bioihbjkbjnl/mcl2 huggingface dataset:
Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion
Condition: Motion Sickness
MeSH terms: Vomiting; Motion Sickness
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, two-arm, randomized, double-blind, placebo-controlled, single dose
      efficacy and safety study evaluating the use of a nasal gel to prevent nausea and vomiting
      associated with motion
    

Detailed description: 
      Eligible participants will be randomized 1:1 to DPI-386 Nasal Gel or matching placebo nasal
      gel and assigned a time and date for travel on an ocean vessel. Participants will be asked to
      self-administer the study medication while the ship is in harbor. The Modified Performance
      Self-Assessment Questionnaire (mPSAQ) will be completed by each participant prior to the
      administration of nasal gel, approximately every 30 minutes of travel, and at the end of
      travel. The participants will complete the Nausea Assessment Scale (NAS) every 30 minutes
      afer dosing, and at the end of travel. The participants will also be asked to complete a
      Sopite Assessment Questionnaire (SAQ) and a Patient Global Assessment of Severity (PGI-S) at
      4 hours to describe their travel experience. All questionnaires will be submitted for
      analysis. An exit interview will also be conducted.

      The treatment phase will last approximately 4-5 hours
    

Intervention name(s): DPI-386 Nasal Gel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will self-administer DPI-386 Nasal Gel or Placebo; Subjects will self-administer DPI-386 Nasal Gel or Placebo
Other intervention name(s): scopolamine
Intervention MeSH terms: Scopolamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Beetroot Juice as a Potential Ergogenic Aid During Exercise in Hypoxia
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The study will aim to describe and evaluate the effect of beetroot juice supplementation upon
      whole body running exercise at altitude. It is hypothesised that beetroot supplementation
      will decrease time to complete a 10 km time trial.
    


Intervention name(s): Beetroot shot then placebo shot; Placebo shot then beetroot shot
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Beetroot shot, four day wash out, then placebo shot; Placebo shot, four day wash out, then beetroot shot
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
The Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess if AZD8529 improves performance on neurobehavioral
      probes of attention, working memory and affective reactivity in patients with schizophrenia.
    


Intervention name(s): AZD8529; Placebo to match AZD8529
Intervention type(s): Drug; Drug
Intervention description(s): 2 capsules by mouth for 3 days; 2 capsules by mouth for 3 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: schizophrenia; early phase trials
Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the long-term efficacy of radiofrequency catheter
      ablation in patients with chronic atrial fibrillation.
    


Intervention name(s): Radiofrequency catheter ablation; Amiodarone and cardioversion
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Amiodarone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation; catheter ablation; amiodarone; cardioversion
Comparison Between Low Dose and High Dose Intra-articular Tranexamic Acid in Total Knee Arthroplasty
Condition: Blood Loss, Surgical
MeSH terms: Hemorrhage; Blood Loss, Surgical
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare blood loss between using low dose (500 mg) and high
      dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in
      double-blind RCT
    


Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention description(s): IA (intra-articular) tranexamic acid after capsule closure
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blood loss; Tranexamic acid; Total knee arthroplasty; Topical administration
Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this follow-up study is to determine if cinnamon can restore menstrual
      cyclicity in Polycystic Ovary Syndrome (PCOS) subjects with oligomenorrhea. As a secondary
      purpose, the investigators intend to confirm the salutatory effect of cinnamon on insulin
      resistance in larger group of study subjects.

      Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing
      age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming
      pregnant. The syndrome can also be associated with more serious conditions such as heart
      disease, diabetes, or cancer of the uterus. Although no one knows the cause of the syndrome,
      scientific studies showed that having too much insulin can be one of the reasons. In fact,
      almost every overweight woman with PCOS has been found to have high insulin levels.

      Recently studies using rats and mice have shown that a commonly used spice, cinnamon, may
      also reduce the body's insulin level. Another study showed that daily use of cinnamon for
      forty days lowered the blood sugar level in patients with diabetes. Our own study also showed
      that using cinnamon everyday for 8 weeks decreased insulin resistance in women with PCOS. The
      purpose of this study is to see if cinnamon can help women with PCOS have more regular
      periods.
    

Detailed description: 
      All patients will eat a balanced diet containing 1800 calories per day, but half of the
      patients in the study will take pre-made cinnamon extract pills three times a day, while the
      other half will take placebo pills (pills with no cinnamon extract) three times a day for 6
      months. During this time, every patient will keep track of her period on a calendar.

      Blood tests measuring insulin, substances important for insulin action, cholesterol, and
      glucose (sugar) will be taken before and after the 6 months of medication. A total of 8
      separate visits will be needed to finish the study. At the end of the study, the
      investigators will then compare the number of periods, blood glucose, insulin, and
      cholesterol levels between the patients that took cinnamon and the patients that took
      placebo.
    

Intervention name(s): Cinnamon Extract; Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.; Placebo capsules containing ground cereal.
Other intervention name(s): Cinnulin PF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PCOS; Insulin resistance; Cinnamon extract; Irregular menstrual cycles; Ovarian cysts
A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
Condition: Granulomatosis With Polyangiitis
MeSH terms: Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Systemic Vasculitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the
      safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with
      severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Participants
      will receive rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1,
      8, 15 and 22.
    


Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Participants will receive rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15 and 22. Rituximab infusions will be given at a rate of 25 milligrams per hour (mg/h). This may be escalated at a rate of 25 mg/h increments every 30 minutes to a maximum of 200 mg/h.
Other intervention name(s): MabThera/Rituxan
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children
Condition: Drug Effect
Study type: Interventional

Summary: 
      To observe the sedative effect and safety of remiazolam combined with small dose of
      esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable
      and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.
    

Detailed description: 
      It is planned to observe the painless two-way endoscopic examination of children in Tongji
      Hospital affiliated to Tongji Medical College of Huazhong University of Science and
      Technology from November 2022 to May 2023.To observe the sedative effect and safety of
      remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in
      children, and to provide a more reasonable and safe sedative and analgesic regimen for
      children's gastrointestinal endoscopy.
    

Intervention name(s): Remimazolam; Esketamine; Propofol; remifentanil
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Remazolam for sedation in children undergoing bidirectional endoscopy; Esketamine; Propofol; remifentanil
Other intervention name(s): Rema; Esket; Prop; remifen
Intervention MeSH terms: Remifentanil; Propofol; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized controlled study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: remiazolam; esketamine; bidirectional endoscopy; children
Does a Relationship Exist Between Fetal Hiccups and Computerised Cardiotocography Parameters?
Condition: Fetal Conditions; Fetal Movement Disorder
MeSH terms: Movement Disorders; Hiccup
Study type: Observational

Summary: 
      BACKGROUND: The physiological function of fetal hiccups and its correlation with fetal
      well-being is unexplored. No previous study examines the correlation between the maternal
      perception of the fetal hiccups and the antepartum cardiotocography.

      OBJECTIVE: To evaluate the correlation between the fetal hiccups and antepartum computerised
      cardiotocography parameters, in nonlaboring term singleton pregnancies.
    


Intervention name(s): Fetal heart rate (FHR) monitoring through computerized cardiotocography (cCTG) analysis antepartum
Intervention type(s): Diagnostic Test
Intervention description(s): The investigator conducted antepartum surveillance through computerized cardiotocography (cCTG) analysis antepartum. This is a non-invasive method to study fetal well being. For each patient, a cCTG was attended using a computerized cardiotocography machine. External cCTG was practised for no less than 20 min (max 60 min), two transducers were fixed on the maternal abdomen: one above the fetal heart level and the other at the uterine fundus
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        physiological nonlaboring term singleton pregnancies (>37 weeks) without maternal or fetal
        complication
      
Keywords: Fetal hiccups; fetal movement; computerised cardiotocography; cardiotocography; computerized analysis
A Study in Healthy Men to Test How BI 1358894 is Taken up in the Body and How Food Influences the Amount of BI 1358894 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of Part 1 of this trial is to investigate the absolute bioavailability of
      BI 1358894 with an intravenous microdose formulation containing labelled [C-14] BI 1358894
      and an unlabelled oral tablet formulation of BI 1358894 in healthy male subjects.

      The main objective of Part 2 of this trial is to investigate the relative bioavailability of
      BI 1358894 administered as an oral suspension.
    


Intervention name(s): BI 1358894
Intervention type(s): Drug
Intervention description(s): BI 1358894
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part 1: non-randomized, fixed-sequence design Part 2: randomized, two-period, two-sequence, crossover design
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Dark Chocolate on Blood Pressure in Individuals With Mildly Elevated Blood Pressure
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The evidence linking chocolate with lowered blood pressure has been observed. However, the
      interventions have been short, at most 4 weeks. The aim of this study is to find out if the
      habitual consumption of dark chocolate for 8 weeks has an effect on blood pressure. Also,
      more insight to the mechanisms linking chocolate to individual healt-responses is needed.
    


Intervention name(s): Dark chocolate; Dietary counselling
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Mildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks.; Usual snacks are limited.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Keywords: cocoa; dark chocolate; hypertension; blood pressure monitoring, ambulatory; flavanols
A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of a combination
      treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese
      participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis
      and for 12 weeks in direct-acting antiviral (DAA)-naive Japanese participants with genotype 1
      or 2 chronic HCV infection with compensated cirrhosis.
    


Intervention name(s): AL-335; Odalasvir (ODV); Simeprevir (SMV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.; Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.; Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Other intervention name(s): JNJ-64146212; JNJ-64289901; TMC435
Intervention MeSH terms: Simeprevir; Odalasvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study for an Oral Contraceptive Containing Folate
Condition: Neural Tube Defects; Contraception; Oral Contraceptives (OC)
MeSH terms: Neural Tube Defects; Spinal Dysraphism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the study drug is safe and effective
    

Detailed description: 
      Acronym is used in result section: suspected/diagnosed (susp/diag)
    

Intervention name(s): Drospirenone/Ethinylestradiol/Methyltetrahydrofolate; Drospirenone/Ethinylestradiol (Yaz)
Intervention type(s): Drug; Drug
Intervention description(s): 0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF); 0.020 mg ethinylestradiol with 3.0 mg drospirenone
Intervention MeSH terms: Drospirenone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Healthy women requesting contraception; Folic Acid
Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol
      inhalation therapy in patients suffering from pulmonary hypertension.
    

Detailed description: 
      This study has previously been posted by Schering AG, Germany. Schering AG has been renamed
      to Bayer Schering Pharma AG, Germany.

      Bayer Schering Pharma AG, Germany is the sponsor of the trial.
    

Intervention name(s): Ventavis (Iloprost, BAYQ6256)
Intervention type(s): Drug
Intervention description(s): Inhaled iloprost
Intervention MeSH terms: Iloprost
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phamacokinetic and Pharmacodynamic Study of Ramosetron in Chemotherapy Induced Nasea and Vomiting
Condition: Colon Cancer
MeSH terms: Vomiting
Study type: Interventional

Summary: 
      This study is designted to know optimal dose of Ramosteron to control for chemotherapy
      induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and
      clinilcal parameters using Rhodes Index.
    

Detailed description: 
      Nausea and vomiting is a common adverse event during chemotherapy treatment. Even if
      preventive medicines such as dopamine receptor antagonist, corticosteroid, serotonin receptor
      antagonist, has been developed and used, there is residual nausea and/or vomiting in a
      significant percentage of patients treated for cancer. Serotonin receptor antagonist is the
      most potent antiemetic agent and has been used widely. However, the optimal dose of serotonin
      antagnosit based on individual symptoms is not defined. Therefore, this study was conducted
      to design standardization model for optiomal serotonin antagonist concentration using
      pharmacodynamic study and Rhodes Index as a suggogate marker for CINV.
    

Intervention name(s): Ramosetron 0.3mg; Ramosetron 0.45mg; Ramosetron 0.6mg
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Nasea 0.3mg; Nasea 0.45mg; Nasea 0.6mg
Intervention MeSH terms: Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: chemotherapy induced nausea vomiting
Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of
      JTT-705 compared with placebo when co-administered with atorvastatin 20 mg in patients with
      low HDL
    


Intervention name(s): JTT-705 600 mg and atorvastatin 20 mg; Placebo and atorvastatin 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): JTT-705 300 mg tablets, 600 mg dose, oral, once daily, immediately following breakfast and/or assessment
Atorvastatin 20 mg tablets, 20 mg dose, oral, once daily, immediately following breakfast and/or assessments; Placebo tablet, 2 tablets, oral, once daily, immediately following breakfast and/or assessments
Atorvastatin 20 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments
Intervention MeSH terms: Atorvastatin; Dalcetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Relative Bioavailability and Bioequivalence of Opicapone
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      the purpose assess the relative bioavailability and bioequivalence of two active
      pharmaceutical ingredient (API) sources of opicapone (OPC, Ongentys® and BIA 9-1067)
      following single 50 mg dose administration under fasting conditions in healthy volunteers
    

Detailed description: 
      This will be a Phase I, open label, randomized, partial-replicate, three-period,
      three-sequence crossover study to investigate the relative bioavailability and bioequivalence
      of 2 API sources of OPC (BIA 9-1067 [Test] and Ongentys® [Reference]) in healthy adult
      subjects.

      Subjects will be randomized in a 3-period, 3-sequence crossover design; each subject will
      receive 2 single oral 50 mg doses of the Reference API source of OPC, and a single 50 mg dose
      of the Test API source of OPC under fasting conditions.

      Potential subjects will be screened to assess their eligibility to enter the study within 28
      days prior to the first dose administration. Subjects will be admitted into the Clinical
      Research Unit (CRU) on Day 1 and be confined to the CRU until discharge on Day 3. There will
      be a washout period of at least 14 days between each dose. A follow-up visit will be
      performed 7 to 14 days after dosing in the last treatment period or early discontinuation.
    

Intervention name(s): Ongentys; BIA 9-1067 (test)
Intervention type(s): Drug; Drug
Intervention description(s): single oral 50 mg (capsule containing 50 mg OPC) under fasting conditions; single oral 50 mg (capsule containing 50 mg OPC) under fasting conditions
Intervention MeSH terms: Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment