cyrilzakka/clinical-trials huggingface dataset:
Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information in Women

The Understanding and Addressing Rejection of Personalized Cancer Risk Information study is a longitudinal observational study conducted to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening.

The Understanding and Addressing Rejection of Personalized Cancer Risk Information study seeks to understand the nature of the phenomenon of personalized cancer risk rejection in the context of mammography screening by 1) identifying demographic and psychological factors associated with risk rejection and 2) identify how risk rejection influences risk-concordant mammography screening behavior. The study will test a priori theory-derived hypotheses about the precursors of risk rejection and the influence of rejection on real-life screening decision making.

The Breast Cancer Risk Assessment Tool (BCRAT) will be used to asses participant's breast cancer risk. This model is designed to estimate breast cancer risk in women 35-84, and uses the following predictors: 1) age, 2) age at first menstrual period, 3) age at first live birth, 4) first-degree relatives with breast cancer, 5) previous breast biopsy with atypical hyperplasia, and 6) race/ethnicity. Participants will be required to complete the baseline survey in which they receive their BCRAT model risk estimate and respond to that risk estimate. They will then complete a 12-month follow-up survey.

An added administrative supplement will assess risk rejection among black women.

Eligibility Criteria:
Inclusion Criteria:

1. Female sex
2. Age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision)
3. English literacy

Exclusion Criteria:

1. Prior diagnosis of

1. breast cancer
2. Ductal carcinoma in situ (DCIS)
3. Lobular carcinoma in situ (LCIS)
4. Known BRCA1/2 gene mutation
5. Cowan syndrome
6. Li-Fraumeni syndrome
7. Having received previous chest radiation for treatment of Hodgkin's lymphoma.
Effect of Exercise With or Without Breakfast, on Metabolism, Appetite and Cognition

The purpose of this study is to assess the effect of eating breakfast in combination with exercise on fat usage, appetite and brain performance later in the day.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 18-45 years
* BMI 18.5-24.9 kg/m2
* Physically active: able to run for 1 h at a moderate pace
* Healthy

Exclusion Criteria:

* Smokers
* Food allergies
* Metabolic disorders
* Restrained eaters (equivalent of \>7 for restrained on TFEQ)
* Consuming herbal/dietary supplements
* History of head trauma
* Learning difficulties
* ADHD
* Dyslexia
* History of migraines
* Gastric problems
ESWL on Disintegration of Renal Stones

The impact of different frequencies on pattern of disintegration of renal stones

* Prior to the introduction of extracorporeal shockwave lithotripsy (ESWL) in 1980, the only treatment available for calculi that could not pass through the urinary tract was open surgery. Since then, ESWL has become the preferred tool in the urologist's armamentarium for the treatment of renal stones, , ESWL is minimally invasive, exposes patients to less anaesthesia, and yields equivalent stone-free rates in appropriately selected patients.
* The efficacy of ESWL lies in its ability to pulverize calculi in vivo into smaller fragments, which the body can then expulse spontaneously. Shockwaves are generated and then focused onto a point within the body. The shockwaves propagate through the body with negligible dissipation of energy (and therefore damage) owing to the minimal difference in density of the soft tissues. At the stone-fluid interface, the relatively large difference in density, coupled with the concentration of multiple shockwaves in a small area, produces a large dissipation of energy. Via various mechanisms, this energy is then able to overcome the tensile strength of the calculi, leading to fragmentation. Repetition of this process eventually leads to pulverization of the calculi into small fragments that the body can pass spontaneously and painlessly.
* It is well recognized that the popularity of extracorporeal shock wave lithotripsy (SWL), despite its non-invasive character, has decreased during recent years. This is partly explained by the technological achievements in endoscopy and urologists' enthusiasm for such procedures. Another explanation is that many urologists have been insufficiently successful with SWL. The latter effect might to some extent be a result of the performance of the lithotripter used, but in too many cases, it is evident that the principles of how shock wave lithotripsy should be carried out are poorly appliedical aspect

Eligibility Criteria:
Inclusion Criteria:

* Pelvic and upper ureteric stones
* Stone size less than 2 cm
* Stone density up to 1000 HU

Exclusion Criteria:

* Lower calycle stone
* Stone size 2 cm or more
* Stone denstiy more than 1000
* age group less than 18 y
* uncontrolled hypertension patient and bleeding disorder
* Pregnancy
* Patients with UPJ obstruction, ureteral strictures,
* Congenital anomalies
* Previous stented ureter
* Narrow neck of the calycx less than 30 %
Post-RAI Therapy Dosimetry and Quality Assessment of Target Tissue Dosing

The goal of this clinical trial study is to(1) determine the tissue specific dose of I-131 taken up by residing thyroid issue in the thyroid bed post-RAI along with any other sites in the neck and mediastinum as well as (2) correlate the dose delivered to residual tissues in the neck with patient follow-up based clinical outcomes, biochemical and imaging data following RAI therapy in patients with well-differentiated thyroid cancer (DTC). The main question\[s\] it aims to answer are:

* \[question 1\] How can obtained whole body and planar images more adequately depict residual iodine-avid disease in the thyroid bed, neck or mediastinum?
* \[question 2\] How can we obtain information on the dose taken up by the tumor remnant to know how much radionuclide actually went to the residual disease/tissue? Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\].

In our current clinical practice, patients with well-differentiated thyroid cancer (DTC) who receive oral administration of radioiodine 1-131 (RAI) have whole body and planar images obtained 4-5 days post-treatment. These images often do not adequately depict residual iodine-avid disease in the thyroid bed, neck or mediastinum. Further, no information about what dose taken up by the tumor remnant is obtained and thus we are unable to know how much radionuclide actually went to the residual disease/tissue.

Using single photon emission computed tomography (SPECT)/CT we will be able to better localize and evaluate disease/tissue remnant or distant iodine-avid metastatic disease. In addition, using Varian Velocity Theranostics Dosimetry suite of software applications, we will be able to do dosimetry on post-RAI therapy patients and be able to better correlate clinical outcomes with tumor absorbed dose in addition to provide quality improvement for the radioiodine ablation.

Eligibility Criteria:
Inclusion Criteria:

* All minorities
* 18 years of age and older
* Ability to give consent
* Male or female
* Differentiated thyroid cancer (DTC)
* Previous total thyroidectomy
* Has either:

  * local lymph node metastases
  * distant mediastinal/cervical metastases
  * lung or osseous metastases as seen on prior imaging studies

Exclusion Criteria:

* Non-iodine avid disease
* Under 18 years of age
* Unable to give consent
* Pregnant women, Non-viable neonates or neonates of uncertain viability.
* Non-English-speaking patients
Shoulder Profile Among Swimmers and Badminton Players

Background: To compare the pre-season clinical measures with shoulder rotator strength and range of motion between bilateral (swimmers) and unilateral (badminton players) overhead athletes. Design: Prospective cohort study Participants: 42 athletes were enrolled including 24 elite badminton players and 18 elite swimmers Independent variables: A pre-season visit consisted in clinical and isokinetic shoulder strength testing. Clinical testing consisted in the shoulder range of motion (ROM) measurements aIsokinetic internal and external rotator shoulder muscles strength was tested at 60. Conventional and functional (eccentric-to-concentric) ratios (FR) were calculated.


Eligibility Criteria:
Inclusion Criteria:

* All the elite badminton players from a high-level club and the National Institute of Sport, Expertise, and Performance
* All the elite swimmers a high-level club

Exclusion Criteria:

* Players who had SSI in the 3 months prior to the isokinetic test or had shoulder surgery
Cerebral Oxymetry and Neuronal Markers in Newborns and Infants Undergoing Surgery

The purpose of this study is to assess whether peri-operative period in neonates and infants is associated with an increase in blood biomarkers, specific for neuronal injury, and to correlate them with clinical variables and sedative/analgesic agents. Patients, who meet inclusion criteria and does not meet exclusion criteria, are enrolled. Blood samples for measurement serum concentrations of markers (S100-B and Neuron-Specific Enolase (NSE)) are drawn before surgery (baseline) and on the 1-st, 2-nd and 3-rd day after surgery. During surgery cerebral oxygenation (rSO2) monitoring is continuously applied; rSO2, hemodynamic and respiratory values are simultaneously recorded every 5 minutes. Anesthesia, pre and postoperative treatment, including analgesia and sedation, are given as per standard of care.

Retrospective studies have shown that surgery in infancy is associated with worse neurodevelopmental outcome, compared to general population. The reasons may be complex, and patients at risk are unknown. Brain growth and central nervous system formation are extremely active in neonates and infants. Metabolic or circulatory derangement may have negative influence on the developing brain. Disease and perioperative period, both may further put this population at risk for physiological abnormalities. Near infrared spectroscopy was shown to be a convenient method for monitoring of cerebral tissue oxygenation during surgery.

The great majority of anesthetics and sedative drugs, used in perioperative period, were shown to cause neuronal apoptosis in experimental animals. Some studies found that neurological marker S-100B increased in cerebrospinal fluid and blood immediately following anesthesia in animals. Several clinical studies supported this founding in children following cardiac and general surgery.

The aim of this study is to assess the dynamics of S-100B protein pre- and during 72 hours after surgery in neonates and infants aged 1-93 days, operated for abdominal/thoracic/urologic malformations/disease. As S-100B in blood may have extracranial sources, we simultaneously assess other neuronal marker Neuron-specific Enolase.

Eligibility Criteria:
Inclusion Criteria:

* patients, undergoing general, thoracic, urological surgery for congenital anomalies or disease
* signed written informed consent by parents/official caregivers

Exclusion Criteria:

* cardiac surgery
* any evidence of neurological disease
* sepsis
* limited ability to obtain blood samples
* clinically significant anemia
* physical status of the patients corresponding to American Society of Anesthesiologists (ASA) class 4 and 5.
Patient Education With or Without Physical Training or Mindfulness and Medical Yoga in Established Spinal Osteoporosis

In the present feasibility and pilot study we aim to investigate the effect and safety of patient education with or without additional physical training or mindfulness/medical yoga in patients with manifest spinal osteoporosis (at least one vertebral fracture).

The study includes a 10-week intervention period with once weekly theory education with or without additional physical training or mindfulness/medical yoga (randomized groups). Furthermore, a proceeding observation period of 10 weeks as well as a 1-year follow up post-intervention observation are included in the study design.

The SOL-study (School of Osteoporosis in Linköping) is a feasibility and pilot study on patient education in manifest spinal osteoporosis. The study design is interventional with patients randomized to one of three different interventions, i.e.

1. Theory only (T group)
2. Theory and physical exercise (TPh-group)
3. Theory and mindfulness/medical yoga (TMMY-group)

The intervention period is 10 weeks, including 1 hour theory session/week (same for all groups) and for TPh- and TMMY-groups a one hour group training session is scheduled before the theory session.

Inclusion criteria are: 1) manifest spinal osteoporosis (diagnosed osteoporosis and \> 1 vertebral fracture \[VF\]); 2) \> 3 months had passed since the most recent VF; and 3) age over 60 years.

Clinical testing and questionnaire evaluation are performed at three timepoints; 1) Baseline (T1), i.e. before intervention; 2) Post-observation (T2) i.e. after a passive observation time of 4 months); and 3) Post-intervention (T3) i.e. after the interventions. A one year follow up post-intervention is performed by questionnaire evaluation.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with established spinal osteoporosis (at least one vertebral fracture and osteoporosis)
* \>3 months had passed since the most recent VF
* age ≥60 years
* physical ability to walk without an indoor walker

Exclusion Criteria:

* inability to understand the Swedish language or difficulty following the research protocol or dementia
Culturally Tailored Behavioral Diabetes Care Intervention for Korean Americans

The purpose of this study is to assess the feasibility and efficacy of a culturally-tailored, comprehensive behavioral intervention program specially designed for linguistically challenged ethnic minority immigrant populations (Korean Americans) with type 2 DM.

Korean American immigrants (KAI), one of the most underserved and understudied minority populations in the U.S., suffer from diabetes, which goes under-diagnosed, inadequately treated and has a potential to result in costly and tragic consequences. Language barriers, the lack of self-confidence, and diminished social support that accompany the acculturation process prevent KAI from improving their health-seeking behaviors. Our previous research has indicated that overwhelming numbers of KAI suffer not only from uncontrolled hyperglycemia but also from a loss of self-confidence and social isolation because of language and cultural barriers. They are in urgent need of an intervention to assist them in their efforts to achieve better glycemic control and restore their self-confidence in diabetes and health management so that they are able to adjust successfully in this new environment. Therefore, The purpose of this study is to assess the feasibility and efficacy of a culturally-tailored, comprehensive behavioral intervention program specially designed for linguistically challenged KAIs with type 2 DM.

This pilot project will test the hypothesis: Compared to KAI in the control group, KAI with type 2 DM who receive a comprehensive DM management intervention through structured psycho-behavioral education, home glucose monitoring with a telephone transmission system, and interaction with a bilingual nurse case manager will show: (1) a greater level of glucose control; and (2) a greater level of self-help skills including knowledge related to glucose control, problem-solving skills, heightened confidence and mood/affect, adherence to treatment recommendations, and quality of life. An additional outcome will be to measure and obtain an ideal BP as the proposed intervention focuses on management of multiple risk factors with which many KA DM patients often struggle.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified as a first generation Korean American
* Age 30 years or older
* Resides in Washington-Baltimore area
* Expresses willingness to participate in all aspects of the study over its full course
* Written consent to participate in the screening/eligibility visit
* Self-identified with DM and HbA1c \>= 8% within 6 months of screening
* Written consent to participate in the clinical trial: agreeing to participate in study data collection procedures, receiving DM self -help education, using HGMT, and permitting contact with their own medical care provider.

Exclusion Criteria:

* Unable to give informed consent
* Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
* Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia.
Post-Market Observational Study of the WINX Sleep Therapy for the Treatment of Obstructive Sleep Apnea (OSA)

The objective of the Study is to observe the use and utility of the Winx Sleep Therapy System in a clinical practice, for the treatment of patients with obstructive sleep apnea (OSA).


Eligibility Criteria:
Exclusion Criteria

* Has a severe respiratory disorder, such as severe lung disease, pneumothorax, etc.
* Has loose teeth or advanced periodontal disease.
* Is under the age of 18.
A Comparative Effectiveness RCT of Optimized Cessation Treatments

This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit smoking will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2) Abstinence-Optimized Cessation Treatment (AOCT). The components for the optimized treatment have strong theoretical and empirical support from the investigators previous screening studies.

The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed. To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study. The goal of each study is to test and identify effective intervention components for distinct phases of the smoking cessation process. These components will then be combined for future research on the effectiveness of this chronic care treatment package

Eligibility Criteria:
Inclusion Criteria:

* age \>=18 years
* smoking \>4 cigarettes/day for the previous 6 months
* able to read, write, and speak English
* have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts
* and if currently using NRT, agreeing to use only study medication for the duration of the study
* we will not exclude participants based on their prior use of cessation medication or if they use multiple tobacco products in order to enhance real-world generalization (these will be statistically controlled in analyses)
* not currently attempting to quit smoking
* not intending to quit smoking (defined as no plans to quit in the next month)
* and planning to remain in the intervention catchment area for at least 12 months.

Exclusion Criteria:

* currently taking bupropion or varenicline
* medical contraindications to using NRT including hospitalized (for at least one night) for a stroke, heart attack, congestive heart failure or diabetes in the last 30 days
* diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years
* and, if the participant is a woman of childbearing potential, being pregnant or intending to becoming pregnant or unwillingness to use an approved method of birth control during treatment.
Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections

The incidence of pleural infection is increasing worldwide since the last two decades. Antibiotics are one of the cornerstones of the treatment of this disease and must be associated to a correct evacuation of the pleural effusion.

Data concerning the pleural diffusion of antibiotics currently used in community acquired pleural infection are scarce. The main objective of this study is to evaluate the pleural pharmacokinetic of amoxicillin and clavulanic acid in patients with a complicated pleural infection (patients who need a chest tube insertion).

Only scarce data are known on the pleural diffusion of antibiotics. Most of these data are concerning antibiotics that are not commonly used for the treatment of community-acquired pleural infections. Moreover, these data are obtained from studies using heterogenous methodologies (single or repeated evaluation of the antibiotic concentration in the pleural effusion, with or without correlation to the serum concentration; animal model or very specific population (i.e. uninfected patients or following lung surgery).

The main objective of this study is to evaluate the pleural pharmacokinetic of amoxicillin and clavulanic acid in patients with a community-acquired complicated pleural infection.

Patients with a complicated pleural infection will be managed according to the French guideline with a chest tube drainage associated to a treatment with amoxicillin (2g\*3 by day) and clavulanic acid (200mg\*3 by day). Repeated samples of pleural fluid and serum will be taken to evaluate antibiotics' concentrations at H0; H½; H1; H2; H3; H4; H8 and H24.

The follow-up and management of the included patients will not be modified by the study protocol except for the pleural and serum samples. Clinical, biological and radiological (chest x-ray and/or thoracic ultrasound) evaluation will be performed daily. Success of the pleural drainage will be assessed at day 3.

Eligibility Criteria:
Inclusion Criteria:

* all adult patients (≥ 18 years old) hospitalized for a complicated community acquired pleural infection at University Hospital Amiens-Picardie.
* Complicated pleural infection is defined by the presence of one of the following criteria: frank pus, loculated pleural fluid, presence of organisms identified by Gram stain and/or culture from a non-purulent pleural fluid sample, pleural fluid pH \<7.2, pleural fluid glucose \<0.32g/l or large non-purulent effusion.

Exclusion Criteria:

* non-infectious pleural effusion
* hospital-acquired pleural infection
* patient treated with amoxicillin and clavulanic acid (if treatment was started more than \> 24h ago)
* Minors, pregnant women, adult patients protected by law.
* Pleural infection requiring instant thoracic surgery
* allergy to beta-lactam
* Injection of contrast agent (Iomeron or Iohexol) during the 24 hours preceding or following the first dose of amoxicillin / clavulanic acid.