bioihbjkbjnl/mcl2 huggingface dataset:
Study to Determine Safety, Tolerability and Pharmacokinetics, of SCO-120 in Healthy Male and Post-menopausal Female Subjects
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Multipart Phase 1 Randomized, Double blind and Placebo controlled Study to
      Determine Safety, Tolerability and Pharmacokinetics, of SCO-120 in healthy male and
      postmenopausal female volunteers.
    

Detailed description: 
      Part A- approximately 76 (Approximately 8 sequential cohorts of 8 subjects per cohort)

      Part B- Up to approximately, 32 healthy males or post-menopausal female subjects will be
      enrolled

      Part C- Approximately 32 healthy male or postmenopausal female subjects (4 sequential cohorts
      of 8 subjects) will be enrolled
    

Intervention name(s): SCO-120; matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part A: single oral administration
Part B: single oral administration in Period 1 and Period 2 (crossover design)
Part C: multiple oral administration (14 day dosing); Part A: single oral administration
Part C: multiple oral administration (14 day dosing)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Effectiveness of a Dietary Counseling to Prevent Early Consumption of Added Sugar and Ultra-processed Foods
Condition: Infant Nutrition Disorders; Feeding Patterns; Health Knowledge, Attitudes, Practice
MeSH terms: Nutrition Disorders; Infant Nutrition Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to prevent the early introduction of added sugar and
      ultra-processed foods and evaluate the impact on breastfeeding duration, complementary
      feeding quality, growth and prevalence of caries during the first year of life.
    

Detailed description: 
      This randomized field trial will be performed at the maternity wards of Friendly Hospitals
      Initiative in three regions of Brazil: North, Northeast and South. After delivery, mothers
      who accepted to participate in the study will be randomized into control and intervention
      groups.It will be performed a weekly block randomization to prevent the contamination of
      information among mothers of different groups in the same facility. The intervention mothers
      will be advised not to give added sugar and ultra-processed foods during the first year of
      life, including a leaflet with colored images as a reminder for mothers. The control group
      mothers will not receive the study intervention but will be have all the routine health
      assistance of the maternity. At 6 months and 12 months, mothers of both groups will be
      visited in their homes and dietary evaluation and anthropometric measurements of their babies
      will be assessed. At 12 months of age the infants will have dental examinations and
      hemoglobin concentration through a capillary blood test.

      .
    

Intervention name(s): Dietary Counseling
Intervention type(s): Other
Intervention description(s): The intervention will consist of an individualized, face-to-face, 20 to 30 minute counseling session to mothers by trained health workers who will address healthy eating practices during the first two years of life. A printed, colorful and illustrated material will be used to assist mothers in appropriate food choices, mainly to avoid the introduction of sugar and ultra-processed foods. In addition, they will receive a booklet which addresses the "Ten Steps of Healthy Feeding for children from Birth to Two years of life". The research team will focus on Step2: "Do not give added sugar or foods with added sugar", and Step8:"Do not offer ultra-processed foods as candies and soft drinks". To reinforce the intervention, mothers will receive telephone calls up to the infant reach six months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: complementary feeding; added sugar; ultra-processed foods; intervention; infants
Impact of Cognitive Control Training on Anger Symptoms and Reactive Aggression
Condition: Anger
MeSH terms: Aggression
Study type: Interventional

Summary: 
      High trait anger is a personality construct characterized by elevations in the frequency,
      duration, and intensity of anger episodes. According to many social cognitive theories,
      hostile interpretations of everyday situations contribute to the development and maintenance
      of anger symptoms. This study will examine the effectiveness of a computer-based cognitive
      control training task.
    

Detailed description: 
      Difficulties with anger control are reported in a number of psychological conditions and are
      associated with social problems, such as dating violence and workplace violence. High trait
      anger is a personality construct characterized by elevations in the frequency, duration, and
      intensity of anger episodes. However, the cognitive processes contributing to high trait
      anger are still poorly understood. According to the Integrative Cognitive Model of Anger and
      Reactive Aggression (ICM), three cognitive processes jointly contribute to the experience of
      high trait anger and reactive aggression: 1) hostile interpretation biases; 2) cognitive
      control; and 3) anger rumination. The proposed study will evaluate the validity of this model
      in relation to cognitive control using a computer-based cognitive control training (CCT)
      program.
    

Intervention name(s): Cognitive Control Training; Sham Cognitive Control Training Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A computer-based flanker task that aims to reinforce the recruitment of cognitive control in the presence of hostile/aggressive stimuli.; A placebo version of the computer-based cognitive control training. Designed to appear similar to the experimental task, but will not reinforce the recruitment of cognitive control in the presence of hostile/aggressive stimuli.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Reactive Aggression; Anger; Cognitive Control Training; Anger Rumination
Effects of Whole Body Vibration (WBV) on Musculoskeletal System of Aged Women
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      A controlled, non-randomized trial will be carried out in 240 postmenopausal women, aged
      55-75 years, over a 18-month period. The group 1 received a physical intervention, consisting
      of whole body vibration (WBV) over 12 months followed by training arrest during 6 months. The
      group 2 served as sedentary control. WBV training is performed 2 or 3 times per week, with
      each session lasting 20 minutes. The training included light squats at 35-50 Hz and ended up
      by stretching and relaxation exercises at 50 Hz. Bone, muscle and postural evaluations will
      be performed at the beginning, 6, 12 and 18 months in each group with evaluation of bone
      micro-architectural trabecular and cortical compartments, at the weight bearing tibia and the
      non weight bearing radius.

      The primary outcome of the project is the pre, mid, and post evaluations of bone. Bone
      exploration included dual x-ray absorptiometry (DXA) and high resolution peripheral
      quantitative computed tomography (HR-pQCT). Bone Mass Density (BMD) will be evaluated by DXA
      at lumbar, femoral levels and humeral, macro and micro-architectures of the cortical and
      trabecular compartments will be evaluated in distal radius and tibia by HR-pQCT and bone
      markers will be analyzed longitudinally. The secondary aim is to assess muscle performance
      and proprioception. Finally will be assessed markers of cartilage degradation and synthesis,
      no study has been published on this tissue.
    


Intervention name(s): sedentary; Vibration
Intervention type(s): Device; Device
Intervention description(s): No intervention; Subjects will be submitted to the WBV for 5 to 20 minutes, 2 or 3 times a week with frequencies between 35 to 50 Hz while 12 months
Other intervention name(s): Power Plate Limited, London, UK
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: osteopenia; whole body vibration; women; bone microarchitecture; bone density
GENETIC SUSCEPTIBILITY FACTOR AS A PREDICTOR OF TYPE 2 DIABETES REMISSION AND WEIGHT LOSS AFTER BARIATRIC SURGERY
Condition: Case-control Study
MeSH terms: Weight Loss; Genetic Predisposition to Disease
Study type: Observational

Summary: 
      Obesity is directly related to an increased risk of diabetes mellitus, hypertension,
      dyslipidemia, cardiovascular disease, and overall mortality. Weight loss is effective in
      decreasing these risks and to reduce disease severity. Bariatric surgery is an effective
      therapy for sustained weight loss and type 2 diabetes (T2D) remission in most of the morbidly
      obese patients. But there is also a significant number of individuals with an inappropriate
      response to bariatric surgery. Two recent retrospective studies assessed the role of genetic
      load as a predictor of this response, but the results are still unelucidated. The aim of this
      study is to assess whether a selection of genetic variants may allow us to identify
      individuals who will have a satisfactory response after bariatric surgery in terms of weight
      loss and T2D remission.
    

Detailed description: 
      A retrospective case-control study of 100 women who underwent bariatric surgery (Roux-en-Y
      laparoscopic gastric bypass): 50 pacients who were diabetic before surgery: 15 cases with
      less than 40% of the excess weight loss (EWL) and 35 cases with more than 75% EWL, matched
      with 50 non diabetic controles: 15 patients with less than 40%EWL and 35 with more than
      75%EWL after one year. All individuals were analyzed with a genetic score from Nutri inCode.
      The predictive ability was analyzed by discrimination (area under the ROC curve), sensitivity
      and specificity and a score was calculated.
    

Intervention name(s): Genetic test
Intervention type(s): Genetic
Intervention description(s): Analysis of the main genetic variants associated with obesity are evaluated, mainly those related to the regulation of appetite, energy expenditure, adipogenesis, diabetes, inflammation of adipose tissue and others .
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The trial aimed to recruit a total of 100 female subjects who underwent a gastric bypass in
        our cente with more than one year of monitoring. These 100 subjects were distributed into 4
        subgroups according to the percentage of excess weight loss (%EWL) and the presence or
        absence of type 2 diabetes before surgery:

        15 women with %EWL <40% without diabetes 15 women with <40%EWL with type 2 diabetes 35
        women with a %EWL> 75% without comorbidities 35 women with a %EWL> 75% with type 2 diabetes
      
Biospecimen description: 
      Blood sample
Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury (FLORALI Study)
Condition: Acute Lung Injury; Acute Respiratory Failure
MeSH terms: Respiratory Insufficiency; Lung Injury; Acute Lung Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to compare, in patients with acute respiratory failure/acute lung
      injury the efficacy of three different methods of oxygenation to prevent endotracheal
      intubation :

        1. conventional oxygen therapy (O2 conventional)

        2. high flow nasal oxygen therapy (O2-HFN)

        3. association of high flow nasal oxygen therapy with non invasive positive pressure
           ventilation (O2-HFN/NPPV).
    


Intervention name(s): O2 conventional; O2-HFN : high flow nasal oxygen therapy; O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation
Intervention type(s): Other; Device; Device
Intervention description(s): standard low flow therapy; The patient will receive high flow nasal of humidified oxygen, set between 30 to 50 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 >92%.; The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 >92% with the minimal FiO2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALI
Effect of Home-Based Exercise Program in Older Adults With Sarcopenia
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      In the prospective, randomized, controlled multi-centre study, 100 patients who were
      clinically diagnosed with sarcopenia were assigned to either a home-based exercise group or
      the control group. The home-based exercise program was performed three days per week for 12
      weeks. Before and three months after the exercise program, all the patients were evaluated.
    

Detailed description: 
      Sarcopenia is a complex and multifactorial syndrome characterized by progressive and
      generalized loss of skeletal muscle mass and strength.The randomized, multicenter study was
      conducted at the physical medicine and rehabilitation departments of five different centers.
      One hundred patients met the inclusion and exclusion criteria and were randomly allocated to
      either a home-based exercise group (n=50) or a control group (n=50). The patients were
      evaluated before and 3 months after inclusion using the timed up and go test, the Berg
      balance scale, the 6-minute walk test , a numeric rating scale to determine QoL, and the
      number of falls.
    

Intervention name(s): Home based exercise
Intervention type(s): Other
Intervention description(s): The home-based training program included posture and stretching exercises, strengthening exercises, balance training, and a walking regimen 3 days per week for 3 months.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Washington University
Condition: Sepsis; Adult Disease; Severe Sepsis; Emergency Department
MeSH terms: Sepsis; Toxemia; Emergencies
Study type: Observational

Summary: 
      The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution
      (MDW) parameter to current standard of care improves a clinician's ability to recognize
      sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics
      from time of ED presentation for sepsis patients (simulated primary endpoint), with
      concomitant reductions in length of stay and in-hospital mortality for those patients
      (secondary endpoints).
    

Detailed description: 
      The objective of this study is to develop a method for identifying sepsis patients from
      electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be
      identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours
      of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The
      patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements
      will be extracted to complete case report form. Furthermore, objectives include to confirm
      the clinical validity and performance of MDW in a control population of sepsis patients where
      MDW is measured but not reported to physicians. This study is an observational study which
      will simulate the decision impact of MDW on sepsis identification and patient management
    

Intervention name(s): CBC-DIFF Monocyte Volume Width Distribution (MDW)
Intervention type(s): Diagnostic Test
Intervention description(s): MDW measurement will be used to detect sepsis. Results will not be used to manage patients.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of
        care
Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Observational

Summary: 
      The purposes of this study are:

        -  To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual
           bleeding treatment by Mirena.

        -  To collect italian data for Mirena in clinical routine.
    


Intervention name(s): Levonorgestrel (Mirena, BAY86-5028)
Intervention type(s): Drug
Intervention description(s): Women using Mirena for intrauterine treatment of menorrhagia
Intervention MeSH terms: Levonorgestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with a diagnosis of idiopathic menorrhagia and Mirena inserted for a period no longer
        than three months according to the assessment of the investigator will be included in the
        study
Trial of Adjuvant Chemotherapy for Gastric Cancer
Condition: Stomach Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III randomized study designed to evaluate the efficacy of mitomycin,
      doxifluridine, and cisplatin compared to mitomycin and doxifluridine.
    

Detailed description: 
      Stomach cancer is the most common cancer in Korea and one of the major health problems
      worldwide. The most effective treatment for gastric cancer is curative surgical resection of
      primary tumor. However, a substantial number of patients eventually die of recurrences after
      curative resection. A number of randomized trials investigating the role of adjuvant
      chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still
      controversial and varied between Western and Asian trials. Meta-analysis of Western trials
      didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely,
      some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative
      resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected
      gastric cancer compared to no treatment.

      This study is designed to evaluate the efficacy of mitomycin, cisplatin and prolonged
      treatment with doxifluridine compared to mitomycin plus doxifluridine.
    

Intervention name(s): Mitomycin, doxifluridine and cisplatin; Mitomycin and doxifluridine
Intervention type(s): Drug; Drug
Intervention description(s): Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168); Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
Intervention MeSH terms: Mitomycins; Mitomycin; Doxifluridine; Floxuridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stomach cancer; Adjuvant chemotherapy; Mitomycin; Cisplatin; Doxifluridine
P4 (Pregabalin for Peripheral Posttraumatic Pain)
Condition: Neuralgia
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic
      peripheral neuropathic pain
    


Intervention name(s): pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): pregabalin; placebo
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 4, post-traumatic neuropathic pain, neuropathic pain, Nep, post surgical pain, nerve injury, phantom limb pain, international
Cognitive Remediation With D-Cycloserine
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      One hundred seventy-five eligible participants will be enrolled with aim of randomizing 60 to
      a double-blind, placebo-controlled trial of D-cycloserine added to cue-exposure treatment to
      prevent relapse to smoking. Subjects who sign an informed consent, meet inclusion criteria,
      and demonstrate response to cue reactivity at the screening visit, will either be:

        -  started on approximately 3 weeks of either nicotine replacement therapy (NRT) at a dose
           of either 14 or 21 mg/day or varenicline titrated to 1.0 mg bid; decision of which
           method to use to quit smoking will be based on participant choice as well as taking into
           account any medical contraindications to either therapy.

        -  evaluated to confirm abstinence from smoking. Recently abstinent participants referred
           by a smoking cessation clinic, PCP or self referred must have an expired air CO < 10 ppm
           to confirm abstinence.

      Subjects who are able to demonstrate 18-24 hours of abstinence prior to the first Cue
      Exposure Therapy Visit (CET I) will be eligible to be randomized to two visits of study
      medication and cue exposure treatment, spaced five to nine days apart. Subjects will complete
      2 follow-up visits at 2-4 days and four weeks after the last CET visit. The entire study
      involves twelve visits and will last approximately ten weeks. For recently abstinent
      participants referred by a smoking cessation clinic, PCP or self referred, the study involves
      7 visits (screening and baseline visit will be merged into one and there is no CBT component)
      and will last approximately 7 weeks.
    


Intervention name(s): D-cycloserine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 single weekly doses, 50 mg capsule
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: D-cycloserine; Smoking cues; Cognitive remediation; physiologic reactivity; craving