bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 3

Summary: 
      This will be a randomized, multicenter, open-label, active-controlled, efficacy, and safety
      study in adult hypogonadal men. The study duration is 12 months (365 days), including a
      90-day, open-label efficacy period and a 9-month (275-day) safety evaluation period.
    

Detailed description: 
      MRS-TU-2019 was a 12-month study designed to determine the efficacy of oral SOV2012-F1 as
      measured by the percentage of male hypogonadal subjects with average total testosterone (T
      Cavg) in plasma within the normal range after 90 days of treatment. This study included an
      AndroGel™ arm as a safety comparator; after the 90-day efficacy period, dosing continued for
      9 additional months in both arms to gather safety data. This study also examined the
      percentage of SOV2012-F1-treated subjects with maximum total testosterone (Cmax) in plasma
      values after 90 days of treatment: a. ≤1.5 X upper limit of normal (ULN); b. 1.8 X ULN to 2.5
      X ULN' and c. >2.5 X ULN. The study also included an adrenal cortical function substudy
      conducted in 30 SOV2012-F1 subjects and 15 AndroGel subjects. Four patient-reported outcome
      measures were also used during the study: IPSS, PDQ, SF-36 and IIEF.
    

Intervention name(s): SOV2012-F1; AndroGel
Intervention type(s): Drug; Drug
Intervention description(s): oral preparation of testosterone undecanoate (TU); topical testosterone gel 1.62%
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Randomized, Single-dose, Crossover Study of 4 Decitabine and Tetrahydrouridine (EPI01) Formulations in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the pharmacokinetic profiles of decitabine and tetrahydrouridine (THU) from 3
      modified release formulations in healthy subjects.
    

Detailed description: 
      This is an open-label, randomized, single-dose per period, four-period, crossover study to
      evaluate relative bioavailability of decitabine in three newly formulated THU and decitabine
      combination capsules in comparison to 3 capsules of THU followed 1 hour later by 3 capsules
      of decitabine.
    

Intervention name(s): Decitabine
Intervention type(s): Drug
Intervention description(s): Combination drugs containing decitabine and tetrahydrouridine
Other intervention name(s): Tetrahydrouridine
Intervention MeSH terms: Decitabine; Tetrahydrouridine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Four-way crossover, single dose with a 7 days washout period in between periods
Masking: None (Open Label)
Primary purpose: Other
Fluid Absorption in Patients Undergoing Operative Hysteroscopy; Results From a Prospective Controlled Study
Condition: Fluid Overload
Study type: Interventional

Summary: 
      To determine if combining intravenous oxytocin infusion and spinal anesthesia will reduce the
      amount of glycine absorption in patients undergoing operative hysteroscopy
    

Detailed description: 
      Prospective controlled study in premenopausal patients who had hysteroscopic surgery
      including endometrial resection, endometrial polypectomy, myomectomy resection and uterine
      septal resection. The effect of combined spinal anesthetic with oxytocin infusion on fluid
      deficit was studied.
    

Intervention name(s): oxytocin and spinal anesthesia; General anesthsia
Intervention type(s): Other; Other
Intervention description(s): start oxytocin 10 IU/200 ml saline at the insertion of the spinal anesthesia; General anesthesia alone.
Intervention MeSH terms: Oxytocin
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Beet Juice and Diet in Female Rowers
Condition: Dietary Habits; Nitrates; Exercise
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of nitrate-rich beetroot juice
      supplementation on exercise performance in female rowers when accounting for habitual
      vegetable nitrate consumption.
    

Detailed description: 
      The objective is to use a stratified block randomization, double-blind crossover trial to
      test rowing ergometer exercise performance after drinking a beetroot juice supplement and
      compare it to the same test after consuming a placebo (a nitrate-free version of the beetroot
      juice supplement) in a convenience sample of athletes from a single Division 1-A collegiate
      women's rowing team.

      Before testing, the participants' habitual vegetable nitrate consumption will be assessed
      from their report of foods consumed in the past 24 hours. Estimates of dietary nitrate intake
      will be calculated from the quantity of vegetables consumed and used to determine whether
      dietary nitrate intake influences the efficacy of the beetroot juice supplement.
    

Intervention name(s): Beet Juice; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 70 milliliter (70mL) standard Beet Juice (Beet It Sport Shot) consumed 2.5 hours before exercise test; 70mL placebo Beet Juice (Beet It Sport Shot with nitrate removed) consumed 2.5 hours before exercise test
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: dietary nitrate; beetroot juice; sex differences; exercise; performance; muscle
Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia
Condition: Patients Undergoing Laparoscopic Gastrectomy
MeSH terms: Hyperalgesia
Study type: Interventional

Summary: 
      Opioids has been reported to cause hyperalgesia. Opioid induced hyperalgesia (OIH) is defined
      as paradoxically lowering the threshold of pain after the exposure of opioid. Remifentanil is
      a short acting opioid that is commonly used during anesthesia and surgery. However, OIH was
      reported to occur after surgery when large amount of remifentanil was administered. On the
      other hand, nefopam is a centrally acting, non-opioid analgesic. Nefopam has been reported to
      have analgesic and anti-hyperalgesic effect.

      The investigators hypothesized that nefopam administration could prevent OIH or reduce the
      severity of OIH. Therefore, the objective of the study is to find out the effect of nefopam
      on remifentanil induced hyperalgesia in patients undergoing laparoscopic abdominal surgery.
    


Intervention name(s): Nefopam; low dose remifentanil; high dose remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg of Nefopam mixed in 100 ml of 0.9% saline IV immediately after induction of anesthesia.; 100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.; 100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
Intervention MeSH terms: Remifentanil; Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Opioid-induced hyperalgesia (OIH)
A Safety andTolerability Study of Multiple Doses of ISIS-DMPKRx in Adults With Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy Type 1
MeSH terms: Myotonic Dystrophy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will test the safety, tolerability, and pharmacokinetics of multiple escalating
      doses of ISIS-DMPKRx administered subcutaneously to adult patients with DM1.
    

Detailed description: 
      This is a Phase 1/2a multicenter, blinded, placebo-controlled study of ISIS-DMPK Rx in adult
      patients with DM1.
    

Intervention name(s): IONIS-DMPKRx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug; Placebo
Other intervention name(s): ISIS 598769
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myotonic Dystrophy; DM1; Adult onset; Neuromuscular Disease; DMPKRx
Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury
Condition: Ankle Fractures
MeSH terms: Ankle Fractures; Ankle Injuries
Study type: Interventional

Summary: 
      Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight
      suture endobutton and one tricortical 3,5 mm syndesmotic screw.
    

Detailed description: 
      Syndesmotic injuries are common and often associated with unstable ankle fractures. The most
      common treatment is with a syndesmotic screw through the fibula and tibia which is later
      removed, usually after 10-12 weeks. The ZipTight suture endobutton (Biomet) is used for the
      same indication. It does not need removal and thus avoids subsequent surgery. This trial will
      compare these two methods and see if they are equal.

      patients 18-70 years presenting to one of the three hospitals with and acute syndesmotic
      injury are eligible for inclusion. 120 patients are randomized to two treatment groups. One
      group will be treated with a ZipTight suture endobutton fixation and the other receives a
      tricortical screw fixation. Neither suture endobutton or screw is routinely removed. Follow
      up intervals are at 6 weeks, 6, 12 and 24 months with clinical and-points. Standardized CT
      scans are taken postoperatively and at 12 and 24 months.
    

Intervention name(s): ZipTight suture endobutton; Tricortical 3.5 mm syndesmotic screw
Intervention type(s): Device; Device
Intervention description(s): Zimmer Biomet ZipTight suture endobutton; Depuy Synthes 3.5 mm screw
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Syndesmosis; Injury; Ankle; Fracture; Weber C
Study in Children Who Have Switched to Isosource Junior Mix Formula
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      A Retrospective study In Children who have switched to Isosource Junior Mix formula (RICIMIX
      study) will review paediatric children > 12 months of age who require Isosource Junior Mix as
      an enteral tube feeding formula and have consumed the formula for at least 1 month. The
      purpose of this study is to understand If there has been an improvement in outcomes/
      experiences

        -  The current usage of ISJMIX formula in children who require blended diets

        -  Improved feeding intolerances

        -  Improved patient outcomes/ experiences
    

Detailed description: 
      Retrospective data will be collected using questionnaire by the dietitians at the nutrition
      and dietetic department. All completed questionnaires will be sent back to Nestle Health
      Science/ CRO company.

      The primary objectives:

      The following measures will be collected retrospectively after 1 month use of ISJMIX

        -  Feeding tolerance [no change, tolerance improved, tolerance worsened]: gastric
           residuals, gagging/retching, vomiting, abdominal distention/ gas, stool consistency
           issues (too hard, too loose)

        -  Volume of formula consumed in a day

      The secondary objective is to collect restropective data on:

        -  Any improved patient outcomes noted

        -  Calculate the potential cost savings made when using ISJMIX to help manage the feeding
           intolerances

        -  Calculate the potential costs benefit of using ISJMIX over other standard formulas
    

Intervention name(s): Isosource Junior Mix
Intervention type(s): Dietary Supplement
Intervention description(s): Single arm study, collecting data on those who have been on Isosourcr Junior mix tube feed formula for 30 days
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Paediatric children > 12 months of age who require Isosource Junior Mix as an enteral tube
        feeding formula and have consumed the formula for at least 1 month
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is conducted to compare the immunogenicity, reactogenicity and safety of
      Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): HBV-MPL vaccine; Engerix™-B
Intervention type(s): Biological; Biological
Intervention description(s): 3-dose intramuscular injection; 3-dose intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Adjuvanted hepatitis B vaccine, hepatitis B, Engerix™-B
Study of Two Tramadol Contramid® OAD 300 mg Controlled-Release Tablets From Two Different Manufacturing Sites Following a 300 mg Dose in Healthy Subjects Under Fasting and Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the rate and extent of absorption of two Tramadol
      Contramid® OAD 300 mg controlled-release tablets from two different manufacturing sites,
      administered as 1 x 300 mg controlled-release tablet under fasting conditions. The effect of
      food on the to-be-marketed formulation was also assessed.
    


Intervention name(s): Tramadol hydrochloride; Tramadol HCl; Tramadol HCl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.; 1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fed condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.; 1x300mg Tramadol Hydrochloride (HCl) tablet (Trillium Healthcare) fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy Subjects
A Novel MSE Score to Predict rHCC Patients
Condition: HCC
Study type: Observational

Summary: 
      Develop and validate a novel scoring system based on pathological factors to predict the
      postoperative survival of patients with rHCC.Patients with rHCC who underwent hepatectomy
      were recruited from two hospitals.Exploring whether this scoring system is related to
      prognosis
    


Intervention name(s): hepatectomy
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 221 patients with rHCC who underwent liver resection from February 2010 to March
        2016 at Tongji Hospital and 97 patients with rHCC who underwent hepatectomy at Zhongshan
        People's Hospital during the same period were included in this study
Effects of Rocabado's Approach Versus Kraus Exercise Therapy
Condition: Temporomandibular Dysfunction
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      TMJ dysfunction is linked to trauma, joint overloading owing to para-functional behaviors,
      mechanical stress, and metabolic issues. Myofascial pain and dysfunction, functional
      derangement, and osteoarthrosis are the three most frequent TMJ-related disorders.
      Temporomandibular joint disorders are a type of craniofacial problems. They affect the
      temporomandibular joint, muscles of mastication, and other musculoskeletal tissues. The most
      common clinical sign and symptoms associated with TMJ dysfunction are orofacial pain and
      clicking. The aim of study will be to compare the effects of Rocabado's approach versus Kraus
      therapy on Pain and Disability in patients with temporomandibular dysfunction.
    

Detailed description: 
      A Randomized Clinical Trial will be conducted at FMH Physiotherapy Clinic and Boston
      Physiotherapy Clinic Lahore through consecutive sampling technique on 40 patients which will
      be allocated using random sampling through opaque sealed enveloped into Group A and Group B.
      Group A will be treated with Rocabado's approach and Group B will be treated with Kraus
      exercises. Outcome measures tools will be conducted through NPRS, TMD disability index,
      Fonseca questionnaire after four weeks. Data will be analyzed during SPSS software version
      21. After assessing normality of data by Shapiro-wilk test, it will be decided either
      parametric or non-parametric test will be used within a group or between two groups.
    

Intervention name(s): Rocabado's approach; Kraus exercises
Intervention type(s): Other; Other
Intervention description(s): Group A will be treated with Rocabado's approach. Rocabado' approach will be comprised of six exercises.
Rest position of the tongue
Control of TMJ rotation
Rhythmic stabilization technique
Axial extension of the neck The patients will receive Rocabado's approach consisting 6 repetitions six times a day thrice per week for four weeks; Group B will be treated with Kraus exercises. Kraus exercises will be comprised of eight exercise programs.
Tongue position at rest
Teeth apart: the patient will be educated to maintain the teeth apart can be therapeutic, which facilitates the resting tongue position
Nasal-diaphragmatic breathing
Tongue up and wiggle
Strengthening
Touch and bite: Proprioceptive re-education: Lateral deviation The patients will receive Kraus exercises with the frequency of 2 sets and 10 repetitions twice a day three times per week for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Rocabado's Approach; Kraus exercises; Disability
Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears
Condition: Rupture of Anterior Cruciate Ligament
MeSH terms: Muscular Atrophy; Atrophy; Rupture
Study type: Interventional
Phase: Phase 2

Summary: 
      Anterior cruciate ligament (ACL) tears are among the most frequent traumatic knee injuries
      that occur in physically active individuals. Despite advances in minimally invasive surgical
      reconstruction techniques and aggressive rehabilitation, this atrophy and loss of strength
      can persist even after patients return to full activity and can place them at considerable
      risk for re-injury and developing osteoarthritis (OA). The design of new therapeutic
      interventions to prevent muscle atrophy is needed to advance the care of patients who suffer
      from ACL injuries. The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis plays an
      important role in promoting muscle growth and protecting muscle from atrophy. While GH
      therapy has shown promise in protecting immobilized muscle from various models of disuse
      atrophy, it remains unknown whether GH can help to restore strength and protect against the
      loss in strength that occurs after ACL tear. GH therapy may help to accelerate the safe
      return to play of patients that suffer ACL tears, and help to prevent the long-term OA and
      reduction in quality of life that occur after these traumatic knee injuries.
    


Intervention name(s): Somatropin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.; A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: muscle atrophy; growth hormone; ACL tear