cyrilzakka/clinical-trials huggingface dataset:
Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer

The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic colorectal cancer (CRC)
* Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* At least 1 measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
* Treatment failure (defined as failure due to either disease progression \[clinical or radiological\] or toxicity \[treatment intolerance\]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination.

  * Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease
* Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
* Man or woman at least 18 years of age
* Adequate hematologic, renal, hepatic and metabolic function
* Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only)
* Subject or subject's legally acceptable representative has provided informed consent.
* Other protocol-specified criteria may apply

Exclusion Criteria:

* Symptomatic brain metastases requiring treatment
* History of another primary cancer within 5 years of randomization
* Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFR inhibitors (eg, gefitinib, erlotinib, lapatinib)
* Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) within 21 days before randomization
* Radiotherapy within 14 days before randomization.
* Exclusion Criteria for corrected QT (QTc) Evaluation Subpart of the Study: Prolongation of QT/QTc interval \> 450 milliseconds at screening
* Other protocol-specified criteria may apply
Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients

Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality of life have seriously deteriorated. There have been a few studies that showed an effect for pain control by hyperthermia (heating the patient's body). However, there are several limitations in conventional hyperthermia. In this study, the investigators tried to show the effect of "Oncothermia" which is more selective to malignant tissue than conventional hyperthermia for pain control, increasing quality of life, and anti-tumor treatment.


Eligibility Criteria:
Inclusion Criteria:

* Inoperable or recurred pancreatic ductal adenocarcinoma
* After the each cycle of chemotherapy, the disease status was "stable disease"

Exclusion Criteria:

* Person who has an experience of hyperthermia treatment
* Person who has a difficulty of sensing heat
* Person who has a skin graft or breast reconstruction surgery
* Person who has a cardiac pacemaker or an implanted metal
* Pregnant or breast feeding women
* Person with uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarct within 6 months
* Person who was treated with unproved drugs within 6 months
* Person who have a serious disease which can affect the person's safety
* Person who do not consent to the study
A Study of Zimberelimab(GLS-010) Combined With AVD for Newly Diagnosed Early-stage Hodgkin's Lymphoma

This is a multicenter, open-label single-arm phase II study to evaluate the efficacy and safety of Zimberelimab (GLS-010) combined with AVD for newly diagnosed early-stage Hodgkin's lymphoma under the guidance of PET/CT.

Despite achieving good disease control and long-term survival rates for over 80% of classical Hodgkin lymphoma (cHL) patients who receive first-line therapy, approximately 10% of early-stage and 30% of advanced cHL patients experience disease relapse or refractoriness after initial treatment, and only half of the patients can be cured through high-dose therapy (HDT) and autologous stem cell transplantation (ASCT). Meanwhile, the current standard first-line treatment still centers around conventional chemotherapy with cytotoxic agents. As such, the clinical challenge of cHL first-line treatment lies in striking a balance between efficacy and toxicity, and developing low-toxicity, high-efficiency treatment strategies to achieve the optimal treatment goal of maximizing efficacy while minimizing short- and long-term toxicities.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with primary classical Hodgkin lymphoma (HL) based on histopathology.
2. Stage I-II .
3. At least one measurable target lesion（Lugano 2014）.
4. Age 18 years or older (including 18 years) to 45 years (recent fertility requirements and concern about chemotherapy side effects), or age \>60 years (older patients who are frail and unwilling to undergo chemotherapy), male or female.
5. ECOG PS 0-3,
6. Expected survival ≥ 3 months.

Exclusion Criteria:

1. Hodgkin's lymphoma with nodular lymphocyte predominant type.
2. Patients who are scheduled to undergo subsequent autologous stem cell transplantation.
3. Contraindications to radiotherapy.
4. With central nervous system (meningeal or parenchymal) involvement.
5. Contraindications to immune checkpoint inhibitors.
Skin to Adductor Canal Distance in Various Positions

To control pain after total knee replacement surgery a catheter (tubing) is sometimes inserted into an anatomic space containing nerves that provide sensation to parts of the knee. This space is called the adductor canal.

The catheters often stop working before we remove them for unclear reasons. The investigators think this is because the catheters become dislodged from where it was meant to be. This could be due to repeated movements of the catheter tip brought on by patients contracting their leg muscles when they ambulate or perform physio.

The investigators want to confirm this by measuring the distance from a fixed spot on the patient's thigh to the adductor canal using an ultrasound machine. The leg will be measured in various positions to simulate muscle movements. A significant change in the distance could possibly contribute to catheter dislodgement and result in catheter failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients over or equal to the age of 18 years old who can understand the study protocol and are able to give consent
* Patients must be undergoing a primary total knee arthroplasty with neuraxial anaesthesia

Exclusion Criteria:

* Patients with an allergy to ultrasound transducer gel or measuring tape
Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy

Hypothesis: Treatment for head and neck tumors often involve methods that affect the auditory system and cause hearing loss. Neck dissection negatively impacts the lymphatic drainage, chemotherapy uses ototoxic drugs, radiotherapy affects blood flow and tissue radiation is toxic to the ear and may lead to hearing losses of various types and degrees.

Objective: To investigate occurrences of hearing loss and complaints among patients with head and neck tumors who underwent radiotherapy.

Study design: Prospective, case-control study. Setting: Tertiary care center hospital.

Subjects and Methods: 282 subjects were evaluated, 141 with head and neck tumors and 141 as an age-matched control group. The controls had never undergone oncological treatment that put their hearing at risk. All subjects underwent audiological evaluation, including the HHIE questionnaire, pure tone audiometry, speech audiometry and immittance audiometry. The radiation dose received by the auditory system was calculated based on the percentage of the external auditory canal included in the radiation field.


Eligibility Criteria:
Inclusion Criteria:

* The group of exposed individuals
* had to be patients with disease-free survival interval of at least two years subsequent to treatment for head and neck cancer
* radiotherapy alone or in combination, in which the auditory system was included in the field of irradiation.
* The group of non-exposed individuals (control group)
* had to be patients who had not undergone oncological treatment that put their hearing at risk
* age-matched (2 years). This group was formed by individuals who had had pelvic tumors or skin tumors and who had only undergone local surgery to remove their tumors, and by female volunteers from the hospital.
* All of these individuals were asked whether they would be willing to participate in a study, without knowing in advance whether they had any previous hearing problems or complaints.

Exclusion Criteria:

* congenital hearing loss
* otological surgery
Pyrotinib Combined With Capecitabine in HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)

This study aims to describe the different treatment time, treatment mode and clinical outcomes of pyrotinib maleate tablets combined with capecitabine in the treatment of patients with HER-2 positive advanced breast cancer with brain metastases.

This study is a multicenter, observational, real-world study with no formal statistical assumptions and sample size calculations; patient efficacy and safety data will be descriptively analyzed to assess the risk of HER2-positive advanced breast cancer patients with brain metastases. Efficacy of pyrotinib combined with capecitabine regimen in the real world, while evaluating the overall survival benefit of local therapy and drug therapy in patients with brain metastases.

The estimated sample size is 300 cases, and at least one group of cohort A, cohort B and cohort C is planned to exceed 100 cases; Cohort A - patients with new brain metastases directly treated with pyrotinib combined with capecitabine; Cohort B- Whole brain radiotherapy or stereotactic radiotherapy concurrently (≤3 months before and after radiotherapy) with pyrotinib combined with capecitabine; Cohort C - group of patients with pyrotinib plus capecitabine after whole brain radiotherapy or stereotactic radiotherapy (more than 3 months after radiotherapy)。

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically diagnosed patients with HER-2 expression-positive advanced breast cancer; Note: Positive HER2 expression refers to at least one tumor cell immunohistochemical staining intensity of 3+ or fluorescence in situ hybridization \[FISH\] in the pathological detection/recheck of the primary or metastatic lesions performed by the pathology department of the participating central hospital confirmed positive;
2. Brain metastases are diagnosed by MRI/enhanced CT imaging, according to RECIST 1.1 criteria, with or without measurable lesions and with or without symptoms of brain metastases;
3. Pyrotinib combined with capecitabine in the treatment of brain metastases with non-PD evaluation at the first treatment, at least ≥ 2 continuous imaging reports or assessments
4. For previous treatment regimens, no previous use of capecitabine or progression after capecitabine discontinuation for 6 months, or progression after discontinuation of capecitabine adjuvant therapy for one year or more;
5. There are traceable medical history data.

Exclusion Criteria:

1. Patients enrolled in the previous PERMEATE study;
2. The research program is receiving other anti-tumor drug treatment at the same time;
3. The initial dose of pyrotinib is lower than the minimum dose in the instructions (240 mg), and the capecitabine is 50% lower than the standard dose;
4. Pyrotinib combined with capecitabine in the treatment of non-brain metastases and progressive patients;
5. The investigator believes that the patient is not suitable to enter this study.
Child Health Improvement Through Computer Automation of Constipation Management in Primary Care

This project seeks to expand an existing computerized decision support system used in pediatric primary care. The expanded system will add a module that helps clinicians recognize constipated children and then provides evidence-based reminders for constipation management, as well as automates patient educational materials. The current system is deployed across multiple sites, and the constipation module will be randomized to deployment in different sites. The difference in constipation management and patient outcomes will then be compared between sites receiving the intervention and sites not receiving the intervention over a 12 month period.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to one of 5 primary care clinics in the Eskenazi Health system in Indianapolis, IN.
* Patients given a pre-screener form as part of the existing CHICA decision support system.
* Age between 2 years and 12 years, inclusive.

Exclusion Criteria:

* None.
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy


Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old at the time of signing the Informed Consent Form (ICF).
* Diagnosed as SLE/Immune-Mediated Necrotizing Myopathy (IMNM)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia Gravis (MG) according to recognized diagnostic criteria for at least 6 months.
* Remains disease active or relapses after treatment with standard of care therapy for at least 8 weeks with the dose stable for more than 2 weeks; patients should have been treated at least two immunosuppressants (immunosuppressants or disease-modifying drug (DMD) for MS participants).
* Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.

Exclusion Criteria:

* Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive.
* Uncontrolled active infection.
* Live vaccine injection within 4 weeks prior to signing the ICF.
* Major organ transplantation history or bone marrow/hematopoietic stem cell transplantation history.
* Severe cardiovascular diseases within the past 6 months prior to screening.
* ≥ Grade 2 bleeding within the past 30 days prior to screening, or requiring long-term anticoagulants treatment.
* Inadequate washing time for previous treatment.
* Previously treated with CAR-T cell products or genetically modified T cell therapies.
* Pregnant or lactating women.
* Severe central nervous system diseases or pathological changes.
* Malignancy history within 5 years prior to signing the ICF.
The Caries-arresting Effect of Incorporating fTCP to NaF Varnish Applied Following AgNO3 in Preschool Children

The objective of this study is to compare the effectiveness of 25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over 30 months in arresting dentine caries of primary teeth among preschool children. Half of Participants will receive topical application of 25% AgNO3 solution and 5% NaF varnish, while the other half will receive topical application of 25% AgNO3 solution and 5% NaF varnish with fTCP.

Aim:The objective of this study is to compare the effectiveness of commercially available of 25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over 30 months in arresting dentine caries of primary teeth among preschool children.

Methods: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, equivalence clinical trial. Approximately 2,000 kindergarten children will be screened and at least 376 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis. The children will be randomly allocated into 2 groups to treat their caries over a 30-month period: Group A - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish with functionalized tricalcium phosphate (fTCP).Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested (primary outcome). Confounding factors such as oral hygiene habits will be collected through a parental questionnaire.

Possible results and implications: As the first of its kind, this study would help to determine whether AgNO3 followed by 5% NaF varnish with and without fTCP are equivalent in arresting dentine caries of primary teeth in preschool children when applied semi-annually.

Eligibility Criteria:
Inclusion Criteria:

* have at least one tooth with cavitated dentine carious lesion

Exclusion Criteria:

* Children have severe forms of dental hypoplasia, under dental treatment or wearing orthodontic devices, have major systemic illness, and are on long-term medication.
Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

The propose of this study to determine efficacy and complication of gentamicin nasal irrigation in chronic rhinosinusitis

Chronic rhinosinusitis (CRS) is characterized by symptoms \> 12 weeks

Two or more symptoms one of which should be either nasal blockage /obstruction/congestion or nasal discharge (anterior/posterior nasal drip):

* facial pain/pressure
* reduction or loss of smell)

Mainstay of treatment are medical and surgical treatment ( ATB, adenoidectomy, ESS) Adjunctive treatment : normal saline nasal irrigation, nasal corticosteroids, nasal decongestants, mucolytics Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis

In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no studies in gentamicin irrigation in chronic rhinosinusitis. The aims of this study are to evaluate:

1. Efficacy of gentamicin nasal irrigation in chronic rhinosinusitis (outcomes: frequency of sinusitis, frequency of antibiotic usage)
2. Complication of gentamicin nasal irrigation usage

Eligibility Criteria:
Inclusion Criteria:

* Chronic rhinosinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between January 1, 2005, and February 28, 2011
* Gentamicin nasal irrigation usage for longer than 3 months

Exclusion Criteria:

* Patients who used azithromycin prophylaxis within 1 year before and 6 months after started gentamicin nasal irrigation
* Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation
* Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation
* Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation
Randomised Controlled Trial of a Digital Programme for Procrastination in UK University Students

The aim of this study is to evaluate the effect of an 8-week self-directed internet based CBT intervention on various psychological outcomes for young students struggling with procrastination in the UK. The psychological outcomes consist of motivation, depressive symptoms, impulsivity and anxiety. More specifically, the study aims to compare the effect of the intervention vs waitlist control at 8 weeks on primary and secondary outcomes. Additionally, the study aims to explore whether changes in primary and secondary outcomes as the result of the intervention are mediated or moderated by key intervention processes.


Eligibility Criteria:
Inclusion Criteria:

* Resident in the UK
* Fluent in English
* Aged between 16 and 24 years of age
* Have access to computer or smartphone
* Score at least 40 points on the Pure Procrastination Scale (indicating difficulties with procrastination)

Exclusion Criteria:

* Ongoing psychological treatment
* New course of change in dose of psychotropic medication in the last two months (self-reported)
Monitoring Radiation Induced Cardiac Damage by Blood Markers

Rationale:

Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In particular, the relationship between radiation dose parameters and the risk of cardiac toxicity remains to be determined.

Clinical prediction models for cardiac toxicity are difficult to obtain, e.g. due to long latency time. Therefore, objective surrogate markers, for cardiac toxicity such as NT pro BNP and hs-TNT, as obtained during and after treatment may be of great value.

Objective:

The main objective to find a correlation between the rise in NT pro BNP level and the radiation dose given to the heart.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven oesophageal- or lung cancer (adeno-, or squamous cell carcinoma or other NSCLC type)
* Older than 18 years
* Written informed consent

Exclusion Criteria:

* Prior radiotherapy to the chest including radiotherapy for breast cancer
* Patients treated with palliative intent
Does the Access to Small Delicious Dishes, Have a Positive Effect on Nutritional Intake in Patients at Nutritional Risk?

Rationale:

The objective of this study was to investigate whether a new energy dense food concept, on order 24 hours a day, would lead to a minimum 75% intake of nutritional needs in patients at nutritional risk. The investigators target was for 70% of patients to reach 75% of their energy and protein requirements.

Methods:

An intervention study was conducted with inclusion of 40 patients at nutritional risk, according to the NRS-2002 criteria. The food concept consisted of 36 small delicious dishes. Patients could choose food from both the new concept and the ordinary patient buffet. The investigators monitored patients' nutritional requirements and daily nutritional intake.


Eligibility Criteria:
Inclusion Criteria:

* patients at nutritional risk, according to the NRS-2002 criteria.
* patient must be able to understand the information and be able to give a written inform consent
* well-functioning gastrointestinal tract
* Anticipated length of hospitalization \> 5 days
* Should understand and speak danish

Exclusion Criteria:

* Terminal patients
* patients with dysphagia
* patient with food allergy or intolerance
* patients who only receives enteral or parenteral nutrition