bioihbjkbjnl/mcl2 huggingface dataset:
Automated Folliculometry Using Five-Dimensional Ultrasound
Condition: Automated Folliculometry Using Five-Dimensional Ultrasound
Study type: Observational

Summary: 
      The aim of the study to evaluate Five-Dimensional Ultrasound in automated measurement of
      ovarian follicles with controlled ovarian stimulation in contrast to the conventional 2D
      ultrasound
    

Detailed description: 
      This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams
      University Maternity Hospital.

      72 women will be recruited from the the Fetal Care Unit who will fulfill the inclusion
      criteria. They will be counseled to be included into the study.

      All cases will be subjected to:

      full history taking including patient's age, parity,last menstrual period , past history of
      medical disorders, clinical examinations (General and abdominal).

      Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases for
      assessment of ovarian follicles after controlled ovarian stimulation by clomid 50 mg5×2×1 The
      automated software allows for automated three-dimensional follicular measurement.The software
      then analyzes the volume and automatically identifies all of the follicles in the ovary. The
      software also automatically generates several volumetric parameters of each and every
      identified follicle.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain
        Shams University Maternity Hospital.

        67 women will be recruited from the the Fetal Care Unit who will fulfill the inclusion
        criteria. They will be counseled to be included into the study.
Effect of Dehydroepiandrosterone (DHEA) on Hot Flashes in Postmenopausal Women
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to evaluate the effect of daily oral intake of DHEA 50 mg for 4
      months on reducing vasomotor symptoms (hot flashes) compared to placebo administration in
      postmenopausal women.
    

Detailed description: 
      Humans, along with the other primates, are unique among animal species in having adrenals
      that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (DHEA)
      and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the
      adrenals during aging results in a dramatic fall in the formation of androgens and estrogens
      in peripheral target tissues, a situation that has been proposed to be associated with
      age-related diseases including skin atrophy, insulin resistance and obesity. Much attention
      has been given to the benefits of DHEA administered to postmenopausal women, especially on
      the bone, skin, vagina and well being after oral as well as percutaneous administration of
      the precursor steroid.

      This study proposes to study the effect of 50 mg oral DHEA capsules during a period of 4
      months administered to postmenopausal women experiencing 50 or more moderate to severe hot
      flushes per week. Participants will be stratified by the number of hot flushes experienced
      per week. The two strata are: 50-70 or more than 70 hot flushes per week. During the study
      several biological and clinical parameters will be evaluated, as well as the reduction of the
      number of hot flashes and improvement of overall quality of life.

      Subjects will be evaluated at specific time intervals during the study for the above
      mentioned parameters as well as tolerability and adverse reactions.
    

Intervention name(s): Placebos; DHEA capsule
Intervention type(s): Drug; Drug
Intervention description(s): Placebo capsule; One capsule of DHEA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hot Flashes; Menopause; Quality of Life; Hot flushes
Cultural Adaptation, Validity, and Reliability of the Turkish Version of North Star Ambulatory Assessment
Condition: Duchenne Muscular Dystrophy; Ambulation Difficulty; Ambulation Disorder, Neurologic
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Nervous System Diseases; Gait Disorders, Neurologic; Mobility Limitation
Study type: Observational

Summary: 
      The aim of this study is to translate the "North Star Ambulatory Assessment (NSAA)" scale
      into Turkish and make its cultural adaptation and to demonstrate the reliability and validity
      of the Turkish version in patients with ambulatory DMD. For the translation into Turkish,
      validity and reliability of the NSAA, necessary permission was obtained from the developer of
      the questionnaire, Prof. Dr. Francesco Muntoni, via e-mail. In the study, first of all, the
      translation and cultural adaptation process will be completed, and then reliability-validity
      studies will be carried out.
    


Intervention name(s): North Star Ambulatory Assessment
Intervention type(s): Diagnostic Test
Intervention description(s): North Star Ambulatory Assessment is an ambulatory assessment developed specifically for Duchenne Muscular Dystrophy.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population include just ambulatory patients with Duchenne Muscular Dystrophy
      
Keywords: Duchenne Muscular Dystrophy; Ambulation; reliability; validity
Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters)
      [formerly known as Omacor] combined with simvastatin for lowering non-high-density
      lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite
      statin therapy.

      Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.
    

Detailed description: 
      Two studies comprise this OM6 Program. Study OM6 / LOV111858 (double-blind study) and is not
      required to post results based on FDAAA. Study OM6X / LOV111818 (open-label extension) is
      posted on NCT00903409.
    

Intervention name(s): Simvastatin; Simvastatin + Lovaza
Intervention type(s): Drug; Drug
Intervention description(s): Simvastatin; Simvastatin + Lovaza (omega-3-acid ethyl esters)
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: omega-3-acid ethyl esters; simvastatin; Lovaza; High triglycerides
Speckle Tracking in Pediatric Patients
Condition: Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Observational

Summary: 
      An echocardiogram, also called a cardiac ultrasound or echo, is a medical test that takes
      pictures of the heart using sound waves. It shows images of the structures of the heart
      without using radiation. During the last year, the FDA has approved a new technology called
      Speckle Tracking that can look at the heart wall motion and contraction (pumping or
      squeezing) abnormalities. The study will also employ tissue Doppler and 3-Dimensional echo
      and uses the same echocardiographic machines which are used right now. The machines are
      upgraded with the new software application. This new technology is currently being used in
      adults, but unfortunately, there is almost no published data about normal heart function in
      infants and children using this technology. It is known from other technologies that the
      developing child's heart is not the same as an adult.

