bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Therapeutic Effects of Trigger Point Injection and Twin Nerve Block in Chronic Myofascial Pain Patients
Condition: Myofascial Pain - Dysfunction Syndrome of TMJ; Trigger Point Pain, Myofascial; Nerve Block
MeSH terms: Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      To see if there is there any difference in the treatment outcomes/results such as changes in
      pain intensity in patients with myofascial pain who have been treated with trigger point
      injections or twin block?
    

Detailed description: 
      Most treatment approaches for chronic myofascial pain are not evidence-based. Studies are
      usually controversial. Most are short-term, non-randomized. An essential limitation has been
      the lack of standardization of diagnosis. Some studies do not differentiate between joint
      pain and muscle pain, which can significantly affect the outcome of the treatment provided.

      Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) was recently published and
      validated. Their protocol allows standardization of the assessment and diagnosis of patients
      with temporomandibular disorder, including myofascial pain.

      To the investigator's knowledge, no previous prospective, randomized study has been conducted
      demonstrating the treatment outcomes of either trigger point injections or twin block in
      patients with chronic myofascial pain.
    

Intervention name(s): Injection of either twin block or trigger point injection.
Intervention type(s): Other
Intervention description(s): Study participants will be randomized into either group and will receive the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure
Condition: Heart Failure, Congestive; Dilated Cardiomyopathy
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is divided into 2 parts. In the first part, the safety of the gene transfer agent
      MYDICAR® will be evaluated. In the second part, the ability of MYDICAR® to improve heart
      function will be studied.
    

Detailed description: 
      The American Heart Association (AHA) 2006 update on heart disease reported that 5 million
      Americans are believed to have symptomatic heart failure (HF), and 550,000 patients are newly
      diagnosed each year. The estimated direct and indirect cost of HF in the United States (U.S.)
      for 2006 will be ~$29.6 billion. Heart failure is a disabling chronic disease and the most
      frequent discharge diagnosis for hospitalization among older adults. Despite the significant
      resources expended on the treatment of this disease, outcomes remain poor. The five-year
      survival for individuals diagnosed with heart failure is less than 50%, and in end-stage
      heart failure, the one-year survival may be as low as 25% regardless of medical therapy.

      Recent studies suggest that the failing heart is not refractory to treatment, as was
      previously believed. For example, the observation that a small percentage of subjects with
      left ventricular assist devices (LVADs) can be permanently weaned from their device strongly
      suggests that damaged hearts are capable of recovering lost function.

      Clinical studies of MYDICAR® have not yet been conducted in humans. Celladon Corporation
      (Celladon) proposes to investigate gene transfer as a method to restore SERCA2a function in
      heart failure (HF) patients using a recombinant adeno-associated viral vector (AAV), which
      consists of an AAV serotype 1 capsid and contains the human SERCA2a complementary DNA (cDNA)
      flanked by Inverted Terminal Repeats (ITR) derived from AAV serotype 2 (AAV1/SERCA2a).
      MYDICAR® refers to AAV1/SERCA2a drug product intended for administration by percutaneous
      delivery.
    

Intervention name(s): MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study); Placebo Infusion; MYDICAR Phase 2 (Placebo-controlled, Randomized Study)
Intervention type(s): Genetic; Procedure; Genetic
Intervention description(s): MYDICAR administered by antegrade epicardial coronary artery infusion; Saline; epicardial coronary artery infusion; MYDICAR administered by antegrade epicardial coronary artery infusion
Other intervention name(s): AAV1/SERCA2a; AAV1/SERCA2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Barley Tortillas Study in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      The variation in starch and fibre composition of prepared barley tortillas will have a
      significant effect on glycemic response.
    

Detailed description: 
      Specifically, we wish to examine the glycemic response of barley tortillas containing
      different ratios of amylose and amylopectin and different amounts of soluble and insoluble
      fibre with an appropriate control during acute phase testing in healthy volunteers. Possible
      relationships between composition of the barley tortillas and the degree of physiological
      response will also be investigated as the secondary objective.
    

Intervention name(s): food product
Intervention type(s): Dietary Supplement
Intervention description(s): food product given at one of six visits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Healthy volunteers
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, randomized, parallel-arm study will assess the early immunologic response in
      treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment
      with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4
      cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally
      daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may
      opt to receive standard of care treatment with Pegasys. Target sample size is <50.
    


Intervention name(s): peginterferon alfa-2a [Pegasys]; tenofovir
Intervention type(s): Drug; Drug
Intervention description(s): 360 micrograms sc/week for 2 weeks; 300mg po daily for 2 weeks
Intervention MeSH terms: Tenofovir; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acupuncture for Body Weight Control
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      In this study, a 18-week, single-blinded, randomized controlled clinical trial will be
      conducted to evaluate the effectiveness, efficacy and safety of acupuncture on weight control
      in Hong Kong.
    

Detailed description: 
      This is a pilot single-blind, randomized, sham-controlled trial. 72 participants will be
      randomly assigned to acupuncture group or control group. The duration of the treatment will
      be 8 weeks with 2 sessions per week and the follow-up period will be 8 weeks.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): Eight body acupuncture points will be chosen as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli(ST-36), Fenlong(ST-40), Sanyinjiao(SP-6). The needles will be retained for 30 minutes.
Participants of the treatment group will additionally receive unilateral auricular acupressure at four auricular points as Hunger, Shen men, Spleen and Stomach with Semen Vaccariae embedded within adhesive tape in each treatment session. Acupressure will be applied by the subjects with repeat pressing of the tape with fingertips for 3 minutes per point, 3 times per day. The embedded tape will be retained in-situ until the next visit and then the alternate side of ear will be treated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: acupuncture; Chinese Medicine; obesity
Effect of Study Probiotics on Body Fat Mass in Overweight and Obese Individuals Following Healthy Lifestyle Intervention
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      A randomized, double-blind, placebo-controlled, multi-center, parallel group study on
      overweight and obese individuals following healthy lifestyle consisting of calorie-reduced
      diet (20% calorie restriction) and increase in daily activity (1000 steps more per day once
      compared to the baseline steps)
    


Intervention name(s): Daily intake of study product
Intervention type(s): Dietary Supplement
Intervention description(s): Daily intake of Bifidobacterium animalis ssp. lactis 420 or placebo for a 6-month period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Overweight; Obesity
The Effect of Vitamin D Sublingual Spray on Vitamin D3 Levels in the Blood Compared to Other Forms of Vitamin D3
Condition: Vitamin D3 Deficiency
Study type: Interventional

Summary: 
      The randomized comparative study was performed on 99 outpatients with below 30 ng/ml of
      vitamin D. Participants were randomized into three groups to receive vitamin D3
      supplementation in three different forms - sublingual spray, oral oil droplets, and capsules.
      Each participant received vitamin D3 4000 IU daily for 30 days and the vitamin D levels were
      measured before and after the intervention.
    

Detailed description: 
      This randomized comparative study was performed in Liepaja, Latvia, on 99 outpatients, with
      vitamin D levels below 30 ng/ml. Participants were randomized into three groups to receive
      vitamin D3 supplementation in three different forms - sublingual spray, oral oil droplets,
      and capsules. Before intervention blood samples were taken to determine vitamin D3 level,
      creatinine, and GFR, each participant received vitamin D3 4000 IU daily for 30 days. After
      that blood test was performed again, to measure changes in vitamin D3 levels in the blood.
      Participants answered the questionnaire to collect information about things that might affect
      vitamin D3 levels, such as dietary habits, physical activities, usage of sunscreen,
      compliance, etc.
    

Intervention name(s): Vitamin D substitution with sublingual sprayable microemulsion.; Vitamin D substitution with oil droplets; Vitamin D substitution with capsules
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants received sublingual sprayable microemulsion of vitamin D3 4000 IU daily for 30 days.; Participants received oil droplets of vitamin D3 4000 IU daily for 30 days.; Participants received capsules of vitamin D3 4000 IU daily for 30 days.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This is a pilot study to assess the effectiveness, safety and feasibility of carotid body
      removal in patients with high blood pressure (hypertension) resistant to medical treatment.
      Patients with high blood pressure are at significant risk of medical complications including
      stroke and heart disease. The principle research question is whether removal of the carotid
      body will lead to an improvement in the blood pressure of this patient group.
    


