cyrilzakka/clinical-trials huggingface dataset:
Radiation Therapy Followed by Surgery in High-Risk, Localized Carcinoma of the Prostate

The purpose of the study is to assess the safety of four different doses of radiation therapy followed by to surgery to remove prostate tumor.

Patients in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fraction), respectively, to the whole pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 Gy, respectively. The patients will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
* Subjects must have a negative bone scan.
* Subjects must have "high-risk" prostate cancer, defined as:

A. PSA \>/= 20, and/or B. Gleason Score (GS) \>/= 8, and/or C. Clinical stage T3 disease per AJCC Staging Manual, 6th edition; or D. At least two out of three of the following: PSA 10-19.9, GS = 7, or clinical stage = T2b / T2c.

* Subjects must be medically fit to undergo surgery as determined by treating urologist.
* Subjects must be under 70 years of age.
* KPS must be \>/= 80.
* Subjects must not have a synchronous primary tumor, or a previous cancer unless disease free for \>/= 5 years.
* Subjects must not have had prior pelvic radiation therapy, chemotherapy, or androgen deprivation.
* Subjects must freely sign informed consent to enroll in the study.

Exclusion Criteria:

* Metastatic disease as demonstrated by bone scan, CT scan or MRI of the pelvis, or chest x-ray.
* Pathologically documented positive pelvic lymph nodes. If Pre-operative CT scan or MRI (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
* Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
* History of prior pelvic radiation therapy.
* History of androgen deprivation therapy or chemotherapy.
Efficacy of Proton Pump Inhibitors in Gastrointestinal Erosions and/or Ulcers

The aim of this study is to collect the data of clinical efficacy and safety after the usage of bonoprazon and esomeprazole when the patients take NSAIDs more than 2 weeks and have gastrointestinal symptoms who have had gastrointestinal erosions and/or ulcers in the past.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of NSAIDs-induced gastrointestinal Erosions and/or Ulcers who want to take Bonoprazan or Esomeprazole

Exclusion Criteria:

* Patients allergic to Bonoprazan or Esomeprazole
Effectiveness of a Bonding and a Fluoride Varnish for Long-term Dentin Hypersensitivity Treatment.

Objectives:

The aim of this in vivo randomized clinical trial with split-mouth design was to evaluate the clinical efficacy of one in-office application of a fluoride containing varnish and in office application of a bonding resin in adult patients presenting with dentin hypersensitivity.

Materials and Methods:

The study cohort consisted of 38 Caucasian outpatients, giving a total of 180 teeth were treated by fluoride varnish (FV) and 160 - by bonding agent (BA). Baseline pain in FV group was slightly higher on both scales (SCHIFF and VAS). Outcome measurements were assessed one or two weeks before product application (enrollment), at baseline at the application days (end of the run-in period: T0a, T0b, T0c), and at 1 week and at 1-2-6 months after first treatment.


Eligibility Criteria:
Inclusion Criteria:

* absence of systemic pathologies (ASA class I);
* not pregnant or lactating;
* good oral hygiene;
* with ≥1 sensitive tooth with exposed dentin on upper or lower dental arches;
* contemporary presence of exposed dentin both on the left and right counterpart of upper or lower arch.

Exclusion Criteria:

* domestic or in-office professional fluoride application and bleaching 6 months before beginning of treatment;
* long-term use of anti-inflammatory, analgesic and psychotropic drugs;
* eating disorders, systemic conditions that cause or predispose patients to develop dentin hypersensitivity (for example, Gastroesophageal reflux disease);
* periodontal surgery and within the previous three months before the study;
* orthodontic treatment within the previous three months before the study.
Extra Corporeal Shock Wave Versus Kinesio Tape in Carpal Tunnel Syndrome

This study would be conducted to answer the following question: was there any difference between the effects of Shock wave versus Kinesio Tape in the treatment of carpal tunnel syndrome for post-menopausal women.

Fifty menopausal women with mild to moderate CTS were selected randomly from outpatient clinic of the physical therapy department of El khazendara general hospital, Age was ranged from 45 - 55 years old.

Group A, consisted of 25 patients who received a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session. Group B Represented the control group, it consisted of 25 patients who received a program of kinesio tape application on the affected wrist for 3 days.

Eligibility Criteria:
Inclusion Criteria:

* -Age was ranged from 45 - 55 years old
* All subjects would not take analgesics by another route during the study.

Exclusion Criteria:

* Patients had previous carpal tunnel release.
* Skin over sensitivity of some patients to the tape.
The Science of the Art of Palliative Care

This feasibility pilot study is designed to learn whether patients and their care partners (e.g., family members) are willing and able to complete two study visits at Dartmouth College while receiving cancer care at Dartmouth-Hitchcock Medical Center.

A feasibility pilot open label, single-arm observational case series of 10 patients with metastatic gastrointestinal and lung cancer patients and 10 care partners. Participants will complete two study visits, separated by approximately 8-16 weeks of usual oncologic care with early integrated specialty palliative care. The palliative care physician will also be a study participant.

Primary Objective: To develop and refine study procedures which can be used in future research in order to further understanding of the mechanisms of action of specialty palliative. Expected products: manual of operating procedures and web-based data collection forms.

Secondary Objectives: To test the feasibility of conducting a mechanism-focused clinical trial of primary palliative care vs. specialty palliative care for advanced cancer patients and their care partners. Expected products: preliminary data demonstrating the feasibility of study procedures sufficient to prove this study design is possible.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Patient: has received a diagnosis of advanced lung or gastrointestinal cancer within the last 24 weeks (note: advanced GI cancer will likely be pancreatic or colorectal)
* Care partner: care partner of a patient who has received a diagnosis of metastatic lung or gastrointestinal cancer who has provided consent for study (either with our without functional MRI study visits)
* Be able to understand study requirements and make an informed decision to participate
* Be able to speak and read English

Exclusion Criteria:

* Life expectancy of \<8 weeks
* Known brain metastases
* Claustrophobia
* Both patient and care partner refuse to participate in fMRI scan (ie., either patient or care partner must agree to an fMRI scan in order for either to participate)
* Contraindications to MRI (e.g.: implanted or embedded metal/metal fragments. Metals in the body make the participant unable to undergo an MRI which makes them ineligible for study participation).
Propofol Effect-Site Target Controlled Infusion in the Obese: Characterization of the Time Profile of Bispectral Index Response

The aim of this study is to characterize the Pharmacokinetic/Pharmacodynamic relationship of a single bolus dose of propofol in obese patients and to extract a time to peak effect (t-peak) from the estimated model parameters.

Target controlled infusion (TCI) is a technique to administer intravenous drugs that allows rapid achievement and maintenance of predetermined drug concentrations, either in plasma (Cp) or at the site of effect (Ce).

To characterize the time profile of propofol effect an additional parameter, the equilibration half time between plasma and effect site (T1/2keo) needs to be incorporated in the pharmacokinetic (PK) model.

Eligibility Criteria:
Inclusion Criteria:

* IMC \> 35 kg m-2
* Scheduled for laparoscopic bariatric surgery
* ASA I-II patients
* Between 20 and 60 yr of age.

Exclusion Criteria:

* Patients with allergy to study drugs
* Uncontrolled hypertension
* Heart block greater than first degree
* Take any drug acting in the central nervous system
A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes

This study will examine the response of several doses of LY2148568 (exenatide) and assess the effect on glucose control and safety and tolerability in Japanese patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes.
* Have a body weight of \>=50 kg.

Exclusion Criteria:

* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Have participated in this study previously, or any other study using exenatide or other GLP-1 analogs.
* Are treated with any exogenous insulin within 3 months of screening.
* Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): \*drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine).
* Have characteristics contraindicating for concomitant medication, according to product-specific label.
* Have severe allergy or hypersensitivity to any drug.
Comparison of Hemodynamic Effect Between the Spinal Anesthesia and Saddle Block Using Levobupivacaine During Transurethral Resection of the Prostate in Cardiac Elderly Patients

Transurethral resection of the prostate (TURP) is the most common surgical intervention for patients with benign prostatic hyperplasia. TURP is mostly applied to elderly patients with hypertension and problems with breathing, circulation system, and kidney functions; therefore, it becomes very important to keep a stable anesthesia that will minimize the hemodynamic differences in these patients. General anesthesia causes more hemodynamic differences than regional anesthesia. Thus, regional anesthesia is highly preferable in TURP applications.

TURP is performed by inserting a resectoscope through the urethra and resecting prostatic tissue with an electrically powered cutting-coagulating metal loop or using laser-22 vaporization energy. This can be accomplished with either a monopolar TURP (M-TURP) or bipolar TURP (B-TURP) technique. Laser energy for TURP has also been used for many years. With each technique, as much prostatic tissue as possible is resected, but the prostatic capsule is usually preserved. If the capsule is violated, large amounts of irrigation solution can be absorbed into the circulation via the periprostatic, retroperitoneal, or peritoneal space. Bleeding during TURP is not uncommon but usually controllable; hemostasis becomes difficult when large venous sinuses are opened. If the bleeding becomes uncontrollable, the procedure should be terminated as quickly as possible, and a Foley catheter should be passed into the bladder and traction applied to it. The catheter's inflated balloon exerts lateral pressure on the prostatic bed and reduces bleeding. Bleeding requiring transfusion occurs in approximately 2.5% of TURP procedures.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) III,
* with Ischemic Heart Disease (history of Myocardial Ischemia,
* a history of a positive treadmill test result (Electro Cardio Graph stress test),
* use of nitroglycerin, chronic stable angina for more than two months, or an ECG with abnormal Q waves), with ejection fraction (EF) 35%-50%,

Exclusion Criteria:

* patients under 65 years,
* patients with any diseases that increase intraabdominal pressure (any intra-abdominal mass),
* general contraindications of spinal anesthesia as patient refusal, coagulation disorders, local infection at the site of the block, psychiatric illness,
The Relative Effects of Three Parent-Intervention Components to Reduce Children's Anxiety

This trial will test the relative effects of three parent-intervention components to reduce emerging anxiety problems in children aged 7-11. The components are: reducing family accommodation (Component A), increasing empathetic reactions to children's anxiety (Component B), and cognitive restructuring to reduce maladaptive parental thoughts about children's anxiety (Component C). The components were selected based on their distinct theoretical backgrounds and their frequent use in existing intervention programs. The investigators will use a full factorial experiment with all possible combinations and orders of components. The study period will be twelve weeks with five points of data-collection: T0 (baseline), T2 (two weeks post baseline, immediately after the first component), T4 (four weeks post baseline, immediately after the second component), T6 (six weeks post baseline, immediately after the third component) and T12 (12 weeks post baseline, follow-up).

Our overarching research questions are:

* How effective are Component A, B, and C in reducing children's anxiety symptoms? The effects of the components will be compared with each other, and with a control condition. This will be investigated both from T0 to T2 (i.e., effects of the individual components) and from T0 to T6 and T0 to T12 (i.e., effects of the components controlled for the presence of other components).
* How effective are the components in reducing children's life impairment? The effects of the components will be compared with each other, and with a control condition.
* Are effects of the components on children's anxiety mediated by changes in the parental risk factors that they target? (i.e., family accommodation for Component A, empathetic reactions for Component B, and parental maladaptive beliefs about child anxiety for Component C)
* Is there a dose-response effect such that children whose parents received more intervention components benefit more in terms of reduced anxiety symptoms in children?
* What parent, child, and intervention characteristics moderate the effects of the components on children's anxiety? In addition to basic sociodemographic information, the investigators will collect data on several putative moderators: the extent to which parents see their child as part of themselves (Inclusion of Child in the Self Scale), children's behavioural inhibition (Behavioural Inhibition Questionnaire), therapist alliance (Session Rating Scale), acceptability of the intervention (TEI-SF), other caregiver's use of the intervention components.


Eligibility Criteria:
Inclusion Criteria:

* Child aged 7;0 - 11;11 years old
* Score of ≥ 4 on the screening questionnaire "Overall Anxiety Severity and Impairment Scale for Youth" (OASIS-Y; Comer et al., 2022) filled in by parents.

Exclusion Criteria:

None
A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin

This is a single cohort observational safety study. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study. Data will be collected from centre's medical records for up to 5 years or death.


Eligibility Criteria:
Inclusion Criteria:

* All patients who are considered candidates to receive Herceptin for this indication

Exclusion Criteria:

* Patients for whom Herceptin is contraindicated
Bladder Endometriosis: Evaluation in MRI of the Involvement of the Posterior Inferior Wall

Evaluate MRI criteria for involvement of the posterior inferior wall of the bladder in patients with endometrial bladder disease.

PURPOSE: to retrospectively evaluate on MRI the local staging with assessment of ureteral orifices extension in bladder endometriosis./ MATERIALS AND METHODS: Institutional review board approval for this study was obtained and waived written informed consent. The MR images of 39 patients operated for bladder endometriosis over a 6 years period in 3 university Lyon hospitals were reviewed. Two experienced readers reported the vesical repletion volume, the largest lesion size, the location and extension of the lesion within the bladder wall, the distance between the ureteral orifices and the lesion when the vesicovaginal wall was involved, the presence of muco-sub mucosal complex edema and the association with external adenomyosis. MR images were compared with surgical and pathological findings. Efficacy parameters were calculated with 95% confidence interval (CI).

Eligibility Criteria:
Inclusion Criteria:

* Patient operated for pelvic endometriosis with bladder resection.
* Performing a preoperative pelvic MRI with at least 2 perpendicular T2 planes

Exclusion Criteria:

* Refusal to use clinical data and exploration acquired
* Absence of interpretable preoperative pelvic MRI
Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes

Ketones are a source of energy and signaling molecule that are produced by the body when not consuming any food or consistently eating a low-carbohydrate "keto" diet. Blood ketones can be used as a source of energy by the body, but they may also act as signals that impact how different cells in the body function.

Recently, ketone supplements have been developed that can be consumed as a drink. These supplements can raise blood ketones without having to fast or eat a "keto" diet. Previous studies have shown that these supplement drinks can lower blood sugar without having to make any other dietary changes. Drinking these ketone supplements may therefore be an effective strategy to improve blood sugar control and influence how cells function.

To find out if it is feasible for people with type 2 diabetes to drink these ketones supplements regularly over 90 days, we will compare between two groups in this study: one group that will be asked to drink ketone supplements, and one group that will be asked to drink a placebo supplement.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with type 2 diabetes by a physician at least 1 year prior
* stable use of glucose-lowering medications for at least three months
* must be able to read and understand English in order to complete the study questionnaires

Exclusion Criteria:

* competitively trained endurance athlete
* actively attempting to gain or lose weight
* having a history of mental illness or existing neurological disease
* having a history of cardiovascular events in the last two years, hypoglycemia, irritable bowel syndrome, or inflammatory bowel disease
* are currently taking SGLT2 inhibitors or insulin
* are using more than 2 classes of glucose-lowering medication
* currently following a ketogenic diet or regularly taking ketone supplements
* unable to commit to a 90-day trial
* being unable to follow remote guidance by internet or smartphone
* currently taking natural or over-the-counter supplements specifically designed to lower blood glucose (e.g., berberine, bitter melon)
Tranexamic Acid for Alloplastic Breast Reconstruction

Hematoma is a common complication of alloplastic breast reconstruction. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Previous studies have shown correlation between the use of tranexamic acid (TXA), an anti-fibrinolytic, and reduced post-surgical bleeding complication events.

In this randomized control trial (RCT) assessing TXA use in alloplastic breast reconstruction, one breast will be randomized to have TXA applied topically, while the other will have normal saline (NS) placebo applied. The primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical TXA in alloplastic breast reconstruction reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. The results of this study will be used to inform the design of a larger multicentered RCT on TXA in breast surgery.

The primary objective of this study is to investigate the use of topical application of tranexamic Acid (TXA) to the surgical wound as a means to decrease hematoma formation compared to placebo in patients undergoing alloplastic breast reconstruction. This project is designed as a single-center RCT to evaluate the effectiveness of topical TXA in this patient population.

If enrolled in this study, patients individual breasts will be randomly assigned to one of two treatment groups for to apply to the wound before it is closed.

One breast will have an intravenous form of TXA applied topically to the surgical site. The other will be have a topical normal saline solution applied to the wound before closure (a placebo).

The patients will have the standard number of drains and postoperative instructions for breast reconstruction. They will follow-up at two weeks time in clinic for assessment, and emergency room visits will be also be evaluated. Standard of care will be practiced with respect to all procedures and visits.

Eligibility Criteria:
Inclusion Criteria:

* Are 18 years or older;
* Are undergoing one- or two-stage bilateral alloplastic breast reconstruction immediately after bilateral mastectomy at either Hamilton Health Sciences or St. Joseph's Hospital Hamilton.

Exclusion Criteria:

* Taking therapeutic anticoagulation;
* Taking antiplatelet drugs;
* Pregnant or breast feeding;
* Allergic to TXA;
* Cannot provide informed consent;
* Alloplastic reconstruction is not performed immediately after mastectomy;
* Have a documented coagulopathy or bleeding disorder, acquired disturbances of colour vision, subarachnoid hemorrhage, hematuria, irregular menstrual bleeding, or seizure disorder.