cyrilzakka/clinical-trials huggingface dataset:
Esketamine for Prevention of Depression After Cytoreductive Surgery in Ovarian Cancer

The goal of this clinical trial is to learn if intraoperative administration of esketamine would prevent or mitigate postoperative depressive symptoms after cytoreductive surgery in ovarian cancer. The main questions it aims to answer are:

* Whether a single low dose of esketamine administered would reduce the postoperative depressive symptoms three days after cytoreductive surgery in ovarian cancer?
* Whether a single low dose of esketamine administered would relief the postoperative sleep disturbance, postoperative recovery? Researchers will compare the esketamine to a placebo (normal saline) to see if the esketamine works to reduce the postoperative depressive symptoms.

Participants will:

* Receive either 0.2 mg/kg esketamine or placebo infused intravenously after induction of general anesthesia.
* The preoperative Patient Health Questionnaire 9 (PHQ-9) scale was used to verify the symptoms suggestive of depression.


Eligibility Criteria:
Inclusion Criteria:

* undergoing cytoreductive surgery for ovarian cancer under general anesthesia
* ASA physical status I-III
* Ages 18-80 years

Exclusion Criteria:

* Patients taking anti-psychotic medications
* Contraindications to esketamine
* Language barrier
* Inability to provide consent
Minimally Invasive Aortic Root and Aorta surGery rEgistry

Minimally invasive aortic valve (AV) surgery has become widely accepted alternative to standard sternotomy. Despite possible reduction in morbidity, this approach is not routinely performed for aortic surgery. Evidence exists, however, on safety of this approach together with promising results regarding its long-term durability. The MIRAGE Registry is aimed to collect and analyse the data from multiple aortic excellence centres and to analyse them in numerous clinical scenarios.


Eligibility Criteria:
Inclusion Criteria:

* isolated, first time aortic root or aorta surgery

Exclusion Criteria:

* active aortic valve endocarditis, redo surgery, acute type A dissection, and concomitant cardiac procedures.
A Novel Incremental Step Test as an Alternative for the Assessment of Exercise Capacity in Patients With COPD

According to the official guidelines of pulmonary rehabilitation, a structured home-based approach is recommended to answer to the inadequate number of pulmonary rehabilitation services due to the chronic obstructive pulmonary disease (COPD) patient's needs. For this new setting, new strategies for the assessment of exercise capacity and exercise training are essential. The modality of step can be a promising tool because it is inexpensive, portable, and reflects one of the main activities of daily living (stair climbing). The development of a new field test implies the study of the measurement properties, to facilitate the selection of tests and the interpretation of the results in rehabilitation. This project hypothesizes that the step test can be valid, reliable, and feasible to apply in this new setting of pulmonary rehabilitation.

The primary aim of this project is to develop and determine the measurement properties (validity and reliability) of a novel step test for the assessment of exercise capacity in patients with COPD.

The investigators will perform two cross-sectional studies for validity and reliability in patients with COPD. Participants attending a pneumology consultation at the hospital will be asked for permission to be contacted about the study. The participants who agree will be seen by the principal investigator who will explain the nature of the study and assess eligibility for the study. The participants will sign informed consent.

The validity study will be performed in two days (separated \>48h). During the first session, the participants will perform the 6-minute walk test (6MWT) twice (a valid test for COPD). On the second day, the step test will be performed twice.

The reliability study will be performed in two days (separated for 7 days). On both days, the step test will be performed one time.

The investigators predict that 50 patients with COPD will be followed in each study (validity and reliability).

The investigators hypothesize that the step test can be a good option to apply in pulmonary rehabilitation programs with good measurement properties for the assessment of exercise capacity in COPD patients. The validation of the test can contribute to applying the step modality in the exercise training as an alternative for the prescription of the exercise intensity. For that, the investigators also hypothesize that the test can be reliable and one test must be enough for the assessment of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible with a diagnose of chronic obstructive pulmonary disease (COPD).

Exclusion Criteria:

* Patients will be excluded if they have a significant cardiac, immune, musculoskeletal or neurological impairment, or any other that does not allow them to perform the tests.
Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

Investigators performing this research want to look at the use of a special imaging process during a specific throat surgery. Using this imaging may help to lower a common complication that called a pharyngocutaneous fistula (PCF). A PCF is a leak in the tube in the throat that helps with breathing and digesting food.

The imaging is called the SPY Fluorescence System. This system can identify tissue that is not receiving enough blood. The SPY Fluorescence System uses a special dye, called Indocyanine green (ICG) to better see the tissues that are not receiving enough blood. When tissue does not receive enough blood, it can lead to infection. Infection of tissue in this area of the throat can lead to PCF. The imaging takes about 1 minute and is performed in the operating room during surgery.

For this study, the investigators (who are also surgeons) will decide to remove tissue that is identified by the SPY Fluorescence System to have decreased blood flow. They will then continue with the rest of the surgery as usual. The investigators will monitor participants as they recover from surgery to identify any complications that may occur. For this research they are interested in complications during the first month after surgery since this is when PCF usually happens.

Investigators will use information that has been documented in the medical records of participants as well as during in-person physical examinations during inpatient recovery and outpatient clinical visits.

Our prior work has demonstrated the efficacy to predict pharyngocutaneous fistula using Indocyanine green (ICG) angiography. In an observational study of 41 patients who underwent salvage TL with onlay free flap reconstruction, 7 (17%) patients developed PCF. Intraoperative angiography has the ability to measure the blood flow rate (ingress) into the tissues. In patients with ingress \<15 (n=25), 24% developed a PCF. In contrast, no PCF was seen in the group with ingress \>15. Of note, in patients with ingress \<15, there was no intervention performed as this was an observational study.

Eligibility Criteria:
Inclusion Criteria:

1. Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV)
2. Prior treatment with radiation +/- chemotherapy
3. Presence of local recurrence of disease, radiation necrosis or an incompetent larynx
4. 18 years or older. 5. Ability to understand and sign informed consent

Exclusion Criteria:

1. Iodine and Shellfish allergy
2. Contraindication to surgery under general anesthesia
3. Anticipated extended laryngectomy (laryngopharyngectomy or laryngopharyngoesophagectomy) with the need for free tissue transfer to reconstruct the pharyngeal mucosa. This may only be determined at the time of surgery
4. Pregnancy or lactation.
5. Patients residing in prison.
Effectiveness of a Digital Application for Adolescents With Mild to Moderate Anxiety

The goal of this randomized controlled trial is to investigate the effectiveness of a new therapist-guided rule based intervention in Bergen Municipality, Child and Family help center.

Do they have a decrease in anxiety symptoms following the intervention? Do they have an increase in functional level following the intervention?

Researchers will compare the therapist-guided rule based intervention with treatment as usual for adolescents with mild to moderate anxiety.

Participants will use the intervention, which is based on CBT, for 8 weeks.

Modi is a mobile application and consists of a training program for adolescents with anxiety problems. Anxiety is one of the most common mental disorders. The anxiety symptoms usually have an age of onset in adolescence. For many, these anxiety symptoms persist into adulthood, and lead to reduced quality of life and functional impairment. The goal is to prevent anxiety disorders, comorbid disorders and loss of function as a result of the anxiety symptoms.

This study wants to investigate the effectiveness of a digital intervention in a randomized controlled trial. The study will recruit N = 128 young people aged 13-16 who will be randomized to either a therapist-guided, rule-based chatbot intervention or treatment as usual in the Child and Family Help Center in Bergen Municipality. The study will examine the clinical effects of the new intervention compared to treatment as usual

Eligibility Criteria:
Inclusion Criteria:

* Ages 13-16
* Resides in Bergen
* Completed RCADS-25
* Reports "yes" to both questions:
* Do you have anxiety symptoms? Do you often feel stressed, scared, worried, or feel it in your body (e.g., stomach pain, heart palpitations, breathing problems, sweating, dizziness)?
* Do anxiety symptoms prevent you from doing things you want or need to do (e.g., meeting new people, giving presentations at school, going to sleepovers, going to the shopping center)? Or do you spend so much time worrying that it affects your daily life? Can read Norwegian

Exclusion Criteria:

* Currently receiving other psychological treatment
* Immediate need for other psychological treatment, such as severe depression, suicide risk, OCD, psychosis/substance abuse issues, autism spectrum disorder
* Anxiety is largely related to bullying
* Extensive school absence of more than 50% in the last three months
Coverage of Requirements After Consumption of a Nutritional Formula in Patients With Chewing/Swallowing Problems.

Effect of a nutritional formula on the nutritional requirements in patients with chewing/swallowing problems during one month

30 patients will receive nutritional education and guidelines for the consumption of a completed shreded diet including 2 packets of 90 grams every day (One salted packet for lunch/dinner and one sweet packet for breakfast/afternoon snack) and recommendations for physical activity for one month.

30 patients will receive nutritional education, guidelines for the consumption of a completed shreded diet and recommendations for physical activity during one month.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years old.
* Individuals with chewing/swallowing disorder.
* Individuals well nourished or at malnutrition risk.
* Adequate cultural level and understanding of the clinical trial.
* Signed informed consent.

Exclusion Criteria:

* Individuals with body mass index ≥40 kg/m2.
* Individuals with acute, severe or chronic disease without control.
* Individuals with major surgeries during the last month.
* Individuals with gastrointestinal surgery the last three months.
* Individuals with moderate/severe cognitive impairment.
* Individuals with severe malnutrition.
* Individuals with amyotrophic lateral sclerosis.
* Individuals who consume nutritional oral supplements seven days prior to the start of the study.
* Enteral or parenteral nutrition.
Impact of Order of Movement on Nerve Root Function

the main objective of this study is to investigate if different neurodynamic test sequencing of the median nerve has a different impact on median nerve root function. We hypothesized that the order of median nerve neurodynamic movements would influence peak-to-peak amplitude and latency.

Neurodynamic concept is used clinically to normalize nerve mobility. It has been manifested in previous studies that neurodynamics have increased mobility by floss like movement of the nerve. Whereas in other studies it has been concluded that neurodynamic techniques has an effect in decreasing fibrous and adhesions between neural tissues and the surrounding tissues therefore giving an outcome of improved infrafasicular gliding.

The upper limb neurodynamic test has an effect to alter the mechanical loads on the nerve by changing its dimensions. For neurodynamic to be more effective, it requires a certain sequence.

The different order of movements will induce different duration of tension in which it will influence the nerve root function, which is needed to be investigated to check for the effectiveness. A previous study has found that the difference of sequence on median nerve, had caused a change on the distribution of the sensory response on the asymptomatic participants. The sensory responses were more prevalent during the neurodynamic of the median nerve when it was applied from a distal to proximal sequence . One of the main purposes of the order of sequences is to add more strain to the nerve segment to increase the sensitivity of the test.

Clinically it has been assumed that the different order of movements could possibly influence the level of strain on a certain nerve segment. When the standard sequence was compared with the distal-to-proximal sequence for the median nerve, there was no physiological difference obtained at the end of the test. In comparison, there was a larger strain in the distal-to-proximal sequence in comparison to the proximal-to-distal sequence observed. However, the longitudinal excursion collected data indicated that the start and end positions for all the three sequences were alike.

In terms of neurophysiological outcomes, in this study we will use the dermatomal somatosensory evoked potential as a primary outcome due to its reliability in comparison with other physiological outcomes. There is a literature gap in regard to the effect of the order of sequence on the median nerve on the nerve root function and this is what the study will focus on. We hypothesized that the order of movements of the median nerve neurodynamic will influence the peak-to-peak amplitude and the latency.

Eligibility Criteria:
Inclusion Criteria:

* not currently experiencing any neck or dominant upper extremity symptoms.
* do not have a history significant for a chronic painful condition.
* do not using pain relievers.

Exclusion Criteria:

* inflammatory joint disease or other systemic pathologies.
* prior history of overt injury and surgery relating to the musculoskeletal system.
* disorder related to the spine and extremities.
* musculoskeletal pain in the last three months
Evaluation of the Effectiveness of an Intervention to Reduce Gaps in Hypertension Care in Low-income Medellin, Colombia

This study evaluates the effectiveness of a multi-component intervention to reduce the gaps in hypertension care and control at a population level in low-income Communes of Medellin, Colombia, and assess the process and fidelity of the intervention's implementation.

A multi-component intervention was designed based on international guidelines, a cross-sectional population survey results, and consultation with the community and institutional stakeholders. Three main components integrate activities related to (I) Health services redesign, (II) Clinical staff training (III) Patient and community engagement. The effectiveness of the intervention will be evaluated in a controlled before-after quasi-experimental study, with two deprived Communes of the city selected as intervention and control arms. Two representative population-based surveys of adults aged 35 years or older will be undertaken in the intervention and the control Communes two years apart, one before the intervention implementation and the other after. The surveys will include different adults. The main outcomes assessed will be the gaps in hypertension diagnosis, treatment, follow-up and control. Effectiveness will be evaluated with "difference in difference" measures. Generalized estimation equations models will be fitted considering the clustered nature of data and adjusting for potential confounding variables. The implementation process will be studied with mixed methods. Finally, implementation fidelity will be documented to assess to which degree the components of the intervention were implemented as intended.

Eligibility Criteria:
Inclusion Criteria:

* 35 years or older
* Permanent inhabitant of the selected Communes
* Must be able to provide written informed consent

Exclusion Criteria:

* Mental disability
* Unable to answer the questionnaire
Enhancing Communication and HIV Outcomes

The goal of this research is to improve communication between the patients with HIV and their health care providers. The overall purpose of doing so is to reduce disparities in medication self-efficacy, adherence to therapy, and HIV viral load suppression. The investigators will conduct a randomized controlled trial to test the effectiveness of a combined provider and patient communication intervention conducted at two separate visits compared to usual care in improving the quality of patient-provider communication, patients' medication self-efficacy, patient adherence to therapy, and HIV RNA suppression.

The goal of this research is to improve communication between the patients with HIV and their health care providers. The overall purpose of doing so is to reduce disparities in medication self-efficacy, adherence to therapy, and HIV viral load suppression. We will conduct a randomized controlled trial to test the effectiveness of a combined provider and patient communication intervention conducted at two separate visits compared to usual care in improving the quality of patient-provider communication, patients' medication self-efficacy, patient adherence to therapy, and HIV RNA suppression. The following primary and secondary hypotheses will be addressed.

Primary Hypothesis.

1) There will be more and higher quality patient-provider communication about antiretroviral medication adherence in the intervention compared to control arm at both visit 1 (V1) and visit 2 (V2).

Secondary Hypotheses

1. Higher quality patient-provider communication in the intervention arm will be associated with

   * higher patient ratings of communication (overall, HIV-specific, adherence-specific, and interpersonal style of provider) at V1 and V2;
   * increased patient preference for a shared decision-making role at V1 and V2;
   * more positive health beliefs at V1 and V2;
   * higher patient medication self-efficacy at V1 and V2;
   * better adherence to antiretroviral medication (assessed by 3-day recall) at V2; and
   * a greater percentage of patients with HIV-1 RNA suppression at V2.
2. The intervention will reduce disparities in medication self-efficacy, adherence, and HIV-1 RNA suppression.

Eligibility Criteria:
Inclusion Criteria (Providers):

1. Currently providing primary care to at least 10 HIV-infected patients in the clinic
2. Physician, Nurse-Practitioner, or Physician-Assistant
3. Agree to give written informed consent.

Inclusion Criteria (Patients):

1. HIV-infected patient of one of the participating providers
2. Has had at least one prior visit with that provider
3. Currently taking antiretroviral therapy
4. Capable of understanding and giving written informed consent
5. Age \> 20 years old
6. English-speaking
7. African-American (or people of African descent living in the United States), Hispanic, or non-Hispanic White race/ethnicity
Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)

The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease heart rate increases on standing in patients with postural tachycardia syndrome.

Chronic orthostatic intolerance, sometimes known as the postural tachycardia syndrome (POTS), is the most common disorder among patients seen at several centers specializing in diseases of the autonomic nervous system. It affects an estimated 500,000 people in the United States alone. POTS (excessive increase in heart rate \[\>30 min-1\] on standing associated with orthostatic symptoms \[including palpitation, chest pain syndrome, dyspnea on standing, mental clouding and difficulties with concentration\], in the absence of orthostatic hypotension) can produce substantial disability among otherwise healthy people. Patients with POTS typically feel tired and run down. Many also report a myriad of symptoms that are hard to categorize, often involving fatigue. One study, from the Mayo Clinic, found that patients with POTS had a diminished quality of life when measured using a standard health status instrument (SF-36).

In this pilot study, we will test the hypothesis that breathing through an inspiratory resistance device will improve orthostatic tolerance and reduce orthostatic tachycardia in patients with postural tachycardia syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
* Increase in heart rate ≥ 30 beats/min with position change from supine to standing (10 minutes)
* Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence
* Able and willing to provide informed consent

Exclusion Criteria:

* Overt cause for postural tachycardia (such as acute dehydration)
* Inability to give, or withdrawal of, informed consent
* Pregnant
* Other factors which in the investigator's opinion would prevent the subject from completing the protocol
Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.


Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia A
* Previously treated patients with at least 150 exposure days to any Factor VIII product

Exclusion Criteria:

* Hypersensitivity to any recombinant Factor VIII product
* History of or current Factor VIII inhibitor
* Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study
Pre-surgical CT Scan Assessment of Bone Mineral Density Before Resection of NHO of the Hip

Neurogenic heterotopic ossification (NHO) is defined as an ectopic ossification around proximal joints usually seen after traumatic brain injury, spinal cord injury or polytrauma.

NHO causes pain, partial or total joint ankylosis and vascular or nerve complications.

The osteopenia (low bone density) induced by ankylose increases the fracture risk of femoral neck during the hip surgery performed to remove the NHO.

The analyse of femoral head bone mineral density from hip pre-surgical CT scan could anticipate this kind of complication establishing a presurgical prognostic.

If as it turns out the bone density measured from hip pre-surgical CT scan is relevant fracture risk marker, a preventive osteosynthesis or femoral head and neck resection could be performed in the same time of NHO resection.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and over
* Patients having surgery resection of surgery resection of Neurogenic heterotopic ossification of hip.
* Patients with pre-surgery CT-scan and surgery report available

Exclusion criteria:

* Minor patients
* Patients didn't have surgery surgery resection of Neurogenic heterotopic ossification of hip.
* Pre-surgery CT-scan and surgery report not available

Exclusion Criteria:

-