cyrilzakka/clinical-trials huggingface dataset:
Revealing Information Genuinely & Honestly Across Time: Pediatric Oncology Stakeholder Preferences and Recommendations for Prognostic Communication

This study is being conducted to better understand the preferences and recommendations of patients and parents regarding optimal ways to share prognostic communication. Specifically, to learn what stakeholders (i.e., patients, parents, and doctors) believe to be the "right" content, timing, and delivery of this important information.

Specific Aim 1

* To define key stakeholder preferences and recommendations for timing, content, and delivery of prognostic communication across the advancing illness course and bereavement.

Specific Aim 2

* To engage stakeholders in the design of a patient/parent centered RIGHTime framework and communication intervention to promote individualized, timely prognostic disclosure.

This study will have two phases.

Phase 1:

Investigators will define key stakeholder preferences and recommendations for timing, content, and delivery of prognostic communication across the advancing illness course and bereavement. Eligible parents and patients will participate in semi-structured interviews on prognostic communication preferences, stratified by cohort: poor-prognosis diagnosis, advancing disease, phase I/II trial enrollment, and bereavement; eligible oncologists will complete interviews on prognostic disclosure preferences. Participants will participate in a single interview that will last anywhere from 30 to 60 minutes.The interview will be audio-recorded and transcribed. Participant demographic and social determinants of health information will be collected.

Phase 2:

Investigators will partner with a smaller group of stakeholders (parents, patients, and oncologist) from phase 1 to develop a clinical communication guide to help improve communication between patients, families, and cancer doctors. The panel will meet across 4 sessions to develop a conceptual framework that explains the interconnecting variables influencing stakeholder preferences and to design a prognostic communication intervention (i.e., a RIGHTime communication guide) that encourages oncologists to provide individualized, timely prognostic disclosure.

Eligibility Criteria:
Inclusion Criteria:

Patients

* Aged 12-25 years
* Recent diagnosis (\< 3 months) of a poor prognosis cancer with an estimated survival of 50% or less by the primary oncologist (cohort 1) OR recent history of disease relapse/progression within the past 3 months (cohort 2) OR active enrollment on a phase I/II trial (cohort 3).
* English-speaking

Parents

* Aged 18 years or older
* Parent (or legal caregiver) of a child with cancer of any age who meets the above criteria for cohorts 1-3 OR of a child who died from cancer 6-24 months from enrollment (cohort 4).
* English-speaking

Oncologists

* Pediatric oncologists who treat patients at SJCRH or who refer patients for treatment to SJCRH

Exclusion Criteria:

* Does not meet the inclusion criteria.
Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program

The hospitalized elderly patient is conditioned by a series of circumstances unrelated to the pathological process itself that caused hospital admission and that usually worsen the results of hospitalization. In fact, the implementation of care models different from the traditional ones has shown a clear benefit in the functional results of these patients in the short and medium term. However, the components of these models that explain these better results have not been differentially evaluated. Some examples of these circumstances are the usual orders of absolute rest without any objective criteria for patients who are able to wander, the perpetuation of continuous fluid therapy, physical and chemical restraints, unnecessary permanent probes, etc. On numerous occasions, hospitalized elderly patients spend most of their time in bed, reaching even more than 83% of bedridden compared to 4% of those who stand up or are walking. The average time that a geriatric patient walks during their hospitalization ranges from 7 to 43 minutes/day. This population, by having their functional and physiological reserve reduced, are more vulnerable to the effects, for example, of bedridden, which range from functional loss or cognitive impairment, to longer stays, mortality and institutionalization, worse emotional situation, delirium, deconditioning, aspirations, pressure ulcers, and falls, decreased caloric intake, social isolation, poorer quality of life, and greater use of health-related resources. This study is a multicenter randomized clinical trial to be conducted in the acute care for elderly (ACE) units of three tertiary hospitals in Spain - Complejo Hospitalario de Navarra (CHN), Hospital Central de la Cruz Roja de Madrid (HCCRM) and Complejo Hospitalario Universitario of Albacete (CHUA). After randomization, the research team (physiotherapist, sport science specialist and geriatrician) will together perform the baseline measurement and follow-up visits of functional, pharmacological, comorbidity and cognitive assessment, as well as of mobility and strength evaluations. The intervention will consist of a multicomponent exercise training programme, which will be composed of supervised progressive resistance exercise training, balance-training and walking for 4 consecutive days. During the training period, patients will be trained in 20 min sessions twice a day (morning and evening).


Eligibility Criteria:
Inclusion Criteria:

* \> 75 years
* Barthel Index ≥60 points
* Able to ambulate (with/without assistance)
* Sing the informed consent
* Able to communicate

Exclusion Criteria:

* Expected length of stay \<6 days
* Terminal illness
* Very severe cognitive decline (i.e., GDS 7)
* Uncontrolled arrhythmias, acute pulmonary embolism and myocardial infarction, or extremity bone fracture in the past 3 months.
Resistance Training and Post Workout Protein to Improve Body Composition During Neoadjuvant Chemotherapy for Breast Cancer

In this study, the investigators hypothesize that a high dose of post-workout protein nutrition regimen focused on food quality and an observed exercise regimen utilizing high-load resistance training initiated during or after cancer treatment will improve body composition and functional capacity.


Eligibility Criteria:
Inclusion Criteria:

1. Age 20-89 years
2. Women with a biopsy proven diagnosis of invasive carcinoma of the breast.
3. Women must undergo neoadjuvant chemotherapy for breast cancer treatment prior to surgery
4. Must be able to read and understand English and consent for themselves.

Exclusion Criteria:

1. Inability to get up and down off the ground or squat body weight
2. Inability to safely engage in group exercise sessions as deemed by study PI
3. Severe arthritic, joint, cardiovascular, musculoskeletal, or any other condition deemed by PI to be unsafe to engage in resistance training
4. Lactose intolerance
5. Cow's milk or whey protein allergy
6. Pregnant women
7. Males
Efficacy of Transversus Thoracis Muscle Plane Block in Patients Undergoing Cardiac Surgery

The goal of this randomized double blind study is to evaluate the analgesic efficacy of Transversus Thoracis Muscle Plane Block in patients undergoing cardiac surgery with median sternotomy.

one group of participants will receive multimodal analgesia plus ultrasound-guided Transversus Thoracis Muscle Plane Block with ropivacaine 0.5 % after induction of general anesthesia, the other group will receive multimodal analgesia without a bloc.

The investigators want to know if participants who receive the Transversus Thoracis Muscle Plane Block with ropivacaine have less pain than participants who do not receive a block.

Participants who undergo elective cardiac surgery with median sternotomy are eligible. They will receive general anaesthesia with multimodal analgesia as is standard in our institution. For study purposes participants will be randomized in a double blinded fashion to receive a Transversus Thoracis Muscle Plane Block with 30 mL of ropivacaine 0.5 %, or no block. As the block is carried out after induction of general anesthesia the participants will not know to which group they are assigned.

all blocks will be carried out after induction of general anesthesia, under full sterile precautions, and with ultrasound guidance. multimodal analgesia intra- and postoperatively is standardized and consists of: sufentanil, ketamine, dexmedetomidine, dexamethasone, paracetamol, metamizole, IV morphine in ICU.

The investigators aim for fast track surgery, i.e. extubation either in the operating room or in ICU within the first 6 postoperative hours.

the primary outcome is postoperative opioid consumption over the first 24 h postoperatively, secondary outcomes are pain scores and opioid-related side effects. all outcomes will be assessed by blinded investigators.

Eligibility Criteria:
Inclusion Criteria:

* • Informed consent

  * Major adult (≥ 18 years old)
  * Body weight ≥ 50 kg. 50 kg is the minimal weight to ensure that participants will not receive an overdose of local anesthetic (ropivacaine 3 mg/kg)
  * Primary cardiac surgery via a sternotomy approach
  * Planned for fast-track procedure (i.e. postoperative extubation time of maximum six hours)

Exclusion Criteria:

* • Participation in another study within the 30 days preceding and during the present study

  * Refusal and/or inability to understand or sign the informed consent
  * Emergency cardiac surgery
  * Previous cardiac surgery
  * Hypersensitivity or allergy to ropivacaine and other amide-class LA
  * History of chronic pain
  * History of substance abuse
  * Severe cardiac dysfunction (i.e. LVEF ≤ 35%)
  * Severe obesity (BMI \> 40kg/m2)
Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery

Assessment of Intubation conditions following administration of neuromuscular blocking agents; BX1000 (investigational) or rocuronium (active control).

Intubation conditions will be assessed in anesthetized subjects undergoing an elective surgical procedure utilizing general anesthesia. Following administration of IV anesthesia, subjects will have electromyography (EMG) neuromuscular monitoring device applied prior to administration of neuromuscular blocking agent (NMBA). NMBA will be administered and assessment of intubation conditions will begin 60 seconds after administration according to the methods defined in Viby-Mogensen 1996; assessment will be repeated at 90 and 120 seconds after administration when intubation has not already been completed.

After intubation is completed, subjects will progress to have their elective surgery completed and will be maintained under general anesthesia until neuromuscular function is recovered. Once recovered from anesthesia and extubation, subjects will be monitored in a recovery area until they are suitable to be discharged to the inpatient floor, after which time they may be discharged at the clinical discretion of the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Providing informed consent
* Undergoing elective surgery utilizing IV general anesthesia
* Normal airway assessment

Exclusion Criteria:

* Unstable disease or emergency surgical conditions
* Known hypersensitivity to rocuronium, other NMB or study medications
* History of anaphylaxis
* History of neuromuscular junction disease
* Personal or family history of malignant hyperthermia or pseudocholinesterase deficiency
* Diagnosed or suspected sleep apnea
* History of prior anesthetic complications
Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection

Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the many prevention and treatment techniques that have been described. Since the introduction of laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia remains a surgical problem of considerable importance, requiring significant consumption of public health and economic resources, and representing a major alteration of the quality of life of these patients.

Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in elective surgery for laparoscopic abdominoperineal resection.

Methodology: prospective, multidisciplinary, multi-center randomized controlled study. Control group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection. Study group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25). Sample size was calculated based on a proportion of parastomal hernia of 65% in the control group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28 patients are required, 14 per group. Estimating a drop-out rate of 10%, the final number will be 32 patients. The efficacy will be evaluated clinically at six months and abdominal CT will be performed at 12 months along with another clinical evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex intervened electively for colorectal surgery (rectal cancer) in whom definitive colostomy is indicated after laparoscopic abdominoperineal amputation.
* Life expectancy above 12 months

Exclusion Criteria:

* - Patients with allergy or intolerance of the compounds in the mesh
* Carriers of prosthetic meshes in the area of the ostomy
* Patients electively intervened for colorectal surgery (neo de reco) in whom definitive colostomy is indicated after abdominoperineal amputation but not via a laparoscopic approach.
* Cirrhotic patients
* Patients with life expectancy below 12 months due to underlying disease
Effectiveness of Vitamin E and Hydrogen-Rich Water on Radiation Therapy-Induced Adverse In Patients With Rectal Cancer

Controlled studies investigating the effects of vitamin E or H2 water or comparing their effectiveness on radiation therapy-induced injuries in RC patients are generally lacking. The present study hypothesis the following: (1) Pre - radiation therapy administration of vitamin E to patients with rectal carcinoma will provide radioprotection for exposed healthy tissues. (2) Consumption of H2 water by patients with rectal carcinoma undergoing RT will reduce the side effects of this modality. (3) Rectal cancer patients receiving H2 water will show better biological improvement than those receiving only vitamin E, i.e., H2 water is more effective antioxidant than vitamin E. (4) The proposed radiation countermeasures will not compromise the anti-tumor effects.


Eligibility Criteria:
Inclusion Criteria:

* - Men or women.
* Older than 18 years.
* Histologically proven adenocarcinoma of the rectum.
* Underwent radiotherapy.
* Absence of any psychological, and sociological condition that potentially affects the compliance with the study protocol and follow-up schedule.

Exclusion Criteria:

* The use of anticoagulant and antiplatelet agents.
* Any disease of disorder capable of contraindicating the absorption of Vitamin E or Hydrogen water in the body of a patient being investigated.
* No known history of problems absorbing fats (e.g., Crohn disease, cystic fibrosis)
A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain

The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624 compared to placebo over a 4 month period.


Eligibility Criteria:
Inclusion Criteria:

Male or non-pregnant female aged 40-75 with chronic moderate to severe knee pain due to OA (scoring 50 out of 100 on a visual analog scale on knee pain).

Subjects must meet one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery

Exclusion Criteria:

History or symptoms of autoimmune disorders, cancer within the last 5 years except for cutaneous basal cell or squamous cell cancer resolved by excision, allergic reaction to monoclonal antibodies or IgG-fusion proteins, Hepatitis B, C or HIV, drug abuse, fibromyalgia, clinically significant cardiac disease, diabetes mellitus requiring oral treatment or insulin, clinically significant neurological disease or clinically significant psychiatric disorders
Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlea Implant User

The aim of the study is to evaluate the interaural time difference (ITD) benefit in patient with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners. Half of participants are bilateral cochlear implants users, while the other are normal hearing listeners.

Listening in noisy environments is part of everyday life, it is based on binaural phenomena such as spatial localization

Bilateral cochlear implants certainly restore a part of binaurality

Eligibility Criteria:
Inclusion Criteria:

* Fluent in local language
* Normal hearing listener:
* pure tone threshold \> 25dB from 125Hz to 12kHz
* Cochlear implant recipient
* bilaterally implanted 6 months at least, the second implant should be implanted 6 months at least before participant inclusion
* Digisonic SP® cochlear implants user

Exclusion Criteria:

* binaural sensitivity threshold \< 1000µs
PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK

Postpartum depression is a disease with a prevalence of 10% which has not only deleterious consequences for the mother but also for the baby and can delay the physical, social and cognitive development of the baby. Therefore we consider very important to prevent this disease as from the centers of care for women with a multidisciplinary approach. The aim of this study is to determine whether psychoeducation oriented in problem solving is effective in preventing the development of postpartum depression in women with very high risk.

Methodology: screening of 1000 women in 3rd trimester of pregnancy. We expect that 25% have at least one risk factor for postpartum depression (250). Of these women, aproximately a 50% will have a very high risk of developing postpartum depressión and will be included in the study (n = 125). These women will be randomized to two groups: treatment with psychotherapy focused on problem solving (6 sessions: 1 individual session + 5 group sessions) or usual care control group (usual postpartum control).

After treatment, women will be evaluated twice, at the end of therapy and at 6 weeks. Survival curves will be used tu assess the time it takes patients to develop major depression in the postpartum.


Eligibility Criteria:
Inclusion criteria

1. General criteria for inclusion in the study:

   1. Pregnant women in the 3rd quarter. In the case of inclusion of children in the study were notified each case their participation to the Department.
   2. Signature of informed consent.
2. Inclusion criteria for treatment group:

   1. Submitted one or more risk factor for developing postpartum depression:

      * Depressive or anxious pathology during pregnancy.
      * Personal history of severe mental disorder (schizophrenia and other psychoses, bipolar disorder, depressive disorder).
      * Family history of severe mental disorder.
      * Concomitant medical diseases associated with depression (diabetes, heart disease, hypertension, obesity).
      * Low or very low socioeconomic status.
      * Lack of support for women (couples, family, friends or others).
   2. Submit a score ≥7.5 in the EPDS questionnaire. According Vega-Dienstmainer (Vega-Diesnstmainer JM, 2002), there weren't women with lower score than 7.5 that had been diagnosed with DPP (sensitivity and positive predictive value of 100%). Therefore, we considered selecting those patients with higher score of 7.5 on the EPDS scale.

Exclusion criteria

1. Mental Retardation.
2. Severe mental disorder decompensation that prevents understanding of the objectives of the study.
3. Submit language difficulties that impede verbal comprehension / reading-writing.
4. Submit a major depressive episode according to DSM-IV TR (depressive symptoms of sufficient intensity and longer duration than 2 weeks).

All participants will be informed that they will be randomized to on of the two study groups and will only be included if they give their informed consent to participate in the study. Women in both groups will be evaluated at baseline (pre-intervention) at 6 and 12 weeks (postinternveción).
Microvascular Flow Assessment Repeatability Study: The MARS Study

The purpose of this study is to test a method of imaging (taking a picture) of the abdomen (belly), neck, thigh and calf (lower leg) areas of the body, using ultrasound along with a drug which makes the pictures look clearer. Ultrasound is a type of imaging that uses sound waves to create a picture of the inside of the human body. Two sets of pictures will be taken on two different days to see if the results are the same each time.

DEFINITY® is a drug given intravenously (through the vein). DEFINITY® is approved by the FDA to be used as an ultrasound contrast agent (makes the pictures look clearer) while taking pictures of the heart. In this study, DEFINITY® will be used while taking pictures of blood vessels in your abdomen (belly), neck, thigh and calf (lower leg). Since this use of DEFINITY® is different than the use approved by the FDA, this study will be performed under an FDA Investigational New Drug (IND) application.


Eligibility Criteria:
Inclusion Criteria:

1. Men and non-pregnant/lactating women between the ages of 18 and 45;
2. Lean (BMI ≥18 and ≤25) or Obese grade I-II(BMI\>30 and ≤35)
3. Provide written informed consent and sign HIPAA Waiver of Authorization
4. Be able and willing to follow all instructions and attend all study visits

Exclusion Criteria:

Subjects must not have been diagnosed with:

1. Coronary artery disease
2. Congestive heart failure
3. Congenital heart disease (Right-to-left, bi-directional, or transient right-to-left cardiac shunts)
4. Hypersensitivity to perflutren
5. Renal disease
6. Chronic obstructive pulmonary disease or Asthma
7. Primary or secondary pulmonary hypertension
8. Obstructive sleep apnea
9. Thyroid disease
10. Vasculitis
11. Peripheral arterial disease.
12. Cancer
13. Any type of immunosuppression
14. Any active infection (systemic or of the underlying skin or subcutaneous tissue).
15. Taking any prescribed medication for hypertension, dyslipidemia or diabetes.
16. Current or past smoking in the last 12 months.
17. Positive urine pregnancy test
18. Creatinine (Cr) above 1.4 mg/dl on screening evaluation
19. Hemoglobin (Hb) less than 10 mg/dl on screening evaluation
20. Aspartate Transaminase (AST) or Alanine Transaminase (ALT) two fold above upper limit of normal on screening evaluation