bioihbjkbjnl/mcl2 huggingface dataset:
Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the analgesic efficacy of single and multiple doses of a new
      fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in
      comparison to each single component.
    


Intervention name(s): nefopam hydrochloride 30mg / paracetamol 500mg X2; Paracetamol 500 Mg Oral Tablet X2; Nefopam HCl 30 MG Oral Tablet X2
Intervention type(s): Combination Product; Drug; Drug
Intervention description(s): The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.; The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.; The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
Other intervention name(s): Acetaminophen
Intervention MeSH terms: Acetaminophen; Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Moderate to severe acute pain; Postoperative pain; Third molar extraction; Analgesics; Nefopam; Paracetamol; Multimodal analgesia; Fixed drug combination
Influence of Light Exposure on Cerebral MAO-A in Seasonal Affective Disorder and Healthy Controls Measured by PET
Condition: Seasonal Affective Disorder
MeSH terms: Mood Disorders; Seasonal Affective Disorder
Study type: Interventional

Summary: 
      This study aims to assess differences in monoamine oxidase A (MAO-A) distribution in the
      brain between seasonal affective disorder patients and healthy controls using positron
      emission tomography. In addition the investigators aim to demonstrate the impact of light
      therapy on MAO-A distribution

      In addition, a pilot study and a sub-study in healthy controls were performed
    

Detailed description: 
      This study aims to assess differences in monoamine oxidase A (MAO-A) distribution in the
      brain between seasonal affective disorder patients and healthy controls using positron
      emission tomography. In addition, the investigators aim to demonstrate the impact of light
      therapy on MAO-A distribution by investigating patients and controls in the winter before
      bright light therapy, in the winter after bright-light therapy, and in the summer. Bright
      light therapy will be placebo controlled, randomized, and double blinded.
    

Intervention name(s): Light Therapy; Placebo Light
Intervention type(s): Other; Other
Intervention description(s): One subgroup of SAD patients and healthy controls respectively will receive bright light therapy using an artificial white light source (PhysioLight LD220 by DAVITA®, www.davita.de/shop/lichttherapiegeraete/lichtduschen-tageslicht/physiolight-ld-220.html) with full-spectrum 10.000lux light intensity. The treatment will be applied 30min per day at a distance of about of 50cm, preferably in the morning, during 3 weeks.; The second subgroup of the SAD patients and healthy controls will receive a non-biologically active light source (<400nm or >500nm). Here, the lamp will have largely similar shape and size as compared to the therapeutic device, but the fluorescent tube with the high light intensity will be replaced by an ordinary bulb.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Plasma Levels of MK0633 in Children Ages 6-12 (0633-023)
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability and plasma levels of single oral doses of MK0633 in
      pediatric asthma patients ages 6 to less than 12 years.
    


Intervention name(s): Comparator: MK0633
Intervention type(s): Drug
Intervention description(s): A single dose of MK0633 10 mg or 25 mg film coated tablet. Dose will be based on patient weight.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects
Condition: Infections, Human Immunodeficiency Virus and Hepatitis
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single-center, two-cohort, three-period study in healthy adult subjects.
      Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14
      evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide
      data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to
      the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after
      the last dose of study drug. There will be a washout period between Period 1 and Period 2 but
      no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last
      day in Period 2. The study will be conducted on an out-patient basis except for days where
      serial pharmacokinetic sampling and safety assessments are scheduled.
    


Intervention name(s): Dolutegravir; Rlipivirine; GSK1265744
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50mg q 24h; 25mg q24h; 30mg q24h
Other intervention name(s): GSK1349572; Edurant
Intervention MeSH terms: Dolutegravir; Cabotegravir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: HIV, GSK1265744, GSK1349572, dolutegravir, rilpivirine, drug interaction, pharmacokinetics
Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Bortezomib and celecoxib may stop the growth of tumor cells by blocking some of
      the enzymes needed for cell growth. Giving bortezomib together with celecoxib may kill more
      tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and
      celecoxib in treating patients with advanced solid tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose (MTD) of bortezomib and celecoxib in patients with
           advanced solid tumors.

      Secondary

        -  Determine the overall pattern of toxicities associated with this combination, including
           the emergence of any cumulative toxicities, during multiple courses of this regimen.

        -  Describe the response rate and duration of response or disease stability during therapy
           in the subset of patients with measurable disease.

        -  Assess changes in plasma/serum sphingosine-1-phosphate, ceramide, and other markers of
           the apoptotic pathway before and during therapy.

      OUTLINE: This is a dose-escalation study.

      Patients receive bortezomib IV on days 1, 4, 8, and 11 or days 1, 8, 15, 22, and 29 and oral
      celecoxib twice daily on days 1-21 or 1-42. Courses repeat every 21 or 42 days in the absence
      of disease progression or unacceptable toxicity. Patients are evaluated every 2 courses.
      Patients achieving complete response (CR) receive 2 additional courses of therapy beyond CR.

      Cohorts of 3-6 patients receive escalating doses of bortezomib and celecoxib until the
      maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
      which 2 of 6 patients experience dose-limiting toxicity.

