bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Chiauranib Capsule on Pharmacokinetics to Assess the Effect of High Fat Diet in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to further study the pharmacokinetic characteristics of
      Chiauranib Capsule in Healthy Volunteers with High Fat Diet.
    

Detailed description: 
      This study is a Randomized, Open-label, Single-dose, Single-center, two-sequence, two- stage
      Phase I Trial. 16 Healthy Volunteers will be enrolled and Randomized into two arms. 8 Healthy
      Volunteers were in each arm. Arm A：Patients receive 50mg Chiauranib po only once In the
      fasting state and after 14 days receive 50mg Chiauranib po Only once with High Fat Diet. Arm
      B: Patients receive 50mg Chiauranib po only once with High Fat Diet and after 14 days receive
      50mg Chiauranib po Only once In the fasting state. During the trial, Blood samples were
      collected.
    

Intervention name(s): Chiauranib
Intervention type(s): Drug
Intervention description(s): 50mg po only once
Intervention MeSH terms: Chiauranib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Rates of Colorectal Cancer Screening Among Never Screened Patients
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC)
      screening using fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy, beginning at
      age 50 and continuing until age 75. Despite this recommendation, rates of CRC screening
      remain inadequate and large disparities exist. Screening rates are lower among Black and
      Hispanic populations, in areas with high poverty rates, among individuals with low education,
      and for those who utilize Medicaid or lack health insurance. This study will determine the
      effectiveness of a multifaceted intervention to increase the number of patients who have
      never been screened for CRC and are cared for at a community health center (CHC) that
      complete a fecal immunochemical test (FIT) within 6 months of randomization to an
      intervention group compared to patients in a usual care group. We believe that the proposed
      intervention will improve the CRC screening rate in a cost-effective and sustainable way,
      ultimately leading to a reduction in the high rate of CRC.

      Aim 1: To conduct a randomized controlled trial to determine if a multifaceted intervention
      increases the proportion of patients who complete a FOBT within 6-months of randomization.

      Hypothesis 1: Compared to usual care, the intervention will increase the proportion of
      never-screened patients who complete FOBT within 6 months of randomization.

      Aim 2: Assess the costs of the intervention and the costs per additional initial screening
      compared to patients who receive usual care.
    


Intervention name(s): Outreach and Reminder Intervention
Intervention type(s): Behavioral
Intervention description(s): This intervention includes (1) phone calls and text messages to inform participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Keywords: Colorectal Cancer Screening; Fecal Occult Blood Testing
Effect of Prolonged GnRh Agonists on Results of Intracytoplasmic Sperm Injection (ICSI ) in Endometrioma Patients
Condition: Endometrioma
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      Investigators compare ICSI results for endometrioma patients with or without cyst aspiration
      if more than 5cm &with or without GnRh agonists for all endometrioma patients
    

Detailed description: 
      Group 1 consists of 30 patients of endometrioma more than 5cm subdivided into:

      Group 1A;Cyst aspiration followed by standard long protocol in 15 patients Group 1B;Cyst
      aspiration followed by GnRh suppression for 3 months then standard long protocol in 15
      patients

      Group 2 consists of 30 patients of endometrioma less than 5cm subdivided into :

      Group 2A;no intervention to the cyst. Standard long protocol Group 2B;GnRh suppression for 3
      months then standard long protocol
    

Intervention name(s): endometrioma aspiration; GnRh agonist ( Decapeptyl ); standard long stimulation protocol
Intervention type(s): Procedure; Drug; Procedure
Intervention description(s): Transvaginal ultrasound guided aspiration; 3 monthly doses of Decapeptyl 7.5mg intramuscular; Decapeptyl 3.75mg in the mid luteal phase followed by human menopausal gonadotropins(HMG);fostimon, or merional injections after bleeding, doses are individualization according to each patient, monitored by follicular size &serum estradiol.
Other intervention name(s): Decapeptyl
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diagnosis of Rectal Cancer by Electromagnetic Device
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      The aim of the present prospective study was to evaluate the prediction accuracy of
      electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively
      enrolled in the investigators' Institute and subjected to electromagnetic detection followed
      by colonoscopy and histopathologic analysis of biopsies. A putative RC carrier status was
      attributed to subjects showing an electromagnetic signal < 50 units (U).
    

Detailed description: 
      Eligibility criteria: Gastrointestinal disease or clinical symptoms related to colorectal
      cancer risk. Exclusion criteria consisted of age younger than 18 years, history of
      psychiatric illness, and preoperative radiotherapy.

      Outcome measures: RC screening was carried out using a Tissue Resonance InterferoMeter probe
      (TRIMprobe) electromagnetic detector (Galileo Avionica, Turin, Italy), which consists of a
      nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency
      spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease
      of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The
      test was performed while the patient stood 120 cm from the receiver. The operator was on the
      opposite side of the examined pelvis. No metallic objects were allowed on the patient and no
      electronic devices were admitted in the test area. The detector was kept at close contact to
      the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis
      volume. Based on the investigators previous study, we used the electromagnetic detection
      system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U. The device lets the
      examination limited to the pelvis and we regarded the rectum cutoff within 15 cm from the
      anal verge.
    

