bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Silver Spike Point Therapy on Pelvic Girdle Pain PAIN
Condition: Pelvic Girdle Pain
MeSH terms: Pelvic Girdle Pain
Study type: Interventional

Summary: 
      The aim of this study is to determine the effects of Silver Spike Point Therapy (SSPT)
      therapy on pelvic girdle pain and functional activities in pregnancy.The finding of this
      study will help to establish the role of SSPT therapy to relieve pelvic girdle pain in
      pregnant females along with exercises. SSP for pelvic girdle pain management can prove to be
      a useful method. The findings of this study can play a role to establish more rigorous
      treatment plans for pelvic girdle pain in the pregnant population in the future.
    

Detailed description: 
      This study will be a randomized clinical trial that will investigate the effectiveness of
      silver spike point therapy and manual therapy in subjects with pregnancy-related pelvic
      girdle pain. Subjects with pregnancy-related pelvic girdle pain meeting the predetermined
      inclusion & exclusion criteria will be divided into two groups using the lottery method.
      Pre-assessment will be done using NPRS and PGPQ as subjective measurements and PSFS as
      objective measurements. Subjects in one group will be treated with silver spike point therapy
      and manual therapy, the other will be treated with manual therapy only. Each subject will
      receive 10 treatment sessions, with 05 treatment sessions per week. Post-treatment reading
      for NPRS, PGPQ, and PSFS will be recorded after the end of the 10th treatment session.
      Recorded values will be analyzed for any significant difference between pre and
      post-treatment values SPSS 21.
    

Intervention name(s): Silver Spike Point Therapy (SSPT); Conservative Managment
Intervention type(s): Device; Other
Intervention description(s): Silver Spike Point Therapy (SSPT) means passing an electric current through the skin surface with the triangle spike silver coated metal electrode. SSPT was reported by Hyoto and Kitade in Edinburg, Scotland. 3rd World Congress on Pain in 1981; It has a number of advantages over traditional narcotic medication in pelvic girdle pain management. It does not depress the cardiovascular, respiratory, or the metabolic systems and has no apparent effect on the sensorium; 2 sets of 10 repetitions Bridging, Cat & cow exercises, Back press exercises, stretching of hip external rotators and extensors 20 sec / stretch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pelvic girdle pain
Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Body Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being carried out to see if dapagliflozin in addition to metformin decreases
      body weight and if so, how it compares with metformin alone.
    


Intervention name(s): Dapagliflozin; Metformin; Sitagliptin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet oral 10 mg total daily dose once daily 102 weeks; Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks; Tablet oral 100 mg total daily dose once daily rescue medication; Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dapagliflozin; Metformin; Type 2 diabetes; body weight
Genetic Polymorphisms of Mannan-binding Lectin (MBL)and Serum Levels of MBL in Patients With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The purpose of the study is to investigate the possible association between low levels of MBL
      and the development of endometriosis
    

Detailed description: 
      Endometriosis is a chronic, inflammatory disease, affecting approximately 10% of the female
      population. The pathogenesis of endometriosis is still unclear, but several studies have
      indicated that the immune system is involved. It has been suggested that endometriosis should
      be considered an autoimmune disease, considering the findings of elevated levels of
      cytokines, decreased cell apoptosis, increased incidence of autoantibodies and a higher
      frequency of other autoimmune diseases in endometriosis patients. MBL participates in the
      innate immune defence by activating complement on the surfaces of microorganisms, but several
      studies have suggested that MBL is also involved in autoimmune diseases. The individual MBL
      level is highly variable due to a number of polymorphic sites in the structural gene and in
      the promoter region, and approximately 12 % of the normal population have very low serum MBL
      levels (<100 ng/ml).

      The possible association between MBL and endometriosis has been investigated in two small
      studies, in which no association was found. The aim of the present study is to investigate
      the prevalence of individuals with low serum levels of MBL and with genotypes associated with
      low MBL production in a larger group of endometriosis patients.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Endometriosis patients referred to the endometriosis clinic at Aarhus University Hospital
      
Biospecimen description: 
      Serum, EDTA blood
    
Keywords: endometriosis; mannan-binding lectin; immunology
A Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711
Condition: NSCLC
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomised, single-dose, cross-over phase I study to evaluate the
      effect of food on the pharmacokinetic profile of BPI-7711 in Chinese healthy male subjects.
    


Intervention name(s): BPI-7711
Intervention type(s): Drug
Intervention description(s): BPI-7711 180 mg
Other intervention name(s): BPI-7711 capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Exploration for Pharmacodynamics and Pharmacokinetics of YH4808 New Formulation in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of
      YH4808 New Formulation in healthy volunteers.
    


Intervention name(s): YH4808 NF 100; YH4808 OF 200; YH4808 NF 200; YH4808 NF 400
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The number of times : multiple-dose Rout : oral administration; The number of times : multiple-dose Rout : oral administration; The number of times : multiple-dose Rout : oral administration; The number of times : multiple-dose Rout : oral administration
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Community-Based Diabetes Care for Korean American Immigrants
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The primary aims are to test the effectiveness of the self-help DM intervention (SHIP-DM), a
      comprehensive, culturally tailored DM management intervention, in improving glucose outcomes;
      To determine the effectiveness of the SHIP-DM in KAI with type 2 DM in improving self-care
      skills and psycho-behavioral outcomes related to DM control, to develop tangible
      infrastructures for the dissemination of valid and effective education materials to a wider
      population of KAI with type 2 DM in the US (e.g., audio-visual education materials, web-based
      intervention materials, mobile telephone-based intervention materials) and to explore the
      feasibility and acceptability of each dissemination module, utilizing the delayed
      intervention group participants. The secondary aims are to obtain preliminary
      cost-effectiveness data related to the proposed intervention, including cost estimates for
      this type of DM intervention, and to establish a systematic, long-term dissemination plan,
      including documenting effective methodologies, to facilitate faster translation of research
      findings and products to direct consumers in non-research settings.
    

Detailed description: 
      Inclusion Criteria

        1. Self-identified as a first generation Korean American

        2. Type 2 diabetes

        3. Age 30-75 years

        4. Resides in Washington-Baltimore area

        5. Self-identified with DM and HbA1c >= 7.0 % within 6 months of screening

        6. Expresses willingness to participate in all aspects of the study over its full course

      Exclusion criteria

        1. Unable to give informed consent

        2. Physical or mental health conditions that could limit active participation in the study
           (e.g., blindness in both eyes, severe immobility, psychiatric diseases)

        3. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell
           anemia

        4. Past experience in diabetes group education
    

Intervention name(s): culturally tailored diabetes education
Intervention type(s): Behavioral
Intervention description(s): lifestyle modification group education
Other intervention name(s): lifestyle modification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Korean American, type 2 diabetes, culturally tailored
Evaluation of Visual Performance of Two Types of Cosmetic Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a single visit, brand-masked, non-dispensing, 2×2 bilateral crossover study. Each
      subject will be bilaterally fitted with one of the two test articles in each of the study
      periods in a random order with a 5-minute washout period in between study lenses.
    


Intervention name(s): etafilcon A with cosmetic pattern; 1-Day Acuvue DEFINE Vivid Style
Intervention type(s): Device; Device
Intervention description(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Prevalence Of Hyperhomocysteinemia In Thai Chronic Kidney Disease (CKD) Patients
Condition: Cardiovascular Disease; Hyperhomocysteinemia
MeSH terms: Cardiovascular Diseases; Hyperhomocysteinemia
Study type: Observational

Summary: 
      It is well recognized that patients with chronic kidney disease (CKD) have an increased risk
      for cardiovascular disease (CVD) and hyperhomocysteinemia appears to be a predictor of future
      CVD events. Hyperhomocysteinemia has been reported to bo of high prevalence in patients with
      CKD. The investigators aim to study the prevalence of hyperhomocysteinemia in Thai CKD
      patients by using Thai Screening and Early Evaluation of Kidney Disease (SEEK) study database
      and their relationship to CVD.
    

