cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures

Aim of this study is to assess the efficacy of endoscopic trans-maxillary surgical approach versus traditional trans-orbital surgical approach (control group) in orbital blow out fractures in terms of postoperative clinical and digital radio-graphical assessments.

(N.M) Operator, data entry \& corresponding author; Assistant lecturer , surgery department .

(I.E) Main supervisor, data monitoring \& auditing; Professor, surgery department.

(R.H) Co-supervisor, data entry \& auditing; Lecturer, surgery department . (AM) Assistant lecturer, surgery department .Faculty of Oral \& Dental Medicine Cairo University outcome assessors and data collection.

(YA) Assistant Lecturer of Surgery department , faculty of oral and dental medicine - Cairo University , for baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents.

intervention:

Preoperative preparation:

Preoperative cone beam CT. A clearance from the ophthalmology department after examination of papillary reflexes, motility restriction and measurement of the visual acuity.

Laboratory Investigations: blood picture, liver functions, kidneys functions,coagulation profile Informed consent signed by the patient. (NM and RH) will perform all procedures under general anesthesia . Intervention :Endoscopic trans-maxillary (through the maxillary sinus) surgical approach.

control group: Traditional trans-orbital surgical approaches. follow up clinically and radio-graphically for 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with unilateral/bilateral orbital blow out fractures.
2. Positive forced-duction test. ( to ensure the muscular entrapment).

Exclusion Criteria:

1. Medical condition affecting bone healing.
2. Medically compromised conditions, not proper candidate for general anesthesia.
3. Tumor case encroaching on the orbital floor.
4. Pathological orbital blow out fractures.
5. Allergy/ metal hypersensitivity.
Prehab for Lung and Esophageal Cancer

Research indicates that individuals diagnosed with lung or esophageal cancer who enter treatment with higher functional capacities, improved body composition, and better nutrition status tend to experience better outcomes and a higher quality of life. The primary objective of a prehabilitation health coaching program is to enhance the overall health and well-being of patients before they undergo major surgery.This personalized 8-week program encompasses elements such as nutrition, smoking cessation, sleep hygiene, and movement, equipping participants with the knowledge and tools needed to adopt healthier lifestyles.

The purpose of this study is to explore the implementation, feasibility and effectiveness of a community-based prehabilitation health coaching program, including nutrition, smoking cessation, sleep hygiene and movement for individuals scheduled to undergo surgery for lung or esophageal cancer.. Participants will have the option to engage in a one-on-one prehabilitation health coaching program tailored to their needs, led by a Qualified Exercise Professional (QEP). The personalized prehabilitation plan will encompass 4-6 in-person or virtual meetings before surgery, including a structured movement plan, education on smoking cessation, sleep quality, stress reduction, mindfulness, and nutrition. Post-surgery, the QEP will provide support through counselling and scheduled sessions for a month after surgery and include one session while the patient is in hospital.

This research adopts a repeated measure, mixed-methods approach. Participants will undergo three clinical assessments at different stages: baseline, pre-surgery, and 4-6 weeks post-surgery. The findings from this study will guide future grant applications aimed at funding larger studies and the implementation of prehabilitation as part of standard of care in lung and esophageal cancer patients in Nova Scotia.

Central to the research endeavor is the driving question: "How can a community-based prehabilitation program be successfully implemented in the community, and can it lead to improved functional outcomes in patients undergoing surgery for lung or esophageal cancer?" This overarching question provides the study with its core focus and serves as a guiding force throughout the research process.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with lung or esophageal cancer
* Scheduled to receive surgical intervention in minimum 2-weeks
* Surgeon approval
* Able to read and write in English
* \>18 years of age

Exclusion Criteria:

* Not able to provide informed consent
Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis

The aim of this study is to investigate the safety and efficacy of geniculate artery embolization (GAE) as pain treatment in patients with mild to moderate knee osteoarthritis.

This is a single arm, prospective, pilot study investigating the safety and efficacy of GAE as pain treatment in patients with mild to moderate knee osteoarthritis. Patient related outcome measurements (PROMs), physical tests and several image modalities will be conducted.

It may form the grounding for further research in the shape of a larger randomized clinical trial.

The hypothesis is, that GAE will reduce synovitis and thereby pain in the patient group. This may secondary improve physical function and reduce consumption of analgesics.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \< 35 kg / m2.
* X-ray verified mild to moderate KOA (Kellgren Lawrence grade 1-3 \[24\]), obtained maximum 6 months prior to inclusion.
* Moderate to severe knee pain during walking (Visual Analog Scale (VAS) \> 50 mm) - resistant to minimum 3 months physiotherapy.
* Willing, able, and mentally competent to provide informed consent.

Exclusion Criteria:

* Local infection in knee or groin areas.
* Moderate to severe pain in ipsilateral lower limb joints; VAS \> 2.
* Intermittent claudication.
* Rheumatoid arthritis or seronegative arthropathies.
* Prior ipsilateral open knee surgery.
* Ipsilateral arthroscopy within 6 months.
* Ipsilateral intra-articular knee injection within 6 months.
* Current/recent (within 4 weeks) use of oral corticosteroids.
* Generalized pain syndrome (e.g. fibromyalgia) or nerve root compression syndromes.
* Pregnant or planned pregnancy during the study period.
* Lactation.
* Active malignancy.
* Known history of allergy to contrast media.
* Contra-indications for MRI (e.g. metallic foreign bodies, etc).
* Manifest hyperthyroidism.
* Diabetes (I+II).
* Liver disease.
* Only one kidney, former kidney surgery, reduced kidney function or failure (chronic or acute).
* Estimated glomerular filtration rate \< 60 ml / min / 1.73 m2 (All participants: blood sample maximum 30 days prior to GAE. Participants \> 60 years: another blood sample maximum 3 months prior to last MRI scan with contrast agents).
* INR \> 1.4, Platelets ≤ 40 x 109 / l (All participants: blood sample maximum 30 days prior to GAE).
* Antithrombotic treatment except acetylsalicylic acid.
* Diseases affecting the bone metabolism (E.g. severe osteoporosis, Paget's disease, or hyperparathyroidism).
* American Society of Anesthesiologists classification \> 3.
Safety of a Ready to Drink Supplement

This study will examine a Ready to Drink (RTD) supplement.

This study will examine the short-term (7 days) characteristics of ingesting a Ready to Drink (RTD) supplement immediately prior to exercise on the blood, heart rate, blood pressure and self-reported side effects.

Eligibility Criteria:
Inclusion Criteria:

* Participants are apparently healthy and recreationally active males and females between the ages of 18 and 40

Exclusion Criteria:

* Participants are under 18 years old and above 40 years old
* Participants have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease
* Participants currently use any prescription medication (birth control is allowed)
* Participants are pregnant or lactating females or plan to become pregnant within the next month
* Participants have a history of smoking
* Participants drink excessively (12 drinks per week or more)
* Participants have a recent history of creatine supplementation within 8 weeks of the start of supplementation
QT Interval in Patients With Pacemaker Dependency

The aim of this study is to examine a correction term for an adapted QT interval during ventricular pacing (right, left and biventricular pacing) to obtain valid formulae correcting for the QT intervals in various pacing conditions.

This investigation aims at determining a possibility to assess the usefulness of various formulae that correct for the different effects of various pacing modes on the QT interval. More specifically, the hypothesis will be tested that applying adequate correction will preserve the predictive power of the QT-interval regarding proarrhythmia in various cardiac pathologies and therapies.

Eligibility Criteria:
Inclusion Criteria:

* caucasian race
* implanted cardioverter/defibrillator or pacemaker
* negative pregnancy test for women of child bearing potential
* stable function of the implanted device
* stable medical therapy relating to the underlying disease
* stable medical therapy of antiarrhythmic drugs and other QT-time changing drugs
* no instability of rhythm
* x-ray of thorax during device implantation in two levels (ap and ll axis)
* written informed consent

Exclusion Criteria:

* coronary heart disease and angina pectoris symptoms
* patient with acute myocardial infarction or CABG while the last 4 weeks
* patient with tachycardia and a rest frequency \>80 bpm
* patient with severe pulmonary disease
* patient with anaemia
* patient with acute infections
* patient with severe kidney or liver disease
How Participants Perceive Biomedical Research in Pulmonology

The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.

Over time, clinical research has become a challenge both in terms of public health and in terms of scientific progress. Additionally, it has also become a financial challenge for institutions, especially in France where a significant part of their government funding is provided according to their ability to conduct quality clinical research. Pulmonology is a sector where clinical research is well established with strong incentives from several pharmaceutical companies and numerous academic research projects. Nevertheless, it is important to put the patient back at the centre of biomedical research.

A better knowledge of patient expectations, questions and misunderstandings would considerably improve treatment observance, clinical trial data quality, doctor-patient trust/relationship, and ultimately, the patient's health.

The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.

The secondary objectives are to determine:

* how biomedical research is experienced / felt;
* if the information delivered to the patient (orally - information note) is clearly perceived.

Comparisons with PROTOACCEPT1 (osf.io/nsjjr) will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* The patient presents with at least one of the following: (1) asthma, (2) chronic obstructive pulmonary disease, (3) bronchiectasis, (4) idiopathic pulmonary fibrosis, (5) pulmonary arterial hypertension, (6) sleep apnoea syndrome
* The patient is participating in a biomedical research protocol.

Exclusion Criteria:

* Patient under 18 years of age
* Patient judged incapable of filling out the questionnaire for linguistic or other reasons.
* The patient has already participated in the present study.
Effects of Pioglitazone in Type 2 Diabetes Mellitus and Coronary Heart Disease

The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone (in comparison to placebo) on biomarkers for atherosclerosis and cardiovascular risk, as well as the degree of activation of the immune system, when given on top of an anti-diabetic treatment (metformin and/or sulfonylurea drugs) that has already resulted in good glycemic control.

PPARgamma activation by pioglitazone has shown to be associated with an improvement of cardiovascular risk when measured with clinical (assessement of intima-media-thickness) or biochemical (hsCRP, MMP-9 etc.) markers. Well controlled patients (HbA1c \< 8.0 %) will receive either pioglitazone or placebo (randomised, double-blind) for 4 weeks. Blood will be drawn to investigate the change in cardiovascular or metabolic markers and mRNA will be isolated from circulating mononuclear cells to investiagte the degree of activation of the immune system, which is another measure for the risk of atherosclerosis development.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* stable oral treatment with metfromin and/or sulfonylurea
* age 20 - 80 years
* angiographically confirmed atherosclerosis or hsCRP \> 1 mg/l

Exclusion Criteria:

* type 1 diabetes
* HbA1c \> 8.5 %
* severe disease
* acute coronary syndrome
* contraindications to pioglitazone (heart failure etc.)
Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer

Watch-and-wait strategy in rectal cancer is gaining momentum. There is a large variability in reporting the proportion of patients achieving clinical complete response (cCR) after routinely delivered preoperative radio(chemo)therapy, likely because of patients' selection. This proportion in population-based level is poorly defined. In addition, predictive factors for cCR are also poorly defined. It is known that cCR response is observed often in small tumours. However, cCR proportion in large cancers has not been sufficiently evaluated. For example, even though pathological complete response (pCR) does occur in large fixed cancer, it is unknown whether cCR does also occur because persistent fibrous stroma may mimic residual cancer in all of such cases.

This is a prospective observational population-based cohort study on low rectal cancer to answer the question of how often clinical or near-clinical tumour response occur after routinely delivered preoperative radiotherapy in relation to the pre-treatment tumour characteristics. The additional question was how often pCR occur in relation to the pre-treatment tumour characteristics in the patients managed by total mesorectal excision because of persistent tumour after radiotherapy. The additional aim was the implementation of watch-and-wait strategy or full-thickness local excision (as an option instead of total mesorectal excision in the patients with sustained near-cCR) within a frame of a prospective study. In the patients managed by organ preservation, the secondary outcome measures were: i) local regrowth rate, ii) effectiveness of salvage surgery, iii) disease-free survival at 3 years and overall survival at 5 years, iv) anorectal function.


Eligibility Criteria:
Inclusion Criteria:

* Primary rectal cancer
* Low tumour (accessible by digital rectal examination)
* Routine preoperative radio(chemo)therapy according to the institutional policy; short-course radiation and immediate surgery is not allowed.
* Informed consent for watch-and-wait strategy or local excision in patients with cCR and near-cCR

Exclusion Criteria:

* Recurrent cancer
* Cancers situated in the upper rectum
* Distant metastases
PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

This is a prospective study that will assess the impact of MammaPrint on chemotherapy + endocrine versus endocrine alone treatment decisions in patients with an Oncotype Intermediate Score.

The frequency of chemotherapy + endocrine versus endocrine alone decisions in Oncotype DX intermediate score patients will be calculated before and after receiving the MammaPrint result.

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically proven invasive stage I-II, node negative, hormone receptor positive, Her2 negative breast cancer, who received an Oncotype DX intermediate score (18-30)
* ≥ 18 years of age at time of consent
* Written informed consent

Exclusion Criteria:

* Insufficient tissue remaining for Mammaprint FFPE
* Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
* Women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy
Use of Optical Coherence Tomography to Determine the Optimal Management of Patients With Drug-eluting Stents Who Need Non-cardiac Surgery

The specific aim of this proposal is to examine the impact of OCT and IVUS-guided management of patients with prior DES implantation who need major non-cardiac surgery and discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery until 30 days post surgery) incidence of major adverse cardiac events.

Patients who receive drug-eluting stents (DES) and subsequently require non-cardiac surgery have increased risk for perioperative stent thrombosis, especially when antiplatelet therapy discontinuation is required. Perioperative administration of a glycoprotein IIb/IIIa inhibitor may decrease the stent thrombosis risk, but it is cumbersome and carries high cost. Stents that have been endothelialized by optical coherence tomography (OCT) are likely to have low risk for perioperative stent thrombosis and therefore intensive management strategies, such as "bridging with a glycoprotein IIb/IIIa inhibitor" would not be required. The current study will assess whether OCT utilization can help optimize the preoperative management of DES patients requiring major non-cardiac surgery.

The specific aim of this proposal is to examine the impact of OCT and IVUS-guided management of patients with prior DES implantation who need major non-cardiac surgery and discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery until 30 days post surgery) incidence of major adverse cardiac events.

The hypothesis is that OCT and IVUS-guided treatment will have low incidence (≤10%) of perioperative major adverse cardiac events.

The specific aim of this proposal is to examine the impact of OCT and IVUS-guided management of patients with prior DES implantation who need major non-cardiac surgery and discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery until 30 days post surgery) incidence of major adverse cardiac events.

The hypothesis is that OCT and IVUS-guided treatment will have low incidence (≤10%) of perioperative major adverse cardiac events.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Need for major non-cardiac surgery requiring discontinuation of dual antiplatelet therapy
* Agree to participate and provide informed consent

Exclusion Criteria:

* Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)
* Challenging vascular access
* History of an allergic reaction to glycoprotein IIb/IIIa inhibitors
Recurrent Low Back Pain:Linking Mechanisms to Outcomes

The purpose of this study is to determine if trunk neuromuscular control strategies are changed by therapeutic exercises emphasizing core stabilization.

Hypothesis: subjects with low back pain who demonstrate clinically meaningful improvements in function and pain will have significantly improved trunk motor control strategies.

Hypothesis: measures of trunk control will demonstrate 'construct-validity'. This will be tested using a known group method demonstrating:

* no significant change in motor control measures within the untreated, healthy control group.
* significant changes within the low back subjects who demonstrate clinically meaningful improvements.

A growing body of evidence suggests that poor neuromuscular control of the lumbopelvic region is an important finding in a large number of patients with recurrent and chronic low back pain and may play a role in recurrence of symptoms. Despite findings of altered trunk motor control in individuals with low back pain, the neuromuscular strategies underlying these alterations have not been satisfactorily characterized. The aims of this study are to(1) identify which neural control strategies are altered following a rehabilitation program that emphasizes trunk control and stability using a motor learning approach and (2) provide preliminary evidence of a link between hypothesized mechanism and effectiveness for programs designed to improve trunk control.

Eligibility Criteria:
Inclusion criteria for healthy controls:

No history of low back is defined as:

1. no pain limiting performance of daily activities for greater than 3 days,
2. no pain for which they sought medical or allied health intervention.

Inclusion Criteria for individuals with a history of low back pain:

1. duration of the current episode of low back pain less than 3 months,
2. average pain intensity over past 2 weeks at least 3 on an 11 point (0 = no pain, 10 = worst pain ever) numeric pain rating scale,
3. no medical intervention for low back pain in last 6 months,
4. Oswestry disability score greater than 20%
5. a physical therapy diagnosis of clinical lumbar instability based upon specific examination findings.

Exclusion Criteria for both groups:

1. permanent structural spinal deformity (e.g., scoliosis)
2. history of spinal fracture or diagnosis of osteoporosis
3. diagnosis of inflammatory joint disease
4. signs of systemic illness or suspected non-mechanical LBP (i.e. spinal tumor or infection)
5. previous spinal surgery
6. frank neurological loss, i.e., weakness and sensory loss
7. history of neurologic disease that required hospitalization,
8. active treatment of another medical illness that would preclude participation in any aspect of the study or any lower extremity injury that would potentially alter trunk movement in standing
9. leg length discrepancy of greater than 2.5 cm.
10. pregnancy
11. vestibular dysfunction
Treatment of Abdominal Abscesses With or Without Fibrinolysis

The objective of this study is to evaluate the utility of fibrinolysis when draining an abdominal abscess as defined by length of stay after drainage.

The hypothesis is that fibrinolysis of a abscess will shorten hospital stay compared to drainage alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients under age 18 found to have an abscess in their abdomen related to perforated appendicitis that requires a drain either prior to or after appendectomy.

Exclusion Criteria:

* Patients with known immune deficiency per medical record review
* Patients with another condition affecting surgical decision making or recovery
* Patients with drain unable to be placed