cyrilzakka/clinical-trials huggingface dataset:
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. This may be effective treatment for primary or metastatic brain tumors.

PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients with primary or metastatic brain tumors.

OBJECTIVES:

* Determine the toxicity of monoclonal antibody (MAb) Astatine At 211 Antitenascin Human/Mouse Chimeric 81C6 (At 211 MAb 81C6) therapy delivered via the intracranial resection cavity in patients with recurrent primary or metastatic malignant brain tumors.
* Identify objective therapeutic responses of these patients to this treatment.

OUTLINE: This is a dose escalation study.

Patients undergo surgical resection of their tumor at which time an indwelling intracranial resection cavity catheter is surgically placed. Patients receive one dose of astatine At 211 antitenascin monoclonal antibody 81C6 (At 211 MAb 81C6) via the intralesional catheter.

Cohorts of 3-6 patients are treated at escalating doses of At 211 MAb 81C6. The maximum tolerated dose is the highest dose at which no more than 3 of 6 patients experience dose limiting toxicity.

Patients are followed initially at 4 weeks, then at approximately 12 weeks, at 24 weeks, and then every 12 weeks for 1 year.

PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 18-24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed newly diagnosed or recurrent supratentorial primary or metastatic malignant brain tumor
* Measurable disease by MRI or CT scan

  * Candidate for surgical resection
  * Extension of tumor no more than 1.0 cm beyond the margin of the surgical cavity
* Demonstrated reactivity of tumor cells with tenascin by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody
* No infratentorial tumors, diffusely infiltrating tumors, tumors with subependymal spread, or multifocal tumors

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 50-100%

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count greater than 1000/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin less than 1.5 mg/dL
* Alkaline phosphatase less than 1.5 times normal
* SGOT less than 1.5 times normal

Renal:

* Creatinine less than 1.2 mg/dL

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 6 weeks since prior chemotherapy, unless unequivocal evidence of progression

Endocrine therapy:

* Concurrent corticosteroids allowed, but must be on stable dose for at least 1 week

Radiotherapy:

* At least 3 months since prior radiotherapy to site of measurable disease in the CNS

Surgery:

* See Disease Characteristics
Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
* Employed for 20 hours or more for a minimum of 1 month prior to baseline.
* Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.

Exclusion Criteria:

* Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
* Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of \>=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
* Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
* Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.
Get Active and Eat Right: Moms at Work

The purpose of this study is to determine the effectiveness of a worksite diet and exercise program on weight loss in postpartum women.

This project is a research study investigating the effects of a worksite diet and exercise intervention on weight loss in overweight postpartum women. Weight loss programs have been shown to be effective in reducing postpartum weight retention. However, high attrition rates in these studies suggest that the added responsibility of a new infant at home and returning to work may limit a woman's ability to follow a diet plan and exercise regularly. We hope that by offering a weight loss program at the workplace, we can increase participant retention and maximize weight loss in this population. Our primary aim is to promote weight loss while preserving lean body mass during the 12 week intervention. Secondary aims include increasing cardiovascular fitness from baseline and improving cardiovascular biomarkers, including total, LDL, and HDL cholesterol, triglycerides, glucose, insulin, and markers of inflammation and metabolism.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older, 10 to 14 weeks postpartum, University faculty, staff, and students, BMI 25-35 or at least 4.5 kilograms heavier than prepregnancy weight, English speaking

Exclusion Criteria:

* Smoking, chronic disease, BMI \>35
Pulmonary Vasculopathy Under Second-line Therapy of Chronic Myeloid Leukemia

Chronic myelogenous leukemia (CML) is a chronic myeloproliferative disorder characterized by a translocation between chromosome 9 and 22, leading to a pathogenic tyrosine kinase signal transduction protein. CML can be treated with tyrosine kinase inhibitors (TKIs), which inhibit BCR/ABL kinase, such as imatinib. In about 20% of CML patients who are treated by imatinib, a complete cytogenetic response cannot be achieved. The other two novel TKIs (dasatinib and nilotinib), achieve higher rates of complete cytogenetic response and they are proposed as second-line therapy for imatinib-resistant patients or for those who do not tolerate imatinib. Dasatinib inhibits BCR/ABL kinase in about \>300 times in vitro in more than imatinib and also inhibits several other kinases, including the Src family. Src tyrosine kinase is crucial for potassium channel function in human pulmonary arteries. Imatinib and nilotinib do not inhibit the Src.

Incident cases of precapillary PH have been reported in patients who have CML treated with the dasatinib. Improvements were usually observed after withdrawal of dasatinib.

This study is designed to identify incident cases of dasatinib-associated PH and describe pulmonary vascular changes induced by dasatinib. As comparison population will be patients who receive another second-line TKI (nilotinib).

Doppler echocardiography at rest will be performed in each patient. Patients without exercise capacity limitation an exercise test (Doppler echocardiography with spiroergometry) will be performed. Patients who show elevated SPAP at rest or during exercise (in this study SPAP ≥ 40 mmHg) or with reduced exercise capacity (peak VO2 \< 75%) a right heart catheterization (RHC) will be suggested. Additionally for the evaluation of exercise capacity a 6 MWD will be performed. This work- up of patients allows clinical and hemodynamic evaluation.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic myeloid leukemia under second-line therapy with dasatinib or nilotinib
* written informed consent

Exclusion Criteria:

* Manifest pulmonary hypertension
* significant pulmonary disease
* Left-sided heart failure or diastolic compliance dysfunction +
* Hemodynamic relevant valvular disease
* Systemic arterial hypertension (at rest systolic \>150 mmHg, diastolic \> 90 mmHg, during exercise \> 220 mmHg)
* Severe anemia
* Uncontrolled supraventricular and ventricular arrhythmias
* Myocardial infarction (within the last 12 months)
* Pulmonary embolism (within the last 12 months)
* Recent therapy changes (within the last 12 months)
* Recent major surgeries (within the last 12 months)
* For exercise tests: musculoskeletal diseases which may unable the exercise tests.
Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma

The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.

Follicular Lymphoma (FL) is a cancer of a B lymphocyte, a type of white blood cell. FL is typically a slowly progressing but incurable disease. Follicular lymphoma cells produce a specific defect in the patient's immune system impairing their ability to control their cancer. Lenalidomide has been shown to reverse the specific immune defect caused by FL in the patient. By including lenalidomide, the RELEVANCE study aims to eliminate the cancer while restoring the patient's immune competence.

The 'Relevance' cooperative group trial is being conducted as two companion studies: RV-FOL-GELARC-0683 (N=750) and RV-FOL-GELARC-0683C (N=250); the combined total of 1000 Follicular Lymphoma patients enrolled in both studies will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed follicular lymphoma grade 1, 2 or 3a, Stage II-IV
* Have no prior systemic treatment for lymphoma
* Symptomatic follicular lymphoma requiring treatment.
* Age ≥18 years
* Eastern Cooperative oncology group performance status 0-2
* Willing to follow pregnancy precautions

Exclusion Criteria:

* Clinical evidence of transformed lymphoma or Grade 3b follicular lymphoma.
* Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent.
* Known seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)
* Known sensitivity or allergy to murine products.
* Presence or history of central nervous system involvement by lymphoma
* At high risk for a venous thromboembolic event (VTE) and not willing to take VTE prophylaxis
* Any of the following laboratory abnormalities:
* serum aspartate transaminase or alanine transaminase \> 3x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
* total bilirubin \> 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver or pancreatic involvement by lymphoma
* creatinine clearance of \< 30 mL/min
AXIOS CHINA (E7148)

To study the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off necrosis in Chinese population, to support the regulatory approval by CFDA


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years old(including 18 and 75 years old)
2. Eligible for endoscopic intervention
3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
4. Diagnostic as symptomatic pancreatic pseudocysts ≥ 6cm in maximum diameter and walled-off necrosis ≥ 6cm in maximum diameter with ≥ 70% fluid content that are adherent to the gastric or bowel wall
5. Patient understands the study requirements and the treatment procedures and provides written Informed Consent.
6. Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.

Exclusion Criteria:

1. \<18 or \>75 years of age
2. pseudocysts or walled-off necrosis which require nasocystic drainage,or\<6cm in maximum diameter, or walled-off necrosis \< 70% fluid content
3. The fluid collection to be drained is an immature pseudocyst
4. The fluid collection to be drained is a cystic neoplasm
5. The fluid collection to be drained is a pseudoaneurysm
6. The fluid collection to be drained is a duplication cyst
7. The fluid collection to be drained is a non-inflammatory fluid collection
8. There is more than one pseudocyst requiring drainage
9. Abnormal coagulation: INR \> 1.5 and not correctable presence of a bleeding disorder; platelets \< 50,000/mm3
10. Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).
11. Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)
12. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.
13. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
14. Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Relapse-Prevention Booklets as an Adjunct to a Tobacco Telephone Helpline("Quitline")

The study primary purpose is smoking relapse prevention. This study is a collaboration between researchers who developed the relapse-prevention intervention, at the H. Lee Moffitt Cancer Center in Tampa, Florida, and those associated with the "New York State Smokers' Quitline" (NYSSQL), at Roswell Park Cancer Institute in Buffalo, New York.

In this study, approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call. One-third will be randomized to a Usual Care (UC) condition, which will receive regular quitline services. One-third will be randomized to a Repeated Mailings (RM) condition, which will receive the 8 Forever Free booklets sent by mail at regular intervals over a period of 12 months. And one-third will be randomized to a Massed Mailings (MM) condition, which will receive all 8 booklets in a single mailing.

Eligibility Criteria:
Inclusion Criteria:

* referrals from the New York State Smokers' Quitline
* at least 18 years of age
Cardiac Complication After Vascular Surgery

The vascular surgery is a highest risk procedure when considering postoperative complications associated with the cardiovascular system. The leading clinical presentation is acute hemodynamic decompensation. However, one of the possible pathomechanisms might be repolarization disturbances. Many of perioperative risk factors of cardiac complications are modifiable. The identification may help in the global perioperative risk reduction.

Aim: The aim of the study was an identification of the factors which may release clinically overt repolarization disturbances.

Methods: The study group consisted of 100 patients, diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The authors investigated whether age, gender, comorbidities or some perioperative factors (including hemodynamic, metabolic or genetic) were related to the occurrence of clinically concealed repolarization disturbances or clinically disclosed cardiac complications in postoperative time up to 30 day and one year after vascular surgery procedure.

Vascular surgery is thought as the highest risk procedure in the context of cardiac complications. The range may include acute coronary syndrome, acute circulatory failure, severe arrhythmias, syncope and sudden cardiac death. The patient population is considered as a high risk, too. Popular calculators used for risk stratifications are based on preoperative patient's history and some general laboratory results. However, general status of the patient changes dynamically during vascular procedures leading to acquired increased risk. For this reason, sole preoperative risk prediction based on standard calculators is unsuitable and suboptimal. Advanced monitoring systems may record some temporary disturbances (e.g. ventricular repolarization disturbances), which may be asymptomatic. The clinical significance in postoperative risk prediction of such observations remains undefined. On the other hand, many of perioperative cardiac complications are caused by modifiable factors. The identification may help in the global perioperative risk reduction.

Eligibility Criteria:
Inclusion Criteria:

* adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure

Exclusion Criteria:

* heart stimulation,
* atrioventricular and intraventricular conduction defects,
* atrial fibrillation recorded before of the study,
* antiarrhythmic drug treatment (except beta-blockers),
* unoptimal patient general status (uncontrolled diabetes, active infection)
* reoperation
* emergency operations
The Role of Myristic Acid in Serum for Early Diagnosis of Sepsis and Comparison With Selected Biomarkers of Sepsis

The aim of the study is to measure serum levels of myristic acid in septic patients and to compare them with myristic acid serum levels in patients with Systemic Inflammatory Response Syndrome of non infective etiology and in healthy volunteers. Furthermore, other biomarkers of sepsis are evaluated in comparison with microbiological findings detected either by standard hemocultures or by molecular biological methods.

Currently, there is an array of biomarkers potentially useful in diagnosis and prognosis in septic patients, either alone or in combination. Only a fraction of them is used in clinical practice. The reasons vary, low sensitivity or specificity is the main one, cost/benefit or difficult processing with the need of highly specialized laboratory to name the other.

Recent pilot study from Swedish authors (A.M.Kauppi et al.) published in 2016 showed high correlation of myristic acid levels in blood in patients with sepsis and bacteraemia. There was no other publication on this molecule in relation to sepsis before. Cambiaghi et al. observed its significant decrease in nonresponders to the treatment of septic shock.

Myristic acid is an organic acid of linear structure. Measurement of its level will be performed using gas chromatography linked with mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis or septic shock.
* Systemic inflammatory response syndrome.
* Subjects without systemic inflammation.

Exclusion Criteria:

* There is no exclusion criteria in the study
Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.

The purpose of the clinical trial is to investigate whether low carbohydrate diet is better than the traditional diabetic diet in the treatment of patients with diabetes mellitus type 2, for blood sugar and body weight.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 2

Exclusion Criteria:

* Severe psychiatric disease or difficulties in understanding Swedish language.
Investigation of the Effects of H-PRF on the Period After Impacted Third Molar Tooth Extraction

After wisdom teeth are extracted, the patient may have some complaints in the post-operative period. Pain, swelling and edema are some of them. These inflammatory complications are important for patients and surgeons to reduce the risk of complications and ensure postoperative recovery and develop customized strategy. Many studies have been conducted in the literature to minimize these situations encountered after tooth extraction.

Many studies have been conducted in the literature to minimize these situations encountered after tooth extraction. Various regenerative methods are being developed to reduce these complaints of patients. Regenerative treatments include non-steroidal anti-inflammatory drugs (NSAIDs), laser therapy, steroids, ultrasound, and PRF applications.

PRF(platelet-rich fibrin) application placed in the extraction socket is one of the regenerative methods used to reduce these complaints. PRF has a fibrin structure obtained from natural blood tissue, containing abundant platelets and leukocytes. This fibrin matrix contains various growth factors and cytokines, including growth factor-beta1 (TGF-β1), platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), interleukin (IL), as well as platelets and leukocytes. These factors act directly on promoting the proliferation and differentiation of osteoblasts, endothelial cells, chondrocytes, and various fibroblast sources.

It is known that PRF has a beneficial effect in relieving pain and swelling and reducing the incidence of alveolar osteitis after extraction of an impacted lower third molar. Therefore, it is placed in extraction sockets to try to reduce post-operative complications.

PRF applications are also developing in their own right, and one of them is the H-PRF (horizontal PRF) application. Recently, horizontal centrifugation of PRF has been shown to provide better cell layer separation and minimize cell accumulation that prevents uniform cell layer formation on the distal surfaces of centrifuge tubes.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer ASA I individuals between the ages of 18-40

Exclusion Criteria:

* Those who are pregnant or lactating
* Those receiving anticoagulant or antiplatelet drug therapy
* Those who received radiotherapy to the head and face area
* Those who are allergic to local anesthetics and prescribed medications
Does Tailored Education in Asthma Care Help Improve Patient Satisfaction, Adherence, and Quality of Life (TEACH) Trial

The primary purpose of this study is to assess whether tailored patient education for patients on Symbicort® Turbuhaler® therapy improves patient satisfaction, adherence and Quality of Life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of asthma.
* Patients with asthma, where the use of Symbicort® Turbuhaler® is indicated and would have been prescribed by the investigator as part of usual care.
* Patient who have public or private insurance coverage for Symbicort® Turbuhaler® or are willing to pay for this medication for the duration of the trial.

Exclusion Criteria:

* Patients who have been treated wth Symbicort® Turbuhaler® in the preceding 3 months.
* A history of smoking \[i.e., 10 pack-years where one pack-year equals one pack (20 cigarettes) per day for one year, or equivalent\].