cyrilzakka/clinical-trials huggingface dataset:
Comparing the Effectiveness of Two Alcohol+Adherence Interventions for HIV+ Youth

Alcohol use among persons with HIV exacerbates health problems and accelerates HIV disease progression. Antiretroviral therapy (ART) is the single most important treatment for people living with HIV. However, ART adherence is suboptimal among adolescents and young adults living with HIV, the age group with the fastest growing rates of HIV infection, and great risk of engaging in risky behaviors such as alcohol use. The proposed study will compare the effectiveness of home-based versus clinic-based "Healthy Choices", a brief, 4- session intervention using Motivational Enhancement Therapy (MET) to address alcohol use, medication adherence, and health outcomes in youth living with HIV (YLH) using a repeated measures design. Unlike previous trials, Healthy Choices will be tested in a "real world" clinical setting and be delivered by community health workers (CHW: already members of the HIV care team). The study population will consist of YLH, ages 16-24, who are current patients at 5 ATN sites. Site staff will recruit potential participants. Youth will be randomized to receive Healthy Choices, either clinic-based or home-based delivered by the same CHW in both conditions. Outcomes are measured at baseline, 4-, 7-, and 13-months. Data collection for biological measures will be through medical record extraction, and self-reported measures will occur using a brief Web-based CASI (computer-administered self-interviewing) survey on an iPad. All intervention sessions will be audio-recorded for MITI fidelity coding, and investigators will support local supervisors during the active intervention phase. We will conduct qualitative interviews with CHWs, supervisors and organization leaders at the end of the trial to obtain information about barriers and facilitators of implementation. Thus, the proposed trial will allow us to use a Type 1 Effectiveness-implementation hybrid design to pilot a sustainable model of MI implementation in real-world youth care settings towards the goals of 1) examining the effectiveness, cost-effectiveness, and scalability of an efficacious behavioral intervention when delivered by CHWs in real-world adolescent HIV care settings; 2) gathering information about who responds under what contexts; and 3) increasing our understanding of the barriers and facilitators for future implementation. The primary hypothesis is that YLH receiving home-based MET will have greater improvements in alcohol use and viral load than YLH receiving clinic-based MET.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Ability to speak and understand English
* Prescribed antiretroviral therapy
* Detectable viral load in the last month

Exclusion Criteria:

* Not fluent in English
* History of sever learning disability, mental retardation, major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression with psychotic features, etc).
* Participation in another adherence intervention trial
* On ART due to pregnancy
Guided Imagery and Music for the Reduction of Side Effects of Chemotherapy in Teenagers

The purpose of this study is to determine whether a modified and resource-oriented form of Guided Imagery and Music (GIM) is effective in reducing side effects of chemotherapy in teenagers with cancer.

(Will be added later)

Eligibility Criteria:
Inclusion Criteria:

1. Teenagers at the ages 12-17
2. Four or five (dependent on their overall plan of medical treatment) consecutive courses of chemotherapy administrated at the involved child cancer units and (administered) over a period of minimum 24 hours incl. hydration with assumed moderate to severe nausea and vomiting.

   The specific type of chemotherapy may vary across the four/five consecutive courses but shall include one of the following moderate and/or highly emetogenic types of chemotherapy:

   Moderate emetogenic chemotherapy:
   * Carboplatin
   * Cyclophosphamide \<1500 mg/m2
   * Cytarabine \>1 g/m2
   * Daunorubicin
   * Doxorubicin
   * Epirubicin
   * Idarubicin
   * Ifosfamide
   * Mitoxantrone
   * Methotrexate \>1000 mg/m2

   Highly emetogenic chemotherapy:
   * Cisplatin \>25 mg/m2
   * Cyclophosphamide \>1500 mg/m2
   * Dacarbazine
3. Understand Norwegian/Danish
4. Read Norwegian/Danish (teenagers or alternatively parents)
5. No significant hearing impairment
6. Informed written consent (teenagers ≥16 years and parents)
7. Subsequent verbal confirmation of written informed consent before enrolment in study

Exclusion Criteria:

1. Previous and/or acute psychiatric diagnosis
2. Cognitive and mental deficits or impaired functioning
Assessment of Antioxidant Therapy on Oxidative Stress Biomarkers in Type 2 Diabetic Patients With Neuropathy

Type 2 DM subjects having numbness, tingling and paresthesia in hands and feet (neuropathy) will be recruited. Screening of neuropathy will be done by Michigan screening instrument. This will be followed by nerve conduction studies. Specific blood parameters will also be checked. The subjects will then be divided into four treatment arms. Three groups will receive single drug and the fourth one will receive all the three drugs. These will be given for four months. Follow up will be done every month. At the end of four months, they will be assessed for any improvement in neuropathy by using Michigan neuropathy instrument and nerve conduction studies. Blood parameters will also be measured again.

