cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis

This will be an interventional safety and efficacy study of CELENT07 when used as a topical treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. This is randomized, double-blind, parallel design, placebo and active controlled study in patients with mild to moderate toenail distal lateral subungual onychomycosis (DLSO) (n=120). Subjects will be randomized (1:1:1) to receive CELENXT07, placebo of CELENXT07 or PENLAC®, daily for 52 weeks. Efficacy assessments will include complete cure, mycologic cure and clinical efficacy and safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible to be included in the study only if they meet all of the following criteria:

1. Age \> 18.
2. Clinically diagnosed onychomycosis of the target nail.
3. Presence of mild to moderate onychomycosis, defined as 20-50% of the area of the target nail being clinically affected.
4. Has a positive KOH examination from the target nail.
5. Has a positive dermatophyte culture from the target nail.
6. Written informed consent obtained.
7. Subject agreed to follow the protocol.

Exclusion Criteria

Subjects will be excluded from the study if they meet any of the following criteria:

1. Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug.
2. Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis.
3. Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit.
4. Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
5. Inability to understand and comply with the instructions of the study
6. Patients less than age 18
7. Individuals with known allergy/hypersensitivity to Thuja occidentalis, Chelidonium majus, Eucalyptus citriodora, Tea tree or Thymus vulgaris.
Liquid Biopsy With PET/CT Versus PET/CT Alone in Diagnosis of Small Lung Nodules

The purpose of this study is to determine if a liquid biopsy, a method of detecting cancer from a blood draw, combined with a PET/CT scan, a type of radiological scan, is better at determining whether a lung nodule is cancerous when compared to a PET/CT scan alone. A PET/CT scan is already used for diagnosis of lung nodules, but its efficacy is uncertain in nodules 6-20 mm in size. Therefore, the PET/CT will be evaluated for its diagnostic ability in lesions this size alone and in combination with a liquid biopsy. Secondarily, a machine learning model will be created to see if the combination of the PET/CT imaging data and the liquid biopsy data can predict the presence of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* ECOG performance status of 0,1, or 2
* Newly discovered lung nodule with:

  1. At least one solid lung nodule measuring 6 mm- 20 mm in greatest diameter detected on screening CT
  2. No single lesion larger than 20 mm in greatest diameter when multiple nodules present
  3. High- or intermediate-risk nodules per American College of Chest Physician (ACCP) guidelines
* Able to provide informed consent

Exclusion Criteria:

* Prior cancer of any type for the previous 3 years
* Prior organ, bone marrow, of hematopoietic stem cell transplant
* Contraindication to administration of \[18F\]FDG
* Inability to undergo a PET/CT scan
* Ongoing infection, either acute or subacute
* Severe COPD or lung disease requiring home oxygen use
* Pregnancy
Metabolic Phenotypes in Melanoma

This is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.

This is a single-centre, correlative study designed to investigate metabolic phenotypes in a longitudinal cohort of patients with melanoma. This study will involve the collection of tissue at the time of surgical excision or biopsy. The key intervention, in a subset of patients, will be to perform peri-operative infusions of a stable isotope, \[U13C\]Glucose. Patients will be intravenously administered sterile, pyrogen-free 13C-glucose, delivered as an 8g bolus followed by infusion of 4g/hour for 2-3 hours. Blood samples will be obtained to monitor glucose and to analyse enrichment of labelled nutrients by gas-chromatography mass spectrometry (GC-MS). At the time of resection or biopsy, tumour samples will be divided and either immediately frozen in liquid nitrogen or processed to form patient-derived xenografts. Frozen tumour samples will be subsequently processed for: isotope enrichment by GC-MS; global metabolomics by liquid-chromatography mass spectrometry (LC-MS); and genomic analyses. Relevant clinical, histologic and genomic features will also be correlated with metabolic findings.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has provided written informed consent
2. Male or female aged 18 years or older at written informed consent
3. Presence of a known melanoma lesion requiring surgical excision or biopsy
4. Patient is willing and able to comply with the protocol for the duration of the study including undergoing biopsies and receiving a stable isotope infusion (where applicable)

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from receiving a \[U-13C\]Glucose infusion:

1. Diabetes mellitus
2. Pregnancy or breast feeding
3. Patients unable to comply with study procedures and follow up in the opinion of the investigator
COntinue the SaMe Systemic Therapy After Local Ablative Therapy for Oligo Progression in Metastatic Breast Cancer - the COSMO Study

