cyrilzakka/clinical-trials huggingface dataset:
A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)

This is a Phase II, double-blind, randomized, multicenter trial designed to preliminarily evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib + placebo in second- and third-line Non-Small Cell Lung Cancer (NSCLC). Up to 180 patients will be randomized in a 1:1 ratio to one of the two treatment arms.


Eligibility Criteria:
Inclusion Criteria:

Patients must meet the following criteria for study entry:

* Histologically confirmed NSCLC
* Availability of a tumor specimen
* Recurrent or progressive disease following at least one chemo containing regimen for Stage IIIB/IV disease
* Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
* At least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose-positron emission tomography (FDG-PET) scan that is also a target lesion on computed tomography (CT) according to RECIST

Exclusion Criteria:

* More than two prior treatments for Stage IIIB/IV
* More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known epidermal growth factor receptor (EGFR)-related toxicity resulting in dose modifications
* Chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization
* Untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (CNS) metastasis
* History of serious systemic disease within the past 6 months prior to randomization
* Uncontrolled diabetes
* Major surgical procedure or significant traumatic injury within 28 days prior to randomization
* Anticipation of need for a major surgical procedure during the course of the study
* Local palliative radiotherapy within 7 days prior to randomization or persistent adverse effects from radiotherapy that have not been resolved to Grade II or less prior to randomization
* Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
Comparing Erector Spinae Plane (ESP) and Thoracic Paravertebral (TPV) Block Analgesic Effect After Elective VATS

The aim of the study is to compare two different locoregional techniques in VATS.

There are clear clinical and logistic reasons for pursuing the best possible post-operative pain management avoiding the negative side effects of opioid treatment; in order to garantee an enhanced recovery after surgery. A short hospital stay is fundamental to reduce patient morbidity and costs. Regional anesthetic nerve blocks are an ideal option to achieve this goal.

Paravertebral block serves as an ideal approach for thoracic and abdominal surgery through delivering segmental anesthesia of operative sites. Thoracic paravertebral block has superior analgesia as well as fewer complications than systemic opioids. It has been successfully applied in sternotomy, breast surgery, abdominoplasty, and laparoscopic cholecystectomy. ESP block is a recently described technique, with promising results in different scenarios. It probabily has a better risk profile than PVB, for its lower possibility of accidental pleural puncture and reabsorption of local anesthtetic than PVB one

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 year of age undergoing elective VATS lung resection at ORBV

Exclusion Criteria:

* patients with inability to consent, contraindications to standard care, or factors that can cause bias in interpretation, absolute contraindications to the regional anesthesia techniques studied (patient's refusal, allergy to local anesthetics, infections in the site of injection). Pregnant women are not a target study-group so they are excluded for design simplification. Conversion to the open technique will be a post-randomization exclusion factor concerning the main outcomes
Roxadustat Combined With Sacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome

A randomized and parallel controlled trial design of comparing the new treatment group of Roxadustat combined with Sacubitril Valsartan Sodium Tablets with the traditional treatment group of recombinant human erythropoietin (EPO) combined with ACEI or ARB in Chinese patients with cardiorenal anemia syndrome.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed as regular dialysis patients with cardiorenal anemia syndrome
* Hemoglobin 60-110g / L (twice with an interval of at least 4 days);
* Volunteered to participate

Exclusion Criteria:

* Anemia caused by diseases other than CKD
* Malignant tumors
* Active liver disease
* Rheumatic immune diseases in active stage
* Hereditary or idiopathic angioedema
* Systolic blood pressure≥180 mmHg;diastolic blood pressure≥110 mmHg
* Acute myocardial infarction and unstable angina pectoris
* Severe parathyroidism
* Active peptic ulcer
* taking aliskiren
* Mental disease
* Alcohol and drug abuse
* Allergy to test drugs
Irrigation of Chronic Subdural Hematomas - is More Better?

There are numerous reported ways to treat chronic subdural hematomas (CSDH) and practice is still differing considerably between departments. Except for a recent randomized controlled trial (RCT) that found that postoperative subdural drainage was better than no drain, there is no higher level evidence. Another recent RCT did not replicate these findings, but the study was severely underpowered.

Aim of this population based study is to compare clinical results (reoperation rates, complications, perioperative death, and survival) between neurosurgical departments treating CSDH with different treatment policies.


Eligibility Criteria:
Inclusion Criteria:

* All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at St.Olav University Hospital
* All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at University Hospital North Norway
* All patients treated with evacuation of primary CSDH from 2006 through 2010 at Karolinska University Hospital (not 2005 due to practical reasons since major changes occurred in electronic surgery protocols 2005).

Exclusion Criteria:

* Chronic subdural hematoma in arachnoid cyst(s)
* Previous CSDH surgery
* External hydrocephalus (hydrocephalus with cerebrospinal fluid (CSF) in the subdural space rather than in the ventricles)
* CSDH due to previous intracranial surgery (within 6 months).
Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults

Basic standard of care emphasis only tooth brushing and flossing without addressing individual pathological factors. For this reason, randomized controlled clinical trials on personalized caries management are needed to be able to compare the effectiveness of personalized caries management to basic standard of care. This is especially true in high caries risk populations and more so for young adults who stand to benefit the most from working towards a caries free adulthood.

Aim of the study: is to conduct an RCT to compare the effectiveness of a new personalized caries-control treatment protocol with standard caries treatment protocol for reducing caries incidence in high caries risk patients

Hypothesis: This project will be designed to test the null hypothesis that there is no significant difference between the new personalized caries-control treatment protocol and existing standard caries treatment protocol, and to test the alternative hypothesis that the new personalized treatment protocol will be superior to the standard preventive measures

Primary objective: is to measure the incidence of new caries lesions

Eligibility Criteria:
Inclusion Criteria:

1. High caries risk patients
2. 18-25 years
3. Males or Females
4. Patients approving to participate in the study -

Exclusion Criteria:

* Patients with systemic conditions
* Current periodontitis (sites of probing pocket depth ≥ 5 mm)
* Allergy to any of the ingredients of the study products
* Evidence of parafunctional habits
* Dysfunction of temporomandibular joint
* Use of antibiotics in the previous 30 days
* Patients with developmental dental anomalies
* Patients with removable prosthesis
* Patients with Orthodontic appliance
* Periapical Abscess or Fistula and exposed pulps.
Effects of Osteopathic Treatment in Patients With Tension Type Headache

The aim of this study is to evaluate the effects of the suboccipital muscles inhibition technique on patients suffering from tension-type headaches.

The tension-type headache is a recurrent condition with a high financial repercussion in Portugal. Their side effects often impact daily activities, reducing the quality of life of the patients.

In several studies, the excessive tension of the suboccipital muscles are usually referred as a cause of tension-type headache, since they can exert tension on the dura mater through the myodural bridge.

Eligibility Criteria:
Inclusion Criteria:

They must have tension-type headache, that is, a headache with:

* a duration of at least 30 min to days, with or without an break;
* must have at least two of the following four characteristics:

  1. bilateral location
  2. pressure or squeezing quality (non throbbing)
  3. weak or moderate intensity
  4. not aggravated by routine physical activity such as walking or climbing stairs;
* must have both of the following criteria:

  1. only one of the following: photophobia, phonophobia, or mild nausea
  2. absence of moderate or severe nausea or vomiting.

Exclusion Criteria:

* They can't be on antibiotics, antivirals, or antidepressants;
* They can't have neurological problems;
* They shouldn't have any absolute contraindication for the osteopathic maneuvers;
* They can't have acute pathologies (ex: infection) or serious (ex: cancer);
* They can't have fractures in the skull, cervical spine or high dorsal spine (up to D4);
* They can't be pregnant.
Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have localized prostate cancer.

OBJECTIVES: I. Compare the 5-year survival rate, in terms of clinical and biological remission, in patients with localized prostate cancer treated with two different radiotherapy regimens using different doses and number of fractions. II. Compare the nadir of PSA and the delay in obtaining the nadir in patients treated with these two regimens. III. Compare acute and long-term toxicity of these two regimens in these patients. IV. Compare overall survival and quality of life in patients treated with these two regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive radiotherapy to the seminal vesicles at 46 Gy in 23 fractions and to the prostate at 70 Gy in 35 fractions, with 5 fractions per week. Arm II: Patients receive radiotherapy to the seminal vesicles as in arm I and to the prostate at 80 Gy in 40 fractions, with 5 fractions per week. Treatment continues in both arms in the absence of disease progression or unacceptable toxicity. Quality of life is assessed annually. Patients are followed every 4 months for a minimum of 5 years.

PROJECTED ACCRUAL: A total of 306 patients (153 per arm) will be accrued for this study within 2.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Localized prostate cancer: T2a-T3a OR T1b or T1c with PSA at least 10 ng/mL OR T1b or T1c with Gleason score 7-10 No T3b or T4; positive biopsy of nodal excision N0, or any N with bilateral removal and the estimated risk of nodal invasion is at least 10% M0 (by bone scintograph and chest x-ray) PSA less than 50 ng/mL

PATIENT CHARACTERISTICS: Age: Under 75 Performance status: WHO 0-1 Life expectancy: At least 10 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior invasive malignancy within the past 5 years except basal cell carcinoma No social, familial, or geographic obstacles that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy No concurrent biologic therapy Chemotherapy: No prior chemotherapy No concurrent chemotherapy Endocrine therapy: No prior hormonal therapy including adjuvant therapy No concurrent hormonal therapy Radiotherapy: No prior pelvic radiotherapy Surgery: No prior radical anterior prostatectomy for cancer No prior castration
Fostering Oral Chemotherapy Understanding and Safety (FOCUS) Study

The purpose of this study is to learn about the experiences of cancer patients during treatment utilizing a mobile app called EveryDose© to track prescribed oral treatment for cancer. Based on these experiences, the study team will decide on expanding this pilot study to evaluate other methods that may prove to be beneficial in supporting cancer patient's ability to take cancer medications as prescribed (another common phrase used for this is adherence to treatment).


Eligibility Criteria:
Inclusion Criteria:

* Any sex/gender Able to provide written informed consent
* Able to read/understand English or Spanish
* Diagnosis of hematologic or solid tumor cancer diagnosis
* Prescribed an oral anti-cancer drug as monotherapy treatment for the first time by their treating oncologist.
* Internet access on a smartphone, tablet, or computer

Exclusion Criteria:

* Less than 18 years of age
* Unable to provide written informed consent
* Unable to read/understand English or Spanish
* History of dementia or major psychiatric disease that would interfere with study participation
* Prior treatment with an oral anti-cancer treatment
* Participating in another clinical trial during the time of screening.
Empowering Patients to Better Manage Diabetes Through Self-Care

This study will look at the impact of health insurance benefits on self management of diabetes for people with this condition. Studies have shown that when people with diabetes manage their disease better, they stay healthier. Our goal in this study is to help those with diabetes better manage their disease (self-care). We will compare two types of health insurance benefits in this study. We want to see if one set of benefits improves self-care more than the other one.

The objective of this particular study is to determine if the addition of regular pharmacist visits to usual care can improve clinical outcomes in patients with diabetes. The central hypothesis is that a program overseen by community pharmacists that empowers patients to self-manage their diabetes will lead to improved clinical and humanistic outcomes and will be cost-effective. Strong preliminary data collected from other sites suggests that patient empowerment programs are effective at reducing hemoglobin A1C after 12 months and in reducing the total cost of care. This hypothesis will be tested by pursuing three specific aims to evaluate the impact of a pharmacist-administered diabetes patient empowerment program on:

1. clinical markers for diabetes and related metabolic disorders;
2. the cost of care and resource utilization; and
3. patient knowledge and perceived ability to manage diabetes. There is an additional specific aim to assess the pharmacists with respect to satisfaction with the training program and the overall project, the activities conducted in patient sessions, and the time taken to complete the visits in this study.

Eligibility Criteria:
Inclusion Criteria:

* diabetes (Type I or Type II)
* enrolled in health plan with participating employer
* age 18 or older
* willing and able to provide informed consent

Exclusion Criteria:

* gestational diabetes
E-learning+ Rehab Therapy

Stroke survivors with arm paresis because of stroke use their "good" arm for daily activities, but in doing so may be self-limiting their own recovery of the "bad" arm. Traditional models of stroke rehabilitation fail to fully engage the survivor and care partner(s) in actively planning post-discharge habits that improve their capacity to live well over their entire lives. This study will test a cutting-edge in-person therapy + online training program designed to progressively transfer the responsibility of driving post-stroke recovery from the therapist to the survivor.


Eligibility Criteria:
Inclusion Criteria:

* paresis of one arm/hand because of ischemic or hemorrhagic stroke \>2 mo. and \<3 yrs prior
* moderate arm impairment defined as a baseline Fugl-Meyer Assessment of the Upper Extremity score of at least 32±2 points but no more than 47±2 points (out of 60 points)
* Montreal Cognitive Assessment score ≥22
* ability to read English
* ability to communicate as per the therapists' judgement at baseline testing
* 21-90 years of age
* wi-fi connection in the home and either a computer, smartphone or tablet.

Exclusion criteria:

* lesion or injury to brainstem or cerebellum
* other neurological disease that may impair motor or learning skills (e.g., Parkinson's Disease);
* pain interfering with reaching
* uncorrected vision making it difficult to read information on a computer, tablet or phone.
A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.

This single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previously untreated chronic lymphocytic leukemia. During the induction phase patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses of MabThera given every 8 weeks, or no further treatment. The anticipated time on study treatment is 2+ years, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=60 years of age;
* CD20+ chronic lymphocytic leukemia (CLL);
* no previous treatment for CLL;
* ECOG performance status 0-1.

Exclusion Criteria:

* co-morbid conditions requiring long term use of systemic corticosteroids during study treatment;
* history of severe cardiac disease;
* transformation to aggressive B-cell malignancy.
A Prospective Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia

The current study aim is to compare between the opioids morphine, fentanyl and methadone in terms of efficacy and side effects profile when administered epidurally for pain management after laparotomies. Intravenous morphine will also be used. The outcomes of that method will be compared to those obtained using epidurally administered opioids, as this is another commonly used postoperative pain relief method.


Eligibility Criteria:
Inclusion Criteria:

\* Elective laparotomy

Exclusion Criteria:

* Subjects with diabetes mellitus, other neurological or systemic disease associated with altered sensory perception
* Illicit drug abusers
* Chronic use of pain medication
* Inability to understand consent form
* Age \< 18
* Renal failure (Clcr\<50 ml/min)
* Chronic use of drugs that can alter plasma levels and\\or effect of the study drugs
* Corrected Q-T interval(QTc)=450msc and above
* Contra-indication for epidural catheter insertion
* Pregnancy
VITARIA Registry Study

This registry will observe patients with symptomatic heart failure with implantable vagus nerve stimulation to provide insights into safety and efficacy during clinical routine.

Observational prospective clinical registry in patients with symptomatic heart failure and implanted with the VITARIA System. Assessments will be made during 12 months of post-titration chronic stimulation. The registry will collect patient- and device follow-up data in clinical routine practice at baseline, 3, 6 and 12 months. Clinical routine safety of the therapy will be assessed by the incidence of procedure and device-related events. Clinical routine efficacy will be assessed by changes in cardiac function and heart failure symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and capable of providing informed consent according to national data privacy regulations
2. Patients with NYHA class II/III
3. LVEF≤40% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, documented less than 12 weeks before implantation of VITARIA system
4. Receiving optimal pharmacological heart failure therapy for at least 3 months
5. Recent implantation of the VITARIA system, prior to device activation

Exclusion Criteria:

1. Hospitalization for heart failure and/or required the use of Heart Failure intravenous therapy in the past 30 days
2. Severe mitral and/or any aortic valve dysfunction
3. History of acute coronary syndrome (ACS) in the past 90 days
4. Stroke or transient ischemic attack (TIA) in the past 90 days
5. Coronary Artery Bypass Surgery (CABG) in the past 90 days
6. PCI in the past 90 days
7. Surgery for Valve replacement (Aortic or mitral valve) in the past 90 days
8. Left ventricular end diastolic diameter (LVEDD) \> 80 mm
9. Patients who have had a cardiac resynchronization therapy (CRT) device implanted and have been actively treated with CRT for \< 12 months
10. Patients that are scheduled for CRT
11. Patients who are listed for heart transplant or expected to be candidates for heart transplant
12. Patients on hemodialysis or peritoneal dialysis
13. Patients with diabetes (type I or type II) that is being medically treated for autonomic or sensory neuropathy, or measured hemoglobin A1c (HbA1c) above 8.0% in the past 3 months
POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies

This is a prospective, randomized control trial in which each patient will be randomly assigned to receive either extended half-life factor VIII based replacement therapy or non-FVIII based replacement therapy, which are both standard of care treatment for persons with Hemophilia A.

This is a research study to find out if there is a difference in the way children with hemophilia A form a clot and also evaluate if they develop tiny bleeds within the joint and subsequently early joint changes when receiving extended half-life factor VIII based replacement therapy vs non-FVIII based replacement as part of their hemophilia treatment to prevent spontaneous joint bleeds.

Both therapies are standard of care therapies for patients with hemophilia A. The only experimental/research procedures as part of this study include the thrombin generation assay and ultrasound. All other procedures are standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate hemophilia A (baseline factor VIII activity 1-5%) or severe hemophilia A (baseline factor VIII activity \<1%) on prophylactic standard half-life FVIII infusions OR subjects with moderate or severe hemophilia A who have not started prophylactic treatment
* Less than 18 years of age

Exclusion Criteria:

* Subjects with documented FVIII inhibitor
* Subjects with a history of ≥ 2 target joints
* Subjects with a history of synovectomy
* Currently using medications known to impact bone and mineral metabolism (e.g., bisphosphonates, corticosteroids, estrogen, testosterone, calcitonin, thyroid hormone therapy);
* Disease states known to affect bone integrity (e.g., primary hyperparathyroidism, Paget's disease, clinically significant liver disease)