cyrilzakka/clinical-trials huggingface dataset:
Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes

Aim of this study is to compare fixation of nasoenteral feeding tubes using either a nasal patch or a nasal bridle in clinical patients with regard to the occurrence of tube dislocation, complications, and discomfort. 78 (2 \* 39) eligible patients will be included in this randomized controlled trial. The study is executed in two general teaching hospitals in the Netherlands (Gelre Hospitals Apeldoorn and Medical Spectrum Twente).


Eligibility Criteria:
Inclusion Criteria:

* adult patient (18 years or older)
* received a nasoenteral feeding tube while being hospitalized
* providing written informed consent

Exclusion Criteria:

* contraindication for a nasal bridle (e.g., cleft lip or damaged nasal mucosa)
* clinical need to place a nasal bridle
* anticipated feeding nasoenteral feeding tube placement for \< 3 days
* failure of nasoenteral feeding tube placement
Deciphering the Role of Dietary Fatty Acids on Extracellular Vesicles-mediated Intercellular Communication

Dietary interventions have been consistently proposed as a part of a comprehensive strategy to lower the incidence and severity of atherosclerosis and coronary vascular disease. Excessive comsumption of fats enriched in saturated fatty acids (SFAs) is associated with an increased risk of atherosclerosis and other cardiovascular diseases (CVD). In contrasts, replacement of SFAs with monounsaturated fatty acids (MUFAs) and omega-3 long chain polyunsaturated fatty acids (ω3-LCPUFAs) has been reported to be inversely associated with risk of atherosclerosis. This is partly due to the ability of MUFAs (and ω3-LCPUFAs) to modulate lipoprotein composition, oxidation state, and consequently their functionality, among others. While most of the nutritional studies have focused on elucidating the mechanisms by which dietary fats affect lipoprotein particles, little or nothing is known about the regulatory effect of dietary fatty acids on extracellular vesicles (EVs). EVs are small phospholipid particles that convey molecular bioactive cargoes and play essential roles in intercellular communication and, hence, a multifaceted role in health and disease. For the first time, the purpose of this project is to establish whether the type of major fatty acids present on a diet (SFAs, MUFAs, or ω3-LCPUFAs) may alter the structure, cargo, and functionality of postprandial- and long-term-EVs. In the precision nutrition era, the investigators expect to offer a new insight on EVs and their relationship with dietary fatty acids through the following objectives: 1) To map changes in the lipidome, proteome, microtranscriptome, and functional properties of circulating EVs in healthy subjects and patients with metabolic syndrome (MetS) both at fasting and at postprandial state upon a challenge of a meal rich in SFAs, MUFAs, and ω3-LCPUFAs; 2) To analyse the contribution of postprandial triacylglyceride-rich lipoproteins (TRL) on EVs-mediated intercellular communication in a fatty acid-dependent manner; and 3) To determine the influence of diets rich in SFAs, MUFAs, and ω3-LCPUFAs on EVs in an animal model of atherosclerosis in the setting of MetS. Collectively, this project will provide fundamental insight into EV biology, and remarks the clinical and functional relevance and divergent consequences of dietary fatty acids in health and disease.


Eligibility Criteria:
Inclusion Criteria:

• Clinical diagnosis of metabolic syndrome

Exclusion Criteria:

* Allergy to dairy products
* Allergy to fish oil
* Vegetarian
* Tobacco smoker
* Current or recent (\<4 wk) use of fish oil supplements or more than four times fish/week
* Received innoculations within 2 mo of starting the study or planned to during the study
* Donated or intended to donate blood from 2 mo before the study till 2 mo after the study
* Unstable body weight (no weight gain/loss \>3 kg)
Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy

This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.

The study consists of two consecutive parts: Part A and Part B. Part A will evaluate the safety and efficacy of two doses of AT-001 vs placebo. The primary objective of Part A is to demonstrate that AT-001 improves or prevents the decline of functional capacity in patients with Diabetic Cardiomyopathy. Part B is an extension of at least 12 months that will evaluate the safety and efficacy of chronic administration of AT-001 vs placebo in the same patients who had previously been evaluated in Part A. Assessments in Part B will include safety endpoints and exploratory clinical efficacy endpoints, i.e. death and hospitalization due to a cardiac event.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Diabetic cardiomyopathy
* Peak VO2 \< 75% of predicted normal value based on age and gender

Exclusion Criteria:

* Prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage C heart failure
* Prior echocardiogrphic measurement of ejection fraction (EF) \< 40%
* Prior acute coronary syndrome (ACS), coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), coronary artery disease (CAD) or stroke
* Severe or moderate cardiac valve disease requiring intervention
* Clinically significant arrhythmia
* Prior diagnosis of congenital, infective, toxic, infiltrative, post-partum, or hypertrophic cardiomyopathy
* Blood pressure \> 140 mmHg (systolic) or \> 90 mmHg (diastolic) at screening
* HbA1c \>8.5% at screening
* Severe disease that would impact the performance of a cardio-pulmonary exercise test
Pattern of Dyslipidemia Among Patients With Acute Coronary Syndrome at Sohag University Hospital

In this study, I am aime to analyze lipid profile in patients with ACS who presents at sohag university hospital, and its clinical and complications pattern.

Coronary artery disease (CAD) is the most important cause of death in men and women The great majority of ACS patients have at least one major risk factor.

Acute Coronary Syndrome (ACS) is a major reason for Coronary Care Unit ( CCU )sohag university hospital admission The risk of CAD was about 4 and 3 times higher in male and female smokers than nonsmokers respectively (Baba S et. al ; 2006) Dyslipidemia has been identified as one of most important modifiable risk factor for CAD . Treating dyslipidemia has clear benefits in the primary and secondary prevention of coronary heart disease (CHD) in both sexes . This study focused on dyslipidemia as a risk factor of acute coronary syndrome (ACS).

Eligibility Criteria:
Inclusion Criteria::

clinical diagnosed Acute coronary syndromes

-

Exclusion Criteria:

* chronic coronary syndrome
Sequelae of Developmental Dysplasia of the Hip

The aim of this study is to assess long term effects of developmental dysplasia of the hip (DDH) to overall health and quality of life later in life. We compare hip radiographs, hip symptoms, clinical examination, head asymmetry, dental examination and intraoral scans of 170 children and young adults treated for DDH in their childhood with age and sex matched controls.

Developmental dysplasia of the hip (DDH) is the most common musculoskeletal disorder in infancy. However there are few reports of long term effects of successfully treated DDH. Incidence of DDH in neonatal period is approximately 1-10/1000 depending on screening protocols used, the age of the infant during screening and which ultrasonographic findings are considered normal and which DDH. The prevalence of hip dysplasia in adult population is grossly 4 % when using Wibergs Centre-Edge (CE) ≤ 20° as definition of dysplasia. It is still unclear, what is the relation between adult acetabular dysplasia and developmental dysplasia in children. Hip dysplasia overall is a major contributing factor in hip osteoarthrosis and total hip replacement in young adults.

The aim of this study is to assess long term effects of developmental dysplasia of the hip to overall health and quality of life later in life. We compare hip radiographs, hip symptoms, clinical examination, head asymmetry, dental examination and intraoral scans of 170 children and young adults treated for DDH in their early childhood with age and sex matched controls.

Eligibility Criteria:
Inclusion Criteria for person treated for DDH:

* DDH has been diagnosed by clinical examination, ultrasound examination or by radiological examination and treatment begun before age of 1,5 years.
* Treated in Oulu University Hospital

Exclusion Criteria:

* neurological or developmental condition which can influence hip development such as cerebral palsy or spina bifida
* other significant congenital anomalies of musculoskeletal system such as club feet
Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding

Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in prophylaxis of the first bleeding. The efficacy \& safety of combining EVL and carvedilol in prophylaxis of the first bleeding is still unknown. This study aims to investigate the value of combination therapy.

Combination of EVL and β-blocker has been proven effective in the prevention of variceal rebleeding . However, Our previous study showed that combination of EVL and nadolol do not have enhanced effect in the prophylaxis of 1st variceal bleeding as compared with nadolol alone . One of the drawbacks of EVL is esophageal ulcer. On the other hand ,carvedilol, an anti-α beta-blocker, has been proven to be more effective than propranolol in the reduction of portal pressure. Carvedilol has been proven to be more effective than EVL in the prevention of 1st variceal bleeding. The investigators thus conduct a multicenter trial to evaluate whether combination of EVL and carvedilol could be more effective than carvedilol alone in the prophylaxis of 1st esophageal variceal bleeding . The goal of patients receiving EVL is to reduce variceal size, not variceal obliteration, in anticipation for fewer sessions required for each patient and fewer possibility of esophageal ulcer bleeding.

