bioihbjkbjnl/mcl2 huggingface dataset:
Thorough QT/QTc Study of Multiple Oral Doses of NOMAC-E2 (Org 10486 0 + Org 2317) in Healthy Women (Study 292011)(P05802)
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is a single-center randomized, double-blind, double-dummy, placebo and positive
      controlled, parallel group clinical trial.

      This trial investigated whether NOMAC-E2 (Org 10486 -0 + Org 2317), a new combined hormonal
      contraceptive, has potential to delay cardiac repolarization. The primary measure of cardiac
      repolarization in this trial is the Fridericia corrected QT interval (QTcF). QTcF represents
      the duration of ventricular depolarization and subsequent repolarization. A delay in cardiac
      repolarization creates an electrophysiological environment that favors the development of
      cardiac arrhythmias, most clearly torsade de pointes (TdP), but possibly other ventricular
      tachyarrhythmias.

      The primary aim of this study is to investigate, if the administration of a therapeutic
      (2.5/1.5 mg) or supra-therapeutic (higher than required for treatment: 12.5/7.5 mg) dose of
      NOMAC-E2 administered over a period of 14 days will prolong the mean QTcF interval to values
      above the accepted threshold of regulatory concern.

      In addition, a single dose of moxifloxacin will be administered in order to prove that
      sensitivity of the applied assay is sufficient to detect the prolongation of the
      QTcF-interval.

      Secondary aims of this study are to evaluate the relation between concentrations of NOMAC
      (therapeutic and supra-therapeutic) after steady state has been reached in the subject's
      body, the time matched change in Estradiol E1 and E2 in relation to baseline and the QTcF
      intervals after multiple dose administration of NOMAC-E2.

      Finally, the safety and tolerability of different treatments are investigated.

      A total of 189 subjects will participate in this trial. The entire study duration is about 9
      weeks with a 4-week screening period, 14-day treatment period and a follow-up period of about
      3 weeks.
    


Intervention name(s): Moxifloxacin; NOMAC-E2 (Org 10486-0 + Org 2317); Moxifloxacin placebo; NOMAC-E2 placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules containing 400 mg moxifloxacin, on Day 14 only; Tablets containing 2.5 mg NOMAC and 1.5 mg E2, once daily dosing, orally taken. Daily dose either NOMAC-E2 2.5/1.5 mg or 12.5/7.5 mg.; Moxifloxacin-placebo capsule taken orally, Day -1 and Day 14 only; Tablets containing NOMAC-E2 placebo, once daily dosing, orally taken.
Other intervention name(s): Avelox®
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Electrocardiography; Pharmacokinetics
Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound
Condition: Placenta Diseases
MeSH terms: Placenta Diseases
Study type: Interventional

Summary: 
      In this study is tested the validity of placental vascular indices obtained from placenta
      ultrasonographic sphere biopsy and entire placenta investigation.
    

Detailed description: 
      Although, to this date, there have been a number of human placental studies that concerned
      the evaluation of placental 3 dimensional power Doppler vascularization with the use of VOCAL
      technique, but there was no one in which placental vasculature has been compared between the
      sonobiopsy and whole placental volume.
    

Intervention name(s): 3 dimensional ultrasound investigation; 2 dimensional ultrasound investigation
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Images that contributed to the determination of placental volume and 3-DPD indices were obtained at the time of visit. All 3-D scans ultrasound measurements were performed by a Voluson 730 Expert ultrasound machine equipped with a multifrequency probe (2-5 MHz) to acquire images. Each sample was examined using 3-D rendering mode, in which the colour and gray value information was processed and combined to supply 3-D image. For laterally located placentas, the investigator positioned the transducer on a slight lateral inclination to obtain proper images. Power Doppler window was placed over the placenta to map the vascular tree from basal to chorionic plates. The 3-D static volume box was placed over the entire placenta volume. The sweep angle was set at maximum 70°. Each image was recovered from the disk in succession for processing. During gestation, the investigator recorded one sample from each patient.; The two-dimensional (2-D) transabdominal conventional study provided data about fetal position, biometry, body movements and fetal heart rate as well as placental localization. The factorial default setting 'Obstetrics' was applied in 2-D mode.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective cohort study was conducted among normal pregnant women recruited at 11 to 40 gestational weeks. Placental vascularization was evaluated using the 3-DPD-indices (vascularization-index (VI); flow-index (FI); vascularization-flow-index (VFI)) with the application of the sphere-technique or scanned from the entire placenta
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 3-dimensional ultrasound; ultrasound; placenta; Investigation of placenta in-vivo
Metastatic Left Colon and Rectal Cancer Treatment With Anti_EGFR Targeted Therapy
Condition: Metastatic Colorectal Adenocarcinoma
MeSH terms: Adenocarcinoma; Rectal Neoplasms
Study type: Observational

Summary: 
      Colorectal cancer ranks the second lethal cancer and third prevalent malignant tumour
      worldwide, Despite of different odern modalities for diagnosis,large number of cases
      diagnosed at metastatic advanced stage .

      New treatment approach has been discovered habe been discovered making a huge revolution in
      metastatic colorectal cancer represented by targeted therapy including anti_EGFR
      ,anti_angiogenic and kinase inhibitors .
    

Detailed description: 
      Retrospective study aims to evaluate the effect of EGFR expression in metastatic colorectal
      cancer and the outcome of treatment with anti_EGFR targeted therapy between left colon and
      rectal cancer
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with left colon and rectum cancer of stage four received target therapy anti_EGFR
        targeted therapy
      
Keywords: EGFR, Targeted therapy ,metastatic colorectal cancer
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women
Condition: Group B Streptococcus Infections
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the
      safety, tolerability, and immunogenicity of the investigational multivalent group B
      streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18
      through 49 years of age.
    


Intervention name(s): Multivalent Group B streptococcus vaccine; Tetanus, diphtheria, and acellular pertussis vaccine; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Multivalent Group B streptococcus vaccine; Tetanus, diphtheria, and acellular pertussis vaccine; Saline control
Other intervention name(s): Tdap
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, double-blind, placebo-controlled, single- and multiple SC dose
      escalating study conducted in 2 parts.
    

Detailed description: 
      A Phase 1, double-blind, randomized, placebo-controlled, single and multiple-dose escalating
      study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PB-718
      following subcutaneous administration in healthy subjects.
    

Intervention name(s): Placebo; PB 718
Intervention type(s): Drug; Drug
Intervention description(s): matching placebo; dose in the next group will be determined following a review of data from the previous group
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: In Part A, 48 subjects will be studied in 6 groups (Groups A1 to A6), with each group consisting of 8 subjects.
In Part B, 32 subjects will be studied in 4 groups (Groups B1 to B4), with each group consisting of 8 subjects Following review of the safety, tolerability, and PK data, additional dose groups may be added to the study. Up to 3 further groups of 8 subjects (6 PB-718: 2 placebo) may be included in each of Parts A and B.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Addition of Naltrexone to Methadone Taper
Condition: Heroin Dependence; Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 2

Summary: 
      There is a continuing search for more effective opiate detoxification treatments. This
      study's purpose is to investigate the effects of adding very low doses of naltrexone to a
      methadone tapering treatment in opioid dependent individuals.
    

Detailed description: 
      Although many different techniques for opiate detoxification exist, the search continues for
      more effective approaches to reduce the duration and discomfort associated with opioid
      withdrawal. It has been shown that very low doses of naltrexone administered in the presence
      of opiates has analgesic and dependency reducing properties. The purpose of this study is to
      investigate the effects of very low doses of naltrexone administered during a methadone
      tapering schedule for opiate detoxification. In addition, this study will compare the
      effectiveness of two different dose regimens of naltrexone.

      Participants in this double-blind study will be recruited among opioid dependent individuals
      already enrolled in a 6-day inpatient opioid detoxification program. Participants will be
      already receiving standard treatment to control discomfort during a methadone tapering
      schedule. Participants will be randomly assigned to one of three groups. Two of the groups
      will be given naltrexone; Group 1 will receive 0.125 mg each day, and Group 2 will receive
      0.250 mg each day. Group 3 will receive a placebo. Participants will be evaluated upon
      enrollment for opiate addiction severity. They will continue to be evaluated daily for signs
      of withdrawal and salivary cortisol. An additional evaluation and urine test will be
      completed 1 day following discharge. Daily evaluations will take 15 minutes to complete.
      Seven days following discharge, participants will be contacted for a 20-minute phone
      interview. During the phone interview, participants will schedule an appointment to provide a
      final urine specimen for the detection of drugs of abuse.
    

Intervention name(s): Naltrexone; Placebo comparator; naltrexone; naltrexone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): low dose naltrexone in addition to daily methadone taper; 1 capsule/day for 6 days; 0.125 mg capsule/day for 6 days; 0.250 mg capsule/day for 6 days
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opiate dependence
Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare intramuscular Olanzapine and intramuscular
      Haloperidol in changing of agitation in patients with schizophrenia
    


Intervention name(s): Olanzapine Hydrochloride; Haloperidol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Haloperidol; Olanzapine; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Mix Vaccine for Metastatic Kidney Cancer
Condition: Metastasis From Malignant Tumor of Kidney (Disorder); Reaction - Mixed Vaccine
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of mix vaccine to small metastases of kidney
      cancer.
    

Detailed description: 
      By enrolling patients with small metastases of kidney cancer adapted to enrolled criteria,
      this study will document for the first time the safety and the short and long term efficacy
      of mix vaccine.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Mix vaccine
Intervention type(s): Biological
Intervention description(s): Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle
Other intervention name(s): Active immunotherapy for cancer
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BLYS and IFN in SLE
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Observational

Summary: 
      This protocol tests whether changes in BLyS or IFN can be detected in a normal immune
      response to a vaccine and, if so, whether the response differs between those with lupus and
      healthy controls.
    


Intervention name(s): fluzone; pneumovax
Intervention type(s): Biological; Biological
Intervention description(s): once; once
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        lupus and healthy controls
Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers
Condition: Colorectal Cancer; Healthy, no Evidence of Disease
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized phase I trial studies the side effects and best dose of linaclotide acetate
      in preventing colorectal cancer in healthy volunteers. Chemoprevention is the use of certain
      drugs to keep cancer from forming. The use of linaclotide acetate may prevent colorectal
      cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the pharmacodynamic effect (PD) of linaclotide (linaclotide acetate) (single
      daily dose x 7 days, stage I cohort dose= 0.870 mg/day) on cyclic guanosine monophosphate
      (cGMP) levels, based on biopsy samples obtained pre- and post-intervention from the rectum,
      until an effect is documented.

      SECONDARY OBJECTIVES:

      I. To confirm the safety and tolerability of linaclotide. II. To assess the pharmacodynamic
      effect of linaclotide on cGMP levels, analyzed sequentially from the transverse colon to the
      cecum, if no cGMP effect was observed in the rectum for the primary endpoint.

      III. To compare the change in the cGMP levels from baseline to day 7 between all the assigned
      doses of linaclotide (including placebo), analyzed sequentially from the rectum, transverse
      colon, and cecum.

      IV. If the study proceeds to stage II, the pharmacodynamic effect of linaclotide on cGMP
      levels will be assessed from day 6 rectal biopsies (un-prepped).

      TERTIARY OBJECTIVES:

      I. To assess the pharmacodynamic effect of linaclotide on an additional pathway-specific
      biomarkers relevant to guanylate cyclase C (GCC) signaling (i.e., vasodilator-stimulated
      phosphoprotein [VASP] phosphorylation) and a marker of general proliferation (Ki67
      expression), based on intestinal mucosa biopsy samples obtained by colonoscopy pre- and
      post-exposure at the anatomical location (rectum, transverse colon, or cecum) in which cGMP
      is elevated following linaclotide exposure.

      OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment
      arms.

      ARM I: Participants receive linaclotide acetate orally (PO) once daily (QD) on days 1-7.

      ARM II: Participants receive placebo PO QD on days 1-7.

      After completion of treatment, participants are followed up for 21-51 days.
    

Intervention name(s): linaclotide acetate; placebo; pharmacological study; laboratory biomarker analysis
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): Given PO; Given PO; Correlative studies; Correlative studies
Other intervention name(s): Linzess; MD-1100 Acetate; MM-416775; PLCB; pharmacological studies
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effects of Acute Red Raspberry Consumption on Vascular Function in Healthy Individuals
Condition: Healthy
Study type: Interventional

Summary: 
      Accumulating evidence from epidemiological and human intervention studies indicates that the
      cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related
      to their (poly)phenol content. Raspberries are rich in phenolic and polyphenolic compounds,
      in particular procyanidins, ellagitannins and anthocyanins, but also phenolic acids. At
      present, a small number of randomized controlled trials investigating the effects of berry
      (poly)phenols on validated surrogate markers of cardiovascular disease risk have shown
      promising results. However, to date, very few human studies have specifically investigated
      the effects of raspberry (poly)phenols on cardiovascular function in healthy subjects.
      Moreover, ellagitannin-derived metabolites are believed to persist for a long period of time
      in the blood and urine. Therefore, the investigators will investigate the presence of plasma
      and urinary raspberry-derived metabolites 24h post-consumption. To the investigators
      knowledge, the effects of red raspberry consumption on vascular function in humans have not
      been investigated before. This information is necessary for the planning of long-term studies
      aiming to assess the potential beneficial effects of raspberries,. Therefore, this study aims
      to investigate the potential role of red raspberry (poly)phenols in the modulation of
      vascular function by monitoring changes in vascular function together with the major
      (poly)phenol derivatives/metabolites in plasma.
    


Intervention name(s): 400 g frozen raspberries; 200 g frozen raspberries; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1x daily intake of 600 mL red raspberry beverage; 1x daily intake of 600 mL red raspberry beverage; 1x daily intake of 600 mL raspberry deprived supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: polyphenols; vascular function; endothelial function; raspberry
Pharmacokinetics of Nalbuphine Injection
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to evaluate pharmacokinetics of nalbuphine hydrochloride (10 mg/mL) after a single
      intravenous administration in healthy volunteers under fasting conditions
    


Intervention name(s): Nalbuphine
Intervention type(s): Drug
Intervention description(s): Pharmacokinetic study under fasting conditions
Intervention MeSH terms: Nalbuphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic
Atorvastatin (Lipitor) to Prevent Bone Pain
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      In the proposed randomized double blind cross-over placebo controlled study, the researchers
      intend to investigate if Atorvastatin (FDA approved statin for children) can be used to
      alleviate the symptom of bone pain (acute phase reaction) that is commonly associated with
      initial doses of pamidronate or zoledronic acid, and also the mechanism that underlies this
      proposed beneficial effect of Atorvastatin. The primary outcome studied will be alleviation
      of bone pain by Atorvastatin compared to placebo by visual analogue pain scale in children
      treated with pamidronate or zoledronic acid. The secondary outcome investigated will be
      changes in blood count and γδT cell count, C-reactive protein (CRP) and cytokine levels of
      interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and gamma interferon (γ-IFN)
      following treatment with Atorvastatin compared to placebo.
    

Detailed description: 
      The proposed study is a double blind cross-over placebo controlled randomized clinical study
      that would be conducted in the Metabolic Bone Clinic of The Children's Mercy Hospital. This
      is a pilot study and a more comprehensive study will be designed only if the results from
      this pilot study are significant. In our proposed double blind cross-over placebo controlled
      pilot study we will have a total of 12 children who will receive either placebo or
      Atorvastatin in a randomized cross-over design. The pilot study with a sample of 12 in a
      cross-over trial will provide reasonably stable estimates even though it is unlikely to
      provide statistical significance on its own but will help plan further large scale studies.
    

Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Osteoporosis; Bisphosphonates; Atorvastatin
Measuring Skin Electrical Potential With the Kelvin Probe: Minimizing Noise
Condition: Healthy State
Study type: Observational

Summary: 
      The Scanning Kelvin Probe measures surface electrical potential without actually touching the
      skin. This is a pilot study to evaluate methods of minimizing noise during Scanning Kelvin
      Probe measurements. This project will focus specifically on noise arising from physical
      movement and environmental electrical field.
    


Intervention name(s): Faraday cage, movement stabilization
Intervention type(s): Other
Intervention description(s): The Faraday cage is a copper-mesh cage that surrounds the device and test site. It helps eliminate surrounding electrical noise. Movement stabilization will be achieved by placing a velcro strap over the arm to minimize random movements.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: Surface potential; Electrical; Motion stabilization