cyrilzakka/clinical-trials huggingface dataset:
Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer

Purpose of the study

1. To assess whether offering visual information to patients with prostate cancer prior to receiving RT increases the participant's compliance.
2. To assess whether increased compliance translates into reduced side effects from RT (assessed with a quality of life questionnaire).

Type of study. This is a randomised control trial which will include 170 patients with the histological diagnosis of prostate cancer in the study arm and 170 patients with the histological diagnosis of prostate cancer in the control/standard arm.

The Oncology Department at the Royal Stoke University Hospital is a state of the art facility. It has radiotherapy (RT) facilities such as IMRT and rapid arc, leading the way in RT planning and delivery. The Investigators want to further their expertise and public involvement in RT planning with this proposal.

This study follows a pilot study in which patients receiving RT were shown how treatment is planned and given using a 3 dimensional (3D) imaging system. It was noticed that patients with prostate cancer entering the pilot study might have been more compliant (holding water before each treatment session) than those with prostate cancer not entering the study. On this basis, the investigators wish to run this project in which prostate cancer patients will be shown how RT is planned and given using 3D images prior to start RT (study arm, 170 patients) or after completion of RT (control/standard arm, 170 patients). A sample size calculation was performed (see below) in order to distinguish a 10% improvement in retention of bladder volume over the course of treatment.

RT planning will be carried out using standard procedures at the Oncology Department. However, each study patient's CT Scan image will be placed in the Virtual Environment for Radiotherapy Training (VERT) system. The original images will not be altered and will be presented using the established JImage Dicom libraries. 3D models will be constructed from the CT Images. The system allows moving the 3D images using a mouse. Planning CT Scans will be taken prior to RT, on the first 3 days, and once weekly during RT to measure bladder volumes (this is standard practice and no patients will have extra CT Scans). The investigators will assess whether patients in the study arm were more compliant in holding water when compared to control cases.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the histological diagnosis of prostate cancer due to receive radical RT.
* Patients with prostate cancer deemed fit enough to complete a course of radical RT to their prostate area.
* Patients able to give informed consent.

Exclusion Criteria:

* The only exclusion criteria is for participants unable to understand the study aims and therefore unable to give informed consent.
The Effect of Aged Garlic Extract Supplementation on Immune System

The purpose of this study is to determine whether consuming capsules of aged garlic extract is effective in enhancing function of NK and/or γδ T cell resulting in fewer cold and flu symptoms.

A non-therapeutic intervention study is described. The Aged Garlic Extract (AGE) supplement (and placebo) intervention occurs over a total of 90 days between mid-January to March. The CDC indicates that this is the cold and flu season (http://www.cdc.gov/flu/weekly/fluactivity.htm ). Blood is taken at baseline and at 45 days, 2 hours after they have taken their capsule. Capsule consumption will continue for a total of 90 days in order to continue monitoring cold and flu symptoms. Subjects will be given a diary to keep a record of their cold and flu symptoms. Peripheral blood mononuclear cells are isolated from the blood draw and used fresh, cultured in autologous serum for 24 hours or cultured in autologous serum for 10 days. Freshly isolated cells will be used for glutathione analysis, for protection against induced DNA strand breaks, and for γδ T cell and NK cell numbers. The supernatant of 24 hour cultures will be used for cytokine determination, specifically, interferon-g, tumor necrosis factor-a and IL-12. Cells cultured for 10 days will be used to determine the rate of proliferation. If cells have been primed by AGE, we expect the AGE cells to proliferate to a greater extent and have greater cytokine secretion compared to placebo.

If AGE enhances the function of one or both of these cell types (NK or γδ T cell), then it is possible that there will be fewer cold and flu symptoms in the group consuming the supplement.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female
* Between the ages of 21 and 50
* BMI between 18 and 35

Exclusion Criteria:

* High blood pressure defined as 140/90
* Ongoing or chronic illness or infection
* On hypertensive medication, immunosuppressive drugs, antibiotics, or chronic use of NSAIDS
* Taking dietary supplements other than those with "normal" levels of vitamins and minerals
* Consumes more than 2 glasses of alcoholic beverages per day
Pre-emptive Analgesia Effect in Different Psycho-emotional Status Patients During Lower Third Molar Surgical Extractions

To increase the effectiveness of pain control, it is recommended to use drugs before the pain onset, therefore the pre-emptive analgesia method is considered as a method, which allows decreasing the post-operative pain to minimum. Previous studies evaluated effectiveness of pre-emptive analgesia but no relation to psycho-emotional status was addressed. Our authors believe that the effect of pre-emptive analgesia may vary based on different psycho-emotional status.

45 volunteers who needed extraction of lower third molars were examined and enrolled in the study (study group - 15; placebo - 15; control - 15 volunteers). Ibuprofen 400mg together with 500mg paracetamol was used for pre-emptive analgesia. Difficulty of the operation, heart rate measurements and operation protocol were documented. Surgeon filled his questionnaire after the procedure. Patients on consultation, operation day and 10 days postop. filled a questionnaire which consisted of general, special and pain evaluation sections. Less favorable psycho-emotional status correlated with more severe pain 6h after operation. This relation was mostly expressed in the control group. Psycho-emotional status of placebo patients was accounted for bigger analgesic consumption frequency. Postoperative pain in study group was minimal compared to other groups. Pre-emptive analgesia enhances patient's psycho-emotional status and sustains postoperative pain control during lower third molar surgical extractions.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients;
* Indications for mandibular third molar removal.

Exclusion Criteria:

* Presence of NSAID usage;
* Acute inflammation in operating site;
* General diseases that might negatively influence the outcomes of operation, such as epilepsy, unstable neurological condition;
* Anticoagulant usage;
* Diabetes mellitus;
* Cardiovascular diseases.
Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer

The purpose of this study is to create new tests to identify biomarkers for ovarian cancer so that a screening test can be developed. For patients who have a diagnosis of ovarian Cancer, researchers will use blood samples before and after treatment to see if disease status can be determined by measuring the amount of biomarker.

Epithelial ovarian cancer is the most lethal female reproductive malignancy, mainly because 80% of tumors have metastasized beyond the ovary at the time of diagnosis. Screening efforts aimed at improved identification of early stage disease have been largely unsuccessful, because of ovarian cancer's propensity for early spread. Our hypothesis is that this obstacle can be circumvented by identifying biomarkers for the precancerous stage of this disease. Since this pre-cancerous stage is currently undetectable, we instead propose to look for biomarkers in women at very high risk for developing ovarian cancer due to genetic mutations. We hypothesize that identification of markers for genetic predisposition to ovarian cancer will also be informative for detection of biological changes that over time lead to sporadic cancers. Given their increasingly recognized role in states of normal and abnormal growth and differentiation, we hypothesize that short non-coding RNAs (sncRNAs) hold significant promise as biomarkers of ovarian cancer predisposition. We will test these hypotheses in two aims. First, we will identify biomarkers for hereditary ovarian cancer risk by comparing serum-derived sncRNAs in women with and without hereditary risk for ovarian cancer. In the second aim we will define serum-derived sncRNAs correlates of ovarian cancer disease status. We will compare sera from ovarian cancer patients at times of highest and lowest disease burden to those of control, cancer-free subjects. Each aim will provide independent, novel, and important information for future investigations. The sncRNAs found to be differentially expressed in both aims will be prioritized for future validation in women under clinical surveillance for hereditary risk of ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing medical care at UVA
* Up to date breast cancer screening
* Subjects must fall into one of the following groups:

  * Women at increased risk of ovarian cancer based on family history, personal history, or genetic factors defined as either BRCA1 or BRCA2 mutations who still retain both fallopian tubes and both ovaries.
  * Women at average risk for ovarian cancer
  * Women with known/suspected or recurrent ovarian cancer who are undergoing evaluation and/or treatment at UVA Cancer Center

Exclusion Criteria:

* Subjects with increased risk for ovarian cancer may not have a history of prior malignancy within the last 10 years excluding cervical carcinoma in situ or basal cell carcinoma
* Pregnancy (self reported)
Examining the Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy in New Mothers Experiencing Anxiety and Depression

In the proposed study, the investigators will examine the efficacy of transdiagnostic, Internet-delivered cognitive behaviour therapy (ICBT) in the treatment of postpartum anxiety and depression. Half of participants will receive the treatment immediately, and half of the participants will be assigned to a treatment-as-usual control condition. Participants assigned to the control condition will be offered the treatment after a 12-week waiting period, although data from this portion will not be included in the current study. All participants will complete questionnaires prior to the start of the treatment, following treatment (or corresponding 8-week waiting period), at 1-months follow-up (or corresponding 12-week waiting period), and at 6-months follow-up (in those assigned to the treatment condition). Further, those who receive the treatment will complete questionnaires on a weekly basis. The primary outcome measures include anxiety and depression. As part of the battery of questionnaires administered after the completion of the program, participants will be asked to rate the program content, the overall service, and their satisfaction with the program.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* female
* have given birth and have a child under one year of age
* score of 10 or above on EPDS or a score of 9 or above on the GAD-7
* be a resident of Saskatchewan
* have access to a secure computer and the Internet, and be comfortable using technology
* be available to work through treatment each week
* be willing to provide a medical contact as an emergency contact

Exclusion Criteria:

* younger than 18 years
* not female
* have not given birth to a child less than one year of age
* are experiencing minimal to no symptoms of anxiety and/or depression
* are not a resident of Saskatchewan
* have been hospitalized within the last year for mental health and/or suicide risk concerns;
* have unmanaged problems with alcohol, drugs, psychosis or mania, or are at increased suicide risk (specific plans and intent reflected by the Suicide Behaviors Questionnaire-Revised)
* started a new psychotropic medication within the past month
* do not have access to a secure computer and the Internet or is not comfortable using technology
* are not available to work through treatment each week
* are not willing to provide a medical contact as an emergency contact
Specific Training After Stoma Surgery

In Sweden, approximately 43,000 people have undergone surgery with ileo-, colo- or urostomy. The most common type of stomy is a sigmoidostomy. A large proportion, about 50%, of patients who receive a permanent sigmoidostomy develop a parastomal hernia which may have major impact.

There are indications that specific abdominal exercise may reduce the risk of parastomal hernias, but randomized studies are lacking.

The aims of the study are:

1. to evaluate the effect of specific exercise to counteract the development of parastomal hernia in sigmoidostomy and the hernia's impact on ostomy function, physical function and quality of life.
2. to examine patients' experience of living with parastomal hernia. The study plans to include 240 patients who on will undergo surgery and receive a sigmoidostomy. These will be randomized to receive only advice according to the usual routine to avoid the development of parastomal hernia or these advice with the addition of specific abdominal muscle training. The training is initiated before the operation and is then carried out during the first postoperative year. Follow-up will be done with a clinical assessment and with measurement of bulge and size of the parastomal hernia manually, with electronic measuring equipment and via computed tomography images. Patients will assess their stoma and stoma function and assess any discomfort and its consequences of hernia via a study-specific questionnaire. Type of ostomy bandage will also be registered. The evaluation will be carried out 6, 12 and 36 months postoperatively.

Prior to the start of sub-study a, the planned measurement methods to assess whether a parastomal hernia is present will be tested for validity. In addition, a group of patients (≥15 people) with parastomal hernia will be included in a qualitative sub-study where they will be interviewed about their experiences of the hernia hernia and how it may affect daily life.

The present study will be able to answer whether specific exercise can reduce the risk of parastomal hernia. Methods for clinically assessing and evaluating bulging and hernias will be tested and evaluated in relation to patient-reported symptoms. In addition, the study will provide information about the patient's experience of having a parastomal hernia and how it affects daily life and physical activity. The results will provide an increased understanding of parastomal hernias, which may change the follow-up of patients in the future.


Eligibility Criteria:
Inclusion Criteria:

- A consecutive series of patients who are scheduled to have a permanent sigmoidostomy

Exclusion Criteria:

* Not Swedish speaking
* Impaired cognitive ability
* Physical disability that limits the possibility of carrying out the intervention.
* Lung disease including chronic cough.
* Previous hernia in the abdominal wall.
* Previous open abdominal surgery with scars ≥20 cm
* Spread malignant disease at inclusion
* Acute surgery
Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact

Our objective is to initiate an exercise program for patients with advanced GI or Gyn cancer, as prehabilitation prior to surgery. The objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. The prehabilitation program will be offered to patients who are eligible for and consent to cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC)

Our objective is to assess the feasibility and impact of implementing an exercise program for patients with advanced GI or Gyn cancer, as prehabilitation prior to surgery. The objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. The prehabilitation program will be offered to patients who are eligible for and consent to cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC).

Eligibility Criteria:
Inclusion Criteria:

* Patients with peritoneal metastasis from appendix, colon, small bowel, endometrium, ovary or any other GI or Gyn primary tumor
* Patients should be eligible for and consent to surgery with the intention of performing CRS / HIPEC at Penn State Hershey Medical Center. Eligibility for CRS/HIPEC is a clinical determination based on a combination of factors including radiographic extent of disease, tumor histology and medical fitness for surgery
* Subjects who are explored but found to be unresectable will be included.
* Male or female.
* Patients should be age 18 or above.
* Surgery is planned for not less than 6 weeks and no more than 10 weeks from consultation

Exclusion Criteria:

* Patients who do not consent to surgery.
* Patients who require urgent surgery, sooner than 6 weeks
* Patients receiving neoadjuvant chemotherapy, with no surgical date planned before 10 weeks from consultation. These patients can be enrolled at the time of the follow-up visit, as long as they meet above criteria
* Patients not fluent in English
* Pregnant women
* Prisoners
* Patients with Cognitive Impairment
A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis

The aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating entirely the use of systemic corticosteroids during the induction period with an inhibitor of the complement C5a receptor plus cyclophosphamide or rituximab.

The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with AAV on background cyclophosphamide or rituximab treatment.

The primary efficacy objective is to evaluate the efficacy of CCX168 based on the Birmingham Vasculitis Activity Score (BVAS) version 3.

The secondary objectives of this study include assessment of the feasibility of reducing or eliminating the use of corticosteroids in the treatment of subjects with ANCA-associated vasculitis without the need for rescue corticosteroid measures and the effect of CCX168 on several disease parameters.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis or renal limited vasculitis
* Male and postmenopausal or surgically sterile female subjects aged at least 18 years with new or relapsed AAV where treatment with cyclophosphamide or rituximab would be required
* Positive indirect immunofluorescence (IIF) test for P-ANCA or C-ANCA, or positive ELISA test for anti-proteinase-3 (PR3) or anti-myeloperoxidase (MPO) at screening
* Estimated glomerular filtration rate (eGFR) ≥ 20mL/min
* Have at least one "major" item, or at least 3 non-major items, or at least 2 renal items on the BVAS version 3

Key Exclusion Criteria:

* Severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage, hemoptysis, rapid-onset mononeuritis multiplex or central nervous system involvement
* Any other multi-system autoimmune disease
* Medical history of coagulopathy or bleeding disorder
* Received cyclophosphamide within 12 weeks of screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1
* Received high-dose intravenous corticosteroids within 4 weeks of screening
* On an oral dose of a corticosteroid of more than 10mg prednisone-equivalent at the time of screening
* Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred; received anti-TNF treatment, abatacept, alemtuzumab, IVIg or plasma exchange within 12 weeks of screening
Energy Expenditure Pre and Post Bariatric Surgery

Obese patients are going to be submitted to indirect calorimetry pre-operatively and we are going to repeat the same exam 6 months after bariatric surgery (post Roux-en-Y gastric Bypass surgery). They are going to do also body composition analysis in both moments.

The investigators are going to compare the results to see if the bariatric surgery increases their energy expenditure.


Eligibility Criteria:
Inclusion Criteria:

* obese patients that will be submitted to bariatric procedure

Exclusion Criteria:

* patients that don´t have clinical conditions to be submitted to a bariatric procedure
Real-life Treatment Outcomes of Ravulizumab in PNH

The PNH-RECORD study, a Polish multicenter observational (non-interventional), open-label, retrospective with prospective follow-up.

PNH-RECORD study aims to aims to collect data on the patients' characteristics and clinical outcomes of ravulizumab administered in the scope of routine clinical practice in PNH.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (aged ≥18) patients with PNH receiving ravulizumab treatment in the frames of NDP in Poland.
2. Patients willing to participate in the study and signed ICF.

Exclusion Criteria:

1. Those who participated in ravulizumab clinical trial in the past, and/or those who participated/plans to participate in clinical trial on/after the date of first ravulizumab infusion through NDP.
2. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.