cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis

The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.


Eligibility Criteria:
Key Inclusion Criteria:

* Multiple Sclerosis (MS) subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria:

  * Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS , OR
  * Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.

Key Exclusion Criteria:

* Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
* History of malignancy
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity
* History of abnormal laboratory results based on investigator judgment
* History of human immunodeficiency virus (HIV) or other immunodeficient conditions
* History of drug or alcohol abuse within the 2 years prior to randomization
* An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
* Positive screening for active infection with Hepatitis B virus or Hepatitis C virus
* Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening
* Exposure to varicella zoster virus within 21 days before Screening.
* Abnormal blood tests at Screening: Hemoglobin ≤9.0 g/dL, Platelets ≤100 × 10\^9/L, Lymphocytes ≤1.0 × 10\^9/L, Neutrophils ≤1.5 × 10\^9/L, alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase \>2 times the upper limit of normal (ULN) and serum creatinine \>ULN.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Missed Serious Medical Illness in Psychiatric Patients Seen in an Academic Emergency Department

The purpose of this study is to determine the prevalence, etiology, and timing of missed Serious Medical Illness (SMI) in patients referred to adult psychiatry by emergency physicians, as well as to determine admission rates for SMI soon after discharge from an inpatient psychiatry admission.


Eligibility Criteria:
Inclusion Criteria:

* All patients greater than or equal to 18 years of age presenting to London Health Sciences Centre, Victoria Hospital emergency department between October 1, 2014 - July 31, 2015 who were referred to adult psychiatry by the emergency physician.

Exclusion Criteria:

* None
Chlorhexidine vs Lactobacillus Plantarum for Oral Care in Intubated ICU Patients

Critically ill patients often need ventilatory support through a plastic tube connected to a ventilator. Those patients have a altered microbiological flora in the mouth, oropharynx as well as throughout the intestine. Bacteria that can cause illness are often found in the oropharynx in such patients and measures are taken in order to reduce the risk of secondary infections by those bacteria. In all intensive care patients oral care is provided by the nursing staff aiming at a reduction of the pathogenic species. This is done by a variety measures.

Chlorhexidine (CHX) is an antisepticum with a capability to reduce bacterial counts in the mouth and oropharynx and has been shown to be of value also for intubated patients. It is used frequently throughout the world.

Ventilator-associated pneumonia (VAP) is a costly rather frequent complication to intensive care and mechanical ventilation and is usually caused by aspiration of infected secretions from the oropharynx. CHX has in some studies been shown to reduce the frequency of VAP.

The probiotic bacterium Lactobacillus plantarum 299 has the ability to adhere to the mucosa throughout the gastro-intestinal tract including the mouth and in our pilot study we found that L plantarum had better ability to reduce colonisation with enteric bacteria in the oropharynx than CHX had. Figures not statistical significant so this present study is aiming to get a larger amount of data.

The procedure was found to be safe Hypothesis: Lactobacillus plantarum is better than CHX for the reduction of pathogenic bacteria in the oropharynx in intubated mechanically ventilated patients and consequently has a better potential to reduce the frequency of VAP

This study is an expansion of a pilot study performed at the ICU Lund University Hospital, Sweden where 50 patients were included (ISRCTN00472141).

Results have been published in Critical Care 2008, 12:R136 The protocol is the same and in this second phase we intend to include 100 patients and results will be summed up.

Three centres are engaged. The results from the pilot study is encouraging and we are aiming at getting statistical significance in the differences in pathogenic findings in the cultures from oropharynx and also better a better basis for the calculation of the number of patients needed to get sufficient power to study difference in VAP frequency.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Critically ill patients anticipated to require mechanical ventilation for at least 24 hours

Exclusion Criteria:

* Pneumonia as admission diagnosis,
* Fractures on the facial skeleton or the skull base;
* Known ulcers in the oral cavity, the oropharynx, or the esophagus
* Known immune difficency
* Carrier of HIV or Hepatitis
* Patient being moribund
Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

The objective of the study is to prove that after the third day of invasive mechanical ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP.

Parallel two group double blind randomized controlled clinical trial. Individual randomization, performed on day 4 of invasive mechanical ventilation, will be stratified on centre in order to account for variations in VAP prevention bundle implementation and use of systemic antibiotics the day of randomization. Patients will be treated three consecutive days with inhaled amikacin or placebo. Patients will be followed up daily in the intensive care unit for the occurrence of VAP according to international guidelines until day 28.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years the day of inclusion
* Mechanical ventilation through an endotracheal tube for more than three consecutive days (72h)
* Written informed consent of the patient or a proxy
* Patients covered by or having the rights to French social security
* Negative pregnancy test, at the time of inclusion, in women of childbearing potential

Exclusion Criteria:

* Suspicion or confirmed VAP the day of inclusion
* Clinical indication for systemic aminoglycoside therapy the day of inclusion : as deemed necessary by the clinician in charge
* Stage 2 or 3 KDIGO\* classification acute kidney injury the day of inclusion excepted in patients undergoing renal replacement therapy
* Chronic kidney failure : baseline glomerular filtration lower than 30 mL/min
* Patient scheduled for extubation within the next 24h
* Patient ventilated through an endotracheal tube for more than four consecutive days before inclusion (96h)
* Patient ventilated through a tracheostomy
* Patients allergic to aminoglycosides
* Myasthenia gravis
* Known pregnant women at the time of inclusion and lactating patients
* Known guardianship or trusteeship at the time of inclusion
* Patients previously included in this study
Effectiveness of Asiaticoside as Intracanal Medication on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis

The objective of this study is to investigate \&#34;clinically\&#34; the effectiveness of Asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.

This study investigate \&#34;clinically\&#34; the effectiveness of Asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.

Eligibility Criteria:
Inclusion Criteria:

• Single-rooted with pulp necrosis and apical periodontitis.

Exclusion Criteria:

Receiving antibiotic treatment within the preceding 3 months.

* Reporting systemic disease.
* Teeth that could not be isolated with rubber dam.
* Teeth with periodontal pockets deeper than 3 mm.
Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy

Two separate studies, idential in design, were planned and initiated under 2 protocol IDs and NCTs, i.e. study ACP-103-54 (NCT03999918) and ACP-103-059 (NCT03968159). In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. At that point in time, about half of the planned patients had been randomized. The Sponsor decided to combine the 2 identically designed trials, with a prespecified combined statistical analysis plan. As a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. No further patients were enrolled.

This entry now includes the combined data of studies ACP-103-054 and ACP-103-059.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, aged 18 years and above
2. A clinical diagnosis of major depressive disorder (MDD)
3. Is being treated with one of the following SSRI or SNRI antidepressants:

   1. Citalopram
   2. Escitalopram
   3. Paroxetine
   4. Fluoxetine
   5. Sertraline
   6. Duloxetine
   7. Venlafaxine
   8. Desvenlafaxine
   9. Venlafaxine XR
4. Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
5. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception

Exclusion Criteria:

1. Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder
2. Has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
3. Has a known history or symptoms of long QT syndrome
4. Is determined to be inappropriate for the study for any reason

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Subject Preference for Scalp Psoriasis Treatment

The scalp is one of the most common affected sites in psoriatic patients as 79% of them have scalp involvement.It has also a psychological aspect with 31% of patients with scalp psoriasis indicating distress.

Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not always ideal because they might be inconvenient and messy to use, stain or damage hair.

The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the tradename of Clobex®) was developed to provide the strongest available corticosteroid as a short-contact therapy in order to improve the chances of it being effective and reduce the potential for traditional side-effects.

The objective of this study is to compare subject's overall preference between Clobetasol propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis.

This study will be a multi-centre, investigator blinded, randomized, cross-over, intra-individual comparison in three parallel groups.

In each parallel group, Clobetasol propionate shampoo, 0.05% will be compared to one of the three chosen competitors, following a cross-over design.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18 years of age or older,
* Subjects with moderate to severe scalp psoriasis,
* Subjects who signed written informed consent prior to any study procedures.

Exclusion Criteria:

* Subjects who need systemic treatment for their body psoriasis,
* Subjects who are at risk in terms of precautions, warnings and contra-indication,
* Female subjects who are pregnant, nursing or planning a pregnancy during the study,
* Subjects with a specific washout period for topical treatment(s) on the scalp,
* Subjects with a specific washout period for systemic treatment(s).
PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma

The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT radiotherapy is effective in preventing or delaying the onset of chest nodules in patients with Mesothelioma.

Mesothelioma is a rare form of cancer affecting the protective lining that covers many of the body's internal organs. The most commonly affected areas are the lungs and internal chest wall. In the UK over 2300 patients are diagnosed with mesothelioma each year and the numbers are increasing.

As part of the diagnosis and treatment of mesothelioma, patients may undergo a procedure which involves inserting a thin tube into the chest wall enabling an internal examination and for any biopsies or samples of fluid to be taken. These procedures can result in the development of skin lumps or nodules along the tract created by inserting the tube. To try and reduce the risk of these nodules developing in the tract or at the site of the scar, radiotherapy can be given to the chest wall at the site of the tract after the procedure has been performed; this type of radiotherapy is known as prophylactic irradiation of tracts or PIT.

Although many hospitals already give patients this type of radiotherapy treatment to the chest wall we still do not know if the treatment works. This trial has been designed to answer the question about the effectiveness of PIT radiotherapy. If PIT is found to be effective in preventing or delaying the development of these skin nodules then it can be offered to all patients as part of their treatment. However, if we discover that PIT is not effective this will save patients from undergoing ineffective treatment and having to spend time making unnecessary extra visits to hospital

Eligibility Criteria:
Inclusion Criteria:

* Either sex, age ≥ 18 years
* Diagnosis of mesothelioma by multi-disciplinary team (MDT). All histological subtypes are eligible for the trial
* ECOG performance status 0-2 (Appendix C)
* Inoperable disease or operable disease in patients unsuitable for surgery as decided by a MDT
* Chest wall intervention with video-assisted thoracoscopy (VATS), open surgical biopsy (mini-thoracotomy), local anaesthetic thoracoscopy or chest drain
* Able to start radiotherapy within 42 days (6 weeks) of the most recent chest wall procedure
* Chest wall intervention scar visible at time of randomisation
* Radiotherapy target volume acceptable by the local radiotherapist
* Patients enrolled on other clinical trials could be considered after discussion with the chief investