cyrilzakka/clinical-trials huggingface dataset:
Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS

While advances in medication have led to greatly improved outcomes for people living with HIV/AIDS, less than one-third of all people living with the disease are adherent enough to their medication to achieve viral suppression. Alcohol consumption has been shown to have a significant effect on HIV medication adherence, so the proposed research will aim to reduce alcohol use among people living with HIV/AIDS through a technology-driven intervention. This eight-session intervention will be delivered using a combination of videoconferencing, smart phones, and Bluetooth-enabled breathalyzers for monitoring of alcohol consumption, with an overall goal of reducing alcohol use, mitigating adherence issues, and achieving optimal prevention and treatment responses for people living with HIV/AIDS.

The TRAC intervention focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage drinking. It requires eight 30-minute sessions with a counselor using videoconferencing and mobile phones. In addition to receiving the eight sessions of intervention content, participants will complete smartphone-based self-monitoring of medication adherence and alcohol consumption, which will be discussed during intervention sessions. Each day, they will be texted at two random times to complete a breathalyzer reading using a BACtrack Mobile Pro, which is sold by a company with FDA clearance and utilizes law enforcement-grade sensors for determining blood alcohol level. It connects wirelessly to phones via Bluetooth, automatically uploads readings, allows the user to view their current and past readings with a mobile app, and allows them to share their readings with counselors. At the time of the breathalyzer reading, participants will also be asked to indicate via survey how many drinks they have consumed and their medication use for the day. The surveys will be programmed using Qualtrics and accessible via a link in the reminder text message. Data analytic methods will be focused on examining effects on alcohol intake, HAART adherence, and HIV-related medical outcomes (CD4 count and viral load).If shown to be feasible, acceptable, and potentially efficacious, this intervention could have a significant impact on improving the accessibility of alcohol reduction counseling among PLWHA.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive
* 18 years or older
* At-risk drinker
* Currently prescribed HIV medication
* Current patient at the study recruitment site(s)

Exclusion Criteria:

* Less than 18 years old
* Non-English Speaking
Procarbazine and Lomustine in Recurrent Glioblastoma

The combination therapy of temozolomide and radiation has been established as the standard therapy for the initial treatment of glioblastoma. However, the prognosis for patients with recurrent/ refractory glioblastoma is dismal, with a median survival of 3\~6 months. There is no efficient and standard care at the time of recurrence or progression following temozolomide administration. Recently, many clinicians have reassessed the efficacy of second-line chemotherapeutic agents such as nitrosoureas for the treatment of recurrent/refractory glioblastoma. It is very important that the effect of the agent is sustained and the adverse effect is reduced to preserve the quality of life in recurrent settings. We have realized that the clinical features of Korean patients are very different from those of foreign patients. Therefore, it is mandatory to develop the new strategy for the treatment of Korean patients. We modify the PCV chemotherapy in the dose and administration schedule of CCNU and procarbazine to reduce the side effect, especially hematologic problems. The dose of CCNU is reduced to 75mg/m2 and the interval between CCNU and procarbazine is increased. Moreover, vincristine is excluded because BBB permeability of vincristine is very poor and the risk of neurotoxicity is high. We introduce the modified PC chemotherapy regimen for the treatment of recurrent/refractory glioblastoma, which is the first multicenter trial for glioblastoma patients in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or radiologically confirmed progressive or recurrent glioblastoma with methylated MGMT promoter
* Within 6 months after or during Stupp regimen (TMZ-RT CCRT + adjuvant TMZ), or After re-treatment of cyclic TMZ, 6 months later after Stupp regimen
* KPS ≥ 60%
* Age ≥ 20 years
* At least two weeks apart from prior surgery and prior chemotherapy
* Adequate hematologic, liver, and renal functions
* Unstained slides for central pathology review
* Signed informed consent

Exclusion Criteria:

* Prior malignancy within 5 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and carcinoma in situ of the cervix
* maternity or breastfeeding
* Evidence of active infection within 2 weeks prior to study
* Previous treatment with procarbazine and/or CCNU
* Evidence of leptomeningeal metastasis
* Unable to comply with the study protocol
Natriuretic Peptides as a Prognostic and Risk Stratification Tool in Assessment of Valvular Heart Disease

NPs can be used To detect subset of asymptomatic with subtle LV dysfunction for further evaluation and earlier referral for intervention and its correlation with echocardiographic finding.

Each patient included in the study will undergo:

1. History taking:

   Analysis of patient symptoms and signs (dyspnea , orthopnea , Paroxysmal nocturnal dyspnea, lower limb edema , tachypalpitations,...etc )
2. Clinical examination:

   * Detecion of each patient body weight , height , calculation of BMI.
   * General examination for detection of signs of Heart failure (raised JVP , lower limb edema, ..etc)
   * Examination to respiratory system
   * Auscultation of the heart for detection of valvular affection before echocardiography

Invesigations:

Laboratory investigations:

Urea and creatinine . b) ECG : for exclusion of atrial fibrillation and other arrythmias. 2D Transthorathic Echocardiography (TTE) Evaluation of valve morphology and thickness , gradients and valve area , regurgitant lesions and its severity.

Evaluation of internal cardiac dimensions and function. 5- Natriuretic peptides: as a useful screening tool to differentiate symptomatic and asymptomatic patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients echocardiographically diagnosed with significant valve lesions. Rheumatic Heart disease with significant but asymptomatic valvular Heart Disease especially (Mitral valve disease )(MS and MR) Gender: male \& female

Exclusion Criteria:

* Cases with increased level of BNP as in :

Renal impairment Advanced age and obesity Atrial fibrillation and acute coronary syndromes Prior lung diseases and acute illness
Supermicrosurgical Lymphvenous Bypass Intervention for Treatment

Background: In addition to antegrade anastomosis, retrograde anastomosis has been thought to offer further improvements after lymphaticovenous anastomosis (LVA) by bypassing the retrograde lymphatic flow. However, this concept has yet to be validated. The aim of this study was to determine the impacts on outcomes of performing both retrograde and antegrade anastomosis, as compared to antegrade-only anastomosis for treating lower limb lymphedema.


Eligibility Criteria:
Inclusion Criteria:

* Lower limb lymphedema patients.

Exclusion Criteria:

* Patients who have had previous LVA, liposuction, or excisional therapy such as the Charles procedure were excluded.
Computed Tomography (CT) Guided Lung Biopsy: Core or Fine Needle Aspiration

This study is a comparison of core needle biopsy with fine needle aspiration biopsy in the evaluation of lung nodules.


Eligibility Criteria:
Inclusion Criteria:

* All patients having a lung biopsy

Exclusion Criteria:

* Lymphoma
Non Interventional Post Marketing Programme in Acromegaly

The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners ("Home Injection Group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) ("Reference Group").


Eligibility Criteria:
Inclusion Criteria:

* The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this post-marketing surveillance programme and any subsequent analysis.
* The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months.
* The patient must have a diagnosis of acromegaly.
* The patient must be at least 18 years of age.
* For patients receiving or intending to receive Somatuline Autogel by home injection:

  * The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their general practitioner/pharmacy on a monthly basis, or receive the medication by a home delivery service.

Exclusion Criteria:

* The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).
Clinical Biological and Pharmacological Factors Influencing Stroke Outcome

In a previous suty, we have demonstrated that prior transient ischemic attack, treatment lipid-lowering drug or physical activity are associated to a better outcome of stroke. The aim of the study is to understand the mechanisms of this preventive neuroprotection by establishing link between biomarkers and preventive and neuroprotective measures.To answer to the question, we conduct a cohort study of stroke patients.

In the cohort, the severity of stroke (NIHSS) will be correlated with :

* clinical factors,
* pharmacological factors,
* biological factors (inflammatory markers, hemostasis...)

Eligibility Criteria:
Inclusion Criteria:

* ischemic or hemorrhage stroke
* hemispheric stroke
* stroke dating from less 48h

Exclusion Criteria:

* non hemispheric stroke
* malformative intracranial hemorrhage
* traumatic intracranial hemorrhage
* subarachnoidal hemorrhage
Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age

This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF genotypes.


Eligibility Criteria:
Key Inclusion Criteria:

* Homozygous or heterozygous for F508del mutation (F/F or F/MF genotypes)
* Forced expiratory volume in 1 second (FEV1) value ≥40% of predicted mean for age, sex, and height.

Key Exclusion Criteria:

* Clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status.
* Solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.
A Dose- and Efficacy-Finding Study of RO5323441 in Combination With Avastin (Bevacizumab) in Patients With Recurrent Glioblastoma

This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the dose-finding part, patients will receive intravenous escalating doses of RO5323441 in combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part, patients will be randomized to receive the established dose (from the dose-finding part) of RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue treatment with RO5323441 and Avastin on the study until evidence of progressive disease or unacceptable adverse events happen. In the efficacy-finding part, patients will receive study treatment until disease progression or death.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Histologically confirmed glioblastoma
* Radiographic demonstration of disease progression by Response Assessment in Neurooncology (RANO) criteria following prior therapy
* Availability of at least 1 formalin-fixed paraffin-embedded tumor tissue sample
* If receiving corticosteroids, patients must have been on a stable or decreasing dose of corticosteroids
* Prior standard radiotherapy for glioblastoma
* Karnofsky Performance status \>/=70
* Over 4 weeks since prior surgical resection
* Over 12 weeks from radiotherapy
* Over 4 weeks from anticancer agents

Exclusion Criteria:

* Patients had second or later glioblastoma relapse
* Patients received more than one systemic treatment regimen for glioblastoma
* Patients have secondary glioblastoma
* Prior treatment with Avastin
* Patients unable to undergo Magnetic Resonance Imaging (MRI)
An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response

This trial evaluates the treatment response of colorectal cancer that has spread to the liver (liver metastases) using intravoxel incoherent motion diffusion weighted imaging (IVIM DWI). IVIM DWI is new kind of imaging scan that may help measure changes in disease before and after chemotherapy in patients with colorectal liver metastases.

PRIMARY OBJECTIVE:

I. To determine whether intravoxel incoherent motion (IVIM) diffusion weighted imaging (DWI) can detect a difference between the changes in the diffusion related parameters in patients before and after chemotherapy between responders and nonresponders.

SECONDARY OBJECTIVES:

I. Use respiratory-triggered DWI and quantitative T2 maps for the evaluation of colorectal liver metastases (CLM) after treatment.

II. Assess whether changes in these parameters correlate to pathologic treatment response (percent necrosis) determined on pathology.

OUTLINE:

Patients undergo IVIM DWI over 10 minutes during standard of care MRI within 30 days of starting chemotherapy and after 4-6 cycles of preoperative chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with treatment-naive resectable CLM, who will start chemotherapy with oxaliplatin with fluorouracil (5-FU)/leucovorin (FOLFOX), irinotecan with 5-FU/leucovorin (FOLFIRI), or a combination, such as fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFOXIRI), with or without a biologic agent
* Patients with at least 1 colorectal liver metastasis measuring at least 1 cm
* Patients with anticipated follow-up before and after surgery at MD Anderson

Exclusion Criteria:

* Patients who have already received preoperative chemotherapy for the CLM or will undergo radiation therapy, ablative therapies, or other non-surgical therapies directed at the liver
* Patients allergic to gadolinium
* Patients with pacemakers
* Greater than 400 pounds in weight
PRIME HFrEF: Novel Exercise for Older Patients with Heart Failure with Reduced Ejection Fraction

This study is trying to find out whether performing a hybrid aerobic-resistance exercise training program (titled PRIME: Peripheral Remodeling via Intermittent Muscular Exercise) results in better health outcomes than the traditional exercise training program (called COMBO) that is used in individuals with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized (like the flip of a coin) to either PRIME (investigational) or the traditional exercise program (standard of care).

This study is a two-arm, prospective randomized clinical trial with participants randomized, in a 1:1 ratio to 4 weeks of either standard progressive whole-body aerobic plus resistance training (COMBO) or PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO assigned to all participants (Phase 2). The objective of this study is to determine whether PRIME exercise training can outperform traditional (COMBO) exercise training to improve outcomes in HFrEF patients. The study aims to test 92 HFrEF patients (46 randomized to PRIME and 46 to COMBO training) over a 5-year period. Data will be collected at each visit and patients will return for a 6-month follow up from the date of the final visit.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
* Subjects may be of either sex with age \> 65 years.
* Subjects must be diagnosed with HFrEF as per established echocardiographic criteria (New York Heart Association Class II-III) with an ejection fraction \<40%.
* Cardiologist approve after thorough chart review and physical examination
* Hemoglobin of at least 10.0 g/dL

Exclusion Criteria:

* Progressive worsening of exercise tolerance or dyspnea at rest or on exertion over previous 3-5 days
* Significant ischemia at low exercise intensities (\<2 METS or \~50 W)
* Uncontrolled diabetes (HbA1c \>10%)
* Acute systemic illness of fever
* Recent embolism (in the 6 weeks)
* Deep Vein Thrombophlebitis
* Active pericarditis or myocarditis
* Severe aortic stenosis (aortic valve area \<1.0 cm2)
* Regurgitant valvular heart disease requiring surgery
* Myocardial infarction within previous 3 weeks
* New onset atrial fibrillation (in the last 4 weeks)
* Resting Heart Rate \>120bpm
Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms

The purpose of this study is to assess the feasibility, acceptability, and fidelity of implementation of the Mindfulness Based Dementia Care (MBDC) program to reduce depressive symptoms in care partners (CPs) of people living with dementia (PLWD).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Self-identify as being an informal CP providing caregiving to a PLWD
* Register for an MBDC course through the Presence Care Website

Exclusion Criteria:

* Previous participation in an MBDC program.
* Does not speak and understand either English or Spanish.
STOP-HSP.Net: a Registry for Hereditary Spastic Paraplegia as an Integration Tool for Future Therapeutic Strategies

Our goal is to create a solid and harmonious disease registry of patient affected by hereditary spastic paraplegia (HSP) that facilitates the collection and management of patients' data over time encouraging the research and the development of future clinical trials. In-depth clinical phenotyping will develop significant clinical outcome measures that can be used in clinical trials and will allow the phenotypic complexity of the disease to be captured with the use of validated clinical scales, biomarkers and so-called patient reported outcomes (PROs).

The registry will involve five recruiting clinical centres (IRCCS Fondazione Stella Maris in Pisa, IRCCS Eugenio Medea in Conegliano, IRCCS Policlinico Gemelli in Rome, IRCCS Istituto di Scienze Neurologiche in Bologna, Università degli studi di Messina) and a data analysis partner (CINECA).

Participants will be assessed annually at one of the five participating clinical sites. For each patient, at least one follow-up visit will be scheduled at an interval of 12 months in order to monitor and compare the longitudinal progression of HSP in similar groups (for example based on phenotype, age at onset, or genotype). At each visit all enrolled subjects will carry out a clinical-instrumental evaluation as per clinical practice, including: anamnestic collection, general and neurological objective examination; administration of illness scales (e.g. the SPRS scale) and quality of life questionnaires. Any biological samples will be collected as tissues, blood or urine and stored in the laboratories or bio-repositories of the individual centers and also reported in the electronic clinical report form (CRF) of STOP-HSP.net. The results of further diagnostic tests carried out such as Optical coherence tomography (OCT), brain magnetic resonance imaging (MRI) or neurophysiology performed during diagnostic practice or clinical follow up will also be collected. Any further clinical scales/evaluation questionnaires to be administered will be selected according to clinical need based on the neurological characteristics and genotype of each participant. All data relating to further instrumental and/or neurophysiological investigations carried out by the patient for clinical needs will also be collected.

The data collected during the aforementioned clinical-instrumental-laboratory evaluations will be entered into the STOP-HSP.net register in pseudonymized form.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of pure or complex HSP/spastic ataxia, even in the absence of a known genetic diagnosis
* participants/parents/legal guardians will have to give informed consent for enrollment in the registry and privacy data management

Exclusion Criteria:

* subjects affected by secondary forms of HSP
* presenting comorbidities that affect the general clinical picture according to clinical judgment
* lack of informed consent
RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields

During percutaneous coronary interventions standard operator radio-protection is generally ensured using a lead apron, a thyroid lead collar, low leaded flaps, an upper mobile leaded glass suspended from the ceiling and leaded glasses. Previous studies showed that adding a bismuth-barium radiation shield drape on the patient right arm or using a pelvic lead shield on the patient, the radiation dose adsorbed by operators was significantly reduced even if was higher compared to transfemoral approach. No studies evaluated the effect of both adjunctive shields placed in the same patient.

Aim of our randomized study is to evaluate if the combination of a shield drape on the patient right arm and a pelvic lead shield during transradial percutaneous coronary procedures may reduce the radiation dose adsorbed by operators compared to the use of only one shield or none.

All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study. Eligible patients will be randomized (using a computer generated randomization sequence) in 4 groups:

1. use of a pelvic shield drape
2. use of a shield drape on the patient right arm
3. use of a pelvic shield drape and a shield drape on the patient right arm
4. Any adjunctive shield drape (only standard radio-protection) For each group a further internal randomization will be performed in order to compare the right or left radial transradial approach.

Each operator will be equipped with dedicated dosimeters placed at left wrist and at thorax level outside the lead apron. Since December 2013 the operators are equipped with a further dosimeter at head level.

Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters.

Secondary end-point are:

1. Radiation dose adsorbed by operators according to the radial access (right versus left)
2. Radiation dose adsorbed by the patients
3. Radiation dose adsorbed at head level.


Eligibility Criteria:
Inclusion Criteria:

All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study

Exclusion Criteria:

1. Previous coronary artery by-pass
2. Acute ST elevation myocardial infarction
3. Hemodynamic instability or cardiogenic shock
4. Ischemic Allen test.