cyrilzakka/clinical-trials huggingface dataset:
Surgery in Treating Patients With Neuroblastoma

RATIONALE: Surgery may be an effective treatment for neuroblastoma.

PURPOSE: This phase II trial is studying how well surgery works in treating patients with neuroblastoma.

OBJECTIVES:

* Evaluate the safety and efficacy of surgical treatment alone for stage II neuroblastoma without N-myc amplification (NMA).
* Describe predictive factors of relapse and survival for stages I and II neuroblastoma without NMA treated by surgery alone.

OUTLINE: Patients with localized resectable tumors undergo surgery. Postoperative evaluations are performed 30 days following surgery. Study patients with stage I (without N-myc amplification) tumors and trial patients with stage II tumors receive no further therapy.

Study patients (except stage I patients) receive surgery and/or chemotherapy according to other protocols as necessary for disease progression or relapse.

Patients are followed every 3 months for the first year, then every 4 and 6 months for the second and third year respectively, then yearly for 5 years.

PROJECTED ACCRUAL: This study will accrue 140 stage II patients for the trial portion at a rate of 40 per year over 3.5 years. At least 70 more patients will be accrued for the study portion.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Trial: Histologically proven International Neuroblastoma Staging System (INSS) stage IIA and IIB neuroblastoma without amplification of the N-myc oncogene
* Study: Histologically proven neuroblastoma

  * Stage I
  * Stage II with amplified N-myc
  * Stage II without evaluation of N-myc
  * Stage II with symptomatic spinal cord compression
  * Stage III
* No metastases diagnosed within 1 month of study

PATIENT CHARACTERISTICS:

Age:

* 20 and under

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy
* No adjuvant chemotherapy planned

Endocrine therapy:

* Prior use of steroids allowed

Radiotherapy:

* Not specified

Surgery:

* Not specified
Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®

The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy, as determined by medical history.
* Subject is between the ages of 7 and 15 years (not yet 16 years).
* For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
* The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for Study MTA23.
* A negative urine pregnancy test is required for menstruating female subjects.
* Parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.

Exclusion Criteria:

* Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects from Study 603-02 who had been recruited for the follow-up challenge study)
* History of documented invasive meningococcal disease
* Received any other meningococcal vaccine
* Received any vaccine in the 28-day period prior to enrollment
* Received antibiotic therapy within the 72 hours prior to collection of a blood sample
* Actively enrolled or scheduled to be enrolled in another clinical study
* Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system)
* Known or suspected impairment of immunologic function
* Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion
* Scheduled to receive any vaccination in the 7-day or 14-day period after enrollment
* Administration of immune globulin, other blood products, or corticosteroid within 8 weeks (56 days) of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
* Personal of family history of Guillain-Barres Syndrome
* Suspected or known hypersensitivity to any of the vaccine components
* Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures
* Any condition which, in the opinion of the investigator, would pose a health risk to the participant.
LIVE SMART: Smartphone Intervention for Weight Control

The purpose of this study is to compare three methods of delivering behavioral weight loss treatment.Participants are randomly assigned to one of three 18-month weight loss treatments (group, individual, or smartphone treatment). Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months. Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (kg/m2) of 25-45.
* English language fluency
* Ability to read at a 6th grade level
* Availability to attend weekly treatment sessions in Providence, RI

Exclusion Criteria:

* Any heart condition that limits ability to participate in physical activity
* Chest Pain
* Any cognitive of physical limitation that would preclude use of a smartphone
* Serious mental illness
* Historical or current eating disorder
* Previous or planned bariatric surgery
* Use of weight loss medication
* Recent pregnancy or a plan to become pregnant in the next 6 months
* Participation in a study at the Weight Control and Diabetes Research Center within the last two years
* A weight loss of greater than 5% body weight in the last 6 months
Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis

The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring.

The treatment phase of the study is 6 months. Study procedures will be conducted such as: history, physical and neurological exam, pregnancy testing (for women of child bearing age) and a Brain MRI. Follow-up appointments will be every 3 months for 1 year at which time, your participation in the study will be concluded.

Eligibility Criteria:
Inclusion Criteria:

* Plan to undergo single or five fraction radiosurgery for a metastatic brain tumor
* Diagnosis of a metastatic brain tumor may be accomplished by histologic confirmation or by clinical confirmation by the treating physician based on MR imaging characteristics in the setting of a known history of cancer
* Age \> 18 years
* Partial or total resection of a metastatic tumor are eligible

Exclusion Criteria:

* Known sensitivity to vitamin E or Trental
* Recent intracranial bleed or retinal hemorrhage
* Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
* History of Avastin treatment
* Anticipated need for treatment with Avastin
* History of bleeding disorder
* History of liver disorder
Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation

The researchers are trying to develop an allergy skin test to help predict allergic responses to medications commonly given to patients during surgery.

This study will be a prospective study to accurately determine the negative predictive value of skin testing with NMBAs.

It is hypothesized that the concentrations that should be used for NMBAs are actually much lower than previously recommended and that the higher incidence of identifiable NMBA induced allergic reactions during anesthesia in the past may be due to irritation of the skin rather than a true allergic reaction (false positives).

Eligibility Criteria:
Inclusion Criteria:

* All adults \> or = to 18 y/o undergoing surgery

Exclusion Criteria:

* Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.
Initial Study of Insomnia/Nightmare Group Treatment for Posttraumatic Stress Disorder (PTSD)

Many combat Veterans suffer from posttraumatic stress disorder (PTSD), an anxiety disorder that develops after an extremely stressful event or events. PTSD is associated with problems falling asleep or staying asleep. Veterans with PTSD also commonly have nightmares from stressful experiences. These symptoms can cause problems in daily life. Behavioral treatments that do not involve taking medication have been shown to help improve problems related to sleep and nightmares. However, very few of these treatments address both sleep problems and nightmares at the same time, even though many people suffer from both problems. The purpose of this study is to examine the effectiveness of a combined treatment for sleep problems and nightmares in Veterans suffering from combat-related PTSD that is presented in a group format. The investigators hypothesize that the completion of this treatment will lead to increases in sleep quality and decreases in the frequency and severity of nightmares as measured by standard questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Must be enrolled in the Michael E. DeBakey VAMC Trauma Recovery Program and qualify for a diagnosis of combat-related PTSD related to service in Vietnam-era conflicts as measured by responses to the Clinician-Administered PTSD Scale (CAPS) and total score ≥ 50 on the Posttraumatic Stress Disorder Checklist Stressor Specific Version (PCL-S)
* Have a clinically significant sleep problem as measured by a total score \> 5 on the Pittsburgh Sleep Quality Index (PSQI)
* Have a repetitive trauma-related nightmare at least once per week on average, as measured by the Nightmare Frequency Questionnaire (NFQ), and which significantly impairs sleep as measured by response ≥ 2 on question 1a of the Nightmare Effects Survey (NES)
* Be stable on current regimen of psychotropic medication (i.e., no changes to medications and/or dosages) if applicable
* Must sign consent to be audio-recorded as part of the course of the treatment

Exclusion Criteria:

* Current substance dependence
* Planned or ongoing participation in Prolonged Exposure or Cognitive Processing Therapy during treatment participation
* Organic psychosis
* Bipolar I disorder
* Epilepsy
* Currently on benzodiazepine or hypnotic medication to treat sleep
* Currently take prazosin
* Indication of undiagnosed sleep apnea defined as score ≥ .5 across items 1, 5, and 8 of the Multivariable Apnea Risk Index
* Uncontrolled sleep apnea
Using Smart Phone Technology To Rural Veterans

The purpose of this study is to see if a new Smart Phone application can help Veterans manage their panic symptoms after completing a two-day treatment for panic attacks.

The first goal is to see how helpful the Smart Phone application is in helping veterans with panic symptoms continue to improve after you complete treatment.

The second goal of this study is to find out how much veterans like the Smart Phone application.

The third goal is to see how practical it is to use the Smart Phone application as a form of follow-up care. We want to see how much time is needed to provide technical support in using the application.

Eligibility Criteria:
Inclusion Criteria:

Participants must

1. be an Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veteran
2. currently meet criteria for PD with or without Agoraphobia
3. complete the weekend PD treatment at the Lufkin, Conroe or Texas City CBOC.

Exclusion Criteria:

1. current substance dependence
2. organic psychosis
3. symptomatic bipolar disorder
4. severe depression with suicidal intent or plan
5. cognitive impairment (indicated by scores \<20 on SLUMS)
İntraoperative Awareness Under General Anesthesia

Intraoperative awareness which means the recall of experiences recorded in patients' memories during general anesthesia in the postoperative period is an important issue in anesthesia practice. The aims of this study are to investigate the incidence and causes of awareness during general anesthesia, incidence of dreaming during anesthesia, intra-operative experiences of patients who report awareness, the risk factors that may be associated with awareness, to analyze the frequency of posttraumatic stress disorder in cases with awareness and possible awareness, the risk factors that may be associated with PTSD in Turkish adults.

Adult patients will be evaluated 4 time following emergence (a) One hour after emergence, (b) Twenty four hour after emergence (c) One week after emergence (d) One month after emergence. The first interview will be made face-to-face in the recovery unit, and other interviews will be made by phone. Each interview will be conducted using the same structured interview (Brice Interview).

Descriptive statistics will be used to determine the incidence of awareness. χ2 test will be used for comparison between groups. Logistic regression will be used to determine the risk factors associated with awareness and PTSD.

We believe that this study will contribute to the prevention of the problem by determining the real frequency and causes of intraoperative awareness under general anesthesia, determining the experiences and results of patients, and analyzing the associated risk factors.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-IV adult patients who will receive general anesthesia and are scheduled to be extubated postoperatively,

Exclusion Criteria:

* ASA V patients
* Patients below 18 years of age,
* Patient who can not give informed consent,
* Patients who have known psychological or psychiatric problems,
* Patients who are not suitable for postoperative follow-up
Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens

The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.

Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Successful wearers of weekly/monthly toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months;
* Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 20/25 Snellen in each eye.
* Able to wear contact lenses within the range of available sphere \& cylinder power and axes.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Daily disposable contact lens wearers.
* Monovision and multifocal contact lens wearers.
* Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 months prior to consent.
* Other protocol-defined exclusion criteria may apply.
Antibody Response to Influenza Vaccine in Patients With Sarcoidosis

The purpose of this study is to determine the efficacy of influenza vaccine (antibody response) in patients with sarcoidosis.

Sarcoidosis is a multisystem disease with unclear etiology characterized by the presence of noncaseating granuloma\[1\]. T helper cells response is exaggerated at the site of disease and cellular immunity depressed in peripheral blood\[2\]. Cutaneous anergy, lymphopenia and inversion of CD4/CD8 ratio in peripheral blood suggest T helper cells involvement\[3\].

The action of humeral immune system in sarcoidosis is a matter of controversy. Standard hepatitis B virus vaccination did not provoke protective antibody titer in patients with sarcoidosis\[3\]. Although antibody response against influenza vaccine in patients with sarcoidosis is not well described, this vaccine is highly recommended in patients with chronic pulmonary diseases such as asthma, COPD and fibrosis \[4, 5, 6\]. In this study we aim to evaluate the humeral response to the influenza vaccine in sarcoidosis patients and assess vaccine safety.

Eligibility Criteria:
Inclusion Criteria:

Sarcoidosis patients:

* Patients with relevant clinical, radiologic and histologic features of sarcoidosis (all stages).
* Signed informed consent.

Exclusion Criteria:

* Organ failure (kidney, heart, liver).
* Collagen vascular diseases.
* Diabetes.
* Contraindications of vaccine (Egg allergy).
* Patients who receive high dose (\> 60 mg/day) steroid therapy.
* Any acute disease.
* Conditions accompanied by immunosuppression (like organ transplantation, HIV).
* Any psychological disease that interferes with regular follow-up.
* Inoculation with influenza vaccine within the past 5 years.
The Effectiveness of a Smartphone Application in the Treatment of Alcohol Use Disorder

Alcohol dependence poses a major problem for Irish and UK society, placing a huge burden on the health system. It is difficult to treat and relapse is common. There is an urgent need to develop novel treatment methods. One growing area of intervention is the use of mobile phone technology to develop personalised, patient-centred treatments. These can be used in outpatient settings, allowing patients to manage their own illness and take control of their recovery. In this study the investigators will investigate how a smartphone application, UControlDrink, can help alcoholics stay abstinent from alcohol. The application consists of a number of features known to aid recovery such as supportive messages and online therapy.

Alcohol use disorder (AUD) is a common and difficult disorder to treat. Only a fraction of sufferers seek treatment and the rate of relapse is high. There is therefore an urgent need for improved methods of promoting long term abstinence and recovery in AUD. This study will explore the effectiveness of a smartphone application, UControlDrink, in aiding recovery from AUD in patients who have been discharged from an inpatient alcohol treatment programme. The application comprises five recovery focused features:

supportive messages, Computerised-Cognitive Behavioural Therapy, a drinking log, activities and trigger avoidance log, craving management and gamification. Patients will use the application for 3 months. A control group of patients will also be followed over the same time period. Cumulative abstinence duration as well as changes in questionnaire measures to baseline, time to first drink, proportion of patients continuously abstinent from alcohol, levels of activity within the app and patient satisfaction with their overall treatment will be measured at 3 months. If successful, this application may offer a unique, patient-centred, technology-driven, cost effective method of improving outcomes in AUD.

Eligibility Criteria:
Inclusion Criteria:

1. Patients will fulfil the criteria for an alcohol use disorder according to the Structured Clinical Interview for DSM-5 Axis I Disorders
2. Patients must complete an alcohol treatment programme at St. Patrick's University Hospital.
3. Primary addiction must be alcohol in poly-substance abusers.
4. Aged over 18 years of age and capable of providing written, informed consent.
5. Mini Mental State Examination (MSSE) score of ≥25.
6. Patients must have an iphone or Android smartphone and are familiar with using smartphone applications.

Exclusion Criteria:

1. Patients whose primary substance of abuse is not alcohol, although may meet the criteria for alcohol dependency/abuse.
2. Patients who do not have an iPhone or Android smartphone.
3. Age \<18years or \>70years.
4. Psychotic disorder
5. Patients who do not fully complete an inpatient treatment programme before discharge.
6. History of alcohol use disorder but not current.
Effects of ASC Secretome on Human Osteochondral Explants

Since the need of finding effective disease-modifying anti-osteoarthritis (OA) treatments is still unmet, with this study the investigators aim to gather further evidences of the therapeutic potential of Mesenchymal Stem/stromal Cell (MSC) secretome in order to pave the way to its future use as a cell-free biological product. In detail, the investigators predict to validate the promising results obtained in vitro, ex vivo on osteochondral explants, an OA model more representative of the physiological situation.


Eligibility Criteria:
Inclusion Criteria:

* males and females
* age≥18 years old
* patients hospitalized in IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto Ortopedico Galeazzi, undergoing arthroplasty

Exclusion Criteria:

* age\<18 years old
* patients unable to sign the Informed Consent
* positivity to serological test (HIV-Human Immunodeficiency Virus, HCV -Hepatitis C Virus, HBV -Hepatitis B Virus and TPHA -Treponema Pallidum Hemagglutination Assay)