Eligibility Criteria:
Inclusion Criteria:

1. Cirrhosis with esophageal varices are larger than F2.
2. No history of variceal bleeding.
3. In three months have not implemented preventive esophageal variceal ligation. (4)age 20yrs～75yrs.

Exclusion Criteria:

1. Association with HCC or other cancers .
2. Refractory ascites.
3. Jaundice, bilirubin \> 5mg/dl.
4. Encephalopathy.
5. Cr.\>3mg/dL.
6. A-V,block bradycardia (PR \< 60/mim).
7. Hypotension systolic blood pressure\<95/mmHg .
8. Refusal to participate.
9. Carvedilol allergy
10. Second degree-third degree Atrio-ventricular block.
11. Bradycardia.
12. WPWsyndrome
13. Hypotension
14. Psychogenic shock.
15. Asthma. All the patients are randomized based on a random number.
The Effect of Single Dose Paracetamol on the Lower Airways of Asthmatic and Healthy Children

Asthma is a common inflammatory airway disease. Several researches have demonstrated a possible connection between asthma and exposure to paracetamol.

Our hypothesis is that even a single dose of paracetamol is sufficient to cause a measurable change in lung functions.

This trial aims to identify a possible effect of single dose paracetamol on lower airway function.

Asthma is a common inflammatory airway disease and its prevalence is on the rise all around the world, Most significantly in children under 5 years.

Paracetamol is one of the most common drugs used with children at thus age groups and several studies have proved a causative connection between exposure to paracetamol and asthma prevalence as well as other allergic conditions.

The mechanism is presumably by reduction of glutathione level, resulting in oxidative burst and formation of reactive oxygen species (ROS).

In addition, paracetamol maybe directly cytotoxic to pneumocytes if given in overdose.

The goal of this research is to identify and quantify the effect of single dose of paracetamol on lung functions of asthmatic and healthy subjects.

The study group will include 40 children aged 7-16 years, who are known to have asthma and a control group of 20 healthy children.

The children will be randomized to receive a dose of paracetamol or placebo, and lung functions will be measured by both spirometry and Fraction of expired Nitric Oxide (FeNO) test.

Each child will receive both paracetamol and placebo, randomly in to consecutive tests, thus children will serve as their own control.

Eligibility Criteria:
Inclusion Criteria:

* age: 7-16 years
* research group: children who have been diagnosed as asthmatic according to the American thoracic society (ATS) criteria
* control group: children who are not known to have asthma

Exclusion Criteria:

* paracetamol sensitivity
* children with any kind of chronic disease (except asthma)
* children with non asthma related chronic lung disease
* acute asthma attack
* children on systemic steroids
A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared with Placebo in Adult Participants with Moderate to Severe Hidradenitis Suppurativa

This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be at least 18 years of age at the time of signing the informed consent.
2. Participants who are diagnosed with hidradenitis suppurativa as determined by the investigator and have a history of signs and symptoms of hidradenitis suppurativa for at least 6 months before signing the informed consent.
3. Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion.
4. Participants who have a total AN count of ≥5.
5. Participants who have HS lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (ie, be Hurley Stage II or III).

Exclusion Criteria:

1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
2. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
3. Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
4. Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
5. Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
6. Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.
Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms.

Endoscopic mucosal resection (EMR) is widely accepted as a minimally invasive treatment for GI neoplasms.However, one disadvantage of EMR is that lesions larger than 2 cm in diameter must be removed in pieces, which may result in a high recurrence rate of residual tumor tissue. In addition, in most patients, pathological assessment cannot be conducted after the procedure. ESD can overcome the disadvantages of EMR. However, it is difficult to perform ESD for GI neoplasms because of the high rate of complications.

Eligibility Criteria:
Inclusion Criteria:

* Submucosal tumor
* Mucosal tumor (T1) in patients unsuitable for surgery

Exclusion Criteria:

* Endoscopic ultrasound (EUS) or CT signs of metastasis
* Insufficient access to tumor
Sequencing T-cells in Type I Diabetes Mellitus

The purpose of this study is to investigate CD8 + T-cell receptor (TCR) repertoire differences between patients with type 1 diabetes mellitus and type 2 diabetes or healthy controls.

Using a systems biology approach by combining high-throughput sequencing, cytometry, gene expression, transcriptome profiling, HLA typing, single cell analysis, and TCR affinity assays, the investigators will define a set of immune metrics for the prediction or early diagnosis of disease that is superior to the current examination of auto-antibodies, which is a fairly late stage in the disease development. This can also be used to guide therapy in advanced disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a current or previous diagnosis of Type I Diabetes (Autoimmune-related T1DA as confirmed by a positive test for glutamic acid decarboxylase (GAD) auto-antibodies. When available, idiopathic T1DB patients with a lack of autoantibodies to GAD will be recruited)
* Patients must be ≥ 18 years old and ≤55 years old

Inclusion criteria: patients T2D as controls

* Patients must have a current or previous diagnosis of T2D
* Patients must be ≥ 18 years old and ≤55 years old

Exclusion Criteria:

• \<18 years old; \> 55 years old
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-103 in Healthy Volunteers

The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-103 when given to healthy male volunteers.

The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-103 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-103 three times daily for seven days. Healthy volunteers taking part in Part II of the study will also receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in addition to ODM-103 on day 9. The study will also look at the pharmacokinetic(how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-103.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged between 18 and 45 years
* BMI 18-30 kg/m2
* Weight 55-90kg
* Written informed consent
* Good General Health

Exclusion Criteria:

* Vulnerable subjects
* Veins unsuitable for repeated venipuncture
* Evidence of clinically significant cardiovascular, renal, hepatic, hematological, Gi, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disorder
* History of or positive test for drug abuse
* Any condition requiring regular concomitant medication
* Blood donation or significant loss of blood within 3 months prior to screening
* Abnormal 12 lead ECG finding of clinical relevance
* Heart rate (HR) \<50bpm or \>90bpm after 10 minutes in a supine position
* Systolic blood pressure \<90mmHg or \>140mmHg after 10 minutes in a supine position
* Diastolic blood pressure \<50mmHg or \>90mmHg after 10 minutes in a supine position
* Abnormal 24 hour Holter recording of clinical relevance at screening
* Any abnormal laboratory value, vital signs or physical examination causing a health risk to the volunteer
A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus patients.

The study involves six weeks of wash out period and two weeks run in period for patients currently on mono-therapy and a two week run in period only for drug naïve patients.

This is a placebo controlled study. One of the five treatment arms is placebo. The duration of treatment is 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥30 years of age
* At screening, females of non-childbearing potential or females of childbearing potential with adequate contraception
* Has an established clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to the screening period
* Is being treated for diabetes either with diet and exercise alone, or on monotherapy with any of the antidiabetic drugs
* Has an HbA1c value at screening between 6.5% and 10%

Exclusion Criteria:

* Has type 1 diabetes
* Is a female who is lactating or is pregnant
* Has a history of acute metabolic diabetic complications
* Has clinically significant disease other than type 2 diabetes mellitus
A Study of Two Versus Three Daily Injections in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. The purpose of this study is to determine whether a split evening injection regimen (insulin injections before breakfast, supper and bedtime) leads to better glucose control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.

The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. No published studies have examined the effectiveness of a split evening (three times daily) injection regimen in this group of patients. Indeed, because the first few years of diabetes management are the easiest (due to a "honeymoon" period characterised by residual insulin secretion), the potential for any benefit from more intensive management (i.e., three daily injections) may be small during this period. In addition, the intensity of the initial insulin regimen may be an important determinant of quality of life, family functioning, and subsequent compliance with diabetes regimens. A randomized controlled trial has been designed to test the hypothesis that a split evening injection regimen leads to better glycemic control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.

Eligibility Criteria:
Inclusion Criteria:

* New onset type 1 diabetes
* Less than 48 hours since first insulin injection
* Child and/or parent able to read and write English
* Family intends to continue treatment at our institution for the next two years
* Informed consent from adolescents greater than 16 years of age, or if less than 16 years, informed consent from the parent/guardian with assent from the child.

Exclusion Criteria:

* Chronic medical conditions other than treated hypothyroidism or mild asthma
* Concerns of the diabetes team regarding future treatment adherence making twice daily insulin preferable to the split evening injection regimen (e.g., cognitive impairment, severe family dysfunction).