive capacity building from a Village health worker based on the prioritised species selected in component 2.
The following topics will be covered for each species selected for promotion:
Where to locally source inputs and expected price
How/when to prepare plots using organic inputs
Planting and best-practice management practices
Seed saving and storage
Possible intercropping combinations OR ecosystem services provided Component 4. Active Cooking demonstrations and Nutrition Education and counselling: Diversified cooking practices
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Biodiversity
Multi-Dose Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of escalating multiple
      doses of S-equol administered twice daily (BID) for 14 days to healthy male and female
      subjects and to describe the pharmacokinetic profile of S-equol.
    

Detailed description: 
      The study is a randomized, double-blind, placebo-controlled trial of doses escalated by
      cohort. Volunteers will be randomized to receive active study drug or placebo twice daily
      (BID) for 14 days. This study will be staggered in timing with the single rising dose study
      (Protocol AUS-CT01) being conducted concurrently, such that the lowest dose cohort of this
      multiple rising dose study may begin after evaluation of safety and pharmacokinetic data from
      the first 8 subjects randomized to the 10 mg dose cohort of the single rising dose study and
      safety data from the 8 Subjects randomized in the 20 mg dose cohort of that study.
    

Intervention name(s): S-equol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral, BID, 14 days; oral, BID, 14 days
Other intervention name(s): AUS-131
Intervention MeSH terms: Equol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy volunteers