      The investigators wish to study this new technology and compare it to other technologies
      currently being used.
    

Detailed description: 
      This study will be done primarily by software analysis.

      The investigators wish to enroll a total of 70 patients aged newborn to 17 years old. The
      patients will be divided into three groups: (1) 0-2 years (2) 2-10 years (3) 10-17 years of
      age. 59 of the patients will be normal volunteers - siblings of patients receiving routine
      echoes or siblings of patient caregivers at Children's Healthcare of Atlanta. The
      investigators will age-match those patients with twenty patients with known or suspected
      heart muscle dysfunction (not working properly) already scheduled for a routine echo. For the
      patients scheduled for a routine echo, the patient and parent/guardian will be approached
      prior to the routine echo being performed. If they consent/assent, it will take an additional
      10-15 minutes to obtain the research images after their routine images have been obtained.
      The healthy volunteers will be screened from the siblings of the patients receiving a routine
      echo or from siblings of patient caregivers, the study explained and informed consent/assent
      obtained. It will take approximately 30 minutes to obtain the research images.

      By studying this new technology, the investigators will be able to find out whether it will
      be able to give us useful information on how the heart muscle contracts, the coordination of
      these contractions and if it may indicate new areas for treatment.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Newborn - 17 year old patients at Children's Healthcare of Atlanta Egleston campus with
        known or suspected heart muscle dysfunction already scheduled for a routine echo. Also
        looking at normal controls.
      
Keywords: congenital cardiac disorders; echocardiography
Integrated Care and Lower Extremity Strength Training Among Community-Dwelling Frail Older Adults in Taiwan
Condition: Frailty
MeSH terms: Frailty
Study type: Interventional

Summary: 
      Objective: To determine the differential effectiveness of integrated care (IC) and lower
      extremity strength training (LEST) among community-dwelling frail older adults in Taiwan.

      Method: The investigators randomize participants at Bei-Hu site from the "Intervention study
      of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial"
      into 12 weeks of either IC or LEST. Outcome assessments are performed at baseline, 12 weeks
      and 6 months after initiation of the interventions.

      Interventions:

        1. IC: Participants visit the study site with health education, social activities, warm up,
           stretch, and low intensity resistance exercise for about 1 hour per week. If any medical
           problems or functional decline suspected during the visit, the case manager refers
           participants to their primary care physicians for further managements.

        2. LEST: Participants receive 2 sessions of 30-minute lower extremity strength straining
           using isotonic strength training machines each week. The intensity is set at 60-80% of 1
           repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks
           for individualized adjustments
    


Intervention name(s): integrated care; lower extremity strength training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants visit the study site with health education, social activities, warm up, stretch, and low intensity resistance exercise for about 1 hour per week. If any medical problems or functional decline suspected during the visit, the case manager refers participants to their primary care physicians for further managements.; Participants receive 2 sessions of 30-minute lower extremity strength straining using isotonic strength training machines each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: frailty; exercise; intervention
Dyslipaemia, Atherosclerosis Risk and Increased hsCRP and Inflammatory and Oxidative Status in the Spanish Population. Database Analysis of Previous Studies Performed in Spain
Condition: Dyslipaemia; Atherosclerosis Risk; Increased hsCRP; Inflammatory and Oxidative Status in the Spanish Population
MeSH terms: Atherosclerosis
Study type: Observational

Summary: 
      The present project is aimed at determining the prevalence of LDL-C <130 mg/dl with hsCRP
      ≥2mg/l, and of HDL-C < 40 mg/dl in Spain together with the estimation of cardiovascular risk,
      to analyze the contribution of measuring hsCRP for primary prevention purposes. In a subgroup
      of that population a number of inflammatory and oxidative status biomarkers would be also
      measured to better understand the meaning of elevated hsCRP.The study aim to analyze data
      already collected in studies (11 studies will participate) carried out in Spain, in 10
      Spanish regions, after the year 2000.
    


Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Data from epidemiological studies performed after the year 2000 with patients between 35
        and 74 years old
      
Biospecimen description: 
      No samples will be obtained, but biomarkers will be analysed from frozen serum samples
      retained by the pervious studies performed.
    
Keywords: Dyslipaemia; atherosclerosis risk; increased hsCRP; inflammatory and oxidative status in the Spanish population
Dose Optimisation Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis Taking Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical trial is to establish what dose level and dosing frequency is
      optimal in the treatment of rheumatoid arthritis patients with ART621.
    

Detailed description: 
      Despite being effective in approximately 60% of subjects, there are limitations to existing
      anti-TNF therapies especially in relation to immunogenicity, safety and administration. In
      addition, due to their high molecular weight, currently marketed products are largely
      confined to the blood stream.

      ART621 is an anti-TNF molecule that contains 2 identical domain "antibodies" that have the
      binding activity of a full antibody but with a substantially smaller molecular size. The
      molecular weight of approximately half that of full size antibodies is predicted to, a) have
      improved tissue penetration and, b) to be less immunogenic than full size antibodies.

      This clinical trial is designed to establish the optimal dose level and dose frequency of
      ART621 in the treatment of patients with rheumatoid arthritis and to obtain data relating to
      the safety, immunogenicity and pharmacokinetics of ART621 when administered with an
      intravenous loading dose followed by subcutaneous administration every week compared to every
      fortnight.
    

Intervention name(s): ART621; ART621; ART621; ART621; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 3.0mg/kg s.c. - weekly; 3.0mg/kg s.c. - fortnightly; 1.5mg/kg s.c. - weekly; 1.5mg/kg s.c. - fortnightly; Placebo s.c. - weekly; Placebo s.c. - fortnightly
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to investigate the effect of multiple oral daily doses
      of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with
      ritonavir.
    


Intervention name(s): Darunavir; Ritonavir; BI 201335
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400 mg tablet for oral administration; tablet for oral administration
Intervention MeSH terms: Ritonavir; Darunavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Diode Laser on Post-operative Pain After Endodontic Treatment in Teeth With Apical Periodontitis
Condition: Apical Periodontitis; Postoperative Pain
MeSH terms: Periodontitis; Periapical Periodontitis; Pain, Postoperative
Study type: Interventional

Summary: 
      Aim: This study aims to assess the effect of root canal disinfection with a 980 µm diode
      laser following chemomechanical root canal preparation on the severity of pain after root
      canal treatment (RCT).

      Materials and Methods: In present study, asymptomatic, single-rooted teeth with periapical
      index (PAI) score 3 or 4 were included. All patients were treated with two visits of root
      canal treatment including dressing with calcium hydroxide. Patients were randomly divided
      into two groups (n: 28). 'Control (no laser)': The final irrigation was performed using 5ml
      2.5% NaOCI, followed by 5 ml 17% EDTA and 5 ml distilled water. 'Laser Disinfection (LD)':
      Root canals were irradiated with 980 µm diode laser after final irrigation at both visits.
      The pain levels were evaluated using visual analog scale (VAS) after 8, 24, 48 hours and 7
      days. In addition, analgesic intake and time intervals were recorded by patients. The
      collected data were statistically analyzed with the Chi-square and Mann-Whitney U test
      (p<0.05).
    


Intervention name(s): Medency Primo Diode Laser Device (Medency, Vicenza, Italy); 2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),
Intervention type(s): Device; Procedure
Intervention description(s): Root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle.; Final conventional irrigation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diode laser; irrigation; post-operative pain; root canal treatment; visual analog scale
Study to Assess the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of AZD3043
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single centre, open label study to assess the safety, tolerability,
      pharmacokinetics (PK) and pharmacodynamics of intravenous AZD3043 after single ascending
      doses in healthy male volunteers.
    


Intervention name(s): AZD3043
Intervention type(s): Drug
Intervention description(s): intravenous solution given once as intravenous infusion over 30 minutes
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sedation; Anaesthesia; Safety; tolerability; pharmacokinetics; pharmacodynamics; healthy male volunteers
Prediction of the Collapse of Necrotic Femoral Head Using Computed Tomography Scan and X-ray Before Hip Arthroplasty
Condition: Hip Arthropathy
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      To verify that CT scan and X-ray can predict the collapse of the necrotic femoral head before
      hip arthroplasty and effectively guide the surgical management.
    

Detailed description: 
      Osteonecrosis of the femoral head (ONFH) is a common and frequently occurring disease. The
      main clinical manifestations are hip pain and dysfunction. The etiology and pathogenesis of
      ONFH caused by various reasons are the problems that have not been solved yet in the field of
      orthopedics. If want to achieve satisfactory therapeutic effect, surgical choice is
      essential. It is very important for prognosis to master the indications of operation and take
      appropriate treatment measures, especially the great difference between palliative surgery
      and hip arthroplasty.

      To determine whether the femoral head collapses and the degree of collapse of the articular
      cartilage of the femoral head can help physicians to select an optimal surgical plan. Chinese
      scholars commonly believe that if the femoral head collapse is less than 2 mm, investigators
      can choose autologous bone graft, allogeneic bone graft and other palliative surgery. If the
      femoral head collapse is more than 2 mm, investigators can choose total hip arthroplasty.
      However, above standard has not been extensively accepted worldwide.
    

Intervention name(s): X-ray; CT; specimen
Intervention type(s): Radiation; Radiation; Other
Intervention description(s): In the X-ray group, the changes in femoral head height were measured with X-ray in an anteroposterior position of the pelvis (healthy and affected sides of the hip) at preoperative 1 week; In the CT group, changes of femoral head height were measured with CT scan on bilateral hips (healthy side and affected side) at preoperative 1 week; In the specimen group, femoral head on the affected side was resected during surgery and directly measured with a ruler and vernier caliper.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic