bioihbjkbjnl/mcl2 huggingface dataset:
PET Imaging Study Using [11C]PIB in Subjects With AD & Healthy Volunteers
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the radiotracer [11C] PIB in participants with
      probably Alzheimer's Disease (AD) and healthy age-matched controls.
    

Detailed description: 
      The objectives of the study are:

        1. To perform PET scans with [11C]PIB to use for direct (i.e., same-subjects) comparison of
           [11C]PIB and [18F]AV-45

        2. To establish the most effective and reliable PET imaging method to detect amyloid
           deposition in AD, in order to understand disease progression and subsequently evaluate
           treatment effects.

        3. To ascertain a PET imaging method that will minimize discomfort for subjects, thus
           increasing the potential for clinical follow-up scans, by reducing the patient burden
           and potential cost of future PET examinations.

      A separate protocol/study will be conducted using [18F] AV-45. Participants who enroll in
      this protocol using [11C] PIB will be consented to participate in the [18F] AV-45 (IRB #
      NA_00033155) protocol/study as it is a mandatory requirement that participants participate in
      both protocols.Up to 20 participants with mild to moderate Alzheimer's Disease and 10 healthy
      volunteers will participate in this study.
    

Intervention name(s): [11C]PIB
Intervention type(s): Drug
Intervention description(s): Approximately 15 mCI [11C]PIB IV x1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Oral HPV Infection in Young Men
Condition: Head and Neck Cancer; Infection; Precancerous Condition
MeSH terms: Infections; Communicable Diseases; Precancerous Conditions
Study type: Observational

Summary: 
      RATIONALE: Gathering information about human papillomavirus infection of the mouth in young
      men may help doctors learn more about risk factors for oropharyngeal cancer.

      PURPOSE: This research study is assessing human papillomavirus infection of the mouth in
      young men and risk factors for oropharyngeal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Estimate the prevalence of oral human papillomavirus (HPV) type 16, 18, 6, or 11
           infection in young adult men.

        -  Assess the independent effect of distinct sexual practices, including kissing, oral sex,
           and vaginal intercourse, on oral HPV prevalence.

        -  Estimate the 6-month incidence of HPV infection in this study population.

      OUTLINE: Participants are assessed for oral human papillomavirus virus (HPV) infection (i.e.,
      types 16, 18, 6, and 11) and for known or potential risk factors associated with the
      infection, including sexual behavior (e.g., kissing, performing oral sex, or vaginal
      intercourse), demographic characteristics (e.g., age or race), and history of HPV or other
      sexually transmitted infections. Prior exposure to HPV vaccine is also assessed.

      Oral rinse samples are collected from participants at baseline and at 6 months for detection
      of HPV genomic DNA in oral exfoliated cells. Baseline serum samples are also collected.
    

Intervention name(s): comparative genomic hybridization; gene expression analysis; study of socioeconomic and demographic variables; evaluation of cancer risk factors; study of high risk factors
Intervention type(s): Genetic; Genetic; Other; Procedure; Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A convenience sample of 500 men recruited from Baltimore-area college health centers (Johns
        Hopkins University, University of Maryland, or Towson University).
      
Biospecimen description: 
      Laboratory Methods:

      Oral rinse sample:

      Standard, well-validated assays will be used to detect HPV genomic DNA in oral exfoliated
      cells from the Scope oral rinse sample.

      Serum sample:

      Standard laboratory assays will be used to detect antibodies to HPV16 L1 viral capsid
      protein.
    
Keywords: recurrent squamous cell carcinoma of the oropharynx; oropharyngeal cancer; oropharyngeal squamous cell carcinoma; infection; precancerous condition; human papilloma virus infection
Definition of Biomechanical Indices Measurable During Sport Movements for the Prevention of Primary and Secondary ACL Injury
Condition: Sport Injury; Anterior Cruciate Ligament Injury; Biomechanical; Lesion
MeSH terms: Wounds and Injuries; Anterior Cruciate Ligament Injuries; Athletic Injuries
Study type: Interventional

Summary: 
      The aim of the study is to define a set of quantitative parameters related to articular
      biomechanics, which will be evaluated during some specific motor tasks. The goal is the
      prevention of primary and secondary anterior cruciate ligament injury in athletes.

      Specifically, the validation of a new comparative methodology of biomechanics analysis will
      be performed, based on inertial sensors and musculoskeletal models. This way, brief but
      exhaustive description of functional characteristics of athletes could be created and easily
      used in ambulatory environment.
    


Intervention name(s): Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)
Intervention type(s): Other
Intervention description(s): The kinematics of lower limbs, trunk and upper limbs will be calculated both with inertial sensors (XSENS) and motion capture marker-based system (BTS ). Inertial sensors and markers will be placed on the subjects clothes and on the skin (totally non-invasive) to identify body segments. Then subjects will perform their motor tasks normally. Lately, through the data post-processing, the kinematics evaluated with both the systems will be used to describe how well the task is performed in terms of ACL prevention, through derived biomechanical parameters.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: injury prevention; biomechanical indices; inertial sensors
Comparative Bioavailability Study of 600mg Azithromycin Monohydrate Tablets Under Fasting Conditions
Condition: Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate
      600 mg Tablets.
    


Intervention name(s): Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals; Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.
Intervention type(s): Drug; Drug
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women
Condition: Arterial Stiffening; Aging; Menopause
Study type: Interventional

Summary: 
      The purpose of this study is to find out why women's arteries stiffen as they go through
      menopause, and how this is affected by estrogen loss. We believe that arteries stiffen with
      the loss of estrogen because of "oxidative stress," the production of molecules that can
      damage cells and tissues in the body, and because the arteries lose their ability to expand,
      or dilate.
    

Detailed description: 
      As women get older and go through menopause, estradiol levels decrease. Also with aging, the
      arteries that are located around the heart get stiffer. Over time this increase in arterial
      stiffness can lead to a number of health problems such as high blood pressure and heart
      disease. In this study we want to find out if a short-term drop in estrogen levels in
      premenopausal and perimenopausal women can cause arteries to become stiffer, and why this
      happens. Additionally, in postmenopausal women, we want to find out if a short-term increase
      in estrogen levels causes their arteries to become more flexible (less stiff).

      Arterial health (i.e., stiffness) will be examined in premenopausal, perimenopausal and
      postmenopausal women before and after they are given a drug called Ganirelix™ (for 7 days),
      which will markedly lower their reproductive hormones. After the first 4 days of taking
      Ganirelix™, the women will be randomly placed into 1 of 2 treatment groups to take either
      estrogen (0.075 mg/d skin patch) replacement or placebo for the rest of the Ganirelix
      treatment. This is to increase estrogen levels back to the normal level. After having the
      patch on for 4 days, arterial health will be examined again.

      Pre-specified Outcome Measures were divided into unit-of-measurement specific Outcome Measure
      tables for the purposes of results reporting to ClinicalTrials.gov
    

Intervention name(s): GnRHant - Ganirelix acetate; Transdermal estradiol patch; Transdermal placebo patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7; 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7); Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)
Other intervention name(s): Ganirelix
Intervention MeSH terms: Estradiol; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: endothelial function; women; female; estrogen deficiency; sex hormones; adiposity; oxidative stress; antioxidants
Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer: Adjuvant DXP
Condition: Resected Advanced Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite the improvement of surgical resection as primary curative treatment for gastric
      cancer, more than 70% of patients with stage IIIB and IV disease undergoing radical primary
      tumor resection relapse and die within 5 years. Therefore, there is an urgent need to further
      improve the treatment for gastric cancer in this population. Recently reported phase III
      study comparing capecitabine/cisplatin (XP) versus 5-FU/cisplatin (FP), XP showed better
      activity and tolerability compared with FP. To improve treatment outcomes of XP chemotherapy,
      the investigators performed a phase I-II study of docetaxel, capecitabine and cisplatin in
      advanced gastric cancer (AGC). Phase I-II study of docetaxel, capecitabine and cisplatin as
      first-line chemotherapy in advanced gastric cancer (Kang et al, Proc Am Soc Clin Oncol
      22,328.2003). The docetaxel/capecitabine/cisplatin (DXP) chemotherapy was highly active for
      the 1st-line chemotherapy of AGC. These findings and experience encourages the investigators
      to design the adjuvant trial of DXP chemotherapy in patients with resected gastric cancer.
      The aim of this study is to assess the efficacy and safety of adjuvant DXP in this patient
      population.
    

Detailed description: 
      Previous in phase II study of docetaxel, capecitabine and cisplatin,total 40 pts with
      measurable disease, median 6 cycles of chemotherapy, there were 4 confirmed complete
      responses (CRs) and 23 confirmed partial responses (PRs), with the overall response rate of
      67.5% (95% confidence interval, 52.7 ~ 82.3) in intention-to-treat analysis. Ten patients
      underwent surgical resection after 4 ~ 9 cycles of chemotherapy. Four pathologic CRs were
      identified. With a median follow-up of 14 months (range, 1 to 28), median time to progression
      was 7.7 months, and median overall survival was 16.9 months. The DXP chemotherapy was highly
      active for the 1st-line chemotherapy of AGC (Kang et al, Proc Am Soc Clin Oncol 22,328.2003).
    

Intervention name(s): docetaxel, capecitabine, cisplatin
Intervention type(s): Drug
Intervention description(s): Docetaxel 60 mg/m2 IV (day 1) every 21 days capecitabine 1,875 mg/m2/day PO, divided two (day 1-day14) every 21 days Cisplatin 60 mg/m2 IV (day 1) every 21 days
Other intervention name(s): docetaxel,xeloda,cisplatin
Intervention MeSH terms: Cisplatin; Docetaxel; Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Resected advanced gastric cancer stage IIIB and IV
Anti-microbial Role of Non-antibiotic Agents Against Cutibacterium Acnes in Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Observational

Summary: 
      -  To evaluate and compare the anti-biofilm activity of Salicylic acid, Isotretinoin, and
           N-acetylcysteine against C. acne .

        -  To assess the possible role of Salicylic acid, Isotretinoin, and N-acetylcysteine in
           improving the susceptibility of C. acne for Azithromycin and Doxycycline.
    

Detailed description: 
      The study was carried out on 24 patients with acne vulgaris. They were recruited from the
      outpatient clinic of the Dermatology and Venereology and Andrology Department, Zagazig
      University Hospitals, Egypt.

      The degree of severity of lesions was determined by the global acne grading system (GAGS)

      Microbiological samples were collected from all patients for:

        1. Isolation of C. acnes

        2. Antibiotic susceptibility testing for C. acnes isolates aganist the most commonly used
           antibiotics in treatment of acne(Azithromycin and Doxycycline) in the presence and
           absence of Salicylic acid, Isotretinoin, and N-acetylcysteine

        3. Testing biofilm forming ability of C. acnes isolates in the presence and absence of
           Salicylic acid, Isotretinoin, and N-acetylcysteine
    

Intervention name(s): assess the possible role of Salicylic acid, Isotretinoin, and N-acetylcysteine in improving the susceptibility of C. acne for Azithromycin and Doxycycline.
Intervention type(s): Diagnostic Test
Intervention description(s): Microbiological samples were collected from all patients for:
Isolation of C. acnes
Antibiotic susceptibility testing for C. acnes isolates against the most commonly used antibiotics in the treatment of acne(Azithromycin and Doxycycline) in the presence and absence of Salicylic acid, Isotretinoin, and N-acetylcysteine
Testing biofilm forming ability of C. acnes isolates in the presence and absence of Salicylic acid, Isotretinoin, and N-acetylcysteine
Intervention MeSH terms: Azithromycin; Doxycycline; Acetylcysteine; Salicylic Acid; Salicylates; Isotretinoin; N-monoacetylcystine
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study were carried out on 24 patients with acne vulgaris
Transdermally Delivered Human Insulin Product
Condition: Hypoinsulinemia
Study type: Observational

Summary: 
      An Early Feasibility Study of a device formulation to deliver human insulin across intact
      skin
    

Detailed description: 
      An attempt was made to formulate an insulin product that would complex human insulin in a
      stable anhydrous solution and when applied to the skin enable the uptake and release of
      insulin in a brittle T1D patient.

      A series of formulations were produced at varing dose strengths and in conjunction with
      injected insulin products, applied and serum glucose measured to ascertain response and
      optimize a fomrula to be submitted for IND approval.
    

Intervention name(s): TD Insulin
Intervention type(s): Combination Product
Intervention description(s): Human Insulin USP formulated in a solution capable of transdermal delivery.
Intervention MeSH terms: Insulin
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Single patient, brittle T1D patient
      
Keywords: Insulin, needle-less, transdermal
Genomic Translation for Amyotrophic Lateral Sclerosis Care
Condition: ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to look for abnormal genes and gene expression profiles that
      help determine why a person develops amyotrophic lateral sclerosis (ALS) and related motor
      neuron diseases (MND) and why their symptoms present and progress with a particular pattern.
    

Detailed description: 
      In all patients, ALS/MND is caused by the progressive death of motor neurons. However, every
      patient is affected differently. Some develop symptoms in their 80's while others get sick in
      adolescence. Swallowing/speech are affected first in some patients, but most have weakness in
      their hands or feet at onset. Some individuals show very rapid progression, even as others
      live for decades. Finally, some patients have loss of mainly motor neurons in the brain (as
      in primary lateral sclerosis), while others lose mainly lower motor neurons in the spinal
      cord and brain stem (as in progressive muscular atrophy). Research has uncovered a few
      genetic factors that contribute to the variability of ALS/MND. For example, mutations in the
      superoxide dismutase 1 (SOD1) gene makes onset in the legs more likely and decreases the
      chance of developing dementia. Conversely, having a mutated C9ORF72 gene makes dementia much
      more likely. Uncovering additional factors causing ALS variability is an important research
      priority and is likely to provide clues about how to better diagnose and treat the disease.

      This study is called "Genomic Translation for ALS Care" (GTAC). The investigators will
      analyze the genome and gene expression patterns of people with ALS/MND and carry out research
      on that data, finding insights that the investigators hope will translate into better care
      for ALS/MND patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ALS (meeting El Escorial criteria for definite, probable or possible ALS), or
        primary lateral sclerosis or progressive bulbar/muscular atrophy.
      
Biospecimen description: 
      DNA, RNA and Peripheral blood mononuclear cells (PBMCs)
    
Keywords: genetics; genomics; amyotrophic lateral sclerosis (ALS); primary lateral sclerosis (PLS); progressive muscular atrophy (PMA); motor neuron disease
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Lung Water Content by Ultrasound
Condition: Effect of High Altitude
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      Prospective interventional trial in lowlanders evaluating effect of acute exposure,
      acclimatization and re-exposure to high altitude.
    

Detailed description: 
      Low altitude baseline measurements will be performed in Santiago de Chile, 520 m, over the
      course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus
      (3 h ride) to the Atacama large Millimeter Array (ALMA) base camp located at 2900 m near San
      Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they
      will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing
      physiological testing. Daily transports from 2900 to 5050 m will be by car (1 h ride, one
      way). After the first 7 day altitude sojourn participants will return to the Santiago area
      (520 m) for a 7 day recovery period.

      A second altitude sojourn cycle with an identical schedule as the one described above and a
      final low altitude stay of 3 days will follow.

      Measurements on study subjects will be performed at baseline (lowland, Santiago de Chile),
      then at 2nd day of altitude exposure and 7th day at altitude before returning to lowland;
      those are repeated in the second altitude sojourn cycle. Measurements will be conducted by
      qualified specialists using a portable ultrasound device.
    

Intervention name(s): Altitude Exposure
Intervention type(s): Procedure
Intervention description(s): Altitude Exposure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Previous studies have indicated that patient expectations, beliefs and preferences may have
      an impact on treatment outcomes. The KIVIS study was primarily designed to compare two
      effective treatments for knee osteoarthritis (tidal irrigation (medical washout of the knee)
      or intra-articular corticosteroid injection). At study entry any preference expressed by the
      patient for each of the treatment interventions was recorded. This study assessed the effects
      of two treatments given at a single time-point and hence the effects of patient preference
      could be assessed independently of any compliance issues.
    


Intervention name(s): Intra-articular CSI; TI of the knee
Intervention type(s): Procedure; Procedure
Intervention description(s): After full aseptic preparation, 40 mg triamcinolone acetonide and 2 ml 1% lignocaine were injected into the joint cavity using the medial patello-femoral approach via a 21-gauge needle.; This was done as a day case procedure under local anaesthetic. The medial patello-femoral approach was used. After full aseptic preparation, the skin and soft tissues were infiltrated with 5e10 ml of 1% lignocaine. The joint was then instilled with a further 10 ml of 1% lignocaine.
After an initial puncture using a scalpel, a 3.2 mm diameter wrist arthroscope was advanced into the joint cavity. Up to 1 l of 0.9% normal saline was then irrigated through the joint: saline was run into the joint until fully distended and then allowed to flow out of the joint in a cyclical method until the aspirated fluid runs clear for at least three successive cycles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment