cyrilzakka/clinical-trials huggingface dataset:
Effects of a Psycho-cognitive Nursing Intervention on Patients' Outcomes in Critical Illness

The purpose of this study is to investigate whether a psycho-cognitive nursing intervention including relaxation, guided imagery, touch and music listening can improve the clinical and psychological outcome of critically ill patients. The investigators hypothesize that, patients who receive the proposed psycho-cognitive nursing intervention will report lower stress, less pain and have altered level of stress neuropeptides in peripheral blood, lower levels of inflammatory molecules, less complications and better self reported lived experience than patients who receive standard care alone.

In previous research on the impact of stress on physiology, it has been shown that stress and its molecules may contribute to derangements prevalent in critical illness, including systemic inflammation, cellular stress, oxidative damage, endothelial dysfunction and coagulopathies which precipitate high mortality and morbidity. Investigators will examine whether a Psycho-cognitive nursing intervention to induce relaxation can improve patients outcomes.

Sixty ICU patients with or without SIRS will be randomized to receive either standard care or a brief Psycho-cognitive Nursing Intervention, plus standard care, up to 5 days during ICU stay.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients
* Understand Greek language
* Age over 18 years
* They have Richmond Agitation Sedation Scale rate: -3 +3
* Have an Arterial line in place

Exclusion Criteria:

* Patient who is expected to stay less than 24 hours in Critical care unit
* Have history of psychiatric disturbances
* Their condition does not permit use of headphones
* Have hearing impairment
* Receive neuro-muscular blockers
* Are confused
* Patients under universal conduct precautions
Comparison of the QT/QTc Interval Between an Outpatient HIV-Infected Population on Antiretroviral Therapy and Two Large HIV-Negative Cohorts

This is a unicentric, two cohorts, observational transversal study.

The purpose of this study is to compare the QT/QTc intervals of HIV positive subjects receiving an antiretroviral therapy and those without HIV in an ambulatory care setting.

Primary objective:

The primary objective is to compare the QT/QTc intervals of HIV positive subjects treated with antiretroviral therapy and followed at the ambulatory HIV clinic and the QT/QTc intervals of :

1. an outpatient HIV negative population from the same health center pre-admission one-day surgical clinic.
2. the large HIV-free korean population studied in the ECG-ViEW database.

Secondary objectives :

* Evaluate the prevalence of QTc interval prolongation in the outpatient HIV positive population comparatively to the two HIV negative outpatient populations available from the one-day surgical clinic and the ECG-ViEW database.
* Evaluate risk factors associated with QTc interval prolongation in the outpatient HIV positive population compared to the outpatient HIV negative population and the population studied in the ECG-ViEW database.
* Compare the QT/QTc intervals and the prevalence of QTc interval prolongation of the outpatient HIV positive population currently on an antiretroviral regimen including a protease inhibitor versus those on an antiretroviral regimen without protease inhibitor.
* Compare the QT/QTc intervals among the outpatient HIV positive population treated with a protease inhibitor, in regard to the presence or the absence of certain genetic polymorphisms that may influence pharmacokinetic aspects of protease inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* Age eligible for study : 18-65 years old inclusively
* Gender eligible for study : Both

Exclusion Criteria:

* Hospitalised at the moment of recruitment
* AIDS status

  o Opportunistic infections acquired in the last 30 days before the date of recruitment
* Age \< 18 years old and \> 65 years old
* Follow-up care in an oncology clinic
* Dialysis during the study period
* Pregnancy
* Without antiretroviral therapy
* History of a myocardial infarction in the 3 weeks preceding recruitment
* Have a pacemaker
* Diagnosed with bundle branch block on ECG
* Principal follow-up care outside of the CHUM HIV clinic
* Refusal to participate in the study
10% Lidocaine Spray for Intrauterine Device Insertion

Intrauterine device (IUD) insertion is a procedure that can cause pain. Fear of pain during IUD insertion is a barrier to use of this method. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD.

Intrauterine device (IUD) is a high efficacy long-acting reversible contraceptive method. However, IUD insertion is a procedure that require well-trained medical personnel and can cause pain in several steps during insertion such as applying tenaculum, applying uterine sound and insertion of IUD. Fear of pain during IUD insertion is a barrier to use of this contraceptive method. Previous researches reported mean pain score with using visual analog scale (VAS) moderated pain (4.7/10 and 34.7-51.2/100). In several countries, pain control is used before IUD insertion procedure. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD.

Lidocaine is introduced to use for pain relieving in medical procedures with advantages of rapid action and minimal side effects.10% Lidocaine spray is a form of local anesthetic method that use in obstetrics and gynecology procedures and has favorable efficacy in reducing pain. Nevertheless, there were limited studies of 10% Lidocaine spray during IUD insertion. In this study, we investigate pain during IUD insertion using lidocaine spray compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Woman who required for Copper T IUD insertion
* Body mass index 18.5 - 30 kg/m2
* Communicable with Thai language
* New IUD user

Exclusion Criteria:

* Suspicion of pregnancy
* Puerperal sepsis/Immediate post-septic abortion
* Untreated abnormal uterine bleeding
* Uterine anomaly/abnormal pathology distorting the uterine cavity
* Current pelvic inflammatory disease
* Untreated cervicitis/vaginitis
* Wilson's disease
* Copper allergy
* known hypersensitivity to local anaesthetic
* Analgesic or anxiolytic use within the last 24 h before the procedure
Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women

Accumulating evidence indicated that neuraxial analgesia in the latent phase of the first stage of labor would be an effective and safe health care procedure for nulliparas. Doulas, women with labor experience trained for parturients, is a new way to alleviate the psychological stress from the laboring pain. Previous data in our study showed that doula accompany is a good method in shortening the progress of labor used in the active phrase of the first stage of labor, and decreasing the rate of cesarean delivery. Investigators hypothesized that doula combined neuraxial (epidural) analgesia in the latent phrase would be a superior means for effective pain relief, decreased rate of cesarean section, and shortened duration of labor.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women
* \> 18 years and \< 45 years
* Spontaneous labor
* Analgesia request

Exclusion Criteria:

* Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
* Participants younger than 18 years or older than 45 years
* Those who were not willing to or could not finish the whole study at any time
* Using or used in the past 14 days of the monoamine oxidase inhibitors;
* Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
* Subjects with a nonvertex presentation or scheduled induction of labor
* Cervical dilation was 4.0 cm or greater before performing epidural puncture and catheterization
Structured Discharge and Follow-up Protocol for COPD Patients Receiving LTOT and NIV

Readmission to hospital is one of the most important problems in chronic obstructive pulmonary disease (COPD) patients who developed chronic respiratory failure. Patients receiving long-term oxygen therapy (LTOT) and noninvasive ventilation (NIV) constitute the most vulnerable group because of the need for comprehensive care. However, because of lack of health care support systems in Turkey, many advanced COPD patients are hospitalized due to preventable problems such as insufficient knowledge about the therapies, nonadherence to therapy and technical issues related to LTOT/NIV equipment. The aim of this multicenter randomized trial is to find out whether a structured discharge and follow-up protocol reduce the rate of unplanned, COPD-related hospital readmissions over 90 days in patients receiving LTOT or NIV.

The study is planned with Turkish Thoracic Society and Global Alliance Against Respiratory Disease-Turkey partnership and being carried out 10 centers throughout Turkey. COPD patients who are prescribed long-term oxygen therapy for hypoxemic respiratory failure and/or noninvasive ventilation for hypercapnic respiratory failure will be included in the study and will be randomized to either intervention or control arm. The intervention mainly consists of not only education about the disease and medications but also the education of the equipment and how to use it to have the best benefit. Control arm patients will receive usual care, which consists of basic education of the patient about the therapies. The primary outcome of the study is readmission in 90 days.

Eligibility Criteria:
Inclusion Criteria:

COPD patients who developed chronic respiratory failure and are eligible for long-term oxygen therapy (LTOT) or noninvasive ventilation (NIV) according to Turkish National Social Security regulations

Definitions:

COPD: The diagnosis of COPD is made according to GOLD criteria Chronic respiratory failure: PaO2\>60mmHg at room air and/or PaCO2\> 45

Eligibility for LTOT:

1. PaO2 ≤ 55 mmHg or SaO2 ≤ 88% under room air
2. PaO2 value of 55-59 mmHg or SaO2 ≤ 89% and cor pulmonale with hematocrit \>55 or p pulmonale in ECG or congestive heart failure.

Eligibility for NIV:

1. PaCO2≥55 mmHg or
2. PaCO2 50 to 54 mmHg and nocturnal desaturation ≤ %88 for 5 minutes under 2lt/min nasal O2 therapy 3. PaCO2 50 to 54 mmHg and \>2 exacerbations within the last year

Exclusion Criteria:

1. Patients receiving LTOT or NIV for a different cause 2. Patients who do not give consent 3. Patients who are unable to be followed up regularly due to reasons such as living far from study center, lack of family support, unwillingness or inability to contact regularly.

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Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles

Microfluidic chips are one of the methods of sperm separation to eliminate DNA fragmentation in sperm. It is thought that the separation of sperm by centrifugation in the classical gradient density (Percoll) method used in sperm separation in IVF and IUI cycles leads to the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.

The increase in infertility rate due to environmental and physiological conditions leads to an increase in the use of assisted reproductive techniques. Isolation of living and morphologically normal live sperm is an integrated procedure in commonly used IVF / ICSI(intracytoplasmic sperm injection) / IUI(intrauterine insemination) procedures. Although current IUI procedures result in a successful pregnancy of around 10-15%, the process can be greatly compromised if the selected sperm is abnormal. Microfluidic chips are one of the recommended sperm separation methods to eliminate DNA fragmentation in sperm. It is thought that the separation of the sperm by centrifugation in the classical gradient density (Percoll) method which is used in the separation of sperm in the IUI cycles, causes the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Apply to the infertility clinic due to unexplained infertility and mild male factor (total motile sperm count \>5 million)
* Volunteer

Exclusion Criteria:

* Inadequate follicle development with medication
* Embryo does not have the appropriate quality for transfer
* Tubal pathology
* Total motile sperm count \< 5 million
* Refuse to participate in research
Are Character Building Lessons Effective in Decreasing Bullying Behaviors?

Through the use of an educational intervention, the object of this study is to reduce the prevalence of bullying behaviors among fifth grade school age children. Bullying behaviors promote an environment of violence , fear, and hostility. The study will arrange to present six character education lessons in the classroom of fifth grade students in a New York City public school. Questionnaires will be administered to the students before and after all the lessons have been completed. Questionnaires will collect information about the students self perception of their levels of misconduct, impulsivity, confidence, value of non violence, ways of handling anger, opinions of their leadership behaviors, prevalence of bullying behaviors, and indications of levels of self esteem. Also, their fifth grade teachers will complete pre and post treatment student behavioral questionnaires.

This is a 2 X 2X 2 research design that will study the constructs of self esteem, leadership skills, and prevalence of bullying among a fifth grade school age population. Before data collection, a letter describing the study along with an informed consent sheet, will be mailed to the student's parent/guardian. The written material will state that their child participation is not mandatory. A 48 item likert style questionnaire pre-treatment, post-treatment survey design will be administered to students. Basic demographic questions will also be asked about.

All fifth graders will be given questionnaires before they receive the six classroom lessons of 45 minutes duration and then after all the six lessons have been completed. Lessons will be offered on a weekly basis. The fifth graders will be divided into small groups of approximately 10 individuals. The lessons will be delivered by baccalaureate nursing students in their last semester of college. The groups will be formed at the beginning and membership will remain consistent to enhance development of trust and ease of authentic communication. The lessons will be selected from the program, Overcoming Obstacles, a formal educational program designed to assist students to communicate well and set meaningful goals for their lives. In addition, the classroom teachers will be asked to complete a 14 item likert style pre-treatment, post-treatment, both before and after the six lessons about their opinions of each student's behaviors pattern.

A statistician is a co-investigator and will identify the type of statistical analysis to be done.

Eligibility Criteria:
Inclusion Criteria:

* Fifth grade elementary school students

Exclusion Criteria:

* Special education students
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK001

This first-in-human study will evaluate the safety and tolerability of single doses of AK001 across a range of potentially active doses. Early signals of pharmacodynamic activity will also be evaluated.

AK001 is a monoclonal antibody which may be useful in the treatment of patients with severe allergic diseases.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18-30
* Determined to be in good health
* Clinical laboratory values within limits of normal values
* Normal 12-lead ECG
* Stool sample negative for parasites
* Non-smoker
* Consumed an average of no more than 2 drinks per day within 6 months
* Subjects of reproductive age must use a highly effective method of contraception
* Positive skin test in certain cohorts
* Elevated total eosinophil counts in certain cohorts

Exclusion Criteria:

* Clinically significant medical history conditions or laboratory values
* Receipt of investigational drug, biologic or medical device within 30 days prior to Screening
* New drug therapy within 1 week of study drug administration
* Antihistamine use within 2 weeks prior to Screening
* Consumption of alcohol within 48 hours of study drug administration
* Positive urine drug test or cotinine test at Screening or Day -1
* History, within the last 2 years, of alcohol abuse, illicit drug use, or significant mental illness
* Demonstration of veins unsuitable for repeated venipuncture or IV infusion
* Recent treatment with alternative therapies which may confound clinical or laboratory assessments
* Donation or loss of more than 500 mL of blood within 56 days prior to study drug administration
* History of malignancy within last 5 years
* History of severe allergic or anaphylactic reactions
* Females who are pregnant or breastfeeding
Somatosensory Evoked Potentials From the Lower Urinary Tract

Spinal cord injury and other systemic neurological diseases (Multiple Sclerosis, Parkinson's disease) affect the integrity of lower urinary tract (LUT) function, leading to neurogenic lower urinary tract dysfunction (NLUTD). The urodynamic investigation is the current "gold-standard" for evaluating LUT function. Nevertheless, the sensory situation of the LUT cannot be investigated objectively. Furthermore, the current classification of the severity of the NLUTD due to spinal cord injury (SCI) does not represent the sensory situation of the LUT. Additional investigations therefore need to be established for assessing the sensory situation of the LUT. Somatosensory evoked potentials (SEPs) are an established method for investigating the processing of sensory nervous activity. However, SEPs from the LUT of SCI individuals have not yet been investigated.

A novel technique, i.e. diffusion tensor imaging (DTI), allows to process magnetic resonance images (MRI) in order to visualize nerve fibers. Using DTI, the innervation of the bladder after SCI can be visualized. The structural presentation of bladder innervation will be compared with the functional results, i.e. the SEP of the LUT in SCI individuals.

The primary objective of the proposed study is to elicit and characterize (latency, amplitude) the somatosensory evoked potentials (SEPs) from the bladder in individuals suffering from neurogenic lower urinary tract dysfunction as a result of spinal cord injury.

Furthermore, the SEPs from the bladder will be compared with the SEPs from peripheral nerves (N. tibialis, N. pudendus, N. medianus).

Moreover, the latency and amplitude of the SEPs from the bladder of individuals with somato-sensory complete spinal cord injury will be compared with those from the bladder of individuals with somato-sensory incomplete spinal cord injury.

Finally, the structural innervation of the bladder after SCI will be compared with the remaining sensory function.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Chronic SCI of a minimum of 1 year
* Aetiology of SCI: traumatic

Exclusion Criteria:

* Age \< 18 years or \> 70 years
* Aetiology of SCI: non-traumatic
* History of bleeding disorder
* History of chronic neuropathic pain
* Intravesical botulinum toxin injections \< 12 months ago
* Bladder management using indwelling catheters (suprapubic, transurethral)
* Bladder augmentation
* Sacral deafferentation
* Sacral neuromodulation
* Acute, symptomatic urinary tract infection
* Pregnancy
* Urolithiasis
* Bladder cancer
* Exclusion criteria for MRI (cardiac pace maker, implanted metal etc.)
Evaluating Sexual Function in Women Undergoing a Radical Cystectomy for Bladder Cancer

This study evaluates the general physical, emotional, and sexual function in women undergoing a radical cystectomy for bladder cancer. A radical cystectomy is a surgical procedure that involves the removal of the bladder, uterus, ovaries, fallopian tubes, and part of the vagina. This may affect sexual function in women. This study seeks to understand how radical cystectomy alters sexual function and well-being, and what factors may affect this change.

PRIMARY OBJECTIVES:

I. To characterize pre-operative sexual function and interest in sexual activity of women undergoing radical cystectomy.

II. To identify patient understanding and expectations as they relate to sexual dysfunction after radical cystectomy.

III. To describe pre-operative importance in sexual function recovery after radical cystectomy.

IV. Quantify the changes in sexual function within the year following radical cystectomy in women.

V. Explore the effects of age, baseline sexual function, general quality of life, parity, menopausal status, hormone replacement therapy (topical versus \[vs.\] oral), general and cancer related quality of life, chemotherapy (neoadjuvant vs. adjuvant), treatment-related complications and performance status on sexual function outcomes.

VI. Explore the effects of robotic vs. open approach, extracorporeal vs. intracorporal approach, organ-sparing (ovaries, uterus, cervix, anterior vaginal wall), type of vaginal closure (vertical vs. horizontal), nerve sparing, urinary diversion type (ileal conduit vs. neobladder vs. continent cutaneous diversion) on sexual function outcomes.

VII. Quantify the changes in sexual activity interest within the year following radical cystectomy.

OUTLINE:

Patients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult women greater than 18 years of age
* A diagnosis of bladder cancer
* Planned to undergo a radical cystectomy
* Willing and able to complete survey questionnaires

Exclusion Criteria:

* Inability to provide informed consent
* Non-English speaking
* Life expectancy less than 2 years