cyrilzakka/clinical-trials huggingface dataset:
Researches of Retinal Artery Lesions and Acute Coronary Syndrome

This study is to investigate the relationship between staging of retinal artery lesions and the prognosis of acute coronary syndrome (ACS) in a Chinese population. All the patients were divided into four groups according retinal artery lesions.The endpoints were main adverse cardiovascular and cerebrovascular events (MACCE), including all-cause death, myocardial infarction (MI), and stroke after 3 to 6 years of follow-up.

The aim of this study was to determine whether retinal artery lesions can predict long-term adverse outcomes in acute coronary syndrome (ACS) patients after drug-eluting stent (DES) implant.

A total of 660 consecutive patients with ACS who underwent coronary angiography and percutaneous coronary intervention enrolled this study at the Beijing Mentougou District Hospital, Beijing Tiantan Hospital and Beijing Shijitan Hospital. All the subjects were divided into two groups based on the retinal artery lesions: Group 1, retinal artery lesions≤ Stage 2 (n=296) and group 2 (n=364), retinal artery lesions \> Stage 2. Beside,the eye fundus examination was done in all patients to mesure the extent and severity of atherosclerotic vascular lesions in the retinal arteries . Patients were excluded from the study if they had severe nephropathy (GFR\< 30 mL/min/1.73 m2), vascular obstruction, acute illnesses or any other condition that was thought to contraindicated coronary angiography.

Primary endpoint was all-cause mortality. The composite endpoint was defined as major adverse cardiac and cerebrovascular events (MACCE), namely recurrent serious angina pectoris, nonfatal MI, revascularization and stroke.

Eligibility Criteria:
Inclusion Criteria:

* consecutive patients with ACS who performed coronary angiography (CAG) and percutaneous coronary intervention (PCI).

Exclusion Criteria:

* Patients were excluded from the study if they had heart failure, malignancies, renal insufficiency (creatinine \> 133µmol/L), liver disease, stroke and severe lung disease.
Cross-linked Hyaluronan Gel Reduces Rectal Toxicity Due to Radiation Therapy for Prostate Cancer

The primary purpose of this study is to determine if cross-linked hyaluronan gel reduces the dose of radiation delivered to the rectum and the rectal toxicity of radiotherapy for localized prostate cancer.

The main risk associated with transperineal injection of cross-linked hyaluronan gel into the anterior perirectal fat is infection. Prophylactic antibiotics will be given, resulting in a \<5% risk. Another possible risk (\<5%) is an allergic reaction such as itching. Patients who are allergic to avian products will be excluded from the study. Tenderness and pain at the injection site are possible. Bleeding, bruising, redness, or discoloration or the formation of a bump (granuloma) or scar (keloid) at the injection site is also possible. Embolization of cross-linked hyaluronan gel through the blood is a potential, rare complication if the gel is injected into a blood vessel rather than into fat. Prada et al. did not see any side effects related to the injection or the material itself in 27 patients based on a mean follow-up of 13 months (range: 9-22 months). Patients did not complain of pain, tenesmus, rectal pressure, or a sensation of rectal filling. Risks beyond 22 months are not well defined. Potential benefits of cross-linked hyaluronan gel include fewer rectal complications due to radiotherapy for early-stage prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically-confirmed adenocarcinoma of the prostate, clinical stage T1c-T2c, NX, N0, M0.
2. Nodes determined to be negative by imaging methods will be classified as NX. Only nodes determined to be negative by surgical sampling will be classified as N0.
3. Prostate cancer biopsy grading by Gleason score classification is mandatory.
4. No prior pelvic radiotherapy. Induction hormonal therapy for less than or equal to 6 months is acceptable.
5. Prostate volume by TRUS \< 50 cc prior to HDR brachytherapy.
6. Prostate specific antigen (PSA) less than or equal to 30 ng/ml.
7. Patient has provided informed consent.

Exclusion Criteria:

1. Clinical stage T3 or T4.
2. Clinical evidence of lymph node involvement (N1).
3. Clinical evidence of distant metastases (M1).
4. Radical surgery for carcinoma of the prostate.
5. Allergy to avian products.
6. Significant mental, medical, or physical impairment.
7. Prisoners.
8. Employees of the Cancer Center of Irvine.
Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries

The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.

Patients will be treated according to hospital routine with anticipated visits 30 days, 6 months, 12months and 24 months after the index procedure. Data on Rutherford grade, wound healing, patency of the target lesion, concomitant antiplatelet medication and Adverse Events will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant, non-breastfeeding female ≥18 years of age;
2. Rutherford Clinical Category 3-5;
3. Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen;
4. Significant stenosis (≥70%) or occlusion of one or more native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment;
5. Lesion(s) can be treated with available Lutonix DCB device size matrix per current Instructions for Use (IFU); and
6. Target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent (\<50% residual stenosis) inframalleolar outflow vessel (planned treatment below-the-ankle is not allowed).

NOTE: Outflow must be assessed AFTER pre-dilatation NOTE: More than one artery allowed, but each target vessel MUST demonstrate inline inframalleolar outflow.

Exclusion Criteria:

Patients will be excluded if ANY of the following conditions apply:

1. Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix BTK registry);
2. Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or
3. Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).
The Analgesic Efficacy of Wound Infiltration With Tramadol

This double-blind, randomized trial examined whether tramadol wound infiltration decreased postoperative pain following cesarean delivery under general anesthesia or reduced the need for analgesics in the immediate postoperative period. Patients in the tramadol group consumed significantly less morphine at all time intervals than those in the control group. The investigators suggest that the use of wound infiltration with tramadol may be a useful technique in patients who undergo cesarean section under general anesthesia to reduce postoperative pain, improve recovery, and facilitate early contact of mothers with their babies.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparity
* Gestation age between 37-40 weeks
* CS under general anesthesia

Exclusion Criteria:

* Pre-eclampsia
* Cardiovascular problems
* Allergy to any of the study medications
* Chronic preoperative pain
* Regular analgesic use
Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)

This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS

This study is a prospective, randomized, placebo-controlled, blinded, dose escalation study of 3 to 4 cohorts with defined number of patients per cohort receiving active drug or placebo for a period of 4 months followed by safety monitoring for an additional 4 months after the last dose

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Secondary Progressive Multiple Sclerosis
* Aged 18 to 57 years old, at the time of informed consent

Exclusion Criteria:

* History of clinically important (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, immune, psychiatric, hepatic, renal or hematologic insufficiency or any other major disease other than MS ( Multiple Sclerosis)
* Inability in the opinion of the Investigator to comply with study requirements
* Other protocol-defined criteria may apply
Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata

Systemic Pulse Glucocorticoids have been shown to be effective in widespread Alopecia areata but not the totalis, universalis or ophiasic type. Whether the failure is due to inadequate dosing, inadequate frequency or other factors is a matter of debate. The investigators decided to conduct this study using the oral pulse steroid, however with higher doses and more frequent pulses to patients with severe forms of Alopecia areata.

This will be a single-center, prospective, randomized study conducted in King Khalid University Hospital. Patients diagnosed with either Alopecia universalis, Alopecia totalis or Ophiasic alopecia will be included in the study. Patients with contraindications such as diabetes mellitus, peptic ulcer, hypertension, infection, psychosis, heart or kidney disease, endocrine disorders (apart from a subclinical hypothyroidism and autoimmune thyroiditis) will be excluded. Children less than 5 years of age and those who received systemic or topical treatment within the last 4 weeks before enrollment will be also excluded. Those of child bearing potential had to have a negative urine pregnancy test result at baseline visit and should practice a reliable method of contraception throughout the study. 42 eligible patients will be randomly assigned to one of 3 treatment groups. Enrolled patients must provide written informed consent. Institutional review board approval will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Alopecia Universalis
* Alopecia Totalis
* Ophiasic Alopecia

Exclusion Criteria:

* diabetes mellitus
* peptic ulcer
* hypertension
* infection
* psychosis
* heart disease
* kidney disease
* endocrine disorders (apart from a subclinical hypothyroidism and autoimmune thyroiditis)
* received systemic or topical treatment within the last 4 weeks before enrollment
* pregnancy
Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT to Predict Left Ventricular Remodelling in Patients Reperfused in the Acute Phase of MI

Left myocardial infarction (MI), has a negative impact of long term morbidity and mortality. Even in patients treated successfully by angioplasty in the acute phase of infarct, the remodelling is observed in approximately 30% of cases. It is important to predict the occurrence of this phenomenon in the early phase after MI for the selection of patients who could eventually benefit from new therapeutic approach as for example cell replacement therapy. It has been advocated that stem cells coronary injections should be performed between the 5th and 10th day after an acute event. We hypothesise that a low dose dobutamine gated Tc-99m-mibi SPECT performed on 5th-6th day after reperfused acute MI can predict left ventricular remodelling and serve as a method to screen patients who could benefit from cell replacement therapy.

All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day) and at 6-month follow-up. Left ventricular remodelling will be defined as an end-diastolic volume increase of \>20% between the two exams. A low dose dobutamine gated Tc-99m-mibi SPECT will be also performed on 5th-6th day. Differences in the infarct size and severity as well as the residual inotrope reserve in the infarct area are expected between groups with and without remodelling.

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction,
* Successful coronary angioplasty in the acute phase,
* Absence of heart failure in the acute phase

Exclusion Criteria:

* acute heart failure in the acute phase
* severe ventricular arrhythmias
* contra indications for MRI imaging
Does Adding Magnesium Sulphate to Low Dose Rocuronium Affects Depth of Blockade

This study aim is to compare the effect of magnesium sulphate combined with low dose rocuronium versus standard dose rocuronium

Comparing the effect of magnesium sulphate combined to low dose rocuronium versus standard dose rocuronium in cancer patients undergoing direct laryngoscopy for laryngeal tumors regarding intubating conditions, intraoperative relaxation, depth of anesthesia and recovery time.

Eligibility Criteria:
Inclusion Criteria:

Patients with Laryngeal tumors

ASA I-II

Age 30-70 years

Exclusion Criteria:

Renal and or hepatic insufficiency

Neuromuscular disease

Large glottic and/or supra-glottic lesions with or without breathing difficulties

Known allergy to any of the used drug
High-intensity Interval Training in Patients With Post-acute Coronary Syndrome

To date, no studies have evaluated the safety or efficiency (improvement of maximal oxygen uptake \[VO2peak\]) of a high-intensity interval training (HIIT) program in post-acute coronary syndrome (post-ACS) patients. Heart rate variability (HRV) and recovery (HRR), QT dispersion (QTd) and ventricular arrhythmias are all indices associated with an increased risk of cardiac death. HIIT has been shown to improve these risk markers and be safe in coronary heart disease patients but not yet in post-ACS patients which are considered more at risks.

The aim of this study was to compare a HIIT program to a moderate-intensity continuous exercise training (MICET) program on HRV, HRR, QTd parameters and occurrence of ventricular arrhythmias in post-ACS patients.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged ≥ 18 years
* Acute coronary syndrome within 6 weeks (unstable angina, or non-ST elevation myocardial infarction (NSTEMI), or ST elevation myocardial infarction (STEMI with the presence of 2/3 criteria (i.e. typical chest pain, electrocardiographic ischemic change or elevated troponin T
* Complete revascularization defined as no major epicardial coronary artery or bypass graft with a residual diameter stenosis \>50% and no residual left main stenosis ≥40%
* Left ventricular ejection fraction \>40%
* Stable doses of medication during the 4 weeks prior to enrolment (STEMI patients must be on a stable dose of beta-blocker)
* Able to perform a maximal cardiopulmonary exercise test, 7) capacity and willingness to sign informed consent.

Exclusion Criteria:

* Recent coronary bypass surgery (\<6 months)
* Incomplete revascularisation, left ventricular ejection fraction \<40%
* Significant valvular disease (mitral stenosis, moderate to severe mitral insufficiency, aortic stenosis, or aortic insufficiency)
* Uncontrolled hypertension (systolic blood pressure/diastolic blood pressure \>180/110 mmHg)
* Significant resting electrocardiogram abnormalities (left bundle branch block, non-specific intraventricular conduction delay, left ventricular hypertrophy, resting ST-segment depression)
* Chronic atrial fibrillation
* Pacemaker or implantable cardioverter defibrillator
* Low functional capacity (\<5 basal Metabolic Equivalent of Task \[METs\])
* Change of cardiac medications within 4 weeks of enrolment and any contraindication to exercise testing or exercise training.
SIRT1 Gene Polymorphism With Premature Myocardial Infarction in Young Egyptian Patients

This is an observertional study aimed at Study the association of SIRT1(rs7069102 ) Gene polymorphism with premature myocardial infarction in young Egyptian patients


Eligibility Criteria:
Inclusion Criteria:

* All patient with recent MI admitted to Sohag University Hospital , CCU under 40 years

Exclusion Criteria:

* patients above 40 year old.
* Patients with malignancies, major trauma or surgery in the previous six months, and acute or chronic infectious disease
Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism

The purpose of this study is to determine the natural course of the androgen profile after bariatric surgery in men with obesity related hypogonadotropic hypogonadism.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 20-55 years
* Planned bariatric procedure
* Helicobacter pylori negative or adequate HP eradication

Exclusion Criteria:

* Liver and/or kidney dysfunction
* Psychiatric disease
* Medication influencing androgen profile and/or bone metabolism
* Weight \> 160 kg
Effect of Postoperative Additive Systemic Steroids in CRSwNP

This study investigate the additive effect of systemic postoperative steroids in patients with chronic rhinosinusitis (CRSwNP). All patients receive a functional endoscopic sinus surgery (FESS) followed by topical steroid spray for 3 months. Postoperatively, patients will be randomized to either an additional systemic steroid or a placebo for 1 month. Patients will be followed for 2 years. Effect on Nasal Polyp score (NPS), Lund-Kennedy-Score (LKS), recurrence rates, smell scores, Rhinosinusitis Disability Index (RSDI), Short-Form 36 (SF-36) and mucus/serum biomarkers will be measured.


Eligibility Criteria:
Inclusion Criteria:

* CRSwNP
* refractory to medical therapy
* no previous sinus surgery
* Lund-Kennedy-Score ≥ 1
* Lund-Mackay-Score ≥ 10

Exclusion Criteria:

* ciliary impairment
* autoimmune disease
* cystic fibrosis
* immunodeficiency
Neuropathy and Anti-GFAP Antibodies

Anti-Glial Fibrillary Acidic Protein (GFAP) are antibodies associated to inflammatory diseases of the central nervous system. The GFAP protein is highly expressed by astrocytes explaining these syndromes, but GFAP is also expressed by immature and non-myelinating Schwann cells. Thus, these antibodies could also lead to damages of the peripheral nervous system (PNS). Moreover, such damages have already been reported on small studies, and there is a need for larger cohorts.

The investigators will use the cohort of patients with neurological syndromes and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the "Reference center for paraneoplastic neurological syndromes and autoimmune encephalitis" to determine the frequency of the PNS involvement in these patients.


Eligibility Criteria:
Inclusion Criteria:

* - Age \> 18 years old
* Neurological symptoms
* Anti-GFAP antibodies identified in the CSF

Exclusion Criteria:

* - Uncomplete data in the medical records of patients
Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit

Sleep of critically ill patients is highly disturbed with a high sleep fragmentation; patients spend most of their sleep in very short sleep episodes, lasting less than 10 minutes. Causes of theses sleep alterations are complex including environmental noise (alarms, beepers, conversations...), continuous light, nurse care and repetitive measures of vital parameters.

Numerous studies have reported a relationship between severe sleep alterations and a prolonged weaning period and mortality. Improving sleep quality in critically ill patients is a major challenge to promote ICU patient's recovery.

A very promising treatment is the application of a nocturnal " quiet-time " during which non urgent care, comfort care, systematic measures of vital parameters are delayed and clustered in order to limit room entries. However, " quiet time " procedures have failed to improve sleep quality to date.

A miniaturized medical device recording one EEG channel and embedding an automated sleep scoring algorithm running in real-time was devised. This device (positioned on forehead, and continuously recording noise and light levels) indicates if the patient is awake or asleep using a tablet positioned at doorstep of the room, so that nurses know if patient is sleeping, without entering the room.

Hypothesis proposes that applying sleep protection procedures (clustering cares, limiting room entries, reducing lights and noise, delaying non urgent care...) when patients are sleeping (= EEG-guided strategies) will increase patients sleep quality.

This study will assess the effect of such device on sleep quality in ICU patients. This is a "before / after" design. The first group ("control group"), will be recorded but the sleep scoring will not be displayed by the tablet and patient will be expose to standard care. Then, procedure will be established collegially with nurses, nurses assistants and doctors. Then, the second group ("treated group") will be recorded with the device displaying the status of the patient (asleep/awake) and all caregivers will be asked to follow the established rules ("EEG-guided sleep protection rules")


Eligibility Criteria:
Inclusion Criteria:

* Adults admitted in medical ICU of University Hospital of Poitiers

  * Un-sedated patients displaying a RASS scale between -2 and +1
  * Intubated or spontaneously breathing patients
  * Patient or family have signed the inform consent

Exclusion Criteria:

* Patients with a central nervous system disease altering sleep scoring
* Patients who received drugs (\<24h) modifying significantly EEG and sleep scoring
* Patients with cutaneous erosion of the scalp
Tattoo Particles: Picosecond Laser Versus Nanosecond Laser

- For treating unwanted tattoos, the gold standard treatment is a nanosecond or picosecond laser. However, comparative microscopic analysis is limited. Therefore, the aim of the present study is to analysis morphological changes of tattoo particles and surrounding tissue in human skin.


Eligibility Criteria:
Inclusion Criteria:

- healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department

Exclusion Criteria:

* laser pretreatment of their tattoos to be treated
* pregnancy, breast feeding
* open wound on the area to be treated