bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Abdominal Wall Thickness at Possible Trocar Sites Based on Body Mass Index
Condition: Surgery
Study type: Interventional

Summary: 
      The purpose of this research study is to determine which sites are best suited for
      laparoscopic entry of bariatric trocars in the morbidly obese population.
    

Detailed description: 
      Patients already scheduled for laparoscopy will be approached for participation prior to
      surgery. During laparoscopy, the investigators routinely inject port sites with a 21-gauge
      needle and inject sites with local anesthetic prior to trocar placement. In the study the
      investigators will insert a 21-gauge 3.5inch spinal needle perpendicular to the abdominal
      wall at each possible trocar site. The seven insertion sites are the umbilicus; 12cm lateral
      to umbilicus on right; 12cm lateral to umbilicus on left; Left lower quadrant lateral to
      inferior epigastric; Right lower quadrant lateral to inferior epigastric, Lower midline of
      abdomen; Left upper quadrant at Palmer's Point. The needle will be placed after the abdomen
      is insufflated under direct visualization with the laparoscopic camera. The needle will be
      inserted to the level of the peritoneum and a hemostat will be place on the needle at the
      level of the epidermis. The abdominal wall thickness will be measured with a ruler and
      recorded to the nearest millimeter. The information will be recorded on the case report form
      attached. The case report form will be kept in a binder in the research coordinators office.
    

Intervention name(s): Laparoscopy
Intervention type(s): Procedure
Intervention description(s): Determine best port sites to insert bariatric trocars
Other intervention name(s): Trocar Insertion Sites
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Multidrug Resistance After Trabeculectomy With Mitomycin C
Condition: Glaucoma; Trabeculectomy
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      We investigate whether mitomycin C treatment during previous filtration surgery induces
      P-glycoprotein expression.
    

Detailed description: 
      Despite the adjuvant use of mitomycin C during trabeculectomy, short-term and long-term
      failures still occur. We investigate whether mitomycin C treatment during previous
      trabeculectomy induces P-glycoprotein expression. Expression of P-glycoprotein is analysed in
      surgically removed Tenon tissue using immunohistochemistry.
    

Time perspective: Other
Keywords: Glaucoma; Drug Resistance, Multiple; Trabeculectomy
A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, observer-blinded, placebo-controlled study to evaluate safety,
      tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV)
      UTTR1147A. The study will consist of a repeat dose escalation in HVs, in participants with
      UC, and in participants with CD across multiple sites.
    


Intervention name(s): Placebo; UTTR1147A
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo to UTTR1147A administered intravenously; Escalating doses of intravenously administered UTTR1147A
Other intervention name(s): efmarodocokin alfa; RO7021610; RG7880; IL-22Fc
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Physiotherapy Efficiency on Child Asthma
Condition: Child; Asthma Crisis
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The study aim is to compare usual asthma crisis treatment of hospitalized children with usual
      treatment associated to sophrology.
    


Intervention name(s): usual treatment; usual treatment + sophrology
Intervention type(s): Other; Other
Intervention description(s): usual treatment; usual treatment + sophrology
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
Condition: Meningitis; Meningococcal Infection
MeSH terms: Diphtheria; Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical trial is to describe the safety and immunogenicity of one or two
      doses of Menactra® (TetraMenD) administered in children less than 2 years of age.

      Primary Objective:

      To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when
      administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of
      one dose of Menomune® when administered to children aged 3 years to <6 years of age.
    

Detailed description: 
      This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy
      toddlers.
    

Intervention name(s): Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular (at age 9 and 12 months); 0.5 mL, Intramuscular (at age 9 and 15 months); 0.5 mL, Intramuscular (at age 12 and 15 months); 0.5 mL, Intramuscular (at age 15 months); 0.5 mL, Intramuscular (at age 18 months); 0.5 mL, Subcutaneous (at 3 years to <6 years of age)
Other intervention name(s): Menactra®; Menactra®; Menactra®; Menactra®; Menactra®; Menomune®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Infection
Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response.
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      In this project we aim to further refine indications for the use of the thyroid hormone - T3
      for patients suffering from depression. We aim to identify a sub-group of patients who are
      more likely to respond to T3 and establish the time in the treatment course when T3 should be
      added. The results of this project could have significant, direct clinical implications.
    

Detailed description: 
      The lifetime risk for major depressive disorder (MDD) is 15% in the general population.
      Current treatment approaches emphasize the achievement of remission. Remission implies
      virtual absence of depressive symptoms and is associated with better function and a better
      overall prognosis than response, which is usually defined as a 50% reduction in symptom
      severity. Sixty percent or more of patients treated optimally with antidepressants remain
      un-remitted and will need additional treatment. A potentially effective but under-exploited
      strategy to augment antidepressant effects is concurrent administration of the thyroid
      hormone, triiodothyronine (T3). We previously demonstrated the clinical efficacy and safety
      of T3 administered concurrently with the SSRI, sertraline, in the context of a randomized,
      double-blind placebo-controlled trial. Although all the patients were euthyroid, remission
      rates were significantly higher in the sertraline plus T3 group and were associated with
      significantly lower baseline T3 values and a significant decrease in serum thyroid
      stimulating hormone (TSH) values during the course of treatment.

      The study aims to:

        -  Delineate a sub-population of depressed patients treated with sertraline, who are more
           likely to respond to T3 augmentation on the basis of thyroid function and genetic
           variation in thyroid pathway genes.

        -  Investigate the appropriate timing for the addition of T3.

        -  Assess the efficacy of reboxetine, a specific noradrenaline reuptake inhibitor, as a
           further supplement to the treatment of un-remitted patients. The results of this study
           could have a significant, direct clinical impact on the pharmacological treatment of
           MDD.
    

Intervention name(s): sertraline; triiodothyronine (T3); reboxetine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Sertraline; Reboxetine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major depressive disorder; Antidepressants; Triiodothyronine (T3); Thyroid Function; Augmentation; Thyroid pathway genes
Combined Metformin and Clomiphene Citrate (CC) or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome; Hyperthermia
Study type: Interventional

Summary: 
      The purpose of this study is to compare and determine the efficacy of combined metformin and
      Clomiphene citrate administration to that of laparoscopic ovarian diathermy (LOD) in
      infertile women with Polycystic ovary syndrome (PCOS) not responding to treatment with
      Clomiphene alone.
    

Detailed description: 
      All patients in the combined metformin-CC group received metformin HCl (Cidophage®;Chemical
      Industries Development,Cairo, Egypt), 500 mg thrice daily for 6-8 weeks. Then after the end
      of this period, they received 100 mg CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt)
      for 5 days starting from day 3 of menstruation (increased by 50 mg in the next cycle in case
      of anovulation ). Patients continued treatment for up to six cycles. Metformin was stopped
      only when pregnancy was documented. All patients in the control group underwent laparoscopic
      ovarian diathermy, then followed up for 6 months.
    

Intervention name(s): metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt); Laparoscopic ovarian diathermy (LOD)
Intervention type(s): Drug; Procedure
Intervention description(s): metformin HCl 1500 daily for 6-8 weeks then 100 mg CC for 5 days starting from day 3 of menstruation up to 6 cycles.; Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome; clomiphene resistance; metformin; laparoscopic ovarian diathermy
The Effect of Acute Phase Treatment Approaches on Creatine Kinase and the Musculoskeletal System in Different Types of Burns
Condition: Burn Injury
MeSH terms: Burns
Study type: Observational

Summary: 
      There are very few studies indicating the effect of acute phase treatment approaches on
      creatine kinase and the musculoskeletal system in the physiotherapy and rehabilitation
      process. Rehabilitation in burn patients is a benchmark due to return to pre-burn life.
      Therefore, this study was conducted to determine the effect of acute phase treatment
      approaches on creatine kinase and the musculoskeletal system in different types of burns.
    

Detailed description: 
      In the literature, there are very few objective and quantitative studies comparing the
      effects of standard wound care and rehabilitation period on different burn types in burn
      patients. Thus, our study was designed to investigate the effects of acute phase treatment
      approaches on creatine kinase and the musculoskeletal system in different types of burns.
    

Intervention name(s): universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase)
Intervention type(s): Other
Intervention description(s): The joint range of motion within the affected areas of burn patients was assessed by a universal goniometer. A 7-mm-wide tape measure was used to evaluate circumference measurement in individuals. The biochemical analysis of CK (creatine kinase) was performed by an expert on blood samples taken from patients in the hospital laboratories.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 37 individuals, including 10 females and 27 males
      
Keywords: Acute-phase burn; Creatine Kinase, MM Form,; Musculoskeletal Development; Treatment Effectiveness
Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life
Condition: Breast Cancer; Quality of Life
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The aim of this study was to investigate the quality of life (QoL) for women with breast
      cancer in Taiwan after using the BCSMS App.
    

Detailed description: 
      After receiving their first diagnosis of breast cancer, women with stage 0 to III were
      randomized into intervention and control groups. Intervention group subjects used BCSMS App
      and the control group subjects received usual care. Two questionnaires: EORTC QLQ-C30 and
      EORTC QLQ-BR 23 were distributed to subjects in both arms at baseline and at 1.5 and 3
      months. All evaluations were anonymous.
    

Intervention name(s): BCSMS App
Intervention type(s): Other
Intervention description(s): Breast Cancer Using a Self-Management Support mHealth Application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: breast cancer; m-Health application; self-management; life of quality
Impact of Physiological, Lifestyle and Genetic Factors on Body Composition
Condition: Body Composition, Beneficial
Study type: Observational

Summary: 
      Research has shown that body composition is a key component of health and future disease
      risk. Being overweight and obese is associated with a higher body fat composition, and a
      greater risk of developing type II diabetes and heart disease. The location where fat is
      stored in the body is becoming increasingly recognised an important predictor of risk, with
      extra fat around the abdomen and waist (referred to as the android pattern of fat
      distribution or 'apple' shape) thought to increase your disease risk than storing fat around
      the thighs and buttocks (gynoid pattern of fat distribution or 'pear' shape). As a result,
      there is significant interest in techniques to accurately monitor and detect changes in body
      composition, and also physiological and lifestyle factors which influence body fat, lean
      tissue mass and bone mineral density. This cross sectional human study will look at how
      physiological, behavioural and genetic factors relate to total body composition in 1,196
      healthy men and women aged between 18 and 70 years. Interested applicants will be invited to
      attend for a single visit at the Hugh Sinclair Unit of Human Nutrition at the University of
      Reading. This visit lasts around two hours and includes noninvasive measures of body
      composition (bio-electrical impedance and dual energy x-ray absorptiometry), arterial
      stiffness and fasting measures of metabolic health. Diet and physical activity will then be
      monitored over a four day period using diet and activity diaries, and an activity monitor.
      The findings from this study will contribute to the evidence base on how subject
      characteristics influence body composition and inform on the design of future human studies
      on body composition methodology.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Men and women living in and around Reading, Berkshire, United Kingdom
      
Biospecimen description: 
      A fasting blood sample will be taken at the end of the study visit for the measurement of
      fasting lipids (total and high density lipoprotein-cholesterol, triacylglycerol and
      non-esterified fatty acids), glucose, insulin, C-reactive protein and for vitamin D status.

      The buffy coat (consisting of white blood cells) will be isolated from the blood sample for
      genotyping analysis.
    
Keywords: Body fat distribution; Bone mineral density; Dual-energy x-ray absorptiometry
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the safety and tolerability of AZD2516
      following administration of a single dose.
    


Intervention name(s): AZD2516; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution administered once orally; Solution administered only once
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Multiple dosing study,; safety
Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients
Condition: Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients
MeSH terms: COVID-19; Disease
Study type: Observational

Summary: 
      This research will provide data on thermal condition of medical workers who use personal
      protective equipment from biological hazards. Aquired data will be used to define acceptable
      period of use for these protective costumes.

      This research will recruit 6 volunteers. During 6 hours each subject will perform their work
      using protective costume. Heart rate, skin and air temperature under costume and hygrometric
      data will be registered. Also there will be questionnaires for volunteers for subjective
      assessment of thermal and moisture sensations.
    


Intervention name(s): Personal protective equipment from biological hazard
Intervention type(s): Other
Intervention description(s): Includes: isolation clothing, mask, eyewear, overshoes
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Health workers
      
Keywords: Thermophysiology; Personal protective equipment from biological hazards; Medical workers; COVID-19
Evaluation of PK of AC1204 v Caprylic Triglyceride Oil Incl Food Effect on Ketone Body Production
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare serum ketone body (i.e., total ketones and β-hydroxybutyrate) levels after
      administration of AC-1204 versus caprylic triglyceride (CT) oil, both after a standard
      breakfast.

      To evaluate the effect of a high fat diet on serum ketone body levels after administration of
      CT oil with a high fat breakfast versus a standard breakfast.
    


Intervention name(s): AC-1204; caprylic triglyceride oil (standard breakfast); caprylic triglyceride oil (high fat breakfast)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40 g (120 mL) AC-1204 administered 30 minutes after the start of a standard breakfast.; 20 g CT oil (21 mL) administered 30 minutes after the start of a standard breakfast.; 20 g CT oil (21 mL) administered 30 minutes after the start of a high fat breakfast.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy volunteers; Caprylic triglyceride oil; AC-1204; Pharmacokinetic; Ketone body
A Comparitive Bioavailability Study of Metformin Hydrochloride Liquid 500mg/ 5 mL Under Fasting Conditions and After Low and High Fat Meal
Condition: Healthy
Study type: Interventional

Summary: 
      To assess the food effect on pharmacokinetic profile of metformin liquid 100 mg/mL of Ranbaxy
      Laboratories in healthy, adult, human subjecis following a dose administration of 10 mL (1000
      mg) under fasting conditions, after a Iow fat meal and after a high fat meal
    

Detailed description: 
      This study was an open label, randomized, three-treatment, three-period, six-sequence,
      single-dose, crossover pharmacokinetic study planned on 36 healthy, adult, human subjects
      under fasting conditions. However 34 subjects were enrolled and 33 subjects completed all the
      periods of the study. All periods were separated by a washout of seven days As per protocol
      (Appendix 1), enough healthy, adult, human subjects were to be enrolled in the study to allow
      the dosing of 36 subjects in the first period. 34 subjects were enrolled and 33 subjects
      completed all the periods of study
    

Intervention name(s): Metformin solution 100 mg/mL
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioavailability Metformin solution 100 mg/mL
Small Airways Disease in Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness (AHR)
Condition: Asthma; Airway Hyperresponsiveness
MeSH terms: Respiratory Hypersensitivity
Study type: Observational

Summary: 
      The purpose of this study is to study differences in small airways (<2mm) parameters in
      asthma patients, subjects with asymptomatic airway hyperresponsiveness and healthy controls.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Out-patient clinic
      
Biospecimen description: 
      Nasal epithelium brushes for mRNA expression
    
Keywords: asthma; airway hyperresponsiveness; asymptomatic airway hyperresponsiveness; small airways