cyrilzakka/clinical-trials huggingface dataset:
Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

This study is to provide additional data to support the safety and efficacy of OP-1 Putty as a replacement for autograft in patients undergoing posterolateral spinal fusion.

Follow-up study 06-UPLF-01 was a prospective collection of longer-term data on the patient population from pivotal study S01-01US, and was conducted to expand the information regarding efficacy, particularly with regard to radiographic assessment of fusion, as well as the longer-term safety of OP-1 Putty in uninstrumented posterolateral fusion (PLF) as compared to autograft

Eligibility Criteria:
Inclusion Criteria:

1. The patient was treated in Stryker Biotech clinical protocol S01-01US (Pivotal IDE study) and not a retreatment failure at the time of completion.
2. The patient or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent.
3. The patient agrees to complete the necessary clinical and radiographic evaluations.

Exclusion Criteria:

1. There are no exclusion criteria for participation in this protocol.
A Trial of TAS-114 in Combination With S-1

A Phase I, Open-Label, International, Multicenter, Non-Randomized, Dose-Escalating Safety, Tolerance and Pharmacokinetic Study of Oral Administration of TAS-114 in Combination with S-1 in a Twice Daily Schedule for 14 Days in Patients with Advanced Solid Tumors.

This is an open-label, non-randomized, dose-escalation Phase I study of TAS-114 administered in combination with S-1, evaluating the safety, tolerability, pharmacokinetics and preliminary antitumor activity of the TAS-114/S-1 regimen in patients with advanced solid tumors.

The study will be conducted in two parts: a Dose-Escalation Phase (Part 1) to determine the MTD; and an Expansion Phase (Part 2) to further evaluate the safety and preliminary efficacy with the MTD. Patients will receive the study medication according to the proposed treatment schedule until disease progression (PD), occurrence of intolerable side effects, removal by the Investigator or withdrawal of consent. A patient is considered discontinued from study treatment when TAS-114 is discontinued.

Male or female patients age 18 years or older with confirmed advanced solid tumor(s) for which no standard therapy exists.

TAS-114/S-1 will be administered BID for 14 days followed by a 7-day recovery period, every 21 days (1 cycle) in patients with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Has provided written informed consent.
2. Is ≥18 years of age
3. Has histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no standard therapy exists.
4. Expansion Phase only: Has at least one measurable lesion
5. Is able to take medications orally (e.g., no feeding tube).
6. Has adequate organ function
7. Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug.
8. Is willing and able to comply with scheduled visits and study procedures.

Exclusion Criteria:

1. Has received treatment with any proscribed treatments within specified time frames prior to study drug administration.
2. Has a serious illness or medical condition(s)
3. Is receiving concomitant treatment with drugs that may interact with S-1
Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Postmenopausal woman who fulfils any one of the following criteria:
* Histological or cytological confirmation of breast cancer
* Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).

Exclusion Criteria:

* Having received any one of the following therapy for advanced or recurrent breast cancer
* 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc
Comparison Between CT and MRI in Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis

The principal objective of the study is to compare between CT and MRI diagnostic performance (sensibility and specificity) in the preoperative assessment of neurogenic para-osteo-arthritis.

The second objectives of the study are:

* besides the diagnostic performance (sensibility and specificity), to evaluate the imaging par MRI in visual and descriptive manner heterotopic ossification and connection with vascular and nervous structures.
* to study the concordance (two by two) of results of preoperative obtained by MRI and by CT and operative reports.
* to study the characteristics of patients with discordant findings (two by two) by MRI, CT scan and operative report.

This is a study on diagnostic performance, non randomized, versus Gold standard (a prospective multicentric cohort).

All eligible patients will be proposed consecutively to participate to the study, to undergo preoperative CT scan and MRI examination as usual procedure. The only additional action in this study will be a neurography sequence of type fluorescence subtraction imaging (FSI) during MRI, permitting to obtain more details in visualization of nerve structure and their relations of the ossifications.

The enrollment visit will performed by neuro-orthopaedic surgeon during preoperative consultation.

The follow-up visit will be an usual post-operative visit, non-specific for the study.

The duration for each participant will compound 1 month (the duration between preoperative imaging and surgical resection) added by up to two months of post-operative follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with neurogenic para-osteo-arthropathy resulted by prior central nervous system, cerebral or medullar damage
* Deformation with limitation of articular amplitude which could result limitation in rehabilitation care
* An indication of partial or total surgical excision of heterotopic ossification
* Indication of pre-operative assessment by CT scan and MRI, with contrast product injection
* Signed consent of patient obtained after clear and relevant informations given by physician
* Patient covered by social security

Exclusion Criteria:

* Contraindications to an MRI examination: cardiac stimulator, metallic intraocular foreign bodies...
* Contraindications to CT scan
* Contraindications to contrast injection product, such as iodinated or gadolinium-based contrast media
* Impractical venous access
* Severe deformation resulting impossibility to positioning for MRI examination or CT scan
* Patient can not give consent
* Participation to another interventional study
* Patient under guardianship
Work of Breathing and Oxygen Saturation in Infants Receiving High Flow Nasal Cannula (HFNC)

The purpose of this study is to compare work of breathing on different levels of high flow respiratory support on infants born between 27 and 37 weeks gestation.


Eligibility Criteria:
Inclusion Criteria:

* Infants between 27 and 37 weeks corrected gestational age
* \>4 days PNA
* Stable (i.e. not meeting exclusion criteria) and receiving non-invasive respiratory support (HFNC) for ≥ 12 hours
* Requiring ≤ 40% supplemental FiO2 as determined by the clinical care team for clinical care purposes independent of this study

Exclusion Criteria:

* Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of WOB measurements
PLATON - Platform for Analyzing Targetable Tumor Mutations (pilot-study)

PLATON (Platform for Analyzing Targetable Mutations) is a prospective, multicentre, observational cohort study with biobanking. In a first approach PLATON's pilot-study assesses genomic profiling in gastrointestinal cancer therapy and the frequencies of targetable mutations including Tumor Mutational Burden (TMB) and Microsatellite Instability Status (MSI), performing Next-generation deep sequencing (NGS) using the Foundation Medicine assays on tumor specimen and EDTA-whole blood samples. The Study Protocol does not define any further medical intervention or evaluate the efficacy or safety of the treatment decision made by the investigator. Another important objective of PLATON's pilot project is to evaluate whether and how many patients are treated based on their genomic profiles.

PLATON (Platform for Analyzing Targetable Mutations) is designed to improve personalized therapy for patients in different cancer entities, such as in hepatocellular cancer (HCC), intra- and extrahepatic cholangiocellular carcinoma (CCA), gallbladder carcinoma (GBCA), pancreatic cancer (PanCa) and esophagogastric cancer (EC/GC), and elevate the treatment guidance within its framework. The key to understand the mechanisms in initiation, progression and response to treatment of cancer is the data integration of genetic mutational signatures with medical and physiological data of diseased cohorts.

PLATON is a prospective, multicentre, observational cohort study with biobanking and does not define any medical intervention or evaluate the efficacy or safety of the treatment decision made by the investigator.In a first approach PLATON's pilot-study assess genomic profiling in gastrointestinal cancer therapy and the frequencies of targetable mutations including Tumor Mutational Burden (TMB) and Microsatellite Instability Status (MSI), performing Next-generation deep sequencing (NGS) using the Foundation Medicine assays on tumor specimen and EDTA-whole blood samples. Another important objective of PLATON's pilot project is to evaluate whether and how many patients are treated based on their genomic profiles.

The pilot-study starts with the national-wide enrolment of 200 participants of both sexes and ages over 18 at 40 german study sites. The long-term vision is to enable cancer patients to receive the best available, scientifically founded, biomarker-based care, tailored to his or her individual needs

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of hepatocellular carcinoma or intra-/extrahepatic cholangiocarcinoma or gallbladder carcinoma or pancreatic ductal adenocarcinoma or esophagogastric adenocarcinoma in the advanced setting and no local curative therapy available.
* Standard first line therapy is planned, or patient is currently receiving first line therapy (started within the last 2 months before enrolment)
* ECOG 0-2
* Life expectancy ≥ 6 months

Exclusion Criteria:

* Not able to understand all implications of study participation
* No written informed consent
* age \< 18 years
Lidocaine in ERAS for FESS

Functional endoscopic sinus surgery (FESS) is a commonly performed procedure. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.

Functional endoscopic sinus surgery (FESS) is a commonly performed procedure in the head and neck field. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.

Use of vasoactive drugs to control bleeding is not without pitfalls. Systemic effects of epinephrine may constitute a potential hazard in patients with hypertension, ischemic heart disease, anemia, preexistent liver or renal damage and endocrine dysfunction (hyperthyroidism, pheochromocytoma and diabetes mellitus).

Lidocaine is a prototypical local anesthetic, but it also has systemic effects that are mediated by inhibitory effects on N-methyl-d-aspartate receptors and leukocyte priming. Consequently, systemic lidocaine is antiinflammatory, analgesic, and antihyperalgesic. Randomized clinical trials, however, have produced mixed results. Several studies have shown reduction in postoperative opioid consumption and pain scores, whereas others have failed to show a benefit.

Eligibility Criteria:
Inclusion Criteria:

* Patients, 20-50 yr ASA class I and II
* Elective Functional endoscopic sinus surgery (FESS) under general anesthesia.

Exclusion Criteria:

* Patient refusal, allergy to the study medication, pre-existing chronic pain at any site requiring treatment, intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs), psychiatric or neurological disorders, seizure disorder requiring medication within the previous 2 years, body mass index \> 30 kg/ m2, revision sinus surgery, pregnancy, and patients with cardiovascular, cerebrovascular, respiratory, renal or hepatic diseases
Heart Failure (HF) Assessment With B-type Natriuretic Peptide (BNP) In The Home

The HABIT clinical study is being performed to determine the benefit and optimal frequency for at home testing of B-type natriuretic peptide (BNP) for heart failure patients following hospitalization from decompensation. Subjects will be enrolled following hospitalization for decompensated heart failure. Enrolled subjects will be trained on the use of the Triage Touch meter for fingerstick BNP assessment; these subjects will then test their BNP levels daily using the Triage Touch product for approximately 60 days.

This is a multi-center, single-arm double-blinded prospective clinical study to determine the optimal frequency of home B-type natriuretic peptide (BNP) testing and the changes in BNP concentrations that correlate with clinical heart failure (HF) decompensation and related adverse clinical outcomes in at-risk HF patients. Approximately 200 subjects will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years of age or older);
* Admitted to the hospital or observation unit with a diagnosis of decompensated HF for which treatment will be administered;
* Blood BNP level measurement \> 400 pg/mL documented during admission; If NT-proBNP is used routinely in the laboratory at a clinical site rather than BNP, then blood NT-proBNP level measurement \> 1,600 pg/mL documented during admission.
* Successfully trained on how to perform a fingerstick and to use the Triage touch.
* Either the subject or their care provider is fluent in reading and writing English

Exclusion Criteria:

* Unwilling or unable to provide written informed consent;
* Acute coronary syndrome (ACS) that is concomitant with the diagnosis of decompensated HF and for which treatment will be provided.

A history of ACS is not reason for exclusion if it is not concomitant with the present decompensated HF for which admission is being made. Small elevations in cardiac troponin that are considered by the treating physician to be associated with myocardial injury due to the acute decompensated HF and not due to a concomitant ACS or myocardial infarction are not a basis for exclusion.

* Previous cardiac transplantation - or cardiac transplantation anticipated within 3 months;
* Current or planned use of a left ventricular assist device (LVAD), use of outpatient intravenous inotropic HF therapy, major surgical procedure or percutaneous coronary intervention within 3 months;
* Life expectancy less than 3 months due to causes other than HF or cardiovascular disease (e.g., cancer);
* End stage renal disease;
* Prisoner or other institutionalized or vulnerable individual;
* Residence in regions where either transmission of Triage Touch data or a home visit on day 5 is not possible.
* Dementia, tremors or other impediments to performing daily home BNP testing via fingerstick.
* Deemed by the Investigator not to be likely to comply with study-mandated procedures or instructions.
Dialysis mHealth Survey

This is a survey of dialysis patients and staff to determine both the readiness of ESRD patients to use mHealth as well as the Readiness of the dialysis center staff (healthcare technicians, nurses and administrative staff) to utilize mHealth in order to assist patients who may have barriers to do so for themselves.

This is a cross-sectional observational study. Approximately 700 ESRD patients currently on dialysis will be recruited from Satellite In-Center (Hemodialysis) and WellBound (Home Dialysis) Centers in the US. These will include centers in Texas, Tennessee, and California. In addition, about 100 dialysis staff will be recruited to complete a staff mHealth Questionnaire.

Patients and staff will be asked questions that conform to Khatun's conceptual model.

* Technological readiness:

  * Availability of the devices and internet
  * Ability to use the devices
* Human resource readiness:

  * Socio-demographics
  * Awareness of mHealth services
* Motivational readiness

  * Concerns (cost/privacy/ other)
  * Attitudes/intentions: Current use or potential for use.

Eligibility Criteria:
Inclusion Criteria:

* • On dialysis (either in-center or home) at a participating Satellite Healthcare center within the recruitment period

  * Any Satellite Dialysis staff member with patient interaction.

Exclusion Criteria:

* Age \< 18 years
* Inability to participate because of cognitive impairment or active psychological condition
Screening for Research Subjects With Anterior Segment Diseases

This study will identify patients with anterior segment disease who may be eligible to participate in current or future NEI studies on this disease. Anterior segment disease includes all disorders that affect the eye surface, anterior chamber, iris and ciliary body and lens of the eye. The eye surface is composed of the cornea, conjunctiva, eyelids, lacrimal and meibomian glands, and the interconnecting nerves.

Patients of any age with anterior segment disease may be eligible for this screening study. Participants will be evaluated with some or all of the following tests and procedures, depending on the nature of their eye problem:

* Medical history and brief physical examination.
* Eye examination, including measurement of visual acuity (eye chart) and eye pressure, examination of the pupils, eye movements, structures in the front of the eye (cornea, conjunctive, etc.), the lens, and the structures in the back of the eye (retinal, optic nerve, etc.).
* Photographs of the eye to help assess the status of the cornea and conjunctive and to evaluate any changes that may occur in the future.
* Assessment of tear and surface status. The amount of tears the eyes can produce is measured by placing a small piece of sterile paper in the corner of the eye every 5 minutes. Special orange and green dyes are placed in the eyes to determine the health status of the surface of the eye.
* Corneal or conjunctival biopsy. A small tissue sample from the surface of the eye may be removed for laboratory examination to help diagnose a condition that is unclear. For this procedure, the eye is numbed with anesthetic eye drops. The required tissue is collected, an antibiotic ointment is placed in the eye to prevent infection, and a patch may be placed over the eye for 12 to 24 hours.
* Blood draw for tests to study the cause of the patient's eye disease.
* Other diagnostic tests as needed.
* DNA testing to look for a genetic pattern associated with the patient's eye disease.

Patients who are found eligible for an NEI study will be offered participation in that study. Patients who are not eligible for current studies will be advised about treatment options.

This is a screening protocol that will allow the NEI clinicians to examine patients with ocular diseases in order to identify those who may be eligible to participate in other NEI studies on anterior segment disease.

Eligibility Criteria:
* ELIGIBILITY CRITERIA:

To participate in this screening study, a patient must have a history of anterior segment disease. Patients of all ages are eligible.
Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP)

Tumor Derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. The primary objective of this study is to demonstrate the non-inferiority of cfDNA-based versus tumor tissue-based genotyping.

Primary objective:

To demonstrate the non-inferiority of cfDNA-based versus tumor tissue-based genotyping as it pertains to the detection of clinically-actionable biomarkers in first line, treatment naïve, metastatic non-squamous NSCLC.

The following secondary objectives will be studied:

* Turn around Time (TAT) of cfDNA vs. tissue results.
* Time to treatment (TtT) initiation.
* Quantity not sufficient rate (QNS) of tissue for clinically-actionable biomarker testing.
* Tumor Not Detected (TND) rate of cfDNA in blood.
* Rescue rate of QNS samples using cfDNA-derived genotyping.
* Rate response for patients that are actionable biomarker positive (either in cDNA or tissue) treated with target-drugs according investigator criteria. Up to three RECIST assessments per patient will be retrospectively done by external personnel (no investigational team).
* Rate of discovery of genomically mediated, acquired resistance to targeted therapies in the biomarker-positive subsets.

Eligibility Criteria:
Inclusion Criteria:

* Patients biopsy-proven, metastatic, previously untreated, non-squamous non-small cell lung cancer (NSCLC). Patients may have received adjuvant cytotoxic chemotherapy, but not targeted neo-adjuvant or adjuvant therapy.
* Age ≥ 18 years
* Ability to understand a written informed consent document, and the willingness to sign it.
* Willingness to provide blood sample at the time points defined in Table 1 \[pre-treatment, Day 14 (+/- 7 days) and End of Study\].
* Patient has or will have standard-of-care tissue genotyping ordered.
* Stable Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

* Pregnancy, recorded from clinical records
* Any concurrent, non-cutaneous, malignancy (with the exception of early stage non-invasive cervical cancer). Any prior cancer must have occurred more than 5 years prior with no evidence of currently active disease