cyrilzakka/clinical-trials huggingface dataset:
Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients with Small Breast Cancer

This prospective, multicentric single arm phase II study is based on the protocol of the international TARGIT-A study. The purpose is to investigate the efficacy of a single intraoperative radiotherapy treatment within elderly low risk patients (≥ 70 years, cT1, cN0, cM0, invasive-ductal) which is followed by WBRT only when risk factors are present. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines.

Patients ≥ 70 years with small, low-risk breast cancer who are operated but not irradiated show local relapse rates around 4% after 4 years. With adjuvant whole breast radiotherapy (WBRT) the local relapse rate drops to 1% after 4 years under Tamoxifen (Hughes et al 2004). It has been demonstrated (Polgar et al. 2007, Vaidya et al. 2010) that the efficacy of radiation of the tumor bed only in a selected group can be non-inferior to WBRT. The TARGIT E study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT) in a well selected group of elderly patients with small breast cancer and absence of risk factors. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines.

Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse, cancer-specific and overall survival and contralateral breast cancer as well as documentation of quality of life and cosmetic outcome. The expected local relapse rates are 0.5/1/1.5% after 2.5/5/7.5 years, respectively.

Discontinuation of the trial is scheduled if rates of local relapse rates rise to 3/4/6% after 2.5/5/7.5 years. Power calculations result in 265 patients with a calculated loss to follow-up of 20%, an alpha of 0.05 and a beta 0.1. Only centers with access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial.

Eligibility Criteria:
Inclusion Criteria:

* cT1c cN0 cM0
* ≥ 70 years old
* invasive-ductal histology
* compliance
* informed consent

Exclusion Criteria:

* extensive intraductal component (EIC)
* multifocality /-centricity
* lymph vessel invasion (L1)
* clinical signs of distant metastases or clinically suspicious lymph nodes
* other histology
* \< 70 years old
* missing informed consent or non-compliance
* bilateral breast cancer at time of diagnosis
* known BRACA 1/2 mutations (genetic testing not required)
Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation

In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional management.

The aim of this study is to evaluate the effectiveness and safety of a non-invasive hemodynamics monitoring tool called ClearSight for monitoring during TAVI procedures compared with standard invasive measurements.

In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional management.

The aim of this study is to evaluate the effectiveness and safety of a non-invasive hemodynamics monitoring tool called ClearSight for monitoring during TAVI procedures compared with standard invasive measurements.

The ClearSight monitoring system works non-invasively by utilizing an inflatable finger cuff which adjusts automatically to measure the arterial blood pressure which enables the calculation of parameters such as cardiac output or index. Multiple studies have demonstrated the reliability and feasibility of continuous non-invasive monitoring, in different settings, however it was never performed in patients undergoing TAVI.

The ClearSight monitoring system will be directly compared to invasive measurements of hemodynamic parameters during the procedure. In addition, information regarding baseline hemodynamics and its changes during/after procedure may give important information on peri- and post-procedural management and short-term outcomes and discharge planning. A tool, providing this information non-invasively with the same accuracy might result in a major improvement in daily practice..

Eligibility Criteria:
Inclusion Criteria:

• Adult patients (\>18 years old) with severe aortic stenosis undergoing elective TAVI.

Exclusion Criteria:

* Emergency indication for TAVI
* Severe tricuspid regurgitation
* Severe mitral stenosis or severe regurgitation
* Invasive right heart catheterization impossible
* Dependency on right ventricle pacing immediately after TAVI implantation
* Vulnerable subjects
* Known or suspected non-compliance, drug or alcohol abuse
* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation affecting this study
* Previous enrolment into the current investigation
The Impact of Training With Whole Body-EMS

Researchers are trying to find out what impact training with whole body-EMS (Electronic muscle stimulation) has on various health outcomes.

All subjects in both groups who enroll into this study will undergo an assessment of peripheral endothelial function with reactive hyperemia-peripheral arterial tonometry (RH-PAT) testing using EndoPAT; an assessment of vital signs including heart rate, blood pressure, weight, height and body mass index; laboratory blood work; cardiorespiratory testing using treadmill testing to determine VO2 max and maximal tolerated heart rate; maximal strength and maximal power testing on chest press and leg press testing; and percent body fat and fat distribution testing at baseline, and at 16-weeks follow-up (immediately after completing a 16-week training program using whole body-EMS). Baseline cardiovascular risk factors will be assessed by subject questionnaire and verified by chart review. In addition, subjects will complete an angina/chest pain symptom questionnaire (Rose Questionnaire), quality of life questionnaire (LASA Questionnaire), depression questionnaire (Patient Health Questionaire-9) and perceived stress questionnaire (Perceived Stress Scale) to assess for psychosocial wellness at each point in the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Employees at the Mayo Clinic, Rochester, MN

Exclusion Criteria:

* Subjects under the age of 18
* Pregnant women
* Subjects with a history of liver or kidney disease, acute illness, taking medications (such as glucocorticoids)
* Subjects who have conditions (such as chronic inflammatory muscular diseases or Cushing's syndrome) that affect muscle mass
* Individuals with pacemakers and implantable cardiac defibrillators
* Individuals who conduct any other type of resistance training (\> 45 minutes/week)
* Individuals who have regular "high" alcohol consumption (\> 80g/day on 5 days a week)
* Subjects unable to consent to or participate in the 16-week EMS intervention or be available for follow up
Drug-Disease Interaction in Crohn's Disease

Objective: To determine the effect of C-reactive protein (CRP) status, and infliximab treatment on the pharmacodynamics and pharmacokinetics of verapamil, a model drug for L-type calcium channel blocking, in Crohn's disease (CD) patients compared to healthy patients.

Hypotheses:CD patients will have elevated plasma verapamil concentrations, but diminished dromotropic response to verapamil; the concentration of circulating norepinephrine, used as a surrogate marker of sympathetic nervous activity, will be similar between the healthy patients and the CD patients; the sympathetic nervous system of the heart will be similar to healthy patients; Crohn's disease patients with normal CRP will have higher drug response compared to high CRP (\>3 mg/l) patients; and that infliximab-treated patients will have higher verapamil response than those with similar symptom profiles who are not infliximab treated.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to adhere the study protocol
* Males of females of non-childbearing potential aged from 18 to 65 years
* Lab values no more than 10% outside of the lab's stated normal range unless the subject is in the Crohn's disease group and the values are related to the disease, or if the PI decides the abnormality is not clinically significant
* The subject is healthy (except for the Crohn's disease group)
* Non-smoker for at least 3 months

Exclusion Criteria:

* History of hypersensitivity to verapamil
* Significant history of gastrointestinal (other than Crohn's disease), liver, kidney, or any other disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
* Significant history of allergies
* Significant history of cardiovascular or hematological disease
* Significant history of asthma, chronic bronchitis or bronchospastic conditions
* Presence of diabetes mellitus or any other condition which would preclude fasting
* Maintenance therapy with any drug (except those prescribed for Crohn's disease) or a history of drug dependence, alcohol abuse, or serious psychological disease
* Any clinically significant illness other than Crohn's disease in the previous 30 days prior to the study
* Use of enzyme-modifying drugs in the previous 30 days before the study
* Blood donation in the previous 56 days or multiple blood samplings in the previous 30 days before the study
* History of fainting upon blood sampling
* Participation in another clinical trial within 30 days of the study
* Narcotic use
* Glucocorticoid treatment in the last 30 days
Patterns of Prescribing and Monitoring of Palbociclib

The purpose of this study is to determine if patients with ER+, human epidermal growth factor 2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring based on manufacturer recommendations at a tertiary academic medical center.

This study was a retrospective, single-center study that included women receiving palbociclib for the treatment of ER+, HER2- advanced breast cancer. Exclusion criteria were the presence of brain metastases or active enrollment in a palbociclib clinical trial.

The primary endpoint was the proportion of patients who were maintained on a palbociclib dose according to the adjustment schedule in package insert recommendations.

The secondary endpoints were the number of patients dose adjusted for hematologic toxicities, the number of patients experiencing neutropenia, duration of therapy, progression-free survival (PFS), and adherence to manufacturer monitoring recommendations.

Eligibility Criteria:
Inclusion Criteria:

* women at least 18 years old
* ER+, HER2- advanced breast cancer
* receiving palbociclib

Exclusion Criteria:

* brain metastases
* on palbociclib clinical trial
Nitrate Consumption and Gingival Inflammation

The aim of this investigation is to evaluate the impact of the 14- day consumption of a nitrate-rich diet on the the extent of gingival inflammation in a cohort of periodontal aftercare patients. Recorded parameters were gingival index, plaque control record, salivary nitrate/nitrite level and vascular parameters

This investigation evaluated the impact of a nitrate-rich diet on the extent of gingival inflammation in a cohort of periodontal aftercare patients. Forty-four (23 test/21 placebo) periodontal aftercare patients with chronic gingivitis were enrolled. At baseline, gingival index (GI), plaque con- trol record (PCR) and salivary nitrate level (SNL) were recorded, followed by sub- and supragingival debridement. Subsequently, participants were randomly provided with 100 ml bottles of a lettuce juice beverage to be consumed 39 daily over 14 days, containing either a standardized amount of nitrate resulting in an intake of approximately 200 mg nitrate per day (test) or being devoid of nitrate (placebo).

Eligibility Criteria:
Inclusion Criteria:

* number of teeth ≥ 10
* body mass index (BMI) ≥ 24 ≤ 30
* presence of mild to moderate gingivitis (Gingiva Index \> category GI 0 ≤ category GI 2) at a minimum of 3 teeth
* history of periodontal disease and inclusion in a regular scheme of supportive periodontal therapy (regularly repeated subgingival biofilm removal 2-4 x/year)

Exclusion Criteria:

* manifestation of severe gingivitis (Gingiva Index = 3) at any tooth
* manifestation of inflammatory oral mucosal diseases other than gingivitis
* xerostomia (salivary flow ≤ 0.1 ml/minute)
* inability for regular oral home care
* known allergies and intolerances to any of the ingredients of the experimental juice beverages
* inability to follow the study protocol due to intellectual or physical handicaps
Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV administered ERB-257 as single ascending doses to healthy Japanese male subjects


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Japanese men between the ages of 20 and 50.
2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg2.
3. Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.
Behavioral Effects of Pregabalin and Cannabis

Cannabis is the most commonly used illicit drug in the United States, and its use is associated with rates of development of abuse and dependence, treatment admission and relapse that are comparable to other illicit drugs. Currently there is no effective pharmacological treatment for cannabis-use disorders. The purpose of the present study is to evaluate the ability of pregabalin to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.


Eligibility Criteria:
Inclusion Criteria:

* regular cannabis use
* good health other than cannabis use
* willingness to attempt abstinence
* effective form of birth control in female subjects
* available for up to 6 hrs every day for two 2-week test periods with an intervening break of 7-10 days each
* located in close proximity to University of Kentucky

Exclusion Criteria:

* medical screening outcomes outside normal ranges or deemed clinically insignificant
* medical history that would contraindicate pregabalin administration
Efficacy of an Acceptance-based Group Behavioral Therapy for Generalized Anxiety Disorder.

Generalized anxiety disorder (GAD) shows the weakest treatment response among anxiety disorders. The present study aimed at examining whether an acceptance-based behavioral treatment, combining mindfulness and exposure strategies, would improve clinical outcome compared to a standard, non-directive, supportive group therapy (NDST) for clients at a Brazilian anxiety disorders program.

Ninety-two individuals diagnosed with GAD were randomized to receive 10 sessions of either an acceptance-based behavior therapy (ABBT) or a Non-directive support Therapy (NDST). Assessments were at pretreatment, mid term, post-treatment, and 3-month follow-up.Data were analyzed using the Mixed effect regression models comparing both groups in primary outcome measures. Secondary outcome measures and putative process variables were assessed and also analyzed. The latter were tested as mediators of efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Literate,
* GAD-diagnosed
* 18-65 years old

Exclusion Criteria:

* Bipolar disorder (or any past maniac episodes),
* Psychosis,
* Substance dependence (apart from those abstemious for 3 months or more, considered as initial remission by DSM 5 - APA, 2015),
* High suicide risks according to the MINI - International Neuropsychiatric Interview (MINI; Sheehan et al., 1998).
* Participants under pharmacological treatment for GAD whose medication dosage had not been stable for a minimum of three months prior to the beginning of the study.
10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes

A combination of diabetes and neuropathy can cause an altered gait, increased tissue stiffness, limited joint mobility, muscle weakness, foot deformities, thus leading to excessive plantar pressure. The presence of an increased plantar pressure and the loss of sensation is a serious risk factor in the risk of development of diabetic foot ulcers (DFU). Therefore, appropriate shoes and insoles are recommended to redistribute high peak pressure (PP) and reduce pressure time integral (PTI) . Shoe modifications and insoles, when used, is effective to prevent the recurrence of plantar ulcer.

The primary aim of the study was to: explore gait characteristics, kinetics and kinematics in a cohort of patients diagnosed with diabetes, with and without neuropathy, assigned to use different types of insoles. The second aim was to assess the relation between gait characteristics, kinetics and kinematics to high plantar PP and PTI. The third aim was to compare gait characteristics, kinetics and kinematics of patients with diabetes and healthy controls.

A combination of diabetes and neuropathy can cause an altered gait, increased tissue stiffness, limited joint mobility, muscle weakness, foot deformities, thus leading to excessive plantar pressure . The presence of an increased plantar pressure and the loss of sensation is a serious risk factor in the risk of development of diabetic foot ulcers (DFU). Therefore, appropriate shoes and insoles are recommended to redistribute high peak pressure (PP) and reduce pressure time integral (PTI). Shoe modifications and insoles, when used, is effective to prevent the recurrence of plantar ulcer.

Patients presenting with mild or absence of neuropathy have lower PP compared to those having more severe stages of neuropathy. However, these findings are not unambiguous. In a study patients walked in a standardize speed of 1.2 m/s, and it was only under the first metatarsal phalangeal joint that the group with neuropathy had higher PP compared to patients with diabetes without neuropathy. In the remaining parts of the foot sole, there was no difference. In a study comparing custom-made insoles and prefabricated insoles used in a walking shoe, a cohort of patients with no history of foot ulcers was studied and there were no differences in PP for the sub groups with and without neuropathy.

More knowledge is needed regarding risk factors such as neuropathy, gait deviation and differences in kinematics and kinetics in order to prevent the onset of the "first" plantar ulcer.

Eligibility Criteria:
Inclusion Criteria:

Intervention groups:

* To be a participant in the original RCT
* To be aged 18 years or more
* To walk without walking aid
* To understand the Swedish language
* No presence of foot ulcer

Exclusion Criteria:

* Presence of foot ulcers

Control group

* To be first-time visitors to the DPO
* To be aged 18 years or more
* To walk without walking aid
* To understand the Swedish language
* No presence of foot ulcer

Exclusion Criteria:

* Presence of foot ulcers
LiDCO Monitor Study

This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid monitor) during a period of phlebotomy and graded blood loss in patients who are having cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for intraoperative phlebotomy following anesthetic induction to obtain autologous blood for use following cardiopulmonary bypass and cardiac surgery.
Aerosol Therapy in Obese COPD Patients.

This study has the objective to clarify the factors that directly influence the effectiveness of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease (COPD) and suggest the use of High Flow Nasal Cannula (HFNC) during their inhalation therapy.

This study has the objective to clarify the factors that directly influence the effectiveness of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease (COPD) and then formulate specific strategies to control the evolution of this disease. The suggested strategy in order to implement the aerosol therapy is the use of High Flow Nasal Cannula (HFNC) during these patient´s inhalation therapy.

It will consist in a cross-over clinical trial. The population will be composed by volunteers of both genders, aged between 45-70 years old. Four distinct groups will be formed: obese participants without copd; obese participants with copd; non obese participants without copd; non-obese participants with copd.

Eligibility Criteria:
Inclusion Criteria:

HEALTHY, non obese

* no history of respiratory disease
* non smokers
* self declared sedentary
* Forced expiratory volume at first second (FEV1) equal or higher than 80% of predicted
* Forced Vital capacity (FVC) equal or higher than 80% of predicted;
* FEV1/FVC higher than 70% of predicted.
* BMI lower than 30 kg/m2

HEALTHY, obese

* no history of respiratory disease
* non smokers
* self declared sedentary
* Forced expiratory volume at first second (FEV1) equal or higher than 80% of predicted
* Forced Vital capacity (FVC) equal or higher than 80% of predicted
* FEV1/FVC higher than 70% of predicted.
* BMI equal or higher than 30 kg/m2

COPD participants, non obese

* ex smokers
* clinical stability (six previous weeks)
* FEV1 lower than 80% of predicted.
* FEV1/FVC lower than 70 % post bronchodilator.
* No cardiopulmonary diseases (self declared)
* BMI lower than 30 kg/m2

COPD participants, obese

* ex smokers
* clinical stability (six previous weeks)
* FEV1 lower than 80% of predicted.
* FEV1/FVC lower than 70 % post bronchodilator.
* No cardiopulmonary diseases (self declared)
* BMI equal or higher than 30 kg/m2

Exclusion Criteria:

* Difficulty to understand verbal commands
* exacerbations during the study period
Right/Left Discrimination Training on Fibromyalgia Patients

To determine whether a targeted right/left discrimination training program can improve pain perception and functional disability in fibromyalgia patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology criteria
* Adults between 35 - 55 years old
* Both sexes
* Stable medication use for at least one month prior to enrollment

Exclusion Criteria:

* History of other musculoskeletal or neurological disorders
* Current involvement in another pain management program or study