Intervention name(s): Electromagnetic measurement
Intervention type(s): Other
Intervention description(s): RC screening was carried out using a Tissue Resonance InterferoMeter probe electromagnetic detector, which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on our previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.
Other intervention name(s): TrimProb
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Rectal cancer; Population screening; Early detection
A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure
Condition: Raised Intraocular Pressure
MeSH terms: Ocular Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of systemically administered AZD4017,
      compared with placebo, over a 28-day period in patients with raised intra-ocular pressure
      (IOP).
    


Intervention name(s): AZD4017; Placebo; AZD4017; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablet, oral, one tablet once daily, 28 days; matching placebo tablet, oral, one tablet once daily, 28 days; tablet, oral 2 tablets twice daily, 28 days; matching placebo tablets, oral, 2 tablets twice daily, 28 days
Intervention MeSH terms: Niacinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Raised intraocular pressure
Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)
Condition: Lupus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of
      intravenously administered MEDI-545 compared with placebo, over a dose escalation range of
      0.3-30 mg/kg, in adult patients with SLE and who are receiving 20 mg/day or less of
      prednisone orally or an equivalent dose of another oral corticosteroid.
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and tolerability of
      intravenously administered MEDI-545 compared with placebo, over a dose escalation range of
      0.3-30 mg/kg, in adult patients who have SLE and who are receiving 20 mg/day or less of
      prednisone orally or an equivalent dose of another oral corticosteroid.

      The secondary objective of this study is to describe the pharmacokinetics and potential
      immunogenicity of MEDI-545.
    

Intervention name(s): MEDI-545; MEDI 545; MEDI-545; MEDI-545; MEDI-545
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.3 mg/kg IV (n=6) at Study Day 0; 0.3 mg/kg IV (n=6) at Study Day 0; 0.3 mg/kg IV (n=6) at Study Day 0; 0.3 mg/kg IV (n=6) at Study Day 0; 0.3 mg/kg IV (n=6) at Study Day 0
Intervention MeSH terms: Sifalimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lupus
Radiolabeled [14C]PF-02341066 Study To Investigate The Absorption, Metabolism And Excretion In Healthy Male Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The rationale for this study is to investigate the absorption, metabolism and excretion of
      [14C]PF 02341066 and characterize plasma, fecal and urinary radioactivity, and identify any
      metabolites, if possible, of [14C]PF 02341066 in humans.
    


Intervention name(s): PF-02341066
Intervention type(s): Drug
Intervention description(s): oral suspension, single 250 mg dose of PF 02341066 containing approximately 100 µCi of [14C]PF 02341066
Other intervention name(s): crizotinib
Intervention MeSH terms: Crizotinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: radiolabeled; healthy volunteers
Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism
Condition: Subclinical Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a
      controversy in effect of subclinical hypothyroidism on cardiovascular diseases. We aim to
      estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the
      effects of levothyroxine therapy on it. Patients with confirmed subclinical hypothyroidism by
      lab results will be randomized to two groups of treatment with one daily dose of 100 mg
      Levothyroxine or placebo. The flow-mediated dilation and intima media thickness are evaluated
      before and after the study.
    


Intervention name(s): Levothyroxine; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subclinical hypothyroidism; Atherosclerosis; Cardiovascular disease; Endothelial function; Prevention
Study to Assess the Bioequivalence of Two Batches of Tamsulosin Hydrochloride in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine the bioequivalence of two batches of Flomax® 0.4
      mg capsules in healthy male subjects. One is a commercial scale batch produced at the Nishine
      facility, and the other is a batch, of equal size, produced at the Norman II facility
    


Intervention name(s): Flomax®, Norman II facility; Flomax®, Nishine facility
Intervention type(s): Drug; Drug
Other intervention name(s): Tamsulosin hydrochloride; Tamsulosin hydrochloride
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S Administered Intramuscularly and Intradermally
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, open-label, prospective, before-and-after comparison study in the same group.

      Subjects suitable for the study will be randomly assigned at a ratio of 1:1 (block 4) to use
      the study vaccine by one of two routes of administration: Intramuscular or Intramuscular.
      Previously-unvaccinated subjects receive three injections of vaccine on day 0, 7 and 21-28.
      The aim of the study is to evaluate the safety and immunogenicity of the inactivated rabies
      vaccine RABIVAX-S administered intramuscularly and intradermally according to a 3-dose
      regimen in healthy volunteers.
    

Detailed description: 
      1 ml dose vaccine containing ≥ 2.5 IU of purified rabies antigen (Pitman-Moore rabies virus
      strain 3218; acclimatized and cultured on vero cells, inactivated with β propiolactone).

      Pre-exposure prophylaxis regimens for two groups

        -  Intramuscular 1ml on days D0, D7 and D21-28

        -  Intradermal injection 0.1 ml on days D0, D7 and D21-28

      Randomization was performed according to two age stratifications:

        -  Stratification of research subjects from 5-15 years old

        -  Stratification of research subjects from 16-60 years old Population selected research
           subjects in the community in Dong Hung district, Thai Binh province
    

Intervention name(s): RABIVAX-S
Intervention type(s): Biological
Intervention description(s): 1 ml dose vaccine containing ≥ 2.5 IU of purified rabies antigen (Pitman-Moore rabies virus strain 3218; acclimatized and cultured on vero cells, inactivated with β propiolactone).
Pre-exposure prophylaxis regimens for two groups
Intramuscular 1ml on days D0, D7 and D21+7
Intradermal injection 0.1 ml on days D0, D7 and D21+7 Blood samples were collected on days D0, D7 and D21 - 28
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Rabies; rabies vaccine; RABIVAX-S
The Impact of Post-tetanic Count on Subsequent Train-of-four During Recovery From Rocuronium
Condition: Post-tetanic Count on One Arm, the Other Arm is the Control
Study type: Observational

Summary: 
      The purpose of this study is to see how long does the effect of a post-tetanic facilitation
      last on subsequent train-of-four. The investigators hypothesis is that the effect last at
      least 30 minutes.
    


Intervention name(s): NMT (a device that can do neurostimulation and can record the response on the stimulation by Datex)
Intervention type(s): Device
Intervention description(s): on one side, we do a post-tetanic count, on the other side we don't, after, we do train-of-four on both sides and check the difference
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Poeple having general anesthesia at HMR
DSM265 Prophylaxis of Plasmodium Falciparum Malaria
Condition: Healthy
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a single centre, randomised, placebo-controlled, double-blind study with DSM265
      including up to two cohorts of healthy male and female volunteers aged 18 to 45 years.

      The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b).
    

Detailed description: 
      Cohort 1:

        -  Controlled human malaria infection on Day 0 (Direct Venous Inoculation of 3200
           cryopreserved Plasmodium falciparum sporozoites)

        -  Drug administration on Day -3

        -  8 subjects: 6 DSM265 400 mg: 2 matching placebo Clinical safety review of Cohort 1 in
           order to proceed to Cohorts 2a and 2b

      Cohort 2a:

        -  Controlled human malaria infection on Day 0 (Direct Venous Inoculation of 3200
           cryopreserved Plasmodium falciparum sporozoites)

        -  Drug administration on Day -X (to be defined following safety and pharmacokinetic data)

        -  8 subjects: 6 DSM265 400 mg: 2 matching placebo

      Cohort 2b:

        -  Controlled human malaria infection on Day 0 (infected mosquito bite)

        -  Drug administration on Day -X (to be defined following safety and pharmacokinetic data)

        -  8 subjects: 6 DSM265 400 mg: 2 matching placebo
    

Intervention name(s): DSM265; Placebo; Sporozoites; Infective mosquito bite
Intervention type(s): Drug; Drug; Biological; Biological
Intervention description(s): DSM265 400 mg single oral dose; Placebo to match DSM265, single oral dose; Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites; Five single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum
Other intervention name(s): PfSPZ
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Controlled; Human; Malaria; Infection; Healthy; Volunteer
Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Vorinostat is a histone deacetylase (HDAC) inhibitor which is approved by the U.S. Food and
      Drug Administration for the treatment of a rare type of cancer involving the skin (cutaneous
      T cell lymphoma), but not for breast cancer. HDAC inhibitors work by unsilencing tumor
      suppressor genes and other genes in the cancer cells that are repressed; when the genes are
      turned back on by the drug, it leads to death of the cancer cells. HDAC inhibitors such as
      vorinostat have been shown to enhance the effects of chemotherapy and trastuzumab in
      experimental systems. The purpose of this trial is to determine the optimal dose of
      vorinostat to use in combination with standard chemotherapy alone (or in combination with
      plus trastuzumab for HER2-positive disease), and to determine whether vorinostat enhances the
      effectiveness of standard chemotherapy (+/- trastuzumab) in patients with locally advanced
      breast cancer.
    

Detailed description: 
      This is a phase I-II trial in which patients with stage IIB-IIIC breast cancer will receive:

        1. Neoadjuvant weekly paclitaxel (80 mg/m2 IV weekly x 12 weeks) plus vorinostat (200 or
           300 mg PO BID on days 1-3 each paclitaxel dose) and trastuzumab (4 mg/kg loading dose, 2
           mg/kg IV weekly x 12 total doses if HER2 positive, followed by:

        2. Doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2) every 2 weeks x 4 cycles (plus
           G-CSF), followed by:

        3. Surgery (lumpectomy or mastectomy)
    

Intervention name(s): Vorinostat; Paclitaxel; Trastuzumab; Doxorubicin; Cyclophosphamide; Surgery
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): Vorinostat 200 or 300 mg PO BID on days 1-3 of each weekly paclitaxel dose; Paclitaxel 80 mg/m2 weekly for 12 weeks; Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose; Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks; Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks; Surgical excision of tumor from breast
Other intervention name(s): Zolinza; Taxol; Perception; Adriamycin; Cytoxan; Mastectomy or lumpectomy
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Doxorubicin; Trastuzumab; Vorinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vorinostat; Neoadjuvant Chemotherapy