cyrilzakka/clinical-trials huggingface dataset:
MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial

1. The investigators hypothesize that increasing radiation dose to the functional MRI-defined lesion in the prostate bed will result in an improved initial complete response (reduction in prostate-specific antigen (PSA) to \< 0.1 ng/mL), which is related to long-term outcome biochemically.
2. Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor regions (when applicable).
3. 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that are related to an adverse treatment outcome.
4. Prostate cancer-related anxiety will be reduced in the MRI targeted SRT arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose (compared to those pts who were treated on standard arm prior to its closure).

Phase 3 arms I (SSRT) and II (MTSRT) were closed. Study recruitment was suspended until re-opening as a single-arm Phase 2 (MTSRT) study.

Eligibility Criteria:
Inclusion Criteria:

1. Prostate cancer patients with a PSA after prostatectomy of at least 0.1 ng/mL and up to 4.0 ng/mL within 3 months prior to enrollment.
2. Patients with or without palpable abnormalities on digital rectal exam (DRE) are eligible.
3. Minimum of 3 months since prostatectomy to allow for return of urinary continence and healing.
4. Imaging detectable lesion or lesions in prostate bed or regional lymph node (LN). Each lesion should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 3 months prior to protocol entry or enrollment.
5. No evidence of metastatic (distant) disease (pelvic nodes are allowed up to common iliac).
6. Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to protocol entry or enrollment.
7. No previous pelvic radiotherapy.
8. Serum total testosterone taken within 3 months prior to enrollment.
9. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 3 years then the patient is eligible.
10. Ability to understand and the willingness to sign a written informed consent document.
11. Zubrod performance status \< 2.
12. Patients must agree to fill out quality of life/psychosocial questionnaires.
13. Age ≥ 35 and ≤ 85 years.

Exclusion Criteria:

a. Prior androgen deprivation therapy is not permitted if it was within 6 months previous to signing consent form. (NOTE: Therapy given as part of the planned course of radiation is allowed).
Trial of a New Online Programme for Physical Activity and Healthy Eating.

Many healthy lifestyle interventions have been developed to help people change their activity and diet, lose weight and thus reduce their risk of developing type 2 diabetes (T2DM) and cardiovascular disorders (CVD). However, these interventions often fail to engage their target audience, which undermines their effectiveness in changing behaviour and health outcomes.

The purpose of this study is to investigate the effectiveness of a self-directed, website-based intervention to promote physical activity and healthy dietary behaviours. The intervention frames health information from a novel perspective, which our previous work has indicated can help to promote interest in the health information and improve attitudes, self-efficacy and motivation towards physical activity and healthy dietary behaviours.

The intervention comprises a website of information resources and personal recording areas to set goals and monitor activity and diet, weekly emails and pedometers. In this trial we aim to see whether the intervention has any impact on people's physical activity and diet, as well as their risk of developing CVD and T2DM. The intervention will be compared with a control condition in which participants will be shown standard resources available on NHS websites. Overweight/obese (BMI 25 - 39.5) males and females aged 35-74 years will be recruited from the community. The active intervention will last 6 weeks (during this period participants will receive weekly emails from the research team) and there will be a 6-week follow-up phase (in which participants will still have access to the website but contact from the research team). Activity, diet, disease risk markers and psychological antecedents of behaviour will be assessed at baseline, post-intervention (6-weeks) and post follow-up (12- weeks).


Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent to participate in the study.
* Male or female and aged between 35-74 years.
* Defined as overweight or obese, i.e. BMI\>25kg/m2.
* Able to travel to the university for assessment days.

Exclusion Criteria:

* Individuals who are not fluent in the English language, and who do not have access to and do not regularly use the internet and an email account.
* Individuals diagnosed with coronary heart disease, chronic kidney disease, type 2 diabetes, stroke, heart failure, severe hypertension (BP\>180/110mmHg) and peripheral arterial disease.
* BMI\>40kg/m2 (morbidly obese).
* Currently using weight loss drugs or other medication that can affect weight.
* Any reported recent (i.e. last 6 months) shift (\>5%) in body mass or large change in habitual lifestyle.
* Individuals unable to change their physical activity (e.g. through disability).
* Current (pre-baseline) or recent (i.e. last 2 months) participation in another research trial or lifestyle supportive intervention or referral.
* Pregnant
Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes, the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.

OBJECTIVES:

* Identify prognostic factors that predict a short survival in patients with stage 0-II B-cell chronic lymphocytic leukemia treated with fludarabine or observation only.

OUTLINE: This is a randomized study. Patients are stratified according to risk (high risk vs low risk). Patients in the low-risk group undergo observation only. Patients in the high-risk group are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive fludarabine.
* Arm II: Patients undergo observation only.

PROJECTED ACCRUAL: A total of 880 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Confirmed diagnosis of B-cell chronic lymphocytic leukemia

  * Rai stage 0-II (Binet stage A) disease
* Meets 1 of the following criteria:

  * High-risk disease, as defined by the following:

    * Serum thymidine kinase level \> 7.0 U/L
    * Elevated β2-microglobulin level
    * Presence of non-nodular bone marrow infiltration
    * Short lymphocyte doubling time
  * Low-risk disease

    * Meets none of the criteria (as listed above) for high-risk disease

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* More than 6 months

Hematopoietic

* No autoimmune hemolytic anemia
* No thrombocytopenia

Hepatic

* Not specified

Renal

* Not specified

Other

* No severe organ dysfunction
* No other prior or concurrent malignancy

PRIOR CONCURRENT THERAPY:

Chemotherapy

* No prior chemotherapy
* No other concurrent chemotherapy
Church-based HIV Screening: Taking It to the Pews

The primary aim of this study is to fully test a culturally/religiously-tailored, church-based HIV screening intervention (TIPS) against a standard HIV information intervention on HIV screening rates at 6 and 12 months with adult African American church members and community members who use church outreach services. Our secondary outcome is to reduce sexual risk behaviors with this same population.

The primary aim of this study is to fully test a culturally/religiously-tailored, church-based HIV screening intervention against a standard HIV information intervention on HIV screening rates at 6 and 12 months with adult AA church members and community members who use church outreach services. In this two-arm clustered, randomized community trial, churches will be matched on SES, membership size, and denomination, then randomized to treatment condition. It is projected that 14 churches (7 churches per arm; 110 church and community members per church; 1,540 participants total) will be required to detect significant increases in HIV screening in the intervention arm. Intervention content is guided by the Theory of Planned Behavior (TPB). Intervention delivery will be guided by a Community Engagement and Social-Ecological approach. This approach includes church leaders delivering culturally/religiously-appropriate HIV education and screening materials (e.g., sermon guides, HIV screening testimonials, church bulletins) and activities (e.g., pastors modeling receipt of HIV screening, HIV screening events) from a church-based HIV Tool Kit through multilevel church outlets (community-wide, church-wide services, ministry and outreach groups, individual) to increase intervention reach and dosage. It was hypothesized that this church-based HIV screening intervention will significantly increase HIV screening rates vs a standard HIV information intervention in AA church-populations at 6 and 12 months. The role of potential mediators and moderators related to receipt of HIV screening will be evaluated and a process evaluation to determine modifiable implementation fidelity, facilitators, barriers, and costs related to increasing church-based HIV testing rates will be conducted. This intervention study could provide an effective, scalable model for HIV screening interventions in AA churches.

Eligibility Criteria:
Inclusion Criteria:

* All participants must be: aged 18 to 64; willing to participate in 3 surveys after church services or church outreach activities
* Willing to provide contact information (two phone numbers, mailing and email address, phone numbers for two persons with whom they have ongoing contact)
* Attend church at least once a month or use church outreach services, such as food and clothing programs, at least 4 times per year.

Exclusion Criteria:

* Minors 18 and under are intentionally excluded since the intervention study has been designed specifically for adults with information of how HIV affects the African American adult population.
Graz Study on the Risk of Atrial Fibrillation

Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient characteristics increase the likelyhood of AF and at the same time the risk of stroke when AF has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease). However, occasional (paroxysmal) AF may occur without symptoms and remain undetected, leaving patients at risk.

Aim of the prospective randomized study is to compare two management strategies for patients at increased risk for AF but without a known history of AF. Patients are seen regularly (monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of patients additionally receives a subcutaneous implantation of a loop recorder for continuous rhythm monitoring, while the control group remains on standard follow-up. Observation period is one year (optional extension for 3 years). The time to first diagnosis of AF is compared between groups, blood samples are analyzed for potential biomarkers of AF.


Eligibility Criteria:
Inclusion Criteria:

* CHA2DS2-VASc risk score \>= 4\*
* 18 years or older

Exclusion Criteria:

* known history of atrial fibrillation
* implanted rhythm device
* pre-existing indication for oral anticoagulation

(\*)CHA2DS2-VASc: C - chronic heart failure (1 point); H - hypertension (1 point); A - age \>= 75 years (2 points); D - diabetes (1 point); S - stroke (2 points); V - vascular disease (1 point); A - age \>=65 and \< 75 years (1 point); Sc - sex category (female) (1 point) ;
Project IntERact Study

This study will use a randomized control trial design (RCT) to pilot test a multisession remote therapy behavioral intervention for risky firearm behaviors and associated behaviors/consequences among adolescents. The study will pilot a state-of-the-art intervention delivery approaches (e.g., remote therapy, smartphone-based APP intervention content delivery) for reducing violence and associated behaviors among urban youth. Given the significant morality and mortality associated with firearm violence, the study will have significant impact by identifying optimal intervention strategies for future large-scale behavioral intervention trials.

The specific aim of this pilot study is to pilot test an m-health intervention, as compared to enhanced usual care \[n=70; 35/group\], with eligible youth to assess intervention acceptability, feasibility, and fidelity, as well as trends towards decreased risky firearm behaviors, substance use, and criminal justice involvement. Specifically, 70 youth (ages 16-24) in the ED screening positive for firearm carriage and smartphone ownership will be randomly assigned (stratified by age/gender) to either the IntERact group or the control group. IntERact group participants will receive an Emergency Department (ED) session of behavioral therapy, followed by five additional remote therapy sessions of behavioral therapy delivered over the 5 weeks following their ED visit. Behavioral therapy will be comprised of motivational interviewing (MI), cognitive behavioral therapy (CBT), and strengths-based care management (CM). In addition, youth in the IntERact group will also receive a smartphone APP that will be downloaded to their phone. The APP will deliver daily surveys, daily tailored MI and CBT messages in response to survey results, one-touch access to pro-social supports, psycho-educational materials, GPS-enabled message alerts, and facilitated access to CM resources. Youth enrolled in the control group will receive a pamphlet with local violence, substance use, and mental health resources. A follow-up assessment will be completed in each group at 4 months post-ED visit. Pilot data will aid in refining and clarifying content and clinical trial design elements for a future fully powered randomized control trial of the intervention (i.e., R01 proposal).

Eligibility Criteria:
Inclusion Criteria:

* Past 4-month firearm carriage
* Ownership of a smartphone with APP capabilities

Exclusion Criteria:

* Non-english speaking patients
* Patients unable to provide informed consent due to mental incompetence, incarceration (i.e., active police custody), medically unstable (abnormal vital signs requiring urgent resuscitation)
* Patients presenting for acute suicidal ideation or acute suicide attempt, child abuse or sexual assault.
Pulpotomy vs.Root Canal Treatment in Managing Irreversible Pulpitis

The study aims to compare two methods of repairing and saving a badly damaged or infected tooth. One method is called root canal treatment (RoCT) and the other (new method) is called pulpotomy. RoCT involves removing the damaged area of the tooth including the tooth nerve (called the pulp), cleaning, disinfecting and sealing it. Pulpotomy however attempts to preserve as much of the tooth nerve as possible (keeping the tooth alive). RoCT is more expensive and painful. Therefore, some patients delay or avoid getting treated, resulting in later complications treated in an emergency setting. This research will aim to show that pulpotomy is less painful, less involved (i.e. less invasive), less time consuming and consequently more cost effective. Long term costs of dental treatment as well as the improved quality of life will therefore offer benefits for patients, public and the NHS who use dental services. Caries (tooth decay) is the most common diseases in the world. The NHS spends at least £3.4 billion per year on dental visits or at dental hospitals. This does not include private (societal) costs to individuals who do not qualify for NHS dental treatment. Consequently, those who end up avoiding or delaying treatment result in complications often treated through the NHS. We have therefore chosen a randomized controlled trial design, a gold standard method to compare the effectiveness of the two treatment options. The participants will be 168 dental patients (male or female) from different parts (London and Liverpool) of the UK so that results can be generalized. This design was considered in consultation with a member of the public (a co-applicant) who will be involved in the trial from the start to completion. The results will be published and discussed at conferences as well as through our patient and public network.


Eligibility Criteria:
Inclusion Criteria:

* • Dental patients from an acute (secondary care) setting from at least three UK centres (including King's College London Dental Institute, Denmark Hill and Liverpool).

  * Male or female (aged \>16) able to provide informed consent in otherwise good general health with at least one molar tooth with clinical symptoms of irreversible pulpitis caused by caries, requiring RoCT (endodontic treatment).
  * Patients enrolled will have clinical symptoms of irreversible pulpitis who need treatment.

Exclusion Criteria: Exclusion Criteria:

* The presence of fistulas or swelling
* Anterior teeth or premolars
* External or internal root resorption
* Multiple teeth with carious lesions in the same quadrant,
* Pregnant women, in view of requirements for radiographs.
* Patients younger than 16.
* Patients unable to give consent.
* Patients who have been administered antibiotics in the previous month.
* Immunocompromised patients
* Teeth with hopeless prognosis with caries extended into root dentine and with tooth margin at crestal bone level
Prediction of Weaning Outcome from Mechanical Ventilation Using Ultrasound

Examine the predictive value of lung ultrasound in assessing the success of SBTs and tracheal extubation among patients receiving mechanical ventilation in the intensive care unit (ICU).


Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patients will be included in the study when the underlying disease that had required intubation is considered by the attending physician as reversed and after fulfilling the criteria of weaning (alertness, and Adequate gas exchange, normal pH levels, low and stable doses of vasoactive drugs, normal electrolyte levels, and a rapid shallow breathing index (RSBI) of 105 breaths per minute per liter or lower ) rendering the patient eligible to a first SBT.

Exclusion Criteria:

* Exclusion criteria include patients aged \< 21yrs , patients with tracheostomy, paraplegia with medullar level above T8, cardiac arrhythmias, severe ICU-acquired neuromyopathy, chronic obstructive pulmonary disease with forced expiratory volume \<50% of the theoretical predicted value, patients with planned prophylactic noninvasive ventilation after extubation, and patients who had previously failed a SBT
Hypoglycemic and Hyperglycemic Disorders

Definition of low birth weight:

Low birth weight infants are those born weighing less than 2500 g. These are further subdivided into:

* Very Low Birth Weight : Birth weight \<1,500 g
* Extremely Low Birth Weight : Birth weight \<1,000 g Their survival is directly related to birth weight, with approximately 20% of those between 500 and 600 g and\>90% of those between 1,250 and 1,500 g surviving. Perinatalcare has improved the rate of survival of low birth weight infants.

Causes of low birth weight:

* Premature birth
* Intrauterine growth restriction, which are most often Due to different placental problems and health problems of the mother or new-born

RISK FACTORS:

* Age: Teen mothers have a much higher risk of having VLBW infant.
* Multiple birth babies are at increased risk of being VLBW because they often are premature. More than 50% of twins and other multiple gestations are VLBW if \<15 years
* Maternal health: Women exposed to drugs, alcohol, and cigarettes during pregnancy are more likely to have low birth weight babies. Mothers of lower socioeconomic
* Race: African-American babies are twice as likely as Caucasian to be very low birth weight

Eligibility Criteria:
Inclusion Criteria:

* All neonates admitted to neonatology unit

  1. From 0-28 days
  2. Weighting less than 2500gm

Exclusion Criteria:

* Any neonate weighting more than 2500 gm
A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy

This study will examine and compare the health-related quality of life and degree of symptom discomfort in two groups of patients receiving intensive drug therapy for HIV infection. One group will receive continuous treatment over the entire 88-week study period; the other will have interruptions in therapy over the same time period.

Patients enrolled in the National Institute of Allergy and Infectious Disease's trial, "Immunologic and Virologic Studies of Intermittent versus Continuous HAART \[highly active antiretroviral therapy\] in the Treatment of HIV Disease," may participate in this study. At periodic intervals for a total of 7 times during the 88-week trial, this companion study will require participants in both the interrupted and the continuous therapy groups to complete the following two questionnaires:

1. MOS-HIV Health Survey - The patient provides a self-assessment of his or her physical and emotional well being. Survey questions are related to the ability to perform work and daily living activities, mood and state of mind, limitations on social activities, ability to concentrate, energy level, pain level, general quality of life, etc.
2. Symptom Distress Scale - The patient rates the degree of symptom distress by ranking from 1 to 5 his or her agreement with statements about various physical and emotional factors, including appetite, nausea, breathing, cough, pain, insomnia, fatigue, bowel problems, concentration, appearance, and outlook.

Understanding the impact of HIV treatments on health-related quality of life and symptom distress may provide information helpful in evaluating new treatment approaches.

Because of multi-drug regimens known as highly active antiretroviral therapy (HAART), HIV infection can now be considered a chronic, manageable disease for many people in the United States. However, these therapies come with complex medication administration regimens and numerous side effects and distressing symptoms, which may impact significantly on a person's health-related quality of life (HR-QOL). The purpose of this study is to evaluate the HR-QOL and symptom distress (the degree of discomfort from specific symptoms) in individuals participating in the NIAID protocol, "Immunologic and virologic studies of intermittent versus continuous HAART in the treatment of HIV disease". In that study thirty-five subjects will be randomly assigned to receive continuous HAART therapy and 35 subjects will receive interrupted therapy. In this, a companion study, HR-QOL and symptom distress will be measured at seven time points during the 88 weeks of the protocol. Data will be analyzed using repeated measures and multivariate statistical tests.

Eligibility Criteria:
Patients must be HIV seropositive man or women of at least 18 years of age who are enrolled in the NIAID clinical trial, "Immunologic and virologic studies of intermittent versus continuous HAART in the treatment of HIV disease".

Patients must be able to read and understand standard English.