bioihbjkbjnl/mcl2 huggingface dataset:
Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Tibolone 1.25 mg is an effective treatment for the prevention of osteoporosis and is expected
      to be effective in preventing fractures in osteoporotic women. Tibolone could be more
      acceptable for long-term use, in particular since it does not induce a regular withdrawal
      bleed.

      The objective of this trial is to compare placebo and tibolone, a steroid with tissue
      specific activity, in the prevention of spinal fractures in women meeting the WHO criteria
      for osteoporosis or who have asymptomatic vertebral fractures.
    


Intervention name(s): Tibolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.25 mg p.o, once daily for 3 years; Tablet p.o, once daily for 3 years
Other intervention name(s): OD-14
Intervention MeSH terms: Tibolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm
Condition: Cancer of the Thyroid; Neoplasms, Thyroid; Thyroid Adenoma; Thyroid Cancer; Thyroid Carcinoma
MeSH terms: Neoplasms; Thyroid Neoplasms; Adenoma; Thyroid Diseases
Study type: Observational

Summary: 
      This protocol will evaluate microRNA biomarkers in blood and fine-needle aspirate biopsies
      (FNAB) of thyroid nodules. MicroRNA profiles will be determined and evaluated for their
      utility in pre-operative diagnosis, in particular to distinguish benign from malignant throid
      neoplasms. Post-surgical fresh-frozen thyroid cancer tissue will be assessed for somatic
      mutations, mRNA, and microRNA expression patterns. FFPE tissue will be used to obtain H&E and
      unstained slides to specific biomarker results using immunohistochemistry.
    

Detailed description: 
      This protocol requires the collection of blood (5 ml), fine-needle aspirate biopsies (FNAB),
      and post-surgical thyroid cancer tissue. The post surgical tissue includes fresh-frozen
      tissue that is considered waste and in excess of that required for pathologic diagnosis, and
      archived formalin-fixed, paraffin-embedded tissue (FFPE). The blood will be used as a
      substrate for assessing known markers, including microRNA expression patterns that may be
      useful to predict disease and thyroid cancer morphotype. The FNABs will be used to screen the
      potential of markers for pre-operative diagnosis. The post-surgical fresh-frozen thyroid
      cancer tissue will be used to isolate DNA and RNA in order to assess somatic mutations (RAS
      and PAX8/PPAR-gamma rearrangement) and messenger RNA, and microRNA expression patterns. The
      FFPE tissue will be used to obtain H&E and unstained slides to validate results using
      immunohistochemistry. The goal of these studies is to define molecular markers that will
      accurately distinguish benign from malignant disease and the multiple thyroid cancer
      phenotypes. Current methods of distinguishing benign from malignant disease requires a
      detailed post-surgical analysis and no known markers have yet been identified to reliably
      differentiate the multiple thyroid cancer morphotypes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All individuals undergoing fine needle biopsy for diagnosis of thyroid cancer, who provide
        written consent to enter the study.
      
Biospecimen description: 
      Blood, RNA/DNA from fine needle aspirate biopsies of thyroid nodules, fresh frozen surgical
      tissue, formalin fixed paraffin embedded tissue.
    
Keywords: thyroid cancer; thyroid neoplasm; thyroid adenoma
The Effects of Peer-led Walking Intervention With mHealth Technology
Condition: mHealth Intervention
Study type: Interventional

Summary: 
      This study will apply the peer-led walking intervention with mHealth technology to maintain
      physical activity and promote prenatal health. Moreover, the participants of the trained peer
      mentors support women walking with mHealth technology, which has pregnant women using the APP
      to set goals, self-monitor, and self-manage, and it will continue to promote physical
      activity for overweight and obese pregnant women
    

Detailed description: 
      This study was to investigate the effectiveness of peer-led walking intervention with mHealth
      technology on physical activity, self-efficacy, weekly steps, exercise involvement and
      depression status. Participants of the trained peer mentors encourage women walking with
      mHealth technology, which has pregnant women using the APP to set goals, self-record, and
      self-monitor, and it will continue to promote physical activity for overweight and obese
      pregnant women.This study's results will be useful to healthcare providers who need to
      promote physical exercise and an active lifestyle for overweight and obese pregnant women.
    

Intervention name(s): mhealth
Intervention type(s): Behavioral
Intervention description(s): the peer-led intervention with mHealth technology (an application (APP) and Sports bracelet)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomize control trial
Masking: None (Open Label)
Primary purpose: Supportive Care
In Vivo Study of Sucrose and Liquid Oral Pediatric Medicines of Long-term Effect on Dental Biofilm pH
Condition: Dental Biofilm pH
Study type: Interventional
Phase: Phase 2

Summary: 
      The aims of this study were to determine the sucrose and liquid oral pediatric medicines of
      long-term effect on dental biofilm pH to evaluate the cariogenic potential in vivo.
    

Detailed description: 
      Te study was carried out with 12 subjects that were refrained from brushing their teeth for
      28 h and did not eat or drink for at least 3 h prior to each appointment. Dental biofilm pH
      was measured in the cervical and proximal regions of anterior teeth with beetrode-type
      microelectrode coupled to a potentiometer. The biofilm was submitted nine paediatric
      medicines a long term and sucrose (negative control). pH measurements were taken at baseline
      to determine resting plaque pH and at time interval 5, 10, 15, 20, 25 and 30 minutes.
    

Intervention name(s): G1, G2 and G3; G4 and G5
Intervention type(s): Other; Other
Intervention description(s): Nutritional, respiratory and endocrine group applicated 12 subjects; Application of trhree pediadic medidines of antibiotic group on dental biofilm 12 subjects
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dental caries; Sucrose; Oral administration; Ion Concentration of Hydrogen; Pediatric medicines
The Study of LTBP1 of Postmenopausal Women Osteoporosis Molecular Mechanism of Kidney Yang Deficiency Syndrome
Condition: Kidney Yang Deficiency Syndrome
MeSH terms: Osteoporosis; Syndrome; Yang Deficiency
Study type: Observational

Summary: 
      Postmenopausal Osteoporosis is characterized by a decrease in bone mass as well as a
      deterioration of the bone architecture resulting in an increased risk of fracture,which is
      directly related to the lack of estrogen and also associated with a variety of genetic and
      acquired factors. Previous studies have found that POP molecular regulation mechanism of
      kidney Yang deficiency syndrome may be associated with LTBP1 gene expression.

      This topic using RT-PCR and Western Blot detection POP of kidney Yang deficiency group and
      healthy group LTBP1 mRNA and proteion's expression level,validate LTBP1 relevance to POP the
      kidney Yang deficiency syndrome.To provide a scientific basis for clinical treatment.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Female ages 45 to 75 had gone through natural menopause before two years
Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel
Condition: Subscapularis Injury
Study type: Interventional

Summary: 
      What is the difference in subscapularis strength between two different methods of
      subscapularis mobilization: incision of the tendon (tenotomy) versus peel.

      It is the investigators' hypothesis that a peel of the subscapularis will result in greater
      strength, a higher healing rate, and a greater improvement in shoulder function and quality
      of life following shoulder replacement.
    

Detailed description: 
      The primary research question is to determine the difference in subscapularis strength
      between two different methods of subscapularis mobilization in shoulder arthroplasty:
      intra-substance division of the tendon "tenotomy" versus direct detachment of the
      subscapularis tendon from its insertion on the lesser tuberosity "the peel". The primary
      outcome is strength as measured by a hand-held dynamometer in the belly-press position at
      one-year post operative. Secondary research questions include determination of the difference
      in disease specific quality of life between patients who undergo a subscapularis tenotomy
      versus subscapularis peel, as measured by the Western Ontario Osteoarthritis of the Shoulder
      Index (WOOS), Constant score and the ASES score at one year post-operatively. Finally, the
      healing rate of the subscapularis, as measured by ultrasound at 1 year post-operative will be
      determined.
    

Intervention name(s): Subscapularis Tenotomy; subscapularis peel
Intervention type(s): Procedure; Procedure
Intervention description(s): After the deltopectoral approach is completed, the subscapularis tendon will be tenotomized one centimeter medial to its insertion on the lesser tuberosity. The tendon will be tagged for later repair. Repair will take place with a combination of transosseous sutures (3) placed in a mattress configuration through the area of exposed lesser tuberosity. In addition, a soft tissue tendon to tendon repair will be carried out using figure-8 stitches using #2 (heavy) non-absorbable suture (Ticron).; The subscapularis will be elevated from the lesser tuberosity. The tendon will be tagged with stay sutures for later reattachment (3 sutures in mattress configuration). Reapproximation will take place with three non-absorbable mattress sutures placed in a trans-osseous fashion through the bicipital groove, exiting the greater tuberosity and tied over a 4-hole mini-fragment plate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Preoperative Anxiety at Oocyte Retrieval
Condition: Infertility, Female; Anesthesia Awareness; Anxiety State
MeSH terms: Infertility; Infertility, Female; Intraoperative Awareness; Anxiety Disorders
Study type: Interventional

Summary: 
      This study evaluated the effects of preoperative anxiety and dosage of anesthesia on IVF
      success. Half of participants according to the recorded Beck's Anxiety Inventory (BAI) score:
      a low-anxiety group, while the other half high-anxiety group.
    

Detailed description: 
      Anxiety is common among women hospitalized for oocyte retrieval. Infertility is usually
      accompanied by psychological and behavioral changes and can result in preoperative anxiety.
      Sometimes, preoperative anxiety can be serious. Furthermore, in the absence of premedication
      for oocyte retrieval, severe degrees of anxiety may occur. Anxiety effects the total
      consumption of analgesic and anesthetic drugs intraoperatively and has a negative impact on
      recovery from anesthesia. In addition, the negative effect of anesthetic agents used on
      fertilization and embryo quality during in vitro fertilization (IVF) has been discussed.
      However, the impact of any of them on fertilization and embryo quality has not been clearly
      determined to date. Studies have reported different results regarding the negative effects of
      anesthetic agents on embryo development and fertilization.
    

Intervention name(s): Monitoring brain function; propofol
Intervention type(s): Device; Drug
Other intervention name(s): propofol %1
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anxiety; Oocyte retrieval; Monitoring of brain function
Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the efficacy of a single dose of larazotide acetate in
      preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects
      with celiac disease
    

Detailed description: 
      This study is an extension of Study CLIN1001-006 (NCT 00492960). This is a Phase IIb,
      randomized, double-blind, placebo-controlled, dose ranging, multicenter study to determine
      the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease
      during a gluten challenge. Subjects will remain on their gluten-free diet throughout the
      duration of the trial.

      Study drug or drug placebo capsules will be administered TID 15 minutes before each meal.
      Gluten or gluten placebo capsules will be taken TID with each meal.
    

Intervention name(s): Larazotide acetate; Placebo; Gluten 900 mg
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): gelatin capsule; gelatin capsule; gelatin capsule
Other intervention name(s): AT1001; INN-202
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo-controlled, dose ranging, multicenter
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: larazotide acetate; gluten
Study to Assess the Safety and Plasma Concentration of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers
Condition: Healthy Chinese Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and plasma concentration change of YM178 after single- and
      repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.
    


Intervention name(s): YM178
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Mirabegron
Intervention MeSH terms: Mirabegron
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: YM178; Mirabegron; OCAS; Chinese Healthy Volunteers; PK; Safety
Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to demonstrate that different doses of once-weekly LY2189265 injected
      subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in
      participants with type 2 diabetes mellitus.
    

Detailed description: 
      Participants in the trial will be randomized to one of the LY2189265 doses (4 doses are
      planned, range 0.1-1.5 milligram [mg]) or placebo. The main purpose is to assess
      dose-dependent effect of this new compound on blood glucose over a period of 12 weeks.
      Therefore, glycosylated hemoglobin (HbA1c) is chosen as the primary efficacy measure. Several
      other attributes of glycemic control and endocrine function of pancreas will be assessed as
      secondary objectives. These secondary objectives will be used to compare the effect of the
      experimental compound and placebo. Since LY2189265 is in early phase of development,
      comprehensive safety assessment is planned to learn more about possible side-effects and to
      establish benefit/risk profile of individual doses of the drug. The trial is organized in
      four phases: screening, lead-in period to establish baseline status of participants in each
      group, treatment period during which participants will be randomized into 1 of 5 groups (4
      will receive one of the LY2189265 doses, 1 group will receive placebo), and safety follow up.
      Maximum of 9 study visits are planned. Study drug (LY2189265 or placebo) will be administered
      once weekly via subcutaneous (SC) injections. Rescue intervention was allowed after
      randomization for those participants whose hyperglycemia reached pre-defined unacceptable
      high values. Participants on rescue therapy remained in the study and continued to receive
      study drug. Participants who received rescue therapy were included in the analysis
      population, but only measurements obtained prior to the beginning of rescue therapy were
      included in specified efficacy analyses.

      A 3-mg LY2189265 dose was discontinued and replaced with the 1.5 mg dose based on dose
      finding Study H9X-MC-GBCF; NCT00734474. Except where noted, data summaries from the 3
      discontinued 3-mg LY2189265 participants (n=3) are not included due to the small number of
      participants and the short treatment duration.
    

Intervention name(s): LY2189265 and Lifestyle Measures; Placebo solution and Lifestyle Measures
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection once-weekly for up to 12 weeks; Subcutaneous injection once-weekly for up to 12 weeks
Other intervention name(s): Dulaglutide
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes, type 2 diabetes
Favipiravir Therapy in Adults With Mild COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Favipiravir is a selective and potent inhibitor of inﬂuenza viral RNA polymerase. It acts as
      a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It
      has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially
      novel coronavirus (2019-nCoV). The purpose of this study is to evaluate the clinical efficacy
      and safety of Favipiravir in comparison to placebo in the treatment of mild COVID-19 cases.
      It is a Multicenter, randomized double-blinded, parallel-group trial.
    


Intervention name(s): Favipiravir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily; (9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Favipiravir; COVID19; Mild illness; Saudi Arabia
A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma
Condition: Advanced Adult Hepatocellular Carcinoma; Advanced Fibrolamellar Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether once-daily dosing with ENMD-2076 will be a
      safe and effective treatment in patients with FLC. Safety will be measured by looking at the
      adverse events that may happen and the efficacy will look at the progression of the disease
      over time.
    

Detailed description: 
      Primary Objective:

      • To determine the 6-month progression free survival (PFS6) rate when patients with advanced
      fibrolamellar carcinoma (FLC) are treated with daily oral ENMD 2076

      Secondary Objectives:

        -  To evaluate the overall response rate using RECIST v 1.1 criteria when patients with FLC
           are treated with daily oral ENMD 2076.

        -  To evaluate the median Progression Free Survival (PFS), Time to Progression (TTP), and
           Overall Survival (OS).

        -  To determine the safety of ENMD-2076 as defined by the frequency and severity of adverse
           events when patients with FLC are treated with daily oral ENMD-2076
    

Intervention name(s): ENMD-2076
Intervention type(s): Drug
Intervention description(s): 250 mg oral dose, QD for 28 day cycles
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced Fibrolamellar Carcinoma
Fuzzy AI Using VR for Collision Prevention
Condition: Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to develop and test a VR training system that integrates GFT AI
      with virtual obstacle scenarios that, when compared to a sham-VR training system, is
      hypothesized to increase neuromechanical and perceptual-motor fitness, decrease collision
      frequency and impact forces for soccer athletes, during a single training session and also
      when assessed at approximately 1 week and 1 month following training.
    

Detailed description: 
      Player collisions cause over 70% of concussion injuries in contact sports, in addition to 50%
      of lower extremity injuries and 40% of catastrophic knee ligament injuries. The majority of
      these collisions are unanticipated, and associated with reduced neuromechanical and
      perceptual-motor fitness underlying an athlete's adaptability to on-field conditions. Thus,
      training collision anticipation necessitates a method that taps into neuromechanical and
      perceptual-motor fitness. Virtual reality (VR) is a tool that can target these mechanisms,
      while providing a safe, well-controlled environment for assessment and training. The current
      proposal innovates on VR with the integration of genetic fuzzy tree (GFT) artificial
      intelligence (AI) to drive scenario configuration designed to target modifiable mechanisms
      and tailored to the individual athlete's performance capabilities, for the optimization of
      behavior modification and skill transfer. The current study will examine test a GFT AI-driven
      VR collision anticipation training compared to a sham-VR training system in healthy soccer
      athletes.
    

Intervention name(s): GFT AI training
Intervention type(s): Other
Intervention description(s): navigates a cluttered environment of stationary and moving/pursuing virtual obstacles to reach a way-point as quickly and efficiently as possible. Block order and difficulty, as well as the behavior of the obstacles in each block, will be driven by the AI and statistically weighted to specifically target the perceptual-motor and neuromechanical mechanisms based on each athlete's visit 1 performance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other