bioihbjkbjnl/mcl2 huggingface dataset:
Spinal Anaesthesia With Levobupivacaine 0.5% and Ropivacaine 0.75% for Lower Limb Orthopaedic Surgery
Condition: Lower Limb Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effects of two intrathecally administered
      drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia
    

Detailed description: 
      Bupivacaine is a highly cardiotoxic drug and also produces prolonged motor blockade.The newer
      drugs levobupivacaine and ropivacaine being comparatively less cardio and neurotoxic are
      preferred now a days.So, we conducted this prospective, randomized double blind study with an
      aim of comparing the efficacy and characteristics of these drugs.
    

Intervention name(s): Levobupivacaine; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of Equipotent doses; Comparison of equipotent doses
Other intervention name(s): Chirocaine; Naropin
Intervention MeSH terms: Ropivacaine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Subarachnoid block; intrathecal; spinal anesthesia; isobaric; levobupivacaine; ropivacaine
Birch-SPIRE Safety and Efficacy Study
Condition: Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of multiple
      administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic
      parameters and clinical outcomes.
    


Intervention name(s): Birch-SPIRE; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Allergy; Birch; Rhinitis; Rhinoconjuntivitis; SPIRE; Toleromune
Posterior Capsular Injection With Femoral Nerve Block for Total Knee Arthroplasty
Condition: Posterior Knee Infiltration
Study type: Interventional

Summary: 
      To assess pain control after total knee replacement surgery using two different nerve block
      techniques. The 2 methods are:

        1. Continuous femoral nerve block with ultrasound guided posterior capsular injection

        2. Continuous femoral nerve block with ultrasound selective tibial nerve block.
    

Detailed description: 
      Patients undergoing total knee replacement surgery experience severe post-operative pain.
      Continuous femoral nerve block combined with selective tibial nerve block provides optimal
      pain control in the anterior and posterior aspect of the knee respectively. However, in
      patients with pre-existing neuropathy of the sciatic nerve, the blockade of tibial nerve is
      contraindicated because of increased risk of nerve damage that may lead to exacerbation of
      neurologic symptoms. In such patients where selective tibial nerve block cannot be offered,
      ultrasound guided posterior knee capsular injection may be an alternative technique for
      controlling posterior knee pain after surgery. Posterior capsular injection by surgeons
      intraoperatively, when combined with femoral nerve block has been shown to provide pain
      control after total knee replacement. With posterior capsular injection, the main trunk of
      the tibial nerve is spared and only the terminal nerve endings innervating the posterior knee
      joint is blocked providing effective pain control. In this study, the efficacy of ultrasound
      guided posterior capsular injections performed pre-operatively will be compared to tibial
      nerve block in controlling knee pain after surgery.

      The results of this study may help establish the efficacy of ultrasound guided posterior
      capsular injection as an alternative to tibial nerve block in patients undergoing total knee
      arthroplasty.
    

Intervention name(s): Ropivacaine with Epinephrine; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles; Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
Other intervention name(s): Naropin; Adrenalin; Naropin
Intervention MeSH terms: Epinephrine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Infiltration between popliteal artery and capsule of knee (iPACK)
A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach
Condition: Osteoarthritis of the Hip
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The purpose of this study is to identify differences in satisfaction, pain and length of stay
      between patients undergoing hip replacement who are discharged from the hospital on the day
      of surgery compared to patients who stay one night in the hospital.
    


Intervention name(s): Same day discharge; Next day discharge
Intervention type(s): Procedure; Procedure
A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)
Condition: Hepatitis B Infection
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B
      vaccine manufactured using an upgrade to the production process. The primary hypotheses
      tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the
      process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen
      (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection
      to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to
      HBsAg that are non-inferior or superior to those induced by the current process vaccine.
    


Intervention name(s): V232 Modified Process Hepatitis B Vaccine: Lot A; V232 Modified Process Hepatitis B Vaccine: Lot B; V232 Modified Process Hepatitis B Vaccine: Lot C; V232 Current Process Hepatitis B Vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
Condition: Alagille Syndrome
MeSH terms: Liver Diseases; Alagille Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome
      who have completed participation in a core LUM001 treatment protocol. The primary objective
      is to evaluate long-term safety and tolerability of LUM001. Efficacy will be assessed by
      evaluating the effect of LUM001 on the biochemical markers and pruritus associated with
      Alagille Syndrome.
    


Intervention name(s): LUM001 (Maralixibat)
Intervention type(s): Drug
Intervention description(s): Dosing of LUM001 also known as Maralixibat (MRX) with the objective of achieving optimal control of pruritus at a dose level that is tolerated by the participant and up to a maximum daily dose of 280 micrograms per kilogram (mcg/kg).
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate Your Super's Moon Balance and Its Impact on Premenstrual Syndrome
Condition: PMS; Menstrual Discomfort; Menstrual Pain
MeSH terms: Premenstrual Syndrome; Dysmenorrhea
Study type: Interventional

Summary: 
      This is an open-label observational single-group clinical trial to study the efficacy of a
      commercially available dietary supplement and its effect on common PMS and menstrual
      symptoms, as well as health-related biomarkers.
    

Detailed description: 
      It is hypothesized that the dietary supplement marketed as "YOUR SUPER Moon Balance" will
      improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and
      menstrual symptoms, such as pain, cramps, bloating, and lack of energy. Further, the ability
      of the supplement to reduce biomarkers of inflammation (CRP) and stress (cortisol), and
      promote sleep, will be evaluated.
    

Intervention name(s): Moon Balance
Intervention type(s): Dietary Supplement
Intervention description(s): Moon Balance is a blend of 6 food ingredients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial
Condition: ADHD; Attention Deficit Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study measures the safety and efficacy of repeated low dose MM-120 as treatment for ADHD
      in adults: a multi-center, randomized, double-blind, placebo-controlled
    

Detailed description: 
      This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a study of
      low dose MM-120 (20 μg) compared with a placebo administered for 6 weeks (twice a week on a
      3/4-day schedule).

      Low dose MM-120 (20 μg) is about 20% of the dose typically consumed for recreational
      psychedelic purposes.

      There will be a 1:1 randomization, double-blind, to MM-120 or placebo with the aim to reach
      26 evaluable patients in each of the 2 arms at Week 6.
    

Intervention name(s): MM-120; Placebo
Intervention type(s): Drug; Other
Intervention description(s): MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.; A treatment which is designed to have no therapeutic value.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Online Social Networking for HIV Prevention
Condition: HIV
Study type: Interventional

Summary: 
      In this randomized controlled trial, we will identify social networks on Facebook, an
      randomly assign each network to control or intervention status. We will then intervene at the
      level of the network with dynamic, interactive HIV prevention messages (intervention) or
      static messages about HIV prevention (control). We will develop the intervention content with
      input from our target audience (Facebook users) and will measure baseline, and 3 and 6 month
      assessments of condom use and abstinence among all participants
    


Intervention name(s): Online social networking HIV prevention
Intervention type(s): Behavioral
Intervention description(s): messages about HIV posted in online social networking sites
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV Prevention; Social Networking; Technology Based Intervention
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety: A Randomized Clinical Trial
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The present study will be conducted at the Department of Physiology in collaboration with the
      Department of Psychiatry of R.D. Gardi Medical College, Ujjain, Madhya Pradesh.

      This double-blind randomized controlled trial will remotely enroll 60 subjects. Each
      participant will complete 20 stimulation sessions at a rate of 3-5 sessions per week. Each
      session will be 30 minutes on the day of usage. The study will be randomized with a 1:1
      active; or sham control allocation. Endpoint analysis will be performed upon completion of
      the study.
    


Intervention name(s): Active VeNS; Sham VeNS
Intervention type(s): Device; Device
Intervention description(s): The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.; The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pain After Laparoscopic Hysterectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The investigators evaluated postoperative pain after total laparoscopic hysterectomy. Two arm
      are evaluated. During laparoscopic hysterectomy, in one arm; abdominal cavity was washed by
      saline at normal room temperature. In another arm; abdominal cavity was washed heated saline
      . Postoperative pain was evaluated by using visual analogy scale.
    

Detailed description: 
      The aim of this study was evaluated the effect of washing abdominal cavity by heated or
      normal temperature saline on postoperative pain.

      This study is double blind randomized controlled study.

      inclusion criteria: all of cases that had laparoscopic hysterectomy for bening condition

      exclusion criteria: maling cases and conversion to laparotomy

      after randomization and completion of surgery, investigator was evaluated postoperative pain
      at 0-4-8 th hours by using visual analog scale participants and investigator were blinded .
    

Intervention name(s): Study group
Intervention type(s): Other
Intervention description(s): Washing by heated saline group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Effect of Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects
      behavior and cognition in children with attention deficit hyperactivity disorder.
    


Intervention name(s): Omega-3 fatty acids
Intervention type(s): Dietary Supplement
Intervention description(s): duration: 4 month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effect of Moderate Alcohol Consumption on Postprandial Mood
Condition: Mood Swings
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      Rationale: Food choice is influenced by postprandial mood; the feelings of well-being after a
      meal. Postprandial mood can be measured by subjective responses. Physiological responses may
      play an important role in the generation of postprandial mood. However, the relationship
      between subjective and physiological responses after a meal is not clear yet. To investigate
      this relationship, moderate alcohol consumption will be used as a mood modulator, because of
      its well-studied effects on mood. Postprandial mood depends on the current mood state.
      Therefore the investigators will manipulate the current mood state by changing the ambiance
      to measure the influence of moderate alcohol consumption with a meal on postprandial mood in
      a pleasant or unpleasant ambiance.

      Objective: To determine whether moderate alcohol consumption with a meal in different
      ambiances affects postprandial mood, evaluated by subjective and physiological parameters.

      Study design: Randomized, placebo-controlled, single-blind, cross-over trial

      Study population: 28 apparently healthy, normal weight (BMI 18.5-27 kg/m2) women (18-45 y),
      taking oral contraceptives.

      Intervention: 4 times having dinner at TNO Zeist with either 3 glasses of sparkling white
      wine (~30g alcohol) or alcohol-free sparkling white wine in either a pleasant or unpleasant
      meal ambiance.

      Hypothesis: It is hypothesized that moderate alcohol consumption with a meal in different
      ambiances changes the response of subjective and physiological parameters of mood.

        -  Ho: there is no effect of alcohol consumption and ambiance on mood

        -  H1: there is an effect of alcohol consumption and ambiance on mood
    


Intervention name(s): Nutrition; mood manipulation
Intervention type(s): Other; Behavioral
Intervention description(s): Moderate alcohol consumption with dinner (3 glasses of sparkling white wine, containing ca. 30 g alcohol); Mood will be manipulated by changing the ambiance in either a pleasant or unpleasant way.
Other intervention name(s): Alcohol; Ethanol; Wine; Ambience; Ambiance; Positive affect; Emotion
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: alcohol; mood; postprandial
Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral
      doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive
      therapy to insulin.
    


Intervention name(s): empagliflozin medium dose; empagliflozin low dose; empagliflozin high dose; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as
      leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making
      androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these
      drugs together with radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide
      or goserelin and either flutamide or bicalutamide together with radiation therapy works in
      treating patients with prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the feasibility of androgen-suppression therapy combined with external-beam
           radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk
           localized prostate cancer.

        -  Determine the safety of EBRT+BT in these patients.

        -  Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local
           recurrence at 5 years, time to prostate-specific antigen failure, and time to first
           rectal/bladder injury, in these patients.

      OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once
      every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three
      times daily or oral bicalutamide once daily for 4 weeks.

      Within 4 weeks after initiation of androgen-suppression therapy, patients undergo
      external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after
      completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with
      implanted iodine I 125 or palladium Pd 103 seeds.

      Patients are followed every 3 months for 2 years and then every 6 months for 4 years.

      PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
    

Intervention name(s): LHRH agonist; antiandrogen; radiation therapy; Brachytherapy boost
Intervention type(s): Drug; Drug; Radiation; Radiation
Intervention description(s): Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2; flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks; 4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions); Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy
Intervention MeSH terms: Androgen Antagonists
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer