cyrilzakka/clinical-trials huggingface dataset:
The Effect of the Training Program Given to Permanent Colostomy Patients on Self-efficacy

The planned research aims to evaluate the impact of a training program on self-efficacy in patients with permanent colostomies. It highlights the importance of holistic patient education in preventing complications and improving adaptation to stomas, which can positively affect patients' quality of life and self-efficacy.

Stomas can be either temporary or permanent. Stomas can cause physical issues such as uncontrolled gas output, bad odor, leakage, and local skin irritation, as well as psychological and social problems such as sexual dysfunction, changes in body image, decreased self-esteem, interpersonal relationship issues, depression, anxiety, loneliness, fear, and shame. These problems can reduce individuals' self-care abilities, negatively affect daily living activities, increase their vulnerability to stoma/peristomal complications, and further delay the closure of temporary stomas. Regardless of the type of stoma, all of these issues negatively impact patients' self-efficacy.

Many of these problems and potential complications after stoma formation are preventable. Patient education provided through a holistic approach covering pre-operative, post-operative, and home care and follow-up is of great importance in preventing complications and improving patients' adaptation to the stoma. However, a review of the literature reveals that stoma-related education programs typically focus on assessing quality of life and similar factors. Some of the studies reviewed include educational content on pre-operative patient preparation and post-operative care, while others focus only on post-operative complication management. However, high-evidence guidelines, such as Enhanced Recovery After Surgery (ERAS) protocols, emphasize that the first step toward a successful surgical process should be patient education delivered through a holistic approach covering the entire surgical process.

Therefore, the planned research will be conducted to evaluate the effect of a training program provided to patients with permanent colostomies on self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* • Patients scheduled for permanent colostomy following colorectal surgery,

  * Aged 18 years and older,
  * Conscious, with orientation to person, time, and place,
  * Able to speak Turkish,
  * Without auditory or visual impairments,
  * Using a phone, were included in the study. Exclusion Criteria:• Patients who could not be contacted during the study period, or those who developed post-operative complications (such as stenosis, necrosis, ileus, dermatitis, parastomal herniation, etc.) were excluded from the sample.
Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma

The investigators hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. Thus, early detection of clinical or biological risk factors will lead to personalized dosage treatment and permit a better tolerance without altering efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 18 year-old.
2. Histologically documented renal cell carcinoma whatever the type.
3. One or two prior therapy with cytokines and/or VEFG-ligand inhibitors are permitted.
4. Patients with an indication to receive everolimus treatment
5. Patients able and willing to give written informed consent, before the first screening procedure.

Exclusion Criteria:

1. Patients currently receiving chemotherapy or immunotherapy
2. Prior treatment with temsirolimus
3. Contraindication in everolimus :

   * Hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients.
   * Patients with severe hepatic impairment (Child-Pugh class C)
   * Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
4. Pregnant or breastfeeding women
5. Patients unwilling to or unable to comply with the protocol.
Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software

We will compare the percentage of patients having therapeutic vancomycin serum concentrations after current standard dosing, after dosing with our software. We will also include therapeutic outcomes and costs in the analysis.

Recent guidelines to use the antibiotic vancomycin for serious, resistant gram-positive bacterial infections advocate higher plasma concentrations than are routinely achieved with conventional dosing. Moreover, there is wide interpatient variability in vancomycin plasma concentrations, even with standardized dosing. The hypothesis for this study is that dosing vancomycin assisted by computer software and Bayesian algorithms will lead to more rapid and accurate attainment of therapeutic blood vancomycin concentrations in children and adults. This study will enroll 90 patients per year for three years, totaling 270 patients. Eligible patients will be of any age and who are to be prescribed vancomycin by their clinicians for medical indications. Patients with vancomycin-resistant organisms, severe vancomycin allergies or who need dialysis will not be eligible. Participants in the first group of 90 will be treated according to standard care. The second and third groups of patients will be dosed with vancomycin according to the recommendations made by the study team using the BestDose software developed by the USC Laboratory of Applied Pharmacokinetics. The second group will be dosed with the software in its current form, and the third group with funded updates. For all groups, no additional blood samples will be drawn for research purposes; only routinely obtained clinical data will be used. The primary outcome in all groups will be the percentage of participants with appropriate vancomycin concentrations. Secondary outcomes in those who receive vancomycin for at least 72 hours will include effectiveness, toxicity rates, and costs of therapy. Participation in the study will cease at the time of hospital discharge or 72 hours after termination of vancomycin therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized infants, children, adolescents, and adults who require, but have not started vancomycin therapy for infections with suspected or proven beta-lactam resistant gram-positive bacteria will eligible for enrollment.
2. Participants will of any age.
3. Participant/parent/legal guardian (as applicable) must be able and willing to provide signed informed consent.

Exclusion Criteria:

1. Prior receipt of vancomycin for the same clinical event (e.g. the same fever of unknown origin in a neutropenic patient defined as \<24 hours of no fever)
2. Known colonization or infection with a vancomycin resistant organism (MIC \> 2 mg/L)
3. Known hypersensitivity or intolerance to vancomycin
4. Patients on any form of dialysis
5. Not expected to survive \>72 hours.
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals

This project aims to investigate the relationship between different dimensions of catastrophizing (rumination, magnification, and helplessness) as well as some specific personality traits related to catastrophizing tendencies like anxiety sensitivity and fear sensitivity in the modulation of itch and pain intensities in an experimental setting.

Chronic itch severely affects the quality of life of patients by interfering with vital functions such as sleep, attention, and sexual activity, with an elevated expression of cognitive and emotional factors such as itch catastrophizing, worrying, as well as personality characteristics such as the predisposition to anxiety, depression, and suicidal thoughts that play an important role in the development, modification, and maintenance of itch. Moreover, chronic itch represents a significant socioeconomic burden due to a prevalence of around 10% in combination with largely suboptimal treatment since limited evidence has been found for the effectiveness of pharmaceutical interventions. The hypothesis of this project is that since it is well documented that the relationship between catastrophizing and pain and that itch and pain share many similarities, investigators can assume the existence of a similar connection between catastrophizing and itching.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
* Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis), musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder, or mental illnesses that may affect the results
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamines, antipsychotics, and pain killers, as well as systemic or topical steroids
* Skin diseases (e.g. atopic dermatitis, pruritus nodularis, eczema, psoriasis)
* Moles, scars, or tattoos in the area to be treated or tested.
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
Evaluate the Performance of JOURNEY II CR in TKA Populations

Background:

The JOURNEY II CR Total Knee System consists of femoral component made from oxidized zirconium (OXINIUM)

Purpose:

Post-market evidence generation for JOURNEY II CR Total Knee System

Objectives:

Evaluate the performance of JOURNEY II CR TKA in APAC populations Evaluate the impact of patella resurfacing on the outcomes of JOURNEY II CR TKA

Research participants / locations:

A total of up to 480 knees' information will be collected in up to 15 sites in India, China mainland, Hong Kong, Singapore, Thailand and Japan There will be up to 240 knees for resurfaced patella group and up to 240 knees for un-resurfaced patella group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with degenerative osteoarthritis.
* Subject is planning to have TKA using JOURNEY II CR.
* Subject is able and willing to provide voluntary consent to study participation.
* Subject is 18-80 years old (inclusive) \* (\* For Japan, the minimum inclusion age is 20 years old.)

Exclusion Criteria:

* Subjects with rheumatoid arthritis/inflammatory arthritis, posttraumatic arthritis.
* Previous surgeries including HTO, UKA or TKA on the subject knee.
* Subject is pregnant or breast feeding or those at a child-bearing age planning to become pregnant during the follow up.
* Subject does not meet the indication or is contraindicated for JOURNEY II CR's IFU.
Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease

Funding Source - FDA OOPD

Pioglitazone is currently used in clinical practice to treat diabetes and this study will examine the potential use of a low dose of the same drug for the treatment of polycystic kidney disease. The purpose of this study is to determine whether the diabetes drug pioglitazone (Actos) is a safe and effective treatment of autosomal dominant polycystic kidney disease when treated in its early stages. Pioglitazone is approved by the FDA for the treatment of diabetes. Pre-clinical models of polycystic kidney disease have shown that low dose treatment with pioglitazone decreases the growth of the cysts. The studies also suggest that effective pioglitazone dosing for polycystic kidney disease may be lower than that used to treat diabetes. The purpose of this study is to see if pioglitazone might slow cyst disease in humans.

Patients will be randomize to placebo or 15 mg pioglitazone for 12 months, and then be crossed over to the other arm. Patients will undergo MRI of the liver and kidney and MRspectroscopy of the lumbar spine (if they choose as this is ancillary study) three times during the study. Assessments will be every 3 months and include blood work, blood pressure, and body water assessments.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with autosomal dominant polycystic kidney disease (ADPKD) aged 18-55
* estimate glomerular filtration rate (GFR) at or above ≥ 50 ml/min/1.73 m2 by any GFR formula
* Normal liver enzymes (ALT/AST)
* fasting blood glucose between 70 and120
* for female patients, a willingness to use double contraception to avoid pregnancy while in study
* able to give informed consent
* In the opinion of the investigator, high likelihood of progressive kidney disease

Exclusion Criteria:

* diabetes, defined as any of the following: fasting blood sugar \> 130 times two, HgbA1C \> 7, on any blood sugar lowering medication, or past diagnosis of diabetes not occurring during pregnancy
* uncontrolled hypertension as determined by the examining physician
* history of impaired systolic function (ejection fraction \< 50%) by previous echocardiogram or known ischemic cardiovascular disease
* findings suggestive of a kidney disease other than ADPKD
* systemic illness requiring immunosuppressive or anti-inflammatory agents
* congenital absence of a kidney or history of a total nephrectomy
* history of cyst reduction or partial nephrectomy
* history of renal cyst aspiration within the previous year
* History of bladder cancer, or gross hematuria
* inability to undergo MRI due to implantable devices or foreign objects that preclude MRI
* active renal transplant
* allergy or sensitivity to any of the components of the test materials
* institutionalized
* currently pregnant or plans to become pregnant during the study
Different Concentrations of Bupivacaine in Erector Spinae Plane Block in Hip Surgeries

The prevalence of hip replacement surgery is increasing nowadays. Patients are usually older age and suffer from comorbidities may be an anesthetic and analgesic challenge. Erector spinae plane block (ESPB) is a newly described technique that is has been demonstrated in previous studies for chronic and acute pain treatment. The exact volume and concentration of local anesthetic (LA) to be used in ESPB is not well established.

Aim of the work is to compare the analgesic effects of three different concentrations of the same volume of local anesthetics; 30 ml of 0.50% vs 0.375% vs 0.25% bupivacaine in patients undergoing hip surgeries.

Prospective randomized double blinded study that will be conducted in at Kasr El-Ainy hospital orthopedic surgical theater.

patients, undergoing hip surgeries will be randomly allocated into three equal groups, each (n=44), using computerized generated random tables

1. Group F: 44 patients will receive single shot erector spinae block at the level of L4 with 30 ml 0.50% bupivacaine.
2. Group M: 44 patients will receive single shot erector spinae block at the level of L4 with 30 ml 0.375% bupivacaine.
3. Group H: 44 patients will receive single shot of erector spinae block at the level of L4with 30ml 0.25% bupivacaine .

Eligibility Criteria:
Inclusion Criteria:

* Both genders (Males and females).
* Type of surgery; unilateral elective hip surgeries
* Physical status ASA I, II.
* Age ≥ 18 and ≤ 65 Years.
* Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.

Exclusion Criteria:

* Patients with known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
* History of psychological disorders and/or chronic pain.
* Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
* Infection of the skin at the site of needle puncture area.
* Patient refusal.
* Severe respiratory or cardiac disorders.
* Advanced liver or kidney disease.
* Pregnancy.
* Patient with surgery duration more than two hours.
Indication for Intraoperative Volume Therapy

This study evaluates which substitution solutions are used in daily clincal practice in various teaching hospitals in a specific district (Frankfurt/Rhine-Main Metropolitan Region). Furthermore the indication for usage of these solutions is investigated.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing surgery receiving at least one bag of cristalloid or colloid solution

Exclusion Criteria:

* decline of participation
Connection Between Vitamin D Level and the Efficacy of Dexamethasone in Immune Thrombocytopenia

The project was undertaking by Qilu Hospital of Shandong University in China. The objective is to find out if there is a connection between vitamin D level and the efficacy of dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

The investigators anticipate to undertaking a prospective, observational，non-randomized control trial of 60 ITP adult patients. Dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days) will be used in the target patients. Vitamin D level will be detected before the utilization of treatment measures. Depend on the vitamin D level, the patients will be divided into 2 groups(higher vitamin D level group and lower vitamin D level group).Platelet count, bleeding and other symptoms were evaluated before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

Corresponding to the diagnostic criteria for immune thrombocytopenia Newly diagnosed ITP patients To show a platelet count \<30 \* 10\^9/L, and with bleeding manifestations Willing and able to sign written informed consent

Exclusion Criteria:

Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit; Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit; Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study; Current HIV infection; Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test; Patients who are deemed unsuitable for the study by the investigator.
Within My Reach (WMR) Adaptation

The purpose of this study is to adapt a relationship education program. The research team is adapting so that it is helpful for Latino sexual minority men.


Eligibility Criteria:
Inclusion:

* Identify as Latino/e/x or Hispanic
* Age 18 years or older
* Currently reside in Miami-Dade County or Broward County
* Identify as gay, bisexual, or other non-heterosexual identity
* Identify as a man
* Comfortable speaking English

Exclusion:

* Unable to provide consent
* Deemed that participating would be potentially harmful to the participant or research staff
Transcutaneous Electrical Acupoint Stimulation for the Treatment of ADHD

RATIONALE: Transcutaneous electrical acupoint stimulation may improve attention deficit hyperactivity disorder (ADHD).

PURPOSE: This randomized-controlled trial study of treating attention deficit hyperactivity disorder of school-aged children with transcutaneous electrical acupoint stimulation to see how well it works compared to sham transcutaneous electrical acupoint stimulation.

OBJECTIVES:

Primary

To determine whether true transcutaneous electrical acupoint stimulation(TEAS) administered twice weekly for 4 weeks (8 sessions) compared to sham TEAS causes a significant improvement in symptoms of ADHD according to the investigator-rated Clinical Global Impression-Improvement (CGI-I) scores at week 4.

Secondary

To evaluate the changes from baseline to week 4 of Clinical Global Impressions Scale-Severity of Illness (CGI-S)，Conners'Parent Rating Scales-Revised: Short Form (CPRS-R: S) score, Conners'Teacher Rating Scales-Revised: Short Form (CTRS-R: S) score, go/no-go task performances, and the concentration of oxygenated hemoglobin within the prefrontal cortex.

OUTLINE: This is a single-center study. Patients are randomized to two treatment arms.

Arm I: Patients receive TEAS twice weekly for 4 weeks . Arm II: Patients receive sham TEAS twice weekly for 4 weeks .

Eligibility Criteria:
Inclusion Criteria:

* Patients must be conform to ADHD clinical diagnostic criteria (DSM-V).
* Patients' ages are between 6\~12 years old.
* An informed written consent from parents and participants

Exclusion Criteria:

* Patients have a history of illness that concomitant with other mental and neurological disorders.
* Patients's IQ score are lower than 75.
* Patients have had prior TEAS or other acupoints-associated treatment experiences.
* Left handedness.
Sphenopalatine Ganglion Block with Bupivacaine and Its Effect on Pain After Functional Endoscopic Sinus Surgery

Functional endoscopic sinus surgery (FESS) is a minimally invasive procedure that is used in many inflammatory and infectious sinus diseases. Acute postoperative pain can lead to adverse consequences and good postoperative treatment of pain is essential. There is no agreement on a single protocol to treat pain after endoscopic sinus surgeries, and the usually used analgesics have some side effects that hinder their use. Current evidence is insufficient for routine clinical use of the sphenopalatine ganglion block for Functional endoscopic sinus surgery and the efficacy of sphenopalatine ganglion block for pain control after functional endoscopic sinus surgery remains controversial. This study aims to explore the influence of sphenopalatine ganglion block on pain intensity after functional endoscopic sinus surgery by comparing two groups, a group receiving the block with Bupivacaine injection, versus saline injection in the other group.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years - 80 years.
2. ASA I and ASA II patients.
3. Consented to participate in the research.

Exclusion Criteria:

1. Pregnant and breastfeeding females.
2. History of allergy to bupivacaine or other local anaesthetics.
3. Patients with uncontrolled hypertension, poorly controlled cardiovascular diseases, or cerebrovascular diseases.
4. Patients with pre-existing neurological conditions.
5. Patients with history of alcohol or drug abuse.
6. Patients on anticoagulation.
7. Occurrence of surgical or anaesthetic complications or change in the anaesthesia protocol.
8. Patients showing sensitivity to Bupivacaine.
9. Patients unable to understand VAS score.
10. Patients refusing to continue participating in the study.