cyrilzakka/clinical-trials huggingface dataset:
Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer

The investigators recently published 2 phase II trials on the use of helical tomotherapy for oligometastatic colorectal cancer \[1,2\]. Despite a dose increase from 40 to 50 Gy, delivered in 2 weeks time, the one-year local control was 54% only \[1,2\]. The high local failure rate is probably the result of geographical misses due to tumor motion and a biologically effective dose (BED) of \< 100 Gy. The current study will investigate whether the one-year local control rate can be improved to 70%, using respiration correlated CT to individualize the margin needed to account for tumor motion, to avoid geographical miss, together with a Monte Carlo or collapsed cone dose calculation algorithm delivering 50 Gy to the 80% isodose, allowing higher doses in the tumor core. As the concept of an internal target volume (ITV) may result in large margins for patients displaying metastases in high mobile organs, such as liver and lung, which may lead to exposure of a relatively high dose to a large volume of normal tissue, dynamic tumor tracking by the VERO SBRT system will be applied in those patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with metastatic cancer from any primary origin and no more than 5 metastases on CT--scan
2. Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy)
3. Functional liver volume \> 1000cc in case of liver metastases and a lung diffusion capacity for carbon monoxide (DLCO) of \> 30% if lung mets
4. No Child B or C liver cirrhosis
5. No systemic treatment within 1 month before initiation of radiotherapy
6. No contra-indications for radiation of all metastatic disease (= no violation of constraints of organs at risk (OAR))
7. No metastases from another carcinoma
8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
9. Age \> 18 years
Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD

The main objective of this proposal is to develop and test the efficacy of two interventions (a telehealth and face-to-face intervention) designed to improve quality of life, self-care, motivation to engage in healthcare, and psychological distress in patients diagnosed with HCV and PTSD. It is hypothesized that

Patients with comorbid diagnoses of HCV and PTSD may experience increased risk of diminished quality of life, given that PTSD is associated with poor self-care and medical non-compliance. To date, no systematic efforts to improve quality of life in this high-risk population have been documented. The main objective of this proposal is to develop and test the feasibility and efficacy of two cognitive-behavioral interventions (a telehealth intervention and a face-to-face intervention) designed to improve quality of life, self-care, motivation to engage in healthcare, and psychological distress in patients diagnosed with HCV and PTSD. A secondary objective is to evaluate the cost effectiveness of the interventions. I plan to develop the interventions, pilot test them, and deliver the refined treatments to veterans with HCV and PTSD. Participants will be 70 patients from VA Boston who meet study criteria. Assessment will occur at pre-treatment, post-treatment, and 3- and 6-month follow-up. Assessments will measure quality of life, self-care, motivation to engage in healthcare, and psychological distress. Analyses will examine study feasibility, the effects of the treatment conditions, and the cost effectiveness of the interventions. It is hypothesized that the telephone and face-to-face intervention will improve outcomes, as compared to treatment as usual, but that the participants will be more satisfied with the telephone intervention. In addition, it is predicted that the telephone condition will be cost effective as compared to the face-to-face intervention

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hepatitis C
* Clinical diagnosis of posttraumatic stress disorder
* Need to have access to a telephone

Exclusion Criteria:

* Life threatening or acute illness
* Current alcohol or substance dependence
* Currently prescribed interferon treatment
* No access to a telephone
A Study of LY3972406 in Adult Participants With Moderate-to-Severe Plaque Psoriasis

The main purpose of this study is to determine the efficacy and safety of LY3972406 in adult participants with moderate-to-severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Have moderate-to-severe chronic plaque psoriasis for at least 6 months prior to baseline
* Have venous access sufficient to allow for blood sampling
* Are able to swallow oral medication

Exclusion Criteria:

* Have any other skin conditions, excluding plaque psoriasis
* Have a current or recent acute, active infection
* Have manifestations of other autoimmune diseases, such as systemic lupus erythematosus.
* Are lactating or breastfeeding women
Cardiopulmonary Testing for Potential Pancreas Transplant Candidates

Patients being assessed for Kidney Pancreas transplantation often have pre-existing co-morbid disease that contributes to structural cardiac and vascular disease. There is no consensus on optimal pre-listing cardiac assessment to reliably minimize risk of peri-operative cardiac events. Functional status using the cardio-pulmonary exercise test (CPET) has been used in cardiac and abdominal surgery, including abdominal aortic aneurysm (AAA) repair and kidney transplantation, but high risk patients with diabetes are often lacking from these studies. This study will investigate the correlation between function, measures using CPET and standard cardiac assessment, and determine the variation in usual measures of anaerobic threshold and VO2 max in this population.

