cyrilzakka/clinical-trials huggingface dataset:
Prevention of Cancer-associated Malnutrition Through Oral Nutritional Supplements

The aim of the randomized controlled study is to determine effects of an adjusted amount of oral nutritional supplements on the quality of life, the nutritional status, side effects, and response to therapy, in patients with pancreatic and hepatocellular carcinoma receiving palliative therapy.

Cancer is often associated with malnutrition and weight loss. The occurence of malnutrition during the course of the disease depends on the type, extent, and therapy of the tumor. Pancreatic cancer patients and patients with hepatocellular carcinoma are particularly at risk of developing a pronounced weight loss. Cancer-related malnutrition has negative impact on the response to therapy, survival, quality of life, and the infection rate of patients, resulting in prolonged hospital stays and higher costs for health care. Maintaining or optimizing the quality of life in patients receiving palliative therapy has priority. Since a poor nutritional status affects the quality of life, patients might benefit from the use of an adjusted amount of oral nutritional supplements.

To determine the effects of oral nutritional supplements, a controlled randomized study will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* assured diagnosis of pancreatic cancer/hepatocellular carcinoma, not treatable with curative intent
* palliative systemic therapy of pancreatic cancer respectively palliative therapy of hepatocellular carcinoma with Sorafenib or TACE (transarterial chemoembolization)
* written informed consent prior to inclusion

Exclusion Criteria:

* prefinal phase with an estimated life expectancy of less than three months
* nutritional support through tube feeding or a central venous catheter
* serious malassimilation (assessed by anamnesis)
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≥ 2
* hepatic encephalopathy ≥ degree 2
Investigating the Frequency and Phenotype of Headaches Associated With Fasting During the Month of Ramadan.

Headaches are more common in the month of Ramadan in patients who already suffer from migraine. The object of the present study is investigate the frequency in the Ramadan month .


Eligibility Criteria:
Inclusion Criteria:

* age 18-60 years.
* expectation of fasting for at least 21 of 30 days during the month of Ramadan.
* understand and answer the questionnaire sent out in Danish.

Exclusion Criteria:

* non-compliance with the headache calendar (defined as non-registration of at least 21 days per 30 days).
A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD

Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label extension study (TNX-CY-P303).

This is an open-label, extension trial designed to evaluate safety over 40 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD.

The study will consist of 5 in-clinic study visits, including Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit of the 12-week open-label extension study TNX-CY-P303), followed by in-clinic visits after 7, 16, 28 and 40 weeks of open-label treatment.

Eligibility Criteria:
Inclusion Criteria:

* The patient has completed a double-blind lead-in HONOR study and a 12-week open-label extension study P303 and is judged by the investigator as reasonably compliant, with at least 60% compliance with study medication usage (based on drug accountability).
* The patient has provided written informed consent to participate in this extension study.
* The patient met all prior inclusion and exclusion requirements for the double-blind lead-in HONOR study, or the site received medical monitor approval for the patient to remain in the lead-in study after the retrospective discovery of an entry violation that did not pose any threat to the patient's safety or well-being.
* During the course of the lead-in HONOR study or 12-week open-label extension P303 study, the patient has had no intervening medical conditions including pregnancy, clinically significant increase in suicidal ideation (plan or intent) or significant worsening of depression, newly arising clinically significant abnormal laboratory tests, or any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the patient's ability to participate in the study or potentially compromise the patient's well-being during the study.
* The patient does not require treatment with a potent (strong) cytochrome P450 subtype 3A4 (CYP3A4) inhibitor, or St. John's wort.
* The patient is willing to refrain from use of all other formulations of cyclobenzaprine for the duration of the study.
* The patient is willing to refrain from use of monoamine oxidase inhibitors for the duration of the study.
* Female patients of childbearing potential continue to agree to practice one of the medically acceptable methods of birth control detailed in the lead-in study.

Exclusion Criteria:

* There are no exclusion criteria for this study.
A Study of Amphotericin B in the Treatment of Fungal Infections of the Mouth in HIV-Infected Patients Who Have Not Had Success With Fluconazole

To assess response and toxicity in patients with fluconazole-resistant oral candidiasis ( thrush ) when given initial induction with amphotericin B oral suspension.

Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.

Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.

Patients swish and swallow amphotericin B oral suspension after each meal and at bedtime for 14 days, at which time they are deemed a responder, nonresponder, or failure to induction therapy. Responders receive maintenance twice daily, while nonresponders receive 14 further days of initial induction. Failures discontinue the study. Responders after 28 days of induction are placed on maintenance. After successful completion of initial induction, patients remain on study for 6 months.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection OR diagnosis of AIDS.
* Diffuse oral candidiasis, symptomatic or asymptomatic, that is resistant to fluconazole.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Current symptoms of esophageal candidiasis unless there are negative endoscopic visualization and biopsy for Candida or related yeasts.
* Perioral lesions only (e.g., angular stomatitis, perleche).
* Inability to swish and swallow oral solution.
* Inability to tolerate further oral therapy for thrush.

