bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Effect of Delafloxacin on the Pharmacokinetics of Midazolam in Healthy Subjects
Condition: VA Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of repeated doses of oral delafloxacin on
      the pharmacokinetic (PK) profile of a single oral dose of midazolam.
    

Detailed description: 
      This study will evaluate the effect of repeated doses of oral delafloxacin on the PK profile
      of a single oral dose of midazolam. The study will also evaluate the pharmacokinetics,
      safety, and tolerability of repeated oral doses of delafloxacin in healthy male and female
      subjects and to obtain a steady state PK profile for oral delafloxacin.
    

Intervention name(s): Midazolam; Delafloxacin
Intervention type(s): Drug; Drug
Intervention description(s): Single 5 mg oral dose of midazolam syrup given in the AM on Day 1 and Day 8.; Oral 450 mg delafloxacin tablets given twice daily (Q12h) on Days 3 to 8
Intervention MeSH terms: Delafloxacin; Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Quality of Postpartum Cesarean Recovery Score Validity Reliability
Condition: Failed VBAC (Vaginal Birth After Cesarean)
Study type: Observational

Summary: 
      In order to provide the best care of patients after cesarean section, to help solve all their
      biopsychosocial problems in the recovery process, and to shorten the hospitalization period,
      it should be measured with appropriate measurement tools for various evaluations. The Scale
      of Post-cesarean Healing Quality You will provide in adapting the ObsQoR-11 questionnaire to
      Turkish.
    

Detailed description: 
      In order to provide the best care of patients after cesarean section, to help solve all their
      biopsychosocial problems in the recovery process, and to shorten the hospitalization period,
      it should be measured with appropriate measurement tools for various evaluations. We will
      provide the Scale of Post-Cesarean Healing Quality in adapting the ObsQoR-11 questionnaire to
      Turkish.It is important to define well the recovery after cesarean section.
    

Intervention name(s): cesarean section women
Intervention type(s): Procedure
Intervention description(s): The test will be applied to women who have had a cesarean section and the Turkish validity and reliability of the scale will be determined according to the answers given.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Study study of 18 patients using large cesarean section.
Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth
Condition: Discoloration of Teeth
MeSH terms: Tooth Discoloration
Study type: Interventional

Summary: 
      The purpose of this study is to daily monitor the discoloration of teeth when participants
      rinse with a mouth rinse and black tea and to determine the time point when unacceptable
      discoloration occurs.
    

Detailed description: 
      Tooth discoloration is a side effect of most mouth rinse solutions. It impairs the aesthetic
      appearance especially of the front teeth. The aim of this pilot study is to determine a time
      point when visible discoloration appears in the front teeth. Therefore, participants of this
      study will rinse twice daily with chlorhexidine mouth rinse for 10 days. To elicit a more
      pronounced discoloration, participants will rinse with black tea right after the
      chlorhexidine rinse. Discoloration will be measured daily by discoloration index, by
      spectrophotometry, and by the use of a digital photo.
    

Intervention name(s): chlorhexidine 0.12%
Intervention type(s): Other
Intervention description(s): twice daily, 10 ml, topical
Other intervention name(s): Perio-Aid 0.12%
Intervention MeSH terms: Chlorhexidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
A Phase I Study Evaluating the Safety, Tolerability, PK and PD in Healthy Chinese Volunteers
Condition: Healthy Chinese Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Trial Objective: To investigate the safety, tolerability, PK, and PD following single
      ascending doses of HBM9161 in healthy Chinese subjects.
    

Detailed description: 
      HBM9161(HL161BKN) is a human monoclonal antibody. HBM9161 targets the neonatal Fc receptor
      (FcRn) . The neonatal FcRn is a potential therapeutic target for many autoimmune diseases.
      This Phase I study will evaluate the safety, tolerability, PK, and PD of subcutaneous (SC)
      doses of HBM9161(HL161BKN) (abbreviated as HBM9161) in healthy Chinese subjects. Up to 24
      healthy Chinese subjects will be randomized into the study. For each dose group, 8 subjects
      will be randomized (6 subjects to HBM9161 group and 2 subjects to placebo group).

