cyrilzakka/clinical-trials huggingface dataset:
Safety and Security Evaluation of Patients Submitted to Minimally Invasive Radical Prostatectomy

This project aims to evaluate safety and security of patients submitted to minimally invasive radical prostatectomy, who received discharge from hospital in the same day of the surgery (Group I), on the 1st post-surgery day (Group II) and in the 2nd post-surgery day (Group III - control). The specific aims are the evaluation of fail index and factors that influence the permanence in the hospital, the satisfaction of patients, the perception of security of patient, the index of post-discharge complications and the costs related to different times of hospitalization. On randomization, those patients in Group I must match the early hospital discharge criteria defined in the study. Thus, they will be forwarded to "Casa de Apoio Madre Paulina", where will receive nursing care until the next day when, in the morning, will be reevaluated in the ambulatory of urology from Barretos Cancer Hospital. The patients of Group II will be evaluated in the ambulatory in the 2nd post-surgery day, before the discharge. In the Group III (control), the patients will be discharged in the 2nd post-surgery day (routine of Barretos Cancer Hospital). All patients who accept to be enrolled in the study will sign the Consent Term previously the surgery. At the 10th post-surgery day, in the follow-up, it will be applied the Patients' Satisfaction with Mental Health Services Scale (SATIS-BR) questionnaire and an inventory. The data will be descriptive considering average, standard deviation, minimum and maximum value and quartile to the quantitative variables and frequency tables to the qualitative variables. In order to determine the groups' homogeneity, some sociodemographic and clinical characteristics will be compared. To the qualitative variables, it will be used chi-squared test (of Fishers exact test), and to the quantitative variables it will be used variance analysis (or Kruskal-Wallis test). The patients' satisfaction will be measured using SATIS-BR, which consists in three numeric domains (ranging from 1 to 5). The comparison of each domain among the groups will be performed using ANOVA. Then, linear regression will be performed in order to analyze the relationship of the patients' characteristics influencing the satisfaction. The rates of fail, clinical security, security perception and post-discharge complications will be compared among the groups using chi-squared test (of Fisher's exact test). There will be considered the significance level of 5%.


Eligibility Criteria:
Inclusion Criteria:

* Localized Prostate Cancer
* BMI ≤ 35
* Specific Prostate Antigen ≤ 30 ng/ml
* Gleason score ≤ 7
* Hemoglobin ≤ 12g/dl
* American Society of Anesthesiologists Score ≤ 2
* Absence of psychiatric disease

Exclusion Criteria:

* Perioperative results with estimated blood loss \> 750 ml
* Blood transfusion need
* Operative time \> 4 hours
* Nausea or vomiting at the discharge
* Uncontrollable pain at the discharge
* Postural hypotension
Quantitative MRI for Non-invasive Assessment of Severity of Alcoholic Liver Disease (ALD)

The current goal in the treatment of Alcoholic Liver Disease (ALD) is to manage ALD-associated complications as there are no disease-specific therapies. Identifying disease-specific therapies to slow ALD progression is critical to improving the outcomes in these patients. Despite preclinical treatment studies in animal models that have shown promise, clinical trials in ALD patients have been limited by the absence of sensitive, quantitative methods for identifying severity and monitoring progression of liver disease. The rates of progression of liver disease in ALD are variable and difficult to predict, which makes assessments of therapies difficult. Clinical measures of hepatic or biliary disease (e.g., bilirubin, transaminases) may be normal, only mildly elevated and/or stable despite ongoing organ damage. Liver biopsies are diagnostic, but are invasive and are of limited value for longitudinal monitoring. Currently clinical imaging, including standard volumetric imaging (MRI and ultrasonography) and hepatic fibrosis assessment (e.g. Fibroscan) are also of limited utility in fully staging disease severity and monitoring progression in ALD. The absence of clinically available methods for accurately determining the severity and progression of liver disease progression in ALD has limited implementation of clinical trials using novel therapeutic agents. Development of non-invasive imaging biomarkers to assess rates of liver progression will overcome this barrier and allow for such studies to be undertaken. This study intends to perform a one-time MRI on patients with ALD to search for these biomarkers that can improve the diagnosis and treatment of ALD patients.


Eligibility Criteria:
Inclusion Criteria:

* All subjects \> 18 years of age, with the clinical diagnosis of ALD and native liver will be eligible

Exclusion Criteria:

* Subjects with history of combined organ transplantation
* Presumed or biopsy-confirmed ascending cholangitis within the last 3 months
* Contraindications for MRI (e.g. pacemakers, implants/hardware that is not MRI compatible)
Effects of the Inclusion of Physical Activity in Secondary School Academic Classes: the ACTIVE CLASS Study

Study based on the inclusion of physical activity in the secondary education classroom through active breaks and physically active learning, aimed at testing its effects on the improvement of physical activity levels, sedentary time, educational indicators, cognition and physical and psychological health markers.

The ACTIVE CLASS is a randomized controlled study coordinated by fully qualified researchers in the physical activity and sport sciences from two universities \[University of Cadiz (UCA) and University of Extremadura (UEX), Spain\]. This study is aimed at 7th and 8th grade students (11-13 years old), belonging to 6 schools in Spain (3 schools in Cadiz and 3 schools in Caceres). One school from each study region will be randomly assigned to one of the three intervention groups:

(i) Active breaks intervention: there will be 2 active breaks per day, 5 days a week of moderate-vigorous physical activity with a duration of 5 minutes.

(ii) Physically active learning intervention: Once a week, moderate-vigorous physical activity will be included in the academic lessons of the mathematics subject.

(iii) Control group.

The interventions will have a duration of 16 weeks. The different outcome measures (physical activity and sedentary behavior, health-related physical fitness, psychological health, academic indicators, cognition, motivational variables, dietary patterns, sociodemographic characteristics and qualitative information) will be evaluated at 3 time points:

1. Pre-intervention
2. Post-intervention
3. Retention measure (this measure will be conducted four weeks after the intervention to analyze the sustainability of the intervention program)

All measures will be assessed at each time point with the exception of qualitative information which will be assessed only in the post-intervention measure.

At the end of the intervention the researchers will determine the changes of the main outcome variables. Likewise, the main hypotheses raised will be:

1. A physically active learning intervention and active breaks will result in improved physical activity levels and decreased sedentary time.
2. A physically active learning intervention and active breaks will produce improvements in markers of physical and psychological health.
3. The inclusion of physical activity in academic classes will result in improved academic indicators and cognitive markers.
4. A physically active learning intervention and active breaks will produce improvements on motivational variables in academic classes.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents who are studying 7th or 8th grade
* Adolescents with the informed consent signed by family/tutor
* Schools with at least 60 students enrolled in 7th and/or 8th grade
* Schools belonging to the regions of Cáceres and Cádiz

Exclusion Criteria:

* Adolescents who have a physical disability or health condition that could limit physical activity levels
* Schools participating in any other physical activity or health promotion program
Evaluation of a Twenty-session Cognitive-behavioral Therapy With Anorexia Nervosa (CBT-20-AN) Among Adults (18+)

The study is a clinical trial assessing the efficacy of a new twenty session cognitive behavioral therapy for adults (18+) with anorexia nervosa (AN). It is expected that participants will gain a significant amount of weight and experience a significant decrease in eating disorder psychopathology and behavior from pre- to post- treatment and that this will be retained after 6-months.


Eligibility Criteria:
Inclusion Criteria:

1. Eligible patients must meet DSM-5 criteria for anorexia nervosa. This diagnosis can be conferred via the EDE 17.0D.
2. Age \> 18
3. Patients must be able to provide informed consent and comply with the study procedures.
4. Patients must be able to complete computer-based self-report questionnaires with adequate accommodation, if necessary.
5. Patients must have a primary care physician, Adolescent Medicine physician, or consulting physician with eating disorder expertise at Massachusetts General Hospital/Massachusetts General Brigham network who can provide ongoing medical monitoring while the patient takes part in the study.

Exclusion Criteria:

Patients will be excluded if they exhibit:

1. BMI \< 15 or \> 19, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
2. HR \<55 or \>100, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
3. Systolic BP (SBP and DBP) \<80 or \>160, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
4. Temperature \< 96.5 F, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
5. Not eating food by mouth and/or any tube feeding, per EDE
6. Purging \> 4x/week, per EDE.
7. Active suicidality (suicidal ideation with intent or plan) to the point that more intensive treatment (i.e. acute hospitalization) is required
8. Active untreated and unstable bipolar disorder (i.e. stable bipolar disorder under care of a psychiatrist is allowed)
9. Psychosis
10. Intellectual disability
11. Any condition that, after the baseline evaluation, is determined to preclude treatment with CBT.
12. Concurrent psychotherapy. Patients must be willing to take a pause from any ongoing psychotherapy in order to focus on CBT-AN-20, which is in alignment with standard clinical care.
13. Symptoms that are not appropriate for outpatient level of care and therefore require a higher level of care (i.e. BMI \<15 or purging more than 4x/week)
14. Homicidal ideation
15. Inability to speak English well enough to engage in CBT
Therapeutic Yoga and Resistance Exercise for Lung Cancer

The purpose of the study is to determine the feasibility and preliminary efficacy of a combined therapeutic yoga and resistance exercise intervention for individuals with lung cancer and their caregivers. The investigators aim is to help reduce the fear of exercise by tailoring the program to meet the specific needs of the survivor with lung cancer. The investigators want to see whether individuals with lung cancer and their caregivers are interested in participating in this type of program, and if they are able to attend the intervention sessions and complete the program. The investigators also plan to study the preliminary effects of therapeutic yoga and resistance exercise on fitness outcomes for both individuals with lung cancer and their caregivers.

To determine the feasibility of a combined therapeutic yoga and resistance exercise intervention for lung cancer survivors and their caregivers. A single group before and after intervention study design will be used for this pilot feasibility trial. Brochures and information about the study will be distributed at the Cross Cancer Institute, and interested individuals will be screened for eligibility. A convenient sampling technique will be used to recruit individuals with lung cancer and their caregiver. Participants deemed eligible to take part in the study will provide written informed consent to participate in the study and will undergo baseline testing. The intervention will be carried out over a period of 8 weeks. The feasibility outcomes will include eligibility rate, completion rate, adherence rate and adverse events. Dyspnea will be the primary self-reported outcome to be measured for individuals with lung cancer. The secondary outcomes will include fatigue, shoulder range of motion, chest expansion, and muscular strength. The outcome measures for the caregivers will include quality of life (QoL) and muscular strength.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Primary Lung Cancer Stage I-IV (all stages)
2. Any form of Lung cancer included: Small Cell Lung Cancer and Non-Small Cell Lung Cancer
3. Age: 18 years or above
4. Patients at any time point during treatment: ongoing treatment, completed treatment or recently diagnosed and about to start treatment
5. Karnofsky Performance Status ≥ 50 (Appendix A)
6. Life expectancy at least one year -

Exclusion Criteria:

1. Metastatic lung disease that would preclude safe exercise prescription
2. Secondary Lung cancer due to metastasis from other parts of body
3. Co-morbid conditions such as diabetes, congestive heart failure, dementia, cerebrovascular diseases.
4. Individuals who would be unsafe to participate in an intervention program.
5. Unable to provide consent in English
6. Unable to complete either testing or intervention components (e.g. extended holiday)

Caregiver eligibility: Caregivers will be screened using the PAR-Q + questionnaire and will be required to obtain approval from a family physician should any safety concerns be identified.
Infraclavicular Brachial Plexus Block With Bupivacaine Alone or With Both Dexmedetomidine and Dexamethasone

Upper-extremity regional anesthetic techniques, using brachial plexus blockade, have been shown to reduce adverse effects related to opioid administration, improve patient satisfaction, and provide significantly improved analgesia immediately following these surgeries. Many medications have been investigated to extend and enhance long-acting local anesthetics' (LA) analgesic effects. Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal long-lasting single-shot nerve block. In general, adjuvants have been used in peripheral nerve blocks to accelerate onset, decrease plasmatic absorption and secondary toxic effects, and prolong the block effects.

Brachial plexus blockade-based upper-extremity regional anesthetic approaches have been demonstrated to lessen opioid administration side effects, increase patient satisfaction, and offer noticeably better analgesia right after these surgeries. A lot of drugs have been tested to prolong and improve the analgesic effect of long-acting local anesthetics (LA). Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal, long-lasting single-shot nerve block. Adjuvants have generally been employed in peripheral nerve blocks to lengthen the block effects, limit secondary toxic effects and plasmatic absorption, and speed the onset of the block. Objectives: To compare the effects of adding dexmedetomidine and dexamethasone to bupivacaine on the start of sensory blockade in an infraclavicular brachial plexus block. Patients and Methods: A prospective, randomized controlled trial will be conducted on patients who are undergoing hand or forearm surgeries. Patients who will be eligible for the study will be divided into 2 groups. The first group will receive dexmedetomidine and dexamethasone as adjuvants to bupivacaine, while the second group will receive bupivacaine alone. Expected Results: The success rate, onset time, duration of the block, and possible adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* American Society of Anesthesiologists physical status I-II
* Body mass index between 18 and 35 kg/ m2
* scheduled for forearm and hand surgeries

Exclusion Criteria:

* Inability to consent to the study
* Coagulopathy
* Sepsis
* Decompensated chronic hepatic or renal illnesses
* Allergy to any of the used drugs
* Pre-existing musculocutaneous/median/radial/ ulnar neuropathy
* Prior surgery in the infraclavicular fossa
Outcomes of Partial Pulpotomy Treatment in Cariously Exposed Teeth

The aim of this clinical trial is to learn how successful Biodentine and Theracal PT dental filling materials are in treating deep tooth decay in adults. It will also provide information about post-treatment pain. The main questions it aims to answer are:

Do Biodentine and Theracal PT dental filling materials treat exposed tooth decay in participants? Do they reduce the need for root canal treatment? After the application of Biodentine and Theracal PT dental filling materials to the participants, the pain and symptoms that cause pain may not decrease. In this case, the tooth may be treated with root canal treatment. The researchers will compare the clinical success of Biodentine and Theracal PT dental filling materials with each other.

Participants will undergo a single-session partial pulpotomy treatment with the dental filling materials mentioned above. Clinical and radiographic follow-ups will then be performed at 3, 6 and 12 months, and records will be kept.


Eligibility Criteria:
Inclusion Criteria:

* • Patient age should be between 18-50 years

  * Should be able to give written informed consent
  * Should have systemic status (ASA 1)
  * Should have permanent molar or premolar (lower and upper) root development
  * Should be asymptomatic, deep (D3) or extremely deep (D4) caries
  * Should give vital response in cold test and electric pulp test
  * Should have teeth where the pulp is exposed with caries
  * Should not have pain during palpation and percussion
  * Should not have periodontal disease
  * Should have restorable teeth
  * Should have teeth without pulp necrosis, sinus tract or swelling/abscess
  * Should have bleeding time less than 10 minutes
  * Should be able to include a maximum of two teeth in a patient in the study (should be in different quadrants and there should be at least 2 weeks between treatment periods)

Exclusion Criteria:

* Teeth with incomplete root development

  * Severely affected teeth that do not respond to pulp sensitivity tests
  * Teeth with signs and symptoms of irreversible pulpitis
  * Teeth without signs of bleeding after communicating with the pulp chamber
  * Teeth with pulp chamber open to the oral environment
  * Teeth with periodontal pockets greater than 4 mm deep
  * Teeth with suspected cracks or crown fractures that may be responsible for pulp pathology
  * Teeth with uncontrolled bleeding
  * Medically at-risk patients will be excluded from the study.
Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre

The objective of this study is to uncover the prevalence of vulnerability among patients aged ≥ 70 coming to the medical oncology division of the Oscar Lambret Centre, according to the short screening test Vulnerable Elders Survey 13 (VES-13).

The objective is to better understand the value of routine screening of patients before the consultation, it was proposed as a secondary objective of this study to assess the correlation between the identification of the vulnerability in the screening test VES-13 and the identification made by the clinician during the consultation. The correlation between VES-13 and opinion of the clinician for three categories of patients (self - intermediate - fragile) will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* patient aged ≥ 70
* coming for a first visit, whatever the purpose and the disease stage

Exclusion Criteria:

* neglect or refusal to answer to the VES-13 test
Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study

The purpose of this pilot study is to describe the relationship of regional cerebral oximetry and cytoximetry, measured using near-infrared spectroscopy, with seizure activity in the periictal period in children with epilepsy.

Pediatric subjects with partial (focal) epilepsy seizure disorders will be studied using near-infrared spectroscopy for cytochrome c oxidase (CCO) redox state and blood oxygen saturation. Along with routine EEG monitoring, a set of light sensors, called optodes, attached to a net/cap/device that goes over the head will be put on. These optodes will send out very weak red light signals, which will pass through the scalp and bounce back to detectors on the netting. The changes in the light signals will be used to calculate the changes in the various forms of the enzyme CCO, as well as the amount of oxygen in the blood. We hope to use these measurements to study changes in blood flow and cellular energy usage in the brain during seizures, which might help us to understand epilepsy better in the future and design better treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric epilepsy patients who can provide assent (lower limit age 7).
2. Diagnosis of partial (focal) epilepsy and/or frequent interictal spike activity on EEG.
3. Clinical EEG supporting diagnosis of partial(focal) epilepsy and/or frequent interictal spike activity

Exclusion Criteria:

1. History of unrepaired or palliated congenital cyanotic heart disease
2. History of traumatic head injury or head wounds to the extent that precludes safe and consistent placement of NIRS-EEG probes.
3. Guardian does not give consent or patient is unable to consent/assent to participate in the study
4. Clinical care provider or investigator determines the patient is not appropriate candidate for the study
5. Lack of current seizure care plan in Children's Hospital medical record
6. Known sensitivity or allergy to EEG gel
Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 2 diabetes
* Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
* HbA1c maximum 10.0%
* BMI (Body Mass Index) maximum 35.0 kg/m2
* Able and willing to perform self-blood glucose monitoring (SBGM)

Exclusion Criteria:

* The receipt of any investigational drug within the last 30 days prior to this trial
* Total daily insulin dose minimum 2.0 U/(kg·day)
* A history of drug abuse or alcohol dependence within the last 5 years
* Impaired hepatic function
* Impaired renal function
* Cardiac disease
* Severe, uncontrolled hypertension