bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      This study was aimed to compare the effect of Schroth therapy method, which is a
      3-dimensional scoliosis exercise method, and traditional exercises on pain, body awareness
      and quality of life in young individuals with idiopathic scoliosis.
    

Detailed description: 
      38 individuals aged between 10-18 with the diagnosis of idiopathic scoliosis will be
      participated in the study. Individuals (study group) underwent 1 hour exercise program 3
      times a week for 6 weeks, and the individuals (control group) undervent a traditional
      exercise program once a week under supervision of physiotherapist for 6 weeks. During the
      rest of the week, same exercise program was given as a home program for at least half an hour
      a day and individuals will followed up. Individuals' subjective pain intensity will be
      assessed with Visual Analogue Scale (VAS), pressure pain threshold by algometer, body
      awareness by Turkish version of Body Awareness Questionnaire and quality of life by Turkish
      version of Scoliosis Research Society (SRS)-22 scale. Measurements will be performed before
      and after the 6-week exercise program.
    

Intervention name(s): exercise programme 1; exercise programme 2
Intervention type(s): Other; Other
Intervention description(s): Schroth three dimensional scoliosis therapy method; Traditional scoliosis exercises
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schroth; idiopathic scoliosis; pain; quality of life; body awareness
Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Observational

Summary: 
      Confocal laser endomicroscopy enables in vivo microscopic imaging within the mucosa layer of
      the gut at a subcellular resolution. Various studies have addressed the potential of
      endomicroscopy for the in vivo diagnosis of esophageal squamous cell carcinoma, Barrett´s
      esophagus and esophageal adenocarcinoma. Currently, there is only one case report from our
      group who noted the utility of endomicroscopy for the in vivo diagnosis of eosinophilic
      esophagitis.

      The purpose of this study is to determine whether endomicroscopy is effective for the in vivo
      diagnosis of eosinophilic esophagitis.
    


Intervention name(s): Confocal laser endomicroscopy
Intervention type(s): Device
Intervention description(s): Confocal laser endomicroscopy
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with eosinophilic esophagitis who underwent EGD for the evaluation of their
        symptoms.

        Control patients who underwent EGD because of other reasons.
Cheek Cells - Non-invasive Fatty Acid Status Marker
Condition: Healthy
Study type: Interventional

Summary: 
      Various biological materials have been investigated to determine dietary fatty acid intakes,
      such as plasma, erythrocytes, and adipose tissue. The applied techniques are invasive
      sampling methods and may have limitations in studies involving infants or young children. In
      1985 the group of McMurchie suggested buccal cheek cells as a marker for dietary fatty acid
      intake; however fatty acid profiling in cheek cells has not been widely used yet.

      In a clinical intervention trial a new method will be tested. The study will consist of two
      consecutive parts: A) a correlation study will investigate the relationship between
      established fatty acid markers (red blood cells (RBC), plasma) and the newly proposed markers
      (cheek cells) before and after intervention B) an intervention study will investigate the
      time depended implementation and steady state of docosahexaenoic acid DHA in plasma, RBC and
      cheek cells.

      The participants will receive 520 mg DHA daily over a period of 30 days. Blood and cheek cell
      samples will be collected once prior to study commencement and regularly during intervention.

      The proposed study aims at verifying cheek cell analysis results as a non-invasive marker for
      fatty acid profiling. This will be shown by correlation analyses of fatty acids in cheek
      cells, erythrocytes and plasma phospholipids. Furthermore, the time kinetics of DHA
      incorporation into cheek cells will clarify if cheek cell fatty acids can be considered as a
      short or long term marker.

      The new non-invasive method is expected to be extremely valuable as a non-invasive approach
      for studying the fatty acid profile in human, including infants and young children.
      Therefore, it is of great interest to validate the new method in a clinical trial.
    


Intervention name(s): DHA (docosahexaenoic acid)
Intervention type(s): Dietary Supplement
Intervention description(s): 1 x 950 mg capsules per day orally, each capsule providing ~520 mg of DHA as a triglyceride. The liquid fill contains DHASCO® oil, derived from the microalgae, Schizochytrium sp., high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitate, and rosemary extract (flavouring). The gelatin shell contains glycerin, water, and colouring (carmel, carmine, turmeric).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cheek cells; phospholipids; fatty acids; docosahexaenoic acid; Buccal Cheek cells; non invasive fatty acid status marker
Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV , randomized, single-blind, single-center study comparing patient related
      outcomes such as postoperative pain and opioid usage for patients who receive ISB 's
      containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine
      HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid
      utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5%
      bupivacaine HCL during the initial 72 --- hour post --- operative period. Additionally, to
      understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene
      block after TSA.
    


Intervention name(s): Liposomal Bupivacaine; 0.5% Bupivacaine HCL
Intervention type(s): Drug; Drug
Intervention description(s): Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL; 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
Other intervention name(s): Exparel
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total Shoulder Arthroplasty (TSA); Interscalene Nerve Block (ISB)
Preeclampsia-like Syndrome Induced by COVID-19: Is it a Real Public Health Issue in Pregnancy During the Pandemic?
Condition: Covid-19; Preeclampsia; Pregnancy Related
MeSH terms: COVID-19; Pre-Eclampsia
Study type: Observational [Patient Registry]

Summary: 
      By applying polymerase chain reaction (PCR) test for Covid-19 to preeclampsia patients who
      applied to our hospital during the Covid-19 pandemic period, we investigated the frequency of
      Covid-19 related preeclampsia-like syndrome in this patient group.
    

Detailed description: 
      The investigators studied the frequency of Covid-19 related preeclampsia-like syndrome by PCR
      test and lung ultrasound for Covid-19 to preeclampsia patients presenting to the instutution
      during the Covid-19 pandemic period. The first consecutive 100 preeclampsia patients
      presented to our hospital during the pandemic will be involved in our study. The primary
      outcome measure is to detect Covid-19 positivity among the preeclamptic pregnant women..
    

Intervention name(s): PCR, lung ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): PCR for Covid-19
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        First consecutive 100 preeclamptic pregnant women applied to our hospital during covid-19
        pandemic
      
Keywords: covıd-19; pregnancy; preeclampsia; preeclampsia-like syndrome
Safety, Tolerance, Efficacy and Pharmacokinetics of JS005 Multiple Dosing
Condition: Moderate to Severe Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      JS005-002 is a randomized, double-blinded, placebo-controlled phase Ib/II clinical study to
      evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of multiple doses of
      JS005 (recombinant humanized anti-IL-17A monoclonal antibody) Injection in patients with
      moderate to severe psoriasis.
    

Detailed description: 
      This study includes a total of two parts, the first part is a double-blinded,
      placebo-controlled, multi-dose escalation study to evaluate the safety, preliminary efficacy
      and pharmacokinetic profiles after multiple doses in patients with moderate to severe
      psoriasis; the second part is a randomized, double-blinded, controlled study, with proposed
      high-, middle- and low-dose groups and placebo group based on the clinical effective dose
      determined in the first part, to evaluate the efficacy and safety of multiple doses of test
      drug in patients with moderate to severe psoriasis.

      Part I of study (phase Ib):

      A total of 4 dose groups are pre-specified in Part I of this study, i.e., 60 mg, 150 mg, 300
      mg and 600 mg; multiple doses will be administered subcutaneously on abdomen. A total of 40
      patients are planned to be enrolled, including 6 and 2 patients receiving test drug and
      placebo in 60 mg and 600 mg dose groups, respectively, 9 and 3 patients receiving test drug
      and placebo in the other two dose groups, respectively. Each patient can receive multiple
      doses at only one dose level.

      Part II of study (phase II):

      Based on the safety data of phase Ib study and the efficacy analysis of ER modeling, 300mg
      and 150mg of the test drug will be selected. A multi-center, double-blind, placebo-controlled
      phase II study was conducted. The patients will be radomized in a 1:1:1 ratio to receive
      300mg, 150mg doses of the study drug or placebo. A total of 126 patients will be enrolled in
      phase II study, with 42 patients in each group. 300mg, 150mg doses of the study drug or
      placebo will be administered abdominal subcutaneously with multiple dosing. Each patient can
      receive multiple doses at only one dose level.
    

Intervention name(s): JS005 (recombinant humanized monoclonal antibody against IL-17A); JS005 placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous injection; Subcutaneous injection
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Correlation of Several Formulas to Evaluate Insulin Sensitivity With the Predicted M Index
Condition: Healthy Lifestyle
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Observational

Summary: 
      Recently, an index based on the oral insulin sensitivity index with glucose (OGIS) has been
      proposed in combination with anthropometric variables, called PREDIcted M (PREDIM), however,
      there is no evidence of the correlation of this with respect to the various indices (McAuley,
      Belfiore, Cederholm, Avignon, Matsuda, Gutt, Stumvoll, HOMA-IR (Homeostatic Model Assessment
      for Insulin Resistance), ISI (Insulin Sensitivity Index), Raynaud, QUICKI (The quantitative
      insulin sensitivity check index), FIRI (Fasting Insulin Resistance Index), Bennett, TyG
      (triglycerides and glucose index)) in healthy patients.
    

Detailed description: 
      Analytical cross-sectional study with 25 healthy patients of both genders (male and female)
      from 30 to 60 years old, residents of the metropolitan area of Guadalajara.

      They will be operated on for a 3-hour oral glucose tolerance test. The insulin sensitivity
      will be calculated with the PREDIM, Matsuda, McAuley, Belfiore, Cederholm, Avignon, Gutt,
      Stumvoll, HOMA-IR, ISI, Raynaud, QUICKI, FIRI, Bennett and TyG indexes.

      This protocol is already approved by the local ethics committee and written informed consent
      it's going to be obtained from all volunteers.

      The statistical analysis will be presented with measures of central tendency and dispersion,
      mean and standard deviation. The nominal variables in numbers and percentages. The
      Kolmogorov-Smirnov test will be performed to determine if the variables follow a normal
      distribution. To correlate the formulas used to evaluate the insulin sensitivity with the
      PREDIcted M (PREDIM) technique, the Pearson or Spearman correlation will be used according to
      the distribution.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients of both sexes who are not sedentary or who participate in heavy physical
        activities and residents of the metropolitan area of Guadalajara.
      
Keywords: Insulin sensitivity; PREDIM; Correlation; Healthy individuals
Vitality Acupunch Exercise Program for Older Adults With Sarcopenia
Condition: Muscle Mass; Muscle Strength; Sleep Quality
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      This project was aimed to test the effects of a six-month VA program on the muscle mass,
      muscle strength, and quality of sleep of institutional older adults with sarcopenia.
    

Detailed description: 
      A cluster-randomized controlled trial was conducted to test the effects of a six-month VA
      program on the muscle mass, muscle strength, and quality of sleep of institutional older
      adults with sarcopenia. Using convenience sampling, 12 long-term care facilities with 114
      older adults were recruited, and then cluster-randomized by the facility to a VA experimental
      or a control group. The experimental group received the VA program led by certified
      instructors 3 times per week and 40 minutes per session for 6 months; the control group
      continued with their regular daily activities. One pre-test and two post-tests, 3 months
      apart, were conducted.
    

Intervention name(s): Vitality acupunch (VA) exercise program; Control
Intervention type(s): Other; Other
Intervention description(s): The VA had 3 phases and took 40 minutes to complete.; Participants maintained their daily activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Effect of Pioglitazone on Ambulatory Blood Pressure
Condition: Hypertension; Diabetes Mellitus Type 2
MeSH terms: Hypertension; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The anti-diabetic pioglitazone has been found to reduce casual blood pressure. To date, no
      data are available looking at this effect in detail. Especially, ambulatory blood pressure
      has not yet been utilized to confirm the hypothesis that pioglitazone has blood pressure
      lowering effects.
    


Intervention name(s): Pioglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 45 mg 8 weeks; Placebo
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypertension
IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the
      effects of food and ketoconazole on the plasma pharmacokinetics of IPI-145.
    


Intervention name(s): IPI-145; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm; ketoconazole drug interaction study; Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Corneal Endothelium Evaluation After Phacoemulsification in Diabetec and Non-diabetic Patients With Pseudoexfoliation
Condition: Pseudoexfoliation
Study type: Interventional

Summary: 
      Our study is a comparative study, that was conducted to evaluate the corneal endothelial
      cells changes and central corneal thickness after uncomplicated phacoemulsification and intra
      ocular lens (IOL) implantation in normal controls, in non-diabetic and diabetic patients with
      PEX, and in patients with PEX only using specular microscopy.
    

Detailed description: 
      Our study is a comparative study that included 4 groups (controls, patients with PEX,
      non-diabetic patients with PEX, diabetic patients with PEX) to evaluate the corneal
      endothelial cells changes and central corneal thickness after uncomplicated
      phacoemulsification and intra ocular lens (IOL) implantation using specular microscopy, over
      a 6 months follow up period.
    

Intervention name(s): phacoemulsification of the lens
Intervention type(s): Procedure
Intervention description(s): all patients underwent phacoemulsification and IOL implantation for immature cataract extraction
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: DM; phacoemulsification; endothelial cell density
Joint Infection Following ACL Reconstruction
Condition: Joint Infection
MeSH terms: Infections; Communicable Diseases; Arthritis, Infectious
Study type: Observational

Summary: 
      This study was conducted to analyze the effect of joint infection on the bone tunnel, graft
      and articular cartilage following arthroscopic single-bundle anterior cruciate ligament (ACL)
      reconstruction with autologous hamstring, to summarize the features of MR findings after
      joint infection, and to correlate these findings with their possible factors.
    

Detailed description: 
      A retrospective matched cohort study was performed in 26 patients who underwent arthroscopic
      single-bundle ACL reconstruction with hamstring graft and developed postoperative joint
      infection in our institute from January 2002 to December 2017. They were matched 1:3 to
      patients who did not sustain joint infection after ACL reconstruction. MR scan was collected
      at the time of follow-up. Bone tunnel enlargement at tunnel aperture, midsection and exit of
      tibial and femoral tunnel was carefully assessed. Graft signal-to-noise quotient (SNQ) on MRI
      was calculated to evaluate graft maturity. Cartilage morphology was graded using Whole Organ
      Magnetic Resonance Imaging Score. A generalized linear mixed model was applied to analyze the
      effect of joint infection on the bone tunnel, graft and articular cartilage.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study population were from 20549 arthroscopic ACL reconstruction surgeries in our
        institute between January 2002 to December 2017.
Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults
Condition: Mildly Hypercholesterolemic Subjects
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effect of consumption of a low-fat, no
      added sugar, dairy fermented product enriched with plant sterols and policosanols at two
      doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of
      product consumption versus active control product.
    


Intervention name(s): 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit; 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit; 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)
Intervention type(s): Other; Other; Other
Intervention description(s): 1- Intervention with test product ( 1.6g of plant sterol + 10 mg of policosanols/ day); 2- Intervention with test product (1.6g of plant sterol + 20 mg of policosanols/day); 3- Intervention with active control product (1,6 g of plant sterol/ day)
Intervention MeSH terms: Policosanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Plant sterol - Policosanols - Hypercholesterolemia - Dairy
Dose Range Evaluation of Norovirus Challenge Pool (GII.4, CIN-1)
Condition: Norovirus Infections
MeSH terms: Caliciviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine a suitable dose of the human norovirus GII.4
      challenge pool(CIN-1;031693) that induces illness in approximately 50% of susceptible
      subjects that would be useful for evaluation of vaccines and antivirals.
    


Intervention name(s): Norovirus challenge pool (GII.4, CIN-1)
Intervention type(s): Biological
Intervention description(s): Norovirus challenge pool (GII.4, CIN-1)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Norovirus