bioihbjkbjnl/mcl2 huggingface dataset:
MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study has two parts. In the first part, the efficacy and safety MK-0954E (losartan
      potassium 50 mg [L50] (+) hydrochlorothiazide 12.5 mg [H12.5] (+) amlodipine besylate 5mg
      [A5]) will be evaluated and compared to the efficacy and safety of MK-0954H (L50/H12.5) in
      Japanese participants. In the second part, the safety and tolerability of long-term use of
      open-label MK-0954E in participants with hypertension will be evaluated. The primary
      hypothesis is that MK-0954E is more effective in lowering mean trough sitting diastolic blood
      pressure (SiDBP) after 8 weeks of treatment compared to MK-954H (L50/H12.5 mg) in Japanese
      participants with essential hypertension who are not adequately controlled following a 8-week
      treatment with filter period study drug of MK-954H.
    


Intervention name(s): L50/H12.5/A5; L50/H12.5; Placebo to L50/H12.5/A5; Placebo to L50/H12.5
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): MK-0954E; MK-0954H
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Essential hypertension; Antihypertensive agents; Blood pressure; Uncontrolled hypertension
CSD201002: Study to Assess Nicotine Uptake From P10 Nicotine Pouches
Condition: Smoking; Tobacco Use
Study type: Interventional

Summary: 
      This study is a single-center, open-label, randomized, 7-way crossover study designed to
      evaluate plasma nicotine pharmacokinetics (PK) parameters following use of the study
      investigational products (IPs) in a confinement setting by generally healthy combustible
      cigarette (CC) smokers.
    

Detailed description: 
      This study is designed to evaluate plasma nicotine PK parameters following the use of
      nicotine pouches (hereinafter referred to as Velo Pouch IPs) in cigarette smokers and smokers
      who also use smokeless tobacco (SST) [e.g., snus, moist snuff]. At least one-third of the
      study population will include smokers who also use ST.

      Potential subjects may complete a pre-screening telephone interview. They will complete a
      Screening Visit to assess their eligibility within 45 days prior to enrollment, randomization
      and confinement.

      Following the Screening Visit, eligible subjects will be scheduled for a Day 1 check-in visit
      to complete procedures to confirm eligibility. Eligible subjects will be enrolled and begin
      confinement at the clinical site for 8 days and 7 nights. Subjects will participate in
      separate Test Sessions for plasma nicotine PK assessment, one for each IP. The IP for each
      Test Session will be determined based on a randomly assigned IP presentation schedule (14
      product sequence) generated using a Williams Design. Each Test Session will last for
      approximately 4 hours following the start of the IP use, and will include collection of
      plasma samples for PK assessments prior to, during and following IP use and completion of the
      Overall Product Liking questionnaire. Subjects will use their randomized study IP one day
      before the respective test session to familiarize themselves with the IP.
    

Intervention name(s): Product A; Product B; Product C; Product D; Product E; Product F; Product G
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): P1012915, a nicotine pouch with 8 mg nicotine; P1013018, a nicotine pouch with 10 mg nicotine; P1013015, a nicotine pouch with 8 mg nicotine; P1012815, a nicotine pouch with 8 mg nicotine; P1013315, a nicotine pouch with 8 mg nicotine; P1013115, a nicotine pouch with 8 mg nicotine; P1013215, a nicotine pouch with 8 mg nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency
Condition: Lactation; Insufficient, Partial; Hypogalactia, Without Mention of Attachment Difficulty
MeSH terms: Lactation Disorders
Study type: Interventional

Summary: 
      This study was meant to see the effectiveness of press tack needle acupuncture in improving
      lactation insufficiency. The acupuncture points used in this study were CV17 Danzhong and SI1
      Shaoze. Press Tack Needles were placed in these acupuncture points for 7 days in hope that it
      will give continuous acupuncture stimulation that might help in improving lactation
      insufficiency with minimal side effect, less time consuming, and more efficient for the
      patient.
    


Intervention name(s): Press Tack Needle Acupuncture
Intervention type(s): Device
Intervention description(s): Seirin Pyonex Press Tack Needle 0.20 x 0.60 mm for SI1 Shaoze acupuncture point Seirin Pyonex Press Tack Needle 0.20 x 0.90 mm for CV17 Danzhong acupuncture point
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; exclusive breastfeeding; breastmilk; press tack needle; lactation insufficiency
Incretin Effect in People With Impaired Fasting Glucose
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of
      glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to
      abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the
      objective of the current study. The investigators hypothesized that defects in GLP-1 may
      explain the inappropriate basal EGP and diminished insulin secretion in IFG, and,
      furthermore, that by increasing circulating GLP-1 levels (using a new medicine called
      "sitagliptin") the investigators could reverse these defects.
    


Intervention name(s): Sitagliptin Phosphate
Intervention type(s): Drug
Intervention description(s): Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
Other intervention name(s): brand name: Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pre-diabetes; isotopes; insulin secretion; insulin action; GLP-1; simple obesity; impaired fasting glucose
Whitening Efficacy of Dentifrice Containing 10% High Cleaning Silica, 0.5% Sodium Phytate and 0.5% Sodium Pyrophosphate
Condition: Tooth Bleaching
Study type: Interventional

Summary: 
      The objective of the present study was to compare the effects of a commercially available
      dentifrice containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium
      pyrophosphate versus a negative control dentifrice on removal of extrinsic stains.
    

Detailed description: 
      There is great concern on the tooth esthetics and color among people, especially young
      adults. Great efforts have been made in order to improve patients' smile. Epidemiological
      studies have reported that dissatisfaction with tooth color ranged from 19.6% to 65.9%,
      depending on different population. An oral health related quality of life questionnaire for
      use among young adults reported that tooth color was the most important concern. This
      dissatisfaction with tooth color has been shown to be associated with increased desire for
      treatments that improve dental aesthetics including tooth whitening dentifrices. Tooth
      whitening products generally help to improve the overall whiteness of teeth, by removing and
      controlling the formation of extrinsic stains. In recent years the interest on the treatment
      of tooth stain with various tooth whitening agents, among which dentifrice containing high
      cleaning silica is widely used.
    

Intervention name(s): Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate; Control toothpaste
Intervention type(s): Drug; Drug
Intervention description(s): Use the toothpaste to brush teeth twice a day for 8 weeks; Use the toothpaste to brush teeth twice a day for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Toothpastes; Controlled Clinical Trial
Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The primary objective of the study is to evaluate the adherence to the treatment with
      interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting
      multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more
      than 6 months in treatment.
    


Intervention name(s): Interferon beta-1b (Betaseron, BAY86-5046)
Intervention type(s): Drug
Intervention description(s): Interferon beta-1b (INFb-1b) was used at the standard dose of 250 mg/ml.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study included patients who had been on interferon beta-1b for more than 6 months and
        who agreed to participate in this study.
      
Keywords: Interferon beta-1b (INFb-1b); Multiple Sclerosis (MS); Relapsing-remitting MS (RRMS); Secondary progressive MS (SPMS); Clinically isolated syndrome (CIS)
HDDO-1614 Bio Equivalence Study
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single-dose, crossover study
    

Detailed description: 
      This clinical trial is conducted with a randomized, open-label, single-dose, and cross over
      study designs. Investigators will compare the pharmacokinetic parameters of test drug(single
      oral dose, single administration) with pharmacokinetic parameters of comparator 1 and
      2(combined administration, single oral dose).
    

Intervention name(s): HDDO-1614; Bazedoxifene / Cholecalciferol
Intervention type(s): Combination Product; Drug
Intervention description(s): Combination drug (Bazedoxifene + Cholecalciferol)
Incrementally modified drug
Not market authorized product; Co- Administration of Bazedoxifene and Cholecalciferol
Intervention MeSH terms: Cholecalciferol; Vitamin D; Bazedoxifene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Predictive Value of Transabdominal Intestine Sonography in Critically Ill Patients
Condition: Gastrointestinal Dysfunction; Critical Illness; Intestine Ultrasonography
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      It is very important to evaluate the degree of gastrointestinal dysfunction in critical ill
      patients. Thus the investigators conducted transabdominal intestine ultrasonography(US) in
      critical ill patients to evaluated the degree of gastrointestinal dysfunction under the acute
      gastrointestinal injury (AGI)
    


Intervention name(s): GIF score; US score
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): assessment by GIF score; assessment by ultrasonography score
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with severe complications after surgery and severe trauma
Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency
Condition: Chronic Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional

Summary: 
      The aim of our study was to compare the effectiveness of active and passive practices in
      patients with CVI.
    

Detailed description: 
      Volunteers who have been diagnosed with venous insufficiency according to the criteria of
      inclusion, who applied to Cardiovascular Surgery Department will be included this study.

      Participants will be randomly allocated 3 groups using the 'Research Randomizer' website. In
      all groups, a common evaluation protocol will be applied to the patients.

      Compression therapy will be applied to the first group. Active treatment in addition to
      compression therapy will be applied to the second group. Passive treatment in addition to
      compression therapy will be applied to the third group.
    

Intervention name(s): Exercise Training; Massage; Neuromuscular Electrical Stimulation; Compression Therapy
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Endurance training with a resistance-free bicycle ergometer Strength training with bodyweight Non-resistance ankle pumping exercises; Classical massage including superficial and deep stroking and friction methods for the lower extremity.; Symmetrical biphasic current at a frequency of 30-85 Hz; Compression therapy is a treatment applied to patients in the form of Four Layer Compression Bandage and Compression Stocking. Four Layer Compression Bandage is a treatment that requires four different types of bandages. The compression stocking is an elastic stock with various tension and length.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; compression; neuromuscular electrical stimulation; massage
A Drug-Drug Interaction Study of Ambroxol and Levodropropizine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-durg interaction between ambroxol and
      levodropropizine.
    


Intervention name(s): Ambroxol and Levodropropizine; Ambroxol; Levodropropizine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ambroxol HCl 30mg & Levodropropizine 60mg, PO, Single dose; Ambroxol HCl 30mg, PO, single dose; Levodropropizine 60mg, PO, single dose
Intervention MeSH terms: Dipropizine; Ambroxol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ambroxol; Levodropropizine; Drug-drug interaction
Bone Marrow Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Combining chemotherapy with bone marrow transplantation may
      allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating
      patients with chronic lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES: Examine the potential role for high dose cyclophosphamide, total body irradiation
      and bone marrow transplantation for patients with chronic lymphocytic leukemia who are at
      high risk for disease progression.

      OUTLINE: Patients receive daily intravenous infusions of cyclophosphamide for two days,
      followed by total body irradiation in four daily exposures. After completion of the total
      body irradiation, allogeneic or autologous bone marrow is infused intravenously.

      PROJECTED ACCRUAL: 50 patients are expected to be accrued.
    

Intervention name(s): Cyclophosphamide; Allogeneic Bone Marrow Transplantation; Autologous Bone Marrow Transplantation; Total Body Irradiation (TBI)
Intervention type(s): Drug; Procedure; Procedure; Radiation
Intervention description(s): Daily intravenous infusions of cyclophosphamide for two days,; After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.; After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.; Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.
Other intervention name(s): Cytoxan; Neosar; Stem Cell Transplant; Stem Cell Transplant; radiation therapy
Intervention MeSH terms: Cyclophosphamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory chronic lymphocytic leukemia; Cyclophosphamide; Cytoxan; Neosar; Bone Marrow Transplantation; total body irradiation; chronic lymphocytic leukemia; allogeneic; autologous
The Effect of Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions
Condition: Breast Cancer; Postoperative Pain; Respiratory Function Impaired
MeSH terms: Respiratory Insufficiency; Pain, Postoperative
Study type: Interventional

Summary: 
      Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves
      between T3 and T9 dermatomes. Serratus anterior plane block is used to block lateral
      cutaneous branches of intercostal nerves between T2 and T6, in addition, it is also known to
      block thoracodorsal nerve and long thoracic nerve. Both of the blocks are usually performed
      for postoperative analgesia following breast surgery. The primary hypothesis of the study is
      that FEV1 value of the patients who will receive modified radical mastectomy (MRM) and
      rhomboid intercostal plane (RIP) block combined with serratus anterior plane (SAP) will be
      higher than FEV1 value of the patients in the no-block group. The secondary hypothesis is
      that RIP+SAP blocks will provide reduction in the pain scores and opioid consumption in the
      postoperative first 24 hours.
    

Detailed description: 
      The patients who are scheduled for MRM under general anesthesia, aged between 18-65 years and
      ASA scores I-II will be included in the study. Respiratory functions (FEV₁, FVC, FEV₁/FVC,
      PEF, FEF25-75) of the patients will be measured by a hand-held spirometry device prior to the
      operation in the surgical ward. The induction of anesthesia will be provided similarly in all
      patients, then patients will be intubated and randomly divided into two groups. One group
      will receive RIP+SAP block using 40 milliliters of %0.25 bupivacaine and patients in the
      control group will receive no block procedures. The standard analgesia will be provided by
      intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg which
      will be administered in 15 minutes before end of the surgery. Respiratory functions of the
      patients will be measured at the postoperative 2nd, 4th and 24th hours. Pain intensity of the
      patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0
      (no pain) and 10 (the worst pain that a person can stand). NRS scores will be evaluated at
      the postoperative 15th, 30th minutes and 1st, 2nd, 6th, 12th and 24th hours, and opioid
      consumption will be recorded at the postoperative 24th hour.
    

Intervention name(s): RIB+SAP blocks
Intervention type(s): Procedure
Intervention description(s): RIB block will be performed after endotracheal intubation, then a SAP block will be performed. No other intervention will be performed to the patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, controlled study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Analgesia; postoperative pain; rhomboid intercostal block; serratus anterior plane block; respiratory function
Hood to Coast Injury Study
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine how certain kinds of fruit juice that contain natural
      antioxidants and natural anti-inflammatory properties may reduce exercise-induced muscle pain
      and injury. Participants will be recruited from registered participants in the Hood To Coast
      Relay. The Hood To Coast Relay Race Officials will post the study on their website to find
      interested teams. Interested participants will then be contacted by the study staff by phone
      regarding the study's inclusion and exclusion criteria and to schedule the initial health
      screening visit. The participants will undergo an initial health screening and survey about
      muscle soreness, and then drink the investigational juice twice daily for 8 days. On the 7th
      day of drink administration, the participants will report to the starting location of the
      Hood To Coast Relay to meet with the investigators for 30 minutes to survey muscle pain and
      juice tolerability. The participants will then participate in the Hood To Coast Relay,
      drinking 2 more bottles of juice over the duration of the relay. At the conclusion of the
      relay, the participants will meet with study investigators to take the same short survey
      about muscle pain and juice tolerability.
    


Intervention name(s): Tart Cherry Juice; Fruit juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will ingest 10.5 fl oz of cherry juice twice a day for 7 days prior to the race, and the day of the race (8 days total).; Participants will ingest 10.5 fl oz of fruit juice twice a day for 7 days prior to the race, and the day of the race (8 days total), which will serve as a 'placebo' juice.
Other intervention name(s): Cherrish
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Muscle pain
Relative Bioavailability of a Linagliptin+Metformin Fixed Dose Combination Tablet Administered With and Without Food to Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effect of food on the relative bioavailability of a 2.5 mg
      linagliptin+1000 mg metformin fixed dose combination (FDC) tablet
    


Intervention name(s): Linagliptin/metformin FDC; high-fat, high caloric meal
Intervention type(s): Drug; Other
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment