cyrilzakka/clinical-trials huggingface dataset:
An Investigation of the Mechanism of Action of Seretide in Chronic Obstructive Pulmonary Disease

This study is investigating the possible mechanisms of action of an inhaled treatment (Seretide), currently used worldwide in millions of patients with COPD (Chronic Obstructive Pulmonary Disease) and how it improves the symptoms of these patients. Previous research has failed to identify the mechanisms at play other than dilation of the airways. The research community has long thought the mechanism to be immune based or anti inflammatory but despite intensive research this has not yet been identified.

We aim to recruit equal numbers of healthy smokers, mild, moderate and severe COPD patients (12 patients to be recruited from each group). These patients will never have been prescribed the components present in Seretide (Salmeterol and Flixotide or similar compounds).

The patients will have spirometry at the beginning of the study to confirm the presence of COPD. Healthy smokers will defined as ex or current smokers who match the study population but have normal lung function.

Patients with a history of asthma, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease will be excluded.

The patients will have a total of four study visits, 2 off treatment and 2 while on treatment, over a 56 day study period. At each study visit induced sputum will be performed and blood extracted. The cells fom both of these samples will be analysed for cells type and activation. Sputum and serum will be stored for cytokine analysis at a later date.

The Sputum will be induced using standardised protocols using nebulised saline solution.

Eligibility Criteria:
Inclusion Criteria:

* \>35yrs.
* \>10 Pack Years COPD as defined as an FEV1\<70% and an FEV1/FVC ratio of \<70%

Exclusion Criteria:

* Asthma
* Lung cancer
* Bronchiectasis
[18F] Fluorocholine FCH Positron Emission Tomography (PET)/Computed Tomography (CT) for Detection of Prostate Cancer Lymph Nodes Metastases

The objective of this trial is to assess the value of 18F-choline PET/CT for the detection of regional lymph node metastases from prostate cancer. In addition, the investigators want to evaluate whether 18F-choline PET/CT can replace lymphadenectomy for the staging of prostate cancer.

The purpose of this prospective trail is to improve the staging of patients with prostate cancer. The investigators focus on the group of patients with a newly diagnosed prostate cancer, and specifically the ones who have an intermediate and high risk of disseminated prostate cancer.

The aim is to improve staging by replacing the traditional invasive method, the lymphadenectomy, which has a rather low sensitivity by a non-invasive method, 18F-choline PET/CT which has a presumably superior sensitivity.

The treatment of patients with prostate cancer relies on the stage of the disease. Patients with disseminated prostate cancer are incurable and are treated with palliatively. In contrast, patients with localized prostate cancer are offered curative therapy. Hence, the stage of prostate cancer is crucial for the choice of treatment.

The potential benefits are

* The patients avoid the surgical trauma including complications and convalescents period.
* The accuracy of the prostate cancer staging is improved, the potential of which is better survival.

The patients are 18F-choline PET/CT scanned prior to their lymphadenectomy, the results of the 18F-choline PET/CT are blinded for the surgeon. The endpoint of the trail is the comparison of 18F-choline PET/CT and the histopathological investigation of the regional lymph nodes of prostate.

Assuming a prevalence of metastasised prostate cancer of 20% and a true (unknown) sensitivity of FCH PET/CT of 95%, 205 patients are sufficient to show that the sensitivity of the FCH PET/CT is greater than 80% with a power of 80% at significance level 5%. The size of the confidence interval for specificity of FCH PET/CT is expected to become reasonable small. In opposition to lymphadenectomy, FCH PET/CT results may point to metastases in neighbouring regions which gives an additional benefit to FCH PET/CT justifying a test level for sensitivity of 80%."

Accordingly 205 patients will be included over 2½ years. The first patients have been included in January 2008. Interim analyses will be done after 25, 50 and 100 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a biopsy confirmed prostate cancer who awaits curative treatment and have
* An elevated level of prostate-specific antigen PSA\>10 ng/mL (nanogram per milliliter) or/and
* A Gleason score \> 6 or/and
* A TNM staging of T3

Exclusion Criteria:

* Patients who withdraw their informed consent.
* Patients who have a bone scan indicates metastatic prostate cancer.
* Patients who have a TNM stage is T4

In the case we detect a patient having an obvious other major illness e.g. lung cancer, the patient is referred to relevant treatment. Depending on the illness the might be excluded from the study.
Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose

Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction


Eligibility Criteria:
Inclusion Criteria:

* Men 18-70 years of age
* Documented clinical diagnosis of erectile dysfunction of at least 3 months duration.

Exclusion Criteria:

* Subjects with penile implants
* Subjects with a known history of retinitis pigmentosa.
* Subjects, due to the requirement of 100 mg dosage, who are receiving concomitant treatment with the potent CYP3A4 inhibitor ritonavir.
Do Isreali Infants of Ethiopian Origin Mother Regurgitate More Than Other Infants?

Nursing team of well baby nursery at Hillel Yaffe medical center in Hadera, Israel have noticed that infant of Ethiopian-origin mothers regurgitate more than other infants. Probably, these infants are breastfeed much more than other infants.

Some Ethiopian-origin mothers are used to eat teff-flower porridge during the last weeks of pregnancy and after birth, in order to expand milk production.

Study goal is to find out if infants of Ethiopian-origin mother do regurgitate more than others, and if they weight gain is similar to other infants. Another goal is to find out if breastfeeding mothers of Ethiopian origin do eat that porridge, and if there is any difference between those who do eat that porridge and those who do not.

Nursing team of well baby nursery at Hillel Yaffe medical center in Hadera, Israel have noticed that infant of Ethiopian-origin mothers regurgitate more than other infants. Probably, these infants are breastfeed much more than other infants.

Some Ethiopian-origin mothers are used to eat teff-flower porridge during the last weeks of pregnancy and after birth, in order to expand milk production.

Study goal is to find out if infants of Ethiopian-origin mother do regurgitate more than others, and if they weight gain is similar to other infants. Another goal is to find out if breastfeeding mothers of Ethiopian origin do eat that porridge, and if there is any difference between those who do eat that porridge and those who do not.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at Hillel Yaffe medical center during 2009 (To Ethiopian origin mother in study group, and to non-Ethiopian origin mothers in control group)

Exclusion Criteria:

* Infants who were transferred to NICU for any reason.
Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis

Cirrhotic patients with AVB across 34 university medical centers in 30 cities in China from February 2013 to May 2020 who underwent endoscopy within 24 hours were included in this study. Patients were divided into an urgent endoscopy group (endoscopy \<6h after admission) and an early endoscopy group (endoscopy 6-24h after admission). Outcomes included the incidence of 5-day rebleeding, in-hospital mortality, need for intensive care unit (ICU) and the length of hospital stay after the endoscopy management. Multivariable analysis was performed to identify risk factors for rebleeding. A propensity score matching (PSM) analysis was performed to achieve a balance at baseline between the urgent and early groups.


Eligibility Criteria:
Inclusion Criteria:

* established diagnosis of cirrhosis (based on liver biopsy or the combination of clinical, biochemical, and imaging findings)
* witnessed or reported evidence of gastrointestinal haemorrhage (hematemesis, melenemesis, or hematochezia)
* esophageal or gastric varices confirmed endoscopically as the source of bleeding

Exclusion Criteria:

* severe dysfunction of a major extrahepatic organ (e.g., heart failure, pulmonary disease, and terminal malignancy except hepatocellular carcinoma)
* history of endoscopic therapy for varices (ligation or sclerotherapy) within three months
* incomplete or missing data
Predictive Tracking of Patient Flow in the Emergency Services During the Virus Winter Epidemics

Epidemics and infectious diseases in general, punctuate much of the activity of an emergency service. The impact of winter infections is particularly important to vulnerable populations such as infant during bronchiolitis epidemics and the elderly during seasonal influenza. Each year, these epidemic phenomena lead to disorganization of emergency services and healthcare teams by lack of anticipation and organizational measures in particular to manage the approval of emergency services for the most vulnerable populations requiring hospitalization.

For 2 years, the pediatric emergency department of St Etienne University Hospital has a decision support tool for the periods of winter epidemics. Through a retrospective analysis of Passages of Emergency summary, this tool provides an estimate of infants with bronchiolitis flow day to day, and the availability in real time of an abnormally high flow of patients to pediatric emergencies. These data can help to affirm that the epidemic begins in this hospital.


Eligibility Criteria:
Inclusion Criteria:

* child \< 24 months with bronchiolitis
* elderly \< 60 years with acute renal failure or breathing problem

Exclusion Criteria:

* refuse of transmission of their data
YAG Vitreolysis for Floaters

This is a single-center, prospective randomized controlled trial evaluating the safety and efficacy of YAG vitreolysis versus sham for symptomatic Weiss ring due to posterior vitreous detachment.

52 subjects will be enrolled in the trial and randomized in a 2:1 ratio to receive either YAG laser vitreolysis or sham laser for symptomatic Weiss ring due to posterior vitreous detachment. Subjects will follow up at one week, one month, three months, and six months after the procedure. Assessments will include a questionnaire regarding duration of floater symptoms prior to presentation, severity of floater symptoms, number of floaters, and activity most inconvenienced by presence of floaters; Medical, ocular history and demographics collected; ETDRS and Snellen visual acuity; Optos color photography; Heidelberg Spectralis Optical Coherence Tomography (OCT) and infrared photo; B scan ultrasound of Weiss ring with caliper measurement of nearest distance between Weiss ring and retina, Weiss ring and posterior lens capsule (only in phakic eyes); Slit lamp and indirect ophthalmoscopy with scleral depression of study eye; Applanation tonometry; Visual Functioning Questionnaire-25 (VFQ 25). Qualitative change in Optos photography will evaluated by a masked physician.

Eligibility Criteria:
Inclusion Criteria:

1. Symptoms of floaters that correlate to the presence of a posterior vitreous detachment for at least 6 months
2. Documented posterior vitreous detachment on clinical examination, OCT, and B scan
3. Self-rating of visual disturbance by the floaters must be at least 4 on a 0-10 scale, with 0 being no symptoms to 10 being debilitating symptoms.
4. Symptomatic Weiss ring (PVD) must be at least 3 mm away from the retina and 5 mm from the posterior lens capsule of the crystalline lens, as measured on B-scan. For pseudophakic patients, there is no minimum required distance from the intraocular lens.
5. Able to position for the YAG laser procedure.
6. Accept the risks of YAG laser including but not limited to retinal detachment, intraocular hemorrhage, retinal damage, cataract formation, optic nerve damage, inflammation, and irreversible loss of vision.
7. Willing and able to comply with clinic visits and study-related procedures
8. If the patient has two symptomatic eyes, only one eye can be randomized and included in the study.
9. Provide signed informed consent

Exclusion Criteria:

1. Snellen best corrected visual acuity worse than 20/50 in the fellow eye
2. History of retinal tear, retinal detachment, or uveitis in the study eye
3. History of diabetic retinopathy, macular edema, retinal vein occlusion, or aphakia in the study eye
4. History of glaucoma or high intraocular pressure defined as having a history of glaucoma surgery or currently taking two or more topical glaucoma medications in the study eye
Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients

To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.

Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index hemoglobin A1c (HbA1c) between 7.5% and 11.5% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1c's. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.

Eligibility Criteria:
Inclusion Criteria:

* Adult type 2 diabetes patients age 18 or older
* HbA1c ≥ 7.5% and ≤ 11.5% after at least 6 months treatment with diabetes medication. Treatment may include oral agents, basal insulin or Glucagon-like peptide-1 (GLP-1) in any combination.
* Patient and provider agree not to add additional diabetes medications during the 14 weeks of the study (unless rescue treatment is indicated).

Exclusion Criteria:

* History of asthma, chronic obstructive pulmonary disease (COPD) or smoking within 6 months
* Forced Expiratory Volume in one second (FEV1) under 70% predicted
* Pregnancy
* Active malignancies and/or life expectancy of \< 12 months
* Major surgery planned during study period
* Currently using rapid acting insulins - Novolog, Humalog, Apidra
* Prior use of Afrezza in the last 3 months
* Unwilling to test blood glucose before or after each meal
* Exposure to systemic glucocorticoids within 6 weeks of screening
* Severe hypoglycemia in last 6 months or hypoglycemia unawareness
* Any medical condition which, in the opinion of the investigator, would interfere with ability to understand or respond to the administration of inhaled insulin
The Care of Stroke in Ziekenhuis Oost-Limburg

A stroke occurs when the blood circulation is hampered due an ischemic or hemorrhagic event. Previous, a stroke was treated only with anti-aggregation. Over time, multiple studies have showed a positive effect of intravenous thrombolysis with rt-PA (recombinant tissue plasminogen activator) in comparison with the standard treatment (anti-aggregation). Since 2015, thrombectomy was proven to have an added value in combination with thrombolysis. Thrombectomy is an endovascular technique where the thrombus is removed or fragmented.

Diagnosis and treatment of stroke will have a significant impact on the health-economic status of the patient. However, little data is known. Unfortunately, the outcome after diagnosis with a stroke is not well documented. Therefore, this follow-up study over a time period of one year, will give us a sufficient amount of data to evaluate patients diagnosed with a stroke in the hospital of Genk.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* older than 18 years
* diagnosed with stroke

Exclusion Criteria:

* younger than 18 years
Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single injection of either clonidine micropellet or sham injection for the treatment of low back and leg pain from sciatica.


Eligibility Criteria:
Main Inclusion Criteria:

1. Be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed.
2. Diagnosis of unilateral radicular leg pain.
3. Women of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to procedure and commit to adequate birth control during the the study.
4. Understands the purpose and any risks associated with the procedure required for the study and is willing to participate in the study.
5. Agrees to follow study-specific medication requirements.
6. Be able to read, write, understand, and complete study-related tasks, and adequately communicate in English.
7. Subject must have failed at least one conservative therapy in two different categories.

Main Exclusion Criteria:

1. Medical condition or radiographic evidence that, in the Investigator's opinion, could adversely impact study outcomes.
2. Received an lumbar epidural steroid injection, nerve block or similar procedure during the 4 weeks prior to Screening.
3. Female subjects who are pregnant or breastfeeding.
4. History of lumbar surgery.
Pharmacokinetics and Food Effect of Sarpogrelate HCl CR Formulation in Comparison to Immediate-release Formulation

The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and Food effect on the pharmacokinetics of sarpogrelate CR.


Eligibility Criteria:
Inclusion Criteria:

* 20 to 55 years of healthy volunteers

Exclusion Criteria:

* Hypersensitivity Reaction about Sarpogrelate HCl or other antiplatelets
The Effects of Mydriatic Eye Drops in Retinopathy of Prematurity Examinations

Retinopathy of prematurity (ROP) is a retinal disorder of preterm neonates and a potential cause of blindness. As early diagnosis and treatment preserve vision, very low birth weight infants must be screened for ROP. Mydriatic eye drop administration is essential to perform funduscopic evaluations. The most commonly used mydriatic drops for pupil dilatation are 0.5-1.0% tropicamide and/or 0.5-1.0% phenylephrine or 0.2-1.0% cyclopentolate. Phenylephrine, an alpha-1 sympathomimetic agonist, is readily absorbed from conjunctival mucosa and has a potent systemic vasopressor effect. Tropicamide causes cycloplegia by inhibition of ciliary muscle contraction and has a short acting para-sympatholytic effect.

Systemic absorption of mydriatic eye drops has been associated with cardiovascular, respiratory and gastrointestinal adverse effects. Systemic side effects include apnea, desaturation, increased heart rate and blood pressure, delayed gastric emptying, and feeding intolerance. The data about the effects of mydriatics on cerebral blood flow and tissue oxygenation are sparse. Cerebral blood flow autoregulation depends in part on the adrenergic and cholinergic control of cerebral vasculature, but whether mydriatics have an effect on cerebral haemodynamics is unknown. Near-infrared spectroscopy and Doppler ultrasonography (US) are non-invasive methods commonly used for neuromonitorization in NICUs. The regional blood flow changes measured using Doppler US have been reported to be associated with cerebral oxygenation and indicate a high correlation with NIRS in newborns.

The aim of this study was to evaluate the effects of mydriatic eye drops on cerebral oxygenation and blood flow in preterm infants by NIRS and Doppler US.


Eligibility Criteria:
Inclusion Criteria:

* Babies born at gestational age less than 34 weeks and/or birth weight below 2000 grams.

Infants undergoing their first retinopathy examination.

Exclusion Criteria:

* Congenital anomaly

  * Continued mechanical ventilation support
  * Having pain from a different cause and/or requiring concurrent analgesic use
  * Sedation analgesia administered within the last 24 hours
  * Hemodynamically unstable
  * Intraventricular hemorrhage, neurological dysfunction
  * Receiving anticonvulsant therapy.
Prone Plank Exercises for Diastasis Rectus Abdominis in Postpartum Women

The purpose of this study was to compare between the effects of prone plank exercises versus ES for DRA in postpartum women.

The study conducted on forty-two woman. They had diastasis rectus abdominis12 weeks to 36 months postpartum. They were randomly divided into two equal groups; group A received prone plank exercises while group B recieved electrical stimulation.All patients recieved three sessions per week foe eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* they had DRA 12 weeks to 36 months postpartum, and were referred to physiotherapy by a gynaecologist, multiparous with the IRD measuring greater than two cm. Age ranged between 20-35 years. Body mass index didn't exceed 30 kg/m2.

Exclusion Criteria:

* they were in ongoing pregnancy, twin pregnancy, premature birth before gestation week 37, and exceeded more than thirty-six months postpartum.
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)

The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart and reduce symptoms (such as shortness of breath, dizziness, and others).

The purpose of the study was to confirm the AT500 intervention pacing effectiveness data previously seen in the ASPECT clinical trial and to gather additional data to understand the effectiveness of the intervention pacing features. Specifically, the goal of the trial is to demonstrate a reduction in frequency in symptomatic atrial tachycardia/atrial fibrillation recurrence with the intervention pacing features in patients with a pacing indication and a history of atrial tachyarrhythmias with atrial pacing leads located in the region of Bachmann's Bundle.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with fast and/or slow heartbeats who are in need of dual chamber pacing (pacing in both the atria and ventricles) as determined by their doctor.
* Subjects who have a history of occasional fast heartbeats originating from the upper heart chambers.
* Subjects who have experienced at least two symptomatic episodes of fast heartbeats three months prior to enrollment.
* Subjects that are expected to stay on the same heart medications during the length study.

Exclusion Criteria:

* Subjects who have permanent (chronic) or persistent (not self-terminating) atrial fibrillation (fast heartbeats originating from the upper heart chambers).
* Subjects who have atrial fibrillation due to a reversible cause, i.e. electrolyte imbalance.
* Subjects who are current or immediate implantable cardioverter defibrillator (ICD) recipients.