cyrilzakka/clinical-trials huggingface dataset:
Effects on Re-endothelialisation With Bydureon Treatment in Type 2 Diabetes Subjects

The aim of the study is to use Exenatide long-acting release (LAR) \[Bydureon\] to minimize vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI) and to accelerate stent endothelialisation.

Exenatide LAR will be given as a once-weekly (s.c.) dose of Bydureon (2 mg) add on to Insulin in combination with Metformin. If patients are Insulin naïve (both groups) an initial dose of 10U (s.c.) at bedtime will be started, and further up-titrated to achieve a fP-glucose levels at 6 mmol/l. Standard care for post myocardial infarction will be given after PCI.

Primary objectives:

To test whether Bydureon, add on to Insulin Neutral Protamine Hagedorn (NPH) + Metformin, is superior vs. Insulin NPH + Metformin alone, in covered stent struts

Secondary objectives:

To test whether Bydureon, add on to Insulin NPH + Metformin, is superior vs. Insulin NPH + Metformin alone: in cardiac and endothelial functions

Eligibility Criteria:
Inclusion Criteria:

1. Patients eligible for PCI with application of DES, due to ACS.
2. Patients with known or newly diagnosed T2D (type 2 diabetes is diagnosed according to current WHO criteria or by the use of anti-diabetic drugs)
3. Male and female subjects 18-80 years.
4. HbA1c (accordingly to IFCC) 47 mmol/mol - 110 mmol/mol.
5. Signed informed consent form.

Exclusion Criteria:

1. Type 1 diabetes (autoantibody positive).
2. Any history of receiving GLP-1 analogues or dipeptidyl peptidase inhibitors within 6 months
3. Known severe heart failure, classified as NYHA 4.
4. Active myocarditis; malfunctioning artificial heart valve.
5. History of ventricular tachycardia within 3 months before study entry; second- or third-degree atrioventricular block.
6. Supine systolic blood pressure \<85 mm Hg or \>200 mm Hg at screening.
7. Primary renal impairment, creatinine clearance \< 45 ml/min if treated with metformin.
8. Uncorrected hypokalemia or hyperkalemia (potassium \<3.5 mmol/l or \>5.5 mmol/l).
9. Significant anemia (Hb \< 90 g/l)
10. Severe gastrointestinal disease, including gastroparesis. As judged by the Investigator.
11. Body mass index (BMI) \> 45 kg/m2.
12. Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Patients with intraepithelial squamous cell carcinoma of the skin treated with topical 5FU and subjects with basal cell skin cancer are allowed to enter the trial.
13. Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant.
14. Current drug and alcohol abuse.
15. History of acute or chronic pancreatitis
16. Subjects considered by the Investigator to be unsuitable for the study.
Effect of Mandala Coloring of Circumcised Children

The aim of this study was to determine the effect of mandala painting on fear, anxiety, emotional symptoms and postoperative pain of circumcised children.

78 volunteer children between the ages of 6-12 who come for circumcision surgery will be randomly divided into two groups: mandala painting group and control group. Children will be evaluated before, during and after the procedure. Pain related to the circumcision procedure will be assessed using FLACC Pain Scale, fear will be assessed using High Fear Scale, anxiety will be assessed using Child Anxiety-State Scale and emotional state will be assessed using Emotional Indicators Scale. In addition, children\&#39;s demographic data will be recorded in the Information Form.

Eligibility Criteria:
Inclusion Criteria:

Children between the ages of 6-12, Written and verbal consent given by their legal guardians, Can speak and are literate in Turkish, Have sufficient mental development to answer questions

Exclusion Criteria:

Children with congenital urological anomalies, Children with who did not agree to participate in the study and who were not in the specified age group
Auricular Acupressure for Smoking Cessation

The purpose of this study is to evaluate the potential efficacy of auricular acupressure to stimulate specific acupoints in enhancing smoking cessation by reducing nicotine withdrawal symptoms among attendees in primary healthcare settings.

Uncontrolled trials indicated that auricular acupressure is an effective treatment for addictive behaviors such as smoking cessation. However, some methodological limitations can be identified among clinical trials in this area, and it is not clear whether it is more efficacious to use the commonly-used acupoints or other points that are specifically for reducing the withdrawal symptoms of nicotine. The study addresses the identified methodological shortcomings of the previous similar studies. It consists of a total of three intervention groups, which allows comparisons between the commonly-used acupoints of acupressure, acupoints specific to smoking cessation, and a sham-controlled intervention. The study does not only focus on the efficacy of smoking cessation but also assesses the mediate effect of auricular acupressure on nicotine withdrawal by questionnaire and biomarkers.

This is the first study of its kind to yield information on the acceptability and effectiveness of a safe, available auricular acupressure technique on smoking cessation in Hong Kong. The findings could provide further information for the development of future tobacco-control activities targeting smokers in a wider population who would like to use acupressure as a treatment option.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and over
* Currently smoking at least one cigarette per day in the past 30 days
* Are Hong Kong residents
* Able to communicate in Cantonese
* Currently reside in Hong Kong and expect to continue to do so for the next 6 months
* Have access to a telephone

Exclusion Criteria:

* Currently undergoing other smoking cessation or similar programme
* With a known history of allergy to adhesive tapes or history of current otitis externa or other ear disease
ARDS Prediction Score in Critically Ill Patients in China

ARDS is a severe disease, it's important to predict the incidence of ARDS.

From January 1 to January 31, 2012 and from January 1 to January 10, 2013 , all patients admit to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded.

Eligibility Criteria:
Inclusion Criteria:

Critically ill patients who admitted into participating ICU

Exclusion Criteria:

Patients with chronic pulmonary disease such as chronic obstructive pulmonary disease (COPD), asthma, lung cancer, pulmonary fibrosis and tuberculosis Age less than 18 years old Pregnancy Died within 24 hours from ICU admission ARDS patients who diagnosed 24hours before ICU admission Referral from other hospital to participating ICU Lack of data of ARDS risk factors
The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

The aim of the study is to determine whether the application of a glyceryl trinitrate patch (GTN patch) helps arteriovenous fistulas, created for renal dialysis access, mature so that they can be used.

Patients with end stage renal failure on haemodialysis must have a mechanism for achieving access to their vascular system for dialysis. Arteriovenous fistulas (surgically created connections between the artery and vein) are critical for the majority of patients. Not all the fistulas that are created work, a proportion fail early on and need to be revised or an alternative fistula created. A recent multicentre study demonstrated a 40% primary failure rate(1). In an attempt to increase the numbers of fistulae that reach maturation sufficient for dialysis access cannulation some renal centres apply GTN patches to the fistula at the time of surgery. It is thought that this works by increasing the size of the blood vessels and promoting blood flow through them and some preliminary work seems to support this(2).

The evidence for the use of GTN patches in arteriovenous fistula creation is theoretical or based on preliminary work rather than robust evidence. Similarly no evidence exists within the literature to determine the safety and definite efficacy of this procedure in this population. We propose to conduct a double-blinded randomised control trial to answer the study question: does the application of a GTN patch increase the venous outflow diameter post fistula formation and does this result in improved fistula patency.

Eligibility Criteria:
Inclusion Criteria:

* Primary arteriovenous fistulas

  * Brachiocephalic
  * Radiocephalic (both proximal and distal)
* \>18 yrs old
* Diabetics and smokers will be eligible for inclusion

Exclusion Criteria:

* All complex vascular access procedures

  * Re-do brachiocephalic and radiocephalic fistulas
  * Brachiobasilic fistulas
  * Prosthetic grafts
* Cardiovascular dysfunction

  * Hypotension (systolic \<90)
  * Obstructive Cardiomyopathy
  * Severe Aortic stenosis (gradient \>40mmhg)
  * Confirmed myocardial infarction within the last 6 months
* Marked anaemia (Hb\<8)
* Migraine
* Medications

  * Sildenafil
  * Pre-existing nitrate use
* Nitrate allergy
* Closed-angle glaucoma
* Chronically raised intra-cranial pressure
* History of hypothyroid disease
* \< 18 years old
Impact on the Intestinal Microbiota of Treatment With Ceftriaxone in Women's Acute Community Pyelonephritis

Acute pyelonephritis (APN) corresponds to infections of the renal parenchyma. The annual incidence of these infections is estimated at 4-6 million cases in France, with 60 to 90% of patients managed in general city medicine. The ceftriaxone, parenteral third-generation cephalosporin (C3G), occupies an important place in the antibiotic treatment of these infections: this is the recommended probabilistic treatment, and in some situations the treatment can be continued in its entirety via a Ceftriaxone monotherapy.

The aim of the last antibiotic plan is to avoid the use of antibiotic therapies with a high selection capacity (cephalosporins, penicillins, fluoroquinolones, etc.) and thus reduce the incidence and prolongation over time of the digestive carriage of multi-resistant bacteria .

To date, there have been few studies evaluating the impact of ceftriaxone on the emergence of multi-resistant bacteria on an individual scale, with rather heterogeneous results (13-86% C3G resistance).

Thus, before considering randomized studies comparing the ecological impact of different molecules or therapeutic regimens in the treatment of ANP, it is necessary to have a precise and rigorous evaluation of the ecological impact of the molecule reference in this indication.

The investigators propose a study to evaluate the impact on the digestive flora at 1 month of a ceftriaxone antibiotic therapy (7 days) in the management of acute pyelonephritis in women.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Over 18 years old
* Admitted to the emergency department with a diagnosis of PNA (simple or at risk of complications, without signs of seriousness)

Exclusion Criteria:

* Hypersensitivity to ceftriaxone, to another cephalosporin or to any of the excipients
* A history of severe hypersensitivity (eg anaphylactic reaction) to another class of antibacterial agent in the beta-lactam family (penicillins, monobatams and carbapenems)
* Severe pyelonephritis, including obstructive APN
* Pyelonephritis in patients with a urinary catheter
* Antibiotic treatment in the previous 6 months
* Chronic dialysis patient
* Patient with hepatic impairment
* Pregnancy or breast-feeding in progress
Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients with Hypertension.

This is a prospective, monocentric, randomized controlled trial to investigate the effect of anti-hypertensive treatment and/or individualized exercise training intervention on blood pressure and vascular health. Furthermore the investigators want to decipher mechanisms, which contribute to vascular health by analyzing changes in metabolism and cell function in relation to vascular reaction.

Arterial hypertension is a global health burden that affects the structure and function of large and small blood vessels and induces disease-specific end-organ damage. Exercise therapy is highly recommended in the treatment of arterial hypertension to reduce blood pressure and ameliorate hypertension-induced vascular damage. Previous exercise intervention studies have shown that exercise treatment improves vascular dysfunction independently of changes in blood pressure. Several sensitive vascular biomarkers exist that could optimize risk stratification and therapeutic decisions based on the progression of individual vascular damage in patients with arterial hypertension. However, individualized vascular assessment during anti-hypertensive treatment is not yet part of routine clinical practice. In order to improve clinical decision making from a personalized medicine perspective, it is essential to better understand which vascular biomarkers have the best sensitivity in detecting therapy-induced vascular adaptations and whether anti-hypertensive therapy with or without additional exercise improves vascular health in patients with hypertension. The proposed study will evaluate the effects of guideline-directed anti-hypertensive therapy with or without individualized exercise training intervention in 60 patients with hypertension and no previous medical treatment for one year. Regular outpatient assessments of blood pressure and large and small blood vessels will be performed every two months. Anti-hypertensive therapy will be based on the current guidelines of the European Society of Hypertension. The investigators aim to achieve the target blood pressure after six months of treatment. A further six-month follow-up is planned to assess the long-term effects of anti-hypertensive therapy, with or without additional individualized exercise training intervention, on blood pressure and macro- and microvascular health. In addition, the investigators will investigate the effect of metabolic changes induced by anti-hypertensive treatment or individualized exercise training intervention on vascular health.

Eligibility Criteria:
Inclusion Criteria:

- systolic hypertension grade I-II (BP values \>140 mmHg to \<180 mmHg) without anti-hypertensive medication treatment

Exclusion Criteria:

* no written informed consent
* age \<18 years
* isolated diastolic hypertension
* medical contraindications for the exercise treatment (for example orthopedic problems or an abnormal ECG during the cardio respiratory exercise test)
* chronic eye diseases on both eyes (for example macular degeneration or glaucoma) or high intraocular pressure (\>20 mmHg)
Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)

This is a randomized, parallel-group, placebo-controlled, multi-site, multinational, double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172) in combination with 50 mg of elbasvir (MK-8742) (grazoprevir/elbasvir fixed-dose combination \[FDC\]) in treatment-naïve (TN) participants with chronic hepatitis C virus (HCV), genotype (GT) 1, 4 or 6 infection. The primary hypothesis is that the percentage of participants receiving grazoprevir/elbasvir FDC in the Immediate Treatment Group (ITG) achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to the historical reference rate of 73%.


Eligibility Criteria:
Inclusion Criteria:

* Has documented chronic HCV GT1, GT4, or GT6 (with no evidence of non-typeable or mixed genotype) infection
* Meets clinical criteria for presence or absence of cirrhosis based on liver disease staging assessment
* Is abstinent or uses acceptable method(s) of contraception

Exclusion Criteria:

* Has evidence of decompensated liver disease
* Is coinfected with hepatitis B virus or human immunodeficiency virus (HIV)
* Shows evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
* Has a clinically-relevant drug or alcohol abuse within 12 months of screening
* Is pregnant or breast-feeding
* Has any condition or abnormality that might confound the results of the trial or pose an additional risk to the participant
Adapting LFI for Melioidosis

Towards the goal of reducing melioidosis, this study will help clinicians in Sarawak to diagnose and understand the causes and risk factors for melioidosis. The data will help the clinicians to provide faster test results and better clinical care. The investigator's laboratory efforts will supplement available diagnostics by adding a new, easier-to-use test involving lateral flow immunoassay to rapidly detect Burkholderia pseudomallei, a bacterium causing melioidosis. The study aims to study up to 400 patients with melioidosis-like symptoms who are admitted to Kapit Hospital, Sarawak, Malaysia. No participants will be enrolled from other sites. The study will also examine the demographic, behavioral and occupational risk factors associated with hospital admissions to understand any existing associations between these variables and melioidosis prevalence.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to Kapit Hospital
* Fever more than 3 days and one or more of the following:

  * Enlarged cervical, inguinal or axillary lymph nodes (greater than 3 cm in diameter), painless adenopathy or lymphadenitis or lymph node abscesses
  * One or both sides glands involvement such as tender swelling over medial aspect of the lower eyelid of the lacrimal glands; submandibular glands, parotic glands
  * Bedside scan with splenic or liver hypoechoic lesion (less than 2cm in diameter)
  * Pneumonia not responding to 48 hours of first line antibiotics
  * One or more joint pain with swelling
  * Purplish vesicle or bullae mainly over the lower limbs, may resulting in ulcer after rupture
  * Deep seated abscess or brain abscess or genitourinary abscess or osteomyelitis
  * Severe sepsis patient with or without shock and/or with multiorgan involvement

Exclusion Criteria:

* Have a clear alternative diagnosis other than melioidosis by a trained health care professional at the Kapit Hospital
* Have already been treated for melioidosis (e.g. received antibiotics before the start of the study)
* Are younger than 6 months of age
Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway

The purpose of this study is to evaluate the efficacy of the standardized care pathway which provides enhanced supportive care for patients with advanced cancer.

A pilot study (single arm pre-post test) will be conducted to evaluate feasibility of applying standardized care pathway to provide enhanced supportive care. A Randomized Controlled Trial will be conducted by randomly allocating participants in a 1:1 ratio to intervention arm (receiving enhanced supportive care according to the standardized care pathway) or control arm (receiving usual care: symptom monitoring only). Participants in the intervention arm will receive enhanced supportive care consisted of symptom management and coping enhancement counseling for 5 times. Data from advanced cancer patients will be collected at baseline (before start of chemotherapy), during chemotherapy (intervention arm), at the visit for cycle 5 of chemotherapy, at 6 month, and at 12 month Data from caregivers will be collected at baseline, 3 month, and 6 month. Primary outcomes will be measured as advanced cancer patients' symptom, coping and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* adult (age \>=19 years old),
* cancer patients and their family
* ECOG =\<2

Exclusion Criteria:

* patients with cognitive or psychiatric issue
Organoid Model Predictive of Response to Immunotherapies

The purpose of this study is to create models out of tissue samples and treat those models with the same immunotherapy treatment the patient will be receiving, in order to validate this process and to predict responses to therapies and use it to choose the best treatments for people in the future. The researchers will then examine the direct effects of the treatment on those models.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old at the time of informed consent
2. Ability to provide written informed consent and HIPAA authorization
3. Biopsy proven diagnosis of cancer
4. Able to obtain at least 2 16 gage cores of fresh tissue safely (3 or more cores preferred)
5. Planning to undergo standard of care Immunotherapy
6. Baseline standard of care CT within 8 weeks of starting Immunotherapy

Exclusion Criteria:

1. Inability to provide fresh biopsy sample
2. Any active infections
3. Any conditions that in the opinion of treating physician and the study team will compromise the ability of the patient to receive prescribed treatment to assess the response.
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512)

The purpose of the study is to evaluate the ability of injections of Ji Gami(TM) or Ji Gami(TM) DO in combination with minoxidil to induce hair growth in male and female subjects with hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 18 to 65 years old, inclusive
* Hair loss consistent with ≥ Grade III-Vertex, IV, VA, V, and VI, based on Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle.
* Have no clinically significant disease or abnormal laboratory results taken at the screening visit.
* Agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, finasteride or dutasteride during the course of this study (other than minoxidil as required in this study).

Exclusion Criteria:

* Known sensitivity to DMEM/F-12 or any component of the study material.
* Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.
* Subjects who have used any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening (with the exception of minoxidil).
* A history of drug or alcohol abuse within 1 year of study enrollment.
* Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
* Any clinically significant abnormal laboratory parameters.
* A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
* Dermatologic condition in donation or treatment area.
* Prior surgery in the treatment and/or study areas.
* Insufficient hair or scarring in the donor area that might impact cell growth.
* Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.
* Hypersensitivity to minoxidil or the ingredients in the topical solution or foam formulations.