cyrilzakka/clinical-trials huggingface dataset:
Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works in treating patients with advanced or metastatic colorectal cancer.

OBJECTIVES:

Primary

* Improve hematologic and gastrointestinal tolerance to cetuximab and irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI) in patients with advanced or metastatic colorectal cancer.

Secondary

* Increase the effectiveness of this regimen by intensifying the treatment.
* Specify the constitutional genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of this regimen.
* Assess the time to progression.

OUTLINE: This is a multicenter study.

Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and cetuximab IV over 1-2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Pharmacokinetic and pharmacogenetic studies are also conducted.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed colorectal cancer

  * Advanced or metastatic disease
* Scheduled to receive first- or second-line therapy for metastatic disease
* No cerebral metastases or symptomatic or uncontrolled meningeal disease

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* ANC ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 2 times upper limit of normal (ULN)
* AST and ALT ≤ 3 times ULN
* Alkaline phosphatase ≤ 5 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No intestinal blockage
* No complete dihydropyrimidine dehydrogenase deficiency
* No chronic inflammatory disease of the colon
* No other cancer except for nonmelanoma skin cancer or curatively treated carcinoma of the cervix or breast
* No other severe condition, or condition that is likely to worsen, including any of the following:

  * Unstable heart disease
  * Myocardial infarction within the past 6 months
  * Active uncontrolled infection
* No contraindication to atropine

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Recovered from prior anticancer therapy
* More than 4 weeks since prior and no other concurrent investigational therapy
* Prior adjuvant chemotherapy allowed
* No prior fluorouracil or irinotecan hydrochloride
* No other concurrent anticancer therapy
Impact of Financial Incentives

This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake.

The researchers will conduct a cluster randomized control trial. This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. The recruitment goal for the trial is 34 clinics in healthcare systems, including 9 rural-serving clinics. The researchers will randomize clinics using simple randomization (1:1). Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 24 months. The study will engage clinical staff. Researchers will not have direct contact with children or their families.

Eligibility Criteria:
This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children to evaluate intervention effectiveness. We will not enroll children or interact with them directly.

Inclusion Criteria:

Clinics are eligible if they are a pediatric or family medicine clinic in North Carolina that in the past year had:

* less than 72% HPV vaccine initiation rate,
* greater than or equal to 50 patients ages 9-12
* greater than or equal to 2 HPV vaccine providers
* no clinic or provider-level financial incentive programs to increase system, clinic, or provider HPV vaccination rates among patients aged 9-12 in the past two years, and
* no HPV vaccine provider communication trainings in the past six months.

Children's medical records will be eligible to be included in the dataset if children:

* are between the ages of 9-12 years at baseline and
* are attributed to a participating clinic at 12- or 24-month follow-up.

Exclusion Criteria:

Clinics are excluded if they:

* do not provide HPV vaccine to children ages 9-12
* have a specialty other than pediatrics or family medicine
* had an HPV vaccine-specific financial incentive program in the past two years
* had a formal HPV vaccine communication training in the past 6 months
* had an HPV initiation rate greater than 72$
* had fewer than 49 patients aged 9-12
* had 1 or fewer HPV vaccine providers

Children's medical records will not be eligible to be included in the dataset if children:

* are not between the ages of 9-12 years at baseline
* are not attributed to a participating clinic at 12- or 24-month follow-up
A Trial of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults

The study is being conducted to evaluate the efficacy and safety of HR091506 tablets for treatment of primary gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.


Eligibility Criteria:
Inclusion Criteria:

1. 18 - 65 years old, male or female.
2. BMI: 18.0 - 30 kg/m2.
3. Meet the 2015 ACR (American College of Rheumatology) gout classification criteria.
4. Fasting serum uric acid ≥480 μmol/L on 2 different days during the screening period.
5. Willing to use contraceptive measures during the study.
6. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. History of acute gout attack within 4 weeks before randomization.
2. Urinary calculi diagnosed by B-ultrasound within 4 weeks before randomization.
3. Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
4. Major cardiovascular disease within 6 months before randomization.
5. History of chronic infection or recurrent infection within 1 year before randomization.
6. History of malignant tumor or current history of combined malignant tumor within 5 years before screening.
7. History of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder.
8. Subjects with poorly controlled blood pressure or diabetes mellitus.
9. History of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease.
10. History of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research.
11. Abnormal laboratory tests that may affect subjects participating in the research.
12. Combined use of prohibited drugs.
13. Allergic to ingredient or component of the experimental drug.
14. Participated in other clinical trials within 1 month before randomization.
15. Pregnant or nursing women.
16. History of drug abuse, drug use and/or excessive drinking within 1 year before screening.
17. The inestigators determined that other conditions were inappropriate for participation in this clinical trial.
Sample Size for Multivariate Time-to-event Data

Most of randomized clinical trials (RCT) using time-to-event criteria as the primary endpoint are designed, powered and analyzed based on an hypothetical hazard ratio (HR) corresponding to the targeted effect size between experimental and control arms. Usually, one assumes that populations are homogeneous within each treatment arm, that is, within each arm, (i) the baseline risk is identical for all patients, and (ii) the treatment effect is identical for all patients. This assumption however may not hold in all circumstances. This project aims at providing a statistical method for the estimation of sample size in RCT, in the presence of heterogenous populations, such as assuming populations with distinct underlying baseline risks or assuming different treatment effects.


Eligibility Criteria:
Inclusion Criteria:

* not applicable

Exclusion Criteria:

* not applicable
Comparison of Treadmill and Whole Body Vibration Training in Children With Attention Deficit Hyperactivity Disorder

It is reported in the literature that children with attention deficit hyperactivity disorder (ADHD) may have executive function deficits, impaired social functions, emotional dysregulation, behavioral disorders and motor impairments. Furthermore, studies have shown that exercise, such as acute and chronic aerobic exercises and acute whole body vibration training, improves executive functions and motor abilities and so it is hypothesized that exercise may have a potential or additional treatment option for children with ADHD. Neurobiological researches have already proven the effects on brain changes during exercise and in the case of ADHD, increasing levels of serotonin, dopamine, and norepinephrine within the front striatal lobes of the brain were highlighted when discussing the effects on this neurodevelopmental disorder. The literature emphasizes the importance of physical activity in children with ADHD, but there is no clarity regarding the frequency, intensity or duration of the exercise. Thus, the aim of this study was to investigate and compare the effects of treadmill training as an aerobic exercise and whole body vibration training on executive functions and balance in children with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosis (Previously not taking or not taking medication for ADHD)
* Being going to primary school

Exclusion Criteria:

* Having a chronic and serious medical condition

  * Seizure-like neurological impairment
  * Autism spectrum disorder, vision, speech, hearing problems
2-week Evaluation of Marketed Silicone Hydrogel Contact Lenses in Indian Population

The primary objective of this study is to evaluate the clinical performance of two marketed silicone hydrogel contact lenses in an Indian population in the following areas: physiological characteristics, comfort characteristics and vision characteristics.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand English, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be 18 and less than 40 years of age.
4. The subject's corrected spherical equivalent distance refraction must be in the range of -1.00 to -5.00D in each eye with visual acuity of 20/25 provided study lenses in each eye.
5. The subject must have less than -1.00 D of cylindrical refraction.
6. The subject must have best corrected visual acuity of 20/25 or better in each eye.
7. The subject must be an adapted soft contact lens wearer in both eyes.
8. The subject must have normal eyes.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued)
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
5. Any previous, or planned ocular or interocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
6. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer, or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
7. Any ocular infections
8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
9. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment
10. History of binocular vision abnormality or strabismus.
11. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self report.
12. Employee of the investigational clinic (e.g. investigator, Coordinator, Technician)
A Phase II Clinical Study of Stereotactic Radiation Therapy in Patients With High-risk Prostate Cancer

Stereotactic body radiotherapy (SBRT) has emerged as an effective and safe treatment for low and intermediate-risk prostate cancer(PCa). However, there is no study that has investigated the effectiveness and safety of SBRT with pelvic radiation and gross target volume(GTV) boost for high-risk prostate cancer patients yet. The investigators designed a phase II clinical study of SBRT with pelvic radiation and GTV boost based on mpMRI in patients with high-risk prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* pathologically confirmed high-risk (T3a or Gleason score ≥ 8 or a PSA \> 20 ng/ml) prostate cancer
* a WHO performance status 0-1
* history of neoadjuvant androgen deprivation therapy(ADT) within 6 months before enrollment
* Patients with pelvic positive lymph node were also included in our study

Exclusion Criteria:

* distant metastasis
* history of neoadjuvant ADT over 6 months before enrollment
* history of definitive treatment for prostate cancer such as radical prostatectomy
* history of pelvic irradiation; prostate volume≥100 cm3
In-Use Test With a Cosmetic Product to Treat Pruritus

The aim of the study is to evaluate the cosmetic features of the product WO 3308 by means of a questionnaire in an interview situation after two weeks of product treatment, giving special consideration to the cosmetic performance, efficacy and skin compatibility and with special focus on the reduction of pruritus. Additionally the tolerance will be evaluated by a dermatologist.


Eligibility Criteria:
Inclusion Criteria:

* age: ≥ 18 years
* sex: approx. 25% to 50% male and 50% to 75% female
* with acute pruritus (lasts less than 6 weeks) or chronic pruritus (lasts longer than 6 weeks): max. 50% with acute pruritus and at least 50% with chronic pruritus

Exclusion Criteria:

* any deviation from the above-mentioned criteria
* known incompatibilities to cosmetics and ingredients of cosmetic test products (please see INCI)
* topical medication in the test area within 1 month prior to study start
* systemic medication with antibiotics within 2 weeks prior to starting of the study
* change in the medication with anti-inflammatory agents within 2 weeks prior to starting the study
* systemic medication with immunomodulators (immunsuppressive drugs in the course of a transplantation) and/or chemotherapeutic agents within 4 weeks prior to starting the study
* neurodermatitis (atopic dermatitis)
* pregnancy and period of breastfeeding
Feasibility Study for Identifying Anti Capsular Antibody Protection Against Invasive Group B Streptococcus (GBS) Disease in Newborns of 0-6 Days Age (Early Onset Disease [EOD]) as Well as Among Infants of 7-90 Days Age (Late Onset Disease [LOD])

The purpose of this study is to evaluate antibody levels against Group B streptococcus in mothers and the risk of developing invasive Group B streptococcus disease in newborns of less than 6 days age as well as infants of age less than 90 days age.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (irrespective of gestational age staging or underlying comorbidities) attending for antenatal care at Chris Hani Baragwanath Academic Hospital (CHBAH) or an allied antenatal clinic and/or delivering at the participating delivery center (CHBAH)
* Subjects aged ≥18 years.
* Able to understand and comply with planned study procedures.
* Provides written informed consent.

Exclusion Criteria:

• Subjects Refusing to consent to study participation.
Vitamin D in Pregnancy and Lactation

Background: Vitamin D is vital throughout pregnancy and lactation for both maternal and infant health. Health Canada recommends women take the AI of 5ug/day of vitamin D during pregnancy, however, it is unknown how much vitamin D is necessary to ensure both mother and baby reach a vitamin D serum concentration of 25OHD\>75nmol/L.

Purpose \& Hypothesis: This project aims to determine maternal and infant responses vitamin D supplementation in pregnancy and lactation. It is hypothesized that the current AI of 5 μg of vitamin D will be inadequate for women and their infants in Canada to achieve optimal 25OHD concentrations (\> 75nmol/L).

Methods: Healthy pregnant women between 18-42 years of age without history of pregnancy complications will be recruited for a double-blind, randomized, controlled trial where they will receive one of three different dosages of vitamin D (10, 25 and 50ug/day) as part of a standard prenatal vitamin. The study at 18 plus/minus 3 weeks gestation and will carry on throughout pregnancy and lactation. Mother and infant vitamin D levels in breast milk and blood will be measured at regular intervals. Skin colour will be measured via light reflectometry. Bone biomarkers such as plasma osteocalcin and urinary n-telopeptide will be assessed. Dietary vitamin D intake and sun exposure will be estimated using a food frequency and lifestyle questionnaire. Data will be analyzed using multiple regression analysis controlling for baseline values.

Expected Results \& Conclusions: It is expected that greater vitamin D intakes (25, 50ug/day) will be necessary to raise maternal and infant serum concentrations to 25OHD\>75nmol/L to avoid infant supplementation. This data will aid policy makers, mothers and healthcare workers in recommended and appropriate vitamin D dosage throughout pregnancy and lactation.

Eligibility Criteria:
Inclusion Criteria:

* Women between 18-42 years of age
* within 18 plus/minus 3 weeks gestation
* planning to breastfeed their infant
* a singleton pregnancy

Exclusion Criteria:

* Any co-morbid condition such pre-gestational diabetes, TB, cardiac or renal disease, HIV/AIDS, chronic hypertension, inflammatory bowel disease, autoimmune disease, liver disease, or epilepsy; conditions associated with vitamin D malabsorption: celiac disease, gastric bypass;
* History of previous adverse pregnancy outcome \[preterm delivery \<37; weeks GA, stillbirth, severe pre-eclampsia, eclampsia, HELLP syndrome (hemolytic anemia, elevated liver enzymes, and low platelet count)\];
* Women will also be ineligible if they are taking more than 10 µg day supplemental vitamin D or drugs known to interfere with vitamin D metabolism (i.e corticosteroids).
Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness

The objective of this feasibility study is to obtain preliminary safety and efficacy data associated with cochlear implantation in individuals with severe to profound sensorineural hearing loss contralateral to an ear with normal, or near-normal, hearing. The hypothesis is that restoration of hearing in the deafened ear will result in improved speech perception in the treated ear and advantages related to restoration of hearing to both ears.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide informed consent.
2. Eighteen years-of-age or older at the time of implantation.
3. Presence of single-sided deafness as follows:

   1. Poorer ear (ear to be implanted):

      * severe to profound sensorineural hearing loss, defined as pure-tone thresholds 80 dB HL or greater for the frequencies 500, 1000, 2000, 3000, and 4000 Hz.
      * Monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, less than or equal to 10%.
   2. Better ear (contralateral ear):

      * Normal or near-normal hearing, defined as pure-tone thresholds no poorer than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer than 40 dB HL at 4000 Hz.
      * Monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, of greater than or equal to 90%.
4. Duration of severe to profound sensorineural hearing loss of at least 6 months (to ensure stability of hearing loss) but no greater than 10 years.
5. English spoken as a primary language.

Exclusion Criteria:

1. Alleviation of tinnitus as the stated primary or sole motivation for seeking implantation by the subject and/or investigator.
2. Actively using an implantable device in the poorer ear.
3. Onset of severe to profound hearing loss \< 6 years-of-age.
4. Evidence of active middle-ear pathology based on otologic examination and/or immittance testing.
5. Medical or psychological conditions that contraindicate undergoing surgery.
6. Ossification or any other cochlear anomaly at the implant ear that might prevent complete insertion of the electrode array.
7. Hearing loss of neural or central origin, including auditory neuropathy.
8. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations inherent to the surgical procedure and prosthetic device.
9. Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure, as determined by the investigator.
Characterization of Olfactory Perception in Post-Traumatic Stress Disorder

The core symptoms of post-traumatic stress disorder (PTSD) include flash backs, intrusive pictures and thoughts related to the traumatic event, hyperalertness, avoidance of traumatic relevant environmental triggers and emotional dysregulation. Some studies suggest that PTSD is also associated with impaired olfactory perception, which seems quite intuitive regarding the close anatomical-functional connections between olfactory and emotional circuits. Furthermore, some studies reported that olfactory stimuli can trigger flashbacks in subjects with PTSD. However, up to know available data is scarce and heterogeneous concerning that topic. The goal of the study is to determine the olfactory phenotype of subjects with PTSD. More precisely, this project aims at filling the above mentioned gap by systematically assessing the olfactory perception of subjects with PTSD along five dimensions: olfactory identity, hedonic value, familiarity, desirability and edibility. As a secondary goal, the relative weight of olfaction compared to the other senses in the relived memories of subjects with PTSD will be assessed.

The investigators here hypothesize a global impairment in olfactory processing (intensity, hedonicity, familiarity and edibility judgments) in PTSD subjects, compared with healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 50
* Subjects with PTSD

Exclusion Criteria:

* Patients with a neurological history such as stroke, head trauma (e.g. exposure to explosions, sports injury...), neurodegenerative disease...
* Any psychiatric condition except PTSD and major depressive disorder
* Current or recent use of psychotropic drugs that may affect olfactory function.
* Any current or remitted addictive disorder.
* Pregnancy and breast-feeding women