cyrilzakka/clinical-trials huggingface dataset:
Study of Serum and Urinary Biomarkers and Radiation Cystitis in Patients Treated With Radiotherapy for Localized Prostate Cancer

Prostate cancer represents the 1st diagnosed cancer in men, with 50400 new cases and 8100 deaths in 2018. Improved diagnostic and therapeutic strategies have led to a 3.7% decrease in mortality between 2010 and 2018 with a 5- and 10-year survival rate of 93% and 80%, respectively.

Pelvic conformal radiotherapy is an important therapeutic technique in the management of pelvic cancers, particularly prostate cancer. However, despite the improvement in radiation techniques, this technique is responsible for acute and late adverse events at the bladder level, these symptoms being grouped under the term radiation cystitis. It has a clear impact on the quality of life of patients. Acute radiation cystitis is likely to occur during treatment or within 3 months after radiotherapy. Its incidence is estimated at nearly 50%. The late form appears on average 2 years after radiation, but can sometimes occur 10 or 20 years later. Its incidence is 5 to 10% of cases.

Although certain factors have been identified, such as the dose received, fractionation or comorbidities, the pathophysiology of radiation-induced cystitis remains unclear, particularly because of the risks of complications arising from access to bladder tissue post-irradiation, thus limiting our knowledge as well as the therapies targeting this process. The use of biomarkers in liquid biopsies allows us to understand the problem of access to irradiated tissues and to highlight protein changes, prognostic of radiation-induced visceral toxicity.

Few works are published on the evaluation of inflammatory and pro-fibrotic biomarkers of radiation-induced cystitis in liquid biopsies. Only 2 retrospective studies have shown a correlation between late radiation cystitis and increased levels of plasminogen activator inhibitor 1 (PAI-1), matrix metalloproteinase inhibitors (TIMP1 and TIMP2), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF) and placental growth factor (PIGF) in urine. However, none of these studies explored the variation of biomarkers in the early stage of radiation-induced bladder toxicity.

This would suggest the feasibility of prospective assay of overexpression of these proteins in liquid biopsies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate;
* Localized adenocarcinoma of the prostate according to the D'Amico Risk Classification for Prostate Cancer;
* Eligible for external beam radiation therapy and/or brachytherapy;
* Patient able, in the opinion of the physician-investigator, to communicate well, understand and comply with the requirements of the study;
* Patient with a phone or a computer.

Exclusion Criteria:

* Patient with advanced or metastatic prostate cancer;
* Patient receiving pre-irradiation hormone therapy;
* Patient with bladder or urethral cancer or a history of it;
* Previous urinary tract surgery (bladder augmentation, cystectomy);
* Patient participating in an interventional clinical study;
* Patient with a history of pelvic irradiation;
Effect of Photobiomodulation Therapy in Patients With Hashimoto's Thyroiditis

The standard lifelong treatment for Hashimoto's thyroiditis (HT), a chronic autoimmune disease, is levothyroxine (LT4) therapy. Despite LT4 replacement therapy, patients continue to experience persistent fatigue, deterioration in psychological and general well-being. Our study was conducted to investigate the effects of photobiomodulation therapy (PMBT) combined with LT4 replacement therapy on fatigue and behavioural status in patients with HT.

Photobiomodulation therapy (PMBT) induces a wide range of molecular, cellular and tissue-based therapeutic effects through a biostimulation process by inducing a photochemical reaction in the cell. Some investigations show useful effects of this treatment with regard to thyroid function, autoimmunity and vascularisation in patients with Hashimoto's thyroiditis (HT). However, little is known about the efficacy of PMBT on neuromuscular symptoms and behavioural status. Therefore, in this study we aim to contribute the present literature on PMBT and to determine the clinical efficacy of PMBT. To the best of our knowledge, this study is the first paper to discuss the symptomatic efficacy of PMBT in patients with HT. Here, we investigate the effects of PMBT applied in combination with LT4 treatment on fatigue, sleep quality and behavioural status in people diagnosed with HT.

Eligibility Criteria:
Inclusion Criteria:

* The study included patients over the age of eighteen years who were diagnosed with HT by a specialist physician and followed up with LT4 treatment.

Exclusion Criteria:

* Exclusion criteria were acute infection, use of immunosuppressants, immunostimulants and drugs that interfere with the production, transport and metabolism of thyroid hormones (e.g. corticosteroids, lithium and amiodarone), thyroid nodules, tracheal stenosis, history of serious illness (e.g. cancer, ischaemic coronary artery disease, stroke, renal and liver failure), history of exposure to ionising radiation or neoplasia in the cervical region, malignancy and thyroid surgery; cancer, ischaemic coronary artery disease, stroke, renal and hepatic failure), history of exposure to ionising radiation or neoplasia in the cervical region, history of malignancy and thyroid surgery, hypothyroidism caused by postpartum thyroiditis, pregnancy and lactation, neurological and psychiatric disorders.
Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs

The purpose of this study is to explore the efficacy of a phone-based weight loss program that has stress management techniques integrated throughout (Weight Talk-Mindfulness). The program is targeted at employees of certain companies who meet a cut-off score on a measure of stress-related eating. The control group will receive a standard phone-based program with no additional stress management information (Weight Talk-Standard).

* Hypothesis 1: Participants in Weight Talk-Mindfulness (WT-M; n=50) will experience decreases in their stress-related \& emotion-related eating compared to the Weight Talk-Standard (WT-S; n=25) group.
* Hypothesis 2: The WT-M group will lose more weight compared to the WT-S control group.
* Hypothesis 3: Participants in WT-M will experience decreased perceived stress, increased eating self-efficacy, increased acceptance of weight-related thoughts \& feelings and increased mindfulness compared to those in the WT-S control arm.
* Hypothesis 4: Participants in WT-M will be equally as satisfied with their weight loss program as those in WT-S.


Eligibility Criteria:
Inclusion Criteria:

* Be enrolled in the Weight Talk program, inclusion criteria:

  * Employment by one of the employers who contract for Weight Talk services
  * Being over 18 years of age
  * Speak and read English
* Have a starting BMI between 25 and 35.
* Score 5 or higher on the 8-item Internal Disinhibition subscale of the Eating Inventory.
* Have regular access to email and internet.
* Willingness and ability to complete study and intervention procedures, including completing assessments, engaging in moderate physical activity (e.g., walking, swimming) and using the electronic scale at least once per week.

Exclusion Criteria:

* Type 2 Diabetes (Type 1 is an exclusion for the Weight Talk program).
* Past diagnosis of anorexia nervosa or bulimia nervosa.
* Weight Talk program exclusion criteria include:

  * Pregnancy
  * Bariatric surgery within past 12 months or planned in the next 6 months
  * Undergoing dialysis
  * Have Type 1 Diabetes diagnosis
* Women who are pregnant are not eligible for the program, but contraception is not required as this is a low risk study
* Currently using or planning to start using a pharmaceutical weight loss drug
Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins

The purpose of this study is to estimate the relative risk of severe hepatic injury in hospitalized patients with invasive candidiasis and candidemia who received anidulafungin, compared to patients who received caspofungin and/or micafungin.


Eligibility Criteria:
Inclusion Criteria:

* Acute-care inpatients;
* Aged 18 years or older;
* At least one dose of echinocandin therapy during the hospitalization;
* Primary or secondary ICD-9 discharge diagnosis of invasive candidiasis / candidemia.

Exclusion Criteria:

* \< 18 years of age;
* No recorded echinocandin therapy during hospitalization;
* Acetaminophen hepatotoxicity;
* Pre-existing autoimmune hepatitis;
* Autoimmune/metabolic liver disease;
* Primary biliary cirrhosis;
* Primary sclerosing cholangitis and orthotopic liver transplantation.
Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA)

Sentinel lymph node biopsy (SLNB) is the standard procedure to stage the axilla in clinically node-negative invasive breast cancer (IBC) patients undergoing upfront surgery.

The ACOSOG-Z0011 and the AMAROS trial demonstrated that SLNB with or without radiotherapy provided equivalent local control and survival to axillary lymph node dissection (ALND) in early-stage breast cancer patients with 1 or 2 positive SLNs. However, the ACOSOG-Z0011 trial did not included patients treated with mastectomy, and the AMAROS trial only included 17% of mastectomy patients.

The investigators conduct an observational cohort study of early stage breast cancer patients receiving upfront mastectomy with 1 or 2 macrometastases after SLNB. The study aim to demonstrate a 5-year disease-free survival of not less than 80% when ALND is omitted and replaced by axillary radiotherapy, and determine the axillary recurrence rate.

This is a multi-center, prospective study with an estimated sample size of 60 early-stage IBC patients.

Clinically node-negative T1-2 IBC patients undergoing mastectomy with up to 2 macrometases after SLNB will be informed about this study.

Patients will be checked with annual mammography and clinical examination. The axilla will be checked with ultrasound at 3 and 5 years of the surgery.

After surgery, patients will receive axillary radiotherapy, but no ALND, and adjuvant systemic treatment based on international guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Patients with T1-2 primary invasive breast cancer
* No suspicion of lymph node involvement prior to sentinel lymph node biopsy
* Patients undergoing upfront mastectomy
* Macrometastasis in not more than 2 lymph nodes at sentinel lymph node biopsy
* Patients treated with adjuvant axillary radiotherapy

Exclusion Criteria:

* Prior history of invasive breast cancer
* Medical contraindication for radiotherapy
* Medical contraindication for adjuvant systemic treatment
* Planned neoadjuvant systemic treatment
* Distant metastasis at initial diagnosis
* Inability to absorb or understand the meaning of the study information
Auricular Acupressure : Improves Oxaliplatin-induced Peripheral Neuropathy

Oxaliplatin-induced peripheral neuropathy (OIPN) is a common adverse effect that becomes worse as the drug dose accumulation impacts cancer patients' daily activities and quality of life.The result of this study will determine the immediate effects of the 8-week auricular acupuncture intervention on alleviating the participants' OIPN symptoms and enhancing their quality of life. This study will continue to evaluate the carry-over effects of auricular acupuncture after the chemotherapy course ends.

Objectives:

Oxaliplatin-induced peripheral neuropathy (OIPN) is a common adverse effect that becomes worse as the drug dose accumulation impacts cancer patients' daily activities and quality of life. This study aims to evaluate the immediate and carry-over effects of auricular acupressure on OIPN symptoms and quality of life for colorectal cancer patients.

Methods :

This randomized trial will recruit 76 participants with colorectal cancer and OIPN from the oncology outpatient department in Taiwan. The control group will receive usual care, whereas the experimental group will receive usual care in addition to auricular acupressure for 8 weeks. Outcomes will be assessed by using the chemotherapy-induced peripheral neuropathy assessment tool, neuropathic pain symptom inventory, pain visual analogue scale, and the European Organization for research and treatment of cancer-quality of life questionnaire-core 30. These assessment tools are used before the intervention, biweekly during the intervention, 2 weeks after the intervention, and one month after the end of the chemotherapy course.

Hypothesis:

Ultimately, the result of this study will determine the immediate effects of the 8-week auricular acupuncture intervention on alleviating the participants' OIPN symptoms and enhancing their quality of life. This study will continue to evaluate the carry-over effects of auricular acupuncture after the chemotherapy course ends.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer patients who are above the age of 20 years
* Have experiencing Oxaliplatin induced peripheral neuropathy
* Must be able to communicate
* Willing to fill out the inform consent

Exclusion Criteria:

* Symptoms of peripheral neuropathy caused by diabetes mellitus
* Symptoms of peripheral neuropathy caused by genetic disease
* Symptoms of peripheral neuropathy caused by spinal cord injury
* Symptoms of peripheral neuropathy caused by alcoholism
* With wounds on ears
* Allergy to latex (the tapes for the auricular acupressure include latex)
Autologous Blood Transfusion After Local Infiltration

Total knee and hip arthroplasty for osteoarthritis is performed on still broader indications even in elderly patients with previous or current medical conditions. Especially comorbidity like cardiovascular diseases and conditions with increased risk of bleeding or previous thrombo-embolic events are major challenges.

To facilitate safe use of ropivacaine as an analgesic, information on the concentrations levels after autologous blood transfusion following local infiltration analgesia is very crucial. However, very limited data are available. To verify the safety of autologous blood transfusion, ropivacaine concentrations were studied in 52 patients undergoing either total knee arthroplasty or total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis for hip arthroplasty
* Clinical diagnosis for knee arthroplasty

Exclusion Criteria:

* Patients \< 18 years
* Lack of informed consent
* Inability to read/understand Danish
* Bilateral diagnosis
* Cancer diagnosis
Dexmedetomidine vs Fentanyl on Time to Extubation in Patients Undergoing Laparoscopic Sleeve Gastrectomy

This study aims to compare the efficacy of dexmedetomidine versus fentanyl during general anesthesia for patients with morbid obesity undergoing laparoscopic sleeve gastrectomy.

The use of opioids in surgeries for patients with morbid obesity is controversial since they are known for having ventilatory depressing effects. Therefore, alternative analgesics are needed to improve anesthetic management for patients with obesity.

Eligibility Criteria:
Inclusion Criteria:

* Age from 20 to 50 years old.
* Both sexes.
* American Standards Association (ASA) physical status II - III.
* Body Mass Index (BMI) ≥ 35 kg/m2.

Exclusion Criteria:

* Allergy to α2 -adrenergic agonist.
* History of cardiac disease (uncontrolled hypertensive patient with blood pressure above 140/90, implanted pacemaker, poor cardiac function (ejection fraction\< 50%), history of myocardial infarction, cerebral stroke, transient ischemic attack, or coronary artery disease with or without stents.
* Neuromuscular disease, liver disease (coagulopathy INR\>1.5 or platelet count \<100.000/μl), renal impairment (serum creatinine \>1.2mg/dl, serum K \>5.5mmol/l).
* Opioid medication within 24 hours before the operation.
* Respiratory diseases as COPD, uncontrolled asthmatic patients.
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection

The purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity.

Anorexia due to infection might lead to weight loss. In many settings total recovery is problematic what might result in a permanent lower weight. A short period high quality food supplementation could improve weight gain after an infection.

A complete high quality food will be tested, but also micronutrients alone as there is no information on what children with an infection exactly need as a supplement.

Children aged 6-59 months presenting with diarrhoea, malaria or lower respiratory tract infection (LRTI) are provided for 2 weeks with

* RUTF supplement (Plumpynut®) of 500 kcal/day
* Multi-micronutrient powder (MNP)
* Placebo to MNP

The followup period is 6 months. Anthropometric indicators and morbidity are assessed monthly. Participants are invited to attend the study clinic if any signs of disease are noticed.

Eligibility Criteria:
Inclusion Criteria:

* 6 to 59 months of age
* Not malnourished or moderately acutely malnourished children
* Diagnosis of malaria and/or diarrhoea and/or LRTI
* Intending to remain in area for the duration of the 6 month follow-up
* Living within approximately 60 minutes walking distance from the clinic
* Informed consent from a guardian\*

Exclusion Criteria:

* Child is exclusively breastfeeding
* Child is severely malnourished
* Presence of 'General Danger Signs'
* Presence of severe disease (including severe malaria, severe LRTI, severe diarrhoea)
* Needing hospitalisation for any reason
* Known history of allergy to the nutritional supplementation
* Having a sibling enrolled in the study\*
Standard Precautions Versus Contact Additional Precautions Against Multi-drug Resistant Bacteria in Intensive Care Unit (PSBMR)

The national recommendations promote the applying of the Contact Additional Precautions (CAP) with the Standard Precautions (SP) to limit the transmission of multi-drug resistant (MDR) bacteria. However, that could entail more costs and a reduction of quality of the patient care.

The national recommendations promote the applying of the Contact Additional Precautions (CAP) with the Standard Precautions (SP) to limit the transmission of multi-drug resistant (MDR) bacteria. However, that could entail more costs and a reduction of quality of the patient care.

This study seeks showing it in way of a non-interventional research in a resuscitation unit. Two periods are compared for noticing the rates of MDR bacteria contaminations.

Eligibility Criteria:
Inclusion Criteria:

* hospitalization in resuscitation unit

Exclusion Criteria:

* opposition for gathering data
Vısual Arts Group Therapy Based On Watson's Human Care Model In Indıvıduals Wıth Schızophrenıa

Purpose: This study was conducted to evaluate the effect of Visual Arts Group Therapy based on Watson's Human Care Model (VAGT-WHCM) on perceived social support and functional improvement in individuals with schizophrenia.

Design: This research was carried out as a randomized controlled experimental study with a pre-test-post-test and follow-up design, which is one of the quantitative research methods.

Method: The study was carried out in Yenimahalle Community Mental Health Center between December 2022 and January 2023. The sample of the study consisted of 67 individuals diagnosed with schizophrenia, including the intervention (n=34) and control group (n=33), who met the inclusion criteria and were determined by simple randomization method. VAGT-WHCM was applied to the intervention group, consisting of six sessions, lasting 90 minutes on average, once a week in three groups. The control group participated only in the routine follow-up, treatment and practices in the institution. The intervention and control groups were evaluated with the "Multidimensional Scale of Perceived Social Support (MSPSS)" and the "Functional Recovery Scale (FRS)" before therapy (pre-test), post-therapy (post-test), and one month later (follow-up). The CONSORT (Consolidated Standards of Reporting Trials) flowcart is used in this study.

Hypothesis:

H1-1: Visual arts group therapy has an effect on perceived social support by individuals with schizophrenia.

H1-2: Visual arts group therapy has an effect on the functional recovery levels of individuals with schizophrenia.

H1-3: The change in the perceived social support level of individuals with schizophrenia before and after visual arts group therapy is associated with the change in functional recovery.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Meeting the diagnostic criteria for schizophrenia according to DSM-5 and being diagnosed with schizophrenia
* Being 18 years or older
* Being in remission (reported by the psychiatrist following the patient in the institution)
* Having medium and high level of insight (reported by the psychiatrist following the patient in the institution)
* Ability to read, understand and respond to instructions and data forms used

Exclusion Criteria:

* Having a diagnosis of a psychotic mental disorder in addition to the diagnosis of schizophrenia
* Using alcohol or psychoactive substances (reported by the doctor/nurse following the patient in the institution)
* Having a mental illness that makes cooperation impossible, such as mental retardation or dementia
* Having a serious physical illness such as cancer
* Being in an acute psychotic process
* Having visual, auditory, speech (verbal) and upper extremity defects
* Having participated in an art therapy program before
* Continuing any individual therapy or group therapy during the study period
Percutaneous Coronary Angioplasty Compared With Exercise Training in Symptomatic Coronary Artery Disease

The purpose of this study is to compare coronary angioplasty with stent implantation with an exercise rehabilitation program in patients with stable coronary artery disease (CAD).


Eligibility Criteria:
Inclusion Criteria:

* Angiographically documented CAD, with at least one coronary artery stenosis of more than 50% in a native segment never subjected to intervention, which is recommended for treatment with percutaneous transluminal coronary angioplasty (PTCA).
* Stable coronary artery disease
* Eligible patients could be asymptomatic or have class I to III angina (Canadian Cardiovascular Society \[CCS\]) with documented myocardial ischemia
* Angina pectoris threshold \> 50 Watt (cycle ergometry)
* Permanent residence should be within 25 km of training facility.

Exclusion Criteria:

* \< 18 or \> 70 years of age
* Patient currently participating in an exercise training program
* Unstable angina pectoris or myocardial infarction during the last 2 weeks
* Symptoms of CCS class IV
* Exercise limitations due to clinical conditions not related to CAD
* Left ventricular ejection fraction (LVEF) of \< 40%
* Ventricular arrhythmia (Lown Ivb)
* Hemodynamically significant valvular heart disease
* Previous cardiac surgery
* PTCA performed during the last 12 months
* Any major non-cardiac condition that would adversely affect survival during the duration of the study
* Reduced compliance