cyrilzakka/clinical-trials huggingface dataset:
Anti-tumor Immune Response in Patients With Cancer Undergoing Radiation Therapy

This research trial studies the effect of radiation therapy on tumor immunity. Standard radiation therapy destroys tumor cells. In response to tumor cell death caused by radiation therapy, the body has an ability to stimulate an anti-tumor response (immunity), but this response is often ineffective in shrinking tumor tissue. Collecting samples of blood from patients before, during, and after radiation therapy to study in the laboratory may help doctors learn more about the effects of radiation therapy on anti-tumor response.

PRIMARY OBJECTIVES:

I. To assess the effect of radiation therapy on tumor immunity.

OUTLINE:

Samples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated Institutional Review Board (IRB)-approved Informed Consent form for the study
* Received an explanation of the study, including satisfactory answers to all questions related to the proposed research
* Is undergoing physician directed radiation treatment

Exclusion Criteria:

* The potential Subject is unwilling or hesitant to participate for any reason and/or fails to complete the appropriate Informed Consent form
Role of Anabolic Steroids on Intensive Care Unit-Acquired Weakness

The researchers intend to investigate possible anabolic effects of bi-weekly exogenous testosterone administration during intensive care unit (ICU) stay for up to 8 weeks. Control group will receive standard ICU management and will also be followed during ICU stay.

For the study chronic critical patients will be included according to criterion of mechanical ventilation by orotracheal tube\> 14 consecutive days or mechanical ventilation by tracheostomy\> 8 consecutive days and that do not present exclusion criteria.

Patients will be randomized into two follow-up groups: Intervention group with anabolic steroid and control group.

The anabolic steroid intervention group will receive a bi-weekly dose of 200mg intramuscular testosterone cypionate and receive the standard treatment of nutritional therapy and physical therapy. While patients in the control group will receive only the standard treatment of nutrition and physical therapy, without addition of the anabolic drug.

At the beginning of the study and weekly the patients will be evaluated in relation to the muscular profile with diaphragm ultrasound and Medical Research Council (MRC) application. In addition to the collection of serum homograms, leukogram, lipid profile and renal function tests.

Weight and nutritional therapy-related data will be identified in the patient's chart regarding caloric and protein requirement and supply adequacy.

In the inclusion and biweekly will be collected serum levels of free testosterone, blood count, leukogram, blood gas, renal function and liver function. Nitrogen balance of patients from urinary urea will be performed.

The evaluations of the groups and the intervention with the anabolic steroid will be of 8 weeks or during the period of dependence of the mechanical ventilation. After this period the patients will be monitored for the outcome: length of stay in the intensive care unit, hospital stay until discharge and clinical outcome: death or discharge.

Eligibility Criteria:
Inclusion Criteria:

* Individuals older than 18 years
* Mechanical ventilation by orotracheal tube for more than 14 consecutive days
* Mechanical ventilation by tracheostomy for more than 8 consecutive days

Exclusion Criteria:

* End of life care
* Known hypersensitivity to formula
* Venous or arterial thrombosis within last 6 months: ischemic stroke, myocardial infarction, acute peripheral arterial occlusion, acute mesenteric ischemia, deep venous thromboembolism, pulmonary embolism
* Decompensated congestive heart failure
* Acute liver failure or acute on chronic liver failure
* Refractory shock (norepinephrine dose \>0.3 mcg/kg/min or equivalent doses of any vasoactive agent)
* Platelets below \<20,000 / mm3 without transfusion plan
* Personal history of prostate cancer
* Primary neuromuscular disorders such as myasthenia gravis, Guillain-Barré syndrome, amyotrophic lateral sclerosis, Duchenne Muscular dystrophy
* Current or prior spinal cord injury
A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension

The main purpose of this study is to assess the serum free cortisol response after ACTH stimulation test at baseline and at Week 8 in participants with uncontrolled hypertension.

This is a placebo-controlled study to evaluate cortisol reserve after ACTH stimulation test following treatment with 2 milligrams (mg) baxdrostat versus placebo.

The study consists of 3 period:

* 4-week screening period.
* An 8-week double-blind treatment period.
* A safety follow-up 2 weeks after last dose.

Participants will be randomized in a 2:1 ratio to one of 2 treatment arms:

1. Baxdrostat
2. Placebo

Participants will receive either baxdrostat or placebo.

