cyrilzakka/clinical-trials huggingface dataset:
Intrathecal Dexamethasone and Atropine on Morphine Induced Post-operative Nausea and Vomiting on Caesarean Section

Pain is a major problem during the postoperative period and can be considered as a challenge for the anesthesiologist. Low dose intrathecal morphine is proven efficient as a mode to reduce postoperative pain. Morphine has many complications like post-operative nausea and vomiting (PONV). the investigators will investigate the utility of intrathecal (IT) atropine and dexamethasone for prevention of morphine induced PONV as a primary outcome in parturient undergoing CS under spinal bupivacaine anesthesia plus morphine sulfate as an adjuvant.

Pain is a major problem during the postoperative period and can be considered as a challenge for the anesthesiologist. Low dose intrathecal morphine is proven efficient as a mode to reduce postoperative pain in many surgical areas including Caesarean delivery. Morphine has many complications namely pruritus, and post-operative nausea and vomiting (PONV). The other risk factors for the development of PONV include female gender, non-smoker status, general anesthesia with inhalational anesthetics and surgical factors (duration and type of surgery). The supplementation of morphine, however raises the occurrences of postoperative nausea and vomiting (PONV) in these patient To tackle this problem, the investigators have to use the combination therapy of antiemetics like a serotonin receptor antagonist of either intravenous (IV) ondansetron or granisetron with IV dexamethasone is administered after the administration of intrathecal morphine. Dopamine receptor antagonists e.g. droperidol and metoclopramide are commonly used, but they carry the risk of extrapyramidal symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. 18-45 years old
3. ASA: 1, 2
4. Elective caesarean section under spinal anaesthesia.

Exclusion Criteria:

1. Patient refusal.
2. Contraindications to spinal anaesthesia as coagulopathy, infection at site of injection, hemodynamic instability and uncooperative patient.
3. Contraindications to administration of morphine as asthmatic patient and hypersensitivity and contraindications to any of the study drugs.
4. Adult-Emergency CS as there is no time for preparation and risk on fetus and mother for time consuming
Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy

According to published studies, there are two main approaches in the dissection of intersegmental plane: stapling devices and energy instrument separation. However, only a few retrospective studies focused on the perioperative outcomes of these two approaches, and there has been no definitive conclusion about which method is better. So the investigators want to conduct a prospective study, trying to figure out this problem.

Lung cancer has been one of the most serious life-threatening diseases of human society. It has the highest morbidity and mortality worldwide among all the malignant tumors. Due to the popularization of low-dose CT and other means of examination, more and more patients with lung cancer are detected in the early phase of disease. Anatomical segmentectomy is one of the standard surgical procedures for these small pulmonary nodules or ground glass opacity (GGO), which are clinically highly suspected or puncture confirmed early lung cancer lesions. Dissection of the intersegmental plane in segmentectomy is a difficulty that have puzzled thoracic surgeons for decades because of the complicated anatomic relationship and variations, along with lack of boundary between pulmonary segments. There are two main approaches in the dissection of intersegmental plane: stapling devices and energy instrument separation. However, only a few retrospective studies focused on the perioperative outcomes of these two approaches in segmentectomy, not to mention in robot assisted segmentectomy, and there has been no definitive conclusion about which method is better. So the investigators want to conduct a prospective study, trying to figure out this problem.

The investigators set incidence rate of postoperative complications as their primary endpoint. According to their calculation, a total of 136 patients will be enrolled (each group has 68 patients).

Eligibility Criteria:
Inclusion Criteria:

* 1. Age: 18 to 70 years old; 2. Pulmonary nodules or GGO found in chest CT examination, and conform with indications for segmentectomy mentioned in NCCN guidelines:

  1. Poor pulmonary reserve or other major comorbidity that contraindicates lobectomy;
  2. Peripheral nodule ≤2 cm with at least one of the following:

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  1. Pure (Adenocarcinoma in situ) AIS histology;
  2. Nodule has ≥50% ground-glass appearance on CT;
  3. Radiologic surveillance confirms a long doubling time (≥400 days). 3. Normal in preoperative tests, such as blood routine examination, liver function, renal function, coagulation function, etc.

  4. ASA score: Grade I-III. 5. Patients who can coordinate the treatment and research and sign the informed consent.

Exclusion Criteria:

* 1. Patients have history of malignant tumor, or have accepted neoadjuvant chemotherapy and(or) radiotherapy.

  2. Patients have comorbidities in cardiovascular, kidney, lung or hematopoietic system, who cannot tolerate the surgery.

  3. Psychiatric patients。 4. Patient have history of chest trauma or surgery on ipsilateral chest.
Effect of Adding Zirconium Oxide Nanoparticles to Printable Implant Overdenture

This clinical study will be conducted to evaluate and compare non-modified printable acrylic resin base material and modified printable acrylic resin base material with zirconia oxide nanoparticles for a 2-implant retained complete overdenture regarding:Surface roughness; microbiological assessment of denture base microbiological analysis peri-implant soft tissue health around used implants


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients are healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This will be achieved through medical history and clinical examination by physician.

  2. They will have completely edentulous jaws for at least 1 year. 3. They will be of angle's class I maxillo-mandibular relationship and have upper and lower completely edentulous arches.

  4. Residual alveolar ridges covered with healthy firm mucosa. 5. All included patients will have sufficient available length and width of mandibular bone to accommodate conventional implant. (At least 5 mm buccolingual width and 12 mm vertical height of bone.

Exclusion Criteria:

* Patients with chronic systemic diseases that affect bone metabolism
* Uncontrolled diabetic patients
* Patients with TMJ dysfunction
* Smokers
Study on Whether Tart Cherry Juice Can Reduce Oxidative Stress and Inflammation

Oxidative stress has been linked to many diseases associated with aging, including coronary heart disease and Alzheimer's disease. Antioxidants and special proteins in the body work together to help prevent damage by free radicals. Some studies have indicated that as people age, they are less able to fight off oxidative stress and have increased levels of inflammation.

Tart cherries are known to be rich in antioxidants and plant-nutrients. The product we are using in this study is an all-natural tart cherry juice, mixed with apple juice concentrate and containing no additives and no preservatives.

We hope to learn whether antioxidant supplementation, such as tart cherry juice, can measurably decrease oxidative damage and inflammation associated with aging.

Objectives

The primary objective of this pilot study is to investigate whether tart cherry juice consumption can reduce oxidative stress in older adults as measured by attenuation of F2-isoprostane responses to a forearm ischemia-reperfusion, and a decrease in urinary excretion products of oxidative damage. The secondary objective is to examine whether age-sensitive markers of inflammation are reduced in response to the cherry juice consumption.

Eligibility Criteria:
Inclusion Criteria:

* men and women, ages 55-80y, in good health, with \>8 years of education
* non-smoker
* able to give informed consent

Exclusion Criteria:

* use of anti-oxidant supplements, in excess of a standard multi-vitamins
* current hormone replacement therapy
* any history of significant chronic disease
* uncontrolled hypertension
* body mass index (BMI) \> 30 kg/m2
* high physical activity level, as determined by questions on the screening questionnaire
* use of anti-inflammatory medication
Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations

Our research hypothesis in this study is that there is no difference in long-term cosmetic outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric facial lacerations.

The standard method of repair for facial lacerations is to close such wounds with non-absorbable sutures. Recently, topical skin adhesives such as n-butyl-2-cyanoacrylate and 2-octyl cyanoacrylate have been used more frequently as these have been shown to be a faster and less painful way to close superficial facial lacerations. However, lacerations that are deeper, gaping or occurring along lines of excessive tension, such as the chin, still need sutures for repair. Non-absorbable sutures have to be taken out at 4-7 days. This involves another physician visit, parental absence from work, and children who need to be taken out of school or daycare for a simple suture removal.

In Part Iof the study, we were able to demonstrate non-inferiority of absorbable sutures to nylon sutures. However, we purposely removed all remaining absorbable sutures on the 5-7 day follow-up visit. In Part II, we will allow the absorbable sutures to dissolve on their own. We will again assess long term cosmetic outcomes, as well parental satisfaction, and short and long-term complication rates at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Clean. minimally contaminated facial lacerations, between 1-5 cms long, less than 8 hours old, not caused by animal bites, not needing plastic surgery repair

Exclusion Criteria:

* Pregnancy
* Bleeding
* Renal
* Endocrine problems
* Dirty wounds
* Irregular wounds
Color and Pupil Function

This study will examine the effects of different colors of light on pupil function and alertness.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-35
* Good health

Exclusion Criteria:

* Sleep disorder
* Extreme chronotype
* Smoker
* Abnormal color vision
* Ocular pathology (other than mild or moderate refractive error)
* Visual field defects
* Alcohol abuse
* Use of illegal drugs
Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients With Uremic Xerosis

* To evaluate the palliative effects of a moisturising emollient, in patients with uremic xerosis of moderate, severe or very severe intensity, associated or not to uremic pruritus.
* To assess the local tolerance of the test product and its vehicle, and to evaluate the overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, of at least 10 years of age
* Patients undergoing either hemodialysis or peritoneal dialysis due to chronic renal failure
* Patients whose xerosis is related to their renal insufficiency status
* Patients suffering from moderate to severe xerosis, i.e. with a severity score of at least 2, on two symmetric areas of the lower legs (Phase I test areas)
* Patients who have not experienced phototherapy within 8 weeks prior to study entry
* Patients with no antipruritic treatment, or with stable antipruritic treatments (e.g. antihistamines, cholestyramine, opioid inhibitors, charcoal) at least 4 weeks before study entry
* Written informed consent (Appendix II) from the patients or parents

Exclusion Criteria:

* Patients under 10 years of age
* Patients undergoing renal dialysis for another reason than MRD
* Patients whose xerosis or pruritus is due to another reason than their MRD status
* Patients suffering from mild xerosis (score £ 1) on the lower legs
* Patients with xerosis of non comparable severity between the lower legs
* Patients with a known history of allergy to one of the ingredients contained in the test product
* Patient with an intercurrent condition which may interfere with a good conduct or the study parameters of the study
* Patients treated with any other emollient/moisturizing topical preparation within the 7 days prior to study entry
* Patients with phototherapy within 8 weeks prior to study entry
* Patients who started an antipruritic treatment other than phototherapy, or who experienced unstable dosage schedule of antipruritic treatments (e.g. antihistamines, cholestyramin, opiod inhibitors, charcoal) within 4 weeks prior to study entry
* Patients who participated in a study within the 3 months prior to study entry
* Patients who are not able or willing to follow the study instructions
* Patients or parents who refuse to give written informed consent
Dose-dense Chemotherapy Versus Intraperitoneal Chemotherapy as First-line Chemotherapy in Advanced Ovarian Cancer

To compare dose-dense chemotherapy with intraperitoneal chemotherapy in patients with advanced stage ovarian cancer.

Women aged 20 and above, diagnosed with advanced stage ovarian cancer (FIGO stage II\~IV), who had received debulking surgery, followed by adjuvant chemotherapy (either dose-dense or intraperitoneal) at our institution between 01 January 2006 and 31 December 2018 were included in the study. Patient characteristics, any treatment related side-effects (peri-operative and post-operative complications, chemotherapy related adverse events), treatment response (complete or partial response, stable disease or progressive disease), post-treatment surveillance (disease status: disease-free, recurrence or cancer-related death) will be recorded. Univariate and multivariate logistic regression analysis will be employed to evaluate the survival benefit of the two different chemotherapy methods.

Eligibility Criteria:
Inclusion Criteria:

* Women with FIGO stage II\~IV ovarian cancer
* At least one cycle of intravenous dose-dense or intraperitoneal chemotherapy had been administered as the front-line chemotherapy.

Exclusion Criteria:

* none
Multifocal High ADD Contact Lens Proof of Concept Trial

The purpose of this study is to evaluate the visual performance of a new multifocal High ADD contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD Contact Lens.


Eligibility Criteria:
Inclusion Criteria:

* Must sign an Informed Consent document;
* Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;
* Current or previous soft contact lens wearer;
* Not able to achieve monocular near visual acuity (VA) 0.2 logarithm of the Minimum Angle of Resolution (logMAR) \[Early Treatment of Diabetic Retinopathy Study (ETDRS)\] or better in each eye with AIR OPTIX® AQUA Multifocal (AOAMF) High ADD Contact Lenses;
* Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;
* Manifest cylinder less than or equal to 1.00 D;
* Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment, as determined by the investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; or any use of topical ocular medications that would require instillation during contact lens wear;
* Any history of herpetic keratitis;
* History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia;
* Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade 3) or severe (Grade 4);
* Corneal vascularization that is mild (Grade 2) or higher;
* A pathologically dry eye that precludes contact lens wear;
* Monocular (only 1 eye with functional vision);
* Anisometropia ≥ 1.50 D (contact lens distance prescription);
* Clinically significant (\> 1 millimeter) anisocoria;
* History of intolerance or hypersensitivity to any component of the investigational products;
* Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
* Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
* Any ocular or systemic medical condition that may, in the opinion of the Investigator, preclude safe administration of the study lenses or affect the results of this study;
* Other protocol-defined exclusion criteria may apply.
ROGYcare: The Impact of a Cancer Survivorship Care Plan on Patient Reported Outcomes and Health Care Providers

Earlier diagnoses and improved treatments have contributed to the growing cohort of cancer survivors. Nevertheless, these patients remain at risk for adverse long-term or late physical or psychosocial effects of cancer and its treatment. There is increasing recognition to improve information disclosure and cancer survivorship care. The American Institute of Medicine (IOM) and Health Council of the Netherlands both recommend that cancer survivors receive a summary of their course of treatment as a formal document, that also includes recommendations for subsequent cancer surveillance, management of late effects, and strategies for health promotion, the Survivorship Care Plan (SCP). However, no evidence exists concerning the positive and negative effects of the implementation of the SCP in daily clinical practice. The purpose of this study is to assess the impact of SCP care in routine clinical practice on cancer survivors' satisfaction with information disclosure and care, quality of life, illness perception, and health care use.


Eligibility Criteria:
Inclusion Criteria:

* Women who are newly diagnosed with endometrial or ovarian cancer in one of the 12 participating hospitals.
* The patients have to be able to complete a Dutch questionnaire.

Exclusion Criteria:

* Patients who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire.
Comparative Effectiveness of Tirzepatide Versus Semaglutide in Individuals With Heart Failure With Preserved Ejection Fraction

Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to assess the comparative effectiveness of tirzepatide vs semaglutide after emulating the pivotal RCTs of each drug used to support regulatory approval in heart failure with preserved ejection fraction (SUMMIT and STEP-HFpEF DM trials).This comparative effectiveness target trial described below draws from eligibility criteria from the SUMMIT and STEP-HFpEF DM trials. Although many features of the target trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the target trial. Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice.

The database study will be a new-user active-comparative study, conducted using 2 national United States claims databases, where we compare the effect of tirzepatide vs semaglutide on the composite end point of all-cause mortality or heart failure hospitalization. Clinical guidelines during the study period recommended both agents for the same indications of glucose lowering and weight reduction. Indication for heart failure with preserved ejection fraction has not been granted for both drugs during the study period.

Eligibility Criteria:
Eligible cohort entry dates:

Optum: Study period between May 13, 2022 to November 30, 2024. Marketscan: Study period between May 13, 2022 to December 31, 2023.

Inclusion Criteria:

* Heart failure
* BMI \> 27.0 kg/m2
* History of type 2 diabetes mellitus
* LVEF ≥ 45%
* ≥ 18 years old, male or female sex

Exclusion Criteria:

* Prior treatment with any GLP-1-RA
* History of type 1 diabetes mellitus
* End-stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis
* History of bariatric surgery
* History of nursing home admission
* Pregnant female or breastfeeding
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
* Treatment with continuous subcutaneous insulin infusion
* Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) for less than 5 years
Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids

Endovascular embolisation is already a common procedure for bleeding haemorrhoids in the acute setting, where surgical options are not possible or have been exhausted. This pilot study aims to add to the small body of evidence that transarterial embolisation of symptomatic haemorrhoids is also safe and effective in the elective setting, providing a good alternative to conventional surgical management. This is a day case procedure that is performed under local anaesthetic. For selected patients, this presents a less invasive management option with reduced potential morbidity. For a health care system under significant financial stress, this provides a potential means of cost improvement, the extent of which this study will try and quantify. A series of 20 selected patients will be recruited to undergo this procedure and then followed up for 24 months. The long-term goal of this pilot study is to form the basis of a national registry of such procedures.


Eligibility Criteria:
Inclusion Criteria:

Patients eligible for the study must comply with all of the following prior to enrolment:

* Patients with grade II-IV haemorrhoid disease with re-current or active bleeding
* Patients with (i) who do not wish to undergo surgery for their symptoms
* Patients with (i) despite recent surgery
* Patients willing and able to give fully informed consent
* Patients aged ≥18 years

Exclusion Criteria:

* Patients who are not otherwise fit for surgery
* Patients with significant ano-rectal comorbidities (cancer, fistula, abscesses)
* Patient who are unable to sign the informed consent form.
* Patients who are pregnant (completed as part of standard IRMER protocol)
* Patients with history of significant colorectal disease or previous colectomy.
* Patients with history of an allergic reaction to x-ray contrast
* Patients who are currently involved in research