Patients with oligoprogression of metastatic breast cancer during palliative treatment that is amenable to local therapy will be included. The local ablative therapy (LAT) may consist of stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy, surgery or radiofrequency ablation (RFA).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast cancer
* Metastatic breast cancer
* Oligoprogression defined as one or two distant metastatic lesions, limited to one organ, or the primary tumor or locoregional lymph nodes, increasing ≥20% in size and be larger than 15 mm or if metabolic activity increases (with 20% in SUVmax) on FDG-PET-CT.
* Systemic treatment can be either endocrine, targeted, chemotherapy or immune-checkpoint blockade
* Patients should be on systemic therapy for at least six months. Status should be stable disease or partial or complete response for at least 6 months.
* Oligoprogression has to be detected with radiological imaging comparing the lesion on the same type of imaging modality as has been used at the start of systemic therapy.
* The radiological imaging that shows progression must be performed within 70days prior to LAT.
* Bone metastases are classified as progressive if the lytic component of the lesion increases by ≥20% or the FDG-uptake increases by ≥20% on FDG-PET-CT
* Oligo-progression has to be confirmed with a FDG-PET-CT-scan 5-7 weeks after the initial scan that showed oligoprogression.
* Lesion(s) must be amenable to resection, radiotherapy or radiofrequency ablation with the intent of local obliteration
* Age ≥18
* World Health Organization (WHO) Performance Status 0 or 1
* Signed written informed consent before patient registration according to ICH/GCP, and national/local regulations

Exclusion Criteria:

* Having received more than two lines of systemic therapy for MBC If a treatment regimen has been de-escalated without adding other therapies, this is seen as one line of therapy. For example: Pertuzumab/trastuzumab+docetaxel followed by pertuzumab/trastuzumab will be viewed as one line of systemic therapy.
* Other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy
* Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection
* Presence of any medical condition that would place the patient at unusual risk, up to the discretion of the clinician
* Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity Using Metabolomics

Identification and evaluation of endogenous markers for the assessment of CYP3A activity using metabolomics.

Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Urine collection is scheduled drug 24 hour before midazolam administration. Subjects will be dosed study drug via intravenous around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests, electrocardiograms and pharmacokinetic samplings. Subjects will be discharged on Day 2, and visited Clinical Trials Center on Day 5-7 for ketoconazole administration. Subjects will be admitted on Day 7 for period 2. Subjects performed scheduled period 2 (ketoconazole co-administration phase), and period 3 (rifampicin co-administration phase) procedure. Study participation was terminated on post-study visit (Day 30-32).

Eligibility Criteria:
Inclusion Criteria:

* Age: Between 20 to 50 years of age, inclusive
* Weight: Between 50 - 95 kg, within 17-28 of Body Mass Index
* Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Exclusion Criteria:

* History of hypersensitive reaction to medication (midazolam, ketoconazole, rifampicin)
* History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease History or evidence of drug abuse
* Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
* Participation in clinical trials of any drug within 60 days prior to the participation of the study
* Judged to be inappropriate for the study by the investigator
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants

The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine.

This trial aims to evaluate the oral adsorption of nepadutant (0.1 or 0.5 mg/Kg given as one single dose as oral solution) in infants divided in three age strata (from 6 to 24 weeks old). Oral absorption is evaluated by measuring the amount of nepadutant in the urine output collected during the 24 hours after oral administration with special diapers.

Safety and tolerability of the drug will be evaluated by monitoring any changes in signs/symptoms at medical examination and vital signs during the fist 4 hours post-dose in the Hospital site and then by the parents at home up to 24 hours and 1 week post nepadutant administration.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible for inclusion in the study if they meet all of the following criteria:

* Infants with a history consistent with a diagnosis of colic or other functional gastrointestinal disorders
* Age \>6 weeks and \< 24 weeks
* At least 44 weeks post-conceptual age at enrolment
* Normal growth
* Informed consent by parents (one or both) or legal guardian
* Caregiver available to be trained in collection and storage of used diapers
* Caregiver available to record feeding episodes and defecations on the diary

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

* Clinical evidence of major cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal (excluding infantile colic and other functional gastrointestinal disorders, unless associated to symptoms which are likely to interfere with drug absorption, e.g. frequent vomiting), haematological, severe dermatological or neurological pathology or other diseases;
* Previous major surgery or blood loss
* Intake of antimuscarinic drugs, simethicone, or dimethicone 24 hours before study treatment administration.
Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair

This study will be comparing the patients overall satisfaction of two different meshes used in laparoscopic inguinal hernia repairs.

This is a clinical trial comparing standard therapy in the use of either lightweight or heavy mesh for the repair of inguinal hernias. Both types of these meshes have been approved for surgical correction but subjective comparisons of patient overall satisfaction and perceived outcomes have not been measured. The investigators intend to measure certain subjective data in the form of a questionnaire will be issued to the patient preoperatively, one week, one month, six months, and one year after the surgery There is no recent literature comparing subjective data between two meshes called Ultra Pro and Surgi Pro. The biological effects of these meshes have identical properties as far as the healing process and inflammation as well as the low rate of infection. The main difference is the material that these meshes are composed of. The Ultra Pro is made of Prolene while the Surgi Pro is made of polypropylene.

The risks are not increased anymore than that for normal surgical complications. They each have the same post operative risks including bleeding, infection and pain, but the investigators are investigating a possible subjective difference between these two separate meshes that are currently used.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 18
* unilateral side to be repaired
* no major abdominal surgery previously

Exclusion Criteria:

* under age 18
* bilateral repairs undertaken
BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension

Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1

Exclusion Criteria:

* Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial
Aggressiveness of Care at the End of Life in Cancer Patients

Cancer is the commonest cause of death in Singapore, and many cancer deaths occur in hospital.

Management of cancer patients is getting more complex with constant development of new drugs, interventional procedures and supportive measures. Despite this, the majority of advanced cancer patients will die from their disease or related complications.

There is a lack of data on the utilisation of health resources in advanced cancer patients in this country. In this study the investigators ask themselves how aggressive care was in the last 3 months of the patient's life. The investigators will be collecting data on specific cancer treatments, interventional procedures, and supportive measures.


Eligibility Criteria:
Inclusion Criteria:

* Advanced cancer patients who passed away as an inpatient in NUH, under the department of Haematology Oncology.

Exclusion Criteria:

* Patients with haematologic malignancies.
To Estimate the Percentage of Children and Adolescents in Tunisia With Acceptably Controlled Diabetes Mellitus Type 1

This study is conducted in Africa. The aim of this study is to estimate the percentage of children and adolescents below or equal to 15 years in Tunisia with acceptably controlled diabetes mellitus type 1.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol).
* Child or adolescent below or equal to 15 years with diabetes mellitus type 1
* Who has been undergoing treatment for diabetes for at least 6 months

Exclusion Criteria:

* Previous participation in this study.
* Current participation to a clinical trial
Cardiac AResT And GENEtic

Sudden death is a major problem in industrially developed countries. Despite a decline in ischemic heart disease mortality and the progress has been made in resuscitation, treatment of sudden death victims is frequently unsuccessful. the ideal solution would be to prevent the disease process that causes the initial episode of cardiac arrest. Parental sudden death is an independent risk factor for sudden death. So, detect a gene predisposing to sudden death may help provide better identification of subjects at high risk of cardiac arrest. This research is a genetic study of sudden cardiac death, recruited 2000 subjects in out-of-hospital cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

* OHCA
* Aged from 18 to 75 years

Exclusion Criteria:

* Pregnant
* People not free
* Inhospital subjects
* Death by other disease
* Violent death
Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing

The project will characterize human gut microbiome response to two different diets and the possible physiological and biochemical implications of such response on cardiometabolic risk factors. The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.

The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.

Eligibility Criteria:
Inclusion Criteria:

* generally good health status based on one routine physical in the past 15 months, current health status
* normal HbA1C, weigh 110 lb or more
* Age 50 years or more, generally healthy, all races and both sexes
* generally practicing a meat-based dietary pattern, do not have any special dietary requirement, and
* willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

Exclusion Criteria:

* medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
* Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight.
* impaired kidney functions
* Active history of cancer, diabetes, heart, liver, and kidney diseases
* major gastrointestinal disorders in the past 3 months
* history of heart attacks or stroke
* Unable to meet in-person visit requirements for dining, picking up meals, and tests
* Any mental health condition that would affect the ability to provide written informed consent.
* If they had not had a routine health checkup during the 12 months prior to recruitment.
* If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverage during the study period.
A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy

To establish a predictive model and scoring system for predicting severe complications after thrombectomy. This scoring system can be used to identify high-risk patients after endovascular thrombectomy, guide the early use of adjunctive interventions, and provide reference for future clinical trials.

Acute ischemic stroke (AIS) accounts for about 80% of all strokes. The focus of AIS treatment is to restore reperfusion of ischemic territory as soon as possible, promote neurological recovery, reduce disability rate and improve long-term survival rate. In recent years, a series of randomized clinical trials have proved that endovascular thrombectomy (EVT) is safe and effective in the treatment of anterior circulation AIS. EVT has been recommend as the first-line treatment for anterior circulation large vessel occlusion (LVO) stroke by guidelines.

Symptomatic intracranial hemorrhage (sICH) and malignant cerebral edema (MCE) are the two most common severe neurological complications, leading to brain tissue hypoxia and neurological dysfunction. Currently, there is a lack of prediction system to identify patients at high risk for severe complications, who can most likely benefit from adjuvant treatment after thrombectomy to improve patient functional independence and survival rate.

Eligibility Criteria:
Inclusion Criteria:

1. Symptoms and signs compatible with ischemia in the anterior circulation
2. Internal carotid artery occlusion or middle cerebral artery M1 and M2 segment occlusion confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA)
3. Premorbid mRS ≤1;
4. National Institutes of Health Stroke Score (NIHSS) ≥6 at admission;
5. Onset to puncture time ≤24h;
6. Treated with thrombectomy resulting in mTICI score ≥2b at end of the procedure.

Exclusion Criteria:

1. Intracranial hemorrhage, aneurysm, and arteriovenous malformation before endovascular thrombectomy;
2. Perioperative complications, including dissection and arterial perforation;
3. Anticipated life expectancy \<3 months;
4. Critical baseline clinical, laboratory and imaging data are missing;
5. Lack of follow-up results within 72 hours and 90 days after thrombectomy;
6. Pregnant or lactating women;
7. Severe systemic diseases (e.g. advanced cancer), potentially interfering with prognosis;
8. Allergy to contrast media and nitinol;
9. Concurrent participation in a study that would interfere with the establishment of predictive models;
10. Unable to complete the assessment due to mental disorders cognitive or emotional disorders before onset.