cyrilzakka/clinical-trials huggingface dataset:
Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia

this is an interventional prospective clinical study which was conducted to evaluate the efficacy, safety, predictability, ocular aberrations, and flap thickness predictability of Visumax femtosecond laser (FSL) compared to Moria M2 microkeratome (MK) in mild to moderate myopia.

This study included 60 eyes who were divided into two groups. Thirty eyes in group (I) in which the flap was created with Visumax FSL, while in group II (30 eyes) the Moria M2 MK was used. Keratometric, refractive, and aberrometric measurements were compared preoperatively and 3 months postoperatively. The intraoperative subtraction pachymetry (the SP 100 Handy pachymeter (Tomey, Nagoya, Japan) was used for preoperative pachymetry and flap thickness measurement.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients were eligible for the study if they were older than 18 years and younger than 40 years.
* Stable myopia up to -6.0D and astigmatism up to -3.0D determined by manifest refraction for at least 6 months.
* best corrected distance visual acuity of at least 20/20, and stable keratometry after cessa¬tion of soft contact lens wear for at least 2 weeks.

Exclusion Criteria:

* any anterior seg¬ment pathology.
* any form of retinal degeneration. unstable myopia.
* severe dry eye.
* corneal thickness that would have resulted in less than 300 µm residual stromal thickness.
* Patients who had keratoconus or were keratoconus suspects.
* previous ocular sur¬gery.
* a history of herpes zoster ophthalmicus or herpes simplex keratitis.
* a history of a steroid-responsive rise in in¬traocular pressure (IOP) or a preoperative IOP of more than 21 mmHg.
* diabetes mellitus, autoimmune dis¬ease, connective tissue disease, and chronic use of systemic corticosteroid or immunosuppressive therapy were also excluded from the study.
A Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa

The purpose of this study is to collect historical occurrences of risk factors that are potentially associated with the development of anti-erythropoietin (EPO) antibody positive pure red cell aplasia (PRCA) in participants with chronic kidney disease who have been recently treated with epoetin alfa (EPREX).

This is a multicenter (study conducted at multiple sites), case-control (study that compare individuals with a disease or condition \[cases\] to a group of individuals without the disease or condition \[controls\] to determine the possible factor which increased disease incidence), retrospective (a study in which the participants are identified and then followed backward, as time passes) study. Retrospective risk factor data will be collected for control participants matched to the subset of participants in Protocol EPO-IMU-301 identified as having chronic kidney disease and anti-EPO antibody positive PRCA that began while the participant was receiving treatment with EPREX (index participants). For each index participant, up to 4 matched non-PRCA control participants with chronic kidney disease will be enrolled in this study. Approximately 600 control participants will be enrolled in this study. Control participants will be selected from the same site as the index participant and the data will be collected from the date closest to the reference date (loss of efficacy \[drop in hemoglobin of greater than 2 g/dL/month\] was first seen) that the control participant satisfies all study inclusion and exclusion criteria. The optional pharmacogenomic part (testing for polymorphisms and haploid types of the erythropoietin gene) will be recorded for the control participants who will sign the pharmacogenomics part of the study. No drug administration or treatment will be mandated by this study. Safety evaluation will include assessment of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* History of anemia due to chronic kidney disease
* Pure red cell aplasia (PRCA) associated with erythropoietin-alpha (EPO) treatment
* Treatment with EPO for a minimum of 2 months occurring within more or less 3 months of the reference date (date of loss of efficacy \[drop in hemoglobin of greater than 2 g/dL/month\] was first observed)

Exclusion criteria

* History of and information related to past exposure to EPO not available
* History of PRCA or anti-EPO antibody positive status before or after the reference date
Ayurveda Self-Management for Flu Like Symptoms During the Covid-19 Outbreak

From the end of January 2020, Coronavirus disease 2019 began to spread in United Kingdom (UK). During the same time, seasonal flu continued to circulate across the UK. With similar course of management at early stages, flu like symptoms were self-isolated to prevent the spread and further complications of infection. Present study aimed to evaluate the effect of self-managed Ayurveda on flu like symptoms in people who self-isolated at home for 7-days in March 2020 during the Covid-19 outbreak in UK.


Eligibility Criteria:
Inclusion Criteria:

* Flu like symptoms present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration
* Willing to consent and follow up

Exclusion Criteria:

* Pregnant/lactating
* Participants with chronic pulmonary diseases or critical condition or already developed severe respiratory distress
* Clinically malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study - Known hypersensitivity to any ayurveda herbal substances
Phase I/II Study of Chemo-Immunotherapy Combination in Melanoma Patients

This phase I/II study is directed at evaluating safety and immunogenicity of a melanoma peptide vaccine in combination or not with Dacarbazine administration in melanoma patients

Recently, it is becoming increasingly accepted that, in order to induce a clinically effective antitumor response, immunotherapy needs to be combined with chemotherapy. Thus, the traditional perception that chemotherapy and immunotherapy act through unrelated mechanisms which may be antagonistic is challenged on the premises that a selected panel of drugs can induce an immunogenic cell death producing specific danger signals. Furthermore, chemotherapy combined to immunotherapy may affect antigen cross-presentation, induce a "cytokine storm", reduce the number of regulatory T cells and activate homeostatic lymphoid proliferation. Our previous results obtained in a mouse model, demonstrated that drug-induced cytokines can favour antitumor immunity. Based on this observation, we explored whether the administration of dacarbazine (DTIC) in disease-free melanoma patients in combination with peptide vaccination could result into an improved anti tumor immune response.

Patients included in the study were assigned to two treatment arms either receiving anti-tumor vaccination with Melan-A and gp100 analog peptides alone (arm 1) or in combination with DTIC pre-treatment (arm 2).

Arm 1, vaccine alone: patients received i.d. injections of Melan-A: 26-35 (A27L) and gp100: 209-217 (210M) peptides (250 µg each) formulated in Montanide ISA-51 plus s.c. injection of 3MU IFN-α, as an adjuvant on day 1 and 8 every 21 days for a total of 5 courses (10 vaccinations). Both peptides and IFN-α were injected in close but separate sites next to local lymph nodes.

Arm 2, DTIC plus vaccine: the same vaccination schedule was combined with DTIC (800 mg/mq i.v.) administered one day before each vaccine administration according to the standard treatment.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven diagnosis of melanoma stage II, III, and IV without clinical/radiological evidence of disease
* Age \>18 years
* life expectancy of more than 6 months
* ECOG performance status of 0-2
* adequate blood cell counts and kidney-liver function
* use of adequate contraceptive methods
* signed informed consent

Exclusion Criteria:

* concomitant or previous history of malignant disease, except for in situ cervical carcinoma or non melanomatous skin cancer
* severe cardiovascular disease
* clinically active infections and/or significant autoimmune diseases
* concomitant or previous (within 6 weeks) treatment with immunosuppressive drugs
* previous treatments with chemotherapy and/or interferon alpha or beta within 4 weeks and/or radiotherapy within 6 weeks an/or biological therapy within 8 weeks before starting vaccination
* psychiatric illness interfering with patient compliance, pregnancy or lactation
Interventions for Postoperative Delirium: Biomarker-2 (IPOD-B2)

The IPOD-B2 Study aims to understand the pathogenesis of postoperative delirium in patients undergoing major surgery. The investigators will identify then correlate soluble biomarkers in blood and cerebral spinal fluid with changes in High Density-Electroencephalogram.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (\>21 years old)
2. Patients scheduled for an elective open thoracoabdominal aortic aneurysm or TEVAR (thoracic endovascular aortic/aneurysm repair)
3. Requiring spinal drain for surgery that is predicted to stay in two or more days
4. Willing and able to provide informed consent

Exclusion Criteria:

1. Contraindication for spinal drain
2. Documented history of dementia
3. Unable to communicate with the research staff due to language barriers
4. Individuals who the PI determines are not appropriate for the study such as a history of appointment cancellations.
5. Pregnant or Nursing
6. Prisoners
Development of Camera Based Gait Quality Measure for Persons With Multiple Sclerosis

The purpose of this study is to develop a measurement of walking quality, called Gait Deviation Index (GDI) for people with Multiple Sclerosis (MS).

In rehabilitation in general, in order to track patients' progress and provide next steps, there is a need for easily obtainable, understandable, and objective measures of ability. Currently, there is no measure that clinicians can utilize to determine walking quality. While Gait Deviation Index has been validated and can reliably be used in adults who experienced a Spinal Cord Injury, it has not yet been validated in people with MS. After the MS-specific GDI is developed from this study, therapists and clinicians will be able use it as a reliable progress measure. Which may lead to the delivery of more effective therapy for patients with MS.

Here we plan to measure body position with camera based tracking during your gait cycle.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of relapsing form of MS (including relapsing-remitting MS and secondary progressive MS)
* Able to ambulate overground
* Relapse free for at least 1 month
* Age ≥18 and ≤ 75 years
* Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening

Exclusion criteria:

- Orthopedic injuries, fractures, surgeries or other conditions affecting locomotor function or weight bearing
Applying Pulsed Radiofrequency to the Pudendal Nerve Bilaterally Vs Its Application to Sacral Nerve Roots S2,3 and 4 Bilaterally in Chronic Prostatitis

Prevalence estimates show that prostatitis is one of the most common urological conditions and that symptoms range considerably among men of various socioeconomic status, race, and age. For men under 50 years, prostatitis is the most common urologic outpatient diagnosis. Chronic prostatitis/chronic pelvic pain syndrome has high prevalence estimates internationally ( 16% North America, 14% Asian \& Europeans). Men suffering from Chronic prostatitis/chronic pelvic pain syndrome report significant impairment in their quality of life which is also associated with greater health care expenditures.

The hallmark indicator of Chronic prostatitis/chronic pelvic pain syndrome has been identified as enduring pain in the perineum, pelvic area, and/or genitalia in many studies. As in other painful chronic conditions, pain does not correspond strongly with objective medical findings and has no orthodox pathology. It is however associated with voiding and sexual disturbances. Symptoms should have been present for at least 3 months within the previous 6 months and must be validated with the standard questionnaire of the National Institute of Health-Chronic Prostatitis Symptom Index. In most patients, pain is the main symptom. Chronic bacterial prostatitis the predominant type of prostatitis is a common and painful condition, typified by pelvic area pain and lower urinary tract symptoms, for which effective diagnostic techniques and treatment strategies remain elusive. Previous studies have documented an association between prostatitis and both psychiatric and rheumatologic diseases. Socioeconomic status indicators, such as lower education and lower income, also played an important role in predicting which men would have worse chronic prostatitis symptoms. These findings are consistent with those found among women with interstitial cystitis; women with lower education and income in the Interstitial Cystitis Database were more likely to report more severe symptoms.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III.

Exclusion Criteria:

* those with infection at the site of injection,
* coagulopathy or another bleeding diathesis,
* a pre-existing neurologic deficit in the targeted region,
ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

The aim of the study is to improve the immediate results after reconstructive and restorative operations on the biliary tract by substantiating the management of the perioperative period on the principles of "enhanced recovery after surgery".

A prospective randomized study on the effect of fast-track surgery on the immediate postoperative results after various reconstructive and restorative operations on the bile ducts. In the Department of Surgical Hepatology and Transplantation, a prospective randomized study will include patients (about 50) with planned reconstructive and restorative operations on the bile ducts for malignant and benign diseases of the bile ducts.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with malignant diseases of the biliary tract (cholangiocarcinoma):

   1.1. tumor resectability 1.2. absence:
   * distant metastases
   * carcinomatosis
   * perforation of the tumor and peritonitis
   * sprouting into adjacent organs and tissues (locally advanced cancer)
   * total adhesion process in the abdominal cavity (after previous operations). 1.3. Planned reconstructive surgery on the biliary tract.
2. Patients with benign biliary tract pathology. 2.1. Planned reconstructive or restorative surgery on the biliary tract for the following diseases:

   * choledocholithiasis
   * Mirizzi syndrome
   * cysts of the common bile duct
   * strictures of the common bile duct
   * injuries to the bile ducts
   * adenoma and stricture of the OBD

Exclusion Criteria:

1. Scale ASA\> III (severe concomitant cardiovascular pathology).
2. Palliative reconstructive surgery.
3. Previously performed operations on the bile ducts (up to 1 month).
4. Cachexia.
Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease

The diagnosis of a patient with pulmonary hypertension (PH) requires many investigations. At present cardiac catheterisation is the cornerstone investigation in these patients where it is used to establish disease severity and estimate prognosis. It is an invasive procedure which is expensive and not without risk to the patient. Despite the multitude of tests performed, identifying those patients with PH who have a poor diagnosis can be difficult. The aim of this study is to improve the assessment of patients with PH using novel magnetic resonance techniques.


Eligibility Criteria:
Inclusion Criteria:

* All cases referred to the clinic for assessment for possible pulmonary hypertension.

Exclusion Criteria:

* patients with a cardiac pacemaker or retained temporary pacing wire
* patients with aneurysm clip
* non MRI compatible heart valve prosthesis
* intra orbital metalic foreign body
* pregnancy
* metal prosthesis/spinal rods
* retained shrapnel
* cochlear implants/bladder stimulator
Glucagon-like Peptide 1 Agonist Exenatide for Improved Glucose Control and Cardiac Function in Patients With Aortocoronary Bypass

GLP-1 has not only beneficial effects on glucose metabolism but also direct positive effects on cardiac function and metabolism in both experimental models and in patients with type 2 diabetes mellitus. Clinical data on the effects of GLP-1 agonists on cardiac function and glucose control in patients undergoing cardiac surgery are not known. Based on the results of experimental studies there is a potential for exenatide to positively influence both cardiac function and glucose metabolism in cardiac surgery patients with and without type 2 diabetes mellitus. The primary endpoint of this study is to examine whether pre- and peri-operative administration of exenatide affects perioperative hemodynamics, echocardiographic parameters, necessity of antiarrhythmic and inotropic treatment and glucose control in patients with coronary atherosclerosis and decreased left ventricular function undergoing elective coronary artery bypass grafting operation (CABG). In addition, safety and tolerability of peri-operative administration of exenatide in these patients will be examined as a secondary study objective.


Eligibility Criteria:
Inclusion Criteria:

* elective coronary artery bypass grafting operation (CABG)
* decreased left ventricular (LV) systolic function (EF LV ≤ 50%)
* Age 18 to 85
* Signed informed consent
* Females with childbearing potential have to use appropriate contraceptive measures during the whole study period and 6 months after terminating exenatide infusion (hormonal contraception or double-barrier contraception for both partners)

Exclusion Criteria:

* allergy to exenatide
* allergy to insulin
* mental incapacity or language barrier
* use of incretin-based therapies \<3 months before inclusion in the study
* diabetic ketoacidosis
* established autonomic neuropathy
* history of acute pancreatitis or severe disease of digestive tract
* renal failure (preoperative creatinine ≥ 180 umol/l)
* liver failure (coagulation times more than 1.5 times higher without use of anticoagulants)
* cardiac surgical procedure on valve, thoracic aorta or MAZE procedure
* pregnancy and lactation
Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest

The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy rate during hypothermia after cardiac arrest.

Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers are in use, together with analgesia and sedation, during the cooling process in many centers to prevent shivering. However, neuromuscular blockers are accused to be associated with various side effects causing serious harm and/or leading to prolonged ICU stay. Furthermore, the use of neuromuscular blockers may mask epileptic activity. Therefore, the advantages and disadvantages of neuromuscular blockers during therapeutic hypothermia need to be re-evaluated.

Aim of this study is to investigate if continuous application of neuromuscular blockers is necessary to prevent shivering and thereby avoiding an increase in energy expenditure in patients during therapeutic hypothermia and rewarming after cardiac arrest (initial 72h).

Eligibility Criteria:
Inclusion Criteria:

* All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin

Exclusion Criteria:

* age \< 18
* cardiac arrest \>6 hours before admittance at the hospital
* patients with known or clinically apparent pregnancy
* patients who reach our hospital with a body temperature below 35°C
* patients with known allergic reactions against rocuronium
* patients with a history of myasthenia gravis
* patients with obvious intoxication
* wards of the state/prisoners
* patients with known epileptic disease
Comparison of Self-ligating Mico One and Conventional MBT Brackets Regarding Alignment Efficiency and Pain Experience- a Randomized Clinical Trial

The rate of Orthodontic tooth movement affects the efficacy and time duration of the treatment. One of the key factors, during the initial alignment phase, is the amount of the force that the arch-wire applies to the dentition. The amount of the applied force and the rate of tooth movement are directly proportional to the frictional resistance between the arch wire and bracket. The quality and degree of resistance is related to the physical characteristics of the arch wire, bracket material, arch wire dimensions, and the type of arch wire ligation. The estimated rate of tooth movement is about 0.35 to 2.04 mm per month, which is influenced by various factors and variables including the biological response of the individual to orthodontic forces, the complexity of the case, treatment mechanics and patient compliance throughout the course of treatment .

To compare the alignment efficiency and pain experience of Mico-one self-ligating and conventional ligating MBT pre-adjusted brackets in the initial alignment stage of patients undergoing orthodontic treatment.CONVENTIONAL MBT BRACKETS: In conventional brackets elastic ligatures or metal ties are used to ligate the wire in the bracket slot. 2. SELF-LIGATING BRACKETS: Self-ligating brackets like conventional braces are placed relatively the same way.

The exception is that self-ligating braces don't use elastics, or metal ties. Instead it has special clips or brackets with a spring-loaded door. The brackets while maintaing pressure on the archwire, help move the teeth along it at a steady pace .\[9\] 3 .ALIGNMENT EFFICIENCY Movement of the teeth measured at four months interval. Scoring method involves measuring the linear distance between anatomical contact points between maxillary and mandibular incisors from adjacent tooth anatomical points. (Little's irregularity index)

4.PAIN Unpleasant sensory and emotional experience associated with tooth movement will be measured as a mean using the VAS at 4 hours, 24 hours, day 3, day 7, 1 st Month, 2 nd Month, 3 rd Month and 4 th Month.

Eligibility Criteria:
Inclusion Criteria

* Patients with Non extraction orthodontic treatment plan
* Crowding of 3 to 6 mm according to Little's irregularity index
* Both male and female patients
* 14-20 years of age.
* All permanent teeth present up to first permanent molar

Exclusion Criteria:

* Poor oral hygiene
* Systemic disease
* Patients with periodontally compromised teeth
* Patient requiring Orthognathic surgery to correct skeletal discrepancies
* Patients taking medications, like NSAIDs or other anti-inflammatory drugs
* Cleft lip or palate
* Hypodontia, or Hyperdontia