cyrilzakka/clinical-trials huggingface dataset:
Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer

The aim of this phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT in patients with unresectable pancreatic cancer.

The aim of this prospective mono-institutional phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions in patients with locally unresectable pancreatic cancer.

Primary endpoint is to evaluate overall survival (OS); the overall survival time will be calculated from the start of chemotherapy to death. Secondary end points are to evaluate acute and late toxicities, freedom from local progression (FFLP) and progression free-survival (PFS). Acute and late toxicities will be scored according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Local progression will be defined according to RECIST criteria. Time to toxicity and time to local or distant progression will be defined from the start of chemotherapy.

Technical success will be defined as the ability to implant at least 2 fiducials in the tumor area. Migration will be defined as a change in inter-fiducial distance. Clinical success will be defined as the ability to guide the application of SBRT by using the fiducials. Any adverse event will be recorded (acute pancreatitis, clinically relevant upper GI bleeding requiring blood transfusion, abscesses in the area of the fiducials, sepsis).

Eligibility Criteria:
Inclusion Criteria:

* Histologically and/or radiologically (CT scan and/or MRI scan and/or FDG-PET) proven unresectable locally advanced pancreatic cancer, discussed multidisciplinary by tumor board.
* Eighteen years of age or older,
* Minimum Karnofsky Performance Status of 70.
* Lesions cannot exceed 5 cm in maximum diameter.
* Absence of lymph-nodal metastases
* Patients received 4-6 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered.
* Baseline total body CT scan performed no more than 2 months before treatment.
* Placing fiducial markers through endoscopes is permitted (EUS-guided fiducials placement before the treatment).
* Acceptable organ and bone marrow function.
* Ability to maintain the set-up position during RT.
* All patients give informed consent and sign a study-specific informed consent form.

Exclusion Criteria:

* Metastatic disease
* Prior abdominal radiotherapy
* Other malignancies diagnosed within 5 years
* Gastric or duodenal obstruction.
* Concurrent chemotherapy.
Use of a 3D Printer to Make Custom Sleep Masks for Positive Airway Pressure Treatment

This is a small pilot study to look at the feasibility of creating a customized sleep mask for use with Continuous Positive Airway Pressure (CPAP) or other similar treatments for sleep apnea. The participant will have three dimensional (3D) pictures of the face taken by special cameras. The pictures will be sent to a 3D printer and a mask will be created based on the participant's face contours. The participant will use the mask for about 6 months. The study will measure the amount it is used during sleep and if there is an increase in reported comfort.

The aim of this study is to improve adherence and effectiveness of noninvasive ventilation by decreasing the side effects commonly seen with noninvasive ventilation. Studies have shown that even though noninvasive ventilation (NIV) with positive airway pressure (PAP) is successful at treating obstructive sleep apnea and hypoventilation, individuals have poor compliance with therapy. The reasons for poor compliance are numerous, but one significant and continually reported reason is poor mask fit. A poor mask fit is not only uncomfortable, but frequently causes side effects such as dry eyes, congestion, skin irritation and breakdown, and ineffective ventilation from inadequate pressures due to air leaking around the mask. Pediatric patients tend to be especially difficult to fit with conventional masks because of their smaller facial features and the lack of masks developed for pediatric use.

In this study, patients will be fitted with a custom made NIV mask following facial imaging with a 3D camera (Artec 3D Scanner). The facial image will be used to construct an NIV mask model using computer design software that will then be created by using a 3D printer.

Eligibility Criteria:
Inclusion Criteria:

* On stable NIV settings for a minimum of 2 months.

Exclusion Criteria:

* New diagnosis
Longitudinal Investigation of Cancer-related Fatigue and Its Treatment (LIFT Project)

The LIFT project aims to thoroughly investigate the current status of health care in Germany regarding cancer-related fatigue from the institutional, professionals' and patients' perspective.

The LIFT project aims to thoroughly investigate the current status of health care in Germany regarding fatigue from the institutional, professionals', and patients' perspective. With a multimodal approach including a comprehensive assessment of fatigue management and support offered by different institutions (uncertified hospitals, uncertified oncological practices, counselling units, certified cancer centers; n=350), a survey and qualitative interviews among practicing physicians ("Niedergelassene Ärzte"), hospital physicians, practicing psychotherapists with psycho-oncological focus, psycho-oncologists at hospitals, nurses at certified cancer centers and nurses at other hospitals (n=420), and a longitudinal clinical study among cancer patients (n=1400) as well as two focus groups with patient representatives (each n=6), the characteristics, patterns, and potential effects or shortcomings of the current fatigue management will be investigated. Furthermore, factors associated with patients' and health care professionals' knowledge about fatigue will be examined.

Concerning the longitudinal clinical study assessing the patients' perspective, online or paper-based questionnaires on socio-demographic, clinical and patient reported outcomes will be sent to the patients 6,9,12 and 24 months after diagnosis. Moreover, detailed data on screening, diagnosis and counseling as well as therapies offered and administered to reduce fatigue will be surveyed, as well as the patients' state of knowledge, perception and prevailing needs regarding fatigue. Tumor and cancer therapy data will be extracted from the Epidemiological Cancer Registry.

The results of the LIFT project shall provide a basis to identify and overcome shortcomings in the actual fatigue management in Germany, and, to eventually ameliorate this severe burden in cancer patients and survivors.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Newly diagnosed with a primary tumor of one of the following malignant neoplasms: colon (C18), rectum (C19-20), liver (C22), pancreas (C25), lung (C33-34), malignant melanoma (C43), breast (C50, only female), cervix (C53), endometrium (C54.1), ovaries (C56), prostate (C61), kidney (C64), bladder (C67), thyroid gland (C73), non-Hodgkin lymphoma (C82-88), leukemia (C91-C95)
* Having received or receiving at enrolment at least one of the following treatments: chemotherapy, radiotherapy, hormone therapy, targeted or immune therapy
* Able to understand and follow the study protocol

Exclusion Criteria:

* Carcinoma in situ
* Any additional malignant or unclear neoplasm before or since time of diagnosis of the considered primary tumor, except unspecified neoplasm of skin (C44)
Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images

This research study establishes a repository for imaging data generated during image-guided proton therapy for various pediatric cancers. The data facilitate the estimation of patient positioning uncertainty, the comparison of image guidance methods, and the identification of factors contributing to large setup deviations to improve the accuracy of radiation therapy in the future.

Primary Objective

To establish a repository of imaging data acquired during the radiation therapy course with linked radiation treatment plans and clinical information from pediatric patients of all cancer types receiving image-guided proton therapy to facilitate secondary and exploratory objectives.

Secondary Objectives

* To estimate distributions of patient setup uncertainty measured with daily pre- treatment volumetric cone beam computed tomography (CBCT) scans.
* To compare patient setup corrections derived based on 2D (orthogonal radiographs) and 3D (volumetric CBCT scans) image guidance.
* To assess residual setup errors after CBCT-guided correction based on post- correction repeat CBCT.
* To estimate distributions and time trends of patient motion during a radiation therapy course based on weekly pre- and post-treatment CBCT scans.
* To identify clinical and treatment factors that contribute to significantly large setup uncertainty and intra-fractional movement in pediatric patients.

Exploratory Objectives

* To determine variation in patient anatomy using images acquired during the treatment course.
* To evaluate the usefulness of on-treatment CBCT scans for detecting daily changes in proton ranges, evaluating deviations from planned tumor dosimetry, and triggering adaptive replanning.

Image guidance data collected in this study include daily volumetric pre-treatment CBCT for image guidance, post-correction CBCT, weekly post-treatment CBCT, and 2D orthogonal radiographs. Setup uncertainty will be estimated for head and body cohorts separately, further divided into different anatomic sites. The usefulness and necessity of daily volumetric image guidance for pediatric proton therapy patients will be determined. Knowledge gained from this study will provide a basis for reducing patient positioning uncertainty and designing optimal treatment plans for pediatric patients receiving proton therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient will receive proton therapy of ≥5 daily fractions.
* Research participant or legal guardian/representative gives written informed consent.

Exclusion Criteria:

* Unwillingness of research participant or legal guardian/representative to give written informed consent.
* If patients previously enrolled in this study and completed protocol-specified imaging scans but return for re-irradiation, they will not be eligible to participate again.
The Effect of Bariatric Surgery on Thyroid Function and Morphology

The aim is to evaluate the effect of dramatic weight loss after bariatric surgery on thyroid function (thyroid hormone levels and particulary morphological changes) in the short and long-term setting of a cross-sectional study. A particular focus will be made with regard to putting into correlation preoperative thyroid function abnormalities and postoperative changes over time with respect to the type of bariatric intervention carried out.

Background:

Over the last decades, there has been an increase in obesity in virtually all population groups with approximately 1.6 billion adults worldwide estimated to be overweight in 2005 and 400 million of these people qualifying as being obese.

Although hormonal disturbances may play a certain role in the development of obesity, more important are the possible consequences of obesity and the influence of surgically-induced rapid weight loss on overall endocrine function of these patients. Studies evaluating the effect of weight loss on thyroid function show inconsistent results. Whilst some authors have shown that weight loss after bariatric surgery may have a positive effect on thyroid dysfunction, especially in individuals with preoperative subclinical hypothyroidism 1 resulting in normalisation of TSH levels, others fail to show any significant postoperative changes.

Objective:

To evaluate the effect of dramatic weight loss after bariatric surgery on thyroid function (thyroid hormone levels and particularly morphological changes) in the short and long-term in the setting of a cross-sectional study. A particular focus will be made with regard to putting into correlation preoperative thyroid function abnormalities and postoperative changes over time with respect to the type of bariatric intervention carried out.

Methods:

BMI, thyroid hormones (TSH, fT3, fT4 levels), need for thyroxin substitution (or equivalent medication) as well as pre- and postoperative morphological changes in the thyroid gland (usually via sonography)and Leptin values will be assessed retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent bariatric surgery between 1998 and 2007

Exclusion Criteria

* age \>18 years
Sternal Plating High Risk

Participants are being invited to participate in a research study at University Hospitals because they have heart disease and are scheduled for open heart surgery. Currently, UH cardiac surgeons close the sternum (or breastbone) after a sternotomy (procedure that allows a doctor to reach the heart and blood vessels) with either a rigid plate fixation Sternal Plate or a Wire Cerclage. However, the study team would like to further evaluate these two techniques. Any volunteer over the age of 18 who is at an increased risk for developing sternal wound complications may be eligible to participate.


Eligibility Criteria:
Preoperative Inclusion Criteria

* Adults (age range: 18-89)
* Undergoing cardiac surgery through sternotomy

  -≥2 risk factors:
* Diabetes mellitus
* Severe COPD
* Chronic steroid use
* Immunosuppression
* Redo sternotomy
* Chronic
* Kidney disease with GFR \>30 ml/min per 1.73m2
* Radiation therapy
* BMI≥35
* High-risk of delirium
* Heavy alcohol use

Preoperative Exclusion Criteria

* Active malignancy
* Chronic narcotic use
* NYHA Class IV
* Known nickel metal allergy
* Compliance concern
* eGFR\<30 ml/min per 1.73m2
* Involvement in another interventional clinical trial (non-registry)
* Any criteria precluding RPF or WC

Operative Inclusion Criteria

* Off-midline sternotomy
* BITA grafting
* CPB time ≥120 minutes
* Transverse sternal fracture

Operative Exclusion Criteria

* Emergent or emergent salvage surgery
* Non-standard sternotomies
* Sternotomy with bony margin \<2 mm
* Bleeding
* Delayed sternal closure
* Surgical complications
* Any criteria precluding RPF or WC
A Study of the Effect of Oats on Post Prandial Glucose Response

The objectives are to assess the effects of high viscosity vs. medium and low viscosity oat β-glucan on post-prandial glycemic response in healthy adult participants.

The trial will be a 3 week double-blinded, randomized, cross-over design with 3 treatment intervention (oatmeal breakfasts costain low, medium and high viscosity of beta glucan) periods separated by about 5-7 days washout period. Normoglycemic (\<5.6 mmol/L) males and females (12 of each) of age 18-45 y with a body mass index (BMI) of 18.5-29.9 kg/m2 will be recruited.

Each participant will receive each of the following breakfast foods in a random order: 1) oat meal containing low viscosity beta glucan; 2) oat meal containing medium viscosity beta glucan; 3) oat meal containing high viscosity beta glucan. The participants will be asked to consume one of the breakfast foods during each visit.

Following each blood sample, appetite, physical comfort, energy/fatigue, and palatability of treatments will be measured by visual analogue scales (VAS).

Glucose measurements: Capillary blood will be collected during each visit by finger prick. Blood will be collected at fasting and at 15, 30, 45, 60, 90 and 120 minutes after the first bite/sip of the test product according to the Clinical Laboratory Standard Institute (CLSI) guidelines. Blood glucose will be measured in finger prick blood samples by glucose meters .

Males will be scheduled for three sessions over 3 weeks. Women will be scheduled during the first two weeks of their menstrual cycle (follicular phase), once per week.

During the wash-out days (5 - 7 days between each phase), participants can go about their daily activities unrestricted with the following exception: no strenuous activity or alcohol consumption on the days before the clinic visit. The investigators will ask that participants go to sleep at the same time on the days before the sessions.

Eligibility Criteria:
Inclusion Criteria:

* Normoglycemic (\<5.6 mmol/L)
* BMI= 18.5-29.9 kg/m²

Exclusion Criteria:

* A change in medication (dose or type) or medical event requiring hospitalization within the past month.
* Daily tobacco use.
* Eat meals at irregular or unusual times.
* Food allergy, aversion or unwillingness to eat study foods.
* Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect blood sugar.
* Presence of a gastrointestinal disorder.
* Currently pregnant or lactating.
A Study of CT-868 in Type 1 Diabetes Mellitus

This study will evaluate the changes in glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus after receiving CT-868 for 16 weeks. The effectiveness and safety of CT-868 will be compared to placebo. All participants will continue with their standard diabetes care using either an insulin pump (CSII) or multiple daily injections (MDI). Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels and diet and exercise recommendations. Treatment assignments, either CT-868 plus insulin or placebo plus insulin will be randomly determined.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older at the time of signing informed consent
* Have a documented clinical diagnosis of T1DM greater than or equal to 1 year before the Screening Visit
* Body mass index greater than or equal to27.0 kg/m2
* Hemoglobin A1c (HbA1c) level between 7.0% and 10.0%, inclusive, at the Screening Visit

Exclusion Criteria:

* Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM
* Experienced diabetic ketoacidosis (DKA) within 3 months prior to the Screening Visit
* Experienced severe hypoglycemia (Level 3 as defined in the ADA Standards of Medical Care in Diabetes (ADA 2022) within 3 months prior to the Screening Visit
Evaluation of Hoarding Behaviour and Eating Disorders Among Holocaust Survivors and Their Descendants

"Hoarding "is a common behavior among Holocaust survivors and is related to the traumatic events they have experienced, and we assume that storage behavior and eating disorders are related to future generations of Holocaust survivors.


Eligibility Criteria:
Inclusion Criteria:

1. Jewish Holocaust survivors living in Germany and Israel who have expressed their written and written consent to participate in monitoring and testing, and who are able to answer the research questionnaires.

   • Their direct offspring and their children (second and third generation)
2. The control population - non-Jewish subjects who are not the descendants of Holocaust survivors living in Germany who have expressed their written and oral consent to participate in monitoring and testing and who are able to answer the research questionnaires and whose parents were not imprisoned in the camps second.

Exclusion Criteria:

* (Participants who do not agree to participate (did not sign informed consent form
* Respondents who are unable to answer interviewer questions
* Non-Jewish subjects whose parents were in camps (ie prisoner camps, labor camps, etc.) during the second war.
Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy given after surgery is more effective than surgery alone for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy following surgery with that of surgery alone in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer.

OBJECTIVES: I. Compare the impact on overall survival of adjuvant cisplatin and either a vinca alkaloid or etoposide (with or without radiotherapy) vs. no adjuvant chemotherapy in patients with completely resected stage I/II/III non-small cell lung cancer. II. Assess the frequency of treatment-related deaths and severe toxic effects. III. Describe the patterns of failure, second malignancies, and toxic effects associated with each treatment regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution, type of prior surgery, and pathologic stage. Each participating center will determine which combination chemotherapy regimen and which of three cisplatin doses will be given to all patients treated at that center. The treatment group receives cisplatin combined with either vindesine, vinblastine, vinorelbine, or etoposide every 3-4 weeks for 3-4 courses, depending on the dose of cisplatin. The second group receives no adjuvant chemotherapy. Treating institutions determine prior to entering the trial which patients receive adjuvant radiotherapy: none; those with node-positive disease; those with N1 disease only; those with N2 disease only; or those eligible for a randomized radiotherapy trial. For patients in the treatment group, radiotherapy begins 3-4 weeks after the last course. Patients are followed at 6 months, then annually.

PROJECTED ACCRUAL: A maximum of 3,300 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically documented non-small cell lung cancer Any non-small cell histology eligible Pathologic stage I/II/III disease that is completely resected with microscopically clear margins within 60 days of entry (30 days preferred)

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No clear contraindication to chemotherapy No second malignancy except: Nonmelanomatous skin cancer Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic radiotherapy Surgery: Complete resection required prior to entry