bioihbjkbjnl/mcl2 huggingface dataset:
Study to Determine if Olmesartan Medoxomil Has the Potential to Benefit the Cardiovascular System in Terms of Arterial Protection
Condition: Metabolic Syndrome; Hypertension
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will analyse the dose-dependent effect of olmesartan medoxomil on the change in
      arterial stiffness in subjects with hypertension and metabolic syndrome
    


Intervention name(s): olmesartan medoxomil; placebo; olmesartan medoxomil; olmesartan medoxomil
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): dosage form: oral tablet; frequency: daily; duration: 52 weeks; dosage form: tablet; frequency: daily; duration: 3 weeks; dosage form: oral tablet; frequency: daily; duration: 52 weeks; dosage form: oral tablet; frequency: daily; duration: 52 weeks
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Arterial stiffness; Vascular protection
Kinematics of Youth (Age 12-15) on Stationary All Terrain Vehicles
Condition: Healthy
Study type: Observational

Summary: 
      To assess the relationship between pre-teen/teen height, age, weight, gender, and body
      proportions and shape and size of youth and comfort and safety when operating adult All
      Terrain Vehicles (ATV).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        PreTeen and Teenage children
      
Keywords: Normal; Healthy Volunteers
Hyaluronan in the Treatment of Painful Achilles Tendinopathy.
Condition: Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The primary objective of this study is to compare OSTENIL® TENDON (2% hyaluronan) and
      Extracorporeal Shock Wave (ESWT) therapy in the treatment of painful Achilles tendinopathy.
    


Intervention name(s): hyaluronic acid sodium salt; ESWT
Intervention type(s): Device; Device
Other intervention name(s): OSTENIL® TENDON
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: tendinopathy; hyaluronan; tendon; hyaluronic acid; extracorporeal shock wave
Effect of Food on Pharmacokinetics of MY008211A Tablets in Healthy Adult Subjects
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single-center, single-dose, open-label clinical study. 12 subjects were randomly
      assigned in a 1:1 ratio to one of the following dosing sequences (sequence 1: AB; Sequence 2:
      BA). Each dosing sequence consisted of two cycles, one dose per cycle, with a 5-day washout
      period between doses.
    

Detailed description: 
      A: A single dose of MY008211A tablets was administered in the fasting state (fasting for at
      least 10 h with water as needed).

      B: A single dose of MY008211A tablets was administered after a standard high-fat,
      high-calorie fed.
    

Intervention name(s): MY008211A tablets
Intervention type(s): Drug
Intervention description(s): A single dose of MY008211A tablet was administered after fasting and high-fat, high-calorie feeding
Other intervention name(s): no other name
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers
Condition: Venous Stasis Ulcers
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Study type: Interventional

Summary: 
      The purpose of this study is to test the efficacy of an oral, nutrient intervention
      containing the bioactive components of fish oil to promote healing of chronic venous leg
      ulcers (CVLU). If this systemic, nutrient intervention is found to alter the microenvironment
      of CVLU, the science of wound healing and care of patients with CVLU will be vastly improved.
    

Detailed description: 
      The pathogenesis of CVLU involves high numbers of activated polymorphonuclear leukocytes
      (PMN) that are associated with persistent inflammation in the wound bed 5-9. We propose to
      test the efficacy of an oral, nutrient intervention containing the bioactive components of
      fish oil to assuage PMN activity and promote healing of CVLU. If this systemic, nutrient
      intervention is found to alter the microenvironment of CVLU, the science of wound healing and
      care of patients with CVLU will be vastly improved.

      The purpose of this study is to test three fundamental corollaries of our organizing
      hypothesis in a 2-group, double-blind, randomized, experimental design on CVLU patients. The
      findings from the proposed experiments will increase our understanding of lipid mediators
      that influence wound healing and PMN function, and may lead to an innovative approach to
      reduce the physical and emotional burdens of nonhealing or recurrent CVLU.
    

Intervention name(s): Fish Oil
Intervention type(s): Dietary Supplement
Intervention description(s): EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: leg ulcers; wounds; fish oil; lipid mediators; chronic venous stasis ulcers
Effect of Antacids on the Pharmacokinetics of Raltegravir
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test whether there is a drug interaction between raltegravir
      (a medicine used to treat the human immunodeficiency virus or HIV) and antacids.
    

Detailed description: 
      This study will determine if an interaction occurs between the HIV medicine raltegravir and
      an antacid. A prior study found an interaction with another medicine like raltegravir called
      elvitegravir and an antacid. The elvitegravir levels were reduced by half. The same
      interaction may occur with raltegravir and an antacid based on the structure of this medicine
      and how it works. When the levels of HIV medications are reduced, people with HIV can "fail"
      their treatment. The virus can multiply when the drug levels are too low and the medications
      can stop working. We need to be sure that antacids will not cause this problem with
      raltegravir.
    

Intervention name(s): raltegravir; antacid
Intervention type(s): Drug; Drug
Intervention description(s): raltegravir 400mg orally once; aluminum, magnesium, simethicone-containing antacid 30mL orally once
Other intervention name(s): Isentress; Isentress, Maalox Plus Extra Strength
Intervention MeSH terms: Raltegravir Potassium; Antacids; Aluminum hydroxide, magnesium hydroxide, simethicone drug combination; TEMPO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIV; antiretroviral; drug interaction; human immunodeficiency virus
The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain
Condition: Chronic Low Back Pain; Fear of Pain; Fear of Injury
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study will measure the effects of interactive, whole-body video games on movement
      behavior in people with chronic low back pain.
    

Detailed description: 
      A fundamental clinical problem in individuals with chronic low back pain is the significant
      alteration in movement patterns that restrict lumbar spine motion. This restriction of lumbar
      motion is particularly evident in patients with kinesiophobia; that is, a fear of movement
      due to possible injury or reinjury. For chronic back pain patients with kinesiophobia it is
      critical to develop an effective intervention to increase spine motion while minimizing
      concerns of pain and harm. Accordingly, we have developed a innovative video games that track
      whole-body motion and are designed to encourage spinal flexion while reducing concerns of
      pain and harm among individuals with low back pain. Our games have two distinct advantages.
      First, within this video game environment, visual feedback can be altered by changing the
      feedback gain of a given movement (e.g., the magnitude of a given joint movement could appear
      on screen as either larger or smaller than the actual movement). Thus, gain manipulation will
      result in progressively larger amounts of lumbar spine flexion during game play. Second,
      video games are potent distractors that can reduce attention to pain.
    

Intervention name(s): Experimental Group 1; Experimental Group 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).; Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of two intervention arms. Both intervention arms involve immersive video games that encourage participants to produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. The two groups are distinguished by the amount of lumbar flexion needed to achieve game objectives.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Postoperative Pain After Craniotomy
Condition: Pain, Postoperative; Post-Craniotomy Headache
MeSH terms: Pain, Postoperative; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      A majority of patients would suffer from moderate-to-severe postoperative pain after
      undergoing craniotomy. As a result, adequate pain control is essential for patients'
      prognosis and their postoperative life quality. Although opioids administration is regarded
      as the first-line analgesic for post-craniotomy pain management, it may be associated with
      delayed awakening, respiratory depression, hypercarbia and it may interfere with the
      neurologic examination. For the avoidance of side-effects of systemic opioids, local
      anesthetics administered around the incision have been performed clinically. However, some
      studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to
      its short pain relief duration. As is reported that postoperative pain of craniotomy is
      mainly caused by skin incision and reflection of muscles, preventing the liberation of
      inflammatory mediators around the incision seems to be more effective than simply blocking
      nerve conduction. Thus, Investigators suppose that pre-emptive scalp infiltration with
      steroid (dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain
      after craniotomy in adults.
    


Intervention name(s): Miscible liquid of dexamethasone and ropivacaine; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Intervention in this study will be peri-incisional scalp infiltration with dexamethasone, ropivacaine and normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing 0.33mg dexamethasone and 5mg ropivacaine per milliliter will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.; Intervention in this study will be peri-incisional scalp infiltration with ropivacaine for participants who will undergo elective craniotomy. The local infiltration solution containing 5mg ropivacaine per milliliter will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
Intervention MeSH terms: Dexamethasone; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative Pain; Post-Craniotomy Headache; Dexamethasone; Ropivacaine; Pre-emptive Scalp Infiltration
Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      Combining fish oil supplementation and Montelukast [a commonly used cyst LT1 receptor
      antagonist to treat exercise-induced bronchoconstriction (EIB)] will provide a greater
      antiinflammatory effect against developing EIB that either agent alone
    

Detailed description: 
      The aim of this study is to extend previous published findings that fish oil supplementation
      represents a beneficial treatment on exercise-induced bronchoconstriction (EIB). An important
      question is how dietary fish oil supplementation fits in with the available armamentarium
      [e.g., leukotriene (LT) modifiers] to decrease the expression of LTs, and whether fish oil
      supplementation may be additive, or used in its own right to block the EIB response. For
      example, it is possible that a combination of fish oil supplementation and a cyst LT1
      receptor antagonist (LTRA) may provide a greater antiinflammatory effect against developing
      EIB that either agent alone.
    

Intervention name(s): Active Montelukast + Fish Oil Placebo; Active Fish Oil + Montelukast Placebo; Active Montelukast + Active Fish Oil
Intervention type(s): Other; Other; Other
Intervention description(s): Montelukast (1 x 10 mg tablet) per day + 10 tablets of fish oil placebo (soy bean oil) per day for a duration of 3 weeks; 10 tablets (3.2 g EPA + 2.0 g DHA) per day and 1 x 10 mg Montelukast Placebo tablet per day for a duration of 3 weeks.; 1 x 10 mg Montelukast tablet per day and 10 tablets of active fish oil (3.2 g EPA + 2.0 g DHA) for a duration of 3 weeks.
Other intervention name(s): Singulair (montelukast). Placebo (no brand name).; Pro-Omega Fish Oil. Montelukast placebo (no brand name).; Singulair (Montelukast) and Pro-Omega (Fish Oil).
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Inflammation; Airway; Fish Oil; Singulair
Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation
Condition: Carotid Stenosis; Carotid Artery Diseases
MeSH terms: Carotid Stenosis; Carotid Artery Diseases
Study type: Interventional

Summary: 
      A prospective comparative randomized single-centre non-inferiority trial. The purpose of this
      study is to compares of modified method of eversion carotid endarterectomy with standard
      eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with
      extensive atherosclerotic disease of carotid bifurcation
    

Detailed description: 
      Introduction. Performing eversion endarterectomy some difficulties arise. Firstly, it
      requires a great deal of coherence between the work of the surgeon and the first assistant,
      as well as a great experience of the latter. Secondly, in some cases, there are difficulties
      in visualizing the distal margin of the intima: in the absence of a rigid skeleton, the soft
      unchanged artery walls after removal of the plaque subside, making it difficult to visualize
      possible fragments of the intima. Thirdly, the cost of the error is high: with a random
      de-version, repeated eversion turns out to be impossible. It should be noted that the use of
      an eversion technique becomes difficult to implement, and sometimes impossible, with extended
      stenosis, since a very high allocation of the ICA is required, which increases the
      invasiveness of the operation and the difficulty of access. With prolonged stenosis, the
      carotid endarterectomy remains the option of choice. The modification used eversion carotid
      endarterectomy combines the advantages of both methods, and also eliminates the limitations
      of the carotid endarterectomy and eversion carotid endarterectomy.

      The aim of study. The purpose of this study is to compares of modified method of eversion
      carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months
      days after operation in patients with extensive atherosclerotic disease of carotid
      bifurcation
    

Intervention name(s): Modified method of eversion carotid endarterectomy; Standard method of eversion carotid endarterectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Mini approach for CCA bifurcation - Clamping ICA, ECA and CCA - ICA is cut off with a scalpel at the mouth itself - Dissection of the ICA and ECA in the distal direction to the distal border of the atherosclerotic plaque - Endarterectomy - Performing of a new bifurcation of the CCA with prolene 7/0; standard eversion technic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: carotid endarterectomy; eversion carotid endarterectomy; prophylaxis of ischemic stroke; carotid arteriosclerosis; carotid artery plasty
AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be
      evaluated.
    

Detailed description: 
      This is an open-label study comprised of two parts. Part I is a single-arm, run-in cycle with
      AG200-15 administered to all subjects as a 21-7 day regimen (three consecutive weeks of patch
      wear followed by a patch-free week).

      Part II employs crossover design with subjects randomly assigned to one of the two treatment
      sequences. Each sequence will include AG200-15 and oral contraceptive (Ortho-Cyclen®) as
      described below: Sequence 1: AG200-15 (Period 1) followed by oral contraceptive,
      Ortho-Cyclen® (Period 2); Sequence 2: Oral contraceptive, Ortho-Cyclen® (Period 1) followed
      by AG200-15 (Period 2) Both AG200-15 and Ortho-Cyclen® will be administered as 21-7 day
      regimen (three consecutive weeks of drug-taking followed by a drug-free week). Duration of
      each treatment Period is 28 days (one cycle of therapy).
    

Intervention name(s): Ortho-Cyclen; AG200-15
Intervention type(s): Drug; Drug
Intervention description(s): Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.; AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE
Other intervention name(s): oral contraceptive; transdermal contraception
Intervention MeSH terms: Moxifloxacin; Contraceptive Agents; Norgestimate, ethinyl estradiol drug combination; Contraceptives, Oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PK and safety; Pharmacokinetic profile (PK) and safety
A Study of Oral AT2101 (Afegostat Tartrate) in Treatment-naive Patients With Gaucher Disease
Condition: Gaucher Disease; Type 1 Gaucher Disease; Gaucher Disease, Type 1
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the safety and tolerability of afegostat tartrate in participants with
      type 1 Gaucher disease who were not receiving enzyme replacement therapy (ERT) or substrate
      reduction therapy (SRT).
    

Detailed description: 
      This was a Phase 2, open-label study in participants with Gaucher disease, a lysosomal
      storage disorder. Afegostat tartrate (also known as AT2101 or isofagomine tartrate) is
      designed to act as a pharmacological chaperone by selectively binding to misfolded
      β-glucocerebrosidase (GCase) and helping it fold correctly, intended to restore GCase
      activity. The study consisted of a 21-day screening period, a 24-week treatment period, and
      follow-up visit (Day 183, end-of-study). Participants were randomized in a 1:1 ratio to 1 of
      2 treatment regimens for afegostat tartrate (3 days on treatment/4 days off or 7 days on
      treatment/7 days off).
    

Intervention name(s): afegostat tartrate
Intervention type(s): Drug
Other intervention name(s): isofagomine tartrate; AT2101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amicus Therapeutics; afegostat tartrate; isofagomine tartrate; AT2101
Risk Factors for Nausea and Vomiting After Cesarean
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Observational

Summary: 
      Investigators will observe the incidence of post-cesarean nausea or vomiting and try to
      associate it with some risk factors.
    

Detailed description: 
      A single prospective cohort of women submitted to cesarean section who received spinal
      anesthesia will be assessed for the proposed risk factors and the incidence of nausea or
      vomiting will be observed during the first 48 hours.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women with indication for cesarean section in the University Hospital of
        University of Brasilia.
      
Keywords: Postoperative Nausea and Vomiting; cesarean; risk factors