cyrilzakka/clinical-trials huggingface dataset:
Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery

After curative lung cancer surgery, there is a risk of recurrence of the primary cancer, or development of a new cancer. Historically, patients who have undergone curative lung cancer surgery have been monitored with chest radiographs (CXR). Unfortunately, 70% of such patients still die of lung cancer. As a result, there has been interest in other methods of surveillance in order to detect recurring or new cancers earlier and have more success in treating them. One such technique is Low Dose Computed Tomography (LDCT), which is currently the standard of care and surveillance at this institution. This pilot study aims to determine whether regimented, intensive, short interval LDCT surveillance leads to higher rates of detection and treatment of recurring lung cancers. The study group will be followed up according to a regimented surveillance program using LDCT. The study group will be compared to a group of historical controls whose follow up after surgery was not standardized, but rather left up to the discretion of the individual surgeon. If the results of this study show improvements in detection and treatment of recurrent cancers, it will allow for a larger trial to study the effects of the LDCT surveillance program on lung cancer survival.

The study question aims to determine whether for survivors after curative surgery for Stage I and Stage II lung cancer, a structured Surveillance Program with Low Dose CT can increase the rate of detection and treatment of recurring or new cancers when compared to historical non-structured surveillance with CXR. This study will also determine if it is warranted to pursue a larger scale randomized controlled trial to further investigate optimal LDCT surveillance follow-up intervals and long-term lung cancer survival.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at minimum 18 years of age
* Patients must have undergone complete resection for pathological Stage I or Stage II lung cancer
* Patients must demonstrate the ability to understand English
* Patients must be able to demonstrate aptitude and willingness to comply with describes study procedures

Exclusion Criteria:

* Patients with residual gross or microscopic disease after surgery
* Patients with pathological Stage III or Stage IV lung cancer
Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.

Endostatin inhibits the pro-angiogenic action of basic fibroblast growth factor and vascular endothelial growth factor in esophageal cancer.This study aims at assessing the efficacy and safety of endostatin combined with concurrent chemoradiotherapy with Oxaliplatin in esophageal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Cytologically or histologically confirmed esophageal carcinoma
2. Age of 18 -80
3. ECOG performance status: 0-1;
4. No treatments prior to enrollment;
5. At least one measurable lesion on CT, MRI or esophageal barium exam;
6. Normal functions of heart, lung, liver, kidney and bone marrow Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
7. Informed consent signed

Exclusion Criteria:

1. Prior treatments of chemotherapy or irradiation;
2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
4. Participating in other clinical trials;
5. Pregnancy, breast feeding, or not adopting birth control;
6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
7. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
Prognostic Value of Plasma Thrombospondin-1 Levels After Acute Intracerebral Hemorrhage

The current study was designed to investigate the change of plasma thrombospondin-1 levels and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the patients with acute intracerebral hemorrhage.

Thrombospondin-1 acts as an anti-angiogenic factor and its expression in rat brain is upregulated after intracerebral hemorrhage. The current study was designed to investigate the change of plasma thrombospondin-1 levels and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the patients with acute intracerebral hemorrhage. About 110 patients will be recruited. All blood samples from the patients at admission were collected. Thrombospondin-1 levels in plasma were measured using sandwich immunoassays. The patients will be followed up till 6 months after intracerebral hemorrhage. The relationships between plasma thrombospondin-1 levels and 1-week mortality, 6-month mortality, 6-month overall survival, 6-month unfavorable outcome (modified Rankin Scale score \>2) and disease severity reflected by hematoma volume and National Institutes of Health Stroke Scale score were assessed using multivariate analysis. It is proposed that elevated plasma thrombospondin-1 levels are independently associated with disease severity and clinical outcomes. It will be suggested thrombospondin has potential to be a good prognostic biomarker of intracerebral hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

* acute spontaneous basal ganglia hemorrhage admitted to the Jinhua People's Hospital within the first 24 h from stroke.

Exclusion Criteria:

* previous ischemic or hemorrhagic stroke, severe head trauma, use of antiplatelet or anticoagulant medication, presence of other prior systemic diseases including autoimmune diseases, uremia, liver cirrhosis, malignancy, and chronic heart or lung disease, recent infection (within a month), a surgical procedure and missing of follow-up.
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia

The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation.

The hypothesis is that HBOC-201 will pass through the partially occluded lesions in the peripheral arteries in the lower extremity and promote the wound healing process by delivering oxygen to the oxygen deprived tissues. This will reduce the incidence of lower limb wound complications at 60 days post-surgery and may reduce the incidence of a second amputation.

This is a Phase II, single-blinded, prospectively randomized, parallel-group, placebo controlled study that will evaluate the safety and feasibility of HBOC-201 when administered therapeutically to patients with a peripheral vascular occlusive disorder and who are undergoing lower limb amputation due to critical lower limb ischemia. Subjects will be randomized (1:1) to receive either HBOC-201 or a colloid control (HAES-steril® 6%).

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 ≤ 75 years of age
* Scheduled amputation at or above ankle joint, or a more proximal location but below or through the knee joint
* Documented severe lower extremity peripheral artery occlusive disease confirmed by clinical symptoms of critical limb ischemia and:

  * Frankly gangrenous tissue that merits amputation or
  * Angiographic evidence of occlusive peripheral artery disease within one month of screening
* Participant or legal representative signs informed consent
* Willingness to follow study instructions and follow-up visits

Exclusion Criteria:

* No informed consent is obtained
* If medically inappropriate to administer 250 mL colloidal solution daily for 4 consecutive days
* Uncontrolled hypertension (BP \> 160/90 mm Hg) despite 2 antihypertensive meds or BP \> 180/100 mm Hg if untreated
* Severe liver dysfunction defined by Total Bilirubin \> 3 mg/dL or twice the normal limit of serum AST or ALT
* Symptomatic CVD diagnosed w/ in last 6 months or known high grade carotid stenosis
* Any severe or unstable medical condition that might interfere w/ the evaluation of study medication
* Cardiogenic shock (cardiac index \< 2 L/min/m2, PCWP \> 18 mm Hg)
* Amputation above knee joint or below ankle joint
* Any amputation whereby primary skin closure not technically feasible
* Candidate for percutaneous or surgical revascularization
* Cardiac failure defined by a NY class III/IV or left ventricular ejection fraction \< 30%
* Life expectancy \< 60 days
* Systemic mastocytosis
* Previously demonstrated beef product allergy
* Myocardial infarction w/ in 30 days
* Participation in another trial w/ in last 30 days
* Woman who is pregnant or breastfeeding
* Amputation with known infection at site of skin closure
* Renal dysfunction requiring dialysis, or serum creatinine level 2.5 mg/dL
* Peripheral vascular occlusion from cardio arterial emboli
* Uncontrolled diabetes blood glucose ≥ 400 mg/dL
Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery

In the coming years, an increase in lung nodule resection is expected, particularly in Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a tool whose use is constantly spreading.

The aim of this study is to evaluate the feasibility of using intraoperative CBCT to develop a new procedure for intraoperative localization of pulmonary nodules in video-assisted thoracoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18;
* patient with unique or multiple pulmonary lesions of a size ranging from 5 to 20 mm;
* Complete preoperative assessment;
* Patient receiving information about the protocol who did not indicate his/her opposition to participate;
* Patient covered by a social insurance system

Exclusion Criteria:

* Reoperation (history of ipsilateral thoracic surgery);
* Inability to achieve or obtain a single-lung ventilation during surgery;
* Adult subject to legal protection (trusteeship, guardianship);
* Person deprived of liberty.
A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

Five year survival following a diagnosis of childhood cancer has reached 83%, making long term health outcomes among survivors an important concern. The growing population of survivors is at an increased risk of physical inactivity and associated adverse health outcomes. Regular physical activity is associated with better cardiovascular and musculoskeletal health. Despite the known benefits of physical activity, nearly half of all childhood cancer survivors do not meet recommended guidelines for physical activity.

Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a rewards-based physical activity intervention delivered via an interactive website among young adolescent childhood cancer survivors, aged 11 through 14 years, will increase physical activity levels and improve cardiovascular and musculoskeletal health. The investigators also want to learn if this rewards-based intervention is effective. To achieve this goal the investigators have designed a three-arm prospective, randomized study with two reward-based intervention groups and a control group.

PRIMARY OBJECTIVE:

* To compare changes in levels of moderate and vigorous physical activity over 24 weeks.

SECONDARY OBJECTIVE:

* To compare changes in cardiorespiratory fitness, muscular strength and flexibility over 24 weeks.

Participants will be randomized to one of three groups. Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. Participants randomized to the two intervention groups will be given access to a rewards program delivered via an interactive website, an activity monitor, and educational materials. Individual physical activity data can be viewed by study participants after uploading information from their monitors to the interactive website. One intervention group will receive minimal rewards, while the other group will receive immediate incentives as well as the minimal rewards as they move from one level to the other on the website.

After 24 weeks, changes in cardiorespiratory fitness, muscular strength, flexibility, and physical function will be compared between the two intervention groups and the control group.

Eligibility Criteria:
Inclusion Criteria:

* Previously treated for childhood cancer at St. Jude Children's Research Hospital (SJCRH)
* 11 through 14 years of age
* Not undergoing active treatment for cancer
* Medical clearance from participant's attending physician via email
* Does not meet the Centers for Disease Control (CDC) physical activity guidelines. CDC guidelines for children age 11 to 14 are defined as 60 minutes or more per day of physical activity, seven days a week
* Internet access and a computer that has software that is compatible with the study device (Windows XP, Windows Vista, Windows 7, Mac OSX 10.5 and Mac OSX 10.6)

Exclusion Criteria:

* Global cognitive impairment (Full Scale Intelligence Quotient \< 70) that prevents use of the interactive website
* Pregnant female
* Inability to read and write English
Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization

Evaluation of a new biological criterion, the local capillary blood lactates to optimize the management of patients with chronic critical ischemia requiring revascularization fast. Potential use in terms of capillary blood lactate as a diagnostic indicator of recurrent ischemia in a limb revascularized.


Eligibility Criteria:
Inclusion Criteria:

* Ischemia Chronic critical lower limb revascularization procedure requiring fast.
* Written consent informed patient age greater than or equal to 18

Exclusion Criteria:

* Presence of an inflammatory or infectious (erysipelas) in the ischemic member.
* Patients at risk for diabetic foot ie, as defined by the HAS (preventing diabetic foot, 2007)

  * presence of sensory neuropathy, and / or
  * foot deformities (hallux valgus, hammer toes or claw, prominence of the metatarsal heads), and / or
  * history of foot ulceration, and / or
  * antecedent of one of these factors (ie antécedant diabetic foot).
* Necrosis of the toes.
* Participation in another clinical research protocol.
* Presence of peripheral arterial disease in the bilateral upper limbs.
* Patient in shock whatever the cause.
* Presence of hepatic failure.
* Too impaired general condition (bedridden, dementia, ...)
* Refusal of the patient to participate in the study
* Protected patients
Patterns of Real-World Isavuconazole Use - a Study of Patients With Mucormycosis or Invasive Aspergillosis

This is a non-interventional medical chart review study aiming to examine the effectiveness, safety, and treatment patterns of isavuconazole in 5 European countries (France, Germany, Italy, Spain, and United Kingdom). Eligible patients are adults who have been treated with isavuconazole in routine practice at participating sites since 15 October, 2015 or since the date of launch in the country if it is after 15 October, 2015 until 30 June, 2019. As this is an observational study, patients will be treated based on the standard of care at the discretion of their physician. No drugs will be supplied for this study and patients will receive treatment through standard local practice.

This observational study will include approximately 600 patients diagnosed with invasive aspergillosis or mucormycosis who received treatment with at least one dose of isavuconazole in the hospital setting.

Patients will be recruited in approximately 20 sites across 5 countries in Europe. Patients will be followed from isavuconazole initiation (index event) until six-months post-index treatment discontinuation, death, loss to follow-up, or 31 December, 2019, whichever occurs first.

De-identified data on patient demographics, disease characteristics, treatment effectiveness, safety outcomes, isavuconazole treatment patterns, and HCRU will be collected from patient medical records and entered into an electronic data capture (EDC) system by site staff. Follow-up data will include details of treatment over time and clinical, radiological, mycological, and healthcare resource utilization outcomes. As this study is retrospective, information pertaining to patient care will already be documented in patient medical records at the time of chart abstraction.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized patient must be aged ≥ 18 years at the time of isavuconazole initiation
2. Patient must have a record of a diagnosis of invasive aspergillosis or mucormycosis in their medical record at the time isavuconazole was initiated (regardless of whether this diagnosis is suspected or confirmed )
3. Patient must have received at least one dose of isavuconazole during the eligibility period (October 15, 2015, to June 30, 2019)

Exclusion Criteria:

1. Patients who did not receive at least one dose of isavuconazole for treatment of invasive aspergillosis or mucormycosis within the eligibility period
Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia

Negative symptoms in schizophrenia present a challenge to the clinician owing to their poorer response to conventional treatment with antipsychotics. Negative symptoms in schizophrenia may be secondary to psychotic symptoms, depressive symptoms, drug-related side effects or lack of environmental stimulation. Alternately, they may represent core features of the illness, characterized as primary deficit symptoms. Previous studies have suggested that atypical antipsychotics may be beneficial in improving deficit symptoms of schizophrenia. This study aimed at characterizing the nature of improvement of negative symptoms in the early phase (12 weeks) of treatment with the atypical antipsychotic, risperidone. In order to account for factors contributing to improvement in secondary negative symptoms, ratings were carried out of change in positive symptoms, depressive symptoms and drug-related side effects. Further, add-on citalopram or placebo were administered in a double-blind design to study the effect of selective serotonin reuptake inhibitor (SSRI) augmentation of risperidone on negative symptoms. The investigators hypothesized that the improvement in negative symptoms during the initial phase (12 weeks) of treatment with risperidone will be largely accounted for by improvement in secondary negative symptoms, rather than of the primary deficit symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling DSMIV Criteria for Schizophrenia
* The patient should be drug naïve or drug free for one month (oral antipsychotic) or three months of parental antipsychotic
* Duration from onset \< 5 years
* Informed consent

Exclusion Criteria:

* Patient with any other current Axis I or Axis II comorbid disorders
* Comorbid substance abuse or dependence except nicotine or caffeine
* Presence of significant medical disorder such as epilepsy, uncontrolled hypertension and diabetes mellitus, thyroid disorder
* Patient who has not responded to adequate course of risperidone (with reference to dose and duration)
* Treatment-resistant schizophrenia defined as non-response to three different antipsychotics belonging to at least two different classes, one of which is an atypical agent and one of which is a depot neuroleptic
* Patient who has received ECT in past 3 months
A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study

Research studies raise the possibility that medications such as quetiapine may improve mood or reduce obsessions in people with anorexia nervosa and may even help to normalize appetite. The medication quetiapine also known as seroquel works by activating certain systems in the brain, such as ones known as dopamine and serotonin chemical systems in the brain.


Eligibility Criteria:
Inclusion Criteria:

* Must be aged 18-65
* Must be at least 15% below ideal body weight

Exclusion Criteria:

* Allergy to quetiapine
* Diagnosis of schizophrenia
Protecting Young Special Risk Females From Cervical Cancer Through Human Papilloma Virus (HPV) Vaccination

A research project is currently being undertaken looking at Human Papilloma Virus (HPV) vaccination in special risk groups. It aims to see if young women with a chronic illness respond well to the HPV vaccine or whether they may require additional doses to ensure protective immunity. The four valent HPV vaccine protects against HPV types 16 \& 18, cervical cancer and HPV types 6 \& 11, anogenital warts.

The six special risk groups include:

Paediatric Rheumatological Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow Transplants This immunity is measured by antibody levels of the HPV types, which requires a single blood test one month after the final dose of HPV vaccine.

This is compared to healthy controls using antibody response to HPV vaccine. This will assess directly whether these special risk groups respond as well to the HPV vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 12-26 years
* Have been diagnosed by a specialist with one of the six chronic medical conditions described:

  1. Paediatric Rheumatological Disease
  2. Inflammatory Bowel Disease
  3. Acute Lymphoblastic Leukaemia
  4. Solid Organ Transplant Recipients (kidney and liver)
  5. Chronic Renal Disease
  6. Bone Marrow Transplant

Exclusion Criteria:

* Previous immunisation with HPV vaccine Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis