bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to
      determine the ability of MK-1075 to reduce HCV viral load, following administration of a
      single dose in HCV-infected participants.
    

Detailed description: 
      Per protocol, panels may be omitted if the objectives of the study are met in preceding
      panels.
    

Intervention name(s): MK-1075
Intervention type(s): Drug
Intervention description(s): MK-1075 supplied as 10 mg or 100 mg tablets for oral administration.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: In each panel (A, B, C, and D), participants will receive a single dose of MK-1075 (100, 200, 400, and 800 mg, respectively) in a fasted state. Safety and viral load (VL) data from the previous panel will be assessed before dosing the subsequent panel.
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the potential for a pharmacokinetic (PK) interaction and provide
      safety and tolerability information when ubrogepant and erenumab or ubrogepant and
      galcanezumab are co-administered.
    


Intervention name(s): Ubrogepant; Erenumab; Galcanezumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration of 100 mg ubrogepant tablet once daily [Intervention A=single dose and Intervention D=repeated daily dose].; Single dose subcutaneous (SC) injection of erenumab 140 mg [Intervention B].; 2 SC injections of galcanezumab 120 mg [Intervention C].
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ubrogepant; erenumab; galcanezumab; safety; tolerability; interaction
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind,
      placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as a
      monotherapy for Major Depressive Disorder.
    


Intervention name(s): REL-1017; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): REL-1017 tablet; Placebo tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: REL-1017
Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Liver Carcinoma
Condition: Liver Cancer
MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of nano drug（Gemzar® mix
      with Compound Glycyrrhizin Injection） interventional therapy using digital subtraction
      angiography（DSA） for liver cancer.
    

Detailed description: 
      By enrolling patients with liver cancer adapted to enrolled criteria, this study will
      document for the first time the safety and the short and long term efficacy of nano drug
      interventional therapy using digital subtraction angiography（DSA）for liver cancer.

      The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection. The nano drug's
      size is detected by laser diffraction particle size analyzer.
    

Intervention name(s): interventional therapy
Intervention type(s): Procedure
Intervention description(s): Liver cancer patients received drug interventional therapy using the digital subtraction angiography（DSA）
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver Cancer; Nano drug
Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
Condition: Chronic Diarrhea; Irritable Bowel Syndrome With Diarrhea; Bile Acid Malabsorption
MeSH terms: Irritable Bowel Syndrome; Malabsorption Syndromes; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare with a randomized trial (n=15 per treatment group), effects of colesevelam and
      placebo treatment, on colonic transit, bowel functions, permeability and tight junction
      expression in rectosigmoid mucosa of IBS-D with Bile Acid Malabsorption.
    

Detailed description: 
      Compare the effects of Colesevelam versus the placebo on diabetic subjects with chronic
      diarrhea. In this study, diabetic subjects will get either the Colesevelam or the placebo,
      not both.

      The plan is to have about 30 subjects complete this study at Mayo Clinic.
    

Intervention name(s): Colesevelam; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam is not approved for the use proposed in this study and is considered investigational.; A placebo looks exactly like the study drug, but it contains no active ingredient. This is used to learn if the effects seen in research participants are truly from the study drug.
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is the third specific aim of a program on IBS-D with increased fecal bile acid excretion.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Given by an Alternate Route in the Elderly
Condition: Orthomyxoviridae Infection; Influenza; Myxovirus Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      All marketed influenza vaccines are injected by the intramuscular route. This study will test
      whether an influenza vaccine is effective when injected by other route than into the muscle.
      In order to prove this, the amount of antibodies in the blood will be measured before and
      after vaccination. In addition, the safety of both influenza vaccines will be tested by
      evaluating all serious reactions occurring after vaccination. The vaccine injected in this
      study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip).

      Primary Objective:

      To demonstrate and compare the immune response of two dosages of influenza vaccine
      administered by an alternate route to the intramuscular administration of the vaccine.

      Secondary Objectives:

        -  To compare the immune response 21 days after vaccination between each investigational
           group versus intramuscular group for each influenza strain.

        -  To describe the safety profile after the vaccination in each study group

        -  To describe the compliance of the two dosages of the vaccine administered by the
           alternate route with the European Medicine Agency.

      Observational Objectives:

        -  To describe the safety profile during the 21-day period following an intramuscular
           revaccination in each group and the possibility of any reaction at the first injection
           site.

        -  To describe the pain at the injection site with a Visual Analog Scale and the
           acceptability of the injection using a questionnaire in each group.

        -  To describe the leakage appearing at the injection site immediately after the alternate
           route injection and to explore the relationship with immunogenicity.

        -  To evaluate the cellular mediated immune response in a subset of subjects.
    


Intervention name(s): Inactivated, split-virion influenza vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Influenza;; Orthomyxoviruses;; Inactivated Split-virion influenza vaccine;; Elderly.
Balance Training With Stroboscopic Vision
Condition: Ankle Inversion Sprain; Proprioceptive Disorders
MeSH terms: Somatosensory Disorders
Study type: Interventional

Summary: 
      Balance training with stroboscopic vision in patients with chronic ankle instability.
    

Detailed description: 
      This study was a single-blinded randomized controlled trial with two intervention groups
      consisted in multimodal balance training, multimodal balance training in addition to
      stroboscopic glasses and control group who received no intervention.
    

Intervention name(s): Neuromuscular training; Stroboscopic glasses
Intervention type(s): Other; Other
Intervention description(s): This intervention consisted of a supervised multimodal exercise protocol addressing different aspects of balance including static and dynamic tasks on the injured ankle. The training program comprised 6 exercises that were progressively adapted depending on the patient's execution controlled by an expert physiotherapist; Patients included in this group performed the same protocol described in the balance training group with the addition of the stroboscopic glasses during the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide
Condition: Pharmacokinetics and Safety of Elevated Doses
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to study the safety and tolerability of teduglutide
      following a once or possibly twice daily subcutaneous injection for eight consecutive days in
      healthy subjects. A secondary objective was to study the pharmacokinetics of teduglutide
      following a once or possibly twice daily injection for eight consecutive days in healthy
      subjects.
    

Detailed description: 
      Healthy subjects are enrolled once they have been screened and it is determined they qualify.
      The subjects are randomized to either placebo or the dose of teduglutide as outlined by the
      protocol at a 1:3 ratio. They will be injected with investigational product for eight
      consecutive days, with measurements taken including safety.
    

Intervention name(s): teduglutide; teduglutide; tedguglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.; Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water; lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
Other intervention name(s): Gattex is the brand name; Gattex; Gattex
Intervention MeSH terms: Teduglutide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Probiotic Supplementation IN NAFLD Patients
Condition: NAFLD
MeSH terms: Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      this study aimed to evaluate the effectiveness of Probiotics supplementation (lactobacillus)
      on NAFLD fibrosis score.
    

Detailed description: 
      Non-alcoholic fatty liver disease (NAFLD) is a disease characterized by accumulation of fat
      (> 5% of the liver tissue), in the absence of alcohol abuse or other chronic liver diseases.
      NAFLD can cause liver inflammation and progress to non-alcoholic steatohepatitis (NASH),
      fibrosis, cirrhosis or hepatocellular carcinoma (HCC).

      The global prevalence of NAFLD in adults is estimated to be approximately 25%.The prevalence
      of NAFLD increases with increasing body mass index. in 2012 Chalasani et al, reported that
      67% of overweight and 94% of obese individuals have NAFLD.

      There is a consensus regarding increasing worldwide prevalence of NAFLD and its impact on
      health, especially the progression to liver cirrhosis and hepatocellular carcinoma.
      Longitudinal studies of NAFLD have reported an increase in all-cause mortality,
      cardiovascular mortality, and liver-related mortality , NAFLD carries a large economic burden
      and therefore poor health-related quality of life.

      Lifestyle changes (diet and exercise) are the major and first suggestions of the guidelines
      ,as regard pharmaceutical interventions, agents with potential benefit in NASH include
      thiazolidinediones (TZDs), statins although they are well recognized in the treatment of
      dyslipidemia, their use as a specific treatment for NAFLD is not well evidenced.

      There is some data suggest that disruptions in the gut microbiome may play a role in the
      pathogenesis of NAFLD and progressions to NASH.

      A probiotic is a live microbial culture or cultured dairy product, which plays an important
      role in health. Probiotics for the treatment of NAFLD are seemingly a promising treatment
      option. Relatively easy availability, low cost, and absence of serious side effects make
      probiotics a lucrative choice.

      liver biopsy remains the gold standard for NAFLD diagnosis but it is impractical as a
      diagnostic tool because it is invasive and expensive.

      NAFLD fibrosis score constructed from routine clinical and laboratory variables can
      accurately predict the presence or absence of advanced fibrosis in NAFLD.
    

Intervention name(s): Control Test
Intervention type(s): Drug
Intervention description(s): Lacteol fort 10 billion which contains culture medium and lactobacillus LS as active ingredients
Other intervention name(s): standard treatment group
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study of the Safety and Tolerability of IBI321 in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-human open-label,dose-escalation study is designed to evaluate the safety,
      tolerability, and primary efficacy of IBI321 in participants with locally advanced,
      recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has
      proven to be ineffective or intolerable.
    


Intervention name(s): IBI321
Intervention type(s): Drug
Intervention description(s): Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain
Condition: Corneal Pain; Chronic Pain; Neuropathic Pain
MeSH terms: Neuralgia; Chronic Pain
Study type: Interventional

Summary: 
      In this study the investigators aim to examine the effects of Transcranial Direct Current
      Stimulation (tDCS) on pain levels as well as the changes in cognitive (thought) processing in
      individuals with chronic pain of the cornea -- and also compared with healthy controls.
    


Intervention name(s): Transcranial Direct Current Stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): Subjects will undergo 2 sessions of 20 minutes of tDCS stimulation (either active or sham)in a randomized order - each session will be separated by at least one week to prevent carry-over effects.
Other intervention name(s): 1x1 direct current stimulator; Soterix Medical
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: transcranial stimulation; direct current stimulation
Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy
Condition: C.Medical Procedure; Digestive System; Disorder of Upper Gastrointestinal Tract; Tolerance
Study type: Observational

Summary: 
      The investigators tested whether a new method which additional lidocaine spray on the tip of
      endoscope can increase the tolerance of examinee during endoscopy than conventional
      pharyngeal anesthesia alone.
    

Detailed description: 
      All the patients underwent upper gastrointestinal endoscopy were consecutively enrolled and
      assigned to case group treated with additional 2 puffs of the 10% lidocaine spray on the tip
      of endoscope before intubation or control group with conventional pharyngeal anesthesia
      without further treatment. And the investigators compared their baseline characteristics,
      past history, sedation or not, and frequency of retching and belching were measured during
      the endoscopy.
    

Intervention name(s): Case Group
Intervention type(s): Drug
Intervention description(s): Consecutively, all the participants were assigned to case group with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope, same medication which was used for prior pharyngeal anesthesia, or to control group with conventional pharyngeal anesthesia without further treatment. Then we compared the primary outcome measures, such as, frequency of belching and retching of two groups.
Other intervention name(s): Beracaine Spray
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All the patients who underwent upper gastrointestinal endoscopy in Endoscopy Room 2,
        Digestive Disease Center, Halla General Hospital, Jeju, Korea were enrolled consecutively
        during Nov. 4 2013 - May 7 2014.
      
Keywords: Upper Gastrointestinal Endoscopy; Pharyngeal Anesthesia; Lidocaine; Belching; Retching; Tolerance
Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a year-long study evaluating the efficacy of both daily and intermittent treatment of
      asthma in children who experience symptoms episodically (i.e., seasonally, usually in the
      context of upper respiratory tract infection).
    


Intervention name(s): montelukast sodium; Comparator: Placebo (unspecified); montelukast sodium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.; Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.; Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.
Other intervention name(s): MK0476; Singulair®; MK0476; Singulair®
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Earlier Triggering in Rec-FSH/GnRH Antagonist Cycles
Condition: hCG
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The effect of altering the timing of hCG administration on the ongoing pregnancy rate in
      patients stimulated with recombinant-FSH (rec-FSH)/gonadotrophin releasing hormone (GnRH)
      antagonists for in vitro fertilisation (IVF).
    

Detailed description: 
      Progesterone elevation has been associated with prolongation of the follicular phase in GnRH
      antagonists cycles by two days after the commonly used criterion of the presence of at least
      three follicles of >or= 17 mm has been met. Such an intervention is associated with
      significantly lower ongoing pregnancy rates in GnRH antagonist cycles, without an apparent
      deterioration of embryo quality.

      The adverse effect of P elevation on the day of hCG administration might be explained by the
      induction of differences at the histological level as well as at the gene expression level
      between endometrial samples exposed to varying concentrations of progesterone (P).
      Prolongation of follicular phase by delaying hCG administration for two days is associated
      with a higher incidence of endometrial advancement on the day of oocyte retrieval in GnRH
      antagonist cycles (Kolibianakis et al., 2005). Moreover, Vaerenbergh et al., (2011)
      demonstrated a distinct difference in endometrial gene expression profile between patients
      with progesterone serum concentration above and below the threshold of 1.5 ng/ml on the day
      of HCG administration.

      Due to the fact that earlier triggering of final oocyte maturation is expected to result in
      lower progesterone levels on the day of hCG administration it might be assumed that such an
      intervention might result in an improved probability of pregnancy by leading to a less
      deranged and more receptive endometrium.

      The purpose of this randomized controlled trial is to evaluate whether triggering of final
      oocyte maturation as soon as ≥ 3 follicles ≥ 16mm are present on ultrasound or one day later
      affects the probability of pregnancy in patients stimulated with rec-FSH/GnRH- antagonists
      for IVF.
    

Intervention name(s): 16mm triggering
Intervention type(s): Other
Intervention description(s): Final oocyte maturation will be achieved by administration of 10.000 IU of hCG (Pregnyl®). Randomization will be into 2 groups:
• Group A (early hCG group): hCG will be administrated as soon as ≥ 3 follicles ≥ 16mm were present on ultrasound.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hCG triggering; pregnancy; GnRH antagonist