cyrilzakka/clinical-trials huggingface dataset:
Axial Length Variability

The accuracy of IOL calculation relies on the one hand on axial length measurements and on the other hand on corneal and lens thickness measurements.

AL difference in pre and postoperative measurements may be caused by changes of lens parameters.

Aim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL.

This is a prospective observational, controlled and unmasked study that would include patients which undergo cataract presurgical examination, after patient signed written informed consent. For each patient only one eye will be included.

In total 50 eyes of 50 patients will be include. Due to missing previous data, the sample size is an approximation.

Prior to surgery, slit lamp examination and cataract grading (LOCS) is performed. Routine biometry is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and Heidelberg Anterion (Heidelberg Engineering, Germany) for AL and lens measurement.

Additionally, evaluation of tilt and decentration will be performed using Purkinje meter device.

Follow-up examination will be performed three months after surgery and will contain: AL and lens measurement using the two ss-OCT biometery devices, lens evaluation (tilt and decentration of the IOL) using the Purkinje meter. Refractive outcome will be evaluated by determining best-corrected visual acuity and subjective refraction.

In women of childbearing age, a pregnancy test will be performed before inclusion into the study.

Main outcome variable:

• Extend of AL difference between pre- and postoperative measurements in both devices

Additional outcome variables:

* Agreement between the two ss-OCT devices in AL measurement
* Evaluation of lens parameter in AL differences between pre- and postoperative measurements
* Limit of agreement in lens tilt and decentration using two ss-OCT devices and Purkinje meter

Eligibility Criteria:
Inclusion Criteria:

* Uneventful cataract surgery
* Age 21 and older
* Axial length 24.00 mm and bigger
* CT Asphina 409 M lens implanted

Exclusion Criteria:

* Intra- or postoperative complication
* Relevant other ophthalmic diseases that are likely to influence the measurement outcome (as: with severe corneal pathology, severe macular degeneration, severe diabetic retinopathy, dens cataract, PEX syndrome, previous ocular surgery or trauma)
* Pregnancy
Pectointercostal Fascial Plane Block Chronic Pain Sternotomy

This study aims to compare the effect of pectointercostal fascial plane block (PIFB) on postoperative chronic pain in patients undergoing open heart surgery with the standard multimodal analgesia technique.

Chronic postsurgical pain (CPSP), defined as persistent pain at the surgical site or referred areas lasting at least three months post-surgery, poses a considerable challenge, notably after median sternotomy in cardiac procedures. Incidence rates, ranging from 28% to 56% within two years post-operation, exhibit variability, partly due to diverse presentations and potential underreporting by patients. The psychological impact of cardiac surgery often leads patients to normalize enduring pain, delaying the identification of chronic post-sternotomy pain.

The multifaceted etiology of CPSP after sternotomy remains incompletely understood. Factors such as neural sensitization during the acute phase, neuropathy from nerve entrapment or injury during surgery, musculoskeletal trauma from incisions, sternal complications, and infections contribute to this complex pain landscape. Inadequate management of acute perioperative pain can trigger central sensitization, a process-altering spinal pain pathway, and predispose individuals to hyperalgesia and chronic pain. Thus, effective acute pain control not only alleviates immediate postoperative discomfort but also potentially averts the onset of chronic pain.

Traditionally, opioids like fentanyl and morphine have been primary choices for post-cardiac surgery pain relief. However, their use is associated with dose-related side effects such as nausea, respiratory issues, chronic opioid dependence, and increased chronic pain risk. Implementing a multimodal approach, including NSAIDs, proves challenging due to bleeding and renal complications post-cardiac surgery. In contrast, regional analgesia offers an opioid-sparing alternative. Parasternal regional blocks like the pectointercostal fascial plane block (PIFB) present a low-risk option and have demonstrated efficacy in alleviating acute post-sternotomy pain.

Addressing this, a prospective, double-blinded randomized controlled trial aimed to evaluate whether a PIF block could provide effective perioperative analgesia and potentially mitigate the incidence of CPSP in patients undergoing sternotomy for cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* ASA 3 risk score patients scheduled for elective open heart surgery

Exclusion Criteria:

* Emergent surgery
* Previous thoracotomy
* LVEF \<30
* Patients with psychiatric disorders
* Presence of hematological disease
* Patients with alcohol-drug addiction
* Patients who use daily opioids for any reason
* Chronic analgesic use
* Allergy to local anesthetics
* BMI \>40
The AIM Study: Assessing the Impact of Margin Reduction

This study will observe patients who receive external beam radiation for prostate cancer. These patients will be localized and tracked (targeted) with the Calypso 4D Localization System. These patients will have a uniform treatment plan with reduced PTVs (prostate treatment volume) and will be assessed at multiple time points for quality of life and side effects related to radiation therapy.

EPIC surveys and adverse events recorded and categorized using the CTCAE v3.0 will be collected and summary statistics performed. The patient's individual tracking graphs will be evaluated for motion type and frequency.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are planning to receive external beam radiation of prostate
2. Patients who are to be implanted with Beacon Transponders in the prostate
3. 18 years of age or older.
4. Histologically confirmed diagnosis of prostate cancer.
5. Ability to comply with study visit schedule.
6. Signed informed consent form.

Exclusion Criteria:

1. Any patients who have received other investigational therapy within the last 60 days are excluded.
2. Individuals that have previously been implanted with permanent Beacon transponders are excluded.
3. Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).
4. Any other medical or other condition that would, at the discretion of the investigator, preclude the individual from participation in a clinical study.
Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

We propose to test the hypothesis that aggressive warming reduces the incidence of major cardiovascular complications, compared to routine care. Half of the participants will be randomly assigned to routine care (core temperature ≈35.5°C), while the other half will receive aggressive warming (\>37°C core temperature) in a multi-center trial.

Hypothermia increases sympathetic activation, promotes tachycardia, and causes hypertension - all of which may increase the risk of myocardial injury. Moderate perioperative hypothermia is now uncommon, but mild hyperthermia (≈35.5°C) remains common. Whether aggressive warming to a truly normothermic level (≈37°C) improves outcomes remains unknown.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for major noncardiac surgery expected to last 2-6 hours;
* Having general anesthesia;
* Expected to require at least overnight hospitalization;
* Expected to have \>50% of the anterior skin surface available for warming;
* Have at least one of the following risk factors:

  a. Age over 65 years; b. History of peripheral vascular surgery; c. History of coronary artery disease; d. History of stroke or transient ischemic attack; e. Serum creatinine \>175 µmal/L (\>2.0 mg/dl); f. Diabetes requiring medication; e. Hypertension requiring medication; g. Current smoking.

Exclusion Criteria:

* Have a clinically important coagulopathy in the judgement of the attending anesthesiologist;
* Are septic (clinical diagnosis by the attending anesthesiologist);
* Body mass index exceeding 30 kg/m2;
* End-stage renal disease requiring dialysis;
* Surgeon believes patient to be at particular infection risk.
WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia

Comparative analysis of efficacy and safety of Aquablation (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA) and transurethral laser enucleation as surgical therapy for benign prostatic hyperplasia with large prostates (80-180ml).

Prospective randomized and non-randomized cohort, two-arm multicenter trial two arm multicenter trial to evaluate the efficacy and safety of Aquablation (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA) compared to transurethral laser enucleation - the current reference standard of minimal invasive therapy for benign prostatic hyperplasia in large prostates (80-180ml).

Eligibility Criteria:
Inclusion Criteria:

1. Age: 45 - 80 years
2. International Prostate Symptom Score (IPSS) ≥ 8
3. Prostate size (measurement by transrectal ultrasound): 80 - 180 mL
4. Subject has diagnosis of LUTS (Lower urinary tract symptoms) due to BPH (Benign Prostatic Hyperplasia)
5. Patient is mentally capable and willing to sign a study-specific consent form
6. Subjects with the ability to follow study instructions and likely to attend and complete all required visits
7. Written informed consent

Exclusion Criteria:

1. Body mass index ≥ 42
2. Suspected or history of prostate cancer
3. Suspected or history of bladder cancer
4. Bladder stone
5. Indwelling catheter for more than 3 months before baseline
6. Active urinary tract infection
7. History of urethral stricture or bladder neck stenosis
8. Damage of the external urethral sphincter
9. Previous prostate surgery or history of lower urinary tract surgery (e.g. urinary diversion, artificial sphincter or penile prosthesis)
10. Use of anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except ASS 100mg/d).
11. Contraindications for general and spinal anaesthesia
12. The investigator considers a pre-existing condition or the subject's life circumstances to be problematic for the conduct of the study and the completion of the follow-up investigations
13. Subject is unwilling to accept a blood transfusion if required
14. Subject is not able to give consent
15. Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
16. Simultaneously participation in another clinical trial in the field of urology
17. Known or persistent abuse of medication, drugs or alcohol
Safety & Efficacy of an Antibacterial Protein Molecule Applied Topically to the Nostrils of Volunteers and Patients

The purpose of this study is to determine whether the antibacterial protein P128 is (i) safe and well tolerated in healthy volunteers and in chronic kidney diseases patients on dialysis, (ii) is it effective in reducing the nasal carriage of pathogen (Staphylococcus aureus) in humans.

Staphylococcus aureus with acquired multiple-drug resistance poses an increasing problem in both hospital and community settings. S. aureus is known to cause infections ranging in severity from skin infection to systemic bacteremia. As nasal colonization is the principal ecological niche for these bacteria and has been shown to be a significant risk factor in developing S. aureus infection, it is of importance to develop an efficient therapy that is able to clear this bacterium from human nostrils.

In-vivo studies have shown that P128 treatment is efficacious in reducing and decolonizing MRSA bacteria from rat nostrils.

Pre-clinical safety studies in animal models indicated no test drug related toxicity signs at the site of application or systemically.

The present clinical trial is conducted in four parts. Part A consists of safety and tolerability studies in 4 cohorts of 3 healthy subjects who are administered a single dose of three escalating concentrations of the drug and placebo intra-nasally. Part B consists of safety \& tolerability as in part A but with multiple doses (3 doses/day for 5 days). Part C comprises of safety/tolerability as well as efficacy studies in chronic kidney disease patients stable on dialysis who are nasal carriers of S.aureus or MRSA on a treatment regimen as in Part B. Part D comprises of safety and efficacy studies in any patient who are nasal carriers of S.aureus or MRSA with single dose of 3 escalating concentrations of the drug and placebo intra-nasally.

Eligibility Criteria:
Inclusion Criteria:

* Healthy human volunteer
* Any patient clinically stable who are nasal carrier of S. aureus or MRSA including Chronic Kidney disease patients stable on dialysis

Exclusion Criteria:

* Presence of active systemic bacterial infection of any nature not cured at least 4 weeks before enrollment.
* Systemic or intra-nasal anti-bacterial treatment during four week period before enrollment
* Pregnancy, breast feeding during the study duration
* Participation in any other intervention study during the past three months
Muscle Strength, Functional Capacity, Respiratory Function and Quality Of Life In Cystic Fibrosis Patients

This study was designed to investigate the relationship between upper extremity muscle strength and endurance, functional capacity, and quality of life child and adolescent with cystic fibrosis

Child and adolescent with cystic fibrosis patients were assessed for upper extremity muscle strength and (Shoulder abductors muscle strength, Elbow flexion muscle strength, Handgrip strength) muscular endurance(arm pull-up test), lung function test, and functional capacity (six-minute walk test distance), and Quality Of Life (Cystic Fibrosis Questionnaire-Revised)

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with CF with clinical findings and gene mutations consistent with CF, having over 60mEq / L in two measurements in sweat chlorine examinations

Exclusion Criteria:

* Patients who did not exacerbate the disease in the last four weeks, who had good cooperation and did not have any orthopedic problems in the hand-shoulder-arm complex were included.
Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

The purpose of this study is to evaluate the safety and efficacy of the blood pressure medication, aliskiren, in heart transplant patients. In terms of safety, the investigators will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood levels of the anti-rejection medication, cyclosporine, in these patients. In terms of efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart transplant patients.

Hypertension is a major complication following cardiac transplantation, with a prevalence of 93% at 5 years post-transplant. Post-cardiac transplant hypertension is due to multiple factors such as use of cyclosporine, chronic kidney disease, and denervation. Hypertension in this population is difficult to treat, and most patients require therapy with multiple antihypertensive agents in order to achieve adequate blood pressure control. Aliskiren, a direct renin inhibitor, is a novel antihypertensive agent with a unique mechanism of action and potent blood pressure-lowering effects. As such, aliskiren is an attractive treatment option for post-cardiac transplant hypertension. This study will characterize the pharmacokinetic drug-drug interaction profile, pharmacodynamics, and safety of aliskiren 75 mg daily (low-dose) and 150 mg daily, when given in combination with cyclosporine, in cardiac transplant patients.

Eligibility Criteria:
Inclusion Criteria:

* 6 months or more since cardiac transplant
* Clinically stable from a transplant perspective
* Maintained on a stable immunosuppressant regimen containing cyclosporine + an antiproliferative agent (e.g., azathioprine, mycophenolate), +/- an oral steroid
* Hypertension, as defined by a seated average systolic blood pressure of ≥ 140 mm Hg and a seated average diastolic blood pressure of ≥ 90 mm Hg, based on 3 separate measurements, spaced 2 minutes apart.

Exclusion Criteria:

* Clinical instability from a cardiac transplant perspective
* Contraindications to aliskiren therapy
* Conditions that may increase the risk of aliskiren adverse effects
* Severe hypertension
* Concomitant medications known to increase or decrease aliskiren plasma exposure.
Human Tumor Sequencing Project

This study is being done to learn more about genetic mutations in cancer cells and to find out how the development of new technologies can increase knowledge of these mutations and possibly predict an individual's response to certain treatments.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a solid tumor or blood borne cancer
* 18 years or older
* Eligible to have blood drawn
Prevalence of a Localized or Diffuse Pruritus in a Population With One or Several, Primitive or Secondary, Brain Tumor(s)

The association between the presence of pruritus, especially centrofacial, and the presence of a brain tumor is a widespread notion in the medical community but based on a single publication by Andreev et al. in the British Journal of Dermatology published in 1975. No other study has studied this association with a rigorous methodology. The aim of this study is to evaluate the prevalence of pruritus in patients with one or more primary or secondary brain tumor(s), benign(s) or malignant(s).

* Monocentric prospective observational study
* On the inclusion period
* Patients who are seen in radiotherapy consultation and / or department of neurosurgery
* Complying with the inclusion criteria, not falling within the exclusion criteria
* Re-reading of cerebral MRI (cMRI) with precision on the location(s) of the brain tumor(s) according to a predefined anatomic descriptive diagram
* Complete the questionnaire by a dermatologist (characteristics of pruritus, brain lesion(s), characteristics of the population)

Eligibility Criteria:
Inclusion criteria:

* Age \> 18 years
* Diagnosis of benign or malignant brain tumor, primary or secondary.
* Accepted non-opposition
* Realization of a cerebral MRI (cMRI)

Exclusion criteria:

* Age \< 18 years
* Absence of cerebral imaging of the cMRI type
* Absence of non opposition
* Realization of a treatment modifying the brain structure (radiotherapy / surgery)
Evaluation of Oncoxin-Viusid® in Cutaneous Melanoma

Malignant melanoma, responsible for 75% of deaths from skin cancer. Current therapeutic options have poor response, many adverse events and high costs. For this reason, a study with nutritional supplement Oncoxin-Viusid was carried out. According to previous studies, it has an antitumor, immunomodulatory effect and to potentiate the antiproliferative effect of standard chemotherapeutic agents in different locations and stages of cancer.

Performed at Manuel Fajardo Surgical Clinical University Hospital in Havana, Cuba from September 2014 to April 2018, following a proof of concept open label study, with no control group in 20 patients diagnosed histologically in Fajardo Hospital or Oncology Institute, as Melanoma, primary cutaneous stage IIB-IIIA. All received conventional surgical treatment and oral Oncoxin-Viusid (25 ml 2 times a day for one year), where it was also indicated adjuvant treatment or chemotherapy. All were evaluated monthly the first year and semesterly the second year. Complying with the provisions of the Helsinki Act.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histological diagnosis of Malignant Cutaneous Melanoma in stage IIB-IIC-IIIA
* Subjects of 18 years and over of both sexes.
* General health status according to the Karnofsky Index ≥ 70.
* Laboratory parameters within the normal limits defined as: Hematopoietic: Hemoglobin ≥ 9 g / L, Total Leukocytes ≥ 3 x 109 cells / L, Neutrophils ≥ 1.5 x 109 cells / L, Platelets ≥ 100 x 109 / L Hepatic: Liver function within 2.5 times upper normal limit and without liver disease demonstrated by TGP, OGT and alkaline phosphatase.
* Patients who express written voluntariness to enter the study with their signature of the informed consent document.
* Women of childbearing age should have a negative pregnancy test and use effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation.

Exclusion Criteria:

* Pregnancy or lactation.
* Patients with a second concomitant tumor.
* Present an associated chronic disease in the decompensation phase (heart disease, diabetes, hypertension).
* History of hypersensitivity to another similar product.
* Severe acute allergic states.
* Severe septic processes.
* Non-operated patients, in whom the surgery was contraindicated.
* Patients at potential risk of not completing the study (those who will travel during the period of the investigation or distance in their residence, outside the city).
* Subjects who are participating in another clinical trial.
* Patients with cognitive disorders or a mental disorder that hinders their follow-up.
Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery

Opioid sparing analgesia is extremely important in the post-operative obese population. With more and more obese patients entering the operating room a multi-modal approach to analgesia is crucial. Finding effective alternatives to opioid therapy is the rationale of this proposal. Literature involving ketamine and magnesium in bariatric surgical patients is very sparse.

1. Patient will be identified by surgeon and consented by member of the research team
2. Patient will be randomized to one of three groups on the day of surgery
3. Following securement of the endotracheal tube, the study medication will be administered over 10 minutes via an IV infusion pump.
4. The subject will receive ketamine, ketamine plus magnesium or a placebo.
5. Following surgery, the patient will be taken to the post anesthesia care unit (PACU) and set up with standard ASA monitoring as well as end-tidal CO2 via nasal cannula. A hydromorphone patient controlled analgesia (PCA) pump will be set-up by nursing and given to the patient. Standard dosing of 0.2 mg bolus, every 6 minutes with a maximum 2 mg will be the starting dose as is standard for these patients post-operatively.
6. Primary outcome will be the total amount of hydromorphone used in the first 24 hours post-operatively.

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Eligibility Criteria:
Inclusion Criteria:

1. Subjects undergoing laparoscopic sleeve gastrectomy
2. Consenting adults age 18-80
3. ASA II to ASA III
4. Ability to understand and use a PCA
5. Required to be hospitalized for at least 24 hours post-op

Exclusion Criteria:

1. Patient refusal
2. Chronic opiate use (daily opiate use for \>3 months)
3. Chronic Kidney disease (Creatinine\>2)
4. Known allergy or adverse effect of ketamine, magnesium or hydromorphone
5. Patients with documented psychiatry (Maniac or MDP) history
6. Patient unable to give informed consent
7. Patient with limited or no English fluency