bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride
      Tablets 1 × 45 mg and Actos® Tablets 1 × 45 mg of Takeda Pharmaceuticals America, Inc. Dosing
      periods of studies were separated by a washout period of 12 days and 11 days respectively.

      Study Design:

      Randomized, Two-Way Crossover, Single-Dose, and Open-Label
    


Intervention name(s): Torrent's Pioglitazone
Intervention type(s): Drug
Intervention MeSH terms: Pioglitazone
A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate the long-term safety and tolerability of
      TV-46000. The primary safety and tolerability endpoint is the frequency of all adverse
      events, including serious adverse events. For new participants, the total duration of
      participant participation in the study is planned to be up to 80 weeks (including a screening
      period of up to 4 weeks, a 12-week oral conversion/stabilization stage [Stage 1], a 56-week
      double-blind maintenance stage [Stage 2], and a follow-up period [8 weeks]). For roll-over
      participants, the total duration of participant participation in the study is planned to be
      up to 64 weeks (including up to 56 weeks in the maintenance stage [Stage 2] and a follow-up
      period [8 weeks]). Participants who started Stage 2 who relapse or meet 1 or more of the
      withdrawal criteria should be invited to perform the Early Termination visit as soon as
      possible within 4 weeks of the last injection. Participants who withdraw from the study
      before completing the 56-week maintenance stage will have follow-up procedures and
      assessments performed at their follow-up visits. During the follow-up period, participants
      will be treated according to the investigator's judgment.

      All participants will be treated with active drug.
    


Intervention name(s): TV-46000; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TV-46000 will be administered per dose and schedule specified in the arm description.; Placebo matching to TV-46000 will be administered per schedule specified in the arm description.
Other intervention name(s): Risperidone
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections
Condition: Skin and Soft Tissue Infections
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections
Study type: Interventional

Summary: 
      Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h)
      administration provides non-inferior clinical efficacy and microbiological efficacy to
      standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in
      an outpatient setting.
    


Intervention name(s): vancomycin; vancomycin
Intervention type(s): Drug; Drug
Intervention description(s): vancomycin 30 mg/kg intravenous administered once daily; vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)
Intervention MeSH terms: Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: outpatient; skin and soft tissue infections; vancomycin intravenous
Improving Bone Health in Adolescent Girls: The Youth Osteoporosis and Understanding Total Health (YOUTH) Study
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Osteoporosis affects nearly half of all American women over age 50. During the teenage years,
      girls can increase bone growth to decrease their risk of osteoporosis later in life. This
      study will test whether girls can change their food intake and physical activity patterns in
      ways that will increase their bone growth during the mid-teen years.
    

Detailed description: 
      Osteoporosis-related fractures incur an annual cost in the United States of more than $8
      billion. Peak bone mass is achieved in the late teens and early 20s. An important component
      of a lifelong osteoporosis prevention strategy is to maximize bone mineral content during the
      teen years and establish lifestyle patterns that will help maintain bone mineral content
      through menopause. This trial will test the efficacy of a comprehensive lifestyle
      intervention to build bone and prevent bone loss among adolescent women 14 to 16 years of
      age.

      Participants in this study will be randomized to either an intervention group or an attention
      control group. The intervention program includes a physical activity component involving high
      impact and spinal motion activities and a diet component rich in fruits, vegetables, and
      calcium. Participants will take part in group and individual meetings and activities and
      receive coaching telephone calls. Participants will be assessed at study entry and two annual
      follow-up visits. Primary outcome measures include objective measures (serum folate and
      carotenoids urinary sodium, lean body mass, accelerometer measure of physical activity) and
      self-reports.
    

Intervention name(s): Diet with increased fruits, vegetables, and calcium; Increased high impact activity and resistance training
Intervention type(s): Behavioral; Behavioral
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Intraoperative Nociception Control Based on Analgesia Nociception Index (ANI) Monitoring on Stress Response During Total Laparoscopic Hysterectomy
Condition: Patients Undergoing Total Laparoscopic Hysterectomy
Study type: Interventional

Summary: 
      The "Analgesia Nociception Index" (ANI; MetroDoloris Medical Systems, Lille, France), derived
      from an electrocardiogram (ECG) trace, has been proposed as a noninvasive guide to analgesia.
      The ANI monitor calculates HR variation with respiration, a response mediated primarily by
      changes in the parasympathetic nervous system (PNS) stimulation to the sinoatrial node of the
      heart. The aim of this study is to determine the relation between ANI monitor values and
      serum catecholamine levels. We will compare the serum catecholamine (norepinephrine,
      epinephrine) levels of conventional nociception control group and ANI-monitor guided
      nociception control group at the end of surgery.
    


Intervention name(s): conventional nociception control; ANI monitor guided nociception control
Intervention type(s): Device; Device
Intervention description(s): While Intraoperative opioid will be administered by conventional clinical practice in control arm.; The intraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50 in ANI-monitor guided nociception control arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Effect of Mannitol on Optic Nerve Sheath Diameter in Patients Undergoing Robotic Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      We aim to evaluate the change in optic nerve sheath diameters as a surrogate of intracranial
      pressure before and after mannitol administration in patients who undergo robot assisted
      laparoscopic radical prostatectomy with pneumoperitoneum and Trendelenburg position.
    

Detailed description: 
      Mannitol has been frequently used for renal protection during surgery. Optic nerve sheath
      diameter is used to evaluate intracranial pressure noninvasively. Robot-assisted laparoscopic
      radical prostatectomy can induce an increase in optic nerve sheath diameter due to
      Trendelenburg position and carbon dioxide insufflation. We therefore aim to evaluate the
      change in optic nerve sheath diameters before and after mannitol administration in patients
      who undergo robot assisted laparoscopic radical prostatectomy.
    

Intervention name(s): Mannitol
Intervention type(s): Drug
Intervention description(s): The mannitol has been administered routinely to prevent renal dysfunction in patients undergoing robot-assisted laparoscopic radical prostatectomy. Participants will receive the mannitol as part of routine medical care, and we will evaluate the change in optic nerve sheath diameters before and after mannitol administration.
Other intervention name(s): Osmotic diuretic
Intervention MeSH terms: Mannitol; Diuretics
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Prostate cancer patients who undergo Robot-assisted laparoscopic radical prostatectomy.
Does Implant Design Improve Postoperative Flexion?
Condition: Non-inflammatory Arthritis
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      This study will evaluate whether design features of one implant design allows more knee bend
      than the other. Patients will have 1 design in the left knee and 1 design in their right
      knee. Both knee surgeries will be on the same day.
    

Detailed description: 
      The primary objective of this study is to determine whether the passive, non-weight-bearing
      flexion is superior with the posterior-stabilized PFC® Sigma™ RP-F compared to the
      posterior-stabilized PFC® Sigma™ RP in bilateral Subjects receiving both implants and if this
      difference is a function of implant design.
    

Intervention name(s): Total knee replacement using the PFC Sigma RPF knee implant.; Total knee replacement using the PFC Sigma RP knee implant
Intervention type(s): Device; Device
Intervention description(s): Total knee replacement; Total knee replacement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Knee Replacement; Flexion; Range of Motion; Activities of Daily Living; Implant design; Subject Satisfaction; Non-inflammatory arthritis
A Study to Evaluate the Relative Bioavailability of Formulations of CKD-510 and to Assess the Effect of Food on the CKD-510 Tablet Formulation in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the relative bioavailability of CKD-510 tablet
      formulation compared with CKD-510 capsule formulation, and to characterize the effect of food
      on the CKD-510 tablet.
    


