bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Topical Application of Iodex® Balm on Local Surface Temperature
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The rationale of this study is to map out changes in temperature distribution brought about
      by topical application of our test product, and use this physiological phenomenon to
      visualize the onset of action involved in overall mechanism of action of the product.
    


Intervention name(s): IODEX® balm; Placebo balm
Intervention type(s): Drug; Other
Intervention description(s): 2 ± 0.2 g of test balm will be applied topically in a crossover fashion at a gap of 3 days between the two product applications.; 2 ± 0.2 g of placebo balm will be applied topically in a crossover fashion at a gap of 3 days between the two product applications.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
A Clinical Trial to Assess the Efficacy of a Plant-based Energy Shot on Focus and ADHD-like Symptoms
Condition: ADHD; Attention Difficulties; Mood; Anxiety; Caffeine
Study type: Interventional

Summary: 
      This is a virtual, single-arm clinical trial that will last 28 days. Participants will drink
      1 bottle of Proper Wild energy shot daily and complete questionnaires at baseline, day 1, day
      14, and day 28.

      Attention deficit hyperactivity disorder (ADHD)-like symptoms, such as concentration, focus,
      and attention, will be evaluated at baseline and at each check-in. Likert scale responses
      will be examined from baseline to each check-in. Participant responses on product feedback
      will be presented as % scores.
    


Intervention name(s): Proper Wild energy shot
Intervention type(s): Other
Intervention description(s): 100% plant-based energy shot containing natural caffeine, L-Theanine, purified water, pineapple juice concentrate, natural flavors, kiwi juice concentrate, organic lemon juice concentrate, organic strawberry juice concentrate, monk fruit juice concentrate, pink himalayan sea salt.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Macroscopic Deciduosis in Pregnancy is Finally a Common Entity
Condition: Deciduitis; Complicating Pregnancy
MeSH terms: Pregnancy Complications
Study type: Observational

Summary: 
      The purpose of this study is to determine the prevalence of macroscopic deciduosis found
      randomly in Cesarean sections and the secondary objective to determine the association with
      any obstetrical complications or adverse effects.
    

Detailed description: 
      Ectopic decidua or deciduosis is defined as the extrauterine location of decidual tissue and
      can occur in the cervix, vagina and various abdominal organs like the ovary omentum,
      appendix, peritoneum, the pelvic lymph nodes. Other rare sites with deciduosis include the
      kidneys , the lungs and even the skin . Decidualization is a physiologic process during
      pregnancy, under the influence of ovarian and placental steroid secretion, with total
      involution in the four to six week post partum period.
    

Intervention name(s): Macroscopic deciduosis
Intervention type(s): Other
Intervention description(s): Deciduosis is a benign lesion during pregnancy that is not correlated with obstetrical complications. Our study has shown that this physiological phenomenon is more frequent that originally thought, being present in 10% of the Cesarean sections, and is associated with abdominal pain during pregnancy.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All cesaren section
      
Keywords: Frequency; Macroscopic; Deciduosis; Ovarian; Neoplasm; Pregnancy
The Effect of E-Mobile and Written Education
Condition: Quality of Life; Sleep; Education; Counseling; Nursing
Study type: Interventional

Summary: 
      Bening's Prostate Hyperplasia (BPH), which is closely related to aging, is one of the most
      common diseases in the world. Although it is not a life-threatening condition, lower urinary
      tract symptoms (LUTS) are seen in many patients, which disrupts their daily activities, sleep
      patterns, and quality of life of the patients. Examination of changes in sleep and quality of
      life after transurethral resection of the prostate (TUR-P) in patients with LUTS due to BPH
      and planning training according to their needs will positively affect the lives of these
      patients. It is very important for nurses to provide individual training and counseling by
      making use of innovative technology to ensure that patients manage the surgical process in a
      healthy way and cope with possible complications. This thesis study was planned as a
      three-group randomized controlled experimental study in order to determine the effect of
      e-mobile training and counseling on quality of life and sleep in patients who underwent TUR-P
      to manage the operative process and cope with possible complications.
    

Detailed description: 
      This thesis study aims to determine the effect of e-mobile training and counseling on quality
      of life and sleep in patients who underwent TUR-P for BPH, to manage the operation process
      and to cope with possible complications, and to determine the effectiveness of the written
      training given to the patients, the control group and the e-mobile application designed for
      comparasion.
    

Intervention name(s): written education
Intervention type(s): Other
Intervention description(s): Other names:
Written/E-Mobile training The study was conducted as a three-group randomized controlled trial to examine the effect of written/mobile education on the quality of life and sleep of patients undergoing transurethral resection of the prostate. Written education was applied to the first group and mobile education was applied to the second group. Group 3 formed the control group.
Other intervention name(s): E-Mobile education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.
Condition: Periodontal Disease; Periodontal Bone Loss; Osteoclastic Bone Loss
MeSH terms: Alveolar Bone Loss; Bone Resorption; Periodontitis; Periodontal Diseases; Chronic Periodontitis
Study type: Interventional

Summary: 
      The present study is an effort to investigate the hypothesis that Platelet Rich
      Fibrin/Biphasic Calcium Phosphate may play a role in inhibiting osteoclasts differentiation
      and in bone loss.
    

Detailed description: 
      Study design

      Fifty-five individuals from a suburban population were recruited. Out of them, 5 individuals
      refused to participate in the study. Finally, 50 participants were selected and divided into
      two groups, control group [Healthy individuals]: 25 Males/Females, aged 25 to 35 years and
      test group [Chronic periodontitis patients]: 25 Males/Females aged 30 to 45 years.

      Demographic variables and periodontal parameters were measured in both the groups.The
      investigators explored the effect of Platelet rich fibrin (PRF)/Biphasic calcium phosphate
      (BCP) on differentiation and survival of osteoclasts obtained from peripheral blood of
      Chronic Periodontitis patients.
    

Intervention name(s): other : PRF
Intervention type(s): Other
Intervention description(s): mononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination
Other intervention name(s): others : BCP; others : PRF/BCP combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Control group: (Healthy individuals) comprised of 25 participants with clinically healthy periodontium.
Test group: (Chronic periodontitis patients) comprised of 25 participants with signs of clinical inflammation and bone loss.
Masking: None (Open Label)
Primary purpose: Other
Keywords: biomaterials; apoptosis; bone regeneration
Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain
Condition: Colonoscopy
MeSH terms: Visceral Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The total incidence of abdominal pain after colonoscopy is almost 50%. Butorphanol is a mixed
      opioid receptor agonist-antagonist, which has strong sedative and analgesic effects. This
      clinical study aims to explore the effectiveness and safety of butorphanol combined with
      propofol for colonoscopy to reduce postoperative visceral pain, and provide a basis for
      improving the quality of surgery and comfortable medical treatment for patients.
    


Intervention name(s): Butorphanol Injection; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Inject 10 μg/kg of butorphanol, then propofol is injected until the patient's eyelash reflex disappears before performing colonoscopy; Inject saline and propofol until the patient's eyelash reflex disappears before performing colonoscopy
Intervention MeSH terms: Butorphanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Butorphanol, Visceral pain, Propofol, Gastroscopy, Colonoscopy
A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      Finding out how fast azelastine nasal spray works in subjects with hay fever.
    


Intervention name(s): Azelastine and placebo; Loratadine and Placebo; Cetirizine and Placebo; Placebo and Placebo (spray and Tablet)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.; One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.; One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.; One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
Intervention MeSH terms: Cetirizine; Loratadine; Azelastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Seasonal Allergic Rhinitis; Ragweed; Pollen; Allergy
Study of Different Suturing Techniques for Perineal Repair After Delivery
Condition: Perineal Lacerations; Episiotomy
MeSH terms: Lacerations
Study type: Interventional

Summary: 
      We wish to determine wich of two standardized suturing techniques is the best for perineal
      repair if a perineal laceration or an episiotomy is present after vaginal birth.

      The participants are healthy primi para and deliver at term.
    

Detailed description: 
      A randomised controlled trial with 400 participants was initiated in August 2004. The two
      suture techniques compared were both 2-layered and either continuous sutures or interrupted,
      inverted stitches to perineal muscles and the subcuticular layer. A polyglactin 910
      multifilament thread on an atraumatic needle was used and the perineal skin was left
      unsutured. Healthy primiparas >36+0 weeks gestation could participate if they had a either a
      2nd degree perineal laceration or an episiotomy.

      The trial was a double-blind and analysis was done on an intention-to-treat basis. Main
      outcomes were pain, wound healing and patient satisfaction.
    

Intervention name(s): Suture technique for perineal repair after delivery
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Suture Techniques
A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the immunogenicity and safety profile of CSL
      Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus
      Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18
      years.
    


Intervention name(s): CSL's Influenza Virus Vaccine (Afluria); Influenza Virus Vaccine (Fluzone)
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines; 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy of Sequential TACE and PVE on the Resectability of Hepatitis B Related HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Hepatitis B; Carcinoma; Carcinoma, Hepatocellular; Hepatitis
Study type: Interventional

Summary: 
      A primary hepatocellular carcinoma (HCC) is generally regarded as unresectable if the future
      liver remnant (FLR)≤40％ of total liver volume in patient with underlying liver disease, such
      as hepatitis B. In China, TACE is the most common treatment for these unresectable HCC.
      Recently, PVE has been employed to enlarge the FLR of the patients so as to increase the
      resectability and surgical safety of major hepatectomies. In order to shut the arterio-portal
      shunt in the liver and control the tumor progress TACE sometimes is performed before PVE. In
      this study we design a randomized control trial to investigate the efficacy of sequential
      TACE and PVE on increasing the resectability of hepatitis B related HCC compared with TACE
      alone.
    

Detailed description: 
      In China, primary hepatocellular carcinoma (HCC) is mostly a hepatitis B related disease. The
      liver function of these patients has been damaged, which often limit the execution of major
      hepatectomy. A tumor is generally regarded as unresectable if the future liver remnant
      (FLR)≤40％ of total liver volume in patient with underlying liver disease. In China, TACE is
      the most common treatment for these unresectable HCC. TACE can slow down tumor progress but
      has little effect on enlarging FLR. Recently, PVE has been employed to enlarge the FLR of the
      patients so as to increase the resectability and surgical safety of major hepatectomies. But
      the intrahepatic arterioportal shunt and the tumor progress has decreased the effect of PVE.
      In order to shut the arterioportal shunt and control the tumor progress TACE sometimes is
      performed before PVE. In this study we design a randomized control trial to investigate the
      efficacy of sequential TACE and PVE on increasing the resectability of hepatitis B related
      HCC compared with TACE alone.
    

Intervention name(s): TACE; PVE
Intervention type(s): Procedure; Procedure
Intervention description(s): 1 time; 1 time
Other intervention name(s): transaterial chemoemblization; portal vein embolization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Carcinoma; Hepatitis B; Transarterial chemoembolization (TACE); Portal vein embolization (PVE); Surgical resection; Disease-free survival; Overall survival
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals'
      investigational vaccine GSK2340272A.
    


Intervention name(s): GSK investigational vaccine GSK2340272A; GSK investigational vaccine GSK2340269A
Intervention type(s): Biological; Biological
Intervention description(s): Two intramuscular injections; Two intramuscular injections
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: GSK Bio's influenza vaccine GSK2340272A; influenza infection
Fentanyl 12 Mcg Transdermal Patch For Postoperative Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators designed a prospective randomized study to investigate the effect of
      fentanyl 12 mcg transdermal patch on postoperative pain following unilateral, single-level
      laminectomy/discectomy.
    


Intervention name(s): Fentanyl transdermal patch
Intervention type(s): Drug
Intervention description(s): Patients received fentanyl 12 mcg transdermal patch group 8 hours preoperatively and until 24 hours after the surgery
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
A Safety, Tolerability and Preliminary Pharmacokinetics of BILR 355 BS Single-rising Dose Study in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male
      volunteers after oral administration of BILR 355 BS
    


Intervention name(s): BILR 355 BS; PEG 400
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study of LY3451838 in Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The reason for this study is to see if the study drug LY3451838 is safe and effective in
      participants who have migraine that have not responded to other preventive treatments.
    


Intervention name(s): LY3451838; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered IV; Administered IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy of Escitalopram in the treatment of
      obsessive compulsive disorder and to determine the optimal treatment dose.
    

Detailed description: 
      Background and Purpose: Obsessive compulsive disorder affects approximately 3% of the
      population. Treatment options include the selective serotonin reuptake inhibitors (SSRIs),
      dual serotonin and norepinephrine reuptake inhibitors, and behavioral therapy. A recent
      double-blind, placebo-controlled trial demonstrated that citalopram is effective in the
      treatment of OCD. Escitalopram is a new SSRI that may be more effective than other SSRIs for
      the treatment of major depression and may have fewer side effects. This study aims to assess
      the efficacy of escitalopram for the treatment of OCD.

      Comparisons: Subject Y-BOCs pre-post treatment. We will also compare the improvement of
      subjects across the three different medication levels: 10 mg, 20 mg, and 30 mg.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obsessive Compulsive Disorder; Escitalopram; SSRI; Open Label
Study of Efficacy of Carbamazepine in Therapy of Patients With Moderate Persistent and Severe Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine whether antiepileptic drug carbamazepine is
      effective in the treatment of chronic moderate persistent and severe asthma.
    

Detailed description: 
      Effective therapy of asthma still remains quite serious problem. According GINA definition,
      asthma is an inflammatory disorder. Consequently, modern pharmacotherapy of asthma provides
      wide use of anti-inflammatory drugs. But asthma also is a paroxysmal disorder: many
      specialists and even some guidelines underline paroxysmal clinical picture of asthma. Besides
      this, according to some authors, neurogenic inflammation may play important role in asthma
      mechanism. But some other neurogenic inflammatory paroxysmal disorders exist, and they are
      migraine and trigeminal neuralgia. Some antiepileptic drugs, like carbamazepine and
      valproate, are very effective in therapy of migraine and trigeminal neuralgia - more than in
      80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, like migraine and
      trigeminal neuralgia, it is possible that some antiepileptic drugs also are very effective in
      asthma therapy.

      We performed a double-blind, placebo-controlled 3-month trial for evaluation of carbamazepine
      efficacy in therapy of bronchial asthma. Carbamazepine is a well-known, comparatively safe
      and effective antiepileptic drug.

      Comparison: Patients received investigational drug in addition to their usual routine
      antiasthmatic treatment, compared to patients received placebo in addition to their usual
      routine antiasthmatic treatment.
    

Intervention name(s): Carbamazepine
Intervention type(s): Drug
Intervention MeSH terms: Carbamazepine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bronchial asthma; Carbamazepine; Antiepileptic drugs; Efficacy