bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Intrathorathic Oscillations on Pulmonary Functions in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Aim: To investigate the effect of intrathoracic oscillations on forced expiratory volume at
      first second and peak expiratory flow in the children with cerebral palsy.

      Methods and Procedures: Children were randomly assigned into two groups (study group and
      control group). Each child was evaluated before and after 6 successive weeks.
    

Detailed description: 
      Methods and Procedures: 24 children with spastic cerebral palsy from both sexes, There ages
      from 6 to 8 years old. Children were randomly assigned into two groups (study group and
      control group). Each child was evaluated before and after 6 successive weeks. The children of
      the control group received traditional chest physiotherapy. while, the children of the study
      group received 4 sessions per week for 6 weeks with quake device.
    

Intervention name(s): Quake device training; Traditional chest physiotherapy
Intervention type(s): Procedure; Procedure
Intervention description(s): In Quake breathing, patients were advised to take a deep breath and hold it for 3-5 seconds. The patient had the mouthpiece firmly sealed to the lips and were asked to inhale and exhale completely; postural drainage - percussion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Oral Care With Propolis in Pediatric Oncology Patients
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional

Summary: 
      According to the data from the World Health Organization, approximately 14 million people are
      diagnosed with cancer every year, and this number is expected to increase further in the next
      10 years. Multidisciplinary treatment consisting of chemotherapy, radiotherapy and surgery is
      applied in childhood cancers. In chemotherapy, the target is cancerous cells, but high doses
      of chemotherapeutic agents do not have selectivity. Intact tissue cells are also affected by
      this cytotoxicity. Mucositis develops in the patient, especially as a result of the mucosal
      cells being affected. Mucositis is defined as damage to the mucosa lining the oral cavity,
      pharynx, larynx, oesophagus and gastrointestinal tract due to cancer treatment. It is one of
      the most important side effects of both chemotherapy and radiotherapy. This study is carried
      out to determine the effectiveness of propolis in preventing the formation of oral mucositis
      due to multiple use of chemotherapeutic drugs.
    

Detailed description: 
      According to the data from the World Health Organization, approximately 14 million people are
      diagnosed with cancer every year, and this number is expected to increase further in the next
      10 years. Multidisciplinary treatment consisting of chemotherapy, radiotherapy and surgery is
      applied in childhood cancers. In chemotherapy, the target is cancerous cells, but high doses
      of chemotherapeutic agents do not have selectivity. Intact tissue cells are also affected by
      this cytotoxicity. Mucositis develops in the patient, especially as a result of the mucosal
      cells being affected. Mucositis is defined as damage to the mucosa lining the oral cavity,
      pharynx, larynx, oesophagus and gastrointestinal tract due to cancer treatment. It is one of
      the most important side effects of both chemotherapy and radiotherapy. This study is carried
      out to determine the effectiveness of propolis in preventing the formation of oral mucositis
      due to multiple uses of chemotherapeutic drugs.
    

Intervention name(s): propolis; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): After obtaining written consent, oral identification of all participants will be performed prior to randomization. Oral diagnosis of children receiving chemotherapy will be repeated on day 0, day 5, and day 10, and the difference between the Oral Mucositis Rating Scale mean scores of the children in the groups will be examined.
Oral Mucositis Assessment: Oral Mucositis Rating Scale will be used. The oral mucosa of children will be evaluated using the World Health Organization Oral Mucositis Classification.; Placebo
Intervention MeSH terms: Propolis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
A Comparative Dissolution and Absorption Study of an Orodispersible Powder, Chewable Tablet and Soft Gel Capsule Vitamin D3 Supplementation
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      This is an open-labelled, randomized controlled clinical trial aimed to compare the
      pharmacokinetics of an orodispersible vs a soft gelatin vitamin supplementation in vitamin D
      deficient healthy adults.
    

Detailed description: 
      Vitamin D is a fat-soluble vitamin used by the body for normal bone development and
      maintenance by increasing the absorption of calcium, magnesium, and phosphate. Vitamin D also
      plays a role in the nervous system, musculoskeletal system and immune system. Vitamin D
      deficiency has been linked with diverse health conditions including diabetes, cardiovascular
      diseases, breast, colorectal and prostate cancer, dementia, depression, erectile dysfunction,
      osteoporosis, and bone disorders. Vitamin D deficiency is a global healthcare challenge. To
      overcome vitamin D deficiency, a daily vitamin D supplementation of 200-1000 IU or a high
      dosage from 25000 to 200000 IU for 4-6 weeks, is normally recommended.

