cyrilzakka/clinical-trials huggingface dataset:
Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO

The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery.

Selecting patients who require systemic anticoagulation as the study subjects from patients undergoing extracorporeal membrane oxygenation assistance after cardiac surgery. Randomly divided into the nafamostat mesilate group and unfractionated heparin group. To evaluate the efficacy and safety of nafamostat mesilate by comparing the incidence of bleeding and thrombosis within the target anticoagulant level range between two groups of patients during ECMO

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. VA-ECMO or VV-ECMO was accepted after cardiac surgery.
3. The ECMO treatment team believes that systemic anticoagulation is needed
4. Sign the informed consent form

Exclusion Criteria:

1. The researchers believe that there are other causes of active bleeding that are not suitable to participate in this study.
2. Long-term use of anticoagulants before establishment of ECMO
3. Antiplatelet drugs were used before the establishment of ECMO
4. Severe liver insufficiency
5. Connective tissue disease
6. There is a history of allergy to heparin or nemolastat mesylate.
7. Pregnant
8. Previous diagnosis of heparin-induced thrombocytopenia
9. Expect to die within 48 hours
10. ECPR
Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Aortic Arch Operation (HPAO)

This study is a single-center, randomized, controlled, double-blind clinical trial. The main purpose of this study is to evaluate if hemoperfusion is sufficient to improve the prognosis of acute type A aortic dissection patients undergoing cardiopulmonary bypass and deep hypothermia circulatory arrest.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 yr-75yr, regardless of gender
2. Patients with Acute type A aortic dissection and arch involvement (onset time ≤ 7 days)
3. Able to understand and sign the informed consent

Exclusion Criteria:

1. Unable to understand and sign the informed consent
2. BMI ≥ 40
3. Pregnant
4. Active hemorrhage or thrombocytopenic purpura
5. Previous history of liver diseasess, renal insufficiency or cerebrovascular diseases
6. Preoperative organ malperfusion
7. Previous history of cardiac surgeries
8. Oral anticoagulant or antiplatelet drugs within one week of disease onset
9. Hereditary connective tissue diseases such as Marfan syndrome, Ehlers-Danlos and Loeys-Dietz syndrome
Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)

Background of the study:

Swallowing dysfunction and xerostomia are the most frequently reported radiation-induced side effects (RISE) after (chemo) radiation ((CH) RT) in head and neck cancer (HNC) patients and have a major impact on the general dimensions of quality of life (QoL). In radiation0oncology, normal tissue complication probability (NTCP) models based on dose-volume parameters being used to determine the risk of acute and late RISE. NTCP models containing genetic determinants of radiosensitivity, such as single nucleotide polymorphisms (SNPs), may improve model performance and thus enable more individualized radiotherapy. Information of the predictive value of SNPs or SNP signatures among patients with HNC is currently not available.

Objective of the study:

The main objective of this project will be to test the hypothesis that SNP profiles can improve the performance of predictive models for the most frequently reported late RISE, i.e. dysphagia, in HNC patients after curative (CH) RT. Secondary objectives will be improvement of NTCP models for HNC patients by adding SNP profiles predictive of (1) acute mucositis; (2) acute dysphagia; (3) salivary dysfunction; (4) acute xerostomia; (5) late xerostomia; (6) osteoradionecrosis; (7) hypothyroidism; (8) patient-rated HNC symptoms and ; (9) quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Histological proven head and neck cancer
* Primary site in the oral cavity, oropharynx, hypopharynx, nasopharynx, paranasal sinuses, and/or salivary glands
* Treatment with curative intent with primary or postoperative radiotherapy either or not combined with systemic treatment
* Northern European ethnicity (ethnicity is a known confounder in SNP association studies)
* Willing and able to comply with the study prescriptions
* 18 years or older
* No prior radiation (in the head and neck area)
* Patients must have sufficient knowledge of the Dutch language to understand the meaning of the study as described in the patient information
* Have given written informed consent before patient registration

Exclusion Criteria:

* Prior radiotherapy
Hypophosphatemia and Bronchiolitis

Bronchiolitis is a major public health problem and the leading cause of paediatric intensive care unit admission in infants. Hypophosphatemia is common in adult intensive care units and was associated with an increase of the duration of mechanical ventilation and the length of stay. Our hypothesis is that hypophosphatemia is common in bronchiolitis and could be a marker of severity.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 7 days and \< 3 months of life
* Admission to the pediatric intensive care unit from 01/11/2016 to 31/03/2020
* With a diagnosis of moderate to severe bronchiolitis according to HAS 2019 criteria

Exclusion Criteria:

* Renal Failure and tubulopathy
* Previous disorder of phospho-calcium balance
* Malignant pathology
* Lenght of stay less than 24 hours
* History of cardiac, aortic or hepatic surgery
Livalo Acute Myocardial Infarction Study (LAMIS)

This study is performed to observe the incidence of major cardiovascular events in Korean patients with AMI after giving pitavastatin 2mg and 4mg longer than 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Patients with STEMI, NSTEMI
* Patients satisfying at least one of the followings

  1. Patients with LDL-C ≥ 130 mg/dL
  2. Patients with LDL-C ≥ 100 mg/dL who are regarded as required cholesterol lowering therapy by the investigator
  3. Patients taking statin are required continuous cholesterol lowering therapy
* Patients satisfying at least two of the followings

  1. The change of Ischemic ECG
  2. CK, CK-MB, Troponin-I increased more than two times
  3. The symptom of ACS

Exclusion Criteria:

1. Patients with in-stent restenosis after PCI or coronary artery bypass
2. Patients with cardiogenic shock
3. Patients with severe heart failure (Left ventricular ejection fraction is less than 30%)
4. Patients who are taking cyclosporine
5. Patients who experienced hypersensitivity to pitavastatin
6. Patients under dialysis treatment
7. Patients who are participating other clinical trials
8. Patients who can not stop taking concomitant drugs
9. Pregnant or lactating women or suspected pregnancy
10. Patients who are regarded as ineligible for this study by the investigator
Transcranial Direct and Alternating Stimulation of the Prefrontal Cortex for Cognitive Improvement in Schizophrenia

The purpose of this study is to investigate different stimulation intensities and frequencies of transcranial direct and alternating current stimulation over the dorsolateral prefrontal cortex for cognitive improvement in schizophrenia.

In this randomized, double-blind study, 50 patients diagnosed with schizophrenia are randomly assigned into two arms. The first group receives transcranial direct current stimulation (tDCS) at three intensities (2 mA, 3 mA, and sham) and the second group receives transcranial alternating current stimulation (tACS) at three different frequencies (8 Hz, 40 Hz, and sham) over the left dorsolateral prefrontal cortex for 20 min. There are at least 72 hours between stimulation sessions. The patients conduct three cognitive tasks from the CANTAB neuropsychological battery for schizophrenia during stimulation including a working memory task, a cognitive flexibility task, and an emotion recognition task. Mood stability is also evaluated before and after each stimulation session with the Positive and Negative Affect Scale (PANAS).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia based on DSM V,
* Being 18-50 years old (male and female)
* If female, negative urine pregnancy test
* feasibility for tDCS interventions according to safety guidelines
* stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment
* fluency in the native language
* right-handed
* Required written informed consent signed by patients' guardian

Exclusion Criteria:

* pregnancy
* alcohol or substance dependence
* history of seizure
* history of neurological disorder
* history of head injury
* Presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces).
Impact of Hepatitis C Virus Variability on Steatosis

Chronic infection by the hepatitis C virus (HCV) is a common cause of liver disease, which may progress to cirrhosis and eventually liver cancer. The therapeutic indication will depend mainly on the importance of liver damage (fibrosis), which can be assessed by physical techniques, blood tests and a liver biopsy. The overall objectives of the project are to understand how HCV variability may influence the severity of steatosis (accumulation of fat in the liver), studying 30 patients chronically infected with HCV (half of these patients infected by HCV genotype 3, versus the other half infected by HCV of another genotype). A small portion of the biopsy performed for the routine pathology examination will be placed in special fixation buffer for electron microscopy (EM). Counting and measuring the size of lipid droplets present in the liver by EM will be used to precisely quantify and characterize the liver steatosis. A blood sample of patients will also be collected to sequence the viral genome present in the patient and identify the amino acids involved in an increase in intracellular accumulation of lipid droplets. This work should clarify the impact of the viral variability in the severity of steatosis. Ultimately, the identification of viral sequences responsible for an increase of this phenomenon could be crucial for understanding the mechanisms involved in the steatosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hepatitis C, naive of an antiviral treatment or after relapse or non-response for an antiviral treatment stopped for more than 1 year
* Liver biopsy necessary for the care of the patient
* Signature of informed consent

Exclusion Criteria:

* Patients for which the liver biopsy is estimated ≤ 18 mm, so a portion of 3 mm could not be devoted for the study
Breather Exerciser Trainer on Diaphragmatic Mobility And Thickness

The purpose of this study is to the effect of the breather exerciser trainer on diaphragmatic mobility and thickness in elderly.

Egypt is the most populous country in Middle East, with expected elder population will reach 20.8% in 2050. Almost, old population undergo sarcopenia, and dynapenia including respiratory musculatures that may associated with elevated mortality rate. Such physiological deteriorations have a potential impact on the elders quality of life.

Therefore, regular specific breathing and exercise training may promote healthier life, and permits more mechanical efficient breathing pattern, thus older population could live a hassle-free life. older adults can maintain and improve their lung capacity.

Eligibility Criteria:
Inclusion Criteria:

* Age range 65-75 years old of both genders
* Oriented elder subjects assessed for cognitive impairment with score greater than 30 on Mini- Mental Scale.
* Healthy elders with normal pulmonary function test values according to reference values.

Exclusion Criteria:

* Using any medications affect muscular strength.
* Active hemoptysis, untreated pneumothorax, recent esophageal surgeries.
* Acute or chronic pulmonary diseases, or decompensated heart failure.
* Acute upper respiratory stenosis 'true vocal fold mass, vocal fold paralysis in adducted position, sub-glottic stenosis' or recent oral, facial or skull trauma or surgeries, also acute sinusitis, epistaxis, hemodynamic instability, tympanic membrane rupture, or acute middle ear pathology 'otitis or labyrinthitis'.
* Active smokers.
* Subjects with previous neurological disorders affecting respiratory muscles or any muscular dystrophies.
* Subjects with previous cervical or thoracic surgeries.
* Presence of hemodynamic instability 'heart rate more than 150beat per minute, or systolic blood pressure more than 140 mmHg, or diastolic blood pressure more than 90 mmHg'
* Presence of severe cognitive impairments affects their understanding of any steps of study protocol.
* Uncooperative individuals during chest ultrasound measurement that require performance of deep inspiration and full expiration.
Photocil (Topical) for the Treatment of Vitiligo

Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of vitiligo.

NB-UVB phototherapy is a common treatment for patients with psoriasis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Vitiligo Area Severity Index (VASI)-75 in 50-70% of patients after 4-6 weeks of NB-UVB treatment.

Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback.

In order to address the drawbacks of phototherapy, we developed a novel topical cream - Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with natural sunlight, Photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with vitiligo confirmed by a dermatologist
* Vitiligo lesions affecting at a minimum 5% of the facial, legs, or arms surface area
* Age: 18 to 65
* Participants able to give informed consent

Exclusion Criteria:

* Subject did not respond to prior phototherapy treatment
* Subject completed phototherapy for same lesion(s) in last 6 months
* Subject has previous history of skin cancer
* Subject has previous history of photosensitivity
* Subject has a history of herpes (HSV I or II) outbreaks
* Subject has previous history of autoimmune disease may be excluded at investigator's discretion
* Subject is currently taking of immunosuppressive or photosensitizing drugs
* Subject plans to use antibiotics, anti-fungal, calcineurin inhibitors or other drugs that may cause photosensitivity during the study period. These patients may be excluded at investigator's discretion
* Subject is pregnant or lactating women
A Clinical Study to Evaluate the Efficacy and Safety of CKD-351

The purpose of this study is to evaluate efficacy and safety of CKD-351

Multi center, Randomized, Open-label, Active controlled, Phase 2 trial, Proof Of Concept Study to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients

Eligibility Criteria:
Inclusion Criteria:

1. More than the age of 19 years old
2. Subjects who has primary open-angle glaucoma or ocular hypertension
3. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

1. Subjects with intraocular pressure ≥ 35 mmHg at Visit 1 or Visit 2 (AM 09:00)
2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 1 or Visit 2
3. Subjects who were diagnosed as below

   * Aphakia
   * Intraocular lens
   * Acute or Chronic Closed-Angle Glaucoma
   * Secondary Glaucoma
4. Subjects with ocular inflammation or infection within the last 3 months
5. Subjects with significant history of ocular trauma during the last 6 months or who underwent surgical opthalmic surgery
6. Subjects who received topical or systemic steroids within the last 1 month.
Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients in a MMT

The efficacy and tolerability of Eptadone® in the context of a maintenance program will be evaluated in an observational prospective, multicenter study, in heroin addicted patients.

515 patients have been selected among all patients addicted to heroin according ICD-10, in maintenance treatment with Eptadone, observed in the involved sites. The investigators have used the treatment schemes with Eptadone conform to the registered use.

The enrollment has been competitive. Patients met incl/excl and that have signed the informed consent have been observed for 1 year. Follow up visits have been performed according to routine procedures, for patients related to the centres at 3/6/12 months post V1. During the visits patients have been assessed by validated and used as clinical practice questionaries. Safety and tolerability have been assessed through the collection of adverse reactions and of laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes
* Over 18 years of age
* Patients with a diagnosis of heroin addiction, according to ICD-10 (International Classification of Diseases-10)
* Patients who receive a "maintenance treatment" with Eptadone® since at least one month
* Accession to the observational study by informed consent

Exclusion Criteria:

* Inability to follow the observation and to understand study procedure and follow them
* Diagnosis of:

  * Decompensated psychotic disorders,
  * Epileptic attacks, not related with drug abuse,
  * Severe-acute or severe-chronic somatic diseases (like AIDS, Tubercolosis, acute hepatitis, Sepsis ecc), whereas chronical HCV is not an exclusion criteria.
A Qualitative Case Study of the Experiences of Children With Cancer as They Learn About Their Diagnosis and Treatment

Thousands of children are diagnosed with cancer each year, many of whom will achieve long term survival due to advances in treatments and technologies. However, when a child is first diagnosed, they are confronted with a wealth of new and unfamiliar medical information that they must integrate in order to understand their diagnosis and treatment plan. Little is yet known about how children with cancer experience learning about their diagnosis and treatment in the hospital setting, or the individuals and materials that may help to facilitate the child's developing understanding. This information could help to identify or guide educational and supportive child life interventions to help children with cancer better understand their illness and its treatment.

This observational study will collect data about how children currently learn about their cancer diagnosis and treatment in the hospital setting. The interventions used do not seek to change the health outcomes of the participants in this study. The observational data collected may serve to improve how future patients learn about their cancer-related diagnosis.

This is a longitudinal qualitative case study, and no randomized interventions will be used. Instead, participants will complete two interview sessions, three guided activities, and observations with the primary investigator to explore their experiences of learning about their diagnosis and treatment in the hospital setting.

PRIMARY OBJECTIVE:

* The primary objective of this qualitative case study is to describe the ways in which children with cancer learn about their cancer diagnosis and treatment in the hospital setting.

Eligibility Criteria:
Inclusion Criteria:

* The child is between the ages of 7 and 11 years on the day of their initial arrival to the hospital
* The child has a working diagnosis or initial diagnosis of a bone or soft tissue sarcoma that will require multimodal therapy to include chemotherapy, plus or minus surgical resection, plus or minus radiation therapy.
* Both the child and parents speak English as their primary language
* Parents are willing to give consent and child is willing to give assent

Exclusion Criteria:

* The child has a pre-existing, documented learning disability or cognitive impairment and has previously received learning accommodations under an individualized education plan (IEP).
* The child has a pre-existing, documented diagnosis of autism spectrum disorder (including autism and Asperger's disorder).
* Child has previously received treatment for a cancer diagnosis either at St. Jude or another institution.
* Parent and/or child are unwilling or unable to give consent/assent.