bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ALS-008176 in Healthy Japanese Adult Participants
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      ALS-008176 following oral administration of single ascending dose of ALS-008176 in healthy
      Japanese adult participants.
    

Detailed description: 
      This is a double-blind (test or experiment in which neither the person giving the treatment
      nor the patient knows which treatment the patient is receiving), placebo-controlled,
      randomized (study medication assigned to participants by chance) and single-center study of
      ALS-008176. The duration of study will be approximately 6 weeks for each participant. The
      study consists of 3 parts: Screening Phase (28 days before study commences on Day 1);
      double-blind Treatment Phase (single oral dose of ALS-008176 or placebo on Day 1 under fasted
      condition); and Follow up Phase (up to 14 days after study drug administration). All the
      eligible participants will be randomly assigned to receive either a single oral dose of
      ALS-008176 or placebo in each group. The planned doses will be escalated in a stepwise
      fashion if the safety and tolerability in the preceding dose is found acceptable.
      Participants in Group 1 will receive ALS-008176, 250 milligram (mg) or placebo, Group 2 will
      receive ALS-008176, 500 mg or placebo and Group 3 will receive ALS-008176, 750 mg or placebo.
      Study drug will be administered following a 10-hour overnight fast. Blood samples will be
      collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment.
      Pharmacokinetics of ALS-008176, ALS-008206, ALS-008112, and its metabolite ALS 008144 will be
      evaluated primarily. Participants' safety will be monitored throughout the study.
    

Intervention name(s): ALS-008176 (250 mg); ALS-008176 (500 mg); ALS-008176 (750 mg); Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Participants will receive ALS-008176, 250 mg oral suspension once on Day 1 under fasted conditions.; Participants will receive ALS-008176, 500 mg oral suspension once on Day 1 under fasted conditions.; Participants will receive ALS-008176, 750 mg oral suspension once on Day 1 under fasted conditions.; Participants will receive placebo oral suspension once on Day 1 under fasted conditions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy; ALS-008176; Japanese adult participants
Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Multistage low-energy pulses are being evaluated for their effect on atrial fibrillation
      during an acute testing procedure.
    

Detailed description: 
      This is a research feasibility study to evaluate various parameters of the multistage
      low-energy pulses and their effect on atrial fibrillation.
    

Intervention name(s): Multistage low-energy stimulation
Intervention type(s): Device
Intervention description(s): The parameters of the Multistage waveform will be altered and the response of the atria will be recorded.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluating Oxidative Stress in Menopause
Condition: Menopause; Oxidative Stress
Study type: Observational

Summary: 
      Thiol disulfide levels will be determined using venous blood samples from pre- and
      postmenopausal women to evaluate oxidative stress in menopause. Furthermore, oxidative stress
      will be assessed according to age, and years since the start of menopause. Also, whether the
      presence of menopause related osteoporosis has any association with oxidative stress will be
      determined.
    

Detailed description: 
      A total of 77 subjects are divided into two groups: study group (postmenopausal women) and
      control group premenopausal women). Biometric data such as age, bmi, obstetric anamnesis,
      history of komorbidities, PAP smear results are recorded. Mammography results, dexa scores of
      post menopausal women are also obtained. Venous blood samples from all subjects are
      collected. Thiol disulfide levels will be determined from serum samples. Thiol disulfide
      levels will first be compared between the study and the control group in order to determine
      the oxidative stress in menopause. In secondary evaluation years of menopause, age, and dexa
      scores will be included.
    

Intervention name(s): Thiol disulfide level
Intervention type(s): Other
Intervention description(s): Venous blood is collected from all subjects and thiol disulfide levels will be determined from the serum samples obtained from the venous blood.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women within 30-75 years of age were recruited to this study. Premenapusal healthy women
        who visited the clinic for routine gynecological control were included in the control
        group. Postmenopausal women older than 45 years of age who entered menopause as a natural
        process were included in the study group.

        A total of 43 subjects were included in the study group and 34 subjects were included in
        the control group
      
Biospecimen description: 
      Thiol disulfide level in venous blood sample
Medication Review in Women With Depression and Anxiety
Condition: Depression, Anxiety; Adherence, Patient
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      This study sought to assess the impact of the MMR service on identifying and resolving TRPs,
      improving adherence, depression and anxiety scores in females diagnosed with depression and
      anxiety in Jordan
    

Detailed description: 
      Participants were recruited into this single-blind parallel randomized controlled trial and
      randomized into active and control groups. A clinical pharmacist identified TRPs for all
      participants. Adherence, depression and anxiety scores were assessed. Active group patients
      received the MMR service: pharmacist-delivered counseling and a letter with recommended
      changes in the patient's treatment plan was sent to the patient's psychiatrist to be applied.
      Control group participants did not receive the intervention. Follow-up assessments were
      completed for all patients at 3 months from baseline. Main outcome measures were TRPs,
      adherence, depression and anxiety scores.
    

Intervention name(s): Medication management review
Intervention type(s): Other
Intervention description(s): The researcher screened each completed an MMR template and verified that all information in each patient template was complete. A classification system was then used to identify the TRPs which either actually or potentially interfered with the clinical outcomes for each patient.[19] This system was explained in detail and applied successfully in many previous studies.[10, 14, 20] The researcher then identified TRPs for each patient in both groups using evidence-based medicine. The TRPs including unneeded drug treatment, untreated condition/s, efficacy/effectiveness issues, safety issues, inadequate knowledge, inappropriate adherence to pharmacological therapy, inappropriate adherence to self-care activities and miscellaneous problems.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Following recruitment, participants were randomized into two groups (1:1 randomization), active and control, using the computer-generated randomization program (www.randomization.com). The researcher generated the allocation sequence, and assigned the participants to their group. Participant who came into the clinic during the clinic's working hours (Sunday to Thursday, from 9 am to 1 pm) were approached consecutively and allocated to the active or control group. Participants were not aware of which study group they were assigned to; only the researcher was aware of each patient's group assignment.
Participants in the active and control groups completed a baseline and follow-up (3 months from baseline) visits at the same outpatient psychiatric clinic with the researcher conducting the interview using the study tool to complete the MMR process.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Medication management review service; Pharmaceutical care; Clinical pharmacist
Study on the Effect of Inulin in Infant Formula on Gut Health
Condition: Healthy Infants
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study the effect of Infant formula with added Inulin will be compared with the effect
      of Infant formula without Inulin on the Bifidobacterium level in stool.

      It is expected that drinking Infant formula with added Inulin will result in higher
      beneficial bacteria level in stool compared to an Infant formula without Inulin.
    


Intervention name(s): Powder based infant formula; Powder based infant formula; Powder based infant formula
Intervention type(s): Other; Other; Other
Intervention description(s): Powder based infant formula with Inulin I; Powder based infant formula with Inulin II; Powder based infant formula without Inulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Healthy infants; Infant formula; Prebiotics
Divalproex Sodium Delayed-Release Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the relative bioavailability of 500 mg Divalproex Sodium
      Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1
      x 500 mg tablets)in healthy subjects under fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): divalproex sodium; Depakote®
Intervention type(s): Drug; Drug
Intervention description(s): delayed-release 500 mg tablet; delayed-release 500 mg tablet
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
B002 in Patients With HER2-positive Breast Cancer
Condition: Recurrent Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability characteristics of B002 in patients with HER2-positive
      recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) was assessed and the
      maximum tolerated dose (MTD) was explored.
    


Intervention name(s): Humanized Anti-HER2 Monoclonal Antibody Compound for Injection .R&D code: B002.
Intervention type(s): Biological
Intervention description(s): Usage: intravenous infusion; B002, doses 2, 6, 12, 16, 20 mg / kg, intravenous drip. The infusion time was 120 ± 10 minutes for the first time; if the patient was tolerated, the follow-up time was adjusted to 60 ± 10 minutes. Pre-treatment was performed using phenergan (25 mg, intramuscular) within 30 minutes prior to each study drug infusion. The dosing cycle is administered once every 3 weeks for one cycle and can be administered continuously until the disease progresses or is intolerable.
Other intervention name(s): Biological Products; Humanized Anti-HER2 Monoclonal Antibody Compound for Injection
Intervention MeSH terms: Antineoplastic Agents, Immunological; Trastuzumab; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Intervention model description: Test staging: Phase I Design Type: Single Arm Test This study was a preliminary study of stage Ia, openness, dose escalation, pharmacokinetics, and efficacy.
To assess safety and tolerability in HER2-positive recurrent or metastatic breast cancer subjects, to determine dose-limiting toxicity (DLT) and to explore maximum tolerated dose (MTD); to evaluate pharmacokinetic characteristics, immunization Originality and preliminary exploration of efficacy.
The study was divided into the main trial period and the extended trial period. The subject trial completed the enrollment and DLT observations of all evaluable DLT subjects for the dose climbing phase; the PK expansion phase completed the enrollment required PK sample collection for the enrolled subjects.
The extension test is the completion of the subject test and the subject continues to take the drug to the stage of progression of the disease or intolerance.
Blind method: open Test range: Domestic test
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis
Condition: Fatty Liver; Liver Fibrosis; Obesity; Metabolic Syndrome; Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this interventional study is to evaluate the efficacy and tolerability of
      docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with
      well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).
    

Detailed description: 
      Sixty children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled.
      They will be randomized to treatment with DHA, VIT E and Choline (n=30)or an identical
      placebo (n=30) given orally for a period of 12 months. All patients will be included in a
      lifestyle intervention program consisting of a diet tailored on the individual requirements
      and physical exercise.

      Patients will undergo a medical evaluation every three months during the 12-month study
      period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric analysis,
      laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals
      during the 12-months study duration. Ultrasonography of the liver will be repeated after six
      months at the end of the study period.
    

Intervention name(s): Docosahexaenoic Acid plus Vitamin E plus choline; placebo pearls
Intervention type(s): Drug; Drug
Intervention description(s): DHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg; placebo
Other intervention name(s): Placebo
Intervention MeSH terms: Vitamin E; Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NAFLD; NASH; fibrosis
Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500
      μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent
      asthma.
    


Intervention name(s): indacaterol maleate/mometasone furoate; placebo to indacaterol maleate/mometasone furoate; fluticasone proprionate / salmeterol xinafoate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.; Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.; Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.
Other intervention name(s): QMF149; Seretide® Accuhaler®
Intervention MeSH terms: Fluticasone; Mometasone Furoate; Salmeterol Xinafoate; Maleic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma, QMF149, fixed combination of indacaterol and mometasone furoate
Evaluation of the Depth and Duration of Anesthesia From Heated Lidocaine/Tetracaine (Synera®) Patches Compared With 5% Lidocaine (Lidoderm®) Patches Applied to Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, single-blind, active-controlled, two-period crossover study in
      adult volunteers to compare the duration and depth of anesthesia between Synera® and
      Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a Screening
      Visit, two Treatment Periods, and a Follow-Up Phone Contact.
    


Intervention name(s): Heated Lidocaine/Tetracaine Patch; 5% Lidocaine Patch
Intervention type(s): Drug; Drug
Other intervention name(s): Synera® Patch; Lidoderm® Patch
Intervention MeSH terms: Lidocaine; Tetracaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Evaluation; Depth and Duration; Anesthesia
Glucose Monitor Accuracy Investigation (Ⅱ)
Condition: Healthy
Study type: Observational

Summary: 
      According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of
      fingertips as samples to evaluate the accuracy of portable BGM.
    

Detailed description: 
      The clinical medical technologists collected blood samples from 319 volunteers including 90
      diabetics and 229 healthy people. The range of the blood glucose concentration was from
      30.2mg/dL to 577.5mg/dL. The result of clinic evaluation shows that the accuracy of BGM
      matches the requirement of ISO15197(2003).
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The glucose concentrations of volunteer shall be distributed as specified in ISO15197 Table
        3
Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine.
Condition: Renal Colic
MeSH terms: Colic; Emergencies; Renal Colic
Study type: Interventional
Phase: Phase 2

Summary: 
      Rate of Intravenous Magnesium Sulfate Vs Lidocaine to treat Renal Colic in the Emergency
      Department.
    

Detailed description: 
      Magnesium Sulfate (MgSO4) is a N-Methyl-D-aspartate (NMDA) receptor antagonist and is thought
      to be involved in the modulation of pain. There has been little direct evidence that MgSO4
      relieve neuropathic pain and prevents opioid-induced hyperalgesia in humans.

      Intramuscular Diclofenac seems to offer the most effective sustained analgesia for renal
      colic in the ED and has few side effects.

      Lidocain became the agent of choice in visceral and central pain. Intravenous Lidocain is
      effective in the management of neuropathic pain such as diabetic neuropathy, post-surgical
      pain, post-herpetic pain, headaches and neurological malignancies. At low doses, Lidocain is
      known as a relatively safe medication. Lidocain seems an effective treatment who can be
      administrated in the renal colic.

      Objective of study:

      Evaluate the analgesic effect of a standard dose of intravenous magnesium added to
      intramuscular diclofenac compared to intravenous Lidocain combined to intramuscular
      diclofenac or intramuscular diclofenac alone in patients presenting to the ED with renal
      colic and whether it can reduce opioid consumption.
    

Intervention name(s): Magnesium sulfate and diclofenac; Lidocain and diclofenac; Placebo and diclofenac
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intramuscular injection of 75 mg/ 3 ml of Diclofenac solution Intravenous injection of 1 g of Magnesium Sulfate solution diluted in 10 ml of saline solution administered over 2 to 4 minutes; Intramuscular injection of 75 mg/ 3 ml of Diclofenac solution Intravenous injection of 10 ml of Lidocaine 1% solution administered over 2 to 4 minutes.; Intramuscular injection of 75 mg of Diclofenac solution and 10 ml Intravenous injection of serum saline ( as a Placebo Comparator ) administered over 2 to 4 minutes.
Other intervention name(s): Intravenous Magnesium Sulfate combined to Diclofenac; Intravenous Lidocain combined to Diclofenac; Diclofenac alone with placebo ( serum saline )
Intervention MeSH terms: Diclofenac; Lidocaine; Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind study
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Acute pain; Renal colic; Magnesium Sulfate; Lidocain; Diclofenac
The Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.
Condition: Aphasia; Virtual Reality; Emotional Disturbances
MeSH terms: Aphasia; Affective Symptoms
Study type: Interventional

Summary: 
      The aim of the study is to determine virtual reality (VR) impact during standard program of
      rehabilitation on emotional state of patients with aphasia.
    

Detailed description: 
      Aim 1: To test the safety of virtual reality in a vulnerable population of patients with
      aphasia during rehabilitation. Participants will be alternately assigned to receiving a
      relaxation session in VR every working day during a standard course of rehabilitation.

      Aim 2: To test the preliminary efficacy of combining VR with the course of rehabilitation to
      promote emotional improvements in patients with aphasia.
    

Intervention name(s): Relaxation in virtual reality
Intervention type(s): Behavioral
Intervention description(s): Natural 360-degrees scenes from different locations in the world with or without interactions with animals in the virtual reality
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Feasibility Study of Rejuvenair™ for Treating Chronic Bronchitis Patients
Condition: Bronchitis, Chronic; Cryotherapy Effect
MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease
Study type: Interventional

Summary: 
      This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic
      bronchitis patients with airflow restrictions.
    

Detailed description: 
      Prospective, open label, single arm study with sequential accrual of subjects with known
      chronic bronchitis. There are two phases to this study. Phase A will enroll up to 12 subjects
      and will treat a single lobe to assess safety, feasibility and histology/immunology. After
      review of the data by the Data Safety Monitoring Board, Phase B of the study would begin. In
      Phase B of the study, Phase A subjects would have their remaining two lobes treated. In
      addition up to 24 subjects will be enrolled and will have all upper and lower lobes treated
      to assess safety, feasibility and immunology.
    

Intervention name(s): RejuvenAir
Intervention type(s): Device
Intervention description(s): Device: RejuvenAir
Intervention model: Single Group Assignment
Intervention model description: RejuvenAir
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spray cryotherapy; cryotherapy; chronic bronchitis; airflow restrictions