bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and Pharmacokinetics of CMS121, a Drug Candidate for Alzheimer's Disease, in Healthy Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind study of CMS121 or placebo given as single and multiple
      escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1
      will be a SAD study enrolling approximately 48 young subjects for a total duration of 36
      days. Part 2 will be a MAD study enrolling approximately 32 young subjects for a total
      duration of 43 days, and Part 3 will be a MAD study enrolling approximately 8 elderly
      subjects for 43 days. Part 4 will be an open-label SAD cross-over cohort of approximately 12
      young subjects in a fed or fasted state to evaluate the effect of food on the bioavailability
      of CMS121, for a duration of 36 days.
    

Detailed description: 
      This is a randomized, double-blind study of CMS121 or placebo given as single and multiple
      escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1
      will be a SAD study enrolling approximately 48 young subjects for a total duration of
      approximately 36 days. Part 2 will be a MAD study enrolling approximately 32 young subjects
      for a total duration of approximately 43 days, and Part 3 will be a MAD study enrolling
      approximately 8 elderly subjects for a total duration of approximately 43 days. Part 4 will
      be an open-label SAD cross-over cohort of approximately 12 young subjects in fed and fasted
      states to evaluate the effect of food on the bioavailability of CMS121, for a duration of 36
      days. Safety will be assessed by periodic measurement of vital signs, physical examinations,
      electrocardiograms (ECGs), blood and urine lab analyses and occurrence of adverse events
      (AEs).
    

Intervention name(s): CMS121; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CMS121 is a small molecule to be delivered orally in capsule form and is a therapeutic drug candidate for treatment of Alzheimer's Disease; Placebo will be provided as visually matching placebo capsules.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a 4-Part study. Parts 1, 2, and 3 are randomized, double blind, placebo-controlled investigations of SAD (Part 1) and MAD (Part 2) in healthy young adult subjects and multiple doses in healthy elderly subjects (Part 3) of orally administered CMS121. Part 4 is an open label, 2 way crossover study to assess the effect of food on a single oral dose of CMS121 in healthy young adult subjects.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's Disease
Influence of IPV on GOR in Infants From 0 to 12 Months.
Condition: Gastro-oesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Intrapulmonary Percussive Ventilation (
      airway clearance technique) provokes or aggravates gastro-oesophageal reflux in infants from
      0 to 12 months.
    


Intervention name(s): Intrapulmonary Percussive Ventilation
Intervention type(s): Device
Intervention description(s): 20 min IPV freq 300/min, p 10cmH2O
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neurofeedback for Tourette Syndrome
Condition: Tourette Syndrome; Chronic Tic Disorder
MeSH terms: Tourette Syndrome; Tic Disorders; Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to train patients with tic disorders to control activity in a region
      of their brain that has been associated with the urge to tic. Patients will be given direct
      feedback regarding activity in this brain area while they are undergoing functional magnetic
      resonance imaging (fMRI) scanning, and will try to learn to control activity in the region
      during these feedback sessions. In separate sessions, patients will be given sham feedback
      based on the brain patterns of a prior subject rather than their own brain patterns. Our
      primary hypothesis is that the biofeedback training will reduce their tic symptoms more than
      the sham feedback.
    


Intervention name(s): Neurofeedback; Sham feedback
Intervention type(s): Procedure; Procedure
Other intervention name(s): biofeedback; real-time fMRI biofeedback
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neurofeedback; biofeedback; real-time fMRI; rt-fMRI; functional connectivity; fMRI
Phase 1 Placebo Controlled Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, activity and pharmacokinetics of a new
      investigational drug (HQK-1001) in healthy human volunteers. This study will also evaluate if
      there are differences in these parameters when HQK-1001 is administered in a fed versus a
      fasted state.
    


Intervention name(s): HQK-1001; placebo
Intervention type(s): Drug; Drug
Intervention description(s): HQK-1001 (5, 10 or 15 mg/kg) capsules administered once a day, orally, for 14 days.; Matching placebo capsules administered once a day, orally, for 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of a Booster Dose of Pneumococcal Vaccine Formulations in Young Adults
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a
      booster dose of pneumococcal vaccines (GSK 2189242A) in young adults.

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT 00707798)
    


Intervention name(s): Pneumococcal vaccine GSK2189242A (formulation 1); Pneumococcal vaccine GSK2189242A (formulation 2)
Intervention type(s): Biological; Biological
Intervention description(s): One dose will be administered intramuscularly at Study Day 0.; One dose will be administered intramuscularly at Study Day 0.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Pneumococcal vaccine; Streptococcus pneumoniae; Young adults
PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
Condition: Macromastia
Study type: Interventional

Summary: 
      The objective of this clinical study is to evaluate the operative performance of the PEAK
      PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain,
      adverse events and skin scarring following surgery; and compare these outcomes to the current
      standard of care (SOC).
    

Detailed description: 
      Bilateral breast reduction is a surgical procedure performed to remove excess breast tissue
      from both female breasts for therapeutic or cosmetic indications. The purpose of the breast
      reduction is to decrease the weight of the breasts and restructure the breast tissue for a
      more favorable appearance. Typically, a scalpel is used for the skin incision and a
      traditional electrosurgical device is used to cut away any excess tissue.

      The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece
      design to enable precision cutting and coagulation at the point of application. The
      PlasmaBlade has received FDA clearance for use in plastic, general, and ear, nose, and throat
      (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised
      tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit
      may improve the post-operative outcome of patients undergoing bilateral breast reduction.

      A total of forty-five (45) subjects were enrolled into the study. Forty-three (43) underwent
      bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery. Enrollment
      and surgeries took place between 18 September 2009 and 12 August 2011. Potential subjects
      were screened against the inclusion and exclusion criteria of the study protocol and were
      required to provide informed consent prior to enrollment. Following enrollment, subject
      operative sites were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study
      groups and scheduled for bilateral breast reduction. Subjects were unaware of which device
      was used on which breast. Subjects were required to attend two follow-up visits after
      surgery, approximately one and six weeks following surgery.
    

Intervention name(s): PEAK PlasmaBlade; Traditional Electrosurgery with scalpel
Intervention type(s): Device; Procedure
Intervention description(s): The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.; Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Other intervention name(s): PlasmaBlade; Scalpel; Electrosurgery; SOC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Breast Reduction; PlasmaBlade; Electrosurgery; PEAK Surgical; Medtronic Advanced Energy; Medtronic
An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a
      pregabalin controlled release tablet following a 400 to 500 calorie, 600 to 750 calorie, or
      800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2)
      evaluate the safety and tolerability of a single dose of a pregabalin controlled release
      tablet following various sized lunches as compared to a single dose of the pregabalin
      immediate release capsule.
    

Detailed description: 
      Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a
      pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR
      capsule
    

Intervention name(s): Pregabalin controlled release, 330 mg, 400 to 500 calories; Pregabalin controlled release, 330 mg, 600 to 750 calories; Pregabalin controlled release, 330 mg, 800 to 1000 calories; Pregabalin immediate release, 300 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch; A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch; A single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch; A single oral dose of 300 mg immediate release capsule administered fasted
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pregabalin; pharmacokinetics; bioavailability; bioequivalence
Relationships Between Plasma PCSK9 Levels, LDL-cholesterol Concentrations and Lipoprotein (a) Levels in Familial Hypercholesterolemia
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Observational

Summary: 
      Familial hypercholesterolemia (FH) is an autosomal codominant single gene disorder caused by
      mutations in the LDL receptor gene (LDLR) that disrupt the normal clearance of LDL particles
      from the plasma. Heterozygous patients (HeFH) present a two- to three-fold raise in plasma
      LDL-cholesterol (LDL-C) concentrations and coronary artery disease occurs earlier among HeFH
      carrying negative-receptor (NR) mutations as compared with HeFH subjects carrying
      defective-receptor (DR) variants. Proprotein convertase subtilisin/kexin type 9 (PCSK9)
      regulates LDL-C levels by binding to LDLR and by enhancing its intracellular degradation.

      The objective of this study is to examine to what extent variations in LDL-C and Lipoprotein
      (Lp) (a) concentrations are related to PCSK9 levels in a large French-Canadian cohort of HeFH
      subjects.

      The primary hypothesis is that that PCSK9 levels have a significant impact on LDL-C
      concentration variability and are associated with Lp(a) levels.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      Plasma
A Sub-study of PREDICT Neurodevelopment Protocol
Condition: Neurocognitive Development
Study type: Observational

Summary: 
      To determine the neurodevelopment (ND) in normal children in Thailand and Cambodia and to use
      this group to compare the neurodevelopmental changes over time to the HIV-infected children
      with and without HAART (main study).
    

Detailed description: 
      Normative data are mostly, if not exclusively, obtained from children in the Western world.
      Comparing data from Asian children to these norms may lead to the wrong interpretation of the
      results, as it does not account for cultural differences, translation issues and a possibly
      different education system. Therefore it is essential to include a matched control group to
      evaluate the participants of the study to the fullest extent in terms of cognition, memory,
      behavior and fine motor skills, in all age groups over the full course of the study.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV negative unexposed and HIV-negative children born to HIV-infected mothers
      
Keywords: normal controls
Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation
Condition: Acute Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research is to compare the effectiveness of Tacrolimus and Rapamycin to
      Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease.
      Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell
      transplants (HCT). An allogeneic hematopoietic cell transplant is a transplant using bone
      marrow and blood cells that come from someone other than the patient (a donor).
    

Detailed description: 
      All drugs used in this study have been used in the prevention of graft-versus-host-disease
      after allogeneic hematopoietic cell transplant. Tacrolimus and Methotrexate used in
      combination are currently used as standard of care in the prevention of
      graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and
      Rapamycin is a newer combination we are testing to see if it would be better than Tacrolimus
      and Methotrexate.
    

Intervention name(s): Tacrolimus (TAC); Methotrexate (MTX); Rapamycin (RAPA)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tacrolimus: administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.; Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance.; Rapamycin: initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily.
Other intervention name(s): FK-506; fujimycin; Prograf; Advagraf; Protopic; Trexall; Rheumatrex; Sirolimus
Intervention MeSH terms: Sirolimus; Methotrexate; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Acute Graft Versus Host Disease (aGVHD); GVHD; graft-versus-host disease; tacrolimus; sirolimus; methotrexate; combination therapy; GVHD prophylaxis
Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
Condition: Mild to Moderate Skin Laxity on Cheek; Mild to Moderate Skin Laxity on Upper Neck; Mild to Moderate Subcutaneous Fat on Cheek; Mild to Moderate Subcutaneous Fat on Upper Neck
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment
      to obtain lift and tightening of the cheek tissue and improve jawline definition and
      submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a
      focused manner below the surface of the skin
    

Detailed description: 
      The primary objective of this study is to demonstrate the effectiveness of the Ulthera™
      System for the non-invasive dermatological treatment to obtain lift and tighten the cheek
      tissue.

      The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™
      System for the non-invasive dermatological treatment for improvement in jawline definition
      and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of
      the three masked reviewers.
    

Intervention name(s): Ulthera treatment
Intervention type(s): Device
Intervention description(s): treatment of cheeks and upper neck area of face
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Biomarkers in Patients With Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will
      respond to treatment.

      PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the mutation rates of HRAS and PIK3CA in patients with head and neck
           squamous cell carcinoma (HNSCC) who were treated with cisplatin/placebo and
           cisplatin/cetuximab on protocol ECOG-E5397.

        -  To determine the association between HRAS or PIK3CA mutation status and clinical
           benefits (i.e., response, progression-free survival, and overall survival) in patients
           treated with cisplatin/cetuximab compared with those receiving cisplatin/placebo on
           protocol ECOG-E5397.

      OUTLINE: DNA is isolated from one unstained slide per patient. The mutations in HRAS and
      PIK3CA are determined using BEAMING technology.
    

Intervention name(s): cetuximab; cisplatin; DNA analysis; gene expression analysis; mutation analysis; laboratory biomarker analysis
Intervention type(s): Biological; Drug; Genetic; Genetic; Genetic; Other
Intervention MeSH terms: Cetuximab
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients participating in E5397
      
Keywords: metastatic squamous neck cancer with occult primary squamous cell carcinoma; recurrent metastatic squamous neck cancer with occult primary; recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the hypopharynx; stage IVA squamous cell carcinoma of the larynx; stage IVA squamous cell carcinoma of the lip and oral cavity; stage IVA squamous cell carcinoma of the oropharynx; stage IVA squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IVB squamous cell carcinoma of the larynx; stage IVB squamous cell carcinoma of the lip and oral cavity; stage IVB squamous cell carcinoma of the oropharynx; stage IVB squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IVC squamous cell carcinoma of the larynx; stage IVC squamous cell carcinoma of the lip and oral cavity; stage IVC squamous cell carcinoma of the oropharynx; stage IVC squamous cell carcinoma of the paranasal sinus and nasal cavity; untreated metastatic squamous neck cancer with occult primary
A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety (especially skin findings) and pharmacokinetics by applying 0.3%, 1%, or
      3% formulation of 5g OPA-15406 ointment to a 1000 cm2 area as a single-dose and as a
      multiple-dose twice daily for 2 weeks in Japanese healthy adult male subjects.
    


Intervention name(s): 0.3% OPA-15406 Ointment; 1% OPA-15406 Ointment; 3% OPA-15406 Ointment; Placebo Ointment
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 0.3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.; 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose; 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.; 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration periodriod, subjects were treated with assigned placebo ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.
Other intervention name(s): OPA-15406 Ointment; OPA-15406 Ointment; OPA-15406 Ointment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment