bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
Condition: Chronic Prostatitis; Chronic Pelvic Pain Syndrome
MeSH terms: Prostatitis; Syndrome; Pelvic Pain; Chronic Disease; Somatoform Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen
      extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was
      investigated. The purpose of this study is to determine whether Cernilton is safe and
      effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.
    

Detailed description: 
      We conducted a multicenter, randomized, double-blind, placebo-controlled trial to assess
      safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory
      CP-CPPS (National Institutes of Health (NIH) type IIIA). Participants were randomized to
      Cernilton or placebo for 12 weeks and were evaluated using the National Institutes of Health
      Chronic Prostatitis Symptom Index (NIH-CPSI) individual domains and total score, the number
      of leukocytes in post prostatic massage urine, the International Prostate Symptom Score
      (IPSS) and the sexuality domain of a life satisfaction questionnaire at baseline and after 6
      and 12 weeks.
    

Intervention name(s): Cernilton; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 23 mg Extractum Pollens siccatum, 4 mg L-glutamate and 0.23 mg Stigmasterol per capsule for 12 weeks.; Oral placebo, 2 capsules every 8 hours with identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic prostatitis symptom index; male; inflammatory; CP-CPPS; Cernilton; pelvic pain; symptoms
Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris
Condition: Facial Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      Acne is a chronic inflammatory dermatosis of the pilosebaceous unit. Topical treatment is the
      first choice in mild and moderate cases of acne, especially topical retinoids. Although
      topical retinoids are very effective in the treatment of acne, local cutaneous irritation
      including burning, itching, erythema, peeling or dryness, is observed in a considerable
      number of patients, resulting in low patient compliance, compromising the efficacy of the
      therapy.

      Several approaches have been proposed to address these concerns, including the use of esters
      of retinoic acid (RA) and RA precursors, such as retinol and retinaldehyde, or novel drug
      delivery systems, which present the potential for controlled release, in turn reducing the
      aforementioned occurrences.

      Encapsulation of retinoids into vesicular carriers as liposomes and ethosomes and
      nanoparticulate carriers can significantly improve their effects for the treatment of acne
      compared with commercial formulations , providing better tolerability of irritating retinoid.

      The aim of work is to assess the efficacy and tolerability of the topical application of
      Retinyl Palmitate-loaded ethosome formulation in the treatment of acne vulgaris in comparison
      to conventional formulation of classic retinoids
    


Intervention name(s): retinyl palmitate; Tretinoin
Intervention type(s): Drug; Drug
Intervention description(s): topical retinyl palmitate loaded ethosomes; topical tretinoin
Other intervention name(s): retinyl palmitate ethosomes; classic retinoid
Intervention MeSH terms: Vitamin A; Tretinoin; Retinol palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Prospective, split face comparative clinical study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne vulgaris; retinoids; retinyl palmitate; ethosomes
A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)
Condition: Myasthenia Gravis; Myasthenia Gravis, Juvenile Form; Myasthenia Gravis, Generalized
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and
      pharmacodynamics of eculizumab in the treatment of pediatric refractory gMG based on change
      from Baseline in the Quantitative Myasthenia Gravis (QMG) score for disease severity.
    

Detailed description: 
      The study will consist of an up to 4-week Screening Period, 26-week Primary Evaluation
      Treatment Period, an additional (up to) to 208-week Extension Period, and an 8-week Safety
      Follow-up Period.
    

Intervention name(s): Eculizumab
Intervention type(s): Drug
Intervention description(s): Eculizumab will be administered by IV infusion.
Intervention MeSH terms: Eculizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myasthenia Gravis; Myasthenia Gravis, Generalized
Effect of an Extract of Green Tea on Adults With Type 2 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study was to determine if taking an extract of green tea for three
      months could improve glucose control in adults with diabetes.
    

Detailed description: 
      Background: Recent evidence suggests that tea from Camellia Senensis (e.g., green, oolong and
      black tea) may have a hypoglycemic effect.

