bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Behavioral Therapy (CBT) for Adherence and Depression in Type 1 Diabetes
Condition: Depression; Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a pilot behavioral intervention trial, designed to initially examine cognitive
      behavioral therapy for medical adherence and depression (CBT-AD) in patients with depression
      and poorly controlled type 1 diabetes.
    


Intervention name(s): Cognitive behavioral therapy for adherence and depression
Intervention type(s): Behavioral
Intervention description(s): Cognitive-behavioral therapy for adherence and depression (CBT-AD) is a weekly, psychosocial treatment focusing on depression and patients' adherence to diabetes self-care. Treatment consists of weekly one-hour sessions for approximately 10 sessions.
Other intervention name(s): CBT-AD
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Diabetes; Adherence; Medication; Glucose; Insulin
A Study to Learn About Recifercept in Patients With Achondroplasia
Condition: Achondroplasia
MeSH terms: Achondroplasia
Study type: Observational

Summary: 
      The purpose of this study is to learn about the study medicine (called recifercept) in people
      with achondroplasia. Achondroplasia is a very rare disease and patients of achondroplasia
      have short arms and legs. The study will include data already collected from a recifercept
      clinical trial and data collected from a separate study of achondroplasia. This study will
      compare patient experiences and will help the investigators determine if the study medicine,
      recifercept, is effective.
    


Intervention name(s): Recifercept
Intervention type(s): Other
Intervention description(s): Patients received recifercept intervention in the phase 2 clinical trial
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Achondroplasia patients, aged 3 months to 11 years old with documented and confirmed
        genetic diagnosis of achondroplasia, who have completed at least 2 valid height and length
        measurement in the natural history study and have at least 6 months of follow-up data in
        either the natural history study or the phase 2 recifercept trial.
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
Condition: Pneumococcal Conjugate Vaccine
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the safety, tolerability and immunogenicity of 13-valent
      pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been
      vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of
      antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease
      after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18
      years of age. They will be given the vaccination twice, each vaccination separated by
      approximately 6 months.
    


Intervention name(s): 13-valent Pneumoccocal Conjugate Vaccine
Intervention type(s): Biological
Intervention description(s): 2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.
Other intervention name(s): 13vPnC
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of California's SB 19 Pupil Nutrition Act
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Four California school districts will be randomized to early implementation of California's
      SB 19 Pupil Nutrition Act or to business as usual. Over 5000 4th, 5th and 7th graders will be
      evaluated at baseline, 4-month, and 16-month follow-up in order to determine if the SB 19
      nutrition and physical activity policies have had an impact on students' risk of excess body
      weight. The impact of early implementation of SB 19 on academic achievement will also be
      assessed.
    

Detailed description: 
      Four California school districts will be randomized to early implementation of California's
      SB 19 Pupil Nutrition Act or to business as usual.

      The nutrition provisions in SB19 include assuring that NO elementary school sells carbonated
      beverages at any time and that no middle schools sell carbonated beverages until after the
      end of the lunch hour each day. The nutrition provisions also include some restrictions on
      the sale of high-fat, high-sugar snack foods as well as encouragement to make fruits and
      vegetables more available to students. The legislation further encourages school districts to
      invest more heavily in providing students with opportunities to be physically active. High
      schools are NOT affected by this legislation.

      Over 5000 4th, 5th, and 7th graders from 28 schools will be evaluated at baseline, 4-month
      and 16-month follow-up in order to determine if the SB 19 nutrition and physical activity
      policies have had an impact on students' risk of excess body weight. The principal outcome
      measure is sex- and age-adjusted BMI percentile as determined from the CDC growthchart
      percentiles. Other measures include waist circumference, time to complete one mile run/walk,
      and blood pressure.

      The impact of early implementation of SB 19 on academic achievement will also be assessed,
      using students' standardized math and language arts achievement test scores.
    

Intervention name(s): State-directed nutrition policy change
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity; food policy; physical fitness (Respiratory Burst); academic achievement
The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function
Condition: Liver Dysfunction
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to examine whether the compound herbal formula (RHD-1) is effective
      on HBV Carrier With Abnormal Liver Function.
    

Detailed description: 
      % change HBV DNA title and liver function.
    

Intervention name(s): Compound Herbal Formula (RHD-1); dilute RHD-1
Intervention type(s): Other; Other
Intervention description(s): 100 ml/per day; 100 ml/per day
Other intervention name(s): Chinese herbal medicine; Chinese herbal medicine dilute
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: HBV carrier; HBV DNA title; Chinese Medicine; Liver function; RHD-1
A Study to Evaluate the Safety and Tolerability of Tecarfarin in Healthy Chinese Volunteers
Condition: Pharmacokinetic and Pharmacodynamic Profile of Tecarfarin
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of a single dose of
      tecarfarin in healthy Chinese Volunteers. the Pharmacokinetic and pharmacodynamic profile of
      tecarfarin will also be evaluated.
    


Intervention name(s): Tecarfarin 10mg; Tecarfarin 20mg; Tecarfarin 30mg; Tecarfarin 40mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tecarfarin 10mg tablets; two tecarfarin 10mg tablets; three tecarfarin 10mg tablets; four tecarfarin 10mg tablets
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This study is an investigator initiated clinical study. A prospective, single arm unblinded,
      open label study will be carried out to determine the feasibility of recruitment, retention
      and adherence of 30 prostate cancer survivors who have been on androgen deprivation therapy
      within the last 5 years for a lifestyle modification intervention.
    

Detailed description: 
      Introduction

        -  Androgen deprivation therapy (ADT) has been demonstrated to improve disease free and
           over-all survival in men with prostate cancer (PCa).

        -  ADT for PCa is associated with adverse cardio-metabolic effects such as reduced libido,
           hot flashes, metabolic syndrome, diabetes, myocardial infarction and stroke. This
           reduces quality of life (QoL) and potentially affects mortality.

        -  There is paucity of data regarding comprehensive lifestyle interventions in men on ADT
           for Pca. Existing studies used non-standardized interventions or lack data on metabolic
           risk factors.

        -  CLIPP is designed to address these gaps by using an intervention modelled after the
           Diabetes Prevention Program (DPP), a standardized multi-component intervention with
           demonstrated effectiveness in reducing diabetes risk factors that has been successfully
           adapted for multiple disease types including breast cancer.

      Intervention:

        -  24 Weeks

        -  Health Coaching Weekly

        -  Serum & Urine Baseline, Week 12 and Week 24

        -  Anthropometric Measures

        -  Questionnaires

        -  Dual-energy X-ray absorptiometry (DXA) at Baseline and Week 24
    

Intervention name(s): CLIPP
Intervention type(s): Behavioral
Intervention description(s): Diabetes Prevention program and Comprehensive Lifestyle Improvement Program consisting of low calorie diet, physical activity, sleep optimization and stress management
Intervention model: Single Group Assignment
Intervention model description: Pre and Post study model
Masking: None (Open Label)
Primary purpose: Treatment
Glycaemic Response to a Liquid Meal Tolerance Test
Condition: Glycaemic Index; Glycaemic Response
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether added food ingredient(s) affect glycaemic
      responses to a liquid meal tolerance test (LMTT).
    


Intervention name(s): Control Drink; Experimental Drink
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effect of a High-fat vs. High-sugar Diet on Liver Fat Accumulation and Metabolism
Condition: Fat; Liver; NAFLD
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease in the world.
      It is currently unclear why fat starts to accumulate in the liver, although both the amount
      and type of food consumed have been implicated. The majority of studies that have
      investigated the effects of dietary fat or sugar on liver fat have fed volunteers excess
      calories, which are known to increase liver fat. The effect of specific dietary components,
      when consumed as part of a diet not containing excess calories, on liver fat accumulation
      remains unclear.
    

Detailed description: 
      This research aims to investigate the role excessive consumption of specific macronutrients
      may play in the development of NAFLD. This will be achieved by subjecting participants to two
      specific dietary interventions (high-fat, low-carbohydrate and low-fat, high-carbohydrate) in
      a randomized, crossover research design. Liver fat content, and whole-body and hepatic
      fasting and postprandial lipid metabolism will be assessed before and after the specific
      dietary interventions.
    

Intervention name(s): High-fat, low-carbohydrate; Low-fat, high-carbohydrate
Intervention type(s): Other; Other
Intervention description(s): Dietary intervention: 4 week; Dietary intervention: 4 week
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised crossover with washout period.
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: NAFLD; Fat intake; Sugar intake
Gastric pH in Intubated Children
Condition: Preoperative Fasting
Study type: Interventional

Summary: 
      Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to
      minimize the risk of regurgitation, vomiting and pulmonary aspiration during general
      anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of
      this study and can be investigated in children undergoing elective procedures in intubation
      anaesthesia without inconvenience or additional invasive procedure and hence without
      additional risk

      Hypotheses: Gastric pH is higher in children that drink until 1 hour before anaesthesia
      induction than in those that drink until 2 hours before anaesthesia induction
    


Intervention name(s): clear fluid ingestion
Intervention type(s): Other
Intervention description(s): drinking of clear fluid in preoperative period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: preoperative care; preoperative period; fasting
Post-Surgical Morbidity and Bone Healing of Impacted Lower Third Molars: Piezosurgery vs. Conventional Instruments
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      The aim of this study is to compare piezosurgery and conventional surgery in impacted third
      molar surgery and to determine its effect on postoperative outcomes and quality of life.
    

Detailed description: 
      The aim of our study is to comparatively evaluate the duration of the operation and the pain,
      trismus, edema and healing of the alveolar bone that occur after tooth extraction in surgical
      extractions of impacted lower third molar teeth using piezosurgery and traditional rotary
      instruments.
    

Intervention name(s): Piezosurgery; Conventional burs
Intervention type(s): Device; Device
Intervention description(s): Piezosurgery used as an osteotomy device; Conventional burs used as an osteotomy device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of Grafts and Endografts for Abdominal Aneurysms on Arterial Stiffness.
Condition: Aortic Aneurysm, Abdominal
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Observational

Summary: 
      The purpose of this study is to evaluate by non-invasive methods the change in central
      hemodynamics and arterial stiffness produced by grafts and endografts after abdominal aortic
      aneurysm repair.

      Our main goal is to measure the changes in:

      Augmentation index, central blood pressure, pulse wave analysis, pulse wave velocity.
    

Detailed description: 
      The measures will be done before the procedure and after them.

      We will use the device called: SphygmocoR (Atcor Medical, Sydney, Australia).
    

Intervention name(s): non-invasive methods
Intervention type(s): Other
Intervention description(s): To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients consecutive treated for abdominal aortic aneurysm. The election of treatment is
        selected based on morphology and health status.
      
Keywords: arterial stiffness, central hemodynamics
Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective - To evaluate food effect on the pharmacokinetics and the pharmacodynamics
      (PD) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition.

      Secondary objectives

      - To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or
      fasting condition.
    


Intervention name(s): HIP1601 40mg
Intervention type(s): Drug
Intervention description(s): Single dosing of HIP1601 40mg, PO
Other intervention name(s): HIP1601
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ProSeal Laryngeal Mask Airway (LMA) Size 3 vs 4 in Non-paralyzed Female Patients
Condition: Oropharyngeal Injury
Study type: Interventional

Summary: 
      The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would
      reduce the incidence of mucosal injury.
    

Detailed description: 
      The ProSealTM laryngeal mask airway (PLMA; Laryngeal Mask Co. Limited, Mahe, Seychelles) is a
      laryngeal mask device with an added dorsal cuff to improve the seal and a drainage tube to
      prevent aspiration and gastric insufflations(Brain, Verghese et al. 2000).Despite its
      utility, there are complications associated with PLMA insertion such as sore throat and
      mucosal injury including oropharyngeal blood.

      The purpose of this randomized controlled study is to determine if size 3 PLMA would induce
      less mucosal damage indicated by blood on the cuff than size 4 in non-paralyzed female
      patients. The secondary objective of this study is to compare insertion time, number of
      attempts, oropharyngeal leak pressure, hemodynamic variables, and incidence of complications
      with size 3 and 4 PLMA.
    

Intervention name(s): insertion of the ProSeal LMA (PLMA); insertion of the PLMA
Intervention type(s): Device; Device
Intervention description(s): ProSeal LMA size 3 is inserted to the patients of Group size 3.; ProSeal LMA size 4 is inserted to the patients of Group size 4.
Other intervention name(s): insertion; ProSeal LMA size 3; insertion; ProSeal LMA size 4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting
Condition: Healthy; Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Our primary objective in this clinical intervention study, therefore, was to explored the
      effect of residual tissue thickness on the palatal mucosa healing from baseline to 1, 3 and 6
      months after free gingival graft harvesting in order to determine as soon as possible to
      re-harvest gingival graft from same site.
    

Detailed description: 
      Forty individuals (19 males and 21 females; age range: 18-35 years) were enrolled in the
      study. Based on the remaining tissue at donor site after free gingival graft harvesting,
      individuals were divided into two groups: 1.0-1.9 millimeter (mm) remaining tissue at donor
      site after harvesting (n = 20), 2-2.9 mm remaining tissue at donor site after harvesting.
      Tissue filling in defect area from three points (mesial, central and distal) was measured at
      various time-points (baseline, post-operative 1, 3, 6 months).
    

Intervention name(s): Less than 2 mm remaining palatal tissue thickness; 2 mm or more remaining palatal tissue thickness
Intervention type(s): Other; Other
Intervention description(s): The greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection. After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance.; The greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection. After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Free gingival graft; Palatal donor site healing
Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      Objective of the study is to find out the effects of Proprioceptive training in addition to
      routine physical therapy on balance and quality of life in patients with Diabetic neuropathy.

      Alternate Hypothesis:

      There will be significant difference in effects of Proprioceptive training in addition to
      routine physical therapy on balance and Quality of life in patients with Diabetic neuropathy.
    

Detailed description: 
      It was a parallel designed single blinded randomized controlled trial conducted in the Green
      Poly Clinic Bahria town, Lahore, Pakistan using non probability convenient sampling. patients
      who met eligibility criteria was informed about the aim of study. consent form were signed by
      all participants.After baseline assessment ,participants were randomly assigned in two
      groups.(ratio 1:1) The calcualted sample size was 27 in each group. i.e. 54 ( 27 in each
      group). After adding 20% drop out the final size will become, 64( 32 in each group) using 95%
      level of significance and 80% power of study.
    

Intervention name(s): Proprioceptive training; routine physical therapy
Intervention type(s): Other; Other
Intervention description(s): Proprioceptive training included exercises on different floor textures composed of 10 stations of exercises with the objective of stimulating the sole of the foot where participants had to coordinate gait by stepping with alternate feet on markers placed on the ground and the progression was manipulated through modifications of speed and direction.
Sequence of materials was 10 cm-thick foam, wood box with beans, two-cm thick mat with a density lower than the foam, wood box with cotton, two-cm thick mat volunteers sat on a bench and trained feet flexors by grasping with the toes a towel put on the floor, Two proprioception balls was used with an eight cm diameter with external projections resting on the floor a box with grains and sandpaper. After that joint Positional Sense Exercises were performed.; Routine physical therapy included range of motion exercises for bilateral ankle joints (5 min.), functional balance training (15 min.) involving sit to stand (5 times); standing weight shift (5 times each); functional reach- sideway and anterior for touching targets set by the therapist (5 times each); bipedal heel rise for 20 seconds (5 times); unipedal standing for 15 seconds (5 times each) and unipedal standing with knee bending for 15 second (5 times each). Other exercises was practiced as wobble board training (6 min).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuropathy; Proprioceptive training; Balance; Quality of life; Physical therapy