cyrilzakka/clinical-trials huggingface dataset:
Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient

The purpose of this study is to learn if the stoma boot camp is a good and effective way to help people adapt to life with a stoma after surgery.

Bladder cancer is the fifth most common cancer in the USA. The primary treatment for invasive bladder cancer is a radical cystectomy (RC) with a urinary diversion. Patients that have this procedure must deal with a stoma that requires daily care and manual skills. A stoma is an artificial opening that allows urine to pass from the ureters outside the body. Having a surgery that results in a stoma can dramatically change a person's life.

This study is being done to test a new education session called the stoma boot camp. The session was created to help people deal with changes in their post-surgery life and living with a stoma.

The session requires a one time visit to the study site and lasts about two hours. Participants can bring a support person to the boot camp if they choose. During the two hour session, nurses will provide teaching, counseling, and hands on practice with an artificial stoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be presumed to undergo a radical cystectomy with ileal conduit diversion
* Diagnosis of bladder cancer

Exclusion Criteria:

* Patients undergoing a radical cystectomy with ileal conduit for any reason other than bladder cancer will not be allowed to participate
The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema

Patients with lymphedema may experience pain and body image issues. This study investigates the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in patients with lymphedema secondary to breast cancer treatment.42 women with breast cancer related lymphedema participated. All patients completed the body image and relationships scale. Researchers divided the participants randomly into an intervention (n=21) or control group (n=21). In the first phase, CDT was accompanied by use of a compression pump for four weeks, three days per week. In the second phase, Combined DecongestiveTherapy was performed daily without compression pump for four weeks by patients at home. At the end of each phase, both groups completed the questionaire. Researchers analyzed the data with SPSS v.17.

Background:

Lymphedema is a common complication for breast cancer therapy. Patients with lymphedema may experience pain and body image issues. This study investigates the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in patients with lymphedema secondary to breast cancer treatment.

methods: 42 women with breast cancer related lymphedema participated. All patients completed the body image and relationships scale. Researchers divided the participants randomly into an intervention (n=21) or control group (n=21). A certified nurse worked on Combined Decongestive Therapy in the intervention group in two phases. In the first phase, CDT was accompanied by use of a compression pump for four weeks, three days per week. In the second phase, CDT was performed daily without compression pump for four weeks by patients at home. At the end of each phase, both groups completed the questionaire. Researchers analyzed the data with SPSS v.17.

Eligibility Criteria:
Inclusion criteria:

1. histoty of breast cancer,
2. history of surgery and chemotherapy and as needed hormone therapy and radiotherapy,
3. affected by lymphedema (with degree of mild to severe) based on specialist diagnosis,
4. at least 1 year ago was undergone axillary node dissection,
5. do not have knowledge about combined decongestive therapy,
6. phone accessibility,
7. 35-70 years old.

Exclusion criteria:

1. psychotic disorder,
2. existence sever pain at axillary area,
3. history of hysterectomy duo to uterus cancer,
4. severe cardiac disease,
5. heart failure,
6. renal failure,
7. severe hypertension,
8. existing other malignancies,
9. recurrent infection in arm,
10. musclo skeletal disease
Tenofovir Alafenamide(TAF) Reduces the Risk of Hepatocellular Carcinoma(HCC) Recurrence

Hepatocellular carcinoma(HCC) is prevalent in the hepatitis B virus(HBV) infection endemic areas. For early stage of HCC, surgical resection, radiofrequency ablation (RFA) or microwave ablation (MWA) are the main treatment options. However, the risk of recurrence is as high as 50% in 5 years by surgical resection or 60-70% in 5 years by RFA. In average, the recurrence rate of HCC at 2 years is 30%. Many factors are associated with the HCC recurrence, including HBV viral load, cirrhotic stage, tumor size, tumor number, vascular invasion, alpha-fetoprotein(AFP) level and so on. Of them, high HBV viral load is associated with the risk of HCC recurrence after surgical resection, especially on late recurrence. In one previous randomized controlled trial, patients who received lamivudine, adefovir dipivoxil, or entecavir had significantly decreased early recurrence of HCC, however, whether nucleos(t)ide analogues(NUCs) can further reduce the risk of recurrence in patients with low viral loads (\<2000 IU/ml) is still unclear.

In EASL 2017 guideline, all patients with compensated or decompensated cirrhosis need antiviral treatment, with any detectable HBV DNA level and regardless of alanine aminotransferase(ALT) levels. In Taiwan, even in chronic hepatitis B(CHB) infection patients with HCC, NUC is not reimbursed if their HBV viral load was less than 2000 IU/ml. It is an important unmet medical need to understanding the role of TAF in reducing the risk of recurrence in HBV-HCC patients with low HBV viral load (HBV DNA\<2000 IU/ml) and significant liver fibrosis after curative treatment (The definition of significant liver fibrosis was based on reference. In our recent retrospective study, the risk of recurrence and survival are comparable between patients with and without NUCs treatment before HCC development only if NUCs treatment can be provided after curative treatment of HCC. However, a higher risk of recurrence was observed in cirrhotic patients with prior NUCs treatment before HCC occurrence. It would be interesting to investigate the incidence of recurrence by switching to tenofovir alafenamide(TAF) after curative treatment of HCC in patients already on NUCs treatment.


Eligibility Criteria:
Inclusion Criteria:

* HBsAg-positive for more than 6 months.
* HCC after curative treatment (eight by surgical resection or RFA or MWA) with significant liver fibrosis (either by Ishak≧2, Metavir≧2, Knodell≧3) or cirrhosis and HBV DNA\<2,000 IU/ml.
* The duration of curative treatment of HCC to study enrollment should be less than 90 days.
* Curative treatment is confirmed by contrast-enhanced CT or MR after the surgery/RFA/MWA.

Exclusion Criteria:

* Child-Pugh class B8-C.
* Active EV bleeding within 4 weeks.
* History of hepatic encephalopathy or intractable ascites.
* BCLC C or D.
Helium 4 Optically Pumped Magnetometers : a New Generation of Sensors for High Speed Functional Brain Imaging

Our goal is to perform a first evaluation of the capabilities of a new generation of non-invasive magnetoencephalography sensors (OPM He4) to record brain magnetic activities. The investigator will record 1) normal subjects stimulated with visual, auditory, somesthesic and motor stimuli and 2) epileptic patient. The investigator will compare the signal to noise ratio of the normal or pathological activities between classical MEG sensors and our OPM He4 prototype.


Eligibility Criteria:
Inclusion Criteria:

Volunteers:

* Age 18+
* Right handed
* Medical insurance
* Strongly motivated to participate to the study
* Signed informed consent for the study
* No previous neurology or psychiatric pathologies
* No major cognitive deficit and able to understand the instructions

Patients:

* Age 18+
* Right handed
* Medical insurance
* Strongly motivated to participate to the study
* Signed informed consent for the study
* No previous neurology or psychiatric pathologies (except epilepsy)
* Epilepsy evolving during at least two years
* No major cognitive deficit and able to understand the instructions

Exclusion Criteria:

Volunteers:

* Age \< 18 years or \> 60

  * previous neurology or psychiatric pathologies
  * Child bearing women
  * Subject having one of the following mettalic parts :

    * (pacemaker, implentable pump, neurosimulator, chochlear implant, auditory prothesis, mettalic prothesis, intracerebral clip, implantable defibrilator, any mettalic parts in the brain or upper part of the body, ventriculoperitoneal valve)
    * Claustrophobia Woman with a positive pregnancy test during the inclusion.

Patients:

Age \< 18 years or \> 60

* previous neurology or psychiatric pathologies except epilepsy
* Child bearing women
* Subject having one of the following mettalic parts :

  * (pacemaker, implentable pump, neurosimulator, chochlear implant, auditory prothesis, mettalic prothesis, intracerebral clip, implantable defibrilator, any mettalic parts in the brain or upper part of the body, ventriculoperitoneal valve)
  * Claustrophobia Woman with a positive pregnancy test during the inclusion.
Contingency Management for Stimulant Use Disorders

The invetigators' objective is to implement Medication Assisted Treatment (MAT) and contingency management in patients affected by co-occurring opioid use disorder and stimulant use disorder. Participants will continue to receive standard of care for their opioid use disorder via MAT at our Outpatient Based Opioid Treatment (OBOT) Clinic. Participants' stimulant use disorder will be targeted through contingency management, with twice weekly urine drug screens and monetary prizes in exchange for negative urine drug screens. Through regular clinic visits and the use of incentives, the investigators hope to increase treatment adherence and increase the number of negative urine drug screens in subjects struggling with co-morbid opioid use disorder and stimulant use disorder. The investigators will determine whether or not this treatment is effective in this population, versus conventional treatment (baseline therapy patients were getting through OBOT). The investigators' primary outcome measure will be stimulant abstinence duration during the twelve week study.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Patients treated for opioid use disorder in the Outpatient Based Opioid Treatment (OBOT) Clinic and who also struggle with stimulant use disorder but failed conventional treatment (positive urine drug screen for substances other than THC and buprenorphine)
* Ideal candidates will test positive for 3 out of 4 weeks or more prior to starting contingency management

Exclusion Criteria:

* Persons under the age of 18
* Persons not able to attend follow-up clinic visits
* Persons not able to consent
Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery

Cardiac surgery with cardiopulmonary bypass exposes patients to the risk of post-operative acute kidney injury. In the specific setting of cardiac surgery, acute kidney injury is often of multifactorial origindue to particular haemodynamic mechanisms, renal hypoxia, or damage linked in the inflammatory reaction or haemolysis.

In recent years, inhibitors of the sodium/glucose co-transporter type 2 have demonstrated their relevance in reducing the morbidity and mortality associated with chronic or acute heart failure and chronic kidney disease. These drugs were initially developed to optimise glycaemic control in diabetic patients. They are currently recommended as part of the management of diabetic patients at high cardiovascular risk, patients with systolic and/or diastolic heart failure, and patients with chronic kidney disease.

Some pharmacodynamic properties of SGLT2i suggest that they could have a beneficial effect in preventing the onset of acute kidney injury, but also that they could lead to potentially deleterious effects in renal haemodynamic in specific situations.

The aim of the study was to estimate the impact of pre-operative exposure to SGLT2i on the occurrence of post-operative acute kidney injury in high-risk renal patients undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Cardiac surgery with cardiopulmonary bypass
* Presenting a simplified renal risk score ≥ 2 points defined as follows:

  * Pre-operative glomerular filtration rate (≤ 60; ≤ 30 mL/min/1.73m2): 1-2 points
  * Diabetes requiring treatment: 1 point
  * LVEF ≤ 40%: 1 point
  * Previous cardiac surgery: 1 point
  * Pre-operative intra-aortic counter pulsation: 1 point
  * Non elective surgery: 1 point
  * Surgery other than closure of an atrial septal defect or coronary bypass surgery: 1 point

Exclusion Criteria:

* Haemodialysis prior to surgery
* Acute kidney injury prior to surgery as defined in the primary endpoint. If this criterion is not available, patients will only be included if glomerular filtration rate estimated by the CKD-EPI formula is ≥75 mL/min/1.73m2.
* Death in the operating theatre
* Opposition of the patient to the use of his/her health data
Safety Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old

This phase I clinical study evaluates the safety of ACYW135 meningococcal polysaccharide vaccine in population aged 2-6, 7-17, 18-50 years old by the method of both passive and active surveillance.


Eligibility Criteria:
Inclusion Criteria:

* With the subject (or his guardian's) informed consent and signed the informed consent;
* The history, physical examination and clinical judgement were determined to be healthy and in accordance with the vaccination age of the product;
* The Subject or his guardian could comply with the clinical study protocol;
* Have not been inoculated with Meningococcal vaccine in the past six months and A + C meningococcal polysaccharide vaccine in the past two years;
* Have not been inoculated with other preventive biological products;
* Axillary temperature≤37.0 ℃.

Exclusion Criteria:

* Children with the history of Neisseria meningitis;
* Had allergies or serious adverse reactions of previous vaccination, such as allergies, urticaria, dyspnea, edema, abdominal pain, etc;
* Had immune inhibitor therapy and cytotoxic therapy, inhaled corticosteroids in the past 6 months (not including allergic rhinitis corticosteroid aerosol therapy, patients with acute non concurrent dermatitis surface corticosteroid therapy);
* Have been accepted blood products in the past 3 months;
* Have been inoculated with other research drugs or vaccines in the past month;
* Have been inoculated with attenuated live vaccine in the past 14 days;
* Have been inoculated with subunit or inactivated vaccine in the past 7 days;
* Had any acute illness, the need for systemic application of antibiotics or antiviral treatment in the past 7 days;
* Had fever in the past 3 days (axillary temperature≥38.0℃) ;
* Have been diagnosed with abnormal coagulation function (such as the lack of coagulation factors, coagulation disorders and abnormal blood platelet), obvious bruises or coagulation disorders by physician diagnosis;
* Had the history of thyroid resection or the need for treatment of thyroid diseases in the past 12 months;
* Asplenia, functional asplenia and asplenia or splenectomy of any situation;
* Had epilepsy, convulsions, encephalopathy, mental illness or family history;
* Suffering from serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, neurological disorders or Guillain-Barre syndrome);
* Suffering from known or suspected concurrent diseases including: respiratory diseases, acute or chronic infection of the activities, children's mother or the subject had HIV infection, cardiovascular disease, high blood pressure, during cancer treatment period, skin diseases;
* The female during her pregnant and lactation period or who plan to become pregnant during the trial.
* The subject of any other factors that are not suitable to participate in clinical trials according to the researcher's judgment.
Mindfulness-Based Self-Compassion Training for Menopausal Women

This study was conducted to determine the effects of mindfulness-based self-compassion training for menopausal women on their genital self-image and self-anger.

Materials and Methods: This study was randomized with 126 menopausal women (study group n=63, control group n=63) between June 2024 and February 2025. Mindfulness-Based Self-Compassion Training (MBSCT) was applied in groups of 10 and 11 participants, twice a week, for 8 sessions of 40 minutes. Data were obtained using the Personal Information Form, Female Genital Self-Image Scale (FGSIS), and DSM-V Level II Anger Scale.

Research Hypotheses:

H1: MBSCT applied to menopausal women enhances the genital self-image of individuals.

H2: MBSCT applied to menopausal women reduces individuals' self-anger.

The menopausal period is a period of physical and mental changes in which the body enters the aging process and the functionality of the genital organs decreases. During this period, women face negative body image, low genital self-image, and inadequate sexual functions. Perceived negative body image can lead to consequences such as low genital self-image and sexual dissatisfaction.

Mindfulness-Based Self-Compassion Training is a very comprehensive approach that addresses the awareness and acceptance of individuals towards their bodies, as well as encouraging them to live a conscious life. Studies found that self-compassion increases well-being during menopause . Psychiatric nursing is a special field that works to evaluate, diagnose, and enhance mental health in every area where people are present. However, midwifery has a wide service area with the priority of preventive health services; primarily women's health, and the duties of evaluating, diagnosing, enhancing, and rehabilitating the physical and psychological health of the whole family. In light of this information, increasing the mindfulness and self-compassion levels of women in menopause may increase the place of women who "age" healthily and therefore mentally healthy elderly women, in society and may make a significant contribution to protecting and improving the mental health of society. Since the literature review revealed a gap in the literature regarding these areas for women in the menopausal period, this study was conducted to determine the effects of mindfulness-based self-compassion training for menopausal women on their genital self-image and self-anger.

Eligibility Criteria:
Inclusion Criteria:

* Being between 45 and 70 years old
* Having no hearing problems
* Being at menopause in the last year
* Having no psychiatric illness
* Having natural menopause
* Not receiving hormone replacement therapy.

Exclusion Criteria:

* Those who did not attend two or more training sessions during the study were excluded from the study.
* Those who entered menopause surgically and received hormone/replacement therapy during the process were not included in the study.
REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy

The purpose of this study was, starting from the Italian clinical practice in liver transplantation, to optimize the immunosuppressive therapy, considering specific patient characteristics as alcoholic cirrhosis, hepatitis C virus (HCV), hepatocellular carcinoma (HCC), and short/long-term implications. Then efficacy and safety of a calcineurin inhibitor (CNI)-withdrawal regimen was evaluated in comparison with a CNI-minimization regimen.


Eligibility Criteria:
Inclusion criteria at Baseline:

* Male and female liver transplant recipients who are ≥ 18 years of age, treated with a tacrolimus-based immunosuppressive regimen, who have received an induction therapy or i.v. steroids as per local clinical practice.
* Recipients of a full-size or technically modified liver allograft will be eligible at 4 weeks (± 7 days) after liver transplantation.
* Allograft is functioning at an acceptable level by the time of Baseline as defined by the AST, ALT, total bilirubin levels ≤ 3 times ULN and INR \< 1.5 times ULN.
* Abbreviated MDRD-4 eGFR ≥ 30 mL/min/1.73m2. Serum creatinine results obtained within 5 days prior to Baseline are acceptable.

Inclusion criteria at Randomization:

* Effective tacrolimus minimization, confirmed by stable blood trough levels in the two months prior to randomization, i.e. verification of last two tacrolimus blood trough level ≤ 5 ng/mL in the two months prior to randomization. Investigators should make adjustments in tacrolimus dosing to continue to target trough levels ≤ 5 ng/mL prior to randomization.
* Abbreviated MDRD-4 eGFR ≥ 30 mL/min/1.73m2. Serum creatinine results obtained within 5 days prior to Visit 5 are acceptable.

Exclusion criteria at Baseline:

* Patients who are recipients of multiple solid organ transplants, (e.g., multivisceral or combined liver-kidney transplants), or have previously received an organ or tissue transplanted, or who received an AB0 incompatible transplant.
* Patients who experienced more than one episode of treated biopsy proven acute rejection (BANFF ≥ 3 or RAI ≥ 7) or one steroid-resistant acute rejection.
* Patients who require renal replacement therapy.
* Patients with a confirmed spot urine protein/creatinine ratio that indicates ≥1.0 g/24 hrs of proteinuria.
* History of malignancy of any organ system within the past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin or HCC.

Exclusion criteria at Randomization:

* Patients who experienced more than two episodes of treated biopsy proven acute rejection (BANFF ≥ 3 or RAI ≥ 7) since transplantation or one steroid-resistant acute rejection during the run-in period.
* Patients with a confirmed spot urine protein/creatinine ratio that indicates ≥ 3.0 g/24 hrs of proteinuria.