bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Metabolism-Boosting Beverages
Condition: Energy Expenditure; Appetite
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of Metabolism-boosting Beverages (MBB)
      containing green tea extract with a standardized amount of epigallocatechin gallate (EGCG)
      and caffeine.
    

Detailed description: 
      The study will assess the effect of MBB's on 24 hour energy expenditure by performing
      indirect calorimetry, and on appetite using visual analogue scales (VAS). The planned sample
      size is 54 healthy male and female adults, both lean and overweight. We plan to test 6
      metabolism-boosting beverages in the following order: 1) Raspberry Tea 2) Banana Shake 3)
      Chai Latte 4) Strawberry Shake 5) Cappuccino 6) Hot Cocoa. In the order that they are
      screened, each subject will be assigned to receive 1 of 6 Metabolism-boosting beverages. Each
      MBB will contain 90 mg EGCG and 100 mg caffeine.
    

Intervention name(s): Medifast Metabolism-boosting Beverages
Intervention type(s): Other
Intervention description(s): Medifast metabolism-boosting beverages containing 90 mg EGCG and 100 mg caffeine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: obesity; metabolism; weight loss; energy expenditure; thermogenesis; Metabolism-Boosting Beverages effect on REE; Metabolism-Boosting Beverages effect on appetite
Efficacy and Safety of HIP1601 Capsule
Condition: Erosive Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in
      patients with erosive gastroesphageal reflux disease.
    


Intervention name(s): HIP1601; HGP1705; HIP1601 Placebo; HGP1705 Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral esomeprazole; Oral Nexium Tab; Oral Placebo; Oral Placebo
Other intervention name(s): esomeprazole; Nexium Tab
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: multicenter, randomized, double-blind, parallel group study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Immunogenicity of a New Formulation of a Bivalent Killed, Whole-Cell Oral Cholera Vaccine
Condition: Cholera
MeSH terms: Cholera
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of a new formulation
      of a locally-produced bivalent, (O-1 and O-139) killed whole cell oral cholera vaccine among
      Vietnamese adults.
    

Detailed description: 
      Cholera remains to be a serious public health problem worldwide. In the mid-1980s following
      technology transfer from Sweden, Vietnamese scientists developed and produced an oral killed
      monovalent cholera vaccine for Vietnam's public health programs. A 2-dose regimen of this
      vaccine has been shown to be safe and efficacious. Subsequently, a bivalent vaccine was
      developed containing the newly emergent O139 V. cholerae. This vaccine has several advantages
      over the existing Swedish vaccine. It confers protection against the El Tor biotype in
      younger children, is considerably less expensive, does not require a buffer during
      administration and does not require strict cold chain requirements. However, this vaccine is
      not licensed for use in countries other than Vietnam. In order to make this vaccine available
      to other countries, the IVI has provided technical assistance to produce this vaccine
      following the WHO Good Manufacturing Practices standards. A new formulation of the current
      oral cholera vaccine was produced following these guidelines. Since this vaccine is slightly
      different from the previous vaccine, a study is necessary to demonstrate safety and
      immunogenicity for local licensure and larger Phase III studies in other countries.
    

Intervention name(s): killed oral cholera vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: watery diarrhea; cholera vaccine
EFFECT of WHOLE BODY VIBRATION on FUNCTIONAL CAPACITY and RESPIRATORY FUNCTIONS IN STROKE INDIVIDUALS
Condition: Stroke; Respiratory Function Impaired
MeSH terms: Respiratory Insufficiency; Stroke
Study type: Interventional

Summary: 
      While there is only one study examining the effect of WBV on oxygen consumption and
      cardiovascular responses in individuals with stroke, no study has been found on the effect of
      WBV on respiratory capacity and flow volumes and changes in functional capacity due to
      effort. In this study, it was aimed to investigate whether the WBV treatment protocol
      determined has an effect on functional capacity and respiratory functions in individuals with
      stroke.
    


