bioihbjkbjnl/mcl2 huggingface dataset:
Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, active comparator, two-part, partial crossover design. The study is designed to
      assess the pharmacokinetics and pharmacodynamics of EnteraBio's Oral PTH(1-34) [EB612
      (EBP05)] in adult patients with hypoparathyroidism.
    


Intervention name(s): EB612 (EBP05); NATPARA/NATPAR
Intervention type(s): Drug; Drug
Intervention description(s): Entera Bio's proprietary drug for the administration of PTH(1-34) orally; A PTH replacement (PTH [1-84]; NATPARA (Shire-NPS Pharmaceuticals, Inc., Lexington, Massachusetts) was approved by the United States (US) Food and Drug Administration (FDA) in April 2015 / NATPAR (Shire Pharmaceuticals Ltd., Dublin, Ireland) was approved by the European Medicines Agency in April 2017 for use as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Like many other hormonally active peptides, PTH (1 84); NATPARA is parenterally administered. In this protocol when a specific formulation is referenced (e.g. NATPARA) it may be read interchanged with the alternate formulation (e.g. NATPAR).
Other intervention name(s): Oral PTH(1-34); PTH(1-84)
Intervention MeSH terms: Parathyroid Hormone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, active comparator, two-part, within-part, partial crossover design.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoparathyroidism, PTH(1-34), Parathyroid Hormone
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects
Condition: Overweight or Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial is conducted in China. The aim of this trial is to investigate Safety,
      Tolerability, PK and PD for Multiple Doses of IBI362 in Overweight or Obese Male and Female
      Subjects.
    


Intervention name(s): IBI362; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is
      well tolerated and causes a non-inferior immune response when compared to administration of
      REPEVAX™ one month following the first dose of V503.
    


Intervention name(s): V503 Vaccine; REPEVAX™ (Concomitant); REPEVAX™ (Non-concomitant)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6; REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1; REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effect of Dexmedetomidine for Suprascapular Nerve Block With Axillary Nerve Block
Condition: Suprascapular Nerve Block; Axillary Nerve Block; Dexmedetomidine; Arthroscopic Rotator Cuff Repair; Postoperative Pain; Pain Related Cytokine
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Suprascapular nerve block (SSNB) is most commonly used for relieving postoperative pain of
      arthroscopic rotator cuff repair and it can be used in combination with axillary nerve block
      (ANB). Dexmedetomidine (DEX) is known as a type of alpha agonist which can elongate the
      duration of regional block. The aim of this study was to compare the results of
      dexmedetomidine combined with SSNB and ANB with SSNB and ANB alone on postoperative pain,
      satisfaction, and pain-related cytokines within the first 48 hours after arthroscopic rotator
      cuff repair.

      Forty patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair
      were enrolled in this single center, double-blinded randomized controlled trial study. Twenty
      patients were randomly allocated to group 1 and received ultrasound-guided SSNB and ANB using
      each mixture of 0.5 ml (50 μg) of DEX and 9.5 ml of 0.75% ropivacaine preemptively. The other
      20 patients were allocated to group 2 and underwent ultrasound-guided SSNB and ANB alone
      using a mixture of 0.5 ml of normal saline and 9.5 ml of ropivacaine. The visual analog scale
      (VAS) for pain and patient satisfaction (SAT) scores were checked within 48 h
      postoperatively. The plasma interleukin (IL)-6, -8,-1β, cortisol, and serotonin levels were
      also measured within 48 h postoperatively.
    


Intervention name(s): Dexmedetomidine injection; Saline injection
Intervention type(s): Drug; Drug
Intervention description(s): We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for preemptive suprascapular nerve block and axillary nerve block just before arthroscopic repair of rotator cuff tear.; We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for preemptive suprascapular nerve block and axillary nerve block just before arthroscopic repair of rotator cuff tear.
Other intervention name(s): suprascapular nerve block and axillary nerve block c ropivacaine; arthroscopic rotator cuff repair; suprascapular nerve block and axillary nerve block c ropivacaine; arthroscopic rotator cuff repair
Intervention MeSH terms: Dexmedetomidine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Single Task vs. Dual Task Assessment in Individuals With Knee Osteoarthritis
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      Osteoarthritis is characterized by progressive degeneration of articular cartilage, weakening
      of subchondral bone, synovial inflammation, meniscal degeneration, and intra-articular
      osteophytes.
    

Detailed description: 
      Dual tasking is when two tasks can be done simultaneously. A dual task may involve two
      different simultaneous motor tasks, or it may include a cognitive task in addition to the
      motor task. Following the additional task given, there may be a decrease in the performance
      of the main task or in the performance of both tasks.

      Decreased balance control can lead to fall injuries that result in serious physical,
      psychological and social losses. Before the management of this condition, an effective
      evaluation of balance control in patients with knee osteoarthritis is required.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        A second assessment will be done 48 hours after the initial one. It will be completed as a
        dual job for the second evaluation. The patient will be given activities involving colors
        and numbers as part of the dual evaluation, and concurrently, after the isokinetic device
        has assessed the patient's muscle strength, the 30-second sit-and-stand test will assess
        the patient's function and balance.
      
Keywords: dual task
Oral Rivaroxaban in Children With Venous Thrombosis
Condition: Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out whether rivaroxaban is safe to use in children and
      how long it stays in the body. There will also be a check for bleeding and worsening of blood
      clots.
    


Intervention name(s): Rivaroxaban (Xarelto, BAY59-7939); Active comparator; Rivaroxaban (BAY59-7939) suspension
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.; Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).; Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.
Intervention MeSH terms: Rivaroxaban
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oxygen Concentration Should be Kept at the Lowest Possible Level During Recruitment
Condition: Laparoscopic Surgery
Study type: Observational

Summary: 
      In This Study, Our Goal is to Compare the Effects of Recruitment Manoeuvre Which is Applied
      With Different Oxygen Concentrations on Oxygenation and Respiratory Mechanics During
      Pneumoperitoneum
    

Detailed description: 
      Detailed Description:

      "Recruitment manoeuvre" which has been defined and become popular in the recent years is
      nowadays widely accepted and applied. The positive effects of the recruitment manoeuvre
      during and after surgery on respiratory mechanics and oxygenation have been reported. The
      duration and the applied pressure values of recruitment manoeuvre have been defined well and
      in detail regarding the definitions for this manoeuvre (1-3). Despite these definitions, no
      detailed information has been provided on the effects of the oxygen and oxygen concentration
      during recruitment manoeuvre .

      Atelectasis develops after the induction of anaesthesia, even in healthy subjects, and is
      associated with an increase in intraoperative shunt leading to impairment of gas exchange
      (4). It is well known that in patients, who have undergone mechanical ventilation with high
      oxygen concentration levels, oxygen replaces the less insoluble nitrogen. Partial oxygen
      pressure increases with the implementation of oxygen in high concentrations, and the oxygen
      flow into the blood increases. But when the gas flow into the blood is more than inspired,
      absorption atelectasis develops in lungs - due to appliance of high oxygen concentration.
      Atelectasis may also develop due to different reasons such as failure in secretion clearance
      during the surgery, replacement of nitrogen with inhalation anaesthetics and appliance of
      pneumoperitoneum.

      In the recent years, many studies have analyzed the effects of recruitment manoeuvre during
      pneumoperitoneum and laparoscopic surgery on respiratory mechanics and oxygenation, and
      reported the benefits of recruitment in these operations (4-6).

      In this study, our goal is to compare the effects of recruitment manoeuvre which is applied
      with different oxygen concentrations on oxygenation and respiratory mechanics during
      pneumoperitoneum.
    

Intervention name(s): Recruitment Manoeuvre
Intervention type(s): Other
Intervention description(s): Recruitment Manoeuvre
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study has been applied on 32 cases which have undergone laparoscopic cholecystectomy.
      
Keywords: Recruitment; Oxygen Concentration; pneumoperitoneum; laparoscopy
KPL-301 for Subjects With Giant Cell Arteritis
Condition: Giant Cell Arteritis
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301)
      versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining
      sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant
      cell arteritis (GCA).
    

Detailed description: 
      This Phase 2 randomized, double-blind, placebo-controlled proof of concept study will
      evaluate the efficacy and safety of mavrilimumab co-administered with a 26-week
      corticosteroid taper in subjects with GCA. The study will consist of a screening period (up
      to 6 weeks), a 26-week double-blind placebo-controlled period during which subjects will
      receive blinded mavrilimumab or placebo co-administered with a 26-week corticosteroid taper,
      and a 12-week washout safety follow-up period during which subjects will discontinue and wash
      off blinded mavrilimumab or placebo.
    

Intervention name(s): mavrilimumab; placebo; prednisone
Intervention type(s): Combination Product; Combination Product; Drug
Intervention description(s): 1 mL of 150 mg in a pre-filled syringe; 1 mL of placebo in a pre-filled syringe; Prednisone tablets for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone United States Pharmacopeia (USP)
Other intervention name(s): KPL-301
Intervention MeSH terms: Prednisone; Mavrilimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Upon successful completion of the screening procedures, diagnosis criteria will be entered into an interactive web response system, and eligible subjects will be stratified for randomized study treatment into two cohorts according to whether subjects have new-onset or relapsing/refractory disease.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GCA; temporal arteritis; Horton's disease
Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
Condition: Fatty Liver
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if therapeutic modification of insulin resistance
      or oxidative stress leads to improvement in serum or histologic indicators of liver injury or
      quality of life.
    


Intervention name(s): Metformin; Vitamin E; Matching placebo
Intervention type(s): Drug; Dietary Supplement; Drug
Intervention description(s): 500 mg, twice daily; 400 IU, twice daily; Twice daily
Other intervention name(s): Nature Made
Intervention MeSH terms: Vitamin E; Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Non alcoholic fatty liver disease
Effect of Roselle-based Drink on Blood Pressure and Skin
Condition: Other Skin and Subcutaneous Infections
Study type: Interventional

Summary: 
      This randomized, placebo-controlled, double-blind, and cross-over study was designed to check
      whether the roselle-based drink (2 bottles every day) can alter blood pressure and skin
      condition in elderly healthy subjects.
    

Detailed description: 
      The subjects were assigned into two groups (control group and test group), each group subject
      was requested to drink 2 bottles every day (100 mL/bottle, one in the morning and another in
      the evening), the rate of drinking is 75.42%. There are 39 subjects (25 females and 14 males)
      completely involved in the thirteen-month trial (cross-over). Blood samples were collected at
      the initial, 3rd, 6th, 7th, 10th, 13th months of the trial. Skin examinations were performed
      at the initial, 6th, 7th, 13th months.
    

Intervention name(s): Drink
Intervention type(s): Dietary Supplement
Intervention description(s): Roselle and placebo drink for 6 months
Other intervention name(s): Roselle Drink (SF-R product of Han Bu)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Tacrolimus in Healthy Volunteers
Condition: Pharmacokinetics of ASP015K; Drug Interactions; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy
      volunteers.
    

Detailed description: 
      The subjects will be confined to the unit for 13 days and have a brief follow-up visit to
      obtain hematology blood samples. Numerous blood and urine samples will be taken to determine
      the pharmacokinetics of the drugs.
    

Intervention name(s): ASP015K; Tacrolimus
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Prograf; FK506
Intervention MeSH terms: Tacrolimus; Peficitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: transplant; ASP015K; tacrolimus; Prograf; healthy volunteers
A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis
Condition: Adult Onset Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether VIB4920 (formerly MEDI4920) is safe and
      well tolerated in participants with adult-onset rheumatoid arthritis (RA).
    


Intervention name(s): VIB4920; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.; Participants will receive a single IV dose of placebo matched to VIB4920 Q2W from Day 1 up to 12 weeks.
Other intervention name(s): MEDI4920
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: MEDI4920, VIB4920, CD40L, RA, rheumatoid arthritis
Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers
Condition: Electrical Stimulation; Neuromodulation
Study type: Interventional

Summary: 
      High-frequency alternating currents of greater than 1 kHz applied on peripheral nerves has
      been used in animal studies to produce a motor nerve block. It has been evidenced that
      frequencies higher than 5 kHz are necessary to produce a complete peripheral nerve block in
      primates, whose nerve thickness is more similar to humans.
    

Detailed description: 
      Our previous studies with transcutaneous HFAC, suggest high-frequency stimulation (10 and 20
      kHz) have an inhibitory effect over muscle strength and somatosensory threshold.

      However, in these studies the intensity needed to reach block threshold is very high. The
      purpose of the present work is to reduce the amount of current intensity needed using a
      percutaneous approach by apply two acupuncture needles near the nerve as electrodes.
    

Intervention name(s): 10 kHz stimulation (Myomed 932, Enraf-Nonius); 20 kHz stimulation (Myomed 932, Enraf-Nonius); Sham stimulation (Myomed 932, Enraf-Nonius)
Intervention type(s): Device; Device; Device
Intervention description(s): A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 10 kHz. The stimulation intensity will be defined as that sufficient to produce a "strong but comfortable" sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands); A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 20 kHz. The stimulation intensity will be defined as that sufficient to produce a "strong but comfortable" sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands); Sham stimulation will be delivered at a frequency of 10 kHz only during the first 30 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: high-frequency alternating current; nerve block; somatosensory threshold; motor threshold; percutaneous electrical stimulation
Multiple Ascending Dose Study of PRX003 in Subjects With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and
      immunogenicity of PRX003 in approximately 56 patients with Psoriasis.
    


Intervention name(s): PRX003; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
Condition: Cocaine Addiction
MeSH terms: Cocaine-Related Disorders; Behavior, Addictive
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the efficacy and safety of TV-1380
      [Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)] in
      facilitating abstinence in cocaine-dependent subjects.
    


Intervention name(s): TV-1380 150 mg; TV-1380 300 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects assigned to TV-1380 150 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. The injection volume will be the same for all treatment groups. Therefore, to accommodate the volume required for the highest dosing group (3.0 mL), subjects in this group will receive 3.0 mL IM injection of TV-1380 150 mg (1.5 mL TV-1380 and 1.5 mL placebo/diluents).; Subjects assigned to TV-1380 300 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL TV-1380.; Subjects assigned to placebo will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL placebo.
Other intervention name(s): Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE); Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine addiction; TV-1380; Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)