Intervention name(s): CKD-510 capsule (reference); CKD-510 tablet (test); CKD-510 tablet (test)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single-dose of CKD-510 will be administered as oral capsule in a fasted state.; Single-dose of CKD-510 will be administered as oral tablet in a fasted state.; Single-dose of CKD-510 will be administered as oral tablet in a fed state.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Backpack Load and Spine Muscles Activity
Condition: Child
Study type: Interventional

Summary: 
      The purpose of the present study is to analyze the influence of four backpack loading
      conditions (0, 10, 15 and 20% of body weight) on the electromyographic activity of the neck
      and lumbar muscles of elementary school children.
    

Detailed description: 
      Elementary school children participated in the present study, between the ages of 6 and 10.
      Bilateral sternocleidomastoid, rectus abdominis and erector spinae muscles activity were
      recorded using surface electromyography (sEMG), while tested for the effect of four
      randomized backpack loading conditions.
    

Intervention name(s): loading conditions
Intervention type(s): Other
Intervention description(s): Different backpack loading conditions 0%, 10%, 15% and 20% allocated randomly
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Surface electromyography; children; backpack
Performance of Wearers of Stenfilcon A Contact Lenses After A Refit With Test Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control
      contact lenses can be refit into test lenses and be successful after one week of daily wear.
    

Detailed description: 
      This study is a prospective, multi-center, open label, bilateral, daily wear, one week
      dispensing study comparing performance of wearers of stenfilcon A control contact lenses
      after refit with test contact lenses.
    

Intervention name(s): Test lens; control lens
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Other intervention name(s): stenfilcon A Test lens; stenfilcon A Control lens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gemcitabine in Combination With Cisplatin as Neoadjuvant NSCLC Chemotherapy
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the clinical response rate of neoadjuvant chemotherapy with gemcitabine and
      cisplatin in patients with operable NSCLC
    


Intervention name(s): gemcitabine; Cisplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Enhancing Inpatient Psychotherapeutic Treatment With Online Self-help : Acceptance and Efficacy
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to determine the acceptance and efficacy of the online self-help
      program deprexis® for depressed patients in reducing the clinical symptoms of their
      depression. The patients of the experimental group use deprexis® for 90 days, the patients of
      the placebo group receive weekly online information about depression for 90 days as well.
      Both groups receive their treatment in addition to their regular inpatient psychosomatic
      treatment and as an aftercare intervention.The investigators hypothesize that the online
      self-help group achieves a greater reduction of depression compared to the control group.
    


Intervention name(s): deprexis®; Information
Intervention type(s): Other; Other
Intervention description(s): Online self-help program in addition to inpatient psychosomatic treatment for 90 days.; The patients receive online information about depression once a week for 90 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test the efficacy, safety and tolerability of XBD173 in the treatment of
      generalized anxiety disorder in patients.
    


Intervention name(s): XBD173
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GAD; Anxiety; XBD173; Generalized Anxiety Disorder
Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Condition: Systemic Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in
      patients with pJIA.
    


Intervention name(s): MRA(Tocilizumab)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Dry Needling on Muscle Mechanical Properties and Muscle Contractility in Latent Trigger Points
Condition: Trigger Point Pain, Myofascial
MeSH terms: Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether application of Dry Needling (DN) is
      effective for improved Muscle Mechanical Properties and Muscle Contractility in Latent
      Trigger Points point (LTrP) of upper trapezius. Randomized controlled trial, in parallel with
      cross-control design. Two groups with LTrP in upper trapezius, and will be randomly selected
      to DN group or Sham-Dn group.
    


Intervention name(s): Intervention-Dry Needling; Control-Dry Needling
Intervention type(s): Device; Device
Intervention description(s): Deep Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle.
1 session in upper trapezius muscle moving the needle up and down ten times.; Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Latent trigger point; Dry needling; Myotonometer; Tensiomyography
Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome; Shock Wave
MeSH terms: Carpal Tunnel Syndrome; Syndrome; Shock
Study type: Interventional
Phase: Phase 4

Summary: 
      This RCT is to investigate the clinical effect of extracorporeal shock wave therapy (ESWT)
      compared to the local corticosteroid injection (LCI) in managing mild to moderate carpal
      tunnel syndrome (CTS).
    

Detailed description: 
      To investigate the effect of extracorporeal shock wave therapy (ESWT) compared to the local
      corticosteroid injection (LCI) in managing mild to moderate carpal tunnel syndrome (CTS).
      About 50-60 patients with mild to moderate CTS are supposed to be randomly allocated into
      either ESWT group or LCI group. The outcomes include the visual analog scale (VAS), the
      Boston Carpal Tunnel Questionnaire (BCTQ), and nerve conduction study at baseline and at 3
      weeks, 9 weeks, 12 weeks, 6 months, and 12 months after the treatments.
    

Intervention name(s): Extracorporeal shock wave
Intervention type(s): Device
Intervention description(s): Participants received 3 ESWT sessions once per week for 3 consecutive weeks or a single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve.
Other intervention name(s): Local corticosteroid injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation
Condition: Shoulder Dislocation
MeSH terms: Joint Dislocations; Shoulder Dislocation
Study type: Interventional

Summary: 
      To compare the results and efficacy of the self-assisted Boss-Holzach-Matter maneuver for
      anterior shoulder dislocation and the Spaso method performed by a physician.
    

Detailed description: 
      Introduction: There are many described maneuvers in literature describing how to reduce an
      anterior shoulder dislocation. Most of these maneuvers are performed by a trained physician,
      however, seldom are these taught to patients in case of recurrence or accidental dislocations
      that may occur far from a trained professional to treat. The Boss-Holzach-Matter maneuver is
      a simple, easy to understand and easy to perform self assisted method that has not been
      compared to any other method.

      Hypothesis: The Boss-Holzach-Matter method is a less painful maneuver compared to the Spaso
      method assuming an equal success rate.

      Objective: To determine whether the Boss-Holzach-Matter method is a less painful method for
      anterior shoulder dislocations compares to the Spaso method assuming equal success rate.

      Methodology: Fifty six patients presenting acute anterior shoulder dislocation will be
      randomized, at the time of the admission , to either Spaso reduction method performed by a
      physician or the self-assisted Boss-Holzach-Matter method.
    

Intervention name(s): Boss-Holzach-Matter method; Spaso method; Anti-Inflammatory Agents, Non-Steroidal
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): The patient holds both his hands around his knees in a supine position until the dislocated shoulder is reduced; The physician holds the dislocated arm of the patient in a supine position and proceeds with gentle, soft movements of adduction, flexion and external rotation of the limb in this order until reduction is accomplished.; All patients will be administered a dose of NSAI intra-muscular or orally ("Dexketoprofen", "Enantyum®") it is part of the normal treatment of these patients to cope with pain.
Other intervention name(s): Self-assited Method; Pain Killer, "Enantyum®"
Intervention MeSH terms: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bone Health in Type 1 Diabetes
Condition: Type 1 Diabetes; Osteoporosis
MeSH terms: Osteoporosis; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      An increased skeletal fracture risk in diabetes has only recently been recognized. This human
      study is designed to elucidate the effect of Type 1 diabetes on bone remodeling and on
      structure.
    

Detailed description: 
      An increased skeletal fracture risk in diabetes has only recently been recognized. Human
      studies of patients with diabetes using bone mineral density and bone markers have noted low
      bone mass and mixed results on remodeling activity. Mouse models of diabetes have suggested
      that low bone turnover is the underlying problem. Low bone turnover could lead to an
      accumulation of microdamage that is not repaired causing compromised bone strength. Low bone
      turnover has not yet been confirmed in humans. This human study is designed to elucidate the
      effect of Type 1 diabetes on 1) bone remodeling, including histomorphometric and biochemical
      measures of bone formation and resorption, and 2) on structure, including micro architectural
      arrangement of trabeculae and bone mineral density.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        males or females who are greater than 19 years of age and less than age 50 who have been
        diagnosed with type 1 diabetes for over 3 years.
      
Biospecimen description: 
      Transilial bone specimens are retained for measurements
    
Keywords: Type 1 diabetes; bone