cyrilzakka/clinical-trials huggingface dataset:
Prevention of Lymphoceles After Robotic PLND

The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si robotic surgical system. It is intended for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit within the jaws of the instrument. Their use in this study will be to perform tissue transection during PLND such that the intended use is within the FDA-approved domain for this instrument. Investigators intend to identify whether its use for PLND reduces lymphoceles given that the device is known to seal vessels up to 7 mm, which is much larger than lymphatic vessels encountered during PLND. Because the instrument is new and has been FDA approved for less than one year, there is no published literature regarding its use to date.

Our hypothesis is that using the Vessel Sealer on a single side of the pelvis will reduce the incidence of screening detected lymphoceles on that side. Investigators propose a total sample size of 120 patients.

Investigators propose a prospective, randomized, single-blinded study of patients diagnosed with pelvic cancer who are electing to undergo robotic surgery with PLND. The patients in our trial will be pelvic cancer patients at risk for lymphocele after PLND. Given the safe nature of the product and the patient's risk for lymphocele after PLND and subsequent potential morbidity, there is justification to give patients the option for inclusion in the study. Investigators intend to determine whether the rate of lymphocele formation after PLND at the time of robotic pelvic cancer surgery can be reduced by using the robotic Vessel Sealer unilaterally for the lymph node dissection. The side of the pelvis of each patient will be randomly selected by Excel's® random number function "RAND()" to receive the Vessel Sealer dissection. Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control and eliminate patient specific confounding variables such as BMI, and surgeon specific factors such as degree and method of hemostasis utilized by each surgeon. In addition, Dr. Abaza will be the only surgeon performing these procedures, eliminating variation in technique between surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Candidate scheduled to undergo robotic prostatectomy surgery with PLND

Exclusion Criteria:

* Age \< 18
* Unable to give informed consent
* Non-English speaking
* Not a candidate for robotic surgery for any reason
Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient

This is a study of pembrolizumab as consolidation therapy for a patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT).

It is an open-label single patient Clinical Trial to be conducted at Princess Margaret Cancer Centre for a patient with Small Cell Carcinoma of Ovary - Hypercalcemic Type (SCCOHT) who has rare and aggressive malignancy with no current consensus on treatment approach and surveillance.

Eligibility Criteria:
Inclusion Criteria:

* Patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT)

Exclusion Criteria:

* N/A
The Effect of Preoperative Education on Anxiety

This randomized controlled study aimed to evaluate the effect of preoperative education on anxiety levels in patients undergoing abdominal surgery at a training hospital in Istanbul. The study population included patients admitted between January and June 2024. After power analysis, patients were divided into experimental (n=40) and control (n=41) groups. The experimental group received preoperative information, while the control group received standard care. Anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI). Data were analyzed with SPSS, using tests such as the Mann-Whitney U and Wilcoxon Sign tests.

As a result of this study, the anxiety levels of patients who received preoperative information training in the prevention or reduction of anxiety were found to be lower than patients who received routine care. The lower score indicated that they experienced less anxiety or were able to manage their anxiety in the experimental group.

Eligibility Criteria:
Inclusion Criteria:

* Admission to the general surgery clinic for abdominal surgery in category A-B-C
* must be over the age of 18
* To be literate- to be a writer
* Being conscious
* Who does not have a psychiatric disorder

Exclusion Criteria:

* Exit the research during the study,
* Group D and E abdominal surgery has been performed
* don't be under the age of 18
* Unconscious patient,
* Who has a psychiatric disorder
* Patients with communication disabilities or who cannot speak Turkish were determined as patients.
Dual Algorithm Post Market Clinical Study

The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening assay (Avioq ELISA).

This is a prospective study designed to assess the safety and effectiveness of a dual algorithm testing for HTLV I/II in blood donors. The study hypothesis is that blood donors testing repeat reactive (RR) on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed screening assay will be confirmed as indeterminate or negative on the MP Diagnostics HTLV Blot 2.4.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Completion of a health history evaluation for routine donor screening
3. Provided a routine blood donation
4. Tests repeat reactive by the Abbott PRISM HTLV assay and non-reactive on the AVIOQ Elisa HTLV assay

Exclusion Criteria:

1. Unwilling or unable to provide informed consent to blood donation
2. Inadequate sample volume for testing
3. Unable to provide samples that meet the suitability requirements for testing
Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery

This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate reconstruction.

This research hopes to determine the duration of patient-reported analgesia provided by ultrasound guided PEC II field block injections. The design of the study randomly assigns the side of injection of the study drugs into each patient. All patients are having bilateral mastectomy with immediate reconstruction. Visual analog pain scores (VAS) will be recorded serially for both sides of the patient's chest in hopes of determining a difference in duration and efficacy of the two drugs. In addition to VAS scores, a subjective, binary question will be our primary outcome: does one side of your chest have more surgical pain than the other? We hope that his question, despite being entirely subjective, overcomes interpatient variability of numerical pain score reporting.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for bilateral mastectomy

Exclusion Criteria:

* allergy to local anesthetics, prior breast surgery, asymmetric surgical plan
The Effect of PXR Activation on Blood Pressure Regulation

We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers and blood pressure is measured 24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* BMI 19-30 kg/m2
* Age 18-40 years
* Systolic blood pressure 95 - 140 mmHg

Exclusion Criteria:

* Any continuous medication
* Any significant medical condition as judged by the study physician
* Diastolic blood pressure over 90 mmHg
* Sensitivity to rifampicin
* Pregnancy and lactation
* Difficult venipuncture
* Abuse of alcohol or medications, or drug use.
* Participation in other trial with medications in previous 30 days
Femoral Neck-shaft Angle in Sohag Population

The femur or thigh bone is the strongest and longest bone of the body and about 45 cm long in an average man that means approximately one fourth of the height of individual. It has upper end, lower end and a cylindrical shaft. Upper end consists of head, neck. The neck is about 5 cm long, connects the head to the shaft and is directed upward, medially and slightly forward and making an angle about 125 with shaft but the angle is wider in children. The neck-shaft angle (NSA ) is defined as the angle formed by the neck axis and long axis of the shaft of femur.The knowledge of the neck shaft angle is valuable in the diagnosis and treatment of fracture of upper end of femur.

The aim of the study is :

1. to evaluate the normal values of femoral neck-shaft angle
2. to detect factors that may affect this angle as age, and sex, in Egyptian adults from Sohag.


Eligibility Criteria:
Inclusion Criteria:

* Adults, eligible and adequate imaging data for measurement, and absence of fracture, arthritis, tumor, deformity, or surgery on the proximal part of the femur or any disorder that may affect measurements of femoral neck-shaft angle

Exclusion Criteria:

* Adults with incomplete imaging data; and fracture, arthritis, tumor, deformity, or surgery on the proximal part of the femur
MICISPORT Survey : Questionnaire

This study offers a questionnaire to patients with Crohn's disease in order to assess their physical activity and / or sport as well as their eating habits in order to assess the impact of these lifestyle habits on activity and the symptoms of the disease.

This questionnaire, validated with Doctor Pineton de Chambrun, is set up within the framework of an exercise thesis in pharmacy focusing on the impact of physical activity and diet on the evolution and patients' Crohn's disease (CD) experience. Along with ulcerative colitis (UC), Crohn's disease belongs to chronic inflammatory bowel disease (IBD), which is a major public health concern. These pathologies currently affect 2.5 million patients in Europe (1 million of CD versus 1.5 million of UC). More specifically, in France in 2015, there were 212,700 patients with IBD, with a proportion of 60% CD and 40% RCH1. These pathologies have a major impact on patient's lifes, both in terms of quality of life and the therapeutic course (efficacy and side effects).

Physical activity and diet are other important concerns of health authorities. They are the subject of numerous recommendations based on age and health status. The World Health Organization (WHO), for example, recommends that adults between the ages of 18 and 64 should practice endurance physical activity of moderate intensity lasting at least 150 minutes per week or 75 minutes per day, sustained intensity endurance activity, or a combination of these two types of activity. Epidemiological data show that the lack of physical activity and a sedentary lifestyle favor the increase of the prevalence of diseases, such as cancer and diabetes, but also the increase in cardiovascular risk factors, such as hypertension, obesity and hyperglycemia. A sedentary lifestyle is also considered to be the fourth risk factor for mortality worldwide. Therefore, it appears interesting to study the potential impact of physical activity and exercise as well as food consumption on the activity of Crohn's disease. This impact felt by patients will be assessed by means of a questionnaire which will be offered to them after their medical consultation. The hypothesis of this work is that physical activity and / or sports and diet control improve the quality of life for patients with Crohn's disease.

Eligibility Criteria:
Inclusion criteria:

- Crohn's disease patients

Exclusion criteria:

- Patients without Crohn's disease
Cue-based Tactile Stimulation and Infant Stress Reactivity

The present study is an examination of cue-directed tactile stimulation (CTDS), administered by mothers and NICU nurses, on infant and maternal stress reactivity, infant immune system functioning, maternal parenting cognitions, and parenting competence.

The overarching aim of this study is to assess the effects of a program of mother-delivered, cue-based infant massage on stress reactivity in the mother-infant dyad, and on other measures of mother-infant functioning. The study has several interrelated objectives:

1. To evaluate the short-term effects of infant massage intervention on infant and maternal stress reactivity from assays of maternal and infant salivary cortisol, and cortisol levels in mothers' breast milk.
2. To examine the impact of mother-delivered infant massage on the development of infant resistance to infectious pathogens and antibody-based protective immunity in response to routine scheduled vaccinations, and to examine if the degree of immunity is mediated by infant stress reactivity.
3. To examine the impact of mother-delivered infant massage, and of changes in stress reactivity in response to massage, on infant physiological functioning (vagal tone, heart rate variability), infant physical development (weight, height, and head circumference), mothers' perception of infant temperament and infant state regulation, parenting self-efficacy, symptoms of depression and anxiety, and mother-infant interaction.
4. To examine associations between cortisol levels in mothers' saliva, mothers' breast milk, and infants' saliva. Establishing such linkages would support recent animal data suggesting that infant glucocorticoid levels can be affected by glucocorticoid levels transferred to the infant in mother's milk.
5. To examine whether a single nucleotide polymorphism (SNP) in three candidate genes (Mu opioid receptor, brain-derived neurotropic factor, and vasopressin V1b receptor), each associated with hypothalamic-pituitary-adrenal axis (HPA) functioning, moderates the effects of infant massage on stress-related outcomes.

Eligibility Criteria:
Exclusion Criteria:

* The following babies will be excluded:

  * With any chromosomal abnormality
  * With congenital heart disease
  * With any surgical intervention
  * With intraventricular hemorrhages greater than grade II
  * If mother dies during delivery
Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women

Breast cancer is the second most frequent cancer worldwide. Principal therapy consists in radiotherapy, but this technic has sides effects as radiodermatitis, concerning about 90 percent of women treated.

Risk of flushing could be reduced by hygienic rules, but no treatment proved its efficacy to prevent radiodermatitis.

Homeopathy is popular but also contested. No clinical trial proved its efficacy for this indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo, to prevent radiodermatitis apparition for women treated for breast cancer.

Breast cancer is the second most frequent cancer worldwide, and the most frequent in France. Principal therapy consists in radiotherapy, that is locoregional, using radiations to kill cancerous cells.

Radiotherapy has sides effects as radiodermatitis, concerning about 90 percent of women treated. Radiodermatitis could be described with three factors : redness, heat, and edema.

Risk of flushing could be reduced by hygienic rules concerning hydratation, clothes, and toilet.

Nowadays, no treatment proved homeopathic efficacy to prevent radiodermatitis. This treatment is popular but also contested. No clinical trial proved its efficacy for this indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo, to prevent radiodermatitis apparition for women treated for breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Major patient;
* Indication of curative intent radiotherapy for breast cancer treated with conservative treatment. Accepted radiotherapy scheme: 50 Gy (main) + 16 Gy on the tumor bed (additional dose);
* Patient affiliated or entitled to a social security scheme;
* Patient who signed an informed consent form.

Exclusion Criteria:

* Pregnant or lactating woman;
* Legal incapacity or limited legal capacity. Medical or psychological conditions that do not allow the subject to understand the study and sign the consent
* Patient followed by a liberal homeopath;
* Patient with bilateral breast cancer;
* Patient with in situ breast cancer;
* Patient with known cognitive impairment;
* Patient with known allergy and / or intolerance and / or malabsorption to fructose, glucose, galactose;
* Patient with a known deficiency in sucrase / isomaltase / lactase.
Transorbital Ultrasound of Optic Nerve Sheath Diameter Between Healthy Pregnant Women and Those With Severe Preeclampsia.

The neurological alterations associated with preeclampsia depend on cerebral autoregulation, a theory that outlines the mechanisms by which the nervous system controls cerebral perfusion. However, with the loss of autoregulation, increased blood flow, edema and eventually increased intracranial pressure are triggered and may be translated into neurological manifestations such as symptoms of vasospasm, one of the criteria for severity in preeclampsia.

Nervous system manifestations frequently found in preeclampsia are headache, blurred vision, scotomas and hyperreflexia. Although uncommon, temporary blindness (lasting a few hours to a week) may also accompany severe preeclampsia and eclampsia.

The optic nerve, as part of the central nervous system, is surrounded by cerebrospinal fluid and dura mater, which forms the optic nerve sheath. Due to the connection with the intracranial subarachnoid space, the diameter of the optic nerve sheath is influenced by variations in cerebrospinal fluid pressure. Increased intracranial pressure is transmitted to the subarachnoid space surrounding the optic nerve, causing its expansion.

Recent studies suggest that an optic nerve sheath diameter greater than 5 mm correlates 100% with ICP (intracerebral pressure) greater than 20 mm Hg. Due to the simple nature of the test and the limited time required to perform it, it is an ideal non-invasive test to assess changes in mental status, severe headache, and to take the necessary measures aimed at reducing intracranial pressure.

The diagnosis of elevated intracranial pressure is challenging and critical, because early recognition and treatment are essential to prevent brain damage or death since preeclampsia with severe data remains one of the most frequent complications in our institution.

These values are not taken from the obstetric population, so this study proposes the description of a standard value for the pregnant population. There are few studies that describe a value to help us define cases of this pathology and correlate it with the signs and symptoms of severity in patients with preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Age between 15-44 years.
* Gestational age between 34-40 weeks of gestation.

Exclusion Criteria:

* Eye disease (Glaucoma, diabetic neuropathy, optic neuritis).
* Nervous disorders.
* Psychiatric disorders
* Diabetes
Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI

Ischemic heart disease remains the leading cause of death in the western world. The beneficial effects of cardiac rehabilitation on the evolution of ischemic heart disease are known, but the effects of rehabilitation on the metabolic processes of the patients are so far poorly understood. Metabolomics is the qualitative/quantitative analysis of the body's metabolic responses to pathophysiological stimuli or genetic alterations. Metabolic changes caused by physical activity have been demonstrated in obese and diabetic patients and in athletes. Aim of the study is to evaluate whether cardiac rehabilitation after a first myocardial infarction induces changes in the metabolic state of patients, and whether these changes may be related with changes in the usual risk factors (i.e. glyco-lipidic profile, natriuretic peptides, homocysteine).


Eligibility Criteria:
Inclusion Criteria:

* recent first acute myocardial infarction

Exclusion Criteria:

* severe diabetes
Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis

The purpose of this study is:

1. To evaluate the prevalence of preclinical atherosclerosis in Chinese patients with RA compared to healthy controls.
2. To determine those clinical and biological measures that best predict the presence of plaque and increased arterial stiffness.
3. To ascertain the efficacy and safety of rosuvastatin in the prevention of atherosclerosis in patients with RA measured by carotid intima-media thickness (IMT) and pulse wave velocity (PWV).

150 consecutive RA patients followed at the Rheumatology clinic of the Prince of Wales Hospital will be recruited for this double-blind, randomized, placebo-control trial. Patients were matched to 150 controls on the basis of age (within 5 years), sex, body mass index (+/-5Kg) and ethnicity for the cross sectional study on the prevalence of subclinical atherosclerosis. Controls were healthy individuals recruited from the same community who underwent similar imaging protocols of the IMT and PWV assessments.

Primary outcome is the improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.

Secondary outcomes:

* Prevalence of premature atherosclerosis in RA patients compared to healthy controls in terms of the presence of plague and PWV.
* Correlation between clinical parameters, inflammatory markers (CRP/hsCRP, TNF-alpha and IL-6) and atherosclerosis (evaluated by IMT, the presence of plaque and PWV).
* Relation among PWV, ABI and AI in RA patients, and clinical significance of their combination.
* Determine which segment's PWV has a better relation with RA disease activity.

Eligibility Criteria:
Inclusion Criteria:

* Men or women, 18 years of age or older
* Clinical diagnosis of RA with a duration of at least 6 month
* Prednisolone \< =10 mg/day
* NSAID or DMARD
* Informed consent

Exclusion Criteria:

* Little or no ability for self-care
* Type 1 diabetes mellitus
* Uncontrolled hypertension(\> 160/95 mmHg)
* Total cholesterol \> 240 mg/dl, current or recent (within the past 3 months)
* History of coronary bypass grafting, myocardial infraction within 28days, left ventricular dysfunction (ejection fraction \< 40%), significant valvular heart disease
* Current treatment with ACE inhibitor, angiotensin II receptor blockers or beta-blockers, lipid lowering drug, or contra-indication to statins
* Current treatment of oral contraceptives, estrogen and progestin was allowed but patient not willing to stop during study
* Current treatment with antioxidant therapy (Vitamin C or multivitamin)
* Received intra-articular, intramuscular, or intravenous corticosteroids in the past 4 weeks before screening
* Clinically significant renal disease(serum creatinine level ≥ 270 µmol/L) or aspartate aminotransferase(AST), alanine aminotransferase ALT), or creatine kinase (CK)≥ 2 X ULN
* Female of childbearing potential, unwilling to use adequate contraception during the study
* Current or recent (within the past 3 months) pregnancy and cancer