cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff

The purpose of this study is to evaluate whether LY3819253 given alone and with LY3832479 prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19). Facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure will receive LY3819253, LY3819253 and LY3832479, or placebo via an injection into a vein. Samples will be taken from the nose. Blood samples will be drawn. Participation could last up to 25 weeks and may include up to 19 visits.


Eligibility Criteria:
Inclusion Criteria:

* Part 1 and Part 2: Resident or facility staff in a skilled nursing or assisted living facility with at least one confirmed case of SARS-CoV-2 detection less than or equal to (≤)7 days prior to randomization
* Are men or non-pregnant women who agree to contraceptive requirements
* Agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal swabs, and venous blood as specified in the schedule of activities
* Have venous access sufficient to allow intravenous infusions and blood sampling
* The participant or legally authorized representative give signed informed consent
* Part 3 only: Resident or staff in a skilled nursing or assisted living facility who satisfy at least one of the following at the time of screening

  * Are greater than or equal to (≥) 65 years of age
  * Have a body mass index (BMI) ≥ 35
  * Have chronic kidney disease
  * Have type 1 or type 2 diabetes
  * Have immunosuppressive disease
  * Are currently receiving immunosuppressive treatment, or
  * Are ≥ 55 years of age AND have

    * cardiovascular disease, OR
    * hypertension, OR
    * chronic obstructive pulmonary disease or other chronic respiratory disease
* Positive SARS-CoV-2 test and infusion within 10 days of symptom onset, OR positive SARS-CoV-2 test and infusion within 10 days of testing if asymptomatic

Exclusion Criteria:

* Parts 1 and 2:

  * Recovered from confirmed COVID-19 disease or asymptomatic infection
  * Prior history of a positive SARS-CoV-2 serology test
  * History of convalescent COVID-19 plasma treatment
  * Participation in a previous SARS-CoV-2 vaccine trial or received an approved SARS-CoV-2 vaccine
  * Previous receipt of SAR-CoV-2-specific monoclonal antibodies
* Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible with less lung toxicity in smaller studies.

Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II according NCI-CTCAE amounts maximum 20%.

Hypofractionated radiotherapy of the breast 16 × 2.50 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 16 × 3.00 Gy).

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
* Indication to adjuvant radiotherapy including boost radiotherapy
* Clearly identified primary tumor region preferably by radiopaque clips
* Primary wound healing after breast conserving therapy without signs of infection
* Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
* Written informed consent

Exclusion Criteria:

* Patients operated by mastectomy
* No indication for boost radiation
* Resection margins positive for disease or insufficient identification of the boost volume
* Indication for radiotherapy of the regional lymph nodes
* History of prior breast or thoracic radiotherapy
* Extended postoperative seroma at the beginning of radiotherapy
* Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
* Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
Changes in Workability and Employment Following the Work-related Medical Rehabilitation PV RehaJET

The objective of this observational study is to gain insight into a new approach to rehabilitation in Austria, with a particular focus on work-specific exercises that are dependent on the specific work-related needs of the patients. Two groups are being observed: one was referred to a three-week work-specific rehabilitation programme immediately upon arrival at the rehabilitation centre, while the other group underwent a three-week medical-focused rehabilitation programme before starting a four-week work-specific rehabilitation programme.

Researchers will monitor for indications of improvement following completion of the rehabilitation program. As the two forms of rehabilitation are not directly comparable, they will be observed and analysed as two distinct entities.

As part of their regular inpatient rehabilitation, participants will complete questionnaires at designated intervals (beginning and end of stay), with follow-up assessments scheduled at six and 12 months post-rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* The study participants are regular patients in the rehabilitation centre Bad Hofgastein
* Presence of a disease in the area of the musculoskeletal system
* Sufficient motivation to maintain professional participation
* Declaration of consent

Exclusion Criteria:

* No completion of all work-specific rehabilitation modules
* Acute or decompensated disease states with severe functional limitations (i.e. not able to continue with the rehabilitation programme)
Effectiveness of CRD-4730 in Participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

This is a Phase 2, multicenter, double-blind, sponsor unblinded, placebo-controlled, single-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CRD-4730 when administered as single oral doses to participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). The study will have 2 cohorts in which participants with CPVT will participate in a 3-period, randomized 2-sequence study. Each participant will receive 2 different doses of CRD-4730 and 1 dose of matching placebo, with each study drug administered as a single dose.


Eligibility Criteria:
Inclusion Criteria:

1. Males or Females ≥18 years of age, at screening.
2. Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a clinical phenotype consistent with CPVT at screening.
3. The participant can perform an EST during which frequent premature ventricular contraction (PVCs) (≥10 per minute), ventricular bigeminy, or higher-grade VA (equivalent to a VA score ≥2) are identified by the investigator.
4. Stable doses of any anti-arrhythmic medication, except amiodarone, for 4 weeks prior to screening.
5. Adhere to all contraceptive criteria.

Exclusion Criteria:

1. Clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
2. History of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of screening.
3. History of malignancy within the past 5 years at screening (except successfully treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ).
4. Female participant that is pregnant or lactating/ breastfeeding, or has plans to do so during the study or within 3 months following last dose of study drug.
5. Use of amiodarone with 3 months prior to screening. NOTE: other protocol defined Inclusion/ Exclusion criteria may apply.
Green Tea in Breast Cancer Patients

Prognostic factors for breast cancer beyond stage at diagnosis and tumor characteristics have not been well studied. Of special interest are lifestyle factors that can be modified by women after diagnosis to increase disease-free survival. Green tea is rich in polyphenols consisting primarily of epicatechins, epigallocatechin, epicatechin gallate, and epigallocatechin gallate (EGCG). The investigators hypothesize that there will be a reduction in proliferation and/or an increase in apoptosis in association with short-term EGCG treatment.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal (at least 2 years since last menstrual period) or age 55 or older if prior hysterectomy
* Non-current (not with past 6 months) user of menopausal hormones
* Mammographic abnormality consistent with any type of incident breast cancer necessitating a diagnostic biopsy (BIRAD IV(b), (c) or V) will be sufficient to draw baseline LFT and complete screening questionnaire. Unless the biopsy confirms incident breast cancer, such subjects will not be included in further research interventions and they will not serve as EGCG treated or control subjects.
* Diagnosed with incident breast cancer on the diagnostic biopsy is required for inclusion in the EGCG or control treatment groups.
* Non-green tea drinker (less than monthly) - this criteria does not apply to black tea or herbal tea
* Provided written informed consent

Exclusion Criteria:

* Green tea drinker (once per month or more)
* History of breast cancer or other cancer including a prior diagnosis of any type of incident breast cancer.
* Known allergy to tea
* Abnormal liver enzymes (plus or minus 10% of the normal ranges).
Fluid Balance During Surgery for Ovarian Cancer

Extensive tumour debulking challenges both surgeon and anaesthesiologist but promotes survival in late-stage ovarian cancer patients. Little is known about the intraoperative fluid balance and its impact on morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for cytoreductive surgery in ovarian cancer

Exclusion Criteria:

* Age \< 18 years
* unability to give consent
High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA

This study will compare Hight Tibial Osteotomy with or without Fulkerson Osteotomy performed on patients with early stages of Osteoarthritis with patellofemoral joint disorders. The purpose of this study is evaluate which type of osteotomy provides better clinical, radiological and laboratory outcomes.

Progression of knee cartilage degenerative changes leads to necessary total knee arthroplasty in future, which is the most popular procedure for treating OA. HTO applied at early stages of osteoarthritis allow slow down cartilage degeneration process, but the choice of performed surgery depends on surgeons personal assessment. Patellofemoral Pain Syndrome often occurs with knee arthritis. Antero-medialisation of tibial tubercle is frequent procedures for patella maltracking. So far, both, HTO and Fulkerson osteotomy was performed separately, even if patient have symptoms from patellofemoral joint and OA. The investigators believe that simultaneously surgery of HTO and fulkerson Osteotomy provides better outcomes and significantly slow down knee degeneration.

Eligibility Criteria:
Inclusion Criteria:

* Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination
* Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests

Exclusion Criteria:

* no informed consent to participate in the study
* age under 18 years or above 65
* multi ligament injury or single plane knee instability
* another musculoskeletal disorders in lower limb
* lower limb deformity requiring axis correction below 4o or above 12.5o
* joints inflammatory diseases
* ASA score \> II
Implementation of Actinic Keratosis Guideline Among General Practitioners.

This study investigates 5-fluorouracil cream prescription trends by general practitioners for the treatment of field changes of actinic keratosis over the years 2016-2021. The aim is to analyse whether the publication of the multidisciplinary guideline on suspect skin lesions for general practitioners in 2017 has made an impact in the prescribing behaviour of general practitioners.

Actinic keratosis is the most common epithelial precancerous lesion among the Caucasian race. With an increase in prevalence worldwide due to an aging population and rise of ultraviolet exposure actinic keratosis are among the most frequently encountered skin lesions in clinical practice. Both dermatologists and general practitioners are increasingly confronted with actinic keratosis, entailing to higher healthcare costs and time burden.

There are many therapeutic modalities for the treatment of actinic keratosis, depending on multiple factors such as distribution, characteristics, patient preference, side effects, availability and costs. Treatment options can be divided into: lesion directed therapy en field directed therapy. Both dermatologists and general practitioners can treat actinic keratosis and 5-fluorouracil cream can also be prescribed by general practitioners.

The objective of this study was to investigate 5-fluorouracil cream prescription trends by general practitioner for the treatment of field changes of actinic keratosis over the years 2016-2021.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* diagnosis actinic keratosis (clinical diagnosed or by biopsy)

Exclusion Criteria:

* cutaneous malignancy (suspicion)
* immunosuppressive co-medication.
Involvement of FFA Metabolism and Insulin Resistance in Cardiac Death

The investigators evaluated predictive values of myocardial fatty acid metabolism and insulin resistance for cardiac death of hemodialysis patients with normal coronary arteries.

Dialysis patients have extraordinarily high mortality rates. Cardiac diseases play an important role in deaths among end-stage renal disease (ESRD) patients undergoing renal replacement therapy. Previous studies have shown that maintenance hemodialysis patients have high prevalence of obstructive coronary artery disease. While obstructive coronary artery disease is undoubtedly involved in cardiac deaths induced by acute myocardial infarction or congestive heart failure and in sudden cardiac death, cardiac death can occur in hemodialysis patients who have apparently no pre-existing obstructive coronary artery disease. However, few studies have investigated the factors which are useful for stratifying the risk of cardiac death in dialysis patients with normal coronary arteries.

We recently showed that visualizing severely impaired myocardial fatty acid metabolism on images can help not only to detect obstructive coronary artery disease \[8\], but also to identify patients at high risk of cardiac death among hemodialysis patients without coronary intervention or old myocardial infarction and among those with coronary revascularization by percutaneous coronary artery intervention. In addition, combination of impaired cardiac fatty acid metabolism with insulin resistance, which is one of the risk factors related with coronary atherosclerosis, may contribute to left ventricular dysfunction in patients with maintenance hemodialysis with normal coronary arteries. Impaired myocardial fatty acid metabolism and insulin resistance, both of which reduce the synthesis of myocardial adenosine triphosphate (ATP), are likely to be involved in fatal cardiac events by causing deficiency of myocardial energy supply. In this study, we prospectively investigated the potential of myocardial fatty acid metabolism and insulin resistance to predict cardiac death in hemodialysis patients without pre-existing obstructive coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patients who had normal coronary arteries identified by coronary angiography and underwent the examination of BMIPP SPECT and measurement of HOMA-IR as a parameter of insulin resistance.

Exclusion Criteria:

* Patients who had not done BMIPP SPECT within one month of coronary angiography
* Congestive heart failure (NYHA 3-4)
* Significant valvular heart disease
* Pacemaker
* Idiopathic cardiomyopathy
* Malignancy
* Patients who had not measured HOMA-IR within one month after coronary angiography
* Patients receiving extrinsic insulin or medication of sulfonylurea
Effects of Non Invasive Brain Stimulation During Prolonged Experimental Pain

Non invasive brain stimulation (NIBS) of the primary motor cortex (M1) through transcranial direct current stimulation (tDCS) has been widely investigated in research and clinical settings in order to modulate brain plasticity and improve clinical pain. Interestingly, newly developed paradigms i.e. tDCS of the resting state motor network have proved higher modulatory effects in terms of corticospinal excitability when compared to traditional M1 tDCS.

However, little is known about the effects of tDCS on the frequency changes of alpha oscillations (alpha peaks).

Interestingly, previous studies show a correlation between reduced frequencies of alpha peaks during 1-hour experimental pain in comparison to baseline.

The present study aims to investigate the effects of tDCS of the resting state motor network on the frequency and power of alpha peaks during prolonged experimental pain during 24 hours.

There is evidence that chronic pain alters the frequency of alpha peaks. Specifically, recent studies showed a correlation between decreased frequency of alpha peaks and perceived pain. Furthermore, a correlation was found between high pain sensitivity and slower alpha oscillations during prolonged pain during 1 hour.

To date, the effects of prolonged experimental pain during 24 hours on brain oscillations has not been explored. Moreover, it is unknown whether non invasive brain stimulation (NIBS) through transcranial direct current stimulation (tDCS) can revert these pain-related feature.

It is hypothesized that prolonged pain during 24 hours will reduce the frequency of alpha peaks and tDCS of the resting state motor network will revert it to baseline values.

Furthermore, it is thought that decreased frequency of alpha peaks will be correlated with perceived pain intensity on Day 1 (before receiving the first tDCS session).

Eligibility Criteria:
Inclusion Criteria:

* Right-handed healthy men and women in the age 21-50 years who speak and understand English

Exclusion Criteria:

* Lack of ability to cooperate
* History of chronic pain or current acute pain
* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Present and previous neurologic, musculoskeletal or mental illnesses
* Chili allergies
* Current use of medications that may affect the trial
* Contraindications to rTMS application (history of epilepsy, metal implants in head or jaw, etc.)
* Failure to pass the questionnaire for tDCS
BIOTRONIK Conduction System Pacing With the Solia Lead

The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area. Safety will be assessed by evaluating serious adverse device effects that occur through 3 months post-implant. Efficacy will be assessed by evaluating implant success rate.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and Cardiac Resynchronization Therapy with a Pacemaker (CRT-P) systems are allowed.
* Patient has an implant planned to utilize left bundle branch area pacing within 30 days of consent
* Patient is able to understand the nature of the study and provide written informed consent
* Patient is available for follow-up visits on a regular basis for the expected duration of follow-up
* Patient accepts Home Monitoring® concept
* Patient age is greater than or equal to 18 years at time of consent

Exclusion Criteria:

* Patient meets a standard contraindication for pacemaker system implant
* Patient is currently implanted with a pacemaker or Implantable Cardioverter-Defibrillator (ICD) device
* Patient has had a previous unsuccessful attempt to place a lead in the LBB area
* Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
* Patient is expected to receive a heart transplant within 12 months
* Patient life expectancy less than 12 months
* Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
* Patient reports pregnancy at the time of enrollment
* Patient is enrolled in any other investigational cardiac clinical study during the course of the study
A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects

First in human study to evaluate the safety, tolerability, and pharmacokinetics of PF-03716539. The potential of PF-03716539 to increase the concentrations of midazolam, darunavir and maraviroc will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.

Body Mass Index (BMI) of approximately 18 to 30 kg/m2. Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

Pregnant or nursing females. females of childbearing potential. Evidence or history of clinically significant hematological, renal (including kidney stones), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at screening.

Treatment with an investigational drug within 30 days (or determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men

Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence world wide with an increased risk of myocardial infarction and stroke. GLP-1 has convincing effects on the high glucose levels in type 2 diabetic patients and is well tolerated. New animal studies indicate a protective effect of GLP-1 in the brain and the heart. The mechanism behind this is yet not known.

The study hypothesis is that GLP-1 will stimulate glucose-uptake in the brain and heart independent of insulin and thereby exert its protective effects.

Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence world wide. T2D is associated with a three-fold increase in cardiovascular complications (myocardial infarction and stroke) leading to significantly higher morbidity and mortality in this group of patients. The prospective British Diabetes Study (UKPDS) showed that neither diet alone nor the pharmaceutical treatment utilized (Sulphonylurea, Metformin, Insulin) were able to reduce these macrovascular complications. GLP-1 (glucagon-like-peptide-1)is an incretin with convincing effects on glycaemia in type 2 diabetic patients with little or no risk of hypoglycaemia. New research in animal models has shown a potential protective effect in the brain and heart in association with ischaemic damage. The mechanism behind this protective effect is not known.

The effect of native GLP-1 on glucose uptake in the brain and heart will by visualized by fluoro-deoxy-glucose FDG-PET-scan during normoglycaemia in healthy young men. At the same time a pancreatic/pituitary clamp will be performed. The hypothesis is that GLP-1 directly will stimulate glucose uptake independent of the pancreatic hormones and through this mechanism exert its neuro- and cardioprotective actions.

Comparisons: FDG-uptake in the brain and heart with GLP-1 infusion compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* Age 20-50 years
* Caucasian
* BMI 20-30 kg/m2

Exclusion Criteria:

* Diabetes in subject and 1.degree relatives
* Any disease of clinical relevance