cyrilzakka/clinical-trials huggingface dataset:
Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients

The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface reconstruction in cases of partial and sever limbal stem cell deficiency.

Ocular surface is composed of corneal and conjunctival epithelial cells. Normal cornea is essential for normal vision. Defects in renewal and repair of ocular surface as a result of limbal stem cell deficiency are now known to cause varying ocular surface morbidity including persistent photophobia, repeated and persistent surface breakdown and overt conjunctivalisation of the cornea. Restoring ocular health in these eyes has traditionally been frustrating. Ex vivo cultured limbal epithelial stem cells have been used successfully to treat limbal stem cell deficiency. Ex-vivo limbal stem cell allograft transplantation is achieved by harvesting limbal corneal tissue from donor eyes (either matched living relatives or cadaveric donors). The donor stem cells are obtained by excising a small area of the conjunctiva at the limbus and are a minor procedure. The tissue so obtained is then grown in tissue culture and once the cells have multiplied sufficiently, small sheets are transplanted on to the affected eye(s), backed with an amniotic membrane. The surgery is undertaken under either local or general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patient with unilateral limbal stem cell insufficiency and totally corneal vascularization
* Presence of Goblet cells on the cornea
* Minimum tear was about 5 mm
* Minimum duration of deficiency was 3 years
* Vision was Light Perception

Exclusion Criteria:

* Systemic disease affecting both eyes such as Stevens-Johnson syndrome
Functional Respiratory Imaging of Airways in ARDS

This is a prospective single-center cohort trial to compare regional bronchial recruitment, bronchial distention and alveolar recruitment in 6 patients with acute respiratory distress syndrome (ARDS). The investigators used CT scan images as the imaging modality, and the subjects were scanned on end-expiratory lung volume with different positive end-expiratory pressures. Those images were post-processed to evaluate the airways.


Eligibility Criteria:
Inclusion Criteria:

* mechanically ventilated
* moderate or severe ARDS, as defined by the Berlin criteria

Exclusion Criteria:

* pregnancy
* hemodynamic instability
* obesity (BMI \>30)
US National OCS Heart Perfusion (OHP) Registry

This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.

The objective of this US National OHP Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and to document the performance of the OCS Heart device in the real-world setting after FDA approval in the US.

The US National OHP Registry will enroll all heart transplant recipients who are transplanted with an OCS-perfused donor heart in the Registry. Patients' clinical outcomes will be followed up to five years post-transplant, loss to follow up, or death, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* N/A

Exclusion Criteria:

* N/A
Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.

Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.

Open-label, Randomized, 3-period, 6-sequence, crossover study

Eligibility Criteria:
Inclusion Criteria:

1. Between 20 aged and 45 aged in healthy male adult
2. Body weight ≥ 50kg and in the range of calculated BMI(Body Mass Index) 18\~29kg/m2
3. Subject who sign on an informed consent form willingly
4. Necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products

Exclusion Criteria:

1. Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system
2. Have a acute disease within 28 days before the beginning of study treatment
3. Have a disease history that can effect drug absorption, distribution, metabolism, excretion
4. Have a clinically significant chronic disease
5. Systolic blood pressure \<100mmHg or \>140mmHg, diastolic blood pressure\<60mmHg or \>90mmHg
6. Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))
7. Subject treated ethical drug within 14 days before the beginning of study treatment
8. Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment
9. Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)
10. Cannot take standard Meal
11. Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing
12. Blood transfusion within 30 days
13. Taking drugs have received any other investigational drug within 90 days prior to the first dosing
14. Continuously taking caffeine(\>5 cups/day), drinking alcohol(\>30g/day), smoking excessive cigarettes(\>10cigarettes/day)
15. Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasone(for example, noncompliance, a disobliging manner)
16. Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days
Evaluating Attitudes Towards Organ Donation in Singapore

One survey is conducted. Exploring the effect of different messages on family members' decision making on organ donation.

The investigators intend to examine the impact of nudging interventions in the form of a vignette designed to emulate the standard procedure of informing family members of a loved one's unfavourable prognosis. The investigators intend to examine the effect of the interventions on the eventual decision-making process of the family member.

Eligibility Criteria:
Inclusion Criteria:

* Above age 21
* Singapore Citizens and Permanent Residents

Exclusion Criteria:

* Below age 21
* Non-citizens
* Not able to make decisions for self
Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department with Suicide Related Behaviour

Suicide is the leading cause of death due to illness among Canadian youth, claiming more lives than any medical illness, including cancer. Suicide prevention is possible, and early intervention is needed. The investigators will examine the effectiveness of a previously-piloted, ED-based suicide prevention intervention, across Canadian sites, using a randomized clinical trial design. The investigators will determine whether the patient- and family-centered intervention is more effective than enhanced usual care in reducing suicide-related behaviors in 330 youth at high-risk of suicide.

This is a Multi-site Randomized Controlled Trial of a patient- and family-centered suicide prevention intervention added to usual care (SAFE + UC) for adolescents aged 12 to 17 years who present to the Emergency Department (ED) with suicidal ideation or suicide risk behaviours. The investigators will determine whether the SAFE + UC intervention is more effective than enhanced usual care (telephone navigation + UC) in reducing suicide-related behaviors in 330 youth at high-risk of suicide across Canadian sites.

SAFE + UC is a 6-week, standardized, manualized outpatient program that teaches participants to the skills to manage suicidal thoughts and impulses effectively. The family component addresses conflictual relationships that may be present in the family as well as improving family communication.

Telephone navigation (NAV) + UC consists of up to 6 weekly telephone calls to ensure that the participant has connected with community resources suggested by the ED team and provide additional resources as needed.

Eligibility Criteria:
Inclusion Criteria:

* Youth presenting in the Emergency Department with SIQ-Jr score ≥ 31,
* Has a participating parent or caregiver who is able to communicate easily in English, or is willing to communicate using a hospital-organized translator,
* Between the ages 12-17 years old,
* Living in the catchment area of one of the three hospital sites and access to a telephone.

Exclusion Criteria:

* Score of 3 on KSADS screen for current psychosis or elevated mood
* Moderate to severe intellectual disability, and/or autism based on clinical chart.
Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics (exposure in the body) of liraglutide-depot in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 20 and 35 kg/m\^2 (both inclusive) with a body weight of at least 60 kg
* Apart from being obese (BMI above 30 kg/m\^2) the subject has to be considered generally healthy

Exclusion Criteria:

* Medical history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
* Clinical or laboratory findings which suggest that the subject cannot be considered generally healthy
* Prescription medicine and non-prescription medicine with few exceptions
* Current and prior history of alcohol or drug abuse
* Current smoking of more than 5 cigarettes per day
* Mental incapacity, language barriers, or unwillingness to comply with the protocol
To Assess the Utility of the Point Digit in a Clinical Take-home Study

This study will allow us to assess whether the Point Digit confers functional and psychological benefit to persons with partial hand amputations in an unconstrained environment. The use of the Point Digit outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.


Eligibility Criteria:
Inclusion Criteria:

* Partial hand amputees with absence of index and/or middle fingers and presence of thumb. Additional finger loss is acceptable if all other criterion are met.
* Fluent in English
* Individuals aged 18 or greater

Exclusion Criteria:

* Significant cognitive deficits as determined upon clinical evaluation
* Significant neurological deficits as determined upon clinical evaluation
* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
* Uncontrolled pain or phantom pain impacting full participation in the study as determined upon occupational therapist evaluation
* Serious uncontrolled medical problems as judged by the project therapist.
Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

This study will examine hormonal differences in ghrelin and growth hormone in obese and normal weight adolescents and their relationship to body composition and insulin resistance. The study will also investigate the effect of the macronutrient composition of a meal on postprandial ghrelin levels and whether ghrelin responses will predict the degree of hunger and caloric intake at a subsequent meal.

Obesity is an epidemic that is striking people at younger ages than ever before. Obesity is associated with changes in the secretory patterns of several hormones including ghrelin, growth hormone (GH), and insulin, which have not been examined in the adolescent age group. Ghrelin, a primarily gastric hormone, increases appetite and is a GH secretagogue. This study will compare the alteration in secretion of ghrelin and GH in overweight and normal weight adolescent girls through frequent blood sampling and GH stimulation testing with growth hormone releasing hormone and arginine. The relationship between these hormones and insulin resistance, measured by 1H-nuclear magnetic resonance spectroscopy, and body composition, measured by dual energy x-ray absorptiometry and magnetic resonance imaging, will be investigated. This study will also determine the postprandial ghrelin response to test meals that vary by the type of predominant macronutrient, which may predict the degree of hunger and amount of intake at a subsequent meal. Understanding obesity-related changes in ghrelin and GH and their relationship to body composition, insulin resistance, and appetite will help in the development of strategies to reduce complications of obesity.

Eligibility Criteria:
Inclusion Criteria:

1. Girls 12-18 years of age
2. Obese subjects: BMI higher than the 95th percentile for age and sex
3. Normal-weight controls: BMI from the 15th to the 85th percentiles for age and sex

Exclusion Criteria:

1. History of disorders other than obesity that may affect growth hormone, ghrelin, cortisol, or insulin secretion such as eating disorder, diabetes mellitus, hypertension, thyroid disease, Cushing's syndrome, liver disease, renal failure, or an excess or deficiency of GH or cortisol
2. Medications that could affect glucose and lipid levels or the secretion of growth hormone, ghrelin, insulin, or cortisol such as rhGH, glucocorticoids, and birth control pills
3. Pregnancy
4. Smoking or substance abuse
5. Active dieting
6. Surgical procedures for obesity
7. Dietary restrictions such as bread, dairy, peanut, aspartame, or meat products used in the study
8. Metal implants, including intracranial surgical clips or pacemakers
Protein and RNA Expression Patterns in Predicting Response to Treatment in Patients With Lung Cancer

RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA) and may also identify protein expression patterns related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study evaluates changes in DNA, RNA, and proteins with the goal of predicting response to treatment in patients with lung cancer.

OBJECTIVES:

* To determine protein and/or RNA expression patterns capable of predicting tumor response to therapy in tumor tissue samples from patients with lung cancer or suspected of having lung cancer.
* To characterize the genes and proteins found to be predictive of response in order to help elucidate the molecular biology underlying cancer chemosensitivity.
* To evaluate DNA mutations found within the lung cancer sample which may be predictive of response or resistance to certain therapeutic agents.

OUTLINE: Patients undergo collection of tumor tissue by percutaneous fine needle aspiration, core biopsy, thoracentesis, or during any medically indicated procedure involving removal of lung cancer tissue. Tissue samples are analyzed by a variety of techniques, including DNA sequencing, RNA sequencing and expression levels, protein assessment \[by immunohistochemistry, western blot, Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-MS\]). The goal of these studies is to identify of gene mutations, gene expression levels, and proteins predictive of treatment response. Blood samples are also collected to obtain normal DNA for analysis.

After completion of study, patients will be followed until their death.

Eligibility Criteria:
Inclusion criteria

* Diagnosis of suspected lung cancer or lung cancer

Exclusion criteria

* Inability to undergo therapy
Costs of Care and Adherence to Treatment for Cystic Fibrosis

Evolution of medical care for patients with cystic fibrosis appeared in recent years: prolongation of life expectancy with consequently increased comorbidities and the use of lung transplantation, systematic neonatal screening of new born since 2002, prescription of expensive new molecules or new presentation. This evolution justifies to realize an update of statistics of costs of care and to assess adherence to treatment


Eligibility Criteria:
Inclusion Criteria:

* Patients with cystic fibrosis,
* Followed by one of the cystic fibrosis center of the Rhône-Alpes region (pediatric and adult of Lyon and Grenoble)
* Affiliated to the general scheme of health insurance,
* And domiciled in the Rhône-Alpes region.

Exclusion Criteria:

* Transplanted patients
Vibration for Pain Reduction During Trigger Point Injection

The aim of this study is to evaluate the effects of vibration anesthesia for reducing pain induced by trigger point injection of gastrocnemius.

Sixty patients were randomized into the vibration or placebo group. In vibration groups, vibrator head was applied (100Hz) on the popliteal fossa, during the trigger point injection. In placebo group, same vibrator head was applied with switch-off sate. Then, a visual analog scale to evaluate the pain of trigger point injection and a five-point Likert scale for patients satisfaction were compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have the trigger point in the gastrocnemius and show referred pain.

Exclusion Criteria:

* Those with prior history of trigger point injection
* Those with taking anti-platelet agent
* Those with hemorrhage tendency
* Pregnancy
* Acute infection
* those who were unable to understand a visual analog scale (VAS) or a Likert scale
A Study to Explore Prognoses of NSCLC Patients Complicated With Oligometastases

An observational study to explore prognoses and clinical treatments of the patients with non-small cell lung cancer complicated with oligometastases

A multi-centre real-world non-interventional observational study to explore prognoses and clinical treatments of the patients with non-small lung cancer complicated with oligometastases

Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed patients with non-small cell lung cancer;
* Tumor metastases in one organ (no more than 3 metastases);

Exclusion Criteria:

* Patients with intrapulmonary metastases or multiple primary tumors;
* Patients with pleural dissemination or invasion of extrapulmonary organs;
* Patients with supraclavicular lymph node metastasis;
* Patients with systematic diseases that would influence patient survivals;
* Patients with no records for visits;
Prevention of Insomnia in At-risk Youth

This study aims to conduct a randomized controlled trial in comparing cognitive behavioral insomnia prevention program with the active control group in youths who are at risk of insomnia. The results of this study will allow us to take this potential efficacious prevention program to scale and reduce the associated burden of insomnia in the future.

Adolescence is a vulnerable period for the emergence of insomnia, which affects more than 10% of the youths (approximately 40% if based on symptoms). Insomnia in youths tends to run a protracted course and is associated with numerous negative outcomes including poor quality of life, cognitive and academic impairment, and predisposing to development of depression and anxiety. The burden arises from insomnia has been increasingly recognized worldwide as a debilitating and costly public health concern.

However, insomnia in youths is often ignored and under-treated, with only 10% of the local youths recognized their insomnia problem and none of them has received the recommended first-line treatment - cognitive behavioral therapy for insomnia (CBT-I). Given the high prevalence, chronicity and long-lasting health-related consequences of insomnia, together with the delay and limited help-seeking behavior, it calls the urgent need for early insomnia prevention and intervention in this vulnerable population.

Thus, this study aims to conduct a randomized controlled trial in comparing cognitive behavioral insomnia prevention program with the active control group in youths who are at risk of insomnia and to explore the effect of prevention program in preventing the incidence of insomnia problems.

Eligibility Criteria:
Inclusion Criteria:

* Youth aged between 15-24 years (as defined by WHO);
* Written informed consent of participation into the study is given by youth and his/her parents if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old;
* Have subclinical insomnia symptoms (at least once a month but less than 3 times/week in the past one month);
* At least one of the biological parents with current or lifetime history of insomnia disorder as defined by DSM-V diagnostic criteria.

Exclusion Criteria:

* A current or past history of neuropsychiatric disorder(s);
* A prominent medical condition or taking medication with potential side effects that may influence sleep quantity and quality;
* Having a diagnosed sleep disorder that may potentially contribute to the disruption of sleep quantity and quality as ascertained by both Structured Diagnostic Interview for Sleep patterns and Disorders (DISP) such as insomnia, delayed sleep phase and narcolepsy, restless leg syndrome;
* Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
* Currently receiving any structured psychotherapy;
* With hearing or speech deficit;
* Trans-meridian flight in the past 3 months and during the study.
Magnetic Resonance Imaging to Detect Signs of Viral Pneumonia in Patients With Coronavirus Infection.

Since the onset of the COVID-19 pandemic, the importance of chest computed tomography (CT) in detecting signs of viral pneumonia has become clear from the literature. However, the increased patient flow creates an additional pressure on CT centers. We believe, the use of chest magnetic resonance imaging (MRI) can help to test patients for CОVID-19 when CT scan is not available. Lung MRI may be useful in routing a patient in a difficult epidemiological situation.

Currently, with increased load of CT studies, alternative methods of viral pneumonia signs' visualization are required.

Investigators hypothesize that chest MRI could be a test for detecting pulmonary features of COVID-19. They consider using MRI to assess COVID-19 viral pneumonia. Absence of radiation exposure to patients is a clear advantage of MRI.

This is a prospective, observational cohort study assessing patients with suspected COVID-19. It's primary goal is to determine the ability of multiparametric MRI to detect lung abnormalities - ground-glass opacity (GGO), consolidation, "crazy paving" pattern, pleuritis - in comparison to CT scan. In this study each patient with suspected pneumonia will sequentially undergo both chest CT and MRI during his/her visit. Scan protocols will be identical for each patient. Each participants completed an online questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* A referral from the attending physician for a chest CT scan
* Suspected pneumonia
* Signed informed consent
* Over 18 years old

Exclusion Criteria:

* Pregnant or nursing women
* Presence of foreign implanted objects in the body at the scan level (including cardiac pacemakers, spine metalware)