cyrilzakka/clinical-trials huggingface dataset:
Fiberoptic Endoscopic Evaluation of Swallowing(FEES) in Infants Graduated From (NICU) Neonatal Intensive Care Unite

Based on study showing the ability of using FEES in infant in NICU; so the aim of this study to screen the newborns graduated from NICU using clinical bed side evaluation as well as flexible endoscopic assessment of swallowing to identify the ones suffering from oropharyngeal and / or esophageal dysphagia as well as newborns at risk for aspiration \&aspiration pneumonia to tailor or identify appropriate feeding plan for those high risk popularities and support them

* Population study\& disease condition Newborns that are discharged from NICU and are hemodynamically stable.
* Interventions The following study will be conducted in neonatal intensive care unit of Kasr alany and Abu EI-Rish hospital, also conducted in Phoniatrics Outpatient of Kasr alany, Cairo university This study will recruit 75 preterm and 75 fullterm will be recruited in this study; all will be hemodynamically stable on discharge

Eligibility Criteria:
Inclusion Criteria:

* Item

  * Neonates who discharged from NICU as they are hemodynamic stable

Exclusion Criteria:

* Item

  * Neonates with congenital anomalies that interfere with the introduction or the procedure of FEES as nasal deformities, choanal atresia, cleft lip and cleft palate.
  * Neonates have liver disease and/ or bleeding tendency
Pivotal Test: WB001

The purpose of the present randomized controlled study is to investigate if there is a difference in postpartum depression symptoms among participants assigned to :

1. an automated conversational agent based on the most researched and scientifically validated psychotherapies, primarily Cognitive Behavioral Therapy (CBT), and accessible via an iOS and Android application, or to
2. a comparison condition without CBT and conversation, though still delivered in an interactive smartphone application that is accessible anytime of day.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45 years who had onset of a major depressive episode within the third trimester of pregnancy or within 4 weeks following delivery as measured by the MINI (Mini International Neuropsychiatric Interview).
* Current mild-moderate depression as measured by the HAM-D (HAM-D score\>13 and \<24)
* Women were \</= to 6 months postpartum at the time of screening
* Owns a smartphone (Anrdroid or iOS smartphone with a recent, supported operating system)
* Available and committed to engage with the program and complete assessments for a 3-month duration
* Able to read and write in English
* U.S. resident

Exclusion Criteria:

* HAM-D score ≥ 24 (severe depression)
* Active psychosis
* Suicidal attempt or ideation with a plan and intent to harm oneself during the current episode of PPD
* History of (a) drug and/or alcohol abuse within the past 12 months (determined by self-report)
* Current pregnancy or plans to become pregnant within the next 4 months
* Fetal demise within the past 24 months
* Previous Woebot user
Evaluation of the Use of Machine Learning Techniques to Classify Neurodegenerative PARKinsonian Syndromes (Artificial Intelligence)

The diagnosis of Parkinson's disease (PD) relies mainly on clinical observation of the patient, looking for the three characteristic symptoms and sometimes remains a real challenge. Machine Learning (ML) algorithms could help to diagnose PD early and differentiate idiopathic PD from atypical Parkinsonian syndromes.

In this context, the work of Castillo-Barnes' team provided a set of imaging features based on morphological characteristics extracted from DaTSCAN® or Ioflupane (iodine-123-labeled radiopharmaceutical) single-photon emission computed tomography (SPECT) scans to discern healthy participants from participants with Parkinson's disease in a balanced set of SPECTs from the "Parkinson's Progression Markers Initiative" (PPMI) data base.

The team of a study evaluated the classification performance of Parkinson's patients and normal controls when semi-quantitative indicators and shape features obtained on the dopamine transporter (DAT) by Ioflupane (123I-IP) single-photon emission computed tomography (SPECT) are combined as a machine learning (ML) feature.

Artificial Intelligence (AI) based methods can improve diagnostic assessments. Several dopaminergic imaging studies using Artificial have reported accuracy of up to 90% for the diagnosis of PD.

These automated approaches use machine learning methods, based on textural analyses, to (i) differentiate PD and healthy subjects, (ii) differentiate PD and vascular parkinsonism, and (iii) distinguish between different forms of atypical parkinsonism.

A study conducted in 2 centers using a linear support vector machine (SVM) model discriminated patients with PD and healthy subjects with an accuracy of 82.5%.This performance is similar to visual assessment by nuclear physicians A linear SVM model based on voxel values of statistical parametric images was able to differentiate PD from vascular parkinsonism with an accuracy of 90.4%. The Nancy team has extensive experience in the detection of PD in SPECT and SPECT/CT scans with Ioflupane or DaTSCAN™


Eligibility Criteria:
Inclusion Criteria:

* Patients who performed a DaTSCAN SPECT scan in the nuclear medicine department of the Nancy CHRU between 21/11/2011 and 01/09/2017.
* Reviews that took place between 11/21/2011 and 9/1/2017 were repatriated from PACS to the processing consoles.
Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Severe hypoglycemia can be dangerous and debilitating and can also impact cognitive function. At the moment no medical therapies have been developed for this disorder. Determining why some but not other patients develop this condition would allow for improved prediction, prevention, and treatment approaches. The purpose of the study is to understand the physiological changes observed in those patients who undergo gastric bypass and develop symptomatic hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18-70 years of age
* Post-bariatric surgery more than 6 months prior to signing the informed consent (not required for non-surgical controls)
* Documented history of hyperinsulinemic hypoglycemia (not required for post-bariatric and non-surgical controls)

Exclusion Criteria:

* Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.
* Participation in any clinical investigation within 4 weeks prior to dosing
* History of or current insulinoma
* Active infection or significant acute illness within 2 weeks prior to dosing
* Female patients who are pregnant or lactating
* Women of childbearing potential and not utilizing effective contraceptive methods
* Inadequate end organ function as defined by: Serum creatinine \>2.0 mg/dL, alanine transaminase (ALT) and aspartate aminotransferase (AST) \> 2 x Upper Normal Limit
* Allergy to test meal or medications used in the study
The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy

The aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.

A randomized controlled study on the effect of mandala application on cancer related fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy has not been found in the literature.

The aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Conscious and no communication problems
* Being literate
* Having a cancer diagnosis
* Receiving chemotherapy treatment (planned to continue treatment for 8 more weeks)
* Willing to participate in our study voluntarily

Exclusion Criteria:

* Not being willing to participate in the research
* Desire to leave the study at any time
* Deterioration of compliance with the working criteria during the time of the study,
* Those who do not participate in up to four mandala applications during the study period
* Those who cannot use a pen
* Those with a diagnosis of psychiatric and neurological disease
* Patients who are scheduled for drug intervention, radiotherapy, surgery other than chemotherapy within 8 weeks
Psychotherapy (Accelerated Resolution Therapy) for Cancer Related Trauma and Distress

This trial studies whether a form of psychotherapy called accelerated resolution therapy can help with cancer distress and psychological trauma. Accelerated resolution therapy is an evidence-based therapy for the treatment of depressive symptoms, trauma, and stress-related disorders. This study may provide evidence to support integration of accelerated resolution therapy into psychological treatment of cancer patients, which may decrease cancer related trauma and distress.

PRIMARY OBJECTIVES:

I. Calculate changes, and estimate mean changes, in primary outcomes of psychological trauma and cancer distress over a six week time period while receiving weekly accelerated resolution therapy (ART).

II. Calculate changes, and estimate mean changes, in secondary outcomes of anxiety and depression over a six week period while receiving weekly ART.

III. Will use a qualitative, descriptive design to explore contextual elements of the cancer experience that are consistently distressing and/or psychologically traumatic to more fully inform a future RCT testing in ART in cancer distress and psychological trauma.

IV. Calculate changes, and estimate mean changes, in secondary outcomes of resilience and symptom distress over a six week period while receiving weekly ART.

OUTLINE:

Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.

After completion of study intervention, patients are followed up at 1 week and again at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, write and understand English
* Undergone chemotherapy, radiation therapy, chimeric antigen receptor T cells (CAR-T), or bone marrow transplant for a cancer diagnosis within the previous 3 years or have metastatic cancer
* A mean score of at least 1.1 on the Cancer and Treatment Distress (CTxD) or at least one item rated at a 3 (often true) or 4 (nearly all the time)
* A minimum score of 3 on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)
* Denial of suicidal ideation or intent, with no evidence of psychotic behavior
* Participants must be willing and able to utilize secure web conferencing software, phone calls, or to travel to Mayo Clinic outside of normally scheduled visits to participate in the study
Drug Screening of Pancreatic Cancer Organoids Developed From EUS-FNA Guided Biopsy Tissues

We are going to establish "organoid" models from pancreatic cancer biopsies achieved via EUS-FNA. Then the sensitivity of the selected FDA-approved anti-cancer drugs will be tested in these organoids.

The survival rate of pancreatic cancer, a kind of malignant tumor, remains poor due to lack of effective treatments. Recently, a new model called "organoid" has been generated from human and murine pancreatic cancer tissues. These organoids are developed from large pieces of surgical tissues or small biopsies taken from EUS-FNA guided samples. Here in our study we are going to establish "organoid" models from pancreatic cancer biopsies achieved via EUS-FNA. After successful generation of these organoids, we will treat them with the selected FDA-approved anti-cancer drugs, and assess the responses to these anti-cancer agents in our established organoids.

Eligibility Criteria:
Inclusion Criteria:

* 1) Patients suspected to have pancreatic cancer who will receive EUS-FNA for diagnosis; 2) Patients who have signed the informed consent.

Exclusion Criteria:

* 1) Those who are under the age of 18; 2) Patients who have received adjuvant chemoradiotherapies or other anti-tumor therapies; 3) Patients with critical illness and cannot tolerate the operations; 4) Women who have been pregnant or are planning to be pregnant.
Maximal Distance for Successful Supraclavicular Block

The achievement of peripheral nerve block requires several needle passes, with each of them being at risk of causing nerve injury either by direct trauma or intraneural injection even with the use of the ultrasound.

The ultrasound guided supraclavicular brachial plexus block is known to be at risk of pneumothorax and / or nerve injury.

This study is designed to determine the maximal effective distance away from the nerve for the injection to be effective.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III
* 18-85 years of age, inclusive
* surgery less than 3 hours

Exclusion Criteria:

* contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
* existing neurological deficit in the area to be blocked
* pregnancy
* history of neck surgery or radiotherapy
* inability to understand the informed consent and demands of the study
Pharmacokinetics/Pharmacodynamics (PK/PD) Characteristics of Tolvaptan Tablet in Korean Healthy Male

To investigate the safety, tolerance, pharmacokinetics and pharmacodynamics of tolvaptan 15, 30 and 60 mg after single oral administration in healthy Korean male subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Korean male subjects between 20 and 45 years of age, inclusive.
2. Body Mass Index (BMI) of 20 to 26 kg/m2, body,weight ≥ 50kg BMI = weight (kg)/height2(m)
3. Informed consent from the subjects

Exclusion Criteria:

1. Clinically significant abnormality of respiratory, cardiovascular, hepatic, neurologic, endocrine, hematologic, urinary, psychiatric.
2. History of gastrointestinal disease or surgery which can affect intestinal absorption of the study drug.
3. History of any significant drug allergy or hypersensitivity.
4. AST or ALT \> 1.25 times upper normal limit at screening clinical laboratory test
5. Supine blood pressure after resting for ≥ 3 minutes, higher than 140/90 mmHg or lower than 100/50 mmHg, Supine pulse, after resting for ≥ 3 minutes, outside the range of 40 to 90 beats/minute.
6. Subjects who had history of drug abuse or alcohol addiction
7. Subjects who used of any prescription drug or herbal medication within 2 weeks prior to the first dosing of the study drug, or any over-the-counter or vitamin supplements within 1 week prior to the first dosing (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied)
8. The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons.
RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).

The study consisted of a screening period (screening and randomization could occur up to 3 days before the administration of the first investigational treatment), followed by a treatment and follow-up period (Day 1 to Day 169).

Eligibility Criteria:
Inclusion Criteria:

* preterm infants with a birth weight of less than 1500 g
* bilateral ROP with one of the following retinal findings in each eye: Zone I, stage 1+, 2+, 3 or 3+ disease, or Zone II, stage 3+ disease, or Aggressive posterior retinopathy of prematurity (AP-ROP)

Exclusion Criteria:

* ROP disease characteristic in either eye other than that listed above at the time of the first investigational treatment
* A history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes
* Had received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
* Had been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
* Had used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever was longer
* Had ocular structural abnormalities that were assessed by the Investigator to have had a clinically significant impact on study assessments
* Had active ocular infection within 5 days before or on the day of first investigational treatment
* Had a history of hydrocephalus requiring treatment
* Had a history of any other neurological conditions that are assessed by the Investigator to have a significant risk of severe impact on visual function
* Had any other medical conditions or clinically significant comorbidities or personal circumstances that were assessed by the Investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments (e.g., poor life expectancy, pupil not able to be adequately dilated, unable to comply with the visit schedule)
Safety and Efficacy Study of Mix Vaccine in Hepatocyte Carcinoma Patient

The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.

In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression.

Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hepatocyte carcinoma based on histology
* Evaluable lesions on imaging study
* Without known immunodeficiency
* Age \>18 and \<80 years ago

Exclusion Criteria:

* Patients is unable or unwilling to sign informed consent
* Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
* Positive HIV and/or RPR (rapid plasma reagin)
* Female patient who is pregnant or breast feeding
* Patients, based on the opinion pf the investigator, should not be enrolled into this study
* Prior anti-cancer vaccine or biological immunotherapy
* Allergic to any known ingredient of the MV compound
Volunteers Adding Life in Dementia

The objectives of our project are to: 1.) Develop a training program and manual for volunteers to implement evidence-based, non-pharmacological interventions for neuropsychiatric symptoms (NPS) of dementia in long-term care (LTC) settings; 2.) Recruit and train volunteers using the VALID program and pilot test the volunteer-led program with 20 individuals with Alzheimer's disease and NPS in a LTC facility in Kingston; and, 3.) Evaluate the effects of the VALID program on the symptoms of NPS, patient quality of life, volunteer's experience, and LTC staff stress.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Alzheimer's disease or related forms of dementia
* significant symptoms of agitation as measured by a Cohen-Mansfield Agitation Inventory (CMAI) total score of \>39
* in nursing home for at least 30 days
* presence of a caregiver or substitute decision maker willing to consent to treatment
* no changes in psychotropic medications in the 2 weeks preceding enrolment in study

Exclusion Criteria:

* depressive symptoms presenting risk
* physically aggressive behavior posing safety risk to others
* uncontrolled pain
* currently receiving palliative care
* medically unstable with life expectancy of \< 6 months
* currently awaiting transfer to another LTC facility or hospital.
Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris

Ultra-violet light B (UVB) therapy has been used by dermatologists to treat psoriasis for decades. Only a few studies have begun to dissect the mechanism of how NB-UVB therapy causes lesion resolution. Results from this study will aid in identifying other diseases that may be treated successfully with NB-UVB. If we can identify the mechanism of action of this therapy, this may give us additional new therapeutic targets for psoriasis and other diseases. Our overall hypothesis is that UVB induces changes that will indicate a mechanism of action of this therapy in psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* History of chronic plaque psoriasis vulgaris, for at least six months.
* ≥10% body surface affected
* Age 18 or greater.
* Concomitant, chronic, but well-controlled medical conditions such as hypertension are allowable.
* No treatment with topical steroids for at least 2 weeks prior to entering the study
* No treatment with systemic therapies, including etretinate, UVB, PUVA, or cyclosporine, other biologics 4 weeks prior to entering the study. However, if a patient is considered to be "unstable", or would deteriorate clinically if the systemic agent is ceased (eg efalizumab), a shorter "washout" period may be considered, and would be documented in the patient charts.
* Patients who receive a stable dose of methotrexate (defined as \<15mg/week for 4 months or greater) for psoriatic arthritis may be included.

Exclusion Criteria:

* Subjects who do not meet the above criteria, or who meet any of the following criteria:

  * Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis.
  * PHOTOSENSITIVITY: Hypersensitivity to sunlight or UVB light of any type; history of Lupus, PMLE, or any disease known to be worsened by UV light exposure
  * A history of non-melanoma skin cancer may be acceptable, and in this situation, the patient will be carefully evaluated.
  * Poorly controlled medical conditions of any kind.
  * Any medical condition that, in the opinion of the Investigator, would jeopardize the health or well being of the patient during the course of this study.