20 participants will be recruited to a blinded observational study. Patients referred for pancreas kidney transplantation assessment will be provided information about the study. They will subsequently be approached at their initial assessment visit and informed consent will be taken.

Participants will have standard clinical assessment which includes:

1. Clinical history and examination
2. 12 lead electrocardiogram (ECG)
3. Chest X-ray (CXR)
4. Myocardial perfusion imaging (MPS)
5. If MPS imaging is suggestive of stress induced ischaemia, or severe left ventricular (LV) dysfunction, the participant will undergo coronary angiography as part of standard assessment protocol.

In addition, study participants will undergo CPET testing. This will take place within 1 week of the standard peri-operative cardiac assessment. The results of this investigation will be recorded against a unique identifier on a secure Oxford University Hospital computer. Information about the study or participants' individual results will not normally be disclosed to the participant or clinical team, and so will not influence clinical management. However if, when the results are analysed, the research team note a CPET result that suggests a clear and significant impairment of functional reserve such that the participant should not be listed, this result will be disclosed to the individual and their medical team so that the information can be used in order to make the safest decision about transplant listing. There will be no further clinical visits but participants will consent to collection of their clinical data until 3 months post-transplant, or until they are removed from the waiting list.

At the end of the study, the results of CPET testing will be correlated to measures from standard cardiac investigations and to peri-operative cardiac events.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent
* Diagnosed with type 1 diabetes mellitus with estimated glomerular filtration rate (eGFR)\<20ml/min or on renal replacement therapy referred for simultaneous pancreas-kidney (SPK) transplant

Exclusion Criteria:

* Participant unable to undergo CPET testing due to limitation on mobility or limb movement
Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks

This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%. The basal rate and patient-controlled bolus volume will depend upon the treatment group, but the total dose of local anesthetic is the same for each. For the duration of the study, all patients will receive the current usual and customary analgesics for bilateral TKA patients. All patients will receive a ropivacaine perineural infusions initiated in the operating room and continued until at least the afternoon of postoperative day (POD) 2, as well as oral acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with 0 equal to no pain and 10 being the worst imaginable pain.

The investigators propose to test the null hypothesis that differing concentrations of ropivacaine (0.1% vs. 0.4%) at an equal total dose has no impact on quadriceps muscle strength during a continuous femoral nerve block following total knee arthroplasty (TKA). These results will help define the optimal concentration of local anesthetic used for continuous peripheral nerve blocks.

Eligibility Criteria:
Inclusion Criteria:

* Primary, bilateral TKA
* Age 18 years or older
* Postoperative analgesic pain includes bilateral continuous femoral nerve blocks

Exclusion Criteria:

* Chronic, high-dose opioid use
* History of opioid abuse
* Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
* Pregnancy
* Incarceration
Impact of MayoExpertAdvisor on Provider Adherence

This study evaluates the efficacy of MayoExpertAdvisor (MEA), a knowledge delivery tool, to improve adherence to best practices for patients with hyperlipidemia, atrial fibrillation and heart failure. Half of the clinicians will receive MEA, while the other half will not receive MEA.

The investigators hypothesize care teams with access to MEA will act upon recommendations at a higher rate than those care teams in the standard of care arm without access to MEA.

MEA is designed to increase adherence to consensus national guidelines and quality measures which are the standard of care for hyperlipidemia, atrial fibrillation, and heart failure. These diseases were selected based on national data which suggest there is less than optimal adherence to standard of care therapy and this non-adherence is associated with adverse cardiovascular outcomes.

There are 29 care teams in the Employee and Community Health (ECH) practice. Care teams are comprised of 4-8 clinicians who provide primary care to between 3,000 and 8000 patients. 8 care teams are resident/fellow led and will be excluded from the study. The remaining 21 care teams in the ECH practice will be stratified by clinic location and provider specialty (Internal Medicine, Family Medicine). 20 care teams will then be cluster-randomized to either the intervention arm or standard of care arm.

Prior to randomization, clinicians in both arms will receive the same educational module to the current guidelines for management of the atrial fibrillation, heart failure and hyperlipidemia. Clinicians in the intervention arm will receive training by the research team on the use of MEA. This training will clearly inform clinicians that they are always to use their best clinical judgment.

