cyrilzakka/clinical-trials huggingface dataset:
Study of a 1-Millimeter Resolution Clinical Positron Emission Tomography (PET) System in Head and Neck Cancer Imaging

The purpose of this study is to gain initial experience imaging HNC patient using a new PET camera, a 1mm spacial resolution. The goal is to understand image quality of the system and to see how it works in a clinical environment.

PRIMARY OBJECTIVE(S): Gain initial experience imaging head/neck cancer patients using a novel PET camera comprising two opposing panels with 1 millimeter spatial resolution.

SECONDARY OBJECTIVE(S):

1. Determine the radioactive dose and scan time required for this novel 1 millimeter (mm) resolution clinical PET camera.
2. Images obtained with the 1 mm resolution PET camera will be compared to conventional PET imaging (which will serve as gold standard) for image quality and lesion/node visualization.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy-confirmed diagnosis of HNC
2. Patient scheduled to undergo surgery for HNC
3. Scheduled to have a PET/CT study on a conventional PET/CT system
4. Age greater than or equal to 19 years of age.

Exclusion Criteria:

1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.
Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications

This study will evaluate the use of acetaminophen in preterm infants when a patent ductus arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational studies over a 3 year period. The first will be of infants with clinically significant PDAs beyond 14 days of life who are medically treated with acetaminophen as a means to avoid surgical ligation, and the second will be of infants who received acetaminophen for a PDA closure during the first 2 weeks of life as a result of ibuprofen, the current standard of care in our NICU, contraindication due to medical status.


Eligibility Criteria:
Inclusion Criteria:

* Infants born at 23 0/7 to 29 6/7 weeks gestation, with PDA determined by medical team to need treatment and infant is beyond 14 days of life.

Exclusion Criteria:

* Congenital heart disease Pneumonia Pulmonary hypertension Pulmonary hemorrhage ALT and AST ≥ 2X the upper limit of normal (=AST\> 150 U/L, ALT\>90 U/L) Sepsis/meningitis Abnormal chromosomes Hydrops Major congenital malformations
Effect of Consumption of Orafti® Inulin on Bowel Motor Function in Subjects With Constipation

Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel motor function in subjects with constipation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
* Constipation defined as an average of 2-3 stools per week. Volunteers should have had constipation for at least the previous 6 months.
* Age ≥ 20 and ≤ 75

Exclusion Criteria:

* Subject under prescription for medication for digestive symptoms such as antispasmodic, laxatives, anti-diarrheic drugs or other digestive auxiliaries.
* Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements potentially interfering with this trial.
* Subjects with stool frequency of \<1 stool every 7 days or more than 3 stools per week.
Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer

Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.

Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor.

Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with HER2-positive refractory cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 19
* Written informed consent
* ECOG 0-2,
* Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
* The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1)
* Adequate organ function

Exclusion Criteria:

* Uncontrolled symptomatic brain metastasis,Uncontrolled active infection
* Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia)
* Prolonged QT interval in ECG (QTc \>450 msec)
* Pregnant, lactating women
* Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication
* Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
Sjogren-Larsson Syndrome: Natural History, Clinical Variation and Evaluation of Biochemical Markers

Sjogren-Larsson syndrome (SLS) is a rare genetic disease in which patients typically exhibit ichthyosis (dry, scaly skin), intellectual disability, spasticity, seizures and a distinctive maculopathy. The purpose of this study is to define the clinical spectrum and natural history of Sjogren-Larsson syndrome, and identify biomarkers that correlate with disease phenotype while establishing a registry for future investigations of biochemical pathogenesis and therapy.

The study will consist of a clinical component and a scientific component consisting of laboratory investigations of potentially useful biochemical (lipid and protein) markers. Up to 50 SLS patients of all ages, gender and ethnic origins will be enrolled. A detailed clinical evaluation will be performed to determine the presence and extent of disease involving the skin, nervous system and eyes. Clinical testing will include brain magnetic resonance imaging (MRI) and spectroscopy (MRS), electroencephalography (EEG), neurocognitive tests, ophthalmologic examination with retinal photographs and optical coherence tomography (OCT), photographs of the skin and tests of cutaneous transepidermal water loss. Laboratory investigations will include lipid analyses (e.g. fatty alcohols, farnesol, fatty acids, ether glycerolipids, etc.) of blood, skin and urine; proteomic analysis of skin (stratum corneum); and measurements of leukocyte fatty alcohol and farnesol oxidation. A skin biopsy (optional) will be obtained for electron microscopy, measurement of lanthanum perfusion (transepidermal water loss), and/or establishing keratinocyte cultures. Correlations between clinical abnormalities and laboratory measurements will be tested to identify the most useful biomarkers for future diagnostic and therapeutic studies. To characterize the progression of phenotypic features over time, patients \<6 years of age will be followed yearly and patients ≥6 years of age will be followed every 3 years. In addition, a SLS patient registry will be established as a resource for future investigations in SLS.

Eligibility Criteria:
Inclusion Criteria:

* The only eligibility criterion is that subjects have a genetically or biochemically confirmed diagnosis of Sjogren-Larsson syndrome.

Exclusion Criteria:

* The primary exclusion criteria are the patients' failure to consent or inability to travel to a STAIR site.
Endotracheal Cardiac Output Monitor (ECOM) for Patients Undergoing Liver Transplantation

The purpose of this study is to determine whether the endotracheal cardiac output monitor (ECOM) is accurate and predictive in liver failure patients with hyperdynamic circulatory changes.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing liver transplantation surgery

Exclusion Criteria:

* Patients who are anticipated to remain intubated postoperatively for greater than 24 hours.
A Study To Taste Three New Types Of Crizotinib Formulation In Comparison Of An Oral Solution And To Measure The Amount Of Crizotinib In The Body After These Formulations Are Orally Given, Relative To Capsule Formulation

This study is intended to evaluate the sensory attributes and estimate the relative bioavailability of three prototype oral formulations. Subjects will either taste 75-mg doses by "swirl and spit" (Cohort 1) or will receive five oral single 250-mg doses with a washout period of at least 14 days (Cohort 2).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
* Female subjects of non child bearing potential must have a Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Pregnant or nursing females; females of childbearing potential.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
ICG-Based Fluorescence Imaging for Intra-operative Detection of Endometriosis

Endometriosis is a common disease for which the current gold standard for diagnosis is a diagnostic laparoscopy with histologic confirmation. However, during the diagnostic laparoscopy endometriotic lesions are hard to identify due to the many appearances of endometriosis. Our hypothesis is that the use of intra-operative near infrared fluorescence imaging will provide real time image enhancement for the detection of endometriotic lesions by using the different vasculature in the endometriotic lesions. This hypothesis will be tested in a prospective study with 15 patients scheduled for an elective diagnostic laparoscopy for suspected endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective laparoscopic surgery in which endometriosis is suspected
* Able to understand the nature of the study and what will be required of them
* Females
* Age \>18years
* Premenopausal
* No history of impaired liver and renal function
* No history of hypersensitivity or allergy to indocyanine green or iodide
* No hyper-thyroidism or autonomic thyroid adenomas
* Willing to participate

Exclusion Criteria:

* Not able to give written informed consent
* Males
* Aged \< 18 years
* Pregnant or breast-feeding women
* Known hypersensitivity or allergy to indocyanine green or iodide
* Known hyper-thyroidism or autonomic thyroid adenomas
* Not willing to participate
Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery

Roux-en-Y gastric bypass (RYGB) leads to weight reduction but has also some unwanted side effects. A part of this population will develop postprandial reactive hypoglycemia (PPRH). At this moment no validated diagnostic tool exists for PPRH. The aim of this study is to prove an association between the Sigstad´s Score and the lowest postprandial glucose level in patients after RYGB surgery. This is investigated using a liquid mixed meal tolerance test (LMMTT). As a secondary hypothesis, associations between Edinburgh Hypoglycemia Scale (EHS) and postprandial glucose levels are investigated. Furthermore, changes of insulin and GLP-1 levels during the test are analysed. Patient characteristics including co-morbidities are studied as possible influencing parameters. Moreover, a healthy control group is included to validate the results. Finally, a flowchart/diagnostic method will be proposed for diagnosing patients who had a RYBG surgery with symptoms suggestive of PPRH. Besides the LMMTT, participants at the Ghent University Hospital will undergo additional tests such as a solid mixed meal tolerance test (SMMTT) and continuous glucose monitoring (CGM). Associations between Sigstad Score, EHS and the lowest glucose measured during CGM and SMMTT will be investigated and compared to the results of the LMMTT.


Eligibility Criteria:
Inclusion Criteria:

* for GBS group: primary GBS, 1-5 years post surgery
* for control group: 10 subjects BMI 18-25kg/m² and 10 subjects BMI \>30 kg/m²

Exclusion Criteria:

* Antidiabetic medication (oral or injectable), somatostatin analogs
* Use of systemic corticosteroids
* for GBS group: Any surgery after RYGB affecting anatomic integrity of the bypass, e.g. banding, conversion of the proximal and/or distal anastomosis
* for GBS group: Any surgery before RYGB affecting anatomic integrity of the bypass, e.g. banding, conversion of the proximal and/or distal anastomosis, sleeve gastrectomy
* Known renal insufficiency: CDK ≥ 4
* Known liver cirrhosis
* Known cardiovascular risk: NYHA ≥ III
* Mental incapacity
* Language barriers with inability to communicate with research staff
* Anemia Hb \< 6.2 mmol/l (10.0 g/dl)
* Cancer within \< 5 years
* Pregnancy
* Allergy to the Fresubin E
* Allergy to components of the solid mixed meal (white bread, cheese spread, margarine, orange)
Luteal Phase Commencing of Growth Hormone

Commencing of growth hormone in luteal phase when follicular cohort for the next cycle is being gathered may increase mature oocytes in poor responder


Eligibility Criteria:
Inclusion Criteria:

* Poor responder

Exclusion Criteria:

* FSH \>20 IU
Early Intervention Efficacy in COPD

This study aims to evaluate the time to escalation to triple therapy among the Japanese Chronic obstructive pulmonary disease (COPD) patients newly initiating therapy with a combination of Olodaterol and Tiotropium (herein referred to as Tio/Olo) using real world data.


Eligibility Criteria:
Inclusion Criteria:

The study cohort will include all patients who initiate Tiotropium/ Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period.

Exclusion Criteria:

The following exclusion criteria will then be applied to generate the unmatched cohort:

* Aged \<40 years on cohort entry.
* Any LAMA, LABA, or ICS maintenance therapy (alone or in combination) during the 180-day baseline period prior to cohort entry for maintenance treatment and duration \>30 days, or any prescription within the 30 days prior to cohort entry.
* Patients without continuous enrolment (days since first inpatient/ outpatient encounter in the data) during the baseline period.
* No prior diagnosis of COPD \[International Classification of Diseases (ICD)-10: J41\*, J43\*, J44\* and doubt (UTAGAIFLG) = 0 (no)\]
* Patients without a second prescription claim of their index medication within 60 days after the cohort entry date.
* Diagnosis of asthma \[ICD-10: J45\* and doubt (UTAGAIFLG) = 0 (no)\] during the baseline period.
* Diagnosis of lung cancer \[ICD-10: C34\*, D02.2, Z80.1, Z85.1 and doubt (UTALAIFLG) = 0 (no)\] or lung transplant (Health claim code: 150317670, 150322510, 150322610, 150336510, 150336610, 150336710, 150399270) prior to the cohort entry date using all available data.
* Patients who initiate both Tio/Olo and Tio simultaneously on the cohort entry date.
* Any use of triple therapy (LAMA + LABA + ICS) during the baseline period or between the cohort entry date and 1 day prior to the start of follow-up.
Rotational Stability of the AcrySof® Toric

To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.


Eligibility Criteria:
Inclusion Criteria:

* Monolateral or bilateral cataracts
* anticipated intraocular lens (IOL) power of +10 Diopters (D) \~ +25D
* 0.75 \~ 2.0 D of astigmatism measured preoperatively by Keratometry readings
* able to sign the informed consent, to comply with scheduled visits and other study procedures

Exclusion Criteria:

* Preoperative ocular pathology
* previous intraocular or corneal surgery
* an increased risk for complications which could require vitreoretinal surgery
* corneal irregularities
* corneal opacities
* current contact lens usage
* uncontrolled diabetes
An In Depth Study Evaluating The Experiences of Patients In Schizophrenia Research

Historically, research participation has been biased toward certain demographics. However, there is a shortage of studies that delve into the underlying factors that influence patient participation, both positively and negatively.

Several people will be invited to enroll in this study so that it may collect a variety of data about schizophrenia clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

The data collected from this study will be analyzed and used to improve the experiences of future schizophrenia patients who are recruited for medical trials.


Eligibility Criteria:
Inclusion Criteria:

* Patient has self-identified as planning to enroll in a clinical trial
* Patient has been diagnosed with schizophrenia
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant
CP-751,871 Treatment For Patients With Multiple Myeloma

This study represents the first-in-human study for CP-751,871. The study aimed to define the safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple myeloma through a dose escalation design.


Eligibility Criteria:
Inclusion Criteria:

* Previously treated multiple myeloma with a quantifiable serum (M spike ≥ 1 g/dL) and/or urine (≥ 200 mg/24-hr) paraprotein
* Adequate bone marrow, renal, liver and cardiac function
* Eastern Cooperative Oncology Group \[ECOG\] performance status less than or equal to 2

Exclusion Criteria:

* Prior allogeneic stem cell transplant (alloSCT)
* Myelosuppressive chemotherapy or immunotherapy within 3 weeks prior to treatment with CP-751,871
* Prior organ allograft
* Concurrent use of insulin, oral hypoglycemic medication, growth hormone (GH), or growth hormone inhibitors
* Female patients who are pregnant or lactating
A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices

The primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. The secondary objectives are to assess the effect four dentifrices, have on plaque and oral microbiome composition.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 16 gradable teeth;
* Have mild to moderate gingivitis with at least 20 bleeding sites;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study;
* Agree to refrain from any oral hygiene the morning of your visit
* Agree to refrain from eating, drinking (except water), using tobacco, floss, use toothpicks, breath mints, or chew gum after performing your evening brushing.

Exclusion Criteria:

* Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
* Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Having had a dental prophylaxis within 2 weeks of plaque sampling visits;
* Removable oral appliances;
* Fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Any diseases or condition that might interfere with the safe participation in the study; and
* Inability to undergo study procedures.
Comparison of Technics for Determination of Epstein-Barr Virus Serological Diagnosis

This study compared the performance of three automated immunoassays, Architect (Abbott), Immulite (Siemens) and Liaison (Diasorin), for Epstein-Barr virus (EBV) serology. Ninety-one serum samples collected in Amiens University Hospital were analyzed for the presence of Viral Capsid Antigen (VCA) IgG and IgM and Epstein-Barr Nuclear Antigen (EBNA) IgG. The agreement between the three assays was calculated for each marker individually and for determination of the EBV profile, based on interpretation of the combination of these three EBV markers.

This retrospective study was conducted on 91 samples collected between 2014 and 2015 for which EBV diagnosis was requested. The serological diagnosis of EBV infection was performed in the Amiens University Hospital virology laboratory (France). The median age of patients was 34 years (mean: 38 years, range: 3-82 year) with a sex ratio of 50%. Sixteen of the 91 samples concerned children (\<15 years).

This study compared the performance of three automated immunoassays, Architect (Abbott), Immulite (Siemens) and Liaison (Diasorin), for Epstein-Barr virus (EBV) serology. Ninety-one serum samples collected in Amiens University Hospital were analyzed for the presence of Viral Capsid Antigen (VCA) IgG and IgM and Epstein-Barr Nuclear Antigen (EBNA) IgG. The agreement between the three assays was calculated for each marker individually and for determination of the EBV profile, based on interpretation of the combination of these three EBV markers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with EBV diagnosis
* Age between 3 and 82 years

Exclusion Criteria:

* Patient \<3 years
* Patient \> 82 years