Concurrent Medication:

Excluded:

* Fluconazole.
* Itraconazole.
* Ketoconazole.
* Flucytosine.
* Intravenous amphotericin or other non-study formulations.
* Nystatin.
* Clotrimazole.
* Other investigational antifungal agents.
* Systemic cytotoxic chemotherapy for malignancy.

Concurrent Treatment:

Excluded:

* Radiation therapy to the mouth, neck, or chest.

Patients with the following prior conditions are excluded:

* Esophageal candidiasis, proven or presumptive, occurring since fluconazole failure.
* Successful treatment of thrush with fluconazole at \<= 200 mg/day after original treatment failure.
* History of oral candidiasis that recurred or persisted despite IV amphotericin B given once or more weekly.
* History of anaphylaxis to amphotericin B.
* History of hypersensitivity to components in amphotericin B oral suspension.

Prior Medication:

Excluded within 6 weeks prior to study entry:

* Cytotoxic therapy for malignancy.
* Corticosteroids at higher than replacement doses.
ARDS Esophageal Balloon Pressure Changes With Positioning Study

The use of esophageal balloon catheters, which use esophageal pressure as a surrogate measurement for transpleural pressure, shows promise in improving outcomes of patients with severe acute respiratory distress syndrome (ARDS) requiring mechanical ventilator. The investigators hope to measure changes in in transpleural pressures in patients undergoing treatment with mechanical ventilation while switching from the supine, upright (head of bed \>30 degrees), and prone positions. The goal will be to measure the changes in chest wall and lung compliance in mechanically ventilated patients with changes in position.

The use of esophageal balloon catheters shows promise in improving outcomes of patients with severe ARDS. The estimation of pleural pressure (Ppl) has been validated in the upright position in humans with few studies commenting on the changes in supine positioning and almost none on prone positioning aside from radiographic analysis. An abstract presented at the annual American Thoracic Society meeting recently reported a series of 18 patients undergoing spinal surgery. In this population of patients without ARDS, esophageal pressure (Pes) decreased when shifting from supine to prone positioning. This suggests that transpleural pressure (PtmL) would be increased at a given airway pressure.

The investigators hope to measure changes in PtmL in patients undergoing treatment with mechanical ventilation while switching from the supine, upright (head of bed \>30 degrees), and prone positions. The esophageal balloon catheter will be placed using standard techniques and secured with tape to the patients' nares during changes in positioning. The goal will be to measure the changes in chest wall and lung compliance in mechanically ventilated patients with changes in position.

Eligibility Criteria:
Inclusion Criteria:

* age at least 18 years old, need for mechanical ventilation, moderate or severe ARDS, and the ability to tolerate prone positioning.

Exclusion Criteria will be patients who:

* are deemed too ill by their clinicians to be included in the study
* have esophageal or nasopharyngeal pathology (such as tumors, sinusitis, epistaxis, ulcerations, recent surgery or bleeding varices) preventing insertion of the esophageal balloon catheter
* diverticulitis
* bronchopulmonary fistula
* solid-organ transplantation
* history of difficult intubation or airway management
* or contraindications to prone positioning (per the UNC Medical Intensive Care Unit Pronation Therapy protocol, attached)
Study of Combination of Cetuximab and Radiotherapy Added to the Standard Treatment for Oesophageal Adenocarcinoma

The purpose of this study is to determine whether the addition of the combination between cetuximab and radiotherapy to the standard chemotherapy for resectable oesophageal cancer is safe and adds efficacy.

This study aims at developing a novel strategy to optimize the treatment of oesophageal adenocarcinoma and gastro-oesophageal junctional tumors with curative intent. Surgery in combination with peri-operative chemotherapy, using the combination epirubicin, cisplatin and 5-FU, as defined by the recent MAGIC trial, results in 13% increase in 5-yr survival. To improve the outcome of patients with this disease we hypothesize that the addition of pre-operative combined cetuximab-radiotherapy (cetux-RT) treatment could improve the outcome of this patient category through better local control.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven resectable adenocarcinoma of the lower oesophagus and gastric-oesophageal junction
* Tumour stage: T2-3 N0-1 M0, as assessed by endoscopic ultrasound and CT-scan of thorax and abdomen and ultrasound neck region. For the patients treated in this study the gastro-oesophageal junctional tumors will be staged as oesophageal tumors with respect to their lymphnode metastases.
* Age \>18y and written informed consent after at least 4 days of deliberation time from the moment the patient information has been given and has been explained.
* Weight loss \< 10% in 0.5 yr
* WHO performance status 0-1
* No prior radiotherapy or chemotherapy for the adenocarcinoma of the oesophagus

Exclusion Criteria:

* Previous malignancy other than basal cell carcinoma of the skin or local resection for cervical carcinoma in situ.
* Inadequate organ function as defined by:
* Inadequate haematology (Hb \< 5,5 mmol/L (red blood cell transfusions are allowed to increase the Hb at the discretion of the investigator) - neutrophils \< 1,5 109/L -platelets \<100\*109/L),
* Liver enzyme elevation (bili \> 1,5\*ULN - ASAT \> 2,5\*ULN - ALAT \> 2,5\*ULN) or
* Impaired renal function (creatinine clearance by cockcroft \< 60 cc/min)
* Proteinuria \>1,0gr/24hr
* Tumour stage: M1a and/or tumour length \> 8 cm and/or \> 5 cm radially
* Major surgery within 4 weeks prior to the start of study treatment
* Bleeding disorder
* Known allergy to one of the study drugs used
* Use of any substance known to interfere with the chemotherapy clearance
* Previous radiotherapy to the chest
* Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments
* Uncontrolled angina pectoris; cardiac failure or clinically significant arrhythmias
* Continuous use of immunosuppressive agents
* Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine
* Prior exposure to anti-EGFR targeting agents.
* Hearing loss \> 25 dB under normal
* Neurotoxicity \> CTC grade 1
* Pregnancy or breast feeding
* Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
Comparison Between Standard and Ultrasound Integrated Approach for Risk Stratification of Syncope in the Emergency Department

This is a observational prospective study. For patients presenting to the Emergency Department with loss of consciousness, emergency physicians will be asked to screen the real syncope without an evident and immediate cause for the loss of consciousness (e.g. vasovagal) and/or at least one high risk condition as listed by the European Society of Cardiology in the 2009 Guidelines for the diagnosis and management of syncope (i.e. severe structural or coronary artery disease, clinical or ECG features suggesting arrhythmic syncope, and important co-morbidities).

In case of a real syncope not clearly physiopathologically explained and no high risk conditions, the emergency physician in charge will check risk factors for high risk syncope and categorize again every cases.

A high risk syncope is characterized by at least one high-risk characteristic (based on 2015 "Syncope clinical management in the emergency department consensus"): syncope during exertion, in supine position, with new onset of chest discomfort, palpitations before the loss of consciousness, family history of sudden death, congestive heart failure, aortic stenosis, left ventricular outflow tract disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, left ventricular ejection fraction \<35%, previously documented ventricular arrhythmia, coronary artery disease, congenital heart disease, previous myocardial infarction, pulmonary hypertension, previous ICD implantation, anemia (i.e. Hb \<9 g/dl), lowest systolic blood pressure in the ED \<90 mmHg, sinus bradycardia (\<40 bpm), new (or previously unknown) left bundle branch block, bifascicular block plus a first degree AV block, Brugada ECG pattern, ECG changes consistent with acute ischemia, a new non-sinus rhythm, bifascicular block, and a prolonged QTc (\>450 ms).

Low and intermediate risk syncopes will be enrolled and evaluated using an integrated point-of-care sonographic approach (based on history, physical exam, electrocardiogram, and lung, focus cardiac and venous compression ultrasonography).

After discharge, the risk of patient's syncope will be determined by reviewing the entire medical records.


Eligibility Criteria:
Inclusion Criteria:

* patients evaluated in the Emergency Department for loss of consciousness

Exclusion Criteria:

* identification of cause of loss of consciousness after initial evaluation;
* loss of consciousness classified as high risk syncope.
CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)

This is a Prospective, observational research study for patients with NMOSD under the care of a licensed neurologist. Approximately 800 patients and 35 clinical sites in North America will be recruited to participate with no defined upper limit for either target.

The objective of the registry is to create a cohort of patients with NMOSD. Data collected will be used to prospectively study the natural history of NMOSD, real-word effectiveness and safety of medications used to treat NMOSD, and drug utilization treatment patterns. Additionally, the data will be used to systematically evaluate the burden for patients with NMOSD and the impact of therapies on quality of life. This will be done through real time capture and adjudication of relapses, the standardized collection of patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns.

Personal information is also collected from each consenting registry patient allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of NMOSD for the purposes of clinical, market, or outcomes research. This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and patient adherence.

Consent for additional ad hoc surveys will be solicited which can allow evaluation of additional aspects of the disease impact such as care giver burden or impact of disease on productivity.

Eligibility Criteria:
Inclusion Criteria:

1. Has a diagnosis of NMOSD at the time of enrollment according to the 2015 IPND consensus diagnostic criteria for NMOSD†.
2. Age 18 years or older at the time of enrollment.
3. Willing to provide Personal Information.

Exclusion Criteria:

1. Has had a clinically confirmed NMOSD neuro-episode within the 12 weeks prior to enrollment.
2. Is participating or planning to participate in a double-blind randomized trial for an NMOSD drug. Note: Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.

   * All serology types (APQ4 +/- and MOG +/-) are eligible to enroll in the registry given they meet the 2015 IPND diagnostic criteria.
A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China

The purpose of this study is to demonstrate the performance and safety of the Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.

This study is a multi-center, randomized, prospective single-sample correlational design without controls. Up to 72 subjects will be enrolled in order to have approximately 60 subjects complete the study. Three investigational centers in China will be used during this study.

Each subject will wear the following devices:

• Two Enlite Sensors each connected to an iPro2 for approximately 6 days

Sensor Location:

• The 2 Enlite Sensors will be worn in the abdomen area. Investigational center staff will insert sensors and connect to the iPro2s.

During the study, each subject will be randomized and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6).

During the study, subjects will continue with their current diabetes regimen independent of the study devices. Subjects will be instructed by the investigational center that they are not to use the study devices (except for the study meter) for the management of their diabetes. The Study Meter may be used for treatment decisions and calibration of Enlite Sensor.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 14 - 75 years of age at time of screening
2. Subject has a clinical diagnosis of type 1 or 2 diabetes as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
3. Subject has adequate venous access as assessed by investigator or appropriate staff
4. Subject is willing to follow the study procedures and willing to come to study visits.
5. Subject is willing to perform at least 4 self-monitoring of blood glucose (SMBG) per day for 6 days

Exclusion Criteria:

1. Subject will not tolerate tape adhesive in the area of Enlite Sensor placement as assessed by qualified individual.
2. Subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, Staphylococcus infection)
3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
4. Subject is female and has a positive pregnancy screening test
5. Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator
6. Subject is female and plans to become pregnant during the course of the study
7. Subject has a hematocrit (Hct) lower than the normal reference range
8. Subject may not be on the research staff of those performing this study
Remotely Supervised tDCS for Slowing ALS Disease Progression

Most ALS care is centered on patient support and symptom management, making rehabilitation an integral aspect for slowing disease progression, prolonging life span, and increasing quality of life. Brain stimulation has been increasingly explored as a promising neuromodulatory tool to prime motor function in several neurological disorders. We propose a novel mechanism using remotely supervised brain stimulation to preserve motor function in individuals with ALS. This project will also aim to explore the effectiveness of brain stimulation on upper and lower motor neuron mechanisms in individuals with ALS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of possible, probable, or definite amyotrophic lateral sclerosis according to El Escorial revised criteria
* Spinal onset ALS with initial weakness in the upper or lower extremity.
* Diagnosed with ALS within the past 5 years
* 1-2 point change in pre-slope of the ALSFRS-R at time of enrollment (ratio of drop in score from 48 to the duration in months from onset of weakness)
* Score ≥ 2 for "swallowing" of the ALSFRS-R
* Score ≥ 2 for "walking" of the ALSFRS-R
* Able to provide informed consent
* Stable dose of riluzole, edaravone, AMX0035 (Relyvrio) or no medications
* Availability of a caregiver for remote administration of tDCS

Exclusion Criteria:

* Subject has bulbar onset ALS
* Any neurological diagnosis other than ALS
* Psychiatric disorders
* Any other concomitant disease that affects prognosis of ALS inclusive of systemic disease, cardiovascular disease, hepatic or renal disorder
* Tracheostomal or noninvasive ventilation for more than 12 hours per day
* Enrollment in an on-going ALS pharmaceutical trial
* Subject plans on moving within 6 months.

TMS Exclusion Criteria:

* Implanted cardiac pacemaker
* Metal implants in the head or face
* Unexplained, recurring headaches
* History of seizures or epilepsy
* Currently under medication that could increase motor excitability and lower seizure threshold
* Skull abnormalities or fractures
* Concussion within the last 6 months
* Currently pregnant
* tDCS Exclusion Criteria:
* Skin hypersensitivity
* History of contact dermatitis
* History of allodynia and/or hyperalgesia
* Any other skin or scalp condition that could be aggravated by tDCS