Eligibility Criteria:
Clinician Inclusion Criteria:

* Physicians
* Assistants
* Nurse Practitioners

Clinician Exclusion Criteria:

* Clinicians providing care to nursing home patients
* Pediatricians
* Residents and fellows

Patient Record Inclusion Criteria:

* Diagnosis of hyperlipidemia, atrial fibrillation, and/or heart failure

Patient Record Exclusion Criteria:

* Unscheduled visits
Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO19)

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile below
* Meeting the demographic requirements

Exclusion Criteria:

* Age below 18 or over 50
* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Carboxyhemoglobin levels over 3%
* Subjects whom the investigator consider ineligible for the study
Pharmacological Properties of Salmeterol

The objective of the study is to help establish a urinary threshold for salmeterol on the World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in competitive sports.

Hence, there is no hypothesis as such.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-45 years
* Healthy

Exclusion Criteria:

* Chronic disease
* Smoking
* Habitual use of medicine
* Allergy towards salmeterol
* Unable to exercise on a bike ergometer
Effect of NMBA on Surgical Conditions in THR

During Total hip replacement arthroplasty (THA), the hip joint first must be luxated in order to have access to the joints. A lot of force and torque must be carried out on the joint to perform this manipulation. This is both difficult for the surgeon and may cause additional tissue damage and postoperative pain. After placement of the prosthesis and reduction of the joint, the tension of the hip joint must be evaluated by the surgeon to ascertain the adequacy of the prosthesis. During luxation, minimal muscle tension would be ideal, while after reduction of the joint, normal muscle tension is desired to permit assessment of the mechanics of the hip joint.

The aim of the study is to investigate whether deep neuromuscular block, combined with a reversal before mechanics assessment improves surgical conditions, surgical time, and postoperative patient comfort.

2X20 patients are randomised: Rocuronium-group (R-group) and Placebo-group (P-group).

All patients receive standardised multimodal intravenous analgesia. After standardised induction of anasthesia and patient positioning, the patient is administered either placebo or rocuronium 0.9 mg/kg, followed by continuous infusion of either placebo or rocuronium 0.4 mg/kg/h. 1 minute before reduction of the hip joint, the patient is administered either sugammadex (R-group) or placebo (P-group) for full reversal of the neuromuscular block.

During the surgery, time points are recorded for: incision, start luxation of the joint, start reduction of the joint, start skin closure.

The surgeon is blinded for patient allocation. At three moments (after luxation, just before reduction of the joint, and after assessment of joint mechanics), the surgeon is asked to appraise the surgical conditions on an analogue scale.

Postoperative analgesic consumption and pain scores are recorded. VAS scores for knee pain and hip pain are assessed before surgery, at the moment of discharge from the post-anesthesia care unit (=D0), the morning after surgery (=D1), at D2, and at D7.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* eligible for primary THA
* BMI \<35

Exclusion Criteria:

* neurological or psychiatric disorders
* intolerance or allergy against investigational drugs or any of the drugs used in the standardized analgetics scheme (acetaminophen, diclofenac, ketamine, clonidine, lidocaine)
Impact of Aerobic Exercise Training on Sympathetic Vasoconstriction and Vascular Function in Essential Hypertension

Sympathetic nervous activity plays an important role in the development of hypertension and studies have shown that the pannexin-1 channel is involved in the signalling of the sympathetic activity to the vascular bed. The main project aim is to investigate the effects of 10 weeks of high intensity training on the effect of the sympathetic nervous activity on vascular function in individuals with essential hypertension. A secondary aim is to assess the role of essential hypertension and physical activity on vascular endothelial function,


Eligibility Criteria:
Inclusion Criteria:

* Sedentary men and women age 35 - 65 years
* Resting blood pressure \>140/90 mmHg or Resting blood pressure \<140/90 mmHg
* Essential hypertension
* Non or exclusively antihypertensive medication

Exclusion Criteria:

* Hypertensive condition other than essential hypertension
* Other chronical diseases
* Smoking
* Excess alcohol intake or drug abuse
A Study to Evaluate the Blood Glucose Regulation and Safety of PPB-R-203-02 Based Noodle Versus Commercially Available Wet Noodle in Patients With Diabetes

To evaluate the result of PPB-R-203-02 based noodle and commercially available wet noodle on blood glucose control in 24 patients with diabetes for 2 days.

The MiniMed Medtronic CGMS (continuous glucose monitoring system), the first model approved by FDA, was used for subcutaneous glucose monitoring. The CGMS continually measures the glucose concentration of the interstitial fluid every 10 seconds and then stores an average glucose value for each 5 minutes period, for a total of up to 288 measurements each day.

Eligibility Criteria:
Inclusion Criteria:

1. Diabetes mellitus patient.
2. Aged between 20 to 65 years old.
3. Informed consent form signed.

Exclusion Criteria:

1. A recent history of drug or alcohol abuse.
2. Sensitivity to analogous product.
3. Serious cardiovascular disorders.
4. Participation in another clinical investigation study.
5. Ongoing influenza, autoimmune disease and other metabolic diseases.
6. Pregnant or lactating women.
7. Individuals are judged by the investigators or co-investigator to be undesirable as subjects.
Canrenone as Add-on in Patients With Essential Hypertension

To evaluate the efficacy on blood pressure reduction, safety and tolerability of two different dosages of canrenone as add-on therapy in patients already treated with Angiotensin Converting-Enzyme Inhibitors (ACE-I) or Angiotensin II Receptor Blockers (ARBs) and diuretics at the maximum dosage.

To evaluate the efficacy on blood pressure reduction, safety and tolerability of two different dosages of canrenone as add-on therapy in patients already treated with Angiotensin Converting-Enzyme Inhibitors (ACE-I) or Angiotensin II Receptor Blockers (ARBs) and diuretics at the maximum dosage.

In this multi-centre, phase IV, randomized, controlled, open-label, parallel groups trial, 180 Caucasian patients affected by uncomplicated, essential hypertension, not well controlled by concomitant administration of ACE-I or ARBs and diuretics at the maximum dosage will be enrolled.

At baseline patients will be randomized to canrenone, 50 mg, or canrenone 100 mg once a day, in addition to their current therapy, for three months.

At the baseline, and after 3 months will be evaluated: systolic (SBP) and diastolic blood pressure (DBP), pulse pressure (PP), heart rate, fasting plasma glucose (FPG), homeostasis model assessment insulin (HOMA-index), total cholesterol, HDL-cholesterol, triglycerides, LDL-cholesterol, sodium, potassium, calcium, magnesium, uric acid, estimated glomerular filtration rate (eGFR), plasmatic urea, brain natriuretic peptide (BNP), aldosterone, and galectin-3.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian patients affected by uncomplicated, essential hypertension, not well controlled by concomitant administration of ACE-I or ARBs and diuretics at the maximum dosage.

Exclusion Criteria:

* diabetes mellitus
* secondary hypertension
* pregnancy
Keeping it LITE: Exploring HIV Risk in Vulnerable Youth With Limited Interaction and Digital Health Intervention

Despite advances in HIV diagnostics, care and prevention strategies, infection rates among adolescent and young adult sexual and gender minorities (SGM) continue to rise in the United States (US). There is an urgent need to describe the epidemiology and trajectories of HIV acquisition in this population and to offer age and culturally appropriate scalable prevention interventions to those at highest risk of infection in the US. This project will engage and retain young SGM in an innovative longitudinal cohort, enroll participants in a dynamic established digital health retention platform (HMP; HealthMPowerment), monitor HIV risk and prevention behaviors and explore the socioecological factors that influence the use of new HIV prevention technologies (UG3 phase), while also allowing targeted testing of novel digital health interventions (UH3 phase). In Aim 1, the investigators will enroll and retain a large (n=6000; 3000/year), diverse cohort of sexually active, SGM adolescents and young adults, ages 13-34, using innovative digital recruitment, engagement and retention strategies. Over the course of the study, the investigators will longitudinally characterize the sexual behavior, HIV transmission risk, and PrEP uptake trajectories of SGM youth utilizing epidemiological trajectory analyses to identify the most effective points of intervention (Aim 2). This study will capitalize upon productive existing partnerships and digital health expertise to articulate the drivers of the ongoing HIV epidemic among the most vulnerable populations in the US in order to identify the most effective, expeditious and scalable strategies to address this ongoing public health crisis.


Eligibility Criteria:
Inclusion Criteria:

* For young adults ages 18-34: self-identified SGM young adults ages 18-34 who meet at least one of the following criteria:

  * 1) condomless anal or vaginal intercourse (CAI) with a cisgender man in the last 6 months OR
  * 2) sex with cisgender men and bacterial STI in the last 6 months OR
  * 3) anal or vaginal sex with a known HIV-infected partner in the last 6 months.
* For adolescents 13-17: self-identified SGM adolescents ages 13-17 who have engaged in any sexual activity (e.g., oral, anal or vaginal sex)

Exclusion Criteria:

* under age 13
* over age 34