cyrilzakka/clinical-trials huggingface dataset:
the Use of a IPOM Mesh for Prevention of Parastomal Hernia

Study is a prospective, multicenter, randomized trial evaluating whether prophylactic laparoscopic placement of a dual-component IPOM mesh around a colostomy may prevent parastomal hernia compared with conventional colostomy after abdominoperineal resection. Eligible subjects will be recruited prospectively from five Finnish Hospitals (Oulu University Hospital,Vaasa Central Hospital, Helsinki University Hospital, Lahti Central Hospital, Jyväskylä Central Hospital). Patients were considered eligible for this study if undergoing laparoscopic abdominoperineal resection for rectal adenocarcinoma. Patients are randomized to prophylactic preperitoneal placement of a dual-component mesh (Dynamesh IPOM) around permanent colostomy or to conventional permanent colostomy. Estimating a parastomal hernia rate of 50%, a sample size of 26 patients per each study group is projected to provide 90% power (1-beta) with a alpha 0.05 (2-beta) to detect a 40% reduction in risk for parastomal hernia at 1-year. Since we expect a dropout rate of 20%, 37 patients per study group will be included in this study.

All abdominoperineal resections are performed using laparosopic technique. At the and of the abdominal laparoscopic phase the straight permanent end colostomy is performed. In the intervention group the 10 x 10 cm Dynamesh IPOM mesh is cut in the middle according to volume of the bowel. Stapled bowel end is then pulled through the crosswise opened mesh, which is pushed to the abdomen and fixed to the peritoneum.

Follow-up visits are scheduled at 1-, 3- and 12-month after surgery. Patients are evaluated for their clinical status and C-reactive protein, leukocytes and hemoglobin are assessed at each control visit. Computed tomography (CT) scan with and without Valsalva maneuver is performed 12 months after surgery for radiological evaluation of possible parastomal hernia.

The primary end-point of this study is the incidence of clinically and radiologically detected parastomal hernias, and their extent 12 months after surgery. The secondary outcome end-points were colostomy-related morbidity such as stomal stenosis, necrosis and/or wound infection.The extent of parastomal hernia was graded at CT according to the Hernia Society criteria.

Statistical analysis is performed using a SPSS statistical software. Continuous variables are reported as the mean and standard deviation, whereas nominal variables are reported as counts and proportions. Univariate analysis is performed with the Mann-Whitney U test and Fisher's exact test. P-values \< 0.05 are considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic abdominoperineal resection for rectal adenocarsinoma

Exclusion Criteria:

* Patients who can not give their consent to participate in the study
* Patients in poor general conditions (American Society of Anaesthesiologists classes 4-5)
* Patients with incurable cancer or another rectal malignancy than adenocarcinoma
* Patients with any abdominal infection
Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis

Purpose of the study:

One bothering feature of atopic dermatitis is its relapsing nature. Hence, it is worthwhile to test modes how to efficiently prevent relapses or at least increase the time until the disease recurs. In order to give recommendations to other patients, this study is to scientifically describe efficacy and safety of a given regimen, namely a maintenance therapy with two days a week Advantan.

The study has initially been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Intendis GmbH, a Bayer HealthCare company, is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Acute 'Severe' or 'Very Severe' flare of atopic dermatitis; no minimum affected body surface
* History of moderate to severe form of atopic dermatitis for at least two years

Exclusion Criteria:

* Pregnancy, breast feeding
* Known immune, hepatic, or renal insufficiency
* Acute herpes simplex or mollusca contagiosa infection
* Acute and severe impetigo contagiosa. A slight superinfection of eczema is no exclusion criterion
* Severe other viral, bacterial, or fungal skin infection (chicken pox, prominent tinea corporis)
* Acute infestations (e.g. head lice, scabies)
Osseodensification and Dental Implant Stability

Osseointegration refers to the formation of a structural and functional bone-to-implant interface, without the interposition of soft tissue. Successful osseointegration will provide long term success for the dental implant. Primary implant stability, is the mechanical stability between bone and the implant at the time of insertion and is key to initiate a successful osseointegration.

Both primary implant stability and osseointegration are affected by the density of the bone where the implant is placed. A relatively new technique known as osseodensification (OD) has been developed and uses specially designed burs (Densah burs). Compared to conventional drills (CD) that remove bone (subtractive drilling) these burs are designed so that they can rotate in a counterclockwise (CCW) (non subtractive) direction which allows bone to be preserved and compacted into the wall of the osteotomy site. These drills therefore theoretically maintain bone volume which then creates higher bone density and bone to implant contact allowing better implant primary stability.

This study will be a randomised control trial comparing OD to CD with regards to implant stability and bone levels. Considering the increased cost of OD, available literature must support a significant clinical benefit of OD over CD to consider them for clinical use. This study will aim to reinforce available clinical research and address some of the limitations of the current evidence to aid clinicians in making an evidenced-based decision on the use of OD when poor bone density could compromise implant success.


Eligibility Criteria:
Inclusion Criteria:

Patient Level

* Male or Female, 18 years old or over
* Capacity to provide informed consent
* Willing to comply with study appointment schedule Willing to maintain a diary of symptoms
* Planned for provision of dental implant(s) at Dublin Dental University Hospital

Site Level

* Location: maxilla
* Sufficient bone volume for implant placement without the need for bone graft/augmentation; alveolar ridge of minimum 6mm width for standard implants (implant diameter 4mm) and of minimum 7mm for wider implants (implant diameter 5mm)

Exclusion Criteria:

Patient Level

* Plaque score \>20%
* Bleeding score \>20%
* Tobacco smoking
* Uncontrolled systemic disease
* Use of systemic medications with an expected impact on bone healing (e.g. bisphosphonates)
* Pregnancy or lactation
* Lack of capacity to give an informed consent

Site Level

* Location: mandible
* Insufficient bone volume for implant placement, requiring bone graft/augmentation
Trial Comparing Radical Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer

This phase II randomized controlled study aims to compare the treatment results of intermediate and high risk prostate cancer patients treated with hormonal therapy and radical radiotherapy with or without pelvic lymph nodes in NCI- Cairo University.

Study Design :

Phase II prospective randomized trial with 2 arms • Prostate Only (Arm A)

Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to dose of 60Gy/20fractions (3 Gy per fraction)

• Prostate \& Pelvic Lymph Nodes (Arm B)

Hypofractionated Intensity modulated radiotherapy (IMRT) with elective pelvic nodes irradiation up to 44Gy/20 fractions (2.2 Gy per fraction) with a Simultaneous Integrated Boost (SIB) to the prostate to dose of 60Gy/20fractions (3 Gy per fraction)

Eligibility Criteria:
Inclusion Criteria:

* Histologically-proven prostatic adenocarcinoma.
* Risk stratification from intermediate to very high risk will be included according to NCCN guide lines September 5, 2019 version 4.2019:

  * Intermediate risk: T2b or T2c and/or GS =7 and/or PSA \>10-20. Both the favorable intermediate (1 intermediate risk factor (IRF) and Grade Group 1 or 2 and \<50% biopsy core positive) and unfavorable intermediate risk (2 or 3 IRFs and/or Grade Group 3 and/or ≥50% biopsy cores positive) will be included.
  * High risk: T3a or PSA \>20 or Grade Group 4 or 5, not very high risk.
  * Very high risk: T3b-4, primary gleason pattern 5 OR \>4 cores with grade group 4 or 5
* N stage: N0
* M Stage: M0
* Performance Status: PS 0-2

Exclusion Criteria:

* Low risk prostate cancer
* Histologies other than adenocarcinoma
* Patients with significant comorbidities might affect treatment completion and follow up
* Previously received pelvic radiotherapy
* Patients with metastatic disease
* Poor performance status (PS ≥ 3)
Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone

The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of diabetes mellitus prior to informed consent
2. Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)
3. Glycosylated haemoglobin A1 \>= 7.5% and \<= 10%
4. Age between 18 and less than 80
5. - Body Mass index less or equal to 45

Exclusion criteria:

1. Uncontrolled hyperglycaemia during run in period
2. Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent
3. Impaired hepatic function
4. Gastric by pass surgery
5. Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent
6. Treatment with anti-obesity drugs
7. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
8. Premenopausal women who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method during the trial
Advanced Analysis of the Carotid Phonoangiography and Diseases

Purpose: To investigate the different sound spectrum of carotid arteries and to analyze its relationship to the vessel disease, and to build a new biomarker about vascular disorder.

Methods: To record the carotid phonoangiography with digital stereoscopy and analysis the spectrum with different algorithm such as FFT, wavelet, entropy, complexity, and HHT. The results will be correlated and comparison to the finding in clinical, carotid Doppler and duplex, CTA, MR, and catheter angiography.

Statistics:

The significance of difference between parameters was computed using t-tests or paired t-test etc. A p value \<0.05 is defined as significant.

The investigators plan to recruit data from patients that come to their department for angiography study and intervention (n=300) with different disease entity such as atherosclerosis, tumor, aneurysm, arteriovenous malformation or fistula, and other vascular disorders. A period of about 20 seconds of the carotid phonoangiography was recorded.

Standard for comparison: catheter angiography, CTA, MRI/MRA. The degree of stenosis, the wall thickness, SI and density change was clustered and compared. The clinical and laboratory data will be reviewed and the vascular risk factors will be calculated.

Spectrum analysis: The sound spectrum will be analysis with the FFT, wavelet, entropy, complexity, and HHT algorithms.

The correlation between change of spectrums and also the correlated clinical, images, and laboratory change will be further analysis by statistic method.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 20 years old to 99 years old
2. Gender: Unlimited
3. Because different types of brain diseases, those who received conventional catheter vascular examination.

Exclusion Criteria:

1. Neck inflammation locally who can not admit the sound.
2. Due to inability to cooperate to accept those recordings.
Psychological Status and Self-care in Chronic Cardiovascular Disease

This is an observational study aimed at exploring the relationship between psychological status and self-care in patients with chronic cardiovascular disease

400 patients with chronic cardiovascular disease were enrolled in this observational study aiming at exploring the relationship between their psychological status (anxiety, depression, emotional distress and quality of life) and their self-care.

Eligibility Criteria:
Inclusion Criteria:

* Being aged \> 18 years old and \> 85 years old
* Being diagnosed with a chronic cardiovascular disease
* Being able and willing to sign the Informed Consent Form

Exclusion Criteria:

* Having a cognitive dysfunction or psychotic disorder signaled in the clinical documentation
* Not speaking Italian
Laparoscopic Versus Open Appendectomy in Pregnancy

The aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis.

The aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis.

Patients' medical records from 2010-2020 were extracted using billing information of the national health insurance fund of Estonia and ICD-10 codes (pregnancy, appendicitis).

Collected data was stored on RedCap electronic database and analyzed with R Studio.

Two group of patients were compared: pregnant patients who had laparoscopic appendectomy and pregnant patients who had open appendectomy.

Eligibility Criteria:
Inclusion Criteria:

Women with confirmed pregnancy who underwent appendectomy for acute appendicitis.

Exclusion Criteria:

Women who were not pregnant when having an appendectomy
Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant

The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent viral infections that may happen after allogeneic stem cell transplant. Allogeneic means the stem cells come from another person. VSTs are cells specially designed to fight viral infections that may happen after a stem cell transplant (SCT).

Stem cell transplant reduces your ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study we are trying to find a way to prevent these infections.


Eligibility Criteria:
Inclusion Criteria:

* Recipient must be at least 21 days after stem cell infusion
* Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent

Exclusion Criteria:

* Patients who have developed viral infection or reactivation will be ineligible for prophylactic infusions of VSTs
* Active acute GVHD grades II-IV
* Uncontrolled relapse of malignancy
* Infusion of ATG or alemtuzumab within 2 weeks of VST infusion. Additionally, in patients who received alemtuzumab as part of their conditioning regimen, alemtuzumab levels will be collected in the second week following stem cell infusion. The level must be less than, or equal to, 0.15 prior to infusion of VSTs. In patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. They would become eligible for prophylactic VST infusion at that point if there is still no evidence of viral infection at that time.
Mindfulness Based Interventions in Pediatric Nurses

The aim of the study was to evaluate the effect of the Mindfulness Stress Reduction Intervention on increasing the psychological resilience of pediatric nurses.

Design: This is a single-center, single-blind, randomized controlled trial

Method:

In the study, the group in which the Mindfulness-Based Stress Reduction Initiative was applied was taken as the experimental (n: 15), the unstructured group (n: 14) in which the stressful life experiences were shared as the control group. Due to the limited number of the research population (N:56), 29 nurses who agreed to participate in the study and met the inclusion criteria were included in the study without using the sampling method. This research was conducted with pediatric nurses working in the inpatient units of a children's hospital affiliated to a university in Izmir. Stress reduction training based on mindfulness, including meditation and breathing techniques, was given to the experimental group for 5 weeks. No intervention was applied to the control group.

The primary outcomes of the study were measured using the Perceived Stress Scale, the Self-Compassion Scale, the Interpersonal Reactivity Index, and Psychological Resilience Scale for Adults.

This study is important because it is the first randomized controlled study on the effect of Mindfulness Based Stress Reduction (MBSR) on resilience in nurses in our country.

In addition, the results will contribute to preventing nurses from leaving the profession in the early period, providing more flexibility and therefore safe patient care to the nursing workforce, especially in today's health system where there is a heavy nursing shortage.


Eligibility Criteria:
Inclusion Criteria:

* Working for at least one year in the children's ward,
* Older than 18 years of age,
* The working program must be suitable for the experiment schedule.

Exclusion Criteria:

* Clinical diagnosis for a psychiatric disorder,
* Long experience of meditation or yoga.
Use of the INAMED LAPBAND System to Reduce BMI's in Obese Renal Failure Patients

The purpose of this study is to assess the use of this Lap-Band system for the purpose of promoting weight loss in renal failure patients who do not qualify as transplant candidates because of excessive BMI's

The concern of transplant surgeons is that obese patients with high BMI's are more likely to experience post-transplantation complications than age-matched recipients \[1\]. Nevertheless, the Summa transplant list contains numerous patients with renal failure that have BMI's above 35. These patients are not considered to be "active" transplant candidates because of their obesity and are not eligible to receive a kidney transplant. Dr. Lal counsels these patients that they must lose weight in order to be considered active candidates for transplantation.

Weight loss for obese patients in renal failure is difficult. These patients must undergo hemodialysis three times weekly. Most of these patients do not, or physically cannot, engage in exercise activities. Many of these patients are burdened psychologically, and further behavioral responsibilities related to weight loss may overstress them. Repetitive diets or behavioral therapy in morbidly obese patients prior to transplantation have had disappointing results \[2\]. Likewise, pharmacological management of obesity in these patients is largely unsuccessful. Noradrenergic appetite suppressants must be restricted because of stimulatory side-effects. Serotonergic agents have cardiovascular and pulmonary complications. Thermogenic agents are minimally effective \[2\].

The INAMED LAPBAND SYSTEM is an FDA-approved, surgically-placed device marketed to facilitate weight reduction in obese individuals. The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years. These adjustments are performed on average 4-5 times during the first year and twice during the second year.

The purpose of this pilot study is to assess the utility of the LAPBAND in facilitating weight loss in obese renal failure patients awaiting transplantation and to document issues related to its use in these patients. The hope is that the LAPBAND will facilitate enough weight loss to reduce the patient's BMI to 35 or below after placement of the LAPBAND. If the patient reaches the intended goal of BMI of 35, they will be placed on the active renal transplant list and will be eligible for transplantation.

A secondary goal of this research is to follow those patients who successfully reach BMI's of 35 or less who are subsequently transplanted to determine any untoward effects of the LAPBAND upon transplantation success

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Hemodialysis patient with BMI between 36 and 42

Exclusion Criteria:

* Patients undergoing peritoneal dialysis
Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas

This is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.

CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory B cell malignancy by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with refractory acute lymphoblastic leukemia and Lymphomas.

Eligibility Criteria:
Inclusion Criteria: Subjects diagnosed as Relapsed or Refractory acute lymphoblastic leukemia and Lymphomas ，and have no effective treatment option (such as autograft or allogeneic stem cell transplantation) and estimated survival time of the current treatment \< 2 years, The specific requirements are as follows:

1. Male or female aged 18-70 years old ;
2. Estimated Survival time \> 12 weeks;
3. Relapsed and refractory acute lymphoblastic leukemia and lymphoma were confirmed by physical examination, pathological examination, laboratory examination and imaging;
4. Chemotherapy failure or recurrent acute lymphoblastic leukemia and Lymphomas;
5. Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level;
6. Bilirubin\<2.0mg/dl;
7. Karnofsky Performance Status\>50% at the time of screening;
8. Adequate pulmonary, renal, hepatic, and cardiac function;
9. Fail in autologous or allogenic haemopoietic stem cell transplantation;
10. Not suitable for stem cell transplantation conditions or abandoned due to conditions;
11. Free of leukocytes removal contraindications;
12. Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent.

Exclusion Criteria:

1. The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
2. Patients have infectious diseases (such as HIV, active tuberculosis, etc.);
3. The patient is an active hepatitis B or hepatitis C infection;
4. Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated ;
5. Abnormal vital signs;
6. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation;
7. Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2;
8. General infection or local severe infection, or other infection that is not controlled;
9. Dysfunction in lung, heart, kidney and brain;
10. Severe autoimmune diseases;
11. Other symptoms that are not applicable for CAR-T.