      Vitamin D supplements are available over the counter in different delivery vehicles
      (formulations) to reach the circulatory system. In the present study the investigators aim to
      evaluate the pharmacokinetics of an orodispersible vitamin D supplement vs a conventional
      oral soft gelatin capsule, in vitamin D deficient healthy adults to assess how different
      vitamin D supplement formulations can efficiently overcome the vitamin D deficiency.
    

Intervention name(s): Soft gelatin 200000 IU vitamin D3 capsule; Orodispersible (sachet) 200000 IU vitamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Weekly single dose for 3-weeks; Weekly single dose for 3-weeks
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas
Condition: Hemangioma
MeSH terms: Hemangioma
Study type: Observational

Summary: 
      Current treatment options for hemangiomas, such as propranolol, steroids and interferon, all
      have the potential for significantly harmful side effects. The purpose of this study is to
      identify potential biomarkers that can be used to design clinical trials and accelerate the
      delivery of new treatment alternatives to children with hemangiomas.
    

Detailed description: 
      Urine will be collected from children with hemangiomas and age-matched healthy controls at
      2,4,6,9,12,18 and 24 months of age. Children with hemangiomas will also have ultrasound
      examination performed at each visit.
    

Intervention name(s): Urine collection and ultrasonography; Urine collection
Intervention type(s): Procedure; Procedure
Intervention description(s): Bagged urine collection and ultrasound at each visit; Bagged urine collection
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with hemangiomas and children without hemangiomas will be enrolled from Hemangioma
        and Vascular Malformation Clinic and Ambulatory Pediatric Clinics.
      
Biospecimen description: 
      serum and urine
A Study to Evaluate ICU Simulation Experience in the Cardiothoracic Surgical Population to Reduce Post-operative Delirium
Condition: Post-Operative Delirium
MeSH terms: Delirium; Emergence Delirium
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effect of a pre-ICU admission virtual reality
      ICU simulation on post-operative delirium in the elective cardiothoracic surgical population
      while in the intensive care unit.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with normal neurologic function scheduled for elective cardiothoracic surgery.
Nutrition Education for Cardiovascular Disease Prevention in Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Cardiovascular Diseases; Wounds and Injuries
Study type: Interventional

Summary: 
      This is a randomized controlled trial to study a nutrition education intervention in
      individuals with spinal cord injuries both in the acute rehabilitation setting (n = 100) and
      the community setting (n = 100). Participants in the treatment group will receive six
      interactive nutrition lectures based upon a successful program that has been used in older
      adults titled "Eat Smart, Stay Well". The goals of intervention are to improve whole-grain,
      fruit and vegetable, and low-fat dairy intake and reduce fat and saturated fat intake.
      Secondary outcomes will include improvements in waist circumference of body mass index and
      some biomarkers such as cholesterol and blood sugar.
    

Detailed description: 
      The prevalence of SCI is significant. Obesity, diabetes, and CVD are more prevalent in the
      SCI population. Many individuals with SCI are unable or have a limited capacity to exercise.
      This reality makes good nutrition even more urgent. This study will be the first to test
      whether additional nutrition education can improve nutrition behavior and knowledge, diet
      quality, adiposity, and metabolic CVD risk factors in individuals with SCI and to determine
      the best setting to deliver nutrition education to individuals with SCI.
    

Intervention name(s): Control; Eat Smart, Live Better
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the control group will receive the standard nutrition lecture currently given at Carolinas Rehabilitation to all inpatients with spinal cord injuries. This one lecture is what is required by Commission on Accreditation for Rehabilitation Facilities (CARF); Intervention participants will participate in a series of six, 60-minute small group sessions of interactive nutrition education discussions led by a Registered Dietitian delivered over 3 weeks. They will also have one follow-up comprehensive nutrition education session approximately 3 months after receipt of the Eat Smart, Live Better curriculum. In order to help us assess the effectiveness of the nutrition education program, we will assess nutrition behavior and knowledge at this time as well. Community participants in the treatment group will attend the sessions at Carolinas Rehabilitation (CR). The control participants from the community will come to CR for the one standard nutrition lecture. Caregivers and spouses of all of the participants will be encouraged to attend the sessions.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pulsed Dye Laser (PDL) vs. Microsecond 1064-nm Nd:YAG Laser for Treatment of Diffuse Facial Redness
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional

Summary: 
      The primary objective of this study is to compare the efficacy of PDL and the 1064-nm Nd:YAG
      laser in the treatment of facial redness.
    


Intervention name(s): Pulse Dye Laser/YAG laser
Intervention type(s): Procedure
Intervention description(s): This study involves treatments with two types of lasers, Pulsed dye lasers (PDL) and the 1064 nm Nd: YAG. Both lasers are FDA approved to treat vascularities in the skin.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Nutritional Health for the Elderly Reference Centre Study (The NHERC Study)
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The prevalence of malnutrition among the elderly in Asia is high. The objective of this
      randomized, parallel, placebo controlled, double-blind study is to evaluate the effects of
      consuming an adult ONS plus dietary counseling (intervention group) for 180 days on
      nutritional status and unexpected hospital (re)admission, compared with a placebo supplement
      plus dietary counseling (control group).
    

Detailed description: 
      This randomized controlled trial will involve 800 elderly who are at risk of undernutrition
      (MUST score ≥ 1). Participants will be screened for eligibility. Recruitment will be at the
      polyclinic and in the inpatient ward prior to their discharge from the hospital. Participants
      will be randomized to intervention group vs. control group at the baseline visit at the
      clinical trial research unit where baseline measurements and baseline survey using the study
      specific questionnaires will be performed. Participants will be followed up prospectively at
      Day 30, Day 90, Day 180 (exit visit), and Day 360 (post-intervention follow-up visit).
      Repeated measures will be performed at the pre-defined time points. Intention-to-treat
      analysis comparing intervention group vs. control group will be performed to study the effect
      of ONS on primary composite outcome consisting of (i) change in body weight from baseline to
      Day 180 or (ii) unexpected admission to the hospital over 180-day intervention period. The
      effect of ONS on nutritional status will be examined by comparing the biochemical and
      anthropometric measurements of intervention group vs. control group at Day 180. Other
      outcomes such as changes in functional assessment, nutritional knowledge levels, and quality
      of life will also be examined. There will be a follow up visit at Day 360.
    

Intervention name(s): Oral Nutritional Supplement with AN 777; Oral Nutritional Supplement
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Oral Nutritional Supplement with AN 777, 2 servings a day; Oral Nutritional Supplement, 2 servings a day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, randomized, placebo controlled, double-blind, parallel design, multi-center study. Eligible participants will be randomly allocated to one of two groups: oral nutritional supplement with dietary counseling group or placebo supplement with dietary counseling group. Randomization will be stratified by MUST malnutrition status (medium risk or high risk) and site of recruitment. All participants, including both recently discharged patients from the hospital or elderly recruited from the polyclinics.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Exercise Intervention Combined With Metformin in the Treatment of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Background: Both exercise and metformin are used to control blood glucose levels in patients
      with type 2 diabetes mellitus (T2DM), while no previous studies have investigated the effect
      of resistance exercise combined with metformin versus aerobic exercise with metformin in T2DM
      patients. This study was conducted to compare the effects of resistance exercise combined
      with metformin versus aerobic exercise with metformin in T2DM patients.
    

Detailed description: 
      Background: Both exercise and metformin are used to control blood glucose levels in patients
      with type 2 diabetes mellitus (T2DM), while no previous studies have investigated the effect
      of resistance exercise combined with metformin versus aerobic exercise with metformin in T2DM
      patients. This study was conducted to compare the effects of resistance exercise combined
      with metformin versus aerobic exercise with metformin in T2DM patients.

      Methods: A total of fifty-seven T2DM patients with a mean age of 46.2±8.3 years were
      randomized to three study groups; each group included nineteen patients. The first group
      conducted a resistance exercise program (REP, 50-60% of 1RM, for 40-50 min) combined with
      metformin, the second group conducted an aerobic exercise program (AEP, 50-70% maxHR, for
      40-50 min) combined with metformin, and the third group received only metformin without
      exercise intervention (Met group). The study program was conducted thrice weekly for
      consecutive twelve weeks. Fasting blood glucose (FBG), glycated hemoglobin (HbA1c),
      homeostatic model assessment of insulin resistance (HOMA-IR), and maximal oxygen uptake
      (VO2max) were evaluated before and after study intervention.
    

Intervention name(s): Exercise training
Intervention type(s): Other
Intervention description(s): The first group conducted a resistance exercise program (REP, 50-60% of 1RM, for 40-50 min) combined with metformin, the second group conducted an aerobic exercise program (AEP, 50-70% maxHR, for 40-50 min) combined with metformin, and the third group received only metformin without exercise intervention (Met group). The study program was conducted thrice weekly for consecutive twelve weeks.
Other intervention name(s): Resistance and aerobic exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Resistance exercise; Aerobic exercise; Metformin; Insulin resistance
The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19)
Condition: COVID-19; Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19
      associated acute lung injury who are being cared for in a critical care environment.
    

Detailed description: 
      This is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19
      associated acute lung injury who are being cared for in a critical care environment.

      Lucinactant is a synthetic surfactant that, in its liquid form (SURFAXIN®), is approved by
      the United States Food and Drug Administration (NDA 021746) for the prevention of respiratory
      distress syndrome (RDS) in premature infants at high risk for RDS.

      It has been studied in over 2000 children and adults. Preliminary data from animal and adult
      human studies indicate that lucinactant may be able to benefit those with acute respiratory
      distress syndrome (ARDS) in the context of COVID-19 infection, improving oxygenation and lung
      compliance. When given to intubated patients, Lucinactant could potentially decrease the
      duration of ventilation.

      Lucinactant has an extensive safety profile in different patient populations for different
      indications.

      It is hypothesized that lucinactant may improve the respiratory status of patients suffering
      from COVID-19.
    

Intervention name(s): Lucinactant
Intervention type(s): Drug
Intervention description(s): Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Other intervention name(s): Sinapultide (KL4) Surfactant
Intervention MeSH terms: Pulmonary Surfactants
Intervention model: Single Group Assignment
Intervention model description: Open-label, single treatment of reconstituted Lucinactant, delivered as an intratracheal liquid.
Masking: None (Open Label)
Primary purpose: Treatment
Oral Polypodium Leucotomos for Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional

Summary: 
      Primary Objective: To determine whether there is improvement in the melasma of participants
      taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium
      Leucotomos is well tolerated in study subjects with melasma.

      To determine whether treatment with Polypodium Leucotomos improves the health-related quality
      of life.
    

Detailed description: 
      Polypodium Leucotomos is a fern, also known as Calaguala used by the natives of northern
      Honduras as a treatment against malignant tumors Used in Spain and Central America for the
      treatment of psoriasis, atopic dermatitis and repigmentation of vitiligo.

      Oral Polypodium Leucotomos is safe and effective in patients with melasma.
    

Intervention name(s): Polypodium Leucotomos; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral capsule at 240 mg taken twice a day for 12 weeks; 240 mg Placebo taken orally twice daily created by company which manufactured active ingredient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Melasma
Visual Function, Center Point Thickness and Macular Volume After Photocoagulation
Condition: Diabetic Retinopathy; Macular Edema
MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy; Edema
Study type: Observational

Summary: 
      The purpose of this study is to correlate changes of visual function three weeks after
      photocoagulation for macular edema, with changes of center point thickness and macular
      volume.
    

Detailed description: 
      Photocoagulation for clinically significant macular edema is effective to reduce the
      incidence of moderate visual loss. Selective photocoagulation for focal macular edema
      statistically reduces macular thickening, measured with optical coherence tomography, as
      early as two weeks after treatment, without significant changes over center point thickness.
      Although anatomic improvement has been demonstrated with OCT, clinical improvement takes
      longer to be evident: the Early Treatment Diabetic Retinopathy Study describe that clinical
      differences in visual function are after the eight month, and all the treatment strategies
      for macular edema used in this study were associated with an increased rate of moderate
      visual loss, during the first six weeks. Differences in research can achieve statistical
      significance, without clinical significance. A study was conducted to identify changes of
      visual function three weeks after photocoagulation for focal macular edema, and to correlate
      them with changes of CPT and macular volume, in order to compare the behavior of anatomical
      changes with visual changes.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Target population were type 2 diabetics from Mexico City and its metropolitan area,
        accessible population were the patients who attended a General Hospital in Mexico City
      
Keywords: center point thickness; diabetic retinopathy; diabetic macular edema; macular volume; visual capacity; visual function