Intervention name(s): rehabilitation
Intervention type(s): Other
Intervention description(s): A specialist physiotherapist in neurological rehabilitation provided the Bobath approach individually to each patients in both groups. Bobath approach included 3 days a week over a total of 12 sessions for four weeks. The Bobath approach consisted of about individual one hour session.
In addition to the Bobath approach, the subjects in the study group received WBV for 20 minutes a day, 2 days a week. The frequency of the device was increased by 5 Hz every week, starting the treatment with 30 Hz. Whole body vibration application was performed on a platform (Power Plate Pro5®) that provides vertical vibration. Two different practice positions were chosen as standing and semi-squatting. In order to prevent muscle fatigue, the set consisting of 1 minute of application - 1 minute of rest in each position was applied for a total of 10 minutes with 5 repetitions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Bobath approach; whole body vibration; functional capacity; respiratory function
Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes
Condition: Miscarriage in First Trimester
MeSH terms: Abortion, Spontaneous
Study type: Observational

Summary: 
      The aim of this study is to establish clinically meaningful ultrasound-based diagnostic
      criteria for AP. To this end, the investigators will prospectively collect clinical and
      ultrasound data from early intrauterine pregnancies and correlate this data with pregnancy
      outcomes (particularly with risk of miscarriage), to establish whether there are any
      diagnostic criteria that can be used to make the diagnosis, facilitate increased surveillance
      of at risk pregnancies and reassure those with normally located pregnancies. The collected
      data will be used to correlate incidence of angular pregnancy and clinical variables such as
      maternal age, uterine fibroids, assisted conception, multiple pregnancy, ethnicity, previous
      uterine and adnexal surgery.
    


Intervention name(s): Ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Ultrasound based observational study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women who are attending for a scan in the early pregnancy unit, aged over 16
        years.
Cangrelor Neonatal PK/PD and Safety Study
Condition: Partial Obstruction of Systemic to Pulmonary Artery Shunt; Complete Obstruction of Systemic to Pulmonary Artery Shunt
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the PK/PD and safety profile of cangrelor in neonatal
      participants at risk of thrombosis.
    


Intervention name(s): Cangrelor
Intervention type(s): Drug
Intervention MeSH terms: Cangrelor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Anlotinib in Metastatic HER2 Negative Breast Cancer
Condition: Breast Neoplasm; Antineoplastic Agents; Anlotinib
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of this study is to discover if the anlotinib can shrink or slow the growth of
      pretreated HER2 negative metastatic breast cancer.
    

Detailed description: 
      Breast cancer is one of the most common malignant tumors in women, which is a serious threat
      to women's health. Despite the continuous improvement of treatment, 30% of breast cancer
      eventually develops into advanced breast cancer. The median survival of advanced breast
      cancer after routine treatment is 2-3 years. The main treatments include chemotherapy,
      endocrine therapy, and targeted therapy. The treatment of metastatic breast cancer (MBC) aims
      to improve quality of life, reduce pain and prolong survival.

      Angiogenesis plays an important role in tumor cell proliferation and metastasis. Various
      anti-angiogenic drugs such as bevacizumab, sunitinib, sorafenib, etc. have been developed and
      widely used in various tumors. Treatments such as colon cancer, lung cancer, and renal cell
      carcinoma significantly improve PFS and OS in patients with advanced disease, and the adverse
      reactions are well tolerated. However, anti-angiogenic therapy has certain limitations in the
      treatment of advanced breast cancer.

      Anrotinib hydrochloride capsule is a new drug independently developed in China. It is a
      multi-target receptor tyrosine kinase inhibitor targeting angiogenesis-related kinases such
      as VEGFR1/2/3, FGFR1/2/3 and other kinases such as cell growth-related kinases such as
      PDGFRα/β, c-Kit, and Ret , and it was approved by China Food and Drug Administation for the
      treatment of patients with locally advanced or metastatic non-small cell lung cancer who have
      progressed or relapsed after receiving at least 2 systemic chemotherapy. Basic research shows
      that anlotinib is effective in breast cancer cell lines, but lacks the results of clinical
      application of advanced breast cancer. This study is based on the results of phase I clinical
      trials of allerinib in a variety of advanced solid tumors, to explore its efficacy and safety
      in HER2-negative advanced breast cancer.
    

Intervention name(s): Anlotinib Hydrochloride
Intervention type(s): Drug
Intervention description(s): Anlotinib 12mg p.o. d1-14, 21days/cycle
Other intervention name(s): anlotinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Erythromycin in Parkinson's Disease
Condition: Parkinson's Disease; Levodopa
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Gastroparesis (slow stomach emptying) is a common feature of Parkinson's Disease. Levodopa
      (Sinemet), a common medication for Parkinson's Disease, can make gastroparesis worse.
      Gastroparesis effects how the levodopa is absorbed and used by the body. This study will
      explore the possibility of using Erythromycin, a drug commonly used (off label) for
      gastroparesis, along with levodopa to determine if there is improved levodopa absorption and
      motor function.
    

Detailed description: 
      Participants will be required to make four visits for evaluation. Visit 1 is a screening
      visit, participants will receive the study drug or a placebo during visits 2 and 3, and visit
      4 is a follow up visit. Participants will provide blood and urine samples during the visits.
      Participants will also be required to complete questionnaires and a series of motor tests.
    

Intervention name(s): Erythromycin; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Levodopa; motor fluctuations; gastroparesis
Abscess Packing Versus Wick Placement After Incision and Drainage
Condition: Superficial Abscess Packing
MeSH terms: Abscess
Study type: Interventional

Summary: 
      Abscesses or "boils" are becoming more common every year and are a common reason children
      come to the Emergency Department. For the abscess to heal the skin needs to be opened to let
      the pus come out. Often doctors put something called "packing material" or gauze into the
      abscess space to help aid in healing. It is not known if the type of "packing" that is done
      is necessary or if a more simple treatment is as good or better. With informed consent we
      randomly place a child into one (1) of two (2) groups in this study that will say if the
      child's abscess/boil is packed with gauze in the traditional way or if a wick (small piece)
      of gauze is placed after the abscess/boil is opened and the fluid is drained. After treatment
      in the emergency department the child will be scheduled to follow-up in the Pediatric Acute
      Wound Service (PAWS) clinic as all other children with this infection are scheduled. At this
      visit the healing of the wound will be checked by the staff in the clinic and will be scored.
      With this evaluation of the wound the hypothesis that for a simple superficial (skin)
      abscess/boil a gauze wick placement into the abscess/boil is as effective as placement of
      traditional gauze packing.
    


Intervention name(s): Full packing into abscess cavity; Wick placement into abscess cavity
Intervention type(s): Procedure; Procedure
Intervention description(s): After incision and drainage plain 1/4-1/2 inch gauze packing material is placed into the cavity to fill it; After incision and drainage of the abscess a piece of plain gauze 1/4-1 inch packing material that is as wide as can be easily passed through the opening is placed into the cavity spanning one diameter of the cavity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Superficial abscess; packing material; wick; incision and drainage
A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep
Condition: Nonrestorative Sleep
Study type: Interventional
Phase: Phase 2

Summary: 
      In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive
      treatment effect relative to placebo on the primary endpoint, the weekly version of the
      Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of
      varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be
      explored in Nonrestorative Sleep subjects.
    


Intervention name(s): PD 0200390; PD 0200390; PD 0200390; PD 0200390; PD 0200390; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.; oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.; oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.; oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.; oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.; oral placebo daily dose, 3 capsules per dose during a six week treatment period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
Condition: Osteoarthritis; Knee
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to determine the safety, tolerability and pharmacokinetics
      after single ascending dose of LNA043 in Japanese participants with osteoarthritis of the
      knee.
    

Detailed description: 
      This was a non-confirmatory, randomized, participant- and investigator-blinded,
      placebo-controlled, single ascending dose study to investigate the safety, tolerability and
      PK of LNA043 in Japanese participants with osteoarthritis of the knee. This study consisted
      of 2 cohorts with a total of 12 participants.
    

Intervention name(s): LNA043; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single intra-articular injection on Day 1; Single intra-articular injection on Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: osteoarthritis; knee; cartilage
Glyburide Advantage in Malignant Edema and Stroke Pilot
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to assess the feasibility of enrolling, evaluating,
      and treating with glyburide for injection severe anterior circulation ischemic stroke
      participants, whether or not treated with standard of care intravenous (IV) recombinant
      tissue plasminogen activator (rtPA). Participants must be between 18-80 years of age, must
      have a baseline diffusion weighted image (DWI) lesion volume 82 -210 centimeters cubed (cm3),
      and time from symptom onset to start of study infusion must be ≤10 hour(hr). The secondary
      objectives are to assess the initial safety and tolerability, and pharmacokinetics (PK)
      /pharmacodynamics (PD) of glyburide in severe stroke participants, as well as to compare the
      clinical and magnetic resonance imaging (MRI) outcome data to benchmark data derived from
      published literature.
    

Detailed description: 
      This is a multi-center, prospective, open label, phase IIa trial of glyburide for injection
      in 10 participants with a severe anterior circulation ischemic stroke who are likely to
      experience clinically significant brain swelling.

      Participants will receive glyburide, delivered as an IV bolus followed by an IV infusion for
      72 hours.

      Participants will have a baseline (pretreatment) MRI scan as standard of care, and three
      follow up MRI scans (at 24+12 hours, 48+12 hours, and 72±12 hours). Since recanalization may
      have an effect on outcome, the results of vascular studies, obtained as part of standard of
      care and defined as CTA, MRA or catheter angiography of the head and neck, will be recorded.
      Additionally, clinical endpoints such as the National Institutes of Health Stroke Scale
      (NIHSS), Glasgow Coma Scale (GCS) and Full Outline of UnResponsiveness Score (FOUR) Score
      (baseline, 24±12 hour, 48±12 hour, 72±12 hour and 7±1 days) and Modified Rankin Scale (mRS)
      (30±5 days and 90±7 days) will be assessed. Safety parameters will be assessed through Day 7
      or discharge (whichever is sooner), and then again at Day 30±5 and Day 90±7.

      Study participation is expected to last 90±7 days.

      This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired
      by Biogen.
    

Intervention name(s): Glyburide for Injection
Intervention type(s): Drug
Intervention description(s): Administered as specified in the treatment arm.
Other intervention name(s): RP-1127; glibenclamide; glybenclamide
Intervention MeSH terms: Glyburide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare the Effect on Heart Rhythm of 3 Days of GSK189075, Placebo, or Moxifloxacin in Healthy Adults
Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assesses for change in heart rhythm of healthy volunteers taking GSK189075 for 3
      days at a normal dose and a higher than normal dose compared to placebo or to a single dose
      of moxifloxacin. Treatments are GSK189075 500mg daily for three days plus moxifloxacin
      placebo on Day 3; GSK189075 4000mg daily for three days plus moxifloxacin placebo on Day 3;
      placebo tablets daily for three days plus moxifloxacin placebo on Day 3; placebo tablets
      daily for three days plus Moxifloxacin 400mg on Day 3. Volunteers are blindfolded during
      dosing. Each volunteer participates in all four treatment periods and will have received each
      dose combination at study end. Volunteers will stay at the research unit from the day before
      the first dose of study drug until the day after the last dose of study drug of each period.
      Safety measures include vital signs, laboratory tests on blood and urine, physical exams and
      ECGs. Volunteers wear a Holter monitor (a device that records heart rate and rhythm
      continuously) on days 1 and 3. Study drug levels are assessed by multiple blood draws, most
      of which occur on day 3.
    


Intervention name(s): GSK189075
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetes,; ECG,; Healthy Volunteers; GSK189075,
A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate bioavailability, pharmacokinetics, safety, and tolerability of
      budesonide, glycopyrronium and formoterol (BGF) metered dose inhaler (MDI) formulated with 3
      different propellants: Propellant 1 (Treatment A [test]), Propellant 2 (Treatment B [test])
      and Hydrofluoroalkane (HFA) (Treatment C [reference]).
    

Detailed description: 
      The study will comprise:

        -  Screening period: up to 28 days prior to first dosing;

        -  Three treatment periods of maximum 3 days each: participants will be resident from the
           morning of the day before the first dosing with BGF MDI (Day -1) in Treatment Period 1,
           throughout all treatment and washout periods up to discharge on Day 2 of Treatment
           Period 3;

        -  Follow-up: within 3 to 7 days after the last administration of BGF MDI. There will be a
           washout period of 3 to 7 days between each dose.

      Each participant will receive 3 single-dose treatments of BGF MDI (1 dose Propellant 1
      [Treatment A]; 1 dose Propellant 2 [Treatment B] and 1 dose HFA [Treatment C]), following an
      overnight fast of at least 8 hours. Each participant will be involved in the study for up to
      53 days.
    

Intervention name(s): Treatment A; Treatment B; Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive 2 inhalations of BGF MDI with propellant 1.; Participants will receive 2 inhalations of BGF MDI with propellant 2.; Participants will receive 2 inhalations of BGF MDI with HFA propellant.
Other intervention name(s): BGF MDI Propellant 1; BGF MDI Propellant 2; BGF MDI HFA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Budesonide; Glycopyrronium; Formoterol; Hydrofluoroalkane; Metered dose inhaler