cyrilzakka/clinical-trials huggingface dataset:
A Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas

This study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma.

This study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma. β-elemene will be given 600mg/d,d1-14,q28 days for 6 cycles.

Eligibility Criteria:
Inclusion Criteria:

* - Page 3 of 4 \[DRAFT\] - Arms Assigned Interventions

  * Temodar Experimental: temozolomide +α-IFN Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN： 3mIU (3million) Day1,3,5 of each 28 day TMZ：150 mg/m\^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m\^2 daily of subsequent cycles Drug: Temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days

Other Names:

• Temodar Drug: α-IFN 3mIU (3million) D1，3，5

Other Names:

Minimum Age: 18 Years Maximum Age: 75 Years Gender: Both Accepts Healthy Volunteers?: No

Criteria: Inclusion Criteria:

* Age: 18 years to 75 years
* complete remission patients of newly diagnosed WHO III-IV glioma following standard treatment
* Karnofsky Performance Score ≥ 60
* Adequate bone marrow, liver and renal function
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent
* anticipating survival ≥2 months

Exclusion Criteria:

* Refusal to participate the study
* Known hypersensitivity or contraindication to temozolomide
* Incompletely radiation
* Pregnant or lactating females
* Malignant tumor other than brain tumor
* Contraindicated for MRI examination
* Unable to comply with the follow-up studies of this trial
* Purulent and chronic infected wounds
* Uncontrolled psychotic disorders or epilepsy
* progression disease
Automated Hovering for Congestive Heart Failure Patients: A Pilot Study

This study offers remote monitoring devices for weight and medication adherence, combined with behavioral economic approaches, to patients with congestive heart failure (CHF). This pilot study aims to evaluate the feasibility of enrollment processes and intervention roll-out to inform a randomized controlled trial, to estimate the readmission rate of participants, and to assess if and how managing clinicians respond to weight gain alerts entered into a participant's electronic medical record.

The specific aims of this study are: (1) To leverage access to the University of Pennsylvania Health System (UPHS) CHF clinic, PennChart (electronic medical record system) resources for identifying eligible patients, and the Way to Health (WTH) platform to launch a pilot study that will inform a randomized controlled trial; (2) to evaluate the feasibility of the enrollment processes and intervention roll-out to inform a randomized controlled trial; (3) to estimate the readmission rate of participants; and, (4) to assess if and how managing physicians respond to weight gain alerts entered into participant charts in PennChart. In this pilot study, no randomization will occur and all participants will receive the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Discharged to home within the past 30 days from a UPHS hospital with a principal diagnosis of CHF
* Aged 18 to 80 years old
* Will receive follow-up in a UPHS outpatient clinic by a cardiologist or primary care physician

Exclusion Criteria:

* Less than 18 years old or older than 80 years old
* Will not or cannot provide informed consent
* Have a markedly shortened life expectancy (listed for heart transplant, have ventricular assist device, are inotrope dependent, have metastatic cancer, or have dementia)
* Have end-stage renal disease
* Have a glomerular filtration rate \<25 ml/min
* On dialysis
* Heart failure is managed with a CardioMEMS monitor
* Receiving another remote monitoring/telemedicine intervention
* Receiving follow-up care outside of UPHS
Evaluation of the Overall Quality of Life After the Neck Dissection Retro-spinal Sector (IIb), in Squamous Cell Carcinomas Clinical and Radiological N0 VADS

The nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is one of the main factors of poor prognosis, justifying the surgical management of neck dissection as a reference treatment.

Under the influence of the American Hayes Martin, it was considered until the 1960s that "over the intervention was, the greater the chance of recovery was". But has since been developed by the Argentine Osvaldo Suarez the concept of functional course, which consists of resection of lymph node tissue while retaining the main structures (muscles, nerves, vessels), as opposed to the recess radical which is reserved for the invasive metastasis.

In addition to these notions, our job is to evaluate the quality of life of patients with SCCHN, N0 clinical and radiological, enjoying a functional neck dissection including IIb sector to support the approach which would be to stop the systematic inclusion of this territory.


Eligibility Criteria:
Inclusion Criteria:

* Patient with SCCHN histologically proven N0 clinical and radiological
* Neoplastic Location: oral cavity, oropharynx, hypopharynx, larynx
* Patient candidate for a neck dissection fonctonnel
* Life expectancy\> 3 months
* Stable patient not exhibiting at the time of recurrence sign of examination or other scalable neoplasia
* Age over 18 ans
* Patient was informed of the study
* Patient fluent French

Exclusion Criteria:

* Patients with a history of malignancy, outside a basal cell cancer or cancer of the neck treated and cured
* Patient has at the time of examination of recurrence of signs or other scalable neoplasia
* Uncontrolled Infectious diseases
* Neoadjuvant radiotherapy
* Patient nursing or pregnant or lack of contraception during their reproductive
* Intercurrent pathology involving life-threatening
* Any medical or psychological condition associated that could compromise the patient's ability to participate in the study
* Inability to submit to medical follow-up study for geographical, social or psychic
Routine Clinical Screening for Substance Use Disorders in the Emergency Room Setting

To ensure consistent documentation of alcohol and substance use, the emergency medicine is initiating a new standard of care for substance use screening: the use of a brief self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed in triage. This questionnaire will allow emergency medicine patients presenting to the emergency room. This study will also review medical records after one year of the index emergency room visit to establish rates or re-presentation and hospitalization correlated with different substance use.

Screening for alcohol use and substances of abuse in the emergency and trauma settings is critical for both effective current treatment of the presenting clinical issue and prevention of future incidents. Identification, engagement and treatment of substance use disorders decreased trauma and emergency department visits and medical comorbidities (Bertholet et al., 2005; Kaner et al., 2007). To ensure consistent documentation of alcohol and substance use, the emergency medicine is initiating a new standard of care for substance use screening: the use of a brief self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed in triage. This questionnaire will allow emergency medicine patients presenting to the emergency room. This research study will perform a chart review on all self-evaluation questionnaires on alcohol, tobacco and substance use to determine the prevalence of use of specific substances in this patient population and associated demographic predictors and medical comorbidities. This study will also review medical records after one year of the index emergency room visit to establish rates or re-presentation and hospitalization correlated with different substance use.

Eligibility Criteria:
Inclusion Criteria:

* Able to complete a questionnaire

Exclusion Criteria:

* Younger than 19 Unable or unwilling to complete a self-assessment form written in English Prisoners
Effect Of Case Management Following Discharge From Methadone Treatment

The purpose of this project is to assess whether enhanced outreach counseling (EOC) is an effective outreach strategy for discharged methadone maintenance patients compared to a standard referral procedure. EOC is a brief (30 minute) face-to-face intervention, followed by six weeks of ongoing telephone counseling/case management designed to help eligible out-of-treatment methadone patients re-enter treatment. Several studies have shown those patients who voluntarily re-enter treatment improve significantly following re-enrollment.


Eligibility Criteria:
Patients who have been discharged from methadone maintenance treatment at the PVAMC who consented (as active patients) to be contacted for follow-up upon discharge.
Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections

Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms during viral infections of the upper respiratory tract. Also, allergic rhinitis makes the mucosa more reactive to infectious agents and potentiates mucus production.

The combination of dexchlorpheniramine, pseudoephedrine and guaifenesin elicits antihistaminic, decongestant and expectorant effects. The study hypothesizes is that this product is superior to dexchlorpheniramine alone in the relief of allergic symptoms and in promoting mucus elimination in atopic patients with viral infections of the upper respiratory tract.


Eligibility Criteria:
Inclusion Criteria:

* Patients with allergic rhinitis with symptoms of viral infection of the upper respiratory tract (rhinorrhea, nasal obstruction and productive cough)
* Compliance of the subject to the treatment protocol
* Agreement with the terms of the informed consent
* Patients who did not use forbidden medications

Exclusion Criteria:

* History of allergy to any component of the formulations
* Use of any investigational drug within the last 30 days
* Patients with bacterial infections of the upper respiratory tract
* Patients with high blood pressure (\> 140 x 90 mmHg)
* Patients who are receiving inhaled beta-agonists or other antihistamine, decongestant or expectorant
* Patients with known pulmonary disease (asthma, COPD, neoplasias)
* Pregnancy
* HIV + patients
* Other conditions considered by the investigator as reasonable for non-eligibility
Effect of Suicide Prevention Training for Professionals

Annually a substantial number of courses and trainings are organised in Flanders with regard to suicide prevention.These trainings are mainly aimed at intermediaries, such as caregivers, teachers, police, etc. From previous research it appears that such trainings are one of the most effective strategies for increasing knowledge, attitudes, skills and self-confidence with regard to dealing with persons who are suicidal and with crisis situations. However, such research has not yet been conducted in Flanders, which means that the effect of the training on the knowledge and attitudes of the intermediaries could not yet be determined. Therefore, this study aims to determine the effect of the trainings in Flanders. These trainings are organised by the Centre for the Prevention of Suicide (CPZ) and by the suicide prevention workers of the Centers for Mental Health Care.

All participants who register for one of these trainings will be invited by e-mail at three moments to complete an online questionnaire:

* Pre-test: one week before the training,
* Post-test: after the training,
* Follow-up: three months after training.


Eligibility Criteria:
Inclusion Criteria:

* Participating in a suicide prevention training organised by 'Centrum ter Preventie van Zelfdoding' or 'Suïcidepreventiewerking Centra Geestelijke Gezondheidszorg'

Exclusion Criteria:

* Not participating in a suicide prevention training organised by 'Centrum ter Preventie van Zelfdoding' or 'Suïcidepreventiewerking Centra Geestelijke Gezondheidszorg'
Energy Homeostasis Under Treatment With Atypical Antipsychotics

The purpose of this study is to evaluate the effects of different atypical antipsychotics on weight changes, energy homeostasis, metabolism, energy intake as well as activity.

Patients with schizophrenia or schizoaffective disorders will be randomly assigned to be treated with ziprasidone or olanzapine for 24 weeks.

Primary outcome parameter are the weight changes after 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or related disorders(DSM-IV)
* Indication for long-term treatment with antipsychotics
* BMI between 20 to 30
* Weight changes less than 3kg in the last 3 months before inclusion
* Informed consent

Exclusion Criteria:

* Psychiatric comorbidity
* Depot antipsychotic in the last 2 months
* Antipsychotics in the last 2 weeks
* Treatment with olanzapine, clozapine or ziprasidone in teh last 3 months
* Treatment with drugs, that may lead to weight changes
* Significant endocrine, neurological, cardiovascular, hepatic, renal, metabolic, or other medical diseases or any clinically relevant abnormalities in laboratory tests
* Female subjects during pregnancy and breastfeeding
* Female subjects within childbearing years who were not using adequate birth control
* Patients who are judged by the investigator to be at serious suicide risk
Evaluation of Reader Training Processes

This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.


Eligibility Criteria:
Inclusion Criteria:

- Scan obtained for clinical reasons

Exclusion Criteria:

- None
Why Are Patients With Absence Seizures Absent? A Brain Imaging Study

Our study examines which different brain regions are involved in child absence seizures and how they are related to attention and cognition.

The fundamental mechanisms of altered brain function and impaired attention in childhood absence epilepsy (CAE) are not known. Absence seizures consist of brief 5-10 seconds episodes of unresponsiveness, associated with a 3-4 Hz "spike-wave" discharge on electroencephalogram (EEG). CAE affects 10-15% of children with epilepsy. In addition to the deficit during seizures, many children also suffer from milder attention impairment between absence episodes, which may not be due entirely to medications. Impaired attention during and between absence seizures has a major negative impact on patient quality of life due to deficits in school performance, potential for injuries, and social stigma.

Recent studies suggest that impaired cognition in so-called "generalized" absence seizures may, in fact, depend on dysfunction in specific brain networks. Our central hypothesis is: abnormal function in focal brain regions, such as the anterior cingulate/medial prefrontal cortex and medial thalamus, causes impaired attention both during and between seizures in CAE. If confirmed, this may lead to innovative regional therapies targeted at improving impaired attention in CAE. Specifically, we hope to determine which specific cortical and sub-cortical networks are selectively involved when patients show impaired attention. Using simultaneous EEG and functional magnetic resonance imaging (fMRI), we will determine which brain regions are involved in absence seizures while using a continuous performance task (CPT) to test attention vigilance in the same patients. A few neuropsychology tests will then follow. Patients will be reimbursed $100 as well as all travel and parking expenses.

For more information, please visit www.yalecae.com

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of childhood absence epilepsy or juvenile absence epilepsy
* No other serious health problems or neurological problems
* 6 years or older

Exclusion Criteria:

* No history of myoclonic or tonic-clonic seizures
Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor

Researchers are investigating improved methods of targeting deep brain stimulators for treatment of essential tremor relying on brain connectivity measures derived from MRI.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of refractory essential tremor scheduled for unilateral thalamic deep brain stimulator placement
* Age ≥ 18 years

Exclusion Criteria:

* Prior deep brain stimulator, stereotactic radiosurgery, or focused ultrasound procedure for treatment of tremor
* Presence of concomitant movement disorder (e.g. Parkinson's disease, dystonia, etc.)
* Known pre-existing structural brain abnormality (e.g, infarction, tumor, prior brain surgery, etc.)
* Contraindication to 3 Tesla brain MRI (e.g. incompatible implanted device)
* Pregnant
A Multicenter, Prospective Observational Study to Evaluate the Incidence of Delayed-onset Nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 Injected Into the Facial Skin Layer.

This is an observational study to evaluate the incidence of delayed-onset nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 injected into the facial skin layer.


Eligibility Criteria:
Inclusion Criteria:

* Planned for YVOIRE Y-Solution 360 or 540 or 720 filler injection in facial area (except middle of the forehead, lips) for the volume enhancement or anti-wrinkle treatment.
* Male and female of 19 years or above age.
* Informed consent to participate in the study.
* Able to participate throughout the study period.

Exclusion Criteria:

* Prohibited in the Product Label.
* Have active or infectious skin disease in injection area.
* Autoimmune disease or HIV infected patient.
* Received immunosuppressive therapy within 2 weeks.
* Previously experienced Delayed-onset nodule after filler injection in facial area.
* Previously experienced Hypertrophic scar or Keloid.
* Have participated in an interventional clinical investigation within 30 days or plan to participate one during the study period.
* Ineligible for this clinical investigation as per Investigator's discretion.
Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients

Immunogenicity is reduced in immunocompromised patients. The aim of this prospective randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3, co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will be evaluate.

RECOMMANDATIONS for hepatitis A vaccination is the same for HIV-infected patients than for general population. However, immunogenicity induced with 2 doses of anti-HAV vaccine is lower in HIV-infected patients. The primary objective of the study is to compare the immunogenicity (percentage of patients with anti-HAV antibodies \> 20 mUI/ml at month 7) of 2 strategies (2 doses at months 1 and 6, versus 3 doses at months 1, 2 and 6)of anti-HAV vaccine in HIV-1 infected patients co-infected with HBV and/or HCV with CD4 cell count between 200 and 500/mm3. The second objectives are to compare mean anti-HAV antibodies titers obtained with the 2 strategies, the durability of the seroprotection 12 months after the end of vaccination, and the safety. The PARAMATERS than may have an effect on the immune response will be evaluated.

This open, prospective, study have included 99 patients, aged from 18 to 55 years old. Patients were randomized to receive 2 or 3 doses of HAVRIX 1440 UI intramuscularly at week O, 4, and 24 or week 0, and 24. Clinical and biological safety is evaluated after each immunisation and blood samples for serological evaluation taken at week -4, 4, 8, 24 and 28 for immunogenicity and week 72 for long term analysis

Eligibility Criteria:
Inclusion Criteria:

* VIH-1 infection, aged 18-55 years negative anti-HAV IgG CD4 cell count between 200 and 500/mm3

Exclusion Criteria:

* prior anti-HAV vaccination immunosuppressive treatment splenectomy Prothrombin time \< 50%, platelets\< 50 000/mm3 fever serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity \> 2 ULN for non co-infected patients, \> 5 ULN for co-infected patients
A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to see whether adding liver stereotactic ablative radiotherapy/L-SABR to standard drug therapy is better than standard drug therapy alone for people with metastatic non-small cell lung cancer/NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Be greater than 18 years of age on day of signing informed consent.
* Have a histologically confirmed diagnosis of stage IV NSCLC (includes patients who have progressed on durvalumab for Stage III NSCLC) without known mutations in (EGFR) or BRAF or rearrangements in ALK (anaplastic lymphoma kinase) or ROS-1.
* Newly diagnosed metastatic non-small cell lung cancer (NSCLC), including both de novo and secondary metastatic disease, with one or more liver metastases
* Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy for at least 3 cycles

  o Regimens combining anti-CTLA-4 immunotherapy with anti-PD-1 (e.g., ipilimumab plus nivolumab) or anti-PD-L1 (e.g., tremelimumab plus durvalumab) immunotherapy are allowed.
* Have a performance status of 0-2 on the ECOG Performance Scale.
* Liver function tests:

  * Total Bilirubin ≤ 1.5 x ULN
  * AST/ ALT ≤ 5 x ULN
* Eligible for L- SABR to all liver metastases.
* Patients with known HIV are eligible provided they are under treatment with effective anti-retroviral therapy with CD4 \>200 cells/microliter ≤ 28 days prior to registration

Exclusion Criteria:

* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
* Patients with prior external beam radiation therapy to the liver.
* Patients with known active Hepatitis B or Hepatitis C.
* Patients with immunosuppression including pharmacological immunosuppression with chronic steroids or immune modulators like cyclosporin or methotrexate and patients with active autoimmune disease.
* Patients who are pregnant or breastfeeding
* Men or women not using effective contraception.