cyrilzakka/clinical-trials huggingface dataset:
Assessment of Quality of Life and Outcomes in Patients With Primary Renal Cell Carcinoma Treated With SBRT

This is a multicenter, single arm phase II study of stereotactic body radiation therapy (SBRT) for patients with medically inoperable primary renal cell carcinoma (RCC).

Primary renal cell carcinoma (RCC) is a common malignancy in Canada. The current standard of care for fit patients with localized RCC is surgical resection of the kidney (nephrectomy). RCC, however, affects predominately an older population with a median age at diagnosis of 65 years. Surgery is often not an option for these patients due to existing co-morbidities, and in an increasing environment of shared decision making in healthcare, some patients decline surgical resection and seek less invasive alternatives.

Stereotactic body radiotherapy (SBRT) is a treatment approach that offers precise delivery of highly conformal radiotherapy to the tumour with minimal exposure to the surrounding normal tissues. SBRT is non-invasive and not limited by the size or location of kidney tumors like other ablative strategies. The worldwide experience of treating RCC with SBRT is growing and the results to date are promising. There is broader enthusiasm from both the radiation oncology and urology community to increase utilization of SBRT for RCC in non-surgical patients within the context of a well-designed prospective trial in Canada.

We will prospectively assess the efficacy, toxicity and impact on quality of life (QoL) of SBRT in the treatment of inoperable RCC.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old
* Newly diagnosed RCC by biopsy (preferred) or radiologic evidence of growth on surveillance over two consecutive assessments (6-12 months)
* Primary lesion \>3 cm, or recurrent lesion following local ablative therapy
* Medically inoperable or patient who refuses surgery following assessment by experienced urologist, and discussed in a multidisciplinary setting
* ECOG 0-2
* Written informed consent
* Participants must be able to understand the English-language or with the aid of a translator

Exclusion Criteria:

* Primary Lesion \>20cm
* Evidence of distant metastatic disease
* Previous abdominal RT in vicinity of kidney preventing definitive SBRT
* History of major radiosensitivity syndrome
* Second invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer)
* Currently pregnant or lactating
Functional Imaging in HNC Undergoing Chemoradiation

The purpose of the study is to generate a library of functional imaging and anatomical imaging for patients with head and neck cancers for evaluation of new radiotherapy strategies and planning techniques including IMRT. Secondary aims would be to observe the changes in the cancers as the treatment progresses as well as to define the biologically most active part of the tumor (biological target volume) which could be given more intensive treatment. Tumor volumes seen on different imaging modalities will be compared with a hope of finding an optimal imaging methodology for accurate visualization of the head and neck cancers

Adult patients who have a head and neck cancer and are planned to receive chemotherapy and radiotherapy will be invited to participate in the study. Patients who are not in very good health, have diabetes or kidney failure will not be considered for the study. Also patients who can not undergo MRI scan or are allergic to contrast injection given prior to the scan or have had any other form of cancer (except skin cancer) will also be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* patients with histologically proven head and neck cancer, planed for chemotherapy and radiotherapy
* age more than 18 years
* patient willing to participate and has signed a consent form
* patients in good physical status (WHO performance status 0-2)

Exclusion Criteria:

* patients in poor health (WHO performance status \>2)
* patients with any other cancer apart from skin cancer
* patients with contraindications to MRI scan and IV contrast
* diabetic patients
* patients with renal failure
Volatility and Heterogeneity of Vaccine Sentiments Means Continuous Monitoring is Needed When Measuring Message Effectiveness

The success of vaccination programs often depends on the effectiveness of the vaccine messages, particularly during emergencies such as the COVID-19 pandemic. The current suboptimal uptake of COVID-19 vaccines across many parts of the world highlights the tremendous challenges in overcoming vaccine hesitancy and refusal even in the context of a world-devastating pandemic. The investigators conducted a randomized controlled trial in Hong Kong to evaluate the impact of seven vaccine messages on COVID-19 vaccine uptake (with the government slogan as the control). The participants included 127,000 individuals who googled COVID-19-related information during July-October 2021.

This study aims to evaluate the effectiveness of using the Google advertising platforms on influencing the uptake of COVID-19 vaccines in Hong Kong. When completed, the rich database compiled through this proposed study will provide increased insight into vaccine hesitancy in Hong Kong. Insights from the optimised online advertising trial can aid in providing crucial technical and theoretical support to the relevant health authorities for any potential evidence-based policy intervention in addressing vaccine hesitancy issues or the public's concerns towards vaccines in Hong Kong.

Eligibility Criteria:
Inclusion Criteria:

* General users of Google search in Hong Kong

Exclusion Criteria:

* None
A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)

This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab \[RO5072759 (GA101)\] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of approximately 15 patients are planned to be enrolled at a subset of investigational sites.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥18 years of age
* Previously untreated cluster of differentiation antigen 20 (CD20)-positive diffuse large B-cell lymphoma
* Ann Arbour Stage III/IV and bulky II (mass \>10 cm)
* At least one bi-dimensionally measurable lesion defined as \>1.5 cm in its largest dimension by CT scan
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Left ventricular ejection fraction ≥50%
* Adequate hematologic function

Exclusion Criteria:

* Transformed lymphoma (follicular IIIB) if previously treated with chemotherapy or immunotherapy
* Prior therapy for diffuse large B-cell lymphoma except for nodal biopsy or local irradiation
* Central nervous system (CNS) lymphoma, primary mediastinal large cell lymphoma, primary cutaneous lymphoma, primary effusion lymphoma
* Patients who received cytotoxic drugs or rituximab as part of their treatment for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
* Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
* Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix, or malignancy treated with or without curative intent and in remission without treatment for ≥2 years prior to enrolment
* Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or human T-cell leukemia virus (HTLV-1) infection
* Pregnant or lactating women
IO vs IV Vancomycin in Tourniquetless TKA

Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during tourniquetless total knee arthroplasty.

Primary Objective: Comparable levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues, as well as in systemic levels, between the intravenous and intraosseous administration groups.

Secondary Objective: Compare 30- and 90-day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) versus the interventional group (intraosseous administration of vancomycin). The research team hypothesizes that there will be no difference in complication (infection) rates between groups

Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing a primary total knee arthroplasty.
* Patient is able to understand the study design and intervention and gives informed consent to participate in the study. No LAR consents will be utilized for this study.
* Age \>18 years.
* Total knee arthroplasty performed without the use of a tourniquet.

Exclusion Criteria:

* Previous surgery on the knee (including arthroscopic knee surgery)
* BMI above 35
* Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
* Inability to locate the tibial tubercle or administer the IO infusion
* Refusal to participate
* Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C \>7.5.
* Immunocompromised or immunosuppressed patients (HIV, Hep C, End-Stage Renal Disease, dialysis, transplant, chemo/radiation treatment in last 6 months, and immunosuppresive medications)
Efficacy of Collagen Sponge Versus Collagen Membrane on Ridge Preservation of Periodontally Compromised Teeth

The study aims to evaluate the efficacy of ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth.

The study aims to evaluate the changes of clinical and radiographic outcomes following ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth. The included patients will be randomized into two groups. The patients in control group will be treated with collagen membrane + collagenated bovine bone mineral, and those in the test group will be treated with collagen sponge + collagenated bovine bone mineral. The horizontal width of ridge, the vertical height of ridge at the buccal and palatal/lingual plates, width of keratinized tissue and thickness of mucosa will be measured before surgery and at 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Need for molar extraction due to periodontal disease and plan for late implantation
3. No acute infection, such as abscess or effusion
4. Presence of bone defects on at one or two socket walls, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is \>50% of the corresponding root length and the bone height of socket walls is at least 3 mm
5. Presence of one adjacent tooth to the extraction site

Exclusion Criteria:

1. Smoking
2. Pregnancy or lactation
3. Untreated periodontal disease
4. Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.)
5. Under radiotherapy
6. Systemic disease or medication that influences bone metabolism and mucosal healing (such as immunosuppressants, phenytoin, bisphosphonates etc.)
7. Extraction of multiple adjacent teeth
8. Allergy to any of the materials used in the study
Effects of the Atkins Diet Versus a Low Fat Diet on Inflammation

The purpose of this research is to assess the effects of a low-carbohydrate (modified Atkins) diet versus a low fat (Heart Healthy) diet on cardiovascular health.

The purpose of this study is to compare the effects of a modified Atkins diet (low carbohydrate and low calorie) and a traditional heart healthy diet (low fat and low calorie) on biochemical markers of inflammation and metabolism, anthropometric measurements, vascular studies of endothelial function, adipose tissue composition, and patient compliance and satisfaction over a twelve week period in healthy men and women. Patients will be recruited from the Nutrition and Weight Management Center at Boston Medical Center. Enrolled subjects will be randomly assigned to a reduced calorie diet (either the Atkins diet or a traditional heart healthy diet), and will be counseled by a dietitian and a physician throughout the study period. The patients will have physical exams, labs, vascular studies of endothelial function, and adipose tissue biopsies at baseline and at twelve weeks to assess progress. Participants dietary compliance will be assessed using food journals and 24 hour recall.

The Atkins diet appears to have potential to reverse the epidemic of obesity-linked cardiovascular disease (CVD) in the United States. Obesity is in effect an inflammatory state in which adipose (fat) tissue releases adipokines- small, inflammatory proteins. High adipokine levels in the blood lead to an inflammatory response, ultimately damaging the endothelial cells which line the blood vessels and increases the risk of vascular disease. Ultimately the effects of these two different diets will be analyzed to help determine if a low carbohydrate, low calorie diet is more beneficial than a traditional heart healthy diet (low fat, low calorie) at reducing the systemic inflammatory response by using physical exam measures, inflammatory blood markers, vascular ultrasound studies, and adipose tissue biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* BMI greater than or equal to 30

Exclusion Criteria:

* Currently pregnant or lactating
* Type 2 diabetes
* Use of oral anti-diabetes medications (with exception of Metformin for control of PCOS)
* Presence of known peripheral arterial or cardiovascular disease
* Change in body weight (greater or equal to 3% within the past 3 months)
* Recent use (within the four weeks prior to screening) of weight loss medications including but not limited to phentermine, sibutramine, orlistat, or over the counter weight loss products
* History of an eating disorder or significant disordered eating behaviors such as binging/purging, abuse of laxatives or diuretics
* History of established renal or hepatic disease
* History of prior bariatric surgery
* Subjects who report routine tobacco use
* Subjects on Angiotensin receptor blockers (medications such as but not limited too Adicant, Losartan, Avapro, Diovan, Micardis, Teveten, Candesarten/thiazide, Ibesarten/thiazide, Valsartan/thiazide, Losarten/thiazide, Telmisarten/thiazide, Teveten/thiazide
Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone

This study investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder.

This is a randomized, double blinded , controlled, two-center study assessing the feasibility, efficacy and safety of intravitreal ranibizumab injection applied as a preoperative adjunct treatment before vitrectomy surgery in severe proliferative diabetic retinopathy (PDR). Comparator arm consists of patients receiving standard vitrectomy alone with sham intravitreal injection preoperatively.

Eligibility Criteria:
Inclusion Criteria:

* male or female 18 or older who have signed an informed consent
* Type I or II diabetes mellitus and severe proliferative retinopathy with tractional retinal detachment, tractional-rhegmatogenous retinal detachment, tractional detachment complicated with vitreous haemorrhage or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation
* study eye BCVA must have at least light perception and must not exceed 70 letters using ETDRS at testing distance 4 meters
* study eye vision decrease must be resulted from severe PDR

Exclusion Criteria:

* Active ocular inflammation or infection
* History of uveitis
* Uncontrolled glaucoma
* High myopia
* Any concurrent intraocular condition in the study eye that in the opinion of the investigator could confound the study results
* Former treatment with anti-angiogenic drugs within 30 days preceding Day 1 in the study eye
* History of vitrectomy within 60 days preceding Day 1 in the study eye
* History of intraocular surgery within 30 days preceding Day 1 in the study eye
* Untreated diabetes mellitus
* Severe hypertension (systolic pressure higher than 160mmHg)
* Current use of systemic medications known to be toxic to the retina
* History of thromboembolic events (incl MI and stroke) within 5 years
* Major surgery within previous 3 months or planned within the next 28 days
* Known coagulation abnormalities or current use of anticoagulative medications other than aspirins
* Known hypersensitivity to ranibizumab or any component of it
* Women of childbearing potential unless 2 methods of birth control applied
* Pregnant or lactating women
Osteoporosis Disease Management Demonstration Project (0000-037)

The purpose of this study is to assess the impact of disease management interventions on bone mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years or older.


Eligibility Criteria:
Inclusion Criteria:

* Members of the Henry Ford Health System

Exclusion Criteria:

* Individuals who are not members of the Henry Ford Health System
An Observational Study of Coronary Microvascular Disease of China

Non-obstructive coronary heart disease refers to patients with angina pectoris without significant narrowing of the epicardial vessels. Coronary microvascular disease(CMD) is a kind of non-obstructive coronary heart disease, and its clinical detection rate is increasing, seriously affecting the quality of life of patients, and increasing the risk of cardiovascular adverse events, but its mechanism has not been fully understood. This study will prospectively collect patients who meet the diagnosis of CMD, observe the development and outcome of the disease, and explore its occurrence and development mechanism.


Eligibility Criteria:
Inclusion Criteria:

1. Angina symptoms
2. Objective evidence of myocardial ischemia
3. Coronary angiography was normal,irregular tube wall, or stenosis \<50%

Exclusion Criteria:

1. People under the age of 18
2. Non-cardiogenic chest pain and other heart conditions such as variant angina, cardiomyopathy, myocarditis or valvular heart disease
Balance and Strength Exercise in Knee Osteoarthritis Patients

The aim of this study is to assess the effect of balance exercise on dynamic balance and physical function in 80 patients with different grades of primary knee osteoarthritis (KOA).

The study will include 80 patients with primary knee osteoarthritis divided into 4 groups according to the Kellgren and Lawrence grading scale (KL):

Group 1: 20 patients with grade I KOA Group 2: 20 patients with grade II KOA Group 3: 20 patients with grade III KOA Group 4: 20 patients with grade IV KOA

* Patients will undergo pre-exercise and post- exercise assessment with:

  1. Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
  2. Modified Stare Excursion Balance test
  3. Timed up and Go test
* Exercise program includes:

  1. Lower extremity kinesthesia and balance exercise program
  2. Strength exercise program

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary knee osteoarthritis according to the EULAR recommendations 2010.
* Patients can complete at least stage 1 of balance and exercise program (minimum of 2 weeks)

Exclusion Criteria:

* Patients that cannot complete at least stage 1 of balance and exercise program
* Patients with medical conditions affecting postural balance including visual, inner ear and neurological problems.
* Patients with lower limb joint or bony problems other than primary knee osteoarthritis .
* Patients with secondary KOA.
* Patients who received intra- articular joint injection in 1 or both knees in the past 90 days.
Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis

Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years.
* Written informed consent.
* With histologically-proven prostate carcinoma.
* ECOG performance status ≤ 2
* Life expectancy \> 12 months
* Current or previously documented diagnosis of at least 1 bone metastasis due to prostate cancer (patient could be hormono naif, Hormono sensible or hormono refractory)
* Patients with partners of childbearing potential should use a barrier method of contraception throughout the study.

Exclusion Criteria:

* ECOG performans status \>3
* Prior treatment with bisphosphonates IV within the last 3 month to the study
* Renal insufficiency (serum creatinine \> 265 micromol/L or \> 3.0 mg/dL)
* Liver function tests \> 2.5 ULN
* Patients with another nonmalignant disease which would confuse the evaluation of primary endpoints or prevent the patient from complying with the protocol.
* History of concomitant disease with influence on bone metabolism such as Paget's disease or primary hyperparathyroidism
* Disabling or non controlled concomitant disease likely to alter the quality of life
* Patient unable to fill in a questionnaire: senile dementia, psychiatric or neurological disease, illiterate or partially sighted patient
* Known hypersensitivity to zoledronic acid or other bisphosphonates

Other protocol-defined inclusion / exclusion criteria may apply.