cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of Durvalumab(MEDI4736) + Tremelimumab in Pulmonary Sarcomatoid Carcinoma

Phase II study of Durvalumab+/- Tremelimumab in patients with recurred metastatic head and neck squamous cell carcinoma

Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma

Eligibility Criteria:
Inclusion Criteria:

* 1. Recurrent or metastatic HNSCC, regardless of PD-L1 or HPV status 2. Age ≥20 3. ECOG PS 0-1 4. Ineligibility for local therapy (surgery or radiotherapy) 5. Prior palliative chemotherapy including platinum-based chemotherapy. When recurred within 6 months of definitive/neoadjuvant/adjuvant chemo- or chemoradiation, the chemotherapy is considered a line of therapy 6. At least one measurable lesion by RECIST ver 1.1 7. Adequate organ function for treatment
* Absolute neutrophil count (ANC) ≥1000 cells/mm3
* Hemoglobin: ≥ 9.0 g/dL
* Platelets ≥100,000 cells/mm3
* Estimated creatinine clearance ≥40 mL/min, or serum creatinine \<1.5 x institution upper limit of normal
* Bilirubin ≤1.5 x upper limit of normal (ULN)
* AST (SGOT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases)
* ALT (SGPT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases) 8. 12-Lead electrocardiogram (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention 9. The patient has provided signed informed consent

Exclusion Criteria:

* 1. Previous treatment with PD-1 or PDL-1 inhibitors 2. Nasopharyngeal carcinoma 3. Cytotoxic chemotherapy within 3 weeks of study entry; immunotherapy or investigational drug within 5 half-lives of study entry 4. Any major operation or irradiation within 4 weeks of baseline disease assessment. Palliative radiation is allowed 5. Symptomatic brain metastasis 6. Patients with known interstitial lung disease 7. Patients with uncontrolled or significant cardiovascular disease 8. Previous or concurrent malignancy (except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, thyroid cancer treated curatively) without evidence of recurrence for at least 3 years prior to study entry.

  9. Pregnant or breast-feeding women 10. Systemic immunosuppressive therapy 11. Active autoimmune disease 12. Patient who have an active systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies) (inactive HBV carrier with adequate prophylactic antiviral agent can be enrolled) 13. Body weight \<30kg

  14. Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation
Optimal Dose of Propofol for Induction of Deep Sedation for Brain MRI Scanning in Children With Cerebral Palsy

The children with CP has been shown different drug responses from the normal population of children and it may related with a various oral medications such as baclofen, tizanidine, diazepam, dantrolene, or anticonvulsant drugs.

The aim of this study is to establish the optimal induction dose of propofol for deep sedation to start MRI for \< 30 min in children with CP.


Eligibility Criteria:
Inclusion Criteria:

* children with cerebral palsy with patient agreement

Exclusion Criteria:

* sleep apnea, difficult airway, cardiorespiratory disease, allergic history to propofol
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery

Deep surgical site infection (DSSI) is one of the most challenging complications for spinal surgeons and can lead to a poor clinical outcome. This ambispective study was designed to examine the effect of vancomycin powder mixed with autogenous bone graft and bone substitute on preventing deep surgical site infection (DSSI) in degenerative lumbar fusion surgeries as well as any interference with bony fusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have instrumented spine fusion surgery due to failed conservative treatment (bed rest, medication, rehabilitation programs) for 3 to 6 months
* Patients who are willing to sign the surgical permit after the surgeon explains all surgical procedures along with the surgical risks
* Patients who fully understand the surgical procedures as well as the surgical risks and are willing to sign the surgical permit and the inform consent
* Patients who agree one more blood withdrawal after operation

Exclusion Criteria:

* Patients who agree to accept the spine surgery but do not agree to sign the inform consent
* Patients who have allergic reaction to vancomycin
A Modified Rehabilitation Intervention for Working Persons With Arthritis

The purpose of this study is to explore the effects of a brief vocational rehabilitation intervention on individuals with arthritis who are concerned about their ability to remain employed.


Eligibility Criteria:
Inclusion Criteria:

* Live or work in eastern Massachusetts
* Age 25-63 years
* Risk of work loss due to arthritis
* Arthritis
* Chronic back pain
* Currently employed

Exclusion Criteria:

* Unemployed
* No arthritis
Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

The purpose of this study is to determine the degree of indirect benefits to family members and classmates resulting from administration of influenza vaccine to children.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents aged between 7 and 11 and their family members.

Exclusion Criteria:

* Children with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations.
* Children receiving aspirin therapy or aspirin-containing therapy.
* Children with asthma or active wheezing.
* Children or family members with underlying immunocompromised condition or receiving immunosuppressive agents.
Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterostomy should be the preferred endoscopic treatment approach.

EUS gastroenterostomy and surgical gastrojejunostomy have been compared in retrospective cohort analysis, suggesting a high technical success rate a shorter hospital length of stay for the endoscopic approach \[4\]. Comparison of these techniques has not been reported in controlled prospective fashion. A prospective trial is necessary in order to define the optimal interventional management option for treatment of malignant GOO in the context of the contemporary and rapidly evolved range of available endoscopic and surgical treatment options.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Able to provide informed consent
* Biopsy-proven cancer
* Cancer without surgical resection as a curative treatment option
* Clinical and radiographic presentation consistent with primary or metastatic tumor causing foregut obstruction at the level of the pylorus and/or duodenum

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Unable to provide informed consent
* White Blood Count \< 3,000
* Absolute Neutrophil Count \< 1,500
* International normalized ratio \> 1.6
* Platelet count \< 100,000
* Cancer with surgical resection as a curative treatment option
* Surgically altered foregut anatomy
* Multifocal intestinal obstruction
* Abdominal ascites prohibitive of surgical candidacy
* Abdominal wall mesh prohibitive of surgical candidacy
* Child's Class B or C cirrhosis
* Gastroesophageal varices or known portal hypertension
* Body mass index \>40
Effectiveness of Smartphone Application for Weight Loss

The aim of this study is

To determine the effectiveness of smartphone application for weight loss in healthy female adults.

To determine the association between fitness application usage and physical activity behavior of the healthy female adults.

Obesity has turned into a significant, rising well-being epidemic around the world. Doing almost no physical work has been connected with chronic weakness results and diminished personal satisfaction in adulthood. It has been perceived that innovation can uphold wellbeing upgrades around the world. The applications that target wellbeing advancement have turned into a focal piece of individuals' lives and have exhibited enormous expansions being used. Proper evidence behind usage of smart phone application for weight loss is sparse and is based on different clinical experiences and a smaller number of studies with limited methodological design. This study will contribute to describing the effectiveness of smartphone application for weight loss in female adults as well as to determine the association between fitness application usage and physical activity behavior.

Eligibility Criteria:
Inclusion Criteria:

* Adult females
* Age between 18-40 years.
* Individuals with BMI ≥ 25

Exclusion Criteria:

* Pathological conditions affecting any system
* Suffering from recent unhealed MSK injury/Trauma
The Use of PET for the Early Response Evaluation in Patients With Diffuse Large B-cell Lymphoma.

Non-Hodgkin lymphoma (NHL) is one of the more frequent cancers in the western world with approx. 800 new cases annually in Denmark. Diffuse large B-cell lymphoma (DLBCL) in Denmark accounts for almost 40% of newly diagnosed NHL cases. Treatment with the combination of chemotherapy and monoclonal antibodies has significantly improved prognosis over the past decade, but a large proportion of patients with DLBCL will continue to relapse with our current treatment options. Therefore, there is a need for reliable methods for detection of treatment response as early as possible in the treatment course in order to identify patients who respond poorly to standard treatment and potentially would benefit from a change in treatment strategy. This has still not been established, but a valid early marker is required in order to allow randomized trials of treatment stratified by early response. One of the most promising applications of PET is the metabolic assessment of the early response of cancer treatment.

This study is a national prospective multicenter study emanating from the Danish Lymphoma Group (DLG). Patients are scanned after each of the early 4 cycles of chemo therapy. The aim is to establish the correct timing of response evaluation. Additionally, the investigators wish to investigate the optimal qualitative and quantitative method of response assessment in order to predict post-therapeutic remission and long-term prognosis.This study will contribute to interim-PET being implemented in the most optimal way in daily clinical practice.


Eligibility Criteria:
Inclusion Criteria:

-Age\>18 years

Exclusion Criteria:

* Previously treatment with chemotherapy or irradiation
* Primary CNS lymphoma
* Recurrent lymphoma
* Transformation from indolent lymphoma
* Presence of diabetes mellitus, HIV, chronic inflammatory disease or infections
* Planned for curative treatment
Genicular Artery Embolization for the Treatment of Knee Osteoarthritis

The purpose of this clinical research study is to examine whether Embozene treatment of the genicular artery is a safe and effective way to treat arthritic knee pain. Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.

This is a phase 2, single-center, prospective, single arm investigational study to evaluate the safety and efficacy of genicular artery embolization (GAE) for treatment of symptomatic knee osteoarthritis (OA). Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain. The primary objective of this investigation is to assess safety of genicular artery embolization (GAE) for knee osteoarthritis (OA) using Embozene particles.

Eligibility Criteria:
Inclusion Criteria:

* Provided informed consent
* Age ≥ 40 years and ≤ 80 years
* Life expectancy greater than 12 months
* Ineligibility for or refusal of surgical management
* Moderate-severe knee pain as determined by visual analog scale \> 4
* Osteoarthritis based on xray
* Local knee tenderness
* Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection)

Exclusion Criteria:• Mild knee pain as determined by visual analog scale \< 4

* Chronic renal insufficiency (serum creatinine \>2 mg/dL)
* Uncorrectable bleeding diathesis: international normalized ratio (INR) \>1.6, Platelets \<50,000
* Significant arterial atherosclerosis that would limit selective angiography
* Allergy to iodinated contrast agents that is not responsive to steroid management
* Active Infection or malignancy
* Appropriate candidate for knee replacement surgery determined by clinical and physical examination
* Recent (within 3 months) or active cigarette use
Bioelectrical Impedance Phase Angle in Predicting Treatment Outcome in Patients With Extensive Stage Small Cell Lung Cancer Receiving First-Line Chemotherapy

This clinical trial studies bioelectrical impedance phase angle in predicting treatment outcome in patients with extensive stage small cell lung cancer receiving first-line chemotherapy. Diagnostic procedures, such as bioelectrical impedance analysis, may help predict a patient's response to treatment for small cell lung cancer.

PRIMARY OBJECTIVES:

I. To evaluate the association between phase angle (PA) measurement and progression-free survival (PFS).

SECONDARY OBJECTIVES:

I. To evaluate the association between PA measurement and treatment-related outcomes of treatment response, adverse treatment events, and overall survival (OS).

II. To determine the feasibility of obtaining PA measurements at a single time point in patients undergoing evaluation in thoracic oncology clinics.

OUTLINE:

Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment.

After completion of study treatment, patients are followed up every 2-3 months for two years.

Eligibility Criteria:
Inclusion Criteria:

* A primary histopathological and/or cytopathological diagnosis of small cell lung cancer (SCLC)
* Diagnosis of extensive stage disease (extensive stage \[ES\]-SCLC), with stage established by computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) scan
* Scheduled to receive front-line platinum-based chemotherapy with carboplatin or cisplatin plus etoposide
* Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document

Exclusion Criteria:

* No recent chemotherapy or surgery, as defined as in the last 6 months
* Presence of a pacemaker or defibrillator
* Patients with major chronic disease known to adversely affect PA, including human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), congestive heart failure, tuberculosis
* Patients with body mass index (BMI) greater than 34 or less than 16
* Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
* Unable or unwilling to follow protocol requirements
* Pregnant women are excluded from participation due to inability to participate in required chemotherapy regimen
Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients.

This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria:

* 18 years of age or older
* Histologically confirmed diagnoses of prostate cancer
* Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph
* Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments

Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up.


Eligibility Criteria:
Inclusion criteria:

* Signed informed consent
* Age \> 18 years
* Histologically confirmed diagnosis of carcinoma of the prostate
* Objective evidence of metastatic disease to the bone as evidenced by bone scan or radiograph at any point since their diagnosis of prostate cancer
* Currently receiving, or will begin receiving, hormonal therapy with an LHRH agonist or other hormonal treatments for either \< 6 months or \> 6 months
* ECOG performance status of 0, 1, or 2

Exclusion criteria:

* Patients who are hormone sensitive without metastatic disease to the bone
* Patients who are hormone refractory typically defined as two or three consecutive increases in PSA measured at least one month apart while on hormone therapy
* Patients who are not treated with LHRH agonist or other hormonal treatments
* Patients who are currently receiving diethylstilbestrol (DES) or PC-SPES
* Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
* Patients with abnormal renal function as evidenced by either a serum creatinine greater than 2 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less
* Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L)
Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection

Clostridioides difficile (CD) infection (CDI) is a global health threat with an urgent need for new treatment strategies. Faecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (CDI), and is currently recommended for multiple (three or more), recurrent CDI infections. The role of FMT earlier in the treatment hierarchy of CDI remains to be determined.

In this randomized, double-blinded, placebo-controlled clinical trial, we compare FMT with placebo following standard antibiotic treatment for first or second Clostridioides difficile infection.

This is a parallel arm placebo-controlled clinical trial. We aim to include 84 adult patients with their first or second episode of Clostridioides difficile (formerly Clostridium difficile) infection. All patients receive vancomycin standard therapy. Patients are randomised in a 1:1 ratio to two treatments with capsules that contain either FMT+FMT or placebo+placebo. The primary outcome is absence of C difficile-associated disease 8 weeks after randomisation. Patients who have fulminant disease where it is deemed unethical to give placebo are offered open-label FMT. The primary outcome in patients with fulminant C difficile infection is 8 weeks mortality.

Eligibility Criteria:
Inclusion Criteria:

* 1. or 2. CDI (within a year) defined as: \> 3 bowel movements of Bristol 6-7 per day and positive stool CD-test.
* Age 18 years or higher.

Exclusion Criteria:

* Pregnancy
* Does not speak or understand the Danish language
* Current antibiotic treatment other than vancomycin
* Current treatment with potential interations with vancomycin
* Allergy to vancomycin
* Previous anaphylactic reactions due to food allergies
* Continuous need for proton pump inhibitor
* Documented gastroparesis
* Fulminant CDI
ProAliFun_6.7_Health Effects of a Low-Salt Bread on Hypertensive Subjects (ProAliFun67)

The purpose of this clinical study is to evaluate the health properties of a dietary intervention carried on with an innovative low-salt bread.

The hypothesis is that the introduction of a low-sodium bread as part of a low-salt diet may improve the compliance to the own regime and that the vascular function, the inflammatory and oxidative state, the composition of the intestinal microbiota and that neurocognitive and neurodegenerative processes can improve in hypertensive patients fed a low-salt diet with low-salt bread.

This clinical trial is a multi-center, randomized, controlled, open label, pilot study, lasting 6 months.

A target number of seventy individuals with hypertension meeting inclusion and exclusion criteria, assessed at enrollment, and which have signed the informed consent, will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* arterial hypertension stage I-II
* stable control of blood pressure
* eGFR \> 60
* informed consent signed

Exclusion Criteria:

* uncontrolled hypertension
* therapy with diuretics
* need for therapy with more than three antihypertensive drugs
* proteinuria greater than 1 g/day
* celiac disease
* systemic inflammatory diseases
* suspicion or clinical diagnosis of malignancy
* chronic liver disease
* treatment with corticosteroids or immunosuppressive drugs
* previous acute cardiovascular diseases (myocardial infarction, stroke)
* psychiatric conditions reducing the compliance to treatment protocols