Detailed description: 
      Ninety eight subjects were sampling from Thai SEEK study database Traditional Traditional
      risk factors of CVD such as total cholesterol, triglyceride, age, sex, history of smoking and
      blood pressure levels were examined and recorded. Stored sera of these subjects were analyzed
      for the total homocysteine (tHcy) level. Analysis of variance was used to evaluate the
      different of mean tHcy among groups
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Ninety eight subjects from CKD stages 3-4 were randomly sampling from Thai- SEEK study
        database. Thai-SEEK study is a community-based cross-sectional survey that was conducted
        between August 2007-june 2008 in four regions of Thailand (i.e Northern, Northeastern,
        Central and Southern) and Bangkok (Metropolitan).
      
Biospecimen description: 
      serum
    
Keywords: Hyperhomocysteinemia; Chronic kidney disease
Pilates Mat Versus Cervical Stabilization Exercises on Myoelectric Activity of Cervical Muscles in Forward Head Posture
Condition: Musculoskeletal Diseases
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      see if there is no statistical significant difference between the effects of Pilates mat
      versus cervical stabilization exercises on myoelectric activity of cervical muscles in young
      adults with forward head posture.
    

Detailed description: 
      Forward head posture (FHP) increases extension of the atlanto-occipital joint and the upper
      cervical vertebrae as well as flexion of the lower cervical and upper thoracic vertebrae.
      Furthermore, this posture causes persistent and abnormal contraction of the suboccipital,
      neck, and shoulder muscles. Additionally, the muscles around the head and shoulders,
      including the trapezius, sternocleidomastoid, suboccipital, and temporal, are affected by
      FHP, which further worsens postural deformity. FHP is the most common deviation from ideal
      head posture and is characterized by the head projecting forward into the sagittal plane such
      that it is anterior to the trunk. Head in forward posture can add up to thirty pounds of
      abnormal leverage on the cervical spine, which pull the entire spine out of alignment, in
      addition, loss of the physiological lordosis could be a possible cause of pain due to
      muscular imbalance.
    

Intervention name(s): Pilates mat exercises; cervical stabilization exercises; conventional physiotherapy
Intervention type(s): Other; Other; Other
Intervention description(s): Pilates mat exercises: Each Pilates session will last for one hour and commence with a 10 minute warm up and finish with a 10 min cool down. The subjects will be taught the 5 key elements of Pilates (lateral costal breathing, centring which is a neutral position of the lumbar spine with activation of the core muscles, ribcage placement, shoulder blade placement and neutral position of the cervical spine with slight upper cervical flexion at the cranio-cervical junction).
Pilates exercise program will consist of warm up exercises, main treatment program (10 level) and cooling down exercises.; training of deep cervical flexor muscles with pressure biofeedback unit, 20 min/day, 3 days/week for 12 weeks.; 10 min hot pack on cervical area range of motion exercises and isometric neck exercises as a home program 3 days/week for 12 weeks
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Forward head posture; Craniovertebral angle; Pilates mat exercises
Management of Atrial Fibrillation With Flecainide : the AFFLEC Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      This is a multicentre non interventional observational study with the objective to follow up
      patients with atrial fibrillation who based on current indications are treated with per os
      flecainide , for cardiac pulse maintenance.
    

Detailed description: 
      the study objectives are

        -  record safety and efficiency of flecainide as antiarrythmic treatment in atrial
           fibrillation

        -  study of flecainide in ST interval
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with history of atrial fibrillation who are under treatment with per os flecainide
A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study designed to evaluate the efficacy and safety of lurasidone in acutely
      psychotic patients with chronic schizophrenia and to confirm the non-inferiority of
      lurasidone relative to quetiapine XR.
    


Intervention name(s): Lurasidone HCL 160 mg; Quetiapine XR 600 mg
Intervention type(s): Drug; Drug
Intervention description(s): Lurasidone HCL 2 80mg tablets, QD; Quetiapine XR 2 300 mg tablets, QD
Intervention MeSH terms: Quetiapine Fumarate; Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Acutely Psychotic Patients with Schizophrenia; Latuda; Lurasidone
Safety Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis
Condition: Silicosis
MeSH terms: Silicosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study was to analyze the safety, pulmonary function, and imaging changes of
      patients with silicosis treated with autologous bone marrow stromal cells with modification
      by hepatocyte growth factor.
    


Intervention name(s): Cells
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Lateral Cephalometric and Cone Beam CT Measurements in Mandibular Symphysis
Condition: Measurements in Mandibular Symphysis
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare the linear and angular measurements of the
      mandibular symphyseal region using lateral cephalometric (LC) and cone beam computed
      tomography (CBCT) images. The main question it aims to answer are:

      Is there a significant difference in measurements on lateral cephalometric and cone beam CT?
      Measurements were made by 3 radiologists, and the intra-class correlation coefficient (ICC)
      was used to measure interobserver reliability.
    

Detailed description: 
      The aim of the study is to compare the linear and angular measurements of the mandibular
      symphyseal region using lateral cephalometric (LC) and cone beam computed tomography (CBCT)
      images. One hundred patients justifying both LC and CBCT exposures were included. Both
      lateral cephalometric and CBCT images of the patients were used for angular and linear
      measurements. Angular measurements included vestibular-concavity, lingual- and
      tooth-inclination angles. Vestibular and lingual cortical bone and total bone thickness
      measurements were obtained for the comparison of linear measurements. Three radiologists
      performed the measurements on 200 images. Comparison of the measurements and the imaging
      methods were done using paired- and Wilcoxon t-tests. Inter-observer reliability was
      evaluated with the intra-class correlation coefficient (ICC).
    

Intervention name(s): LC images; CBCT images
Intervention type(s): Radiation; Radiation
Intervention description(s): Angular and Linear Measurements were compared in mandibular symphysis region using the LC images; Angular and Linear Measurements were compared in mandibular symphysis region using the CBCT images
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: mandibular symphysis; lateral cephalometry; cone beam CT
Biological Significance of the Bloom's Syndrome Protein
Condition: Bloom Syndrome
MeSH terms: Bloom Syndrome; Syndrome
Study type: Observational

Summary: 
      Since 1960, persons with the very rare disorder Bloom's syndrome (BS) have been followed
      clinically, documenting clinical matters as obtained from their doctors. This has been a
      worldwide search for cases, though a few in the New York City area are seen (personally, by
      us) perhaps once every 2-3 years. BS is a rare genetically-determined disorder described in
      NYC in 1954. The clinical courses of the 169 persons diagnosed BS by 1991 are followed in a
      program referred to as the Bloom's Syndrome Registry. BS is the prototype of the
      "chromosome-breakage syndromes." BS cells mutate at a greater rate than any other, and the
      consequence is the greatest known predisposition to cancers of the types that affect the
      general human population. We are defining the clinical syndrome and at the same time are
      studying cells from affected families in the experimental laboratory. BS is a model for
      learning about cancer. Our contact with families lets us know of cancers arising, but blood,
      and sometimes tiny biopsies of skin, is taken if available so that (a) the chromosomes can be
      studied and (b) the gene mutations can be defined in molecular terms.
    

Detailed description: 
      Although an occasional person with BS will be admitted to the hospital for special study
      (endocrine evaluation mainly)--two in the last 25 years--the Registry does not develop a
      doctor/patient relationship with affected persons. They have their own doctors. We gather
      information about the affected persons and publish reports. We also publish reports of
      experiments carried out in the research laboratory using BS cells. Because we are a central
      repository for information on BS, families or their physicians find contact with us
      beneficial, and we provide them with information requested. Sometimes pregnancies at risk
      occur, and we have on occasion made cytogenic (chromosome) analysis of cultured cells of
      amniotic fluid (the cultures being initiated elsewhere and sent to us for cytogenetic study).

      Although the accessioning of new cases to the Registry was closed in 1991, 4-5 new patients
      are referred to us each year, and their clinical courses also are being followed. To date,
      the 169 officially registered and 36 additional cases are under our surveillance.
    

Observational model: Defined Population
Time perspective: Other
Keywords: Bloom syndrome protein