Type 2 DM subjects having numbness, tingling and paresthesia in hands and feet (neuropathy) will be recruited. They will be screened by Michigan neuropathy scale. This is tool used for screening neuropathy. Subjects having a score equal to or greater then 4 will be examined for further evaluation. This will be followed by nerve conduction studies for objective assessment of neuropathy. For inclusion criteria the test performed will be HbA1c, CBC, ESR, RFTs and LFTs. After screening the baseline levels of Superoxide radical, Super oxide dismutase, Glutathione peroxidase and Malonaldehyde will be measured. The subjects will be randomly divided into four treatment arms. Group A will receive Triple regime antioxidant therapy including Resveratrol 1500 mg two times a day, Alpha lipoic acid 600 mg two times a day and Superoxide dismutase 250 mg once a day. Group B will receive Resveratrol 1500mg BD, Group C will be on Tab Alpha lipoic acid 600 mg BD and Group D will take Superoxide dismutase once a day. The subjects will be kept blinded about the medication. They will be followed every month in which their quality of life will be assessed using Nottingham health profile and neuropathy will be assessed by Michigan neuropathy scale. At the end of four months blood tests will again be performed to check the levels of Superoxide radical, Superoxide dismutase, Glutathione peroxidase and Malonaldehyde. NCS will be done to see any improvement in neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus
* Age between 40-60 years

Exclusion Criteria:

* Malignancy
* Vitamin B12 deficiency
* History of drug or alcohol abuse
* Taking antioxidant treatment
* History and baseline investigations for renal hepatic and haematological diseases
* Pregnant or lactating women.
Group Versus Individuals Telehealth Exercise Programs for People With Parkinson Disease

This study will compare the impact of physical therapist led telehealth exercise programs on people with Parkinson disease. Eligible participants will complete this program individually or in a group of 9 other participants. The impact of participation in this program on motor function, postural control, gait, quality of life, and self-efficacy for exercise will be measured.

This program will be delivered 2 times per week for 8 weeks with examination of outcome measures prior to and after completion. The investigators plan to enroll 20 participants with 10 completing a group program led by a physical therapist and 10 completing an individual exercise program led by a physical therapist.

Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of idiopathic Parkinson disease
* been prescribed a stable dose of levadopa medication for at least 4 weeks prior to study participation
* be able to walk independently
* have a referral from a physician to participate in the program
* have access to a computer/tablet/or phone to use for telehealth sessions with reliable internet and access to the Zoom platform

Exclusion Criteria:

* have any other neurological condition other than Parkinson disease
* have a score less than 20/28 on the Mini-Balance Systems Evaluation Test (reflecting a higher risk of falls)
* demonstrate unstable/unsafe blood pressure or heart rate responses during the initial evaluation with response to submaximal exercise
* have any musculoskeletal condition that affected their ability to participate in the exercise group
* score less than 24/30 on the Mini Mental Status Examination during the initial evaluation
Clinical Evaluation of Genetron TERT/BRAF PCR Kit in Thyroid Cancer Patients

The purpose of this trail is to evaluate the performance of Genetron TERT/BRAF PCR Kit in Thyriod Cancer patients using real-time PCR method.

This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron TERT/BRAF PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinical diagnosis of suspected thyroid cancer who underwent fine-needle aspiration (FNA)
2. The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc.
3. Subjects who can provide a complete FNA sample
4. Subjects who agree to provide follow-up diagnosis and treatment information

Exclusion Criteria:

1. The investigator considers that it is not appropriate to continue the clinical trial, such as the samples that are not prepared according to the required steps.
2. Samples with incomplete information required.
3. The amount of DNA extracted is not enough to complete the samples tested by the assessment reagent or comparative method.
Therapeutic Nutrition With Technology in Primary Care

Low-carbohydrate diets (less than approximately 130 grams per day) are emerging as an efficacious treatment option with several studies supporting weight loss and remission of type 2 diabetes. Many physicians are now implementing this strategy but the time it takes to educate patients on nutrition is a barrier. The research team is working with physicians to develop a solution whereby the nutrition education and intervention is delivered via mobile/online technology (i.e., an app). This study will test whether it is feasible and efficacious for physicians to recommend this app to their patients with obesity and type 2 diabetes to help them lose weight and improve their condition.

The study is a non-experimental feasibility study to explore the acceptability, practicality and demand for the use of a 12-week, personalized, online program to teach and coach patients about therapeutic carbohydrate restriction for individuals with obesity and/or at risk for type 2 diabetes/with type 2 diabetes. The program is intended to enhance the usual clinical care provided for patients with these conditions and will allow for physicians to monitor patient progress through the program. Both physician and patient perspectives will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese (BMI \>25 kg/m2)
* At risk for T2D as deemed by physician
* Diagnosed with T2D
* Able to read and speak English (in order to communicate with the technology platform/app
* Over the age of 18

Exclusion Criteria:

* Unable to read or speak English (due to the app being provided in English)
* Unable to access a computer or mobile phone that has access to the internet.
* Currently compliant with a very low carbohydrate ketogenic diet or very low calorie commercial weight loss program
* Planning to change doctors in the next 12 months.
Study of Imaginomics Predicting Early Surgical Rates in Crohn's Disease

Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. Most CD patients require surgery for complications, including stenosis, perforation, and severe intestinal bleeding. Predicting early-onset surgery risk is of great importance to assist launching of therapeutic strategies. We aim to establish a digital prognostic model and nomogram using radiomics, which will help clinical practice.


Eligibility Criteria:
Inclusion Criteria:

patients with a confirmed diagnosis of CD; a follow-up more than 1 year; without previous CD-associated intestinal surgeries; complete data of CTE.

Exclusion Criteria:

patients without a confirmed diagnosis of CD; with incomplete data and a follow-up less than 1 year; patients have previous intestinal surgeries; patients who have never undergone CTE examination.
Effect of Aminobiphosphonates and Statins on Circulating Vgamma9Vdelta2-T Cells

The purpose of this study is to investigate the effects of aminobiphosphonate treatment on the phenotype and function of circulating Vgamma9Vdelta2-T cells and to determine whether these effects are inhibited by simultaneous treatment with statins.

A total of 40 patients will be entered in this study. Half of the patients will receive standard intravenous treatment with aminobsiphosphonates, the other half will be additionally be treated with a statin. Patients already receiving statin treatment will continue this treatment, other patients will be asked whether they are willing to be treated with a statin for a maximum of 5 weeks. Consenting patients will be randomized to receive i.v. aminobisphosponates plus or minus simvastatin 40 mg once daily. Simvastatin will be started one week prior to the first administration of aminobisphosphonates and continued for a maximum of 5 weeks. In each patient 10 ml peripheral blood will be drawn (t=0, t=24 hr, t=1 week, t=3-4 weeks (prior to the 2nd aminobisphosphonate administration). In addition, patients will be requested to measure their temperature thrice daily during the 2 days following the first aminobisphosponate administration. This, because a relation between the occurrence of a febrile response upon aminobisphosponate administration and an activation and expansion of Vy9Vd2-T cells has been suggested. Peripheral blood mononuclear cells will be isolated from the drawn peripheral blood. Using intra- and extracellular flowcytometry Vy9Vd2-T cells will be characterized phenotypically (APC markers: CD1d, CD40, CD80, CD83, CD86, HLA-DR; activation/memory markers: CD25, CD27, CD45RA, CD45RO, CCR7) and functionally (IFN-γ, TNF-α, granzyme B). In addition, the frequency of CD3+, CD4+, CD8+ T cells, NK cells, B cells, iNKT cells, CD4+CD25+ regulatory T cells, and circulating dendritic cells will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication for intravenous treatment with an aminobiphosphonate because of a malignant tumor
* WHO 0,1,2 performance score

Exclusion Criteria:

* WHO 3, 4 performance score
* prior or current use of aminobisphosphonates -immunosuppressive medication (NSAID allowed)
* chemotherapy and/or radiotherapy in 4 weeks prior to start of aminobisphosphonate administration
* renal insufficiency (creatinine clearance \< 30 ml/min)
* liver enzyme abnormalities:

  * bilirubin \> 1.5 times ULN (upper limit of normal)
  * ASAT or ALAT \> 2.5 times ULN (in absence of liver metastases)
  * ASAT or ALAT \> 5 times ULN (in presence of liver metastases)
* concomitant use of strong inhibitors of CYP3A4, such as itraconazole, ketoconazole, erytromycin, clarithromycin, hiv-protease inhibitors or grapefruit juice is contra-indicated.
Evaluation of an Incentive-based Intervention to Improve 90-day Adherence in PAP-Naive Patients

This is a prospective, randomized, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to PAP therapy.

This is a prospective, randomized, two-arm, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to therapy. Randomization will include an allocation ratio of 2:1 (control:treatment).

Participants will be recruited based on evidence that they are struggling to achieve adherence to therapy after the first 3 nights of usage. Two 'site to participant' contacts are required during this study. These contacts can either occur at the clinical site or remotely (e.g., by telephone). During the initial contact, their interest in the study and eligibility will be confirmed, then they will be consented, asked to complete the Baseline Questionnaire, and their demographic information will be collected on case report forms (CRFs).

Participants randomized to the intervention (Group B) will be provided with information and assistance in downloading Restful to their smartphone and registering with Wellth.

At the final contact (90 days), the participant will be asked to complete an End of Study Questionnaire and the investigative staff will collect PAP therapy data for the trial period and record it on CRFs. Participants in Group B will have access to the Restful app discontinued. This completes the participant's active participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants (≥ 18 years of age)
* New diagnosis of OSA
* Prescribed CPAP or APAP for treatment of OSA
* Prescribed a ResMed flow generator compatible with AirView
* Owns a smart phone and is willing to download an app on their phone
* Willing and able to give informed consent
* Can read and comprehend written and spoken English

Exclusion Criteria:

* Have used PAP therapy in the past
* Have been prescribed bi-level or adaptive servo-ventilation therapy
* Are participating in another app-based research study
* Cannot participate for the full duration of the study (at least 90 days)
* Participants who have a medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this study, or constitutes an unacceptable risk to the participant for the duration of the study
Mechanisms of Anxiety and Depression Study

Eligible participants will come in for three separate visits in which they will be interviewed, perform a variety of tasks, and undergo a non-invasive MRI scan. The investigators anticipate that (1) participants with anxiety and depression will likely perform differently than the healthy controls on cognitive tasks, (2) participants with anxiety and depression will likely show differences in brain functionality compared to the healthy controls, and (3) depression and anxiety likely share some underlying mechanisms.

In order to determine eligibility, a brief phone screen lasting approximately 15 minutes will be conducted. If participants are eligible, they will be asked to come in for three separate visits. During the first visit, participants will complete questionnaires as well as a structured interview with one of the study's staff members at Palo Alto University in Los Altos. During the second visit, participants would come to Palo Alto University in Los Altos and complete questionnaires as well as a testing session involving various tasks. During the third visit, participants would undergo a non-invasive brain scan in which participants would complete a task as well as various questionnaires at Stanford University in Stanford.

The investigators have flexible hours and can work around participants' schedules! To inquire more about participation, participants can either email the investigators at paloalto.study@gmail.com or call the investigators at (650) 417-2000 ext. 3642

Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Healthy with no medical conditions OR have a history of anxiety and/or depression
* Ability to travel to both Palo Alto University and Stanford University
Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB)

This study aims to understand the efficacy of two probiotic interventions as prophylaxes of fibromyalgia symptoms in individuals diagnosed.

The primary outcome measure will be the progression and treatment of fibromyalgia, defined as a decrease in the Fibromyalgia Impact Questionnaire (FIQ) score, other otucomes will be the effect on the symptoms of anxiety and depression associated with fibromyalgia, defined as a decrease in the Hospital Anxiety and Depression Scale (HAD) score; perception of pain by scoring on a Visual Analogical Pain Scale (VAS), and differences in the patient's usual medical treatment. Finally adverse effects will be evaluated.

The study will have two arms: one arm including a probiotic preparation and a placebo arm.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 - 65 years.
2. Signature of informed consent by the patient.
3. Patients diagnosed according to the 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia

Exclusion Criteria:

11. Women who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.

2. Known allergy to any of the components of the study product or the placebo. 3. Consumption of antibiotics in the 2 weeks prior to the start of the study. 4. Consumption of probiotics in the 2 months prior to the start of the study. 5. Evidence of neuropsychiatric disorders including: Parkinson's disease, psychotic disorder, bipolar depression 6. Regular consumption of alcohol in excess of 45 g ethanol/day in the year prior to study inclusion.

7. Any concurrent malignant pathology known at the time of inclusion in the study or serious metabolic, cardiovascular, renal, hepatic or gastrointestinal diseases which may lead to non-completion of the study according to the investigator's criteria.
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in OSA

This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to obstructive sleep apnea.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 21 to 65 years inclusive
2. Diagnosis of obstructive sleep apnea (OSA) per International Classification of Sleep Disorders (ICSD-3)
3. BMI 18 to \<40 kg/m2
4. Willing and able to provide written informed consent

Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or lactating
2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria
4. History or presence of any unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy and/or safety assessments per the judgment of the investigator
5. History of bariatric surgery within the past year or a history of any gastric bypass procedure
6. Presence or history of significant cardiovascular disease
7. Unable to washout or refrain from taking any over-the-counter (OTC) or prescription medications that could affect sleep-wake function