      Objective: We evaluated the ability of an extract of green and black tea to improve glucose
      control over a three month period using a double blinded randomized multiple dose (either
      placebo, 375mg or 750mg) study in adults in with Type 2 Diabetes.

      Patients: The 49 subjects who completed this study were predominantly whites with an average
      age of 65, a median duration of Diabetes of 6 years, and 80% reported using hypoglycemic
      medication.

      Measurements: HbA1c at three months was the primary endpoint. Results: After three months the
      mean changes in HbA1c were +0.4, +0.3 and +0.5, in the placebo, 375mg and 750mg arms,
      respectively. The changes were not significantly different between study arms.

      Limitations: Evaluation of a particular extract that contained components of black teas as
      well as green tea. Power insufficient to detect changes in HbA1c < 0.5.

      Conclusions: We did not find a hypoglycemic effect of extract of green tea in adults with
      Type 2 Diabetes, but cannot rule out the possibility that tea may have a small beneficial
      effect.
    

Intervention name(s): Extract of Green and Black Tea
Intervention type(s): Drug
Other intervention name(s): Placebo Arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis
Condition: Rotator Cuff Tendonitis; Bicipital Tendonitis; Subdeltoid Bursitis of the Shoulder; Subacromial Bursitis of the Shoulder; Medial Epicondylitis of the Elbow; Lateral Epicondylitis of the Elbow; DeQuervain's Tenosynovitis of the Wrist
MeSH terms: Tennis Elbow; Tendinopathy; Bursitis; Tenosynovitis; Elbow Tendinopathy; Rotator Cuff Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary purpose of this study is to assess the effectiveness of once daily application of
      a diclofenac sodium patch to the skin near or over the painful area. In this study, the
      location being studied will be one of the following: the affected shoulder, elbow, or wrist.

      The secondary purpose of this study is to assess the safety and tolerability of the
      diclofenac patch on the subject's skin, in the location being studied.
    

Detailed description: 
      Cerimon Pharmaceuticals is investigating a topical patch formulation of diclofenac sodium
      containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.
    

Intervention name(s): diclofenac sodium; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily; Matching placebo patch, containing identical constituents to active patch except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily
Other intervention name(s): diclofenac; placebo
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tendonitis; Bursitis
Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment
Condition: Dental Caries; Child Discomfort
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the current study was to compare pain perception of young children treated with
      SDF and ART, as well as their parents' acceptability of both modalities.
    

Detailed description: 
      Eighty, 3-8-years-old children, having at least one deciduous asymptomatic tooth with active
      caries were randomly assigned into 2 groups; SDF for caries arresting in the test group, and
      ART for caries removal in the control group.
    

Intervention name(s): SDF; ART
Intervention type(s): Drug; Drug
Intervention description(s): Steps of SDF 38% application were carried out following the manufacturer's instructions. Eligible primary carious teeth were first dried and isolated using cotton rolls and gauze. Adjacent soft tissues were isolated using petrolleum gelly in order to prevent any irritation or staining from SDF that was directly placed into the carious lesion using a microbrush, allowed to absorb for 2 minutes, then dried with air. Parents were instructed that children should not eat for one hour after treatment. The second application was done after 6 months.; Steps of ART caries removal were carried out following the Frencken et al. criteria where the cavity opening was widened using the tip of a dental hatchet. The carious dentin was then removed using a spoon excavator starting at the enamel-dentin junction, unsupported enamel was removed using the hatchet, and finally the cavity was cleaned using a wet cotton pellet and dried. After complete removal of infected dentin, the cavity walls and floor were conditioned for 10 seconds, washed and dried with cotton pellets, then restored with chemically cured glass ionomer cement that was applied under finger pressure, then coated with petroleum jelly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation
Condition: Unspecified Complication of Liver Transplant
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the effectiveness of the administration produced antioxidant N-acetylcysteine (NAC),
      decreasing the incidence of primary graft dysfunction and primary failure. The degree of
      dysfunction will be monitored by the method of LIMON, metabonomics techniques and according
      to the latest published validation Liver Transplantation (16 943-949 2010), total
      billirrubina greater than 10 mg / dl, INR greater than 1.6 in the seventh postoperative day
      and alanine or aspartate aminotransferase greater than 2000 IU / L in the first seven days.
      Liver dysfunction is considered, the presence of a transaminase value> 2000 IU / L 1-7
      postoperative day or BT> 10 mg / dl or INR> 1.6, both only in the 7th postoperative day
      (Olthoff et al Liver Transplantation 16,943 -949 2010).
    

Detailed description: 
      The reason of this study is to evaluate the efficacy of the use of n-acetylcysteine in liver
      transplant, by administering it in the perfusion liquid, at the time of extraction of the
      liver of the donor to improve the damage caused by ischemia / reperfusion. The dose is 400 mg
      in the portal perfusion liquid.

      The study included all considered valid and perfused livers. Patients are randomized to
      contain no drug or n-acetylcysteine by randomization. Then analyzed using blood tests and in
      the receiver and daily during the first seven days post-transplant hepatic dysfunction
      parameters, in order to objectify if liver function improves after administration of the
      antioxidant (n-acetylcysteine ). Safety assessments were performed with intraoperative
      monitoring anesthetic depth, postoperative parameters of liver and kidney function and graft
      pathologic examination after perfusion.
    

Intervention name(s): N-acetylcysteine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Bath transplanted liver with N-acetylcysteine; Bath saline transplanted liver
Other intervention name(s): Flumil Solution injectable 300 Mg; It's not describe in a protocol
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Liver transplantation, n-acetylcysteine
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
Condition: Stroke; Transient Ischemic Attack
MeSH terms: Stroke; Ischemic Attack, Transient; Foramen Ovale, Patent
Study type: Interventional

Summary: 
      The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE®
      HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical
      management is safe and effective and reduces the risk of recurrent stroke or
      imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical
      management alone in patients with a PFO and history of cryptogenic stroke or
      imaging-confirmed TIA.

      A co-primary objective is to demonstrate that medical management plus closure with the study
      device reduces the risk of new brain infarct compared to medical management alone.
    


Intervention name(s): Septal Occluder Device; Antiplatelet Medical Therapy
Intervention type(s): Device; Drug
Intervention description(s): PFO closure with study septal occluder device; Investigator's choice of one of three regimen options specified in protocol
Other intervention name(s): GORE® HELEX® Septal Occluder; GORE® CARDIOFORM Septal Occluder; Aspirin; Dipyridamole; Aggrenox; Clopidogrel; Plavix
Intervention MeSH terms: Dipyridamole; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cryptogenic; stroke; transient ischemic attack; TIA; PFO; Patent foramen ovale; HELEX; Septal Occluder; PFO Occluder
Effects of tDCS in M1 and DLPFC on Pain Processing in Healthy Volunteers
Condition: Pain Processing in Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of a direct current applied transcranial
      over two cortical areas on healthy volunteers' pain processing.
    


Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Direct current application over the scalp to stimulate and change the excitability of the cortical areas underneath the electrodes (in this case left primary motor cortex and left dorsolateral prefrontal cortex).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three groups cross over study with two intervention groups and one sham group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Virtual Reality for Pain Management Study
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Virtual Reality (VR) is one non-pharmacological method that has shown promise as an effective
      means of decreasing pain levels following treatment, and for significant periods of time.
      Additionally, neurobiology studies of VR have demonstrated a decrease in brain activity
      associated with pain. While VR is clearly a promising, drug-free option for pain treatment,
      existing VR systems are expensive and use unconvincing graphics. Recent advances in VR
      technology (i.e., improved realism and immersion using 360-degree 3D technology and more
      affordable delivery systems) allow the development of more realistic and more cost-effective
      applications. Capitalizing on these advances and the investigators' experiences with VR
      intervention development and evaluation, the current study will test a state-of-the-art VR
      experience in pain management intervention (Live-Action 360° Video Virtual Reality(VVR)) and
      compare it to established standard computer generated imagery (CGI) 360° VVR content for pain
      management intervention in a medical setting. The participant's participation will help the
      investigators determine which VR intervention is most effective in reducing acute pain in
      hospital patients.
    


Intervention name(s): Live-Action 360° Video Virtual Reality; CGI 360° Video Virtual Reality
Intervention type(s): Device; Device
Intervention description(s): 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.; Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Virtual Reality; Opioid; Prescription pain reliever; Treatment
Acute Effects of Exercise in Smokers With Schizophrenia
Condition: Tobacco Dependence; Cigarette Craving; Smoking Behavior
MeSH terms: Tobacco Use Disorder; Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      People with schizophrenia have two- to three-times the mortality risk of the general
      population. This is primarily due to their unusually high rates of cigarette smoking, as well
      as other cardiovascular risk factors such as physical inactivity, obesity, high blood
      cholesterol and diabetes. Effective smoking treatments are needed to reduce morbidity and
      mortality in this population. Over a dozen experimental studies indicate that walking and
      other forms of exercise acutely reduce cigarette craving, nicotine withdrawal symptoms and
      smoking behavior in non-psychiatric smokers. However, the effects of acute exercise on
      smoking measures have not been studied in smokers with schizophrenia. This study will use a
      within-subjects, repeated-measures design, in which participants will undergo 4 laboratory
      sessions (order counterbalanced across participants): (1) smoking cues followed by exercise,
      (2) smoking cues followed by passive activity, (3) neutral cues followed by exercise, (4)
      neutral cues followed by passive activity. Outcome measures include cigarette craving,
      nicotine withdrawal symptoms, mood and smoking behavior. If the results of this study
      indicate that walking acutely reduces craving and smoking in smokers with schizophrenia, the
      next step in this research would be to test the effectiveness of a smoking cessation
      intervention that incorporates exercise bouts as a behavioral strategy for improving smoking
      cessation rates in this population.
    


Intervention name(s): Exercise; passive control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 1-mile treadmill walk; 20 min inactivity
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: psychiatric; comorbidity; craving; tobacco
Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)
Condition: Gallbladder Disease; Biliary Colic; Gallstones
MeSH terms: Gallstones; Gallbladder Diseases
Study type: Interventional

Summary: 
      The investigators hypothesize that the da Vinci Fluorescence Imaging Vision System provides
      real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as
      identifying biliary vessels; either cystic duct, common hepatic duct (CHD) or common bile
      duct (CBD). Irradiation given to the patient during a classic cholangiography can be reduced.
    

Detailed description: 
      Up to 40 patients will be prospectively enrolled in this multi-centre (up to 5 centres)
      single arm study. After given consent, patients will undergo minimally invasive
      cholecystectomy with da Vinci Fluorescence Imaging using Indocynine green (ICG) and near
      infra-red light (NIR) to identify the surgically relevant anatomy of the biliary tree during
      this procedure.

      Efficacy endpoints The efficacy of the da Vinci Fluorescence Imaging Vision System to
      identify biliary anatomy will be demonstrated by successful detection (90%) of one or more of
      the following biliary vessels: Cystic duct, common hepatic duct (CHD) or common bile duct
      (CBD).

      Safety endpoints To observe and report peri-operative safety outcomes, including but not
      limited to incidence of adverse events and allergic reactions (rare according to the current
      knowledge and applications). Safety endpoints will be met by affirming the safety profile of
      the procedure, compared to currently available literature.
    

Intervention name(s): Indocyanine green (ICG)
Intervention type(s): Drug
Intervention description(s): 2.5mg indocyanine green (ICG) will be administerly (IV injection) 30 minutes before surgery
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cholecystectomy; chronic right upper quadrant pain