The overall study duration will be up to 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participants with mean seated systolic blood pressure (SBP) on automated office blood pressure measurement (AOBPM) greater than equal to (\>=) 130 millimeter of mercury (mmHg) and less than (\<) 170 mmHg at screening.
* Participants with mean seated SBP on AOBPM of \>=130 mmHg and \< 170 mmHg at randomization.
* Participants must have a stable regimen of \>=1 antihypertensive medication (at least one should be a diuretic), for at least 4 weeks prior to screening.
* Participants must have an estimated glomerular filtration rate (eGFR) \>=45 milliliter per minute (mL/min)/1.73-meter square (m\^²) at screening.
* Participants must have a serum potassium+ (K+) level \>=3.5 and \< 5.0 millimole per liter (mmol/L) at screening.

Exclusion Criteria:

* Mean seated diastolic blood pressure (DBP) on AOBPM \>=110 mmHg at randomization.
* Prior treatment (within the 4 weeks before screening) with angiotensin receptor Blocker (ARBs) and angiotensin converting enzyme inhibitor (ACEIs) (both taken simultaneously).
* Serum sodium (Na+) level \< 135 millimole per liter (mmol/L) at screening, determined as per central laboratory.
* New York heart association functional heart failure (HF) Class IV at screening.
* Planned percutaneous coronary intervention/coronary artery bypass grafting or percutaneous coronary intervention/coronary artery bypass grafting done within 6 months prior to screening.
* Uncontrolled diabetes with glycated haemoglobin (HbA1c) \> 10.0% (86 mmol/mol) at screening.
* Fridericia's corrected QT (QTcF) value \> 470 milliseconds (ms) at screening, unless having a pacemaker.
* Heart rate \< 45 or \> 110 beats/min in a resting position, as per vital signs assessment.
Balancing of Patients Treated by Vitamin K Antagonists (VKAS) in General Medicine

Despite the rise in prescriptions for direct oral anticoagulants,Vitamin K antagonists(VKA) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. They remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. The balance of the patients under VKA can be appreciated thanks to the time spent in the therapeutic zone or TTR which is correlated with the risk of occurrence of haemorrhagic or thrombotic events.

Despite the rise in prescriptions for direct oral anticoagulants, Vitamin K antagonists (VKA) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. They remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. The balance of the patients under VKA can be appreciated thanks to the time spent in the therapeutic zone or TTR which is correlated with the risk of occurrence of haemorrhagic or thrombotic events.

The management of VKA in France seems hardly comparable to that of the neighboring countries in front of:

* A TTR estimated at 60%.
* Majority management of anticoagulant treatments by general practitioners.
* The weak development of clinics anticoagulants.
* The takeoff of direct oral anticoagulant prescriptions.
* Preponderance of fluindione prescriptions among the various oral anticoagulants.

It therefore seems interesting to study a cohort of French patients under VKA. Through the calculation of the TTR, the investigators will be able to draw a picture of the balance of the anticoagulant treatment and try to identify factors that can influence it.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated with VKA.
* Realization of INR in one of the labs of the territory of LaboSud Oc biology between 1 September 2015 and 13 January 2016.

Exclusion Criteria:

* Less than 3 INR during the data collection period (TTR calculation not possible).
* Time greater than 56 days between two INRs (calculation of the invalid TTR).
* Interrupted treatment (calculation of invalid TTR).
* Lack of information about the patient
Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN

The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active LN in multiple countries of interest. This study aims to provide the first long-term (up to 5 years) assessment of renal function preservation in belimumab treated participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants to provide a signed informed consent at the time of enrollment per protocol,
* Male or female aged 18 or over at initiation of belimumab,
* Participants received belimumab for the treatment of active LN prescribed as per local label in combination with standard immunosuppressive therapy/ies at initiation of belimumab,
* Participants initiated belimumab 6 to 24 months prior to study enrollment,
* Accessibility of medical records starting at belimumab initiation (including accessibility of medical records for the prior 12 months and confirmatory biopsy within the prior 24 months from belimumab initiation),
* Biopsy-confirmed diagnosis of active LN in the two-years prior to the initiation of belimumab

  * Class III (focal LN) with or without Class V (membranous LN),
  * Class IV (diffuse LN) with or without Class V,
  * Class V.

Exclusion Criteria:

* Participants receiving renal replacement therapy at initiation of belimumab,
* Participant is concomitantly receiving another biologic at initiation of belimumab,
* Participants in a clinical trial during the observation period (with the exception of allowing participation in other non-interventional studies),
* Participant is pregnant at the initiation of belimumab,
* Participant with a kidney transplant at the initiation of belimumab,
* Participants will be excluded from the study if they are planning to become pregnant or are pregnant at study enrollment.
Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy

Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.

The Researcher developed a diagnostic device called Diffuse Optical Spectroscopy Imaging is a non-invasive optical technique that utilizes intensity-modulated, near-infrared light to quantitatively measure optical properties in thick tissues.

Diffuse Optical Spectroscopy Imaging can images tissue hemoglobin , oxygen saturation, blood volume fraction, water content, fat content and cellular structure. The measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development.

There is no therapeutic benefit to the subject, especially none that might influence the indication for the diagnostic procedure as indicated. However, information obtained may lead to a new form of non-invasive imaging for the early detection of breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old
* Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy

Exclusion Criteria:

* Female pregnant and age less than 21 years old and have no diagnosis of breast cancer
Doctor's Health - Health Behavior of Physicians in Germany

This is an observational study to assess the health behavior of Physicians from medical practices in Germany. Physicians will be asked by a questionnaire (self-report) on health behavior, self-diagnostics and self-medication in case of sickness. We will send the questionnaire to 1000 General Practitioners and to 300 medical specialists in Germany. We expect a response rate of 25-30 %. After electronically data-entry we will run a descriptive analysis for primary outcome. Results may provide a better understanding of the Physicians health behavior.


Eligibility Criteria:
Inclusion Criteria:

* Physicians in German ambulatory setting

Exclusion Criteria:

* any
"Quit Smoking on Your Own" Brief Online Study

Most individuals who smoke want to quit smoking. Most individuals who want to quit, quit on their own. The purpose of this study is to determine whether very brief suggestions provided online are comparatively more effective than others in increasing motivation to quit immediately after the suggestions are implemented and actual quit rates one month later.

There are no costs associated with participating in this study and participants will not be compensated for their participation.

To join the study paste the following link into your browser:

https://www.i4health-pau.org/quit-smoking-on-your-own

The entire study takes place online on an automated website.

Participants will be recruited online using search engine ads (e.g., Google), online association list serves, community websites designed to reach individuals interested in participating in research studies, and social media sites related to smoking cessation efforts.

The entire study will be administered online. Participants may complete it at a time and place of their convenience.

To join the study paste the following link into your browser:

https://www.i4health-pau.org/quit-smoking-on-your-own

The website will automatically obtain consent, ask 16 brief questions as a pre-test, randomize to 4 very brief interventions, ask 4 post-test questions, and at 1-month follow-up, send an email with a link to a 6-question survey. The initial online session is expected to take between 3 and 8 minutes and the 1-month follow-up survey less than 2 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years of age or older)
* Smoker who wants to quit
* Access to the Internet

Exclusion Criteria:

* Less than 18 years of age
ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd

A single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 75 years old (including upper and lower limits), male or female;
2. Unresectable locally advanced, recurrent or metastatic BC;
3. Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
4. Received T-DXd treatment in the advanced stage;
5. Adequate bone marrow, liver, kidney and coagulation function;
6. Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.

Exclusion Criteria:

1. With meningeal metastases or disseminated brain metastases or active brain metastases;
2. Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
3. Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
4. Has cardiac insufficiency;
5. Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;
Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients

An evaluation of the effects of genetically determined variant metabolizing and transporting proteins involved in the disposition of the immunosuppressive drug tacrolimus in renal transplant recipients. In a five year follow-up study tacrolimus dose-corrected exposure changes significantly and the effect(s) of single nucleotide polymorphisms of the CYP3A4/CYP3A5 and MDR1 genes on the latter is assessed in this study.

A 5-year pharmacokinetic follow-up study in 95 renal allograft recipients assessing tacrolimus exposure using repeated abbreviated Area-Under-the-Concentration-time (AUC) curve measurements at regular time points after grafting. The effects of the CYP3A5\*1, CYP3A4\*1B, MDR1 G2677T/A and C3435T single nucleotide polymorphisms on the evolution of tacrolimus disposition are studied over 5 years in order to clarify the interrelationship between CYP3A5, CYP3A4 and MDR1 genotypes, time-dependent exposure and tacrolimus-related toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary single kidney transplantation
* Age older than 18 yrs

Exclusion Criteria:

* Combined organ transplantation
A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors

This is a prospective study on the safety and effectiveness of radiofrequency ablation in patients with desmoid tumors.

In the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month.

In the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically verified diagnosis of dermoid tumor
2. The presence of progressive, symptomatic or functionally significant DF.
3. Written Informed consent to participate in the study
4. Age from 18 to 75 years
5. The functional status of the patient according to the ECOG 0-2 scale
6. Normal renal function (estimated creatinine clearance 60 ml/min);
7. Normal level of bilirubin and liver enzymes (AST, ALT - no more than 3 norms);
8. Left ventricular ejection fraction \&gt; 55%
9. Satisfactory bone marrow function (hemoglobin level 9 g/dl, neutrophil count 1.5 thousand/ml, platelet count \&lt; 100 thousand/ml);

Exclusion Criteria:

1. The inability to obtain informed consent to participate in the study
2. Synchronous or metachronous cancer
3. Clinically significant diseases of the cardiovascular system
4. Clinically significant CNS diseases
5. Previous grade 2 polyneuropathy and above
6. Current infection or other severe or systemic disease that increases the risk of complications of therapy
7. Pregnancy, lactation
VO2peak and Exercise Efficiency in Upper-body Poling

This study compares peak oxygen uptake (VO2peak) and exercise efficiency in upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic participants.

Peak oxygen uptake (VO2peak) and exercise efficiency are key factors for endurance performance. In persons who are primarily able to use their upper-body during exercise, such as many Paralympic athletes, the mode most commonly used in assessing VO2peak and efficiency is arm crank ergometry (ACE). However, sport-specificity of the test mode has been suggested to be of importance for achieving VO2peak and exercise efficiency that are reflective of the aerobic capacity in the respective sport. For ice sledge hockey players, cross-country sit skiers and sitting biathletes, upper-body poling (UP) is the most sport-specific test mode. However, it has not yet been investigated whether VO2peak and efficiency differ between ACE and UP. Therefore, the aim of this study was to compare VO2peak and exercise efficiency in upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic participants. Participants performed four 5-min submaximal stages at increasing effort and an incremental peak test to exhaustion in both ACE and UP.

Eligibility Criteria:
Inclusion Criteria:

* participants between the age of 18 and 50
* well upper-body-trained participants with or without paraplegia

Exclusion Criteria:

* people with injuries or sicknesses that might have impacted the testing
Trazodone for Sleep Disorders in Alzheimer's Disease

The purpose of this study is to determine whether trazodone is effective in the treatment of sleep disorders in Alzheimer's disease (AD).

Sleep disorders (SD) affects 35 to 50 percent of patients with AD. These disorders often make caring for patients at home very difficult. Trazodone is commonly prescribed drugs for SD in AD patients. There are no controlled studies in this sample of patients for this purpose.

Eligibility Criteria:
Inclusion Criteria:

* Fifty-five years of age or older;
* Diagnosis of probable Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke/the Alzheimer's Disease and Related Disorders Association criteria;
* Hachinski Ischemia Scale score less than 5
* Mini-Mental State Examination score of O to 26
* Actigraph evidence of a mean time immobile of less than 7 hours per night based on at least 7 nights of complete actigraph data collected over a single week;
* For-week history of sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver using the Neuropsychiatric Inventory (NPI) Nighttime Behavior scale;
* Sleep disturbance observed was not present before the diagnosis of AD;
* Other co-morbidities, especially delirium, depression, chronic pain and medication use may be present, but do not cooperate in the primary symptoms;
* Computed tomography or magnetic resonance imaging since the onset of memory problems showing no more than 1 lacunar infarct in a nonstrategic area and no clinical events suggestive of stroke or other intracranial disease or normal;
* Stable medications for 4 weeks prior to the screening visit;
* Having a mobile upper extremity to which to attach an actigraph;
* Residing with a responsible spouse, family member, or professional caregiver who is present during the night and would agree to assume the role of the principal caregiver for the 3-week protocol;
* Ability to ingest oral medication and participate in all scheduled evaluations

Exclusion Criteria:

* Sleep disturbance associated with an acute illness, delirium or psychiatric disease;
* Clinically significant movement disorder, such as akinesia, that would affect actigraphic differentiation of sleep and wakefulness
* Severe agitation;
* Unstable medical condition;
* Discontinuation of psychotropic or sleep medications within 2 weeks of the screening visit;
* Patient unwilling to maintain caffeine abstinence after 2:00 PM for the duration of the protocol;
* Patient unwilling to comply with the maximum limit of 2 alcoholic drinks per day, and only 1 alcoholic drink after 6:00 PM for the duration of the protocol;
* Prior use of trazodone for the treatment of sleep disturbances;
* Caregiver deemed too unreliable to supervise the wearing of the actigraph, to administer trazodone the proper time, to maintain tbe sleep diary, or to bring the patient to the scheduled visits;