Intervention name(s): Carotid body excision
Intervention type(s): Procedure
Intervention description(s): This surgery does not involve any study drug or investigational device.
The carotid body will be removed by the so called 'lateral approach' or a combined 'lateral and medial approach'. In all cases the target area was defined as the tissue in between the ECA and ICA, up to 5-6mm above the bifurcation point of the common carotid artery into the ECA and ICA. In a lateral approach the carotid bifurcation is not turned. A combined approach includes usually dissection of the superior thyroid vessel and turning of the carotid bifurcation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Effect of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the
      body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s)
      with mild or moderate hepatic impairment and matched control Participants with normal hepatic
      function.
    

Detailed description: 
      This is an open-label (identity of assigned study drug will be known) pharmacokinetics and
      safety study of abiraterone acetate administered as four 250 mg tablets (1000 mg) to 3
      cohorts (groups) in Cohort 1 (Mild Hepatic Impairment), Cohort 2 (Moderate Hepatic
      Impairment) and Cohort 3 (Normal Hepatic Function). There will be approximately 8
      Participants per cohort (total of approximately 24 Participants for the study). The cohorts
      will be dosed sequentially and activities will consist of Screening, Study and Follow-up
      periods, a total of up to approximately 36 days. Possible Participants will be screened to
      assess their eligibility to enter the study within 14 days prior to study Day 1. Participants
      will be confined at the Clinical Research Center (CRC) from the time of Check-in on Day -1
      until discharge on Day 5. Participants will return to the CRC on Days 8 and 15 and there will
      be a follow-up call or visit on Day 22. A review of all clinical and laboratory data through
      Day 8 evaluations in each cohort will be done by the Medical Monitor and the Principal
      Investigator (PI) prior to proceeding with dosing any further cohort, if indicated. Safety
      will be monitored throughout the study.
    

Intervention name(s): Abiraterone acetate
Intervention type(s): Drug
Intervention description(s): On the morning of Day 1, each participant was given four 250 mg tablets of abiraterone acetate with 240 mL of room temperature tap water. Dosing followed at least a 10-hour fast from food (not including water).
Intervention MeSH terms: Abiraterone Acetate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate Cancer; Abiraterone acetate; Pharmacokinetics
Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
Condition: Diabetes Mellitus; Diabetes Mellitus Complications; Gastroparesis
MeSH terms: Gastroparesis; Diabetes Mellitus; Diabetes Complications; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of multiple dose regimens of relamorelin
      on vomiting episodes, gastric emptying and gastroparesis symptoms in participants with Type 1
      and Type 2 diabetes mellitus and gastroparesis. Study drug (relamorelin and placebo) will be
      administered subcutaneously in a blinded fashion.
    


Intervention name(s): Relamorelin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Double blind relamorelin was given subcutaneously BID for 12 weeks.; Placebo given subcutaneously for 12 weeks.
Other intervention name(s): RM-131
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Delayed Gastric Emptying; Vomiting; Gastroparesis; Gastrointestinal Motility Disorder
A Study Evaluating the Bioavailability of Oral Insulin (N11005)
Condition: PK, PD, and Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to preliminarily verify whether the oral insulin N11005 is a
      prandial insulin by assessing the PK, PD, and safety profiles of N11005.
    


Intervention name(s): N11005; Novolin R
Intervention type(s): Drug; Drug
Intervention description(s): oral insulin N11005, 300IU, p.o.; reference preparation Novolin R, 0.1 IU/Kg, i.h.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
IOTA Versus Pattern Recognition Method in Diagnosis of Ovarian Masses
Condition: Gynecology
Study type: Interventional

Summary: 
      To compare between the efficacy of IOTA simple rules and pattern recognition method in the
      differentiating between benign and malignant adnexal masses
    


Intervention name(s): Transvaginal ultrasonography
Intervention type(s): Device
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Home and School Visits Intervention for Children With DM TYPE 1
Condition: Diabetes Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Home and school visits by multidisciplinary team will improve metabolic control in kids
      having insulin dependent diabetes mellitus
    


Intervention name(s): Home and school visits
Intervention type(s): Other
Intervention description(s): Each child in the intervention group received, in addition to the standard care at the diabetic clinic, home and school visits by a multidisciplinary team during one year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Percutaneous Neuromodulation on the Anterior Pain Knee
Condition: Neuromodulation; Anterior Pain Knee; Femoral Nerve
Study type: Interventional

Summary: 
      Anterior knee pain (AKP) is one of the most frequent pathologies of the lower limb, in young
      and adult subjects. In the field of Physiotherapy, ultrasound-guided Percutaneous
      Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance
      of an electrical current at low or medium frequency, seeking a sensitive and / or motor
      response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor
      point, with a therapeutic objective. The objective of this study is to analyze that the
      effect of PNM on the femoral nerve produces statistically significant changes in pain, joint
      range and knee functionality in patients with chronic AKP. Thirty subjects will be recruited,
      which will be divided into 2 groups: group 1 to which PNM will be applied to the femoral
      nerve of the pain knee; and group 2 to which PNM will be applied to the femoral nerve of the
      non-pain knee. The PNM intervention with NMP will consist in the single application of an
      asymmetric rectangular biphasic current (250 microseconds, 10 Hz)
    


Intervention name(s): PNM
Intervention type(s): Other
Intervention description(s): an asymmetric rectangular biphasic current (250 microseconds, 10 Hz)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System
Condition: Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer
Study type: Interventional

Summary: 
      The goal of this study is to observe the clinical safety and effectiveness of the ArstasisOne
      Access System in patients undergoing diagnostic angiographic procedures through the femoral
      artery.
    


Intervention name(s): Diagnostic catheterization procedure
Intervention type(s): Device
Intervention description(s): Intervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Pharmacokinetic and Pharmacodynamic Study of Glufast Tablets 10mg(Mitiglinide)
Condition: Type 2 Diabetes Mellitus; Liver Dysfunction
MeSH terms: Liver Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical trial is designed to assess the effect of hepatic impairment on the
      pharmacokinetic and pharmacodynamic of glufast tablets 10 mg.
    

Detailed description: 
      Mitiglinide calcium hydrate (Glufast Tablets) is an insulinotropic agent of the glinide class
      with rapid onset and is chemically designated as (+)-monocalcium
      bis[(2S,3a,7a-cis)-α-benzylhexahydro-γ-oxo-2-isoindolinebutyrate] dihydrate.By transiently
      increasing insulin secretion, mitiglinide exerts a hypoglycemic effect with rapid onset and
      short duration of action.This effect results from the inhibitory effect of mitiglinide on the
      ATP-sensitive potassium (KATP) channel current through binding to sulfonylurea receptor in
      pancreatic cells.

      In an in vitro study, it was confirmed that mitiglinide is metabolized in liver and kidney,
      and the glucuronide and hydroxyl metabolites are mainly produced by drug metabolizing
      enzyme,UGT1A9 and 1A3, and by CYP2C9, respectively.Considering that the patient population
      with T2DM to be targeted appears to have hepatic impairment and the effects of liver
      dysfunction on pharmacokinetics and pharmacodynamics of mitiglinide are still unknown, this
      study was designed to investigate the pharmacokinetics (PK), pharmacodynamics (PD) and safety
      of mitiglinide when administered to T2DM patients with impaired hepatic function.
    

Intervention name(s): Mitiglinide
Intervention type(s): Drug
Intervention description(s): Day 1: one tablet of Mitiglinide 10mg with 240 ml of water approximately 5 mins before breakfast. An indwelling non-heparin catheter will be placed in an antecubital vein of the forearm or direct venipuncture will be adopted for blood sample collection at belowing time point:
For PK evaluation:
-30 (Predose), 5, 10, 15, 20, 30 min, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10 hr post dose (a total of 17 samples per subject)
For PD evaluation:
-30 (Predose), 15, 30 min, 1.0, 1.5, 2.0, 3.0, 4.0 hours post dose (a total of 8 samples per subject)
Other intervention name(s): glufast
Intervention MeSH terms: Mitiglinide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 DM; mitiglinide; Pharmacokinetics; Pharmacodynamics; liver dysfunction