cyrilzakka/clinical-trials huggingface dataset:
A Nurse-Led Intervention for Fear of Progression in Advanced Cancer

This clinical trial focuses on a nurse-led program that is designed to help patients cope with worries, fears, and uncertainty about the future. The purpose of this study is to understand if the program is helpful and practical to carry out at medical centers and community clinics. This study may help patients learn more effective ways to cope and respond to your concerns and any unhelpful thoughts.

PRIMARY OBJECTIVES:

I. To assess the feasibility and acceptability of the revised day by day (DBD) intervention in an academic and community settings.

II. To assess the preliminary effects of the revised DBD intervention for reducing fear of progression (FOP) and improving distress, anxiety, depression, metacognitions (beliefs about worry), and mindfulness.

OUTLINE:

Patients participate in 5 videoconference sessions over 30 minutes each over 6 weeks focused on worry management skills, values-based goal setting, and brief mindfulness-based practices, then complete patient workbook activities after each session over 15-20 minutes per day. Patients also complete a survey over 8 minutes at 6 weeks, an exit interview at 7 weeks, and questionnaires over 25 minutes each at baseline, 6 weeks, and 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with stage III or IV gynecologic (GYN) or lung cancer
2. At least 3 months from initial diagnosis
3. Score \>= 34 on the Fear of Progression-short form (SF) questionnaire

Exclusion Criteria:

1. Severe mental illness (e.g. psychosis)
2. Hospice enrolled
3. Non-English speaking
The Efficacy of Everolimus with Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus in Treatment of BK Virus Infection in Kidney Transplantation Recipient

BK virus infection is one of the causes of renal allograft loss in the current era. Reduction of immunsuppression is the only intervention that prooved to be effective in treating of BK virus in kidney transplant recipient. However, there are evidences from retrospective and prospective studies showed that leflunomide and mTOR inhibitor such as everolimus or sirolimus have positive outcomes in treatment of BK virus in kidney tranplant recipient. The investigators conduct the RCT to compare the efficacy of leflunomide and mTOR inhibitor everolimus, in treatment of BK virus infected patients who do not respond to immunosuppression reduction.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients at King Chulalongkorn Memorial Hospital
* age \>= 18 years
* persistent BK viremia \>1000 copies/mL at least 2 times in 3 weeks or single time \> 10000 copies/mL

Exclusion Criteria:

* BK VL \>10\^5 log
* Previous BKVAN treatment
* Drug hypersensitivity to mTORi or leflunomide
A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity

This study will compare the safety and effectiveness of a potassium oxalate desensitizer on adjacent teeth with dentinal hypersensitivity.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* sign an informed consent form and be given a copy
* be in good general health as determined by the Investigator/designee
* have at least one pair of adjacent teeth, each of which has a screening score of - -greater than or equal to 1 on the Schiff Sensitivity Scale in response to the cold water challenge.

Exclusion Criteria:

* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
* active treatment for periodontitis
* any diseases or conditions that might interfere with the subject safely completing the study
* inability to undergo study procedures
* fixed facial orthodontic appliances
* self-reported pregnancy or nursing
* a history of kidney stones
* known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate.
Patient-Defined Treatment Success and Preferences in Stage IV Lung Cancer Patients

Our long-term goal is to integrate non-small cell lung cancer patient treatment preferences into clinical treatment planning.

The following specific aims are proposed:

Aim 1: Determine whether individual patients' preferences, characteristics, and treatment experiences affect the definition of treatment success.

Aim 2: Determine how to best predict real-life patients' treatment choices based on patients' preferences of adverse events.

Aim 3: Determine whether physicians are likely to change their oncologic clinical practice after receiving a detailed communication of their patients' preferences of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide consent
* Greater than or equal to 19 years of age
* Diagnosed with stage IV non-small cell lung cancer (NSCLC)
* Able to understand spoken English
* Eligible to undergo chemotherapy for stage IV NSCLC, to include, but not limited to, those who:

  1. have not yet started chemo
  2. are currently undergoing chemo for stage IV NSCLC
  3. have completed first line stage IV NSCLC chemo or progressed to maintenance for stage IV NSCLC within the last 30 days
  4. elect to have chemo elsewhere -- not at one of the study sites
  5. decline chemo

Exclusion Criteria:

* Age \<19 years
* Not willing and/or able to provide consent
* Not able to understand spoken English
* Not eligible to undergo chemotherapy for stage IV NSCLC
Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.

Subject will be randomize in two groups. Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.Since the dosage of Sodium Benzoate is Sta t250mg/Kg and then 250mg/Kg in next 24 hours, each patient would be given 750mg /kg stat and 750mg /kg in next 24 hours,keeping in view that 2/3 of powder used would be powdered sugar in the intervention arm. The dose of the powder used would be doubled in case of the ammonia level more than 300 mcg/dl. The drug will be prepared in sterile water and administered per orally or via the nasogastric tube. All the enrolled patients would be treated with SMT as per the recommendations of the EASL/AASLD 2014 guidelines of management of hepatic encephalopathy.

Group B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is similar in appearance and taste as sodium benzoate.


Eligibility Criteria:
Inclusion Criteria:

- Infants, children and adolescents under 18 years of age with decompensated Chronic liver disease with hyperammonemia \< 400 mcgm and /dl.

Exclusion Criteria:

1. Patients who have received sodium benzoate within 1 week priorto evaluation.
2. Baseline serum sodium above 155 mEq/L
3. Patients with Grade 3 ascites as per IAC classification.
4. Patients who did not give a written informed consent.
Lung Resection and Pulmonary Rehabilitation

Lung cancer is the most common cancer in the world and surgical resection remains the gold standard curative treatment in early stage non-small cell lung cancer. However, surgery itself is the direct cause of pulmonary function impairment, which dramatically reduces patients tolerance to exercise and their quality of life. Pulmonary rehabilitation (PR) complements surgical treatment and improves patients' exercise and functional capacity, decreases dyspnea, improves health status.

Our aim is to examine the effectiveness of PR applied after lung resection in patients with lung cancer, 2- To determine whether the respiratory exercise training given to patients who could not participate in the PR program is effective.

Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, comprehensive exercise program that targets patients with symptomatic chronic respiratory disease. PR integrates exercise and training interventions into a personalized treatment program. PR has become an important component of the general treatment strategy in patients with high-risk surgical diseases such as lung resection. It helps patients return to normal not only physically, but also emotionally and mentally. In patients with lung cancer, preoperative PR increases exercise capacity, decreases post-operative morbidity and mortality. Although it is reported that the PR program applied in the post-operative period increases physical performance and improves the quality of life, referral of patients in need of the PR unit is less than 25%. There is a need to increase the awareness of both pulmonologists and thoracic surgeons about the benefits of the PR program, which is a non-pharmacological and effective intervention.

The investigators have had two objectives in this study. 1- To examine the effectiveness of PR applied after lung resection in patients with lung cancer, 2- To determine whether the respiratory exercise training given to patients who could not participate in the PR program is effective.

An 8-week comprehensive outpatient PR program will applied to half of 66 patients with non-small cell lung cancer who underwent lung resection, and the other half received respiratory exercise training. After the intervention, the results of both groups will compare.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had undergone surgery for non-small cell lung cancer in the last two years
* Patients who had no chemotherapy or radiotherapy

Exclusion Criteria:

* Patients who were found unsuitable with the cardiology consultation
* Patients with psychiatric problems
* Patients with severe joint diseases
* Reluctant patients
Detection of Cancer in Breath Samples by Trained Detection Dogs

The goal of this study is to show that trained detection dogs can identify breast, lung, prostate or colorectal cancer by sniffing masks containing breath samples. In this study, individuals who will undergo cancer screening at an integrated cancer prevention center or biopsy for a suspected malignancy, will be asked to provide a breath sample by breathing into a surgical mask. The mask will then be sent to the laboratory, where trained detection dogs will determine if the person who provided the mask has breast, lung, prostate or colorectal cancer or if the person does not have these types of cancer. The results provided by the dogs will be compared to the actual cancer screening results or biopsy results in order to determine the accuracy of cancer detection by the trained dogs.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18 and over.
2. Signing an informed consent prior to performing the test.
3. Intended to undergo screening tests for cancer detection.
4. Did not smoke 2 hours before providing the breath sample
5. Did not drink coffee in the hour before providing the breath sample
6. Did not drink an alcoholic beverage in the hour prior to providing the breath sample.
7. Did not eat food in the hour before providing the breath sample.

Exclusion Criteria:

1. Was diagnosed with cancer or was treated for cancer in the seven years preceding the study, excluding non-metastatic skin tumors that were surgically removed.
2. Undergoing chemotherapy for any purpose.
3. Pregnant or breastfeeding
4. Had a medical procedure in the chest cavity and/or airways in the two weeks prior to providing the breath sample that may interfere with the ability to correctly provide a breath sample.
5. Has a Helicobacter pylori infection.
6. Has a peptic ulcer disease.
7. Has a flare-up of an inflammatory bowel disease (Crohn's disease/ulcerative colitis).
8. has an active infection, such as COVID-19, abscess, bacterial/viral/fungal infection, pneumonia, laryngitis, intestinal inflammation, active tuberculosis infection.
A Comparison Between Continuous and Intermittent Intraabdominal Analgesia Using Local Anaesthetics

The investigators hypothesis is that patient controlled local anesthetics administered intraabdominally are more efficacious compared to continuous infusion in reducing postoperative pain and morphine consumption.

Open abdominal hysterectomy is a common procedure performed for many benign and malignant gynaecological diseases and is associated with moderate to severe pain. Traditional methods for postoperative pain management include patient controlled intravenous analgesia (PCA) using morphine, epidural analgesia and spinal analgesia with opiates but recently, even local aesthetic (LA) has been used intra-abdominally and into the abdominal wall. Although epidural analgesia may be considered by some to be gold standard for pain relief following abdominal surgery, a recent publication and past experience over several years may question the use of invasive techniques for lower abdominal surgery. Thus, there is a trend towards movement from central blocks towards other non-invasive methods for pain relief.

PCA with morphine is now commonly used for management of pain following major surgery and compared to central blocks, has advantages in being relatively safe, easy to use and associated with a high degree of patient satisfaction. However, the large doses of morphine necessary to ensure adequate postoperative analgesia means that side effects such as postoperative nausea and vomiting (PONV), tiredness, pruritus, headache and constipation may be a major problem in this group of patients. Therefore, alternative techniques to reduce morphine requirements are increasingly being used. These include the use of paracetamol, non-steroidal anti-inflammatory drugs (NSAID) and recently local anaesthetics (LA). The latter have been found to result in morphine sparing by 30 - 40 % and even a reduction in postoperative nausea (PON). LA infused intraperitoneally is safe and effective and a recent study showed that using 12.5 mg/h levobupivacaine could attain adequate analgesia. Thus, efficacy of LA has been established as well as the dose. However, the method of administration of LA intraperitoneally remains unclear.

This study is designed with the primary aim of studying whether morphine consumption can be reduced postoperatively using the patient-controlled administration system for intraperitoneal LA compared to a continuous infusion, and whether this translates into improved recovery parameters or reduced side effects and improved patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. 18 -65 year old patients undergoing open abdominal hysterectomy.
2. ASA I - II (Appendix 1).
3. Have signed and dated Informed Consent.
4. Willing and able to comply with the protocol for the duration of the trial.

Exclusion Criteria:

1. Patients undergoing open abdominal hysterectomy due to suspected cancer.
2. Patients with chronic pain who are taking analgesics regularly.
3. Allergy to components in levobupivacaine (Chirocaine)/Saline (Sodium Chloride).
4. Participation in other clinical trials.
Telepsychiatry to Improve the Management of Adolescent Depression in Primary Care

Background: Depression is common in adolescents and it is associated with serious consequences. In Chile, primary care team has a leading role in the management of depression in adolescents. Nevertheless, the majority of primary care professionals report not feeling adequately prepared to take on this responsibility and having difficulties referring patients to specialists. This situation is particularity complex in regions far away from the central zone. Telepsychiatry is a potential solution to an equitable access to specialized clinical expertise.

Purpose: The purpose of this study is to determine whether a telepsychiatry-based collaborative program is effective to improve the management of depression in adolescents between 13 and 19 years of age in 16 primary care clinics in the Araucanía Region, Chile.

Study design: A cluster-randomized clinical trial will be carried out with 237 adolescents. The efficacy, adherence, and acceptability of the telepsychiatry-based collaborative program will be evaluated.

General aim To carry out a randomized controlled trial to compare the efficacy of telepsychiatry intervention versus usual care to treat depression in adolescents in primary care clinics in the Araucanía Region, Chile.

Specific aims

1. To compare the level of depressive symptoms of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
2. To compare the level of health-related quality of life (HRQoL) of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
3. To compare adolescents' adherence with a telepsychiatry program versus usual care in primary care clinics.
4. To evaluate adolescents' satisfaction with a telepsychiatry program.
5. To evaluate health staff's satisfaction with a telepsychiatry program.

Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria of a depressive disorder according a structured interview (MINI-KID)

Exclusion Criteria:

* Psychotic symptoms
* Bipolar disorder
* Current substance and/or alcohol dependence
* Suicide risk that requires specialized treatment
* Current treatment with antidepressant and/or psychotherapy
* Low intellectual abilities
Influence of Hepatic Steatosis on the Therapeutic Effect of Entecavir in Chronic Hepatitis B Patients

To investigate the influence of hepatic steatosis on the anti-viral effect of entecavir in chronic hepatitis B patients.

Chronic hepatitis B (CHB) affects approximately 360 million persons worldwide and is the most common cause of liver disease and affects over 10% of the general population in China. Hepatic steatosis is the main hepatic presentation of non- alcoholic fatty liver disease that is becoming another important liver disorder both in China and worldwide with economic development. It would be expected that hepatic steatosis might occur in CHB patients and recent studies show the frequency of steatosis in CHB ranges from 27% to 51%. However, the effect of steatosis on the anti-viral treatment in CHB patients is still vague. The aim of this RCT is to investigate the effect of steatosis on the therapeutic effect of entecavir in chronic hepatitis B patients. We will compare the anti-viral effect of entecavir among four groups: CHB group with entecavir therapy, CHB + steatosis group with entecavir therapy, CHB + steatosis group with entecavir + essentiale therapy and CHB + steatosis group with entecavir + vitamin E therapy. The speculated points are set as 3 months, 12 months and 15 months. Liver biopsy will be carried out at beginning and the 12th month. Other serum biochemical and viral markers are recorded as well as CT or ultrasound scan are repeated.

Eligibility Criteria:
Inclusion Criteria:

Patients should be diagnosed with chronic hepatitis B infection and hepatic steatosis

1. CHB infection

   * HBV-DNA ≥ 1×105 copies/ml；
   * HBeAg positive ；
   * ALT between the 2-10 times of the upper limit level
2. hepatic steatosis According to the "Guidelines for the assessment and management of non-alcoholic fatty liver disease in the Asia-Pacific region: executive summary", with test of CT scan or B ultrasound and confirmation of liver biopsy(in portion of patients)

Exclusion Criteria:

1. those receiving antiviral treatment before the study
2. those on hepatoxic drug treatment,
3. those consuming alcohol regularly or excessively,
4. those diagnosed of cirrhosis, anti-HCV or anti-Delta positive patients,
5. those diagnosed as having autoimmune or other metabolic liver diseases
6. those have wilson's disease, PBC, PSC, IBD and other diseases that may influence the process and effect of therapy
7. those who are pregnant, have mental disorder and were received anti-viral treatment
DNA Double-strand Breaks After SPECT

Ionizing radiation has a number of harmful effects in humans. The most important among these is the induction of cancer. It is assumed that damage to DNA in the nucleus of a single cell can induce cancer. Among the different types of lesions inducted, DNA double-strand breaks (DSBs) are considered to be the most relevant effects that can initiate carcinogenesis.

The investigators are already conducting several other studies to prospectively compare the inducted DSBs by coronary CT-angiography and conventional coronary angiography. Extending these examinations to investigate the induced DSBs by myocardial scintigraphy allows a comparison of all three relevant imaging methods of the heart that incorporate ionizing radiation.

To evaluate this, the investigators are planning to examine patients who are scheduled for a clinically indicated myocardial scintigraphy. These examinations are routinely done by the Department of Nuclear Medicine in either a 1-day or a 2-day protocol according to the diagnostic reference values of the Federal Department for Radiological Protection. Blood samples will be taken from these patients at predefined time steps before and after the examination and DNA double-strand breaks will be determined from these blood samples specifically considering the applied activity of the tracer and the exposition kinetics.


Eligibility Criteria:
Inclusion Criteria:

* myocardial SPECT clinically indicated

Exclusion Criteria:

* acute leukaemia or lymphoma
* radiation or chemotherapy in the last 6 months
* x-ray or scintigraphy within the last 3 days
* age below 18 years
* eGFR of below 60 ml/min
Complex Peri-operative Intervention in Older Patients With Cancer

Incidence of digestive cancers increase and half of new cases will be people of 75 years or more in 2050. Surgery is one of the main treatment's strategy but post-operative morbi-mortality increases with age. Pre-operative Geriatric Assessment enable to identify frail or vulnerable patients at risk of post-operative complications.

The coordinating team postulate that a geriatric and surgical co-management with a combination of several targeted geriatric interventions with usual post-operative care could improve the post-operative care and decrease the risk of morbi-mortality in older patients with digestive cancers.

Multicenter Randomized Clinical Trial in 2 parallel-groups with masked adjudication of main endpoint

Eligibility Criteria:
Inclusion Criteria:

* Aged 75 years or more
* Gastric, colo-rectal, pancreatic cancer or hepatic metastasis needed a surgical treatment
* Health Insurance
* At risk of post-operative complication through Surgical Risk Calculator (\>25%) or surgeon judgment.
* Written consent

Exclusion Criteria:

* Surgery in emergency