      After completion of study treatment, patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
    

Intervention name(s): bortezomib; celecoxib
Intervention type(s): Drug; Drug
Intervention MeSH terms: Celecoxib; Bortezomib
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Effects of a Lifestyle Intervention on Gestational Diabetes Management
Condition: Gestational Diabetes; Type 2 Diabetes; Nutritional and Metabolic Disease
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Metabolic Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of nutrition education focusing on
      colorful fruit and vegetable intake with after-meal physical activity guidance on glycemic
      control and complications in women with gestational diabetes and pre-gestational diabetes.
    

Detailed description: 
      Diabetes (high blood sugar) developed during pregnancy can be harmful to the mother as it can
      lead to delivery complications because of a large baby and increases risks of type 2 diabetes
      and heart disease in the mother and baby in later life. Thus, pregnancy is a critical time
      during the human lifespan to make effective dietary changes that are safe for both mother and
      the fetus and reduce risks of developing diabetes and pregnancy complications. Women at risk
      for gestational diabetes will be randomly assigned to the standard care or the nutrition
      education group. Blood draws and other biomedical measures will be collected at baseline and
      at end of the study before delivery.
    

Intervention name(s): Dietary Intervention
Intervention type(s): Behavioral
Intervention description(s): Increasing fruit and vegetable by two servings a day and at least 30 min a day of postprandial physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Assessing Treatment Response in Breast Cancer With Functional Imaging
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Patients with large primary operable breast cancers are offered chemotherapy prior to surgery
      to shrink the tumour and enable breast conserving surgery. Conventional assessment of
      response to chemotherapy relies on a change in tumour size which does not always correlate
      with the change in amount of viable tumour. Newer techniques such as functional MRI,
      microbubble and optoacoustic ultrasound offer the potential to detect responses to
      chemotherapy by evaluating functional changes in tumour vascularity and oxygenation. Neither
      modality utilises ionising radiation.

      Although MRI is widely used for detecting breast cancer, its ability in assessing functional
      responses to chemotherapy prior to surgery has not been fully exploited. Dynamic contrast
      enhanced (DCE) MRI has a sensitivity around 90% and provides quantitative measurements of
      blood volume and flow. Other functional techniques detect variation in tissue oxygenation:
      this is called the blood oxygen level-dependent (BOLD) mechanism. The BOLD technique uses a
      special magnetic resonance (MR) sequence called T2* to measure the weakly magnetic effect of
      deoxygenated haemoglobin. The investigators wish to develop and validate T2* measurements
      which relate to oxygenation of a tumour. The investigators also want to validate other MR
      sequences including diffusion weighted (DW) MRI, which quantifies microcirculation of blood
      in the capillary network and the diffusion of water within tissues.

      Microbubble ultrasound is an established technique that utilises an intravenous contrast
      agent comprising tiny microbubbles of gas that can increase the reflectivity of blood and
      enhance spectral and colour Doppler signals obtained from routine ultrasound imaging.
      Optoacoustic imaging is new technique where the output signal depends on the oxygenation of
      the tissues under study. It utilises a light signal input and measures ultrasound signal
      output.

      The investigators want to correlate our imaging findings with histopathology after surgical
      resection of the tumour.
    


Intervention name(s): MRI; Ultrasound
Intervention type(s): Other; Other
Intervention description(s): Functional magnetic resonance imaging; Optoacoustic imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with breast cancer who are due for neoadjuvant chemotherapy
      
Keywords: Magnetic Resonance Imaging; Ultrasound; Breast Cancer
Safety and Tolerability Study of Clemizole Hydrochloride to Treat Hepatitis C in Subjects Who Are Treatment-Naive
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the hypothesis that clemizole hydrochloride is safe and
      well tolerated when administered to subjects who are infected with hepatitis C virus and have
      not yet received treatment. This study will also examine how the virus and body respond to
      clemizole hydrochloride.
    

Detailed description: 
      This study is a phase 1b, open label study of four weeks of treatment with 100 mg po BID of
      clemizole hydrochloride administered immediately prior to the initiation of treatment with
      HCV standard of care therapy consisting of pegylated interferon and ribavirin in
      treatment-naïve subjects chronically infected with HCV genotype 1 or genotype 2. The duration
      of the study for each subject will be approximately 11 weeks (up to three week screening
      period, four week treatment period and four week safety follow-up period). The duration of
      the entire study is anticipated to be approximately four months (first subject in to last
      subject out). Pharmacokinetic sampling will be done at Day 1 and Day 28 of dosing. PK
      sampling will be conducted only on subjects who have consented to participate in the PK
      portion of this study. Participation in PK sampling is optional for each subject.
    

Intervention name(s): clemizole hydrochloride
Intervention type(s): Drug
Intervention description(s): Two 50 mg capsules containing clemizole hydrochloride are to be administered orally twice a day for 28 days for a total daily dose of 200 mg. Followed immediately by standard of care treatment consisting of interferon and ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV; Hepatitis C; Hepatitis
A Study of MCAF5352A in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, randomized, placebo-controlled, double-blind, multiple ascending dose
      study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy
      volunteers. Subjects will be randomized to receive either MCAF5352A or placebo on Days 1, 15
      and 29.
    


Intervention name(s): MCAF5352A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple ascending doses; Matching MCAF5352A, multiple doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Allopurinol and Quality of Life in Liver Cirrhosis
Condition: Cirrhosis, Liver
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study aims to evaluate the impact of allopurinol on patients' related quality of life.
    

Detailed description: 
      Cirrhosis is the late stage of liver damage and possess two phases:. The shift from
      compensated to decompensated cirrhosis is characterized by the onset of complications) which
      are associated with substantial morbidity and negative Impact on quality of life
      (QOL)Cirrhosis and its complications have a substantial economic, social, and personal impact
      on affected patients, as well as their families and caregivers
    

Intervention name(s): Allopurinol Tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): allopurinol300mg once daily; placebo once daily
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The single-dose randomized, open-label, two-period crossover study was executed in the Phase
      I Clinical Research Center of the Affiliated Hospital of Qingdao University. According to the
      random table generate by SAS 9.4, the subjects were divided into two groups at the ratio of
      1:1. The select qualified volunteers were hospitalized in the Phase I Clinical Research
      Center, and fasted for 10 hours overnight until administration. The medicine was swallowed
      with 240 ml water at room temperature. Blood samples were taken before administration and at
      1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after
      administration. The samples were centrifuged at 1,800 g for 10 min at 4 °C to separate the
      plasma. The plasma samples were divided into two aliquots and stored at -80 °C until
      bioanalysis. The half-life of levamlodipine is 30 ~ 50 hours. Washout period, the interval
      between two administration, is 21 days. In the two periods, the operation was kept the same.

      Moreover, in high fat meal group, the high-fat breakfast was arranged within half an hour
      before taking the medicine. Other procedures were the same as those in the fasting group.
    


Intervention name(s): Amlodipine 10 mg; Levamlodipine 5 mg
Intervention type(s): Drug; Drug
Intervention description(s): The subjects randomly received single oral administration of amlodipine 10 mg.; The subjects randomly received single oral administration of levamlodipine 5 mg.
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: levamlodipine; bioequivalence; pharmacokinetics
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure
Condition: Colonic Diseases
MeSH terms: Colonic Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of the night procedure in regards to
      colon cleansing level and capsule excretion rate.
    

Detailed description: 
      The evaluation of subjects with suspected colonic disease includes endoscopic imaging by
      colonoscopy and radiologic imaging such as air-contrast barium enema, or CT colonography. The
      Given® Diagnostic System offers an alternative approach for endoscopic visualization of the
      colon using capsule endoscopy, an ingestible device which contains imagers, light sources, a
      power source and a RF transmitter. Advantages of the Given® Diagnostic System include the
      elimination of the need for sedation, the minimally invasive, painless nature of the exam,
      and the ability to pursue normal daily activities immediately following the procedure .
      Furthermore, compared to standard colonoscopy, the Given® Diagnostic System may be more
      readily accepted by the subjects, thereby improving subjects' willingness to undergo a
      diagnostic evaluation of the colon and comply with colorectal cancer screening
      recommendations.

      The PillCam™ SB capsule (formerly M2A® Capsule) that was FDA-approved in August 2001 for
      small bowel evaluation has been ingested to date by more than 500,000 people worldwide and is
      well accepted by patients and physicians as well as the processional societies. However,
      adequate visualization of the colon cannot be achieved with the standard PillCam™ SB capsule
      because of the anatomical and physiological properties of the colon which are significantly
      different than the small bowel. Moreover, other issues that limit the evaluation of the
      colonic mucosa by the standard PillCam™ SB procedure include an unsatisfactory level of colon
      cleanliness and slow progression of the PillCam™ SB capsule through the colon during the
      desired examination time. Therefore, the development and introduction of a specially
      designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure
      protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to
      improve the capability of the Given® Diagnostic System to detect colonic pathologies and to
      serve as a diagnostic and screening tool for colonic disease. Further details of the PillCam™
      Colon Capsule Endoscope (PCCE) can be found in the device description section.

      This is a pilot study that is designed to evaluate the level of cleanliness and visualization
      of colon achieved by colon capsule endoscopy when using Night procedure regimens for
      preparation of the colon.
    

Intervention name(s): PillCam™ (Capsule Endoscopy)
Intervention type(s): Device
Intervention description(s): Medical Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Colonic Diseases
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
Condition: Neoplasms, Prostate
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This 4-year study will compare how safe and effective an oral investigational medicine is
      (compared to placebo) in preventing the development of prostate cancer in men that are
      defined by the study entrance criteria as being at an increased risk for prostate cancer.
      Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits),
      and a prostate biopsy will be performed at 2 and 4 years of treatment.
    


Intervention name(s): Dutasteride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years.; After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years.
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prostate cancer prevention; prostate; BPH; enlarged prostate; PSA; prostate cancer