cyrilzakka/clinical-trials huggingface dataset:
The "ToPIC" Study = Tool to Improve Participation In Clinical Trials

The purpose of this study is to pilot the "ToPIC" tool, a communication tool to facilitate clinical trial decision making conversations between oncologists and patients.

The ToPIC tool is a structured delivery of important treatment-related information. The oncologist remains entirely in charge of the information delivered (e.g. what are the treatment options, what are the potential benefits) and uses the ToPIC framework to organize the information and create a pen and paper diagram for the patient to assist in their processing and deliberation. The tool creates a forum for a clear presentation of options and facilitates a patient's ability to express their individual preferences.

Oncologists are the intervention population and will be trained in how to use the ToPIC communication tool. Volunteer oncologists will be randomly assigned to immediate training or wait list control. Oncologists who are randomly assigned to the intervention group will receive training, and once they have demonstrated competence with the tool, they will begin using the tool with their patients. Data collection for any patient whom they present treatment options which include a clinical trial will be included for the primary analysis related to recruitment for clinical trials. This collection will begin once the oncologist, regardless of their assigned group, has signed consent and been randomized.

Eligibility Criteria:
Inclusion Criteria:

* (Oncologists) - All UW Health oncologists who engage with patients about treatment decisions which involve therapeutic clinical trials. Eligible oncologists may work at UW Hospital and 1 South Park and include all medical, radiation and surgical oncologists. Participation by oncologists is completely voluntary.
* (Patients)

  * Any adults (over age 18)
  * Seen in any UW oncology clinic
  * Participated in a discussion with a participating oncologist about treatment options that included a therapeutic clinical trial.

Exclusion Criteria:

* (Oncologists) ToPIC Study PI
* (Patients) Non-English speaking patients. We exclude non-english speakers due to the unpredictable impacts of the translation/interpreter dynamic and the lack of a pen/paper diagram in the patient's native language. This would include deaf patients.

  * Blind patients (or someone who cannot see the pen/paper diagram)
  * Those who do not have capacity for decision making.
  * Those offered participation in non-therapeutic intent clinical trials. This would include Phase 1 clinical trials due to the non-therapeutic intent.
Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

The aim is to study whether the budesonide component within the budesonide/ formoterol combination inhaler has additive value in a model of "slow onset acute asthma" , namely three AMP provocation tests performed on one day


Eligibility Criteria:
Inclusion Criteria:

* asthma diagnosis according to ATS criteria,
* lung function (FEV1) above 60% of predicted,
* AMP-PC20 below 160 mg/ml with a documented fall in FEV1 of 30% in this provocation test

Exclusion Criteria:

* having smoked \> 10 Pack-years,
* hypersensitivity to one of the study drugs,
* significant co-morbidity, pregnancy or lactating
A Pilot SMART Design for Pathological Gamblers

Pathological gambling is serious problem, with significant psychological, financial, and public health consequences. Nevertheless, controlled trials examining the efficacy of therapeutic interventions for pathological gamblers are sparse, and many pathological gamblers recover on their own, or with only minimal interventions. In this initial study of a SMART design for pathological gamblers, we will offer a brief intervention to all (n = 100), and subsequently randomize individuals based upon their initial treatment response to varying intensities of additional care from none to 8 sessions of individual cognitive behavioral therapy (CBT) plus 14 weeks of Aftercare. Gambling outcomes will be assessed pre-treatment and at about weeks 10, 24, 36 and 52.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old, DSM-IV criteria for pathological gambling
* \>2 gambling episodes in past 60 days
* spent \>$100 wagering in the past 60 days
* willingness to accept random assignment after the brief intervention.

Exclusion Criteria:

* Reading level below 5th grade
* uncontrolled psychiatric conditions (e.g., active suicidal intention, psychosis, bipolar disorder)
Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer

A randomized trial of remote blood pressure monitoring, compared to usual care, in patients receiving bevacizumab to determine whether remote blood pressure monitoring improves the collection of blood pressure data, identification and management of clinically significant hypertension, and patient satisfaction.

Remote patient monitoring (RPM) technology has the potential to improve the early detection and management of clinically significant hypertension in cancer patients undergoing therapy with bevacizumab, by allowing immediate communication of abnormal measurements to the clinical care team. Additionally, RPM may decrease patients' and caregivers' burdens of ongoing cancer care through an improved user experience compared to usual care.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is a male or female 18 years of age or older.
2. Participant is a current patient at West Michigan Cancer Center/Bronson Cancer Center.
3. Participant is receiving bevacizumab as part of active treatment.
4. Participant is willing and able to provide written informed consent.

Exclusion Criteria:

1. Participant is unable to understand English.
2. Participant is hospitalized.
3. Participants are unable to obtain blood pressure readings at home.
Physical Training Per se

The investigators aimed to evaluate the health benefits of physical training per se, weight loss per se and exercise-induced weight loss in young, overweight men. The investigators hypothesized that physical training would have independent effects on various health parameters (insulin sensitivity, fasting glucose and insulin, total and abdominal fat mass, waist circumference, blood pressure and key muscle proteins), and that a concomitant weight loss from physical activity would increase the effect.

At baseline, during the intervention and in the week following the intervention participants underwent a panel of tests:

* Cardio respiratory fitness
* blood pressure
* anthropometric measures

At baseline and after the intervention a hyperinsulinemic, euglycemic clamp were performed to asses insulin sensitivity.

Tissue and blood samples were also collected for further analysis:

* Total-protein analysis of selected proteins
* Fasting plasma glucose, insulin and free fatty acids

Eligibility Criteria:
Inclusion Criteria:

* Overweight (body mass index 25-30 kg/m2)
* Weight stable (±2 kg during the past 6 months)
* Body fat% \>25%,
* Maximal oxygen uptake \<45 mL/min/kg
* Sedentary and healthy according to interview
* Fasting glucose \<6.1 mmol/L
* Blood pressure \<140/90 mmHg
* No first degree relatives with type-2-diabetes

Exclusion Criteria:

* Resistance training
* Inability to meet intervention criteria
Sleep Longitudinal Exploration of the Experience of Patients

Many epidemiological studies report that insomnia is common after fifty years in the general population but also in the post-operative period of surgery. Preoperatively, sleep quality can be disturbed by fear of general anesthesia and surgery. Postoperatively, it seems to be altered by pain, the ambient environment and night care.

Literature shows that the occurrence of post-operative sleep disorders seems to lead to (increased) hypnotic consumption in patients who did not consume them in the pre-operative phase with known risks of dependence.

Nowadays , general anesthesia is widely practiced worldwide. However, despite continuous improvement in techniques, a large number of patients still experience poor quality postoperative sleep, even with short-term anesthesia.

It therefore appears that general anesthesia disrupts the circadian rhythm of patients, even if the mechanisms are still poorly understood.

Thus, sleep deprivation could be responsible of physiological alterations that are still unknown, such as delayed healing or impaired respiratory muscle performance, promoting postoperative complications.

The aim of this study is to identify the factors impacting the quality of sleep of patients undergoing scheduled surgery during the first postoperative night. And its implication on the occurrence of drowsiness described by the patient the day after their surgical intervention.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged 18 years or older;
* Subject scheduled to undergo surgery under general anesthesia (orthopedic, thoracic, vascular or visceral surgery);
* Subject able to complete a self-administered questionnaire;
* Subject having given oral consent;

Exclusion Criteria:

* Subject wishing to discontinue participation in the study before the end;
* Subject for whom the surgical procedure could not be performed after admission to the operating room (whatever the reason);
* Subject for whom the surgical procedure was performed urgently before the date initially scheduled (whatever the reason);
* Subject for whom a serious perioperative complication occurred during the surgical procedure
Self-screening of Cognitive Impairment in Primary Care

According to 2011 HAS recommendations, early detection of Alzheimer disease is the major objective in order to allow an earlier care and support. These recommendations strengthen general practitioner role, who plays a key role in the identification of cognitively impaired patients. HAS recommendations are the use of MMSE like test (Mini Mental State Examination) at general practitioner office. A self-screening test, without medical presence, would allow a self-administered cognitive assessment by the patient. A review of the literature about self-administered cognitive tests has been realized. The Self-Administered Gerocognitive Examination (SAGE) has been chosen. It is a brief, valid and reliable cognitive assessment tool, rated on 22 points, which allows an early detection of cognitive impairment, with a sensitivity close to the MMSE test. Nevertheless, SAGE has never been tested at home without medical supervision. In this study, the investigators will determine if SAGE scores at home correlates with MMSE scores at general practitioner office.

Patients with inclusion criteria will be recruited during the general practitioner consultation and will have a clinical assessment included MMSE and clinical data collection. Then, SAGE will be given to the patient in order to be completed at home without medical supervision and send to the general practitioner.


Eligibility Criteria:
Inclusion Criteria:

* Subjects from three Picard general practitioner's practice
* 60 years old or more
* patients who accept to complete the tests
* with ou without cognitive complaint
* patients able to read and write
* affiliated to social security system

Exclusion Criteria:

* major visual disorders
* legal safeguard
* diagnosis of neuro-cognitive disorder
Assessment of Complications in Patients Who Underwent LPN According to the CCI

This study aims to compare the strength of the classical Clavien-Dindo classification system (CDC), which is a Likert scale analysis versus the comprehensive complication index (CCI), a new quantitative evaluation system, in patients undergoing laparoscopic partial nephrectomy (LPN).

Prospectively collected data of sixty-two patients undergoing LPN with postoperative complications from November 2009 to August 2020 were evaluated retrospectively. Postoperative complications were classified according to the CDCs and calculated using the CCI calculator (https://www.assessurgery.com) quantitatively. Major complications were determined as ≥ grade 3 complications according to the CDC. The complexity of the renal mass was defined according to the RENAL nephrometry score. The cut-off value for CCI was analyzed by the ROC analysis technique. The significance level was taken as p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* patients with complete data
* patients with consent
* Patients \> 18 year-old
* The surgeries performed by the surgeon EO

Exclusion Criteria:

* Missing data
* patients without consent
* patients who underwent open or retroperitoneoscopic laparoscopic partial nephrectomy
Biomarker-based Prognostic Assessment

Coronary artery disease (including stable angina and acute coronary disease) remains the leading mortality and morbidity worldwide. Improvement in biomarker, imaging research have led to new predictors for the prognosis, which may have great clinical value in the current era of personalized medicine. However, there is no available biomarker-based prediction rule for risk assessment of adverse events in patients with stable angina and acute coronary disease. Therefore, we aim to develop and validate a new biomarker-based risk model to improve the prognostication of adverse events (e.g. ischemic and bleeding events ) in the patient population.

Patients enrolled in Qilu Hospital of Shandong University (Jinan, China), Chinese PLA General Hospital Hospital (Beijing, China) and Peking University First Hospital (Beijing, China) are designed as the development cohort to derive the risk prediction models of ischemic and bleeding events. Patients enrolled in Peking University Third Hospital ( Beijing, China) Zibo Central hospital (Zibo, China) are designed as the independent validation cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized patients with the diagnosis of any type of coronary artery disease (stable angina, unstable angina, non ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction)
2. Age ≥18 years of age and \<85 years of age
3. Patient or guardian provided informed written consent

Exclusion Criteria:

1. Prior surgery (cardiac or non-cardiac), trauma or clinically evident coagulopathic bleeding (e.g. gastrointestinal, genitourinary, et al)
2. Patient with non-cardiac co-morbidities with life expectancy less than 12 months
3. Patients unwilling or unable to comply with all clinical follow-up schedules at 30 days, 6 months and 12 months after discharge
Consent Forms in Cancer Research: Examining the Effect of Length on Readability

Researchers are using mock consent forms to see if wordiness has any effect on patients' understanding and willingness to sign up for a cancer clinical trial.

This study will determine whether there is a relationship between wordiness of a consent form and whether or not the consent form helped the patient decide to enroll in a clinical trial. This study will also determine whether wordiness of a consent form is associated with patients' willingness to sign the consent form.

Eligibility Criteria:
Inclusion Criteria:

* Patient-reported history of cancer
* Patient is able to read English
* Patient-reported age of 18 years or older

Exclusion Criteria:

* None
Norwegian Intensive Care Unit Dalteparin Effect Study

The main purpose of the NORIDES study is to investigate the effect of pharmacological thromboprophylaxis with low molecular weight heparins (LMWHs) in critically ill patients, and how it is affected by presence of acute kidney injury (AKI) and treatment with hemodialysis. The main objective is to compare the prophylactic effect of dalteparin in intensive care unit (ICU) patients with AKI and Citrate-Calcium dialysis (CiCa-dialysis) with a control group of ICU patients with normal kidney function. Our main hypothesis is that CiCa-dialysis reduces dalteparin effect, and that patients undergoing CiCa-dialysis do not achieve adequate prophylaxis against venous thromboembolism (VTE). The primary endpoint is development of DVT during ICU stay, the secondary endpoint inadequate heparin effect measured in blood samples.

Description of deep venous thrombosis (DVT) diagnosis: Screening for DVT using Doppler Ultrasound (DUS) of both upper- and lower extremities will be performed within 48 hours after ICU admission and thereafter twice a week until discharge from ICU or ICU stay equal to 30 days. An additional DUS will be performed 3 months after ICU discharge.

Description of heparin effect measured in blood samples: Blood samples will be drawn from intravasal catheters (preferably arterial, alternatively central venous) to examine heparin effect (anti-Xa activity, thrombin generation assay (TGA) and thrombelastography (TEG) and other haematological analyses including antithrombin concentrations. Whole blood will be drawn on two separate days (from minimum day 2 to maximum day 30 dependent on the dialysis therapy) of ICU stay immediately before and 4 hours after dalteparin administration in order to measure tough and peak effect of heparin. Dalteparin effect in ICU patients undergoing dialysis therapy will be measured one day with and one day without ongoing dialysis therapy in order to distinguish the effect of AKI from the effect of continuous renal replacement therapy (CRRT).

Eligibility Criteria:
Inclusion Criteria:

* ICU patients receiving prophylactic dalteparin

Exclusion Criteria:

* Age \< 18 years
* Intraocular bleeding
* Intracranial bleeding
* Acute spinal cord lesion
* Inherited coagulopathy
* Ongoing, uncontrolled bleeding
* Therapeutic anticoagulation
* Uncorrected coagulopathy
* Pregnancy or postpartum \< 6 weeks
* Participation in an interventional study
* RIFLE class E
* Consent not received
* ICU length of stay less than 48 hours
* DVT detected at first DUS examination
Dental Age Estimation by Different Methods in Patients With Cleft Lip and Palate

The aim of this study is to investigate whether there is a significant difference in dental age between children with CLP and healthy controls using the Willems method, Cameriere European formula and London Atlas. It is aimed to create a new formula if there is a significant difference in dental age between children with CLP and healthy controls.

Dental age is widely evaluated by pedodontists, forensic dentists and orthodontists. While a delay in tooth development may be associated with growth retardation and learning difficulties, dental age determination can also be used for forensic age determination for children whose birth information is uncertain. A clear assessment of maturation in children with continued growth is important in establishing a dental treatment plan.

There are two basic approaches to dental age determination in children:

evaluation of eruption of teeth in the oral cavity, evaluation of the development and mineralization of crowns and roots on dental radiographs.

In many methods, the developmental stages of different numbers of permanent teeth are used.

The most commonly used method for determining dental age in children; is the Demirjian method that evaluates the development of seven left permanent mandibular teeth in eight stages (from A to H). Willems et al. In 2001, they modified the Demirjian method by conducting a study on the fact that it showed higher age determination in the Belgian Caucasian population. The adapted method was named the Willems method. It is stated that one of the advantages of this method is that it is a relatively simple system for determining tooth age.

One of the most widely used methods of dental age determination recently is the European formula of Cameriere et al., which is calculated based on open apex. It has been reported that this method has been tested on different population groups, and the results are accurate and reliable.

An atlas method was proposed by a group of London researchers in 2010. The Atlas shows all the teeth array images of certain age groups as a schematic series. Age determination is made by deciding which reference image matches the individual's panoramic radiography image more.

Eligibility Criteria:
Inclusion Criteria:

* 5-14 years old
* Healthy children
* Children with CLP
* Patients without missing left mandibular permanent teeth on panoramic radiography

Exclusion Criteria:

* Children younger than 5 years old and older than 14 years (children that cannot be assessed by the Willems and Cameriere method)
* Poor quality panoramic radiography
* Patients who have received orthodontic treatment
* Patients who received restorative or endodontic treatment
Impementation of the Exercise Recommendations for the Treatment of Primary Headaches: A Qualitative Approach to the Headache Units in Catalonia

Therapeutic exercise, including aerobic activity and strength training, has shown promise in treating primary headaches with a moderate effect size, despite limited evidence. Implementation requires specialized professionals, infrastructure, and defined care pathways. These strategies are cost-effective for similar chronic pain conditions. More research is needed to better understand the varying effects on headache frequency, duration, and intensity in larger patient samples.

Therapeutic exercise strategies (TES) includes modalities such as aerobic activity and strength training, which have been investigated as treatments for primary headache in recent years. These modalities have been previously summarized, and despite the fact that the body of evidence available is less than in other therapeutic modalities, this is increasing, and they are positioned as strategies with a moderate effect size and recommendation.

However, its implementation is not simple and requires resources, such as professionals with specialized training, infrastructure, and clearly defined care circuits. Conversely, these strategies have demonstrated cost-effectiveness in other chronic pain conditions with similar treatment and care demands.

It is of interest to increase knowledge in this area given that the size of the effect of these interventions is large, although it varies according to the analyzed variable and type of exercise modality. The reduction in days per month with headache or migraine, reduction in headache hours per month, or decrease in headache intensity has been demonstrated in a non-negligible number of patients, but larger samples are needed.

The present study aimed to determine the status of exercise recommendations in the headache units of the Catalan territory and to evaluate the possible fit of specialized physiotherapy for the treatment of patients with headaches within these units based on the opinion of the responsible members of these units and available resources.

Contact with the headache units of the Catalan territory will be made by email or telephone during November 2023.

Semi-structured interviews and a survey developed from the interviews with the members of the units will be conducted to determine the status of exercise recommendations in the headache units of the Catalan territory and to evaluate the possible viability of specialized physiotherapy for the treatment of patients with headaches.

A total of 8-12 interviews and 20-30 responses to the surveys were expected. These will include neurologists, nurses, pharmacists, managers, rehabilitation doctors, and physiotherapists linked to neurology services.

Eligibility Criteria:
Inclusion Criteria:

* Be part of the headache unit
* Be a part of a service related to the headache unit
* Be a healthcare practitioner, researcher, health manager or rehabilitation service manager.

Exclusion Criteria:

* Decline participation
* Unable to understand Catalan, Spanish or English