bioihbjkbjnl/mcl2 huggingface dataset:
Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
Condition: Type 2 Diabetes; Psoriasis
MeSH terms: Psoriasis; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the study is to evaluate after 4 to 6 months the effects of a GLP-1 analog
      treatment on psoriatic skin lesions in patients with type 2 diabetes.
    

Detailed description: 
      The objective of this study is to analyse short and medium-term efficacy on clinical,
      immunological and histopathological parameters of a GLP-1 receptor agonist on moderate to
      severe psoriasis plaques in a group of patients with type 2 diabetes.
    

Intervention name(s): GLP-1 analog
Intervention type(s): Drug
Intervention description(s): GLP-1 analog treatment
Other intervention name(s): Liraglutide, Victoza or Exenatide, Byetta.
Intervention MeSH terms: Liraglutide; Exenatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes; psoriasis; exenatide; liraglutide
Sitagliptin in Combination With Metformin and Sulfonylurea
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in
      comparison to thiazolidinediones as the third-line oral agent, in patients with type 2
      diabetes mellitus.
    

Detailed description: 
      The aim of this protocol is to determine the non-inferiority of the effectiveness of
      sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on
      therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain
      adequate control with maximal doses of metformin and a sulfonylurea agent.
    

Intervention name(s): Sitagliptin
Intervention type(s): Drug
Intervention description(s): Sitagliptin 100 mg by mouth once daily
Other intervention name(s): Trade name: Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sitagliptin; type 2 diabetes; combination therapy
Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes; Overweight; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to learn about the effect of Liraglutide, (Victoza®),
      on the fat surrounding the heart.Excessive amount of the fat around the heart is common in
      people with type 2 diabetes and can be associated with poor sugar control. Liraglutide is an
      injectable prescription medicine that can improve blood sugar control in adults with type 2
      diabetes.
    


Intervention name(s): Liraglutide; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide (Victoza) is an acylated analogue of glucagon-like peptide-1 (GLP-1) indicated for the treatment of type 2 diabetes mellitus• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued. .
Intervention MeSH terms: Metformin; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epicardial fat; Type 2 diabetes; Obesity; GLP-1 analogs
Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia
Condition: Severe Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional
Phase: Phase 4

Summary: 
      Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal
      duration of this treatment after delivery is still to be established. The hypothesis is that
      in stable patients a shorter course of treatment is possible without prejudice to the mother.
    

Detailed description: 
      Magnesium sulfate (MgSO4) is certainly the ideal drug for prevention and control of eclamptic
      seizures. However, there is no consensus on the appropriate duration of prophylaxis with this
      anticonvulsant postpartum.The objective of the present study is to compare effectiveness of
      12 hours of magnesium sulfate versus 24 hours (standard treatment) in stable patients with
      preeclampsia.
    

Intervention name(s): Magnesium sulfate 12 hours; Magnesium sulfate 24 hours
Intervention type(s): Drug; Drug
Intervention description(s): Magnesium sulfate, 1g/h, (10% solution), for 12 hours; Magnesium sulfate, 1g/h, (10% solution), for 24 hours
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Severe preeclampsia; magnesium sulfate; anticonvulsivant
Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery
Condition: Hemifacial Spasm; Microvascular Decompression; Lateral Spread Response Monitoring
MeSH terms: Hemifacial Spasm
Study type: Interventional

Summary: 
      There have been reports of monitoring LSR during MVD surgery helps predicting the clinical
      outcome of MVD.However, there have been no evidence of which degree of partial neuromuscular
      blockade should be performed or no neuromuscular blockade could be performed during LSR
      monitoring. Therefore, we performed a randomized controlled trial to evaluate the effect of
      different degree of partial neuromuscular blockade, including no neuromuscular blockade on
      the LSR monitoring for MVD surgery.
    

Detailed description: 
      Hemifacial spasm develops by vascular compression of facial nerve at the root exit zone from
      brain stem. Microvascular decompression (MVD) is known for its curative treatment. Lateral
      spread response (LSR) is a kind of pathologic electromyographic (EMG) wave form which
      develops when facial nerve is compressed by vessel. There have been reports of monitoring LSR
      during MVD surgery helps predicting the clinical outcome of MVD.

      As neuromuscular blockade during LSR monitoring decreases the amplitude of EMG, partial
      neuromuscular blockade is usually maintained during general anesthesia for MVD. However,
      there have been no evidence of which degree of partial neuromuscular blockade should be
      performed or no neuromuscular blockade could be performed during LSR monitoring. Therefore,
      we performed a randomized controlled trial to evaluate the effect of different degree of
      partial neuromuscular blockade, including no neuromuscular blockade on the LSR monitoring for
      MVD surgery.
    

Intervention name(s): TOF count-guided partial NMB; T1/Tc guided partial NMB; No NMB
Intervention type(s): Other; Other; Other
Intervention description(s): Using partial neuromuscular blockade to maintain train-of-four response of two, TOF response measured by the neuromuscular transmission module (NMT module); Using partial neuromuscular blockade to maintain T1/Tc amplitude of 50%, T1/Tc amplitude measured by the neuromuscular transmission module (NMT); to maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The study has 2 Parts: The primary purpose of Part 1 is to determine the supratherapeutic
      dose of brensocatib to be used in Part 2 of the study.

      The primary purpose of Part 2 is to assess brensocatib's potential for prolonging the QT
      interval.
    


Intervention name(s): Brensocatib; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablet.; Oral tablet.; Oral tablet.
Other intervention name(s): INS1007
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brensocatib; INS1007
Inion OTPS Biodegradable Fixation System for the Ankle
Condition: Surgery
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the investigation is to compare post-operative fracture and wound healing
      using Inion OTPS Biodegradable Fixation System implants versus Conventional metal implants.
    


Intervention name(s): Inion OTPS Biodegradable Fixation System
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Pressure Garments on Hypertrophic Hand Scar in Burn Children
Condition: Burns Laser
MeSH terms: Burns
Study type: Interventional

Summary: 
      Burns are type of injury that affect the skin or other tissues and are typically caused by
      acute trauma, including thermal sources, electricity, chemicals, friction, or radiation.
      Thermal burns are frequently caused by exposure to high temperature solids or liquids, as
      well as flames. The epidermis is the only layer of skin affected by superficial burns
      (sometimes known as "first degree" burns). Blistering is a common symptom of partial
      thickness (second degree) burns, which damage both the epidermis and dermis.
    

Detailed description: 
      This study will include patients with age 2-10 & having burns on hands and develop scars will
      be recruited through Randomized Controlled trial in which convenience sampling technique will
      be used. Two groups will be formed in which participants will be divided by lottery method.
      Group A which will be treated by low level laser therapy with pressure garment (8-10hrs a
      day) and group B which will receive low level LASER therapy (422-800nm) without pressure
      garment only for the duration of 6 weeks (3 days in a week with 20-30 minutes per session).
      Vancouver Scar Scale and PSOAS tool will be used. The result after statistical analysis will
      either show both treatments equally effective or not. Data will be calculated before and
      after treatment with the help of outcome measure tools. Results will be analyzed on SPSS.
    

Intervention name(s): Low Level LASER Therapy with Pressure Garment; Low Level LASER Therapy without Pressure Garment
Intervention type(s): Other; Other
Intervention description(s): This group will be treated by low level laser therapy with pressure garment (8-10hrs a day) by Laplace' s Law method because it is more accurate since the range of pressures that can be delivered to a particular range of body circumferences varies depending on the fabric used and its particular tension- extension profile, the method is difficult to utilize manually and till present there is no available design tool to aid in its application. Pressure garments generate an increase in subdermal pressures in the range 9- 90 mmHg depending on the anatomical site. Garments over soft tissues generate pressures ranging from 9 to 33 mmHg. Over bony prominences the pressures range from 47 to 90 mmHg. 25mmHg pressure will be provided by garments and garments will be replaced in every 2 months; This group will receive low level LASER therapy (422-800nm) without pressure garment only for the duration of 6 weeks (3 days in a week with 20-30 minutes per session).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Burn scar, Hypertrophy Scar; Pressure garment,; Low level laser,
The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer
Condition: Pancreatic Neoplasms; Biliary Tract Neoplasms
MeSH terms: Neoplasms; Pancreatic Neoplasms; Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of combination therapy with gemcitabine
      and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary
      adenocarcinoma.
    

Detailed description: 
      Try a new drug association on this advanced cancer
    

Intervention name(s): Docetaxel; Gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines; Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines
Other intervention name(s): TAXOTERE; GEMZAR
Intervention MeSH terms: Gemcitabine; Docetaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreas or biliary cancer
Nimotuzumab Combined With Chemoradiotherapy for Unresectable Locally Advanced Squamous Cell Lung Cancer
Condition: Non-small-cell Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in
      combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.
    

Detailed description: 
      This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab
      combined with chemoradiotherapy for unresectable,locally advanced squamous cell lung cancer.

      All patients were planned to receive radical dose of chest radiation and concurrent
      chemotherapy of weekly docetaxel and cisplatin, each of 1 day's duration.

      Nimotuzumab group was treated with weekly nimotuzumab (200mg, IV) combined with
      chemoradiotherapy, while control group was treated with chemoradiotherapy.
    

Intervention name(s): Nimotuzumab; docetaxel and cisplatin; daily RT to the chest
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy.; Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy; Patients received daily RT to the chest
Intervention MeSH terms: Docetaxel; Nimotuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nimotuzumab, Chemoradiotherapy,Squamous Cell Lung Cancer
Comparison of Conventional With Sonography Assisted Breast Surgery After Neoadjuvant Chemotherapy
Condition: Breast Cancer Surgery
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Aim of the study is to investigate whether intra-surgical visualisation of malignoma reduces
      the resection rate in the case of R1 resection compared to the procedure without sonographic
      visualisation
    


Intervention name(s): Sonographically assisted breast surgery; Conventional breast surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Sonography; Conventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Determine Efficacy and Safety of Inhaled AeroLEF in the Treatment of Acute Post-op Pain in Adult Patients Undergoing Elective Orthopedic Surgery
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effect of pain relief with AeroLEF in adult
      patients, following orthopedic surgery.
    


Intervention name(s): AeroLEF
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pain; Fentanyl; Analgesics; Opioid; Inhalation
Safety of Tuberculosis Vaccine, MVA85A, Administered by the Intramuscular Route and the Intradermal Route
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study that will compare the safety and immunogenicity of candidate
      tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal
      route in healthy adult individuals who have been previously vaccinated with Bacillus
      Calmette-Guerin (BCG).
    

Detailed description: 
      We postulate that the intramuscular route is not inferior to the intradermal route of
      administration of MVA85A in BCG vaccinated adults when evaluated for safety and
      immunogenicity.

      If MVA85A can be given safely by intramuscular route and it is at least equally immunogenic
      and efficacious in a prime-boost strategy, then it would probably be the preferred route in
      subsequent phase II and III trials. There are several reasons for this:

        -  Reduced pain associated with injection.

        -  Reduced local reaction at the injection site.

        -  More straightforward procedure; less technically demanding; less time consuming.

        -  Easier production and storage of vaccine.

        -  Larger volume of vaccine can be given.

      Trials of MVA85A to date have established 1 x 10^8 pfu as the optimal dose for intradermal
      injection in adults. We therefore intend to administer this same dose intramuscularly in
      order to directly compare the two routes for both safety and immunogenicity. These results
      will guide future trials in which the intramuscular route, if safe, could be further
      evaluated at either higher or lower dose depending on immunogenicity at 1 x 10^8 pfu dosage.
    

Intervention name(s): MVA 85A
Intervention type(s): Biological
Intervention description(s): Single injection of 1 x 108 pfu MVA85A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; MVA 85A
A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants
Condition: Electrocardiography
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the effects of therapeutic and
      supratherapeutic doses of avacopan on the heart rate corrected QT interval, using
      Fridericia's formula (QTcF).
    


Intervention name(s): Avacopan; Moxifloxacin; Placebo for avacopan; Placebo for moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Complement 5a receptor (C5aR); Anti-neutrophil cytoplasmic antibody-associated vasculitis; Complement; Vasculitis
Reducing Hypoglycemia Fear in Parents of Young Children With Type 1 Diabetes
Condition: Parents
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      Pilot of a novel video-based telemedicine intervention to reduce fear of hypoglycemia in
      parents of young children with type 1 diabetes.
    

Detailed description: 
      This was a two group randomized controlled study using a wait-list control design. All
      participating parents had the opportunity to receive 10 video-based telemedicine sessions
      administered over 13 weeks. Study assessments took place at baseline, post-treatment, and 3
      month followup. Study outcomes included parent reported hypoglycemia fear, parenting stress,
      diabetes distress, and child glycated hemoglobin.
    

Intervention name(s): REDCHiP
Intervention type(s): Behavioral
Intervention description(s): 10 week video-based telemedicine intervention to reduce hypoglycemia fear
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized control pilot using a waitlist control group
Masking: None (Open Label)
Primary purpose: Prevention
Nuedexta in Treatment-Resistant Major Depression
Condition: Major Depressive Disorder; Treatment Resistant
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      There is an urgent need, therefore, to identify well-tolerated, orally available compounds
      that target the NMDA receptor as a novel treatment approach for TRD. The current project aims
      to test the safety, tolerability and efficacy of Nuedexta - containing the NMDA antagonist
      dextromethorphan.
    

Detailed description: 
      Approximately one-third of patients with major depressive disorder do not achieve adequate
      symptom control despite a series of multiple treatment trials with currently available
      antidepressant medication (for example a serotonin-selective reuptake inhibitor). This group
      of patients - representing treatment-resistant depression (TRD) - accounts for an alarmingly
      high public health burden and signifies a critical area of need in pharmaceutical treatment
      development. While current treatments are slow to act and only partially effective, new basic
      and clinical research focusing on the glutamate system is yielding promising new avenues for
      novel drug discovery. Ketamine - a glutamate N-methyl-d-aspartate (NMDA) receptor antagonist
      - has now been demonstrated in several studies to bring about a rapid and robust
      antidepressant effect, even in patients suffering from TRD. Ketamine is limited as a
      treatment for TRD by the need for intravenous administration and the potential for untoward
      medical or psychiatric adverse effects. There is an urgent need, therefore, to identify
      well-tolerated, orally available compounds that target the NMDA receptor as a novel treatment
      approach for TRD. The current project aims to test the safety, tolerability and efficacy of
      Nuedexta - containing the NMDA antagonist dextromethorphan.
    

Intervention name(s): dextromethorphan/quinidine
Intervention type(s): Drug
Intervention description(s): up to 45/10 mg every 12 hours in patients with TRD with a short 7 day tapering period in which subjects are tapered off 45/10 mg dose from twice a day to once daily for an additional 7 days at post 8-week treatment period to minimize the potential for discontinuation effects
Other intervention name(s): Nuedexta
Intervention MeSH terms: Quinidine; Dextromethorphan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; major depressive disorder; treatment resistant; Nuedexta; dextromethorphan; antidepressant; glutamate; NMDA receptor
Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy Recreational Sports People
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy of Ginsana in improving hemoglobin re-oxygenation in healthy,
      recreational sports people and to assess the safety of the product.
    


Intervention name(s): Ginsana; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment