cyrilzakka/clinical-trials huggingface dataset:
Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants

The purpose of this study is to compare the immune response, safety and reactogenicity of Tritanrix™-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B vaccine to Tritanrix™-HepB/Hiberix™ when given to healthy infants (born to mothers who do not carry hepatitis B virus) at 6, 10 \& 14 weeks of age. This study will also include a small group of infants born to mothers who do carry hepatitis B virus; these infants will receive a birth dose of hepatitis B vaccine and will be vaccinated with Tritanrix™ HepB/Hib-MenAC at 6, 10 \& 14 weeks age.

Randomized study with three groups (subjects born to mothers who do not carry hepatitis B virus) to receive one of the following vaccination regimens: - GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and hepatitis B vaccine at birth

- GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and no hepatitis B vaccine at birth - GSK Biologicals' Tritanrix™-HepB/Hiberix™ There will also be a fourth group (subjects born to mothers who do carry hepatitis B virus) to receive: - GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and hepatitis B vaccine at birth

Eligibility Criteria:
Inclusion criteria:

* Healthy infants aged 3 days or less, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
* Result of the maternal blood sample (presence/not of hepatitis B virus) is available.

Exclusion criteria:

* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (except for immunoglobulins given at birth to infants born to HBsAg seropositive mothers).
* Acute disease at the time of enrolment.
* Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease.
* Hepatitis B vaccine given at birth outside the study.
Effect of Ramosetron on Bowel Motility After Colorectal Resection

Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies reported that ramosetron is also effective treatment diarrhea-predominant irritable bowel syndrome. The investigators examine the effect of ramosetron used for preventing postoperative nausea and vomiting on bowel motility.

Ramosetron, a new potent and long-acting selective 5-HT3 receptor antagonist, is effective for preventing postoperative nausea and vomiting. Also several studies reported that ramosetron is effective treatment of irritable bowel syndrome because it inhibits the accelerated colonic transit, abnormal colonic water transport, defecation abnormality, and the lowered colonic perceptual threshold by corticotrophin-releasing hormone. There is no study about the effect of ramosetron used for preventing postoperative nausea and vomiting on postoperative bowel motility. In this study, the investigators examine the effect of ramosetron on postoperative bowel motility.

Eligibility Criteria:
Inclusion Criteria:

* 20-70 yr of age,
* ASA I or II,
* scheduled for laparoscopic colorectal surgery

Exclusion Criteria:

* antiemetic use within 24hr prior to surgery
* steroid use within 24hr prior to surgery or 48hr after surgery
* insulin dependent DM
* cardiovascular or pulmonary disease
* renal or hepatic insufficiency
* BMI \>=35kg/m2
* pregnancy
PRO-VISION: Patient Reported Outcomes-Based Monitoring of VEGF-Inhibitor Side Effects in ONcology

The purpose of this study is to investigate how collecting information about treatment-related side effects directly from patients can help manage the side effects associated with certain oral chemotherapies. This study is specifically investigating this approach in patients taking oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) for metastatic renal cell carcinoma (mRCC).

Participants in this study will receive a survey via email or telephone once a week while receiving treatment with a VEGFR TKI. The survey will ask about symptoms such as nausea or fatigue and overall quality of life. This survey should take no more than 15 minutes to complete.

The survey will be sent directly to the oncology care team. Participants will receive a follow-up phone call or message from the team when participants have new or worsening symptoms. The participants will continue to receive surveys for as long as they are receiving a VEGF TKI treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years or older
* Histologically confirmed renal cell carcinoma requiring treatment with VEGF TKI.
* Patients may be receiving other concurrent cancer-directed therapy such as immune checkpoint inhibitors.
* English or Spanish speaking
* Ability to complete PRO surveys (i.e. ability to read/write or access to telephone or internet)
* Willing and able to meet all study requirements

Exclusion Criteria:

All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.

• Inability for any reason to complete PRO surveys
Implementation of a Delirium Screening

The purpose of this project is to improve patient outcomes in individuals affected by cancer, through the implementation of a delirium screening and treatment protocol in the ICU setting. The hypothesis is that patients who receive an accurate and early diagnosis of delirium coupled with a standardized intervention protocol will demonstrate improved patient outcomes as evidenced by fewer days spent in the ICU, fewer days spent in the hospital (overall length of stay) and the need for less sedative medication throughout their ICU stay as compared to patient data prior to the implementation of a delirium protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be included into the study who:

  * Are over 18 years old
  * Speak and read English
  * Are admitted to the Sylvester Comprehensive Cancer Center intensive care unit in the first 60 days following implementation of the delirium protocol; approximately 10 patients per month.
  * Patient data via electronic medical record (EMR) for all patients who were admitted to the Sylvester Comprehensive Cancer Center intensive care unit up to 60 days prior to the implementation of the delirium protocol.

Exclusion Criteria:

* This study will exclude:

  * Patients who are unable to speak and read English
  * Patients who are unable to provide written consent to participate.
  * Patient data via EMR for any patients who were admitted to the Sylvester Comprehensive Cancer Center intensive care unit prior to 60 days before to the implementation of the delirium protocol.
Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Type 1 Diabetics

This trial is conducted in Europe. The aim of this clinical trial is to compare the blood glucose lowering effect of NN5401(insulin degludec/insulin aspart (IDegAsp)) with NN1250 (insulin degludec (IDeg)) and insulin aspart (IAsp) in subjects with type 1 diabetes where the trial participant will receive one single dose of each trial product in varying order.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day).
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma

To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8 weeks of HyBryte (topical hypericin ointment) photodynamic therapy.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IB or Stage IIA
* CTCL lesions covering ≥ 10% of their body surface area

Exclusion Criteria:

* History of allergy or hypersensitivity to any of the components of HyBryte
* Pregnancy or mothers who are breast-feeding
* Males and females not willing to use effective contraception
* Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)
* Subjects whose condition is spontaneously improving
* Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on index lesions for CTCL within 2 weeks of enrollment
* Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
* Subjects who have received electron beam irradiation within 3 months of enrollment
* Subjects with a history of significant systemic immunosuppression
* Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
* Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks
The Impact of Hypo-osmolar Drops on Contact Lens Comfort

This pilot study will investigate the impact of sterile saline drops that are formulated at hypo-osmolar levels on CL comfort in comparison to an iso-osmolar drop, in a group of symptomatic CL wearers.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age;
* Has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Is willing and able to stay within the School of Optometry and Vision Science building for the duration of each Study Day;
* Currently wears daily, soft, frequent replacement lenses licensed in Canada (daily, bi-weekly or monthly disposable lenses, no extended wear, no monovision) for at least 3 days/week and 6 hours/day during the 2 months prior to enrolment;
* Is symptomatic according to the following classification:

  * Reports a difference between average and comfortable wear time with habitual lenses of at least 3 hours;
  * Fall into the symptomatic group as per Young's criteria (Appendix 4).
* Is able to remove and insert the lenses by themselves;
* Owns a wearable pair of spectacles;
* Is willing to wear the study lenses for 10 hours;
* Has visual acuity (VA) correctable to logMAR 0.20 or better in each eye;
* Shows an acceptable lens fit with their habitual lenses;

Exclusion Criteria:

* Is participating in any concurrent clinical or research study;
* Has any known active\* ocular disease and/ or infection;
* Has any ocular abnormality that would contraindicate contact lens wear;
* Has any known infection or inflammation that requires treatment or has a systemic condition that in the opinion of the investigator may affect the study measures;
* Is using any systemic or topical medications that in the option of the investigator may affect the study measures;
* Has any known sensitivity to the diagnostic pharmaceuticals and products to be used in this study;
* Is pregnant or lactating (by verbal communication) due to potential ocular physiology changes that may affect the study outcome;
* Is aphakic;
* Has undergone refractive error surgery;
* Is a member of the CCLR directly involved in the data collection. \*For the purpose of this study, active ocular disease is defined as an infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered an active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.

Purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs Gonal-F® Serono) when administered in patients undergoing ICSI

This is a multicentric, prospective, randomised, investigator blind, controlled clinical trial (phase III) of two parallel groups, one receiving the test drug FSH (Fostimon® , IBSA) and the other the reference drug FSH (Gonal-F®, Serono). The groups will be paired on the major prognostic criteria.

In effect, a double blind trial is not really feasible since the drugs presentations are very different. However, in IVF, drugs are usually dispensed and/or injected by a nurse and therefor the Investigator can be blind. Moreover, the used preparations will contain the same amount of gonadotrophin units (75 IU), will be repackaged in anonymous boxes and the following sentence will be written in the Patient Information Sheet: "You are required not to inform the Investigator about the product's name".

The randomisation is necessary to get groups as comparable as possible for all the other aspects. The multicentric design has the double interest of facilitating the patients' recruitment and of decreasing the biases related to attitudes in a specific centre.

Eligibility Criteria:
Inclusion Criteria:

Women undergoing ovarian stimulation for IntraCytoplasmic Sperm Injection (ICSI) with the following characteristics:

\>/= 18 and \< 40 years old BMI between 19 and 30 kg/m2 less than 3 previous completed cycles basal FSH level less than 10 IU/l within the 6 months prior to the study

Exclusion Criteria:

age \< 18 and \>/= 40 years primary ovarian failure or women known as poor responders, i.e. requiring more than 225 IU of FSH as starting dose in previous treatment cycles or having less than 3 oocytes retrieved or with an oestradiol serum concentration \< 900 pmol/l (250 pg/ml) ovarian cysts \> 20 mm oocyte donation thawed embryos replacement patients affected by pathologies associated with any contraindication of being pregnant ascertained or presumptive hypersensitivity to the active principle and/or their ingredients abnormal bleeding of undetermined origin uncontrolled thyroid or adrenal dysfunction neoplasias severe impairment of the renal and/or hepatic functions women deprived of their freedom by administrative or legal decision
An Observational Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in Chinese Pediatric Participants With Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease affecting children, characterized by chronic synovitis with systemic multi-organ damage. Polyarticular juvenile idiopathic arthritis (pJIA) is a subtype of JIA defined as disease involving more than five joints in the first 6 months of disease. This study will assess how safe and effective adalimumab (Humira®) is in treating pediatric participants with pJIA in China real-world setting.

Adalimumab is an approved drug for the treatment of pJIA. Approximately 50 participants age 2 to 17 who are prescribed adalimumab for the treatment of pJIA in routine clinical practice will be enrolled at multiple sites in China.

Participants will receive adalimumab per their physician's usual prescription. Individual data will be collected for 52 weeks.

No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 2-17 years old with body weight ≥ 10kg.
* Diagnosis of polyarticular pJIA by treating physician.
* Adalimumab (Humira®) treatment is indicated as per Chinese label and according to judgement of the physician to Chinese clinical practice guidelines for the diagnosis and treatment of juvenile idiopathic arthritis.
* Participants or their parents/legal guardians are able and willing to give assent as well as informed consent approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) if applicable according to local law, and to comply with the requirements of this study protocol and Adalimumab (Humira ®) label.

Exclusion Criteria:

* Participants who cannot be treated with adalimumab according to Chinese Humira® label and by judgement of treating physician.
* Participants who receive any biological disease-modifying anti-rheumatic drugs (bDMARDs) within 6 months prior to the screening visit or who are on concomitant use of any bDMARD.
* Post menarche adolescent female subjects who are pregnant or breastfeeding or considering becoming pregnant during the study
* Participant is considered by the investigator or sub-investigator, for any reason, to be an unsuitable candidate for the study.
A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations

This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m\^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m\^2 iv on Day 1.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, ≥ 18 years of age.
* Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
* Presence of epidermal growth factor receptor (EGFR) mutations in tumours.
* Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.
* European Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria:

* Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).
* Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.
* Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease.
* Any inflammatory changes of the surface of the eye.
* ≥ Grade 2 peripheral neuropathy.
* History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
* Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months.
* Human immunodeficiency virus (HIV) infection.
* Pregnant, nursing, or lactating women.
TPAP for Comfort in OSA

TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what is called TPAP . TPAP is a pressure control algorithm that lowers the pressure from the set pressure at the beginning of inspiration and does not return the pressure to the full set level until about halfway through expiration. The present study, TheraPAP Comfort, aims at assessing whether TPAP improves patient comfort vs. CPAP during supine wakefulness.

The TheraPAP Comfort Study is an in-office study to assess comfort of TPAP vs. CPAP in CPAP-naïve patients with OSA during supine wakefulness. Patients will be recruited after routine outpatient visits. They will be asked to breath normally for approximately 1 minute in supine wakefulness while being administered background CPAP (at 9 or 13 cmH2O) or TPAP at various pressure drops. TPAP drops will be administered in a paired comparison before or/and after each corresponding CPAP level, according to a randomized design. Eventually, 6 one-to-one comparisons (TPAP vs. corresponding background CPAP or TPAP vs. TPAP) will be made, 3 per each randomized order. As an example, CPAP 9 will be compared to TPAP 1/1 cmH2O drops; CPAP 9 will be compared to TPAP 2/2 cmH2O drops; and TPAP 1/1 cmH2O drops will be compared to TPAP 2/2 cmH2O drops in a random sequence.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 70 age range
* AHI (apnea/hypopnea index) \> 10 on a previous HST (Home Sleep Test)
* CPAP-naive participants
* BMI (Body Mass Index) \>= 18 kg/m\^2

Exclusion Criteria:

1. Current clinically significant sleep disorder other than OSA (Obstructive Sleep Apnea) of a severity that would interfere with study participation or interpretability of data (including central sleep apnea, per central AHI \> 5 events/h).
2. Any chronic lung diseases.
3. Chronic oxygen therapy.
4. A serious illness or infection in the past 30 days as determined by investigator.
5. Patients with hypoglossal nerve stimulation implant.
6. Any non-previously mentioned vulnerable population.
7. Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
Prevention of Opioid-Induced Hypoxemia

To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.

The investigators will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. All patients will wear the Oxalert for 24 hours preoperatively in the monitoring only mode (no alerts), throughout hospitalization up to six days, and for 24 post-discharge hours. Randomization will be to Oxalert in monitor-only mode or to its normal mode which provides progressive audible and tactile alerts for hypoxemia.

Eligibility Criteria:
Inclusion Criteria:

* Adults having major laparoscopic and open abdominal or pelvic surgeries;
* Body Mass Index ≥25 kg/m2
* American Society of Anesthesiologists physical status 1-3;
* Age 18-85 years old;
* Able to understand and consent to the trial and fully participate;
* Anticipated primary opioid analgesia after surgery;
* Expected duration of hospitalization at least 24 hours after surgery;
* Consenting at least 24 hours before anticipated surgery.

Exclusion Criteria:

* Epidural analgesia (field and fascial plane blocks permitted);
* Pre-operative SpO2 \<95%;
* No wrist available for the study;
* Severe hearing loss;
* Lack of English language fluency.
* Serious hearing deficit (unable to understand normal speech in a quite environment)
* Serious peripheral neuropathy (unable to feel pin prick at wrist).