      This study will also provide guidance on doses to be used in future studies involving
      patients with autoimmune diseases.
    

Intervention name(s): HBM9161(HL161BKN); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection; Single dose on Day 1; Subcutaneous injection; Single dose on Day 1
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS Patients
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      Probiotics may improve symptoms in IBS patients. The aim of this study is to test the
      efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome
      III criteria.
    

Detailed description: 
      The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea
      predominant IBS patients according to Rome III criteria.
    

Intervention name(s): Lactobacillus FARCIMINIS; placebo (starch)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10.10 UFC of lactobacillus FARCIMINIS; Once daily
Other intervention name(s): 10.10 UFC of lactobacillus FARCIMINIS; Once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBS; Diarrhea; Rome III
Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection
Condition: Upper Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Socheongryong-tang (SCRT) and
      Yeongyopaedok-san (YPS) are effective in the treatment of upper respiratory tract infection.
    

Detailed description: 
      Upper respiratory tract infections (URTIs) are the most prevalent disease of human beings, it
      incur a significant health burden on populations in terms of human suffering and economic
      losses. Usually, antibiotic therapy is not helpful since most infections are virally induced.
      Over 200 serologically different viral types are responsible for human URTIs, so that
      preventions of URTIs including vaccination are impassable. SCRT and YPS are widely used to
      treat the respiratory disease. The objective of this study is to determine the efficacy of
      SCRT and YPS in symptomatic relief of patients with URTIs.
    

Intervention name(s): SCRT; YPS; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4 capsules,three times daily, for 7days or within symptom disappearance; 4 capsules, three times daily, for 7days or within symptom disappearance; 4 capsules, three times daily, for 7days or within symptom disappearance
Other intervention name(s): Xiao-qing-long-tang; Lian-qiao-bai-du-san
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: upper respiratory tract infections; herbal medicine
A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome
Condition: Restless Legs Syndrome (RLS); Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and
      placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome
      (RLS) in the United States.
    


Intervention name(s): Ropinirole
Intervention type(s): Drug
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: fatigue; sleep; sleep disorder; Legs; RLS; Restless Legs Syndrome; Ropinirole
Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      A 4mm Punch biopsy is obtained from lesional and non lesional skin of 25 psoraitic patients
      as well as of 30 controls.

      Skin biopsy from patients (psoriasis lesional and non lesional) & control will be kept in
      lysis solution (which contains RNAase inhibitor) for the stability of the parameter to be
      assessed. ERAP-1 gene expression will Research Template 5 Final Version: 8/3/2 016 be
      detected by quantitative real time -PCR, which include RNA extraction, cDNA synthesis & PCR.
    


Intervention name(s): RT-PCR for ERAP1 detection
Intervention type(s): Diagnostic Test
Intervention description(s): Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Evaluate Analgesic Efficacy of Fast Release Aspirin
Condition: Drugs, Investigational
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of
      fast release aspirin tablets, 1000 mg (2 x 500 mg) compared to regular aspirin tablets, 1000
      mg (2 x 500 mg) and placebo in subjects with postsurgical dental pain.
    


Intervention name(s): Acetylsalicylic acid (Fast release Aspirin, BAY1019036); Acetylsalicylic Acid (Aspirin, BAYE4465); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of fast release aspirin tablets 1000 mg (2 x 500 mg) with a full glass of water (240 milliliter [mL]) between 14 hours post dental surgery.; Single oral dose of regular aspirin tablet 1000 mg (2 x 500 mg) with a full glass of water (240 mL) between 14 hours post dental surgery.; Single oral dose of 2 placebo tablets with a full glass of water (240 mL) between 14 hours post dental surgery.
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Aspirin
EPO906 Therapy in Patients With Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine whether the new investigational drug EPO906, given by intravenous
      infusion (IV directly into the vein), is effective in shrinking tumors and preventing the
      growth of cells that cause melanoma.
    


Intervention name(s): epothilone b
Intervention type(s): Drug
Intervention description(s): intravenous 2.5 mg/m2 as a 5 minutes bolus infusion once every week for three weeks followed by one week off
Other intervention name(s): Patupilone, EPO906
Intervention MeSH terms: Epothilones; Epothilone B
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: melanoma; cancer; tumor; tumour; malignant; metastatic; intravenous; epothilone
A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)
Condition: Diarrhea-predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the superiority of YM060 to a placebo in global assessment of relief of
      overall IBS symptoms and stool form normalization, and to evaluate safety in female patients
      with diarrhea-predominant irritable bowel syndrome (D-IBS).
    


Intervention name(s): YM060; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): ramosetron,; Irribow
Intervention MeSH terms: Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: YM060; Ramosetron; Diarrhea-predominant Irritable Bowel Syndrome
A Study of GFH018 in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first in human study of GFH018 comprised of a dose escalation part and a dose
      expansion part in subjects with advanced solid tumors after single/multiple administration.
      The study is designed to explore the safety/tolerability, pharmacokinetics, and MTD of GFH018
      and to define a RP2D of GFH018.
    


Intervention name(s): GFH018
Intervention type(s): Drug
Intervention description(s): Subjects will receive GFH018 orally at different dose levels following twice daily, 14-day on/14-day off regimen.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      To assess the effect of rimonabant on visceral fat area over a period of 12 months when
      prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome

      Secondary objectives:

        -  To assess the effect of rimonabant over a period of 12 months on:

             -  Liver fat content using CT scan (Computed Tomography scan)

             -  Anthropometric measures (weight, waist circumference, body composition using Dual
                Energy X-ray Absorptiometry (DEXA))

             -  Lipid, lipoprotein profile

             -  Glycemia, insulinemia and HbA1c

             -  Adipokines, inflammatory and hemostatic markers

        -  To evaluate the percentage of patients with metabolic syndrome at 12 months

        -  To evaluate the safety and tolerability of rimonabant in these patients

      In four selected US sites the effect of rimonabant at 12 months will be also assessed on:

        -  Basal lipolysis and insulin suppressed lipolysis (euglycemic hyperinsulinemic clamp).

        -  Resting metabolic rate and substrate oxidation at rest using indirect calorimetry.

        -  Adipose tissue histology and expression of genes involved in glucose and lipid
           metabolism (superficial adipose tissue biopsy).
    

Detailed description: 
      The total duration per patient will be approximately 15 months including a 12-month
      double-blind treatment period.
    

Intervention name(s): Rimonabant; Placebo (for Rimonabant); Mild hypocaloric diet
Intervention type(s): Drug; Drug; Other
Intervention description(s): Tablet, oral administration; Tablet, oral administration; Calculated by the dietitian based on the estimated basal metabolism rate and the physical activity
Other intervention name(s): SR141716; Acomplia
Intervention MeSH terms: Rimonabant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with
      refractory glaucoma.
    

Detailed description: 
      CADENCE a single use implantable glaucoma drainage device used for the surgical treatment of
      refractory glaucoma. The device is implanted in the eye using an ab-externo approach
    

Intervention name(s): Cadence implant
Intervention type(s): Device
Intervention description(s): CADENCE Glaucoma Drainage Device System is a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach
Intervention model: Single Group Assignment
Intervention model description: Open Label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glaucoma
Measurement of Core Temperatures During Therapeutic Hypothermia
Condition: Cardiac Arrest
MeSH terms: Hypothermia
Study type: Observational

Summary: 
      The purpose of this study is to determine that the measurements of rectal and bladder
      temperature are correctly consistent with core temperature by using the pulmonary artery
      catheter during therapeutic hypothermia; rapid cooling, maintenance, and slow rewarming
      phase.
    

Detailed description: 
      The guidelines of therapeutic hypothermia(TH)are rapid cooling, from normothermia to mild
      hypothermia(32~34 degree), maintenance, and slow rewarming phase. If core temperature
      maintained below 32 degree during TH, som complications will be developed, such as arrythmia,
      hypotension, cold diuresis, coagulopathy, and so on. Therefore correct measurement of core
      temperature during TH is very important process for successful post cardiac arrest care. we
      will know that rectal or bladder temperature are really reflect the core temperature during
      TH for post cardiac arrest care, especially rapid cooling phase, maintenance phase, and slow
      rewarming phase, respectively.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Post cardiac arrest care with therapeutic hypothermia
      
Keywords: resuscitation, hypothermia
Meropenem Dosage Strategy Based on PPK Model
Condition: Lower Respiratory Tract Infection
MeSH terms: Infections; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a
      population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract
      infection patients.
    

Detailed description: 
      -  Subjects:lower respiratory tract infection patients

        -  Study design:randomized control study.The patients in study group will accept meropenem
           therapy with the regimen decided by a software developed from a PPK-PD model. The
           patients in control group will accept meropenem therapy with the regimen decided by
           attending physician.

        -  Primary endpoint: clinical successful rate of meropenem therapy. The clinical efficiency
           of meropenem therapy will be evaluated one week later from stop of meropenem therapy.

        -  Second endpoint: amount of used antibiotics and bacteriological successful rate.
    

Intervention name(s): Routine meropenem therapy; Meropenem therapy based on a PPK and PD model
Intervention type(s): Drug; Drug
Intervention description(s): Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician; Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model
Other intervention name(s): Standard care; Experimental meropenem therapy
Intervention MeSH terms: Meropenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infection; Meropenem; Pharmacokinetics; Pharmacodynamics
ML Models for Predicting Postoperative Peritoneal Metastasis After Hepatocellular Carcinoma Rupture
Condition: Peritoneal Metastasis
MeSH terms: Neoplasm Metastasis; Carcinoma, Hepatocellular; Rupture
Study type: Observational

Summary: 
      This study aimed to address the issue of peritoneal metastasis (PM) following the rupture of
      hepatocellular carcinoma (HCC) and its adverse impact on patient prognosis. Clinical data
      from 522 patients with ruptured HCC who underwent surgery at seven different medical centers
      were collected and analyzed. Machine learning models were employed for analysis and
      prediction.
    


Intervention name(s): Peritoneal Metastasis
Intervention type(s): Other
Intervention description(s): Patients experiencing postoperative peritoneal metastasis
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        522 rHCC patients who underwent radical hepatectomy
The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out if omega-3 fatty acid supplements are more effective
      than an inactive placebo at reducing pain, reducing fatigue and elevating mood in patients
      with fibromyalgia.
    


Intervention name(s): Omega-3 (oil); Fatty Acids (placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5ml daily with breakfast for 56 days.; 5ml daily with breakfast for 56 days.
Other intervention name(s): NutraSea HP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia; Omega-3; Chronic Pain; Fatigue; Mood; docosahexaenoic acid (DHA); eicosapentaenoic acid (EPA)
At-Home Care for Subjects With Periodontitis
Condition: Periodontitis; Dental Plaque
MeSH terms: Periodontitis; Dental Plaque
Study type: Interventional

Summary: 
      The effect of use of powered toothbrushing in patients exhibiting periodontal inflammation
      has been observed repeatedly in clinical studies conducted over a 20+ year period. Whether
      these subjects also had periodontitis, or not, was not a collected data metric as it was
      outside the scope of the Investigation. This study, therefore, will specifically include and
      document that a subject exhibits periodontitis upon study entry, and measure the ensuing
      response following professional treatment of scaling and root planing, followed by home use
      of the assigned study products (powered or manual toothbrushing).
    


Intervention name(s): ADA approved Manual Toothbrush; Marketed Power Toothbrush
Intervention type(s): Device; Device
Intervention description(s): ADA approved Manual Toothbrush; Marketed Power Toothbrush
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment