cyrilzakka/clinical-trials huggingface dataset:
Impact of Perioperative Analgesia in Prostatectomy Patients on Early Quality of Recovery (SPITALIDO)

The rationale behind this RCT is to assess within 24 hours after surgery the quality of recovery of prostatectomy patients treated with 3 different analgesia concepts (intraoperative spinal analgesia, transversus abdominis plane block, intravenous lidocaine administration) using the quality of recovery (QoR) 15 questionnaire.

Prostatectomy (open or robotic assisted) is a major urological surgery, which is associated with relevant acute postoperative pain. Perioperative analgesic techniques aiming at optimizing postoperative analgesia have to be investigated. Optimal postoperative pain management is one of the key factors leading to enhanced recovery after surgery. Optimal analgesia should aim for optimized patient comfort, fast functional recovery with the fewest side effects thus encouraging the DREAMS concept (DRinking, EAting, Mobilizing and Sleeping).

The perioperative additional use of a spinal single shot analgesia, or a transversus abdominis plane block to general anaesthesia are validated options to enhance pain therapy compared to systemic analgesia alone. However, if the impact on pain scores has been described previously, the impact on the quality of recovery (QoR) is still unclear. Using the assessment of QoR allows for a much more objective and broader assessment of the quality of the postoperative treatment. Indeed, patient's perioperative experience cannot be only focused on pain scores but should involve items like physical independence, patient support, comfort, emotion. All these items are included in already validated QoR questionnaires like the QoR 15 or QoR 40.

The rationale behind this randomized, parallel group, single centre, interventional, active controlled trial is to assess with the QoR 15questionnaire within 24 hours after surgery the quality of recovery of prostatectomy patients treated with 3 different analgesia concepts.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* \>18 years old
* eGFR \>40ml/min
* Normal liver function
* Prostatectomy (open, robotic assisted)

Exclusion Criteria:

* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
* Patients with regular use of antiemetics, laxatives, opioids or other types of analgesics
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Severe psychiatric disorder
* Patients with chronic pain
* Preoperative regular use of non-steroidal anti-inflammatory drugs
* Refusal of regional analgesia (SSS or TAP block)
* Contraindication to regional analgesia (SSS or TAP block)
FLT PET/MR for Evaluation of Pseudoprogression in Patients With Brain Lesions

This is a single arm, single center study of 15 patients with brain lesions being treated at UNC Hospitals. Subjects will undergo one (1) FLT-PET-MRI scan before their scheduled surgical biopsy of their brain lesion(s).

Identifying imaging biomarkers of metastatic brain tumor treatment response could allow early modification of treatment by determination of tumor progression vs. treatment related effects (pseudo-progression, radiation necrosis). Earlier treatment response assessment could reduce cost, improve clinical trial efficiency and allow better assessment of prognosis. The development of PET/MRI offers the possibility of combining the functional imaging of PET with the exquisite soft tissue contrast and physiologic imaging capabilities of MRI. Combining FLT-PET imaging with MRI may allow better evaluation of new and unclear lesions in brain metastatic disease. The goal of this study is to explore FLT-PET imaging combined with dynamic MR imaging techniques for the identification of tumor response markers in metastatic brain tumors.

Eligibility Criteria:
Inclusion Criteria:

* Known brain lesion in central nervous system (CNS) scheduled to have surgical biopsy of the lesion, identified by the UNC Brain Tumor Board as having clinical question of radiation necrosis vs. recurrence
* At least one measurable lesion greater than 1 cm in diameter
* ≥ 18 years of age
* Study-specific informed consent reviewed and signed

Exclusion Criteria:

* Pregnant, nursing, or planning to become pregnant within 30 days of anticipated PET-MRI scan
* Condition that makes MRI unsafe (e.g., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, metal aneurysm clips, metal halo devices)
* Inability to tolerate MRI (e.g., unable to lie flat for \> 1 hour, severe claustrophobia)
* Allergy to MRI contrast agent (Magnevist, Multihance, Ablavar, Dotarem, Eovist, Gadavist)
* Known allergy to fluorothymidine
* Study participation would cause significant delay (\> 2 weeks) in scheduled standard of care therapy
* Creatinine clearance \< 60 ml/min, as estimated by the Cockcroft-Gault formula
* Body Mass Index (BMI) \> 35
* Poorly controlled diabetes mellitus (fasting blood glucose \> 200 mg/dl)
Homeless Population and Mental Health: Impact of Primer la Llar Program

The main goal is to evaluate the impact of the Primer La Llar housing program for the homeless population on the mental health of the participants.

The hypothesis is that the housing program, which follows Housing first model, for the homeless population has a positive impact on the mental health of the participants, compared to the group that does not receive the intervention -treatment as usual group (meaning the "positive impact" a lower score on the symptomatology scales and lower toxic intake in the group receiving the intervention).

The specific objectives are:

Identify the socio-demographic and clinical characteristics of the participants.

Compare the severity of psychiatric symptoms and improvement among the participants in the intervention group and the control group (depressive, anxious, psychotic or manic symptomatology, depending on the case).

Compare the consumption of alcohol and drugs among the participants of both groups.

Compare the basic daily life skills among the participants in both groups, as well as the improvement of them in the experimental group.

Compare the use of services and between the participants of the intervention group and the control group.

Intervention group receives entry to the program (which means individual and permanent housing without previous requirements such as abstinence, compliance with treatment or sobriety.

Control group receives treatment as usual, as they are users of homeless population network of Barcelona.

Eligibility Criteria:
Inclusion Criteria:

* Single people, adults (exceptionally sentimental couples, friends with positive support relationship for both).
* Long life on the street (minimum 1 year staying overnight on the street) and / or accommodation centers without linking, using them in a timely manner in the last year.
* Social needs concurrent to the lack of housing: mental illness and / or drug abuse.
* Functional autonomy for daily life.
* Have regular economic income or possibility of obtaining them.
* Sign informed consent form.

Exclusion Criteria:

* language barrier
* severe neurological or organic pathology
* severe dementia
* alcoholic dementia Wernicke Korsakoff
Comparing Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of GAD

Meta Cognitive Therapy (MCT) has been introduced as a new specific treatment for generalised anxiety disorder. So far, no studies have examined CBT and MCT in comparison with each other in a randomised controlled trial. Sixty patients with a diagnosis of generalised anxiety disorder will be selected and randomised into three treatment conditions. The first group (N=20) will be treated with CBT, the second group (N=20) with MCT, and the third condition is a waiting list control (N=20). The patients in both groups will have full treatment, in accordance to treatment manuals developed by the originators. Patients in the waiting list control will be randomly allocated to either CBT or MCT after 12 weeks of waiting period.

The patients will be assessed with the primary measures at pre-treatment, at the end of treatment, and at follow-up after one and two years. In addition they will be assessed weekly on symptom measures and worry outcome diary. The therapist will be treating equally amount of patients in both conditions to control for any biased distribution connected to the therapist's characteristics.

Measures will be used on at least three main sources; self-report inventories (including symptom diaries), clinical assessments by independent raters and psycho-physiological assessments.

We aim to (1) evaluate and compare the effectiveness of CBT and MCT, (2) investigate the patterns of change and the mechanisms of action involved during treatment in each of the conditions and, (3) evaluate pre and post-treatment somatic change by psycho-physiological assessments as a response to CBT and MCT.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent obtained prior to entry in the study.
2. Diagnosed with generalised anxiety disorder (DSM-IV, APA, 1994).
3. 18 years or older.

Exclusion Criteria:

1. Known somatic diseases
2. Psychosis
3. Past suicidal attempts and/or current intent
4. PTSD
5. Cluster A or cluster B personality disorder
6. Substance dependence
7. Not willing to accept random allocation.
8. Patients not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial
Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease

The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923 compared to placebo, for the treatment of symptoms of agitation in participants with Alzheimer's Disease (AD).

Eligible participants for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD.

This is a multicenter, randomized, double-dummy, double-blind, placebo-controlled study, consisting of 10 weeks of treatment.

Up to 200 participants will be enrolled at approximately 30-40 centers in the US.

Study medication will be administered orally twice-daily from Day 1 through Day 70. Screening must occur within within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

Eligibility Criteria:
Key Inclusion Criteria:

Diagnosis of probable Alzheimer's disease (AD).

The participant has clinically significant symptoms of agitation secondary to AD, that interfere with daily routine and for which a prescription medication is deemed indicated, in the opinion of the investigator.

Either out-patients or residents of an assisted-living facility or a skilled nursing home.

CGI-S score is ≥ 4 (moderately ill) at screening and baseline.

Mini Mental State Examination (MMSE) score at screening between 8 and 28 (inclusive).

Caregiver who is able and willing to comply with all required study procedures, ensuring that the participant attends all study visits and takes the study medication as instructed. In order to qualify as a caregiver for this study, the individual should spend time with the participant for a minimum of 4 hours on 4 separate days per week.

Key Exclusion Criteria:

Participant has other type of dementia (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia).

Participant with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g. malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac conduction abnormalities including QTc prolongation, or unstable valvular heart disease).

Participant with myasthenia gravis.
Allo HSCT for High Risk Hemoglobinopathies

A single center, open label, interventional, phase II trial for donor transplant for high risk hemoglobinopathies and other red cell transfusion dependent disorders utilizing allogeneic hematopoietic stem cell transplantation (HSCT) regimens.


Eligibility Criteria:
Inclusion Criteria:

* Sickle Cell Disease (SCD)
* SCD Patients with a fully matched sibling donor (MSD) irrespective of the frequency or severity of symptoms MSD transplant can be considered. Parents/patient must be counseled as to the risks and benefits and provide their voluntary informed consent
* Transfusion Dependent Alpha- or Beta- Thalassemia
* Diamond Blackfan Anemia
* Other Non-Malignant Hematologic Disorders
* Karnofsky ≥ 60%, Lansky play score ≥ 60. Patients with lower performance score can be considered based on study team's evaluation.
* Sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the transplant.

Exclusion Criteria:

* Pregnant, breastfeeding or intending to become pregnant during the study. Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of the start of treatment
* HIV Positive
* Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted
* Known allergy to any of the study components
* Psychiatric illness/social situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements
* Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study
Analysis of the Clinical and Histological Correlation of Oral Graft-Versus-Host-Disease (GVHD)

Introduction: Graft-versus-host-disease (GVHD) is the major cause of morbidity and mortality in patients submitted to the Bone Marrow Transplantation (BMT). The oral manifestations can be very debilitating and interfere in the results of medical therapy, leading to systemic complications, committing the prognosis and quality of life of the patient.

The early diagnosis can be done through biopsies of oral mucosa with or without apparent injury clinic. The association between the clinical and histopathological tables of GVHD, especially through the use of recent consensus established in these areas, can bring new benefits to physicians.

Objective: This study aims to apply and compare the two classifications histological to GVHD, Horn (1995) and Consensus (2006) in specimens obtained from clinical oral lesions suggestive of GVHD; correlate them with clinical classification according Akpek (2001) and with the survival of the patients.

Methods: For this study we analyzed histological samples of oral mucosa of 10 patients with clinical diagnosis of GVHD, which have areas of epithelium, and salivary gland. The histopathological aspects were observed by the author of this work and his advisor, so blinded by applying the criteria for Horn and the Consensus. We consistency between the two classifications obtained and histological correlation with the clinical classification of GVHD (Akpek, 2001) and the curve of survival.

Eligibility Criteria:
Inclusion Criteria:

* all patients with clinical signs of oral GVHD that underwent oral biopsy

Exclusion Criteria:

* samples without epithelium or minor salivary glands
Topical CBD for Musculoskeletal Pain

Various OTC and CBD containing topicals are evaluated in a double blind survey. Each sample has a QR code that is to be scanned before applying. The QR code links to a survey form with application instructions and collects participant information and feedback.


Eligibility Criteria:
Inclusion Criteria:

* has Pain

Exclusion Criteria:

-
Assessment of Coagulation Profile and Haematopoietic Responses in Patients With Acute-on-chronic Liver Failure During Systemic Inflammatory Response (SIRS) and Sepsis

This study attempts to clarify the pathophysiology of haemostasis and haematopoiesis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. Further research is needed for proper understanding of the influence of sepsis on coagulation disorders in ACLF (Acute on Chronic Liver Failure) patients in particular, to correctly identify the type and optimal quantity of blood product requirement in at risk patients.

Thromboelastography (TEG) /Sonoclot have been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. Secondly, the study of derangement in coagulopathy after the onset of sepsis is of paramount importance because of increased mortality after the onset of sepsis. In the present study, patients with ACLF (Acute on Chronic Liver Failure) without evidence of sepsis on admission will be included in the study cohort, and will undergo a baseline diagnostic workup as described. They will be followed for development of any signs of infection after hospitalization. Then the effect of sepsis on their coagulation and haematopoietic cellular responses will be assessed. Thus the effect of sepsis on the progression and outcome of patients with ACLF (Acute on Chronic Liver Failure) will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* ACLF (Acute on Chronic Liver Failure), as diagnosed by APASL (Asian Pacific association of Study of Liver Disease) criteria mentioned above.

Exclusion Criteria:

* Patients with evidence of sepsis at presentation.
* Current therapy: Recent blood or blood component transfusion in the last 2 days.
* HIV positive/ AIDS patients
* Patients requiring anti platelet therapy,
* Renal insufficiency requiring dialysis
* Active malignancy within the last 5 years
* Patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease
* Administration of anticoagulants, antifibrinolytics,
* Not willing to participate in the study
* Pregnancy
Heart Function in Patients Assessed for Sleep Apnoea

This study aims to determine the prevalence and prognosis of heart failure with preserved ejection function (HFpEF) among patients being assessed for sleep disordered breathing (SDB).

Patients with sleep disordered breathing (SDB) and those with heart failure with preserved ejection fraction (HFpEF) share similar characteristics. Increasing age, hypertension, obesity, diabetes mellitus and atrial fibrillation are well recognised links in both groups. It also known that SDB is common in patients with heart failure, both with reduced and preserved ejection fraction. It is therefore hypothesised that among patients being referred for SDB assessment, we can identify a group with unrecognised HFpEF.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥40 years and referred for respiratory polygraphy

Exclusion Criteria:

* Previous diagnosis of Heart Failure
* Treated sleep disordered breathing
The Influence of Oxytocin on Socio-communicative Sensitivity

Oxytocin (OT) is a neuropeptide that acts as a neurotransmitter and neuromodulator in the brain. Previous studies have shown that intranasal administration of OT improves social cognition and behavior (e.g. emotion recognition). In the current study, we want to gain more insight into the underlying mechanisms by which OT influences emotion recognition. More specifically, we will investigate whether intranasal administration of OT enhances the salience of social (compared to non-social) information and whether it increases the neural sensitivity for subtle socio-emotional cues, by recording scalp electroencephalography (EEG) during Fast Periodic Visual Stimulation (FPVS).

The present study is a double-blind, randomized, placebo-controlled, crossover clinical trial, in which (approximately 30) neurotypical male adults (18 to 30 years old) will participate. All participants will perform two sessions (OT and placebo), separated by two weeks. For the first session, the participants are randomly assigned to the placebo or the OT condition. Syntocinon nasal spray will be used for intranasal administration.

In each session, we will measure the neural salience/sensitivity for socio-emotional information, by recording EEG during FPVS. Participants simply have to press a button when the fixation cross turns red, while watching rapidly alternating visual stimuli. Starting 20 minutes after substance intake, four FPVS paradigms are administered in randomized order:

1. A frequency-tagging FPVS paradigm, to measure the salience of social versus non-social stimuli.
2. The oddball face detection paradigm, to assess the neural sensitivity to faces embedded in a series of objects.
3. The oddball identity discrimination task, to examine the ability to discriminate between faces with a different identity.
4. The oddball expression generalization task, to investigate the sensitivity for facial emotional expressions embedded within neutral faces with varying identities.

After two FPVS paradigms, a four minutes resting state EEG measure will be performed. At the end of the session, emotion recognition will be measures with the Palermo matching task (65 items).

The primary aim is to investigate whether the performance on each of these paradigms/tasks differs between the OT and the placebo condition. Furthermore, we want to explore whether the effect of OT is influenced by the participant's attachment style, social responsiveness, social phobia, or mood, which will be assessed via self-reported questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 30 years
* male
* right-handed
* typically developing
* Normal or adjusted-to-normal vision (with glasses or lenses)

Exclusion Criteria:

* psychiatric disorder
* neurological disorder (e.g. epilepsy, migraine)
* color blindness
* psychoactive medication