bioihbjkbjnl/mcl2 huggingface dataset:
Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Observational

Summary: 
      The aim of this study is to develop novel magnetic resonance imaging (MRI) protocols suitable
      for patients with multiple sclerosis using advanced MRI such as rotating frame relaxation
      imaging. In addition, the investigators want to study the correlation between advanced MRI
      parameters and clinical disease progression.
    


Intervention name(s): Brain MRI
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        MS patients with relapsing-remitting or secondary progressive MS will be recruited from
        amongst the MS patients in the neurological outpatient policlinics in the Hospital District
        of Southwestern Finland.
      
Keywords: Multiple Sclerosis, MRI, rotating frame
A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential
      hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).
    


Intervention name(s): MK-0954A; MK-954H; Placebo to MK-0954A; Placebo to MK-954H
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily; Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily; Placebo tablet to match MK-0954A, once daily; Placebo tablet to match MK-954H, once daily
Other intervention name(s): Preminent®
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Essential hypertension; Uncontrolled hypertension; Antihypertensive agents; Blood pressure
Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a randomized, double-blind phase Ⅳ clinical trial of quadrivalent influenza
      vaccine (Split Virion), inactivated manufactured by Sinovac Biotech Co., Ltd.The purpose of
      this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of
      quadrivalent influenza vaccine (Split Virion), inactivated in health subjects aged 9-59 years
      old.
    

Detailed description: 
      This study is a randomized, double-blind phase Ⅳ clinical trial in health subjects aged 9-59
      years old to evaluate the lot-to-lot consistency,immunogenicity and safety of quadrivalent
      influenza vaccine (Split Virion), inactivated.The experimental vaccine was manufactured by
      Sinovac Biotech Co., Ltd.A total of 1260 subjects,including 360 subjects aged 9-17 years and
      900 subjects aged 18-59 years will be enrolled.The subjects in each age group will be
      randomly divided into three groups in a ratio of 1:1:1 to receive one dose of three lots of
      quadrivalent influenza vaccine (Split Virion), inactivated produced on a commercial
      scale,respectively.
    

Intervention name(s): Quadrivalent Influenza Vaccine (Split Virion), inactivated
Intervention type(s): Biological
Intervention description(s): The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. The four influenza strains（including 4 antigens H1N1, H3N2, BV and BY, 15μg for each) in 0.5 mL of sodium chloride,disodium hydrogen phosphate,sodium dihydrogen phosphate water for per injection.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Food Intake, Satiety and Blood Glucose After Ingestion of Potato Chips Produced From Three Potato Cultivars
Condition: Obesity; Overweight; Diabetes; Metabolic Syndrome
MeSH terms: Overweight; Metabolic Syndrome
Study type: Interventional

Summary: 
      Potato is one of the world's most popular foods and is widely accepted as a staple food. The
      objective of this study is to determine the effect of consuming potato chips from different
      cultivars on blood glucose, subjective appetite and food intake. It is hypothesized that the
      chips produced from various potato cultivars will differ in their effect on blood glucose,
      satiety and food intake.
    


Intervention name(s): dietary treatment
Intervention type(s): Other
Primary purpose: Prevention
Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Open label, flexible dose, long-term multicenter study of safety and efficacy of SPN-812 in
      adult ADHD patients
    

Detailed description: 
      This is a multicenter, open-label extension study aimed to assess long-term safety and
      efficacy of SPN-812 when administered alone or in conjunction with an Food and Drug
      Administration (FDA)-approved Attention-Deficit Hyperactivity Disorder (ADHD) medication in
      the treatment of ADHD in adult subjects who completed a blinded study of SPN-812 (812P306).
      Subjects initiate SPN-812 dosing at 200 mg/day once daily (QD) during first 2 weeks. At or
      after Visit 2 (Week 2), per the Investigator's discretion and based on Investigator's
      assessment of subject's clinical response and tolerability, the dose of SPN-812 can be
      titrated up or tapered down in increments of 50 mg/day, 100 mg/day, 150 mg/day, or 200 mg/day
      per week to a target dose within the ranges between 200 and 600 mg/day. Additionally, after
      12 weeks of dosing (after Visit 4), at the discretion of the Investigator and based on
      subject's clinical response, the optimized dose of SPN-812 may be supplemented with an
      adjunctive FDA-approved stimulant treatment. Total treatment duration per subject from Visit
      1 to Visit 22 (end of study) is approximately 3 years (156 weeks ± 1 week) or until SPN-812
      becomes commercially available.
    

Intervention name(s): SPN-812
Intervention type(s): Drug
Intervention description(s): SPN-812 200 to 600 mg/day
Other intervention name(s): viloxazine extended-release capsules (Qelbree)
Intervention MeSH terms: Viloxazine
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions
Condition: Nausea; Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under
      non-fasting conditions.
    


Intervention name(s): Ondansetron HCl 24 mg Tablets (Sandoz, Inc.); Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antiemetic
Ultrasound Guided Fascia Iliaca Block for Pain Control After Elective Hip Replacement Surgery
Condition: Arthroplasty, Replacement, Hip; Fascia Iliaca Block
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether ultrasound guided fascia iliaca blocks
      performed before surgery help to reduce pain after elective total hip replacements.
    

Detailed description: 
      Total hip arthroplasty is associated with moderate to severe pain in the acute postoperative
      period, which can increase the risk of postoperative complications such as thromboembolism,
      myocardial ischemia/infarction, pneumonia, poor wound healing, insomnia, and delirium.

      Sensory innervation of the hip joint comes from a combination of peripheral nerves, including
      femoral, obturator, sciatic, superior gluteal, and nerve for the quadratus femoris muscle.
      Superficial innervation of the skin involved in incision for hip arthroplasty comes from the
      lateral femoral cutaneous nerve (LFCN).

      The fascia iliaca block (FIB) was originally described in 1989 using a landmark technique.
      The ultrasound guided FIB was introduced in recent years, and has been shown to produce a
      better quality of block than the landmark technique. It appears to consistently block the
      femoral and LFCN, while being less successful in achieving consistent obturator blockade.

      The FIB is effective for analgesia for hip fracture injuries in the emergency department.
      Thus far, there has been limited exploration into the potential use of this block as a tool
      for postoperative analgesia after elective hip arthroplasty. The potential benefits of this
      regional block, as with other regional techniques, include better analgesia, less opioid use
      and associated side effects, and an improved overall patient satisfaction with postoperative
      recovery.
    

Intervention name(s): .2% Ropivacaine; Saline; Fascia Iliaca Block
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Ultrasound-guided regional anesthesia block to the groin area.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthroplasty, Replacement, Hip; Pain, Postoperative; Nerve Block; Anesthesia, Regional; Fascia Iliaca Block; Ultrasound Guided
Study of the Composition and Bacterial Diversity of the Vaginal Microbiota in Healthy Versus Pathological Conditions (Bacterial Vaginosis) Using a Targeted Metagenomic Approach (RNA 16s)
Condition: Vaginosis, Bacterial
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional

Summary: 
      It aims to determine and compare the degree of vaginal bacterial alpha diversity in the
      absence (healthy population) or presence of bacterial vaginosis (pathological population).
    


Intervention name(s): vaginal swabs
Intervention type(s): Diagnostic Test
Intervention description(s): Nugent score: Vaginal swabbing with the dry swab, make two smears on slides.
Cytobacteriological examination: swabbing at the exo-endocrine junction using the swab
Evaluation of the vaginal microbiota: swabbing at the exo-endocrine junction using the swab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Bacterial Vaginosis
Safety, Tolerability and Pharmacokinetics (PK) Study of Oxytocin (GR121619) Administered Via an Inhaled Route in Healthy Female Volunteers
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      Intramuscular (IM) oxytocin is the gold standard prophylactic therapy for post partum
      haemorrhage (PPH). However, in resource-poor settings within the developing world, the
      stability and therefore effectiveness of prophylactic IM oxytocin is diminished by a lack of
      appropriate refrigeration facilities and availability of trained health care professionals
      (HCPs) to administer IM injections. This study will be the first investigation of oxytocin in
      humans via the inhaled (IH) route and is designed to evaluate the safety and tolerability of
      inhaled oxytocin and the five non-pharmacologically active components in the placebo, and to
      establish the PK characteristics of up to four fixed escalating doses of inhaled oxytocin. In
      this single blind ascending dose-escalation study, the systemic exposure from up to four
      proposed escalating inhaled fixed-dose levels (50 micrograms [mcg], 200 mcg, 400 mcg and 600
      mcg) will be compared with the systemic exposure following 10 international units (IU) of IM
      oxytocin in healthy premenopausal females.. A total of 15 subjects will be enrolled after
      screening sufficient number of healthy female subjects and the subjects will be assigned to
      one of the two treatment sequences. The total duration of this study is approximately 20
      weeks.
    


Intervention name(s): IM oxytocin 10 IU; IH oxytocin 50 mcg; IH oxytocin 200 mcg; IH oxytocin 400 mcg; IH oxytocin 600 mcg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): IM oxytocin 10 IU is a colourless and clear sterile solution in a 1 mL ampoule containing 10 IU of oxytocin, which is administered intramuscularly; IH oxytocin 50 mcg is a powder blend for inhalation in a hard capsule containing 50 mcg of oxytocin, which is administered by oral inhalation.; IH oxytocin 200 mcg is a powder blend for inhalation in a hard capsule containing 200 mcg of oxytocin, which is administered by oral inhalation.; IH oxytocin 400 mcg is a powder blend for inhalation in a hard capsule containing 400 mcg of oxytocin, which is administered by oral inhalation.; IH oxytocin 600 mcg is a powder blend for inhalation in a hard capsule containing 600 mcg of oxytocin, which is administered by oral inhalation.; Placebo is a powder blend for inhalation in a hard capsule containing five inactive components, which is administered by oral inhalation.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pharmacokinetics; safety; tolerability; oxytocin
Ketamine Infusion for Adolescent Depression and Anxiety
Condition: Major Depressive Disorder; Anxiety Disorder
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the tolerability and short-term efficacy of a
      single ketamine infusion for the treatment of adolescents with 1) medication-refractory major
      depressive disorder (MDD) and/or 2) medication-refractory anxiety disorders (social anxiety
      disorder, panic disorder, generalized anxiety disorder and/or separation anxiety disorder).
    

Detailed description: 
      We will conduct a crossover trial in which as many as 36 adolescents (18 with MDD and 18 with
      anxiety disorders) will be given a single infusion of ketamine (study drug) or midazolam
      (active control). MDD symptoms and anxiety symptoms will be monitored over a two-week period.
      If applicable, comorbid school refusal symptoms will also be monitored over a two-week period
      for both cohorts. A 2-week washout period will be required between infusion doses. Our
      primary outcomes will be 1) improvement in MDD symptoms (measured by Montgomery-Asberg
      Depression Rating Scale, revised (MADRS) score) 1 day after infusion, for the cohort of
      subjects enrolled in the MDD arm of this trial and 2) improvement in the anxiety symptoms
      (measured by the Multimodal Anxiety Scale for Children (MASC) acute physical symptoms
      subscale) for the cohort of subjects enrolled in the anxiety disorders arm of the trial.
    

Intervention name(s): Ketamine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 0.5mg/kg of Ketamine will be administered Intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.; A single dose of 0.045mg/kg of Midazolam will be administered intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.
Other intervention name(s): Ketalar; Versed
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants were randomly assigned the treatment order, with participants receiving a single infusion of either ketamine hydrochloride (0.5 mg/kg) or midazolam (0.045 mg/kg) on Day 1, and the alternate compound 2 weeks later.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ketamine; Depression; Major Depressive Disorder; Anxiety; School refusal; Suicide; Generalized Anxiety; Suicidal Ideation
External Validation of a Predictive Model for Bowel Preparation in Patients Undergoing Colonoscopy
Condition: Bowel Preparation; Colonoscopy
Study type: Observational [Patient Registry]

Summary: 
      Bowel preparation is closely lined to the quality of colonoscopy, inadequate bowel
      preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher
      health expense. For the patients with possible IBP before the examination, it may be better
      to cancel the colonoscopy and repeat bowel preparation through modified or enhanced
      strategies. This study aimed to externally validate the efficiency of a procedure-based model
      in predicting inadequate bowel preparation
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Before colonoscopy, the following information was obtained by the colonoscopists through asking patients: the characteristics of last stool, the time of drinking first dose of laxative, the time of first defecation, the time of drinking last dose of laxative. The beginning time of colonoscopy was also recorded. During withdrawal phase, the quality of bowel preparation was evaluated based on BBPS scale.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective study involving eleven tertiary-centers in China.
IMPACT Study (Improving Measurements of Persistence on "ACtonel" Treatment)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the impact of physician's reinforcement
      using bone marker data on the subject's compliance (at least 50% drug taken) and persistence
      on treatment after one year in postmenopausal osteoporotic women.
    


Intervention name(s): risedronate
Intervention type(s): Drug
Intervention MeSH terms: Risedronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Significance of Marginal Acute Inflammation for Stage II Colon Cancer
Condition: Inflammation; Colon Cancer
MeSH terms: Colonic Neoplasms; Inflammation
Study type: Observational

Summary: 
      Marginal acute inflammation would make reporting the serosal involvement of tumors
      controversial. We aimed to investigate the clinical significance and explore the prognostic
      value of MAI for stage II localized colon cancer.
    


Intervention name(s): MAI detection
Intervention type(s): Diagnostic Test
Intervention description(s): to detect the presence of marginal acute inflammation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        stage II colon cancer patients
Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects
Condition: Rabies; Japanese Encephalitis
MeSH terms: Rabies; Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Establish non-inferiority of the immune response and evaluate the safety and tolerability of
      Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to
      either of 2 schedules for preexposure prophylaxis.
    


Intervention name(s): Rabies; Japanese Encephalitis; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).; Subjects received two doses of Japanese Encephalitis vaccine.; Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rabies; JE; accelerated schedule
To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg.
    


Intervention name(s): Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc); Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antidepressant
A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Cancers.
Condition: Advanced Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a modular Phase I/IIa, open-label, multi-centre, study of AZD7648 administered
      orally, either as a monotherapy, or in combination with either cytotoxic chemotherapies or
      novel anti-cancer agents in participants with advanced malignancies.
    

Detailed description: 
      The modular design allows for an escalation of the dose of AZD7648 alone or in combination
      with either cytotoxic chemotherapies or novel anti-cancer agents, with intensive safety
      monitoring to ensure the safety of the participants.

      The study consists of 2 modules each evaluating the safety and tolerability of AZD7648
      monotherapy or with a specific combination partner.

      Core module of the study is dose escalation (Part A) of AZD7648 monotherapy, administered
      orally, in participants with advanced solid tumours.

      Combination module 1 has 2 study parts: Part A consisting of dose escalation cohorts and Part
      B, a safety and proof of concept Phase IIa expansion. A Safety Review Committee will review
      evaluable participants at each cohort and assess if the study should progress to Part B.
    

Intervention name(s): AZD7648; PLD
Intervention type(s): Drug; Drug
Intervention description(s): Core: AZD7648 will be administered orally; The starting dose of PLD is 40 mg/m^2, administered by intravenous infusion once every 4 weeks, for a maximum of 6 cycles
Other intervention name(s): DOXIL, Caelyx
Intervention MeSH terms: AZD7648
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety,; Pharmacokinetics,; Pegylated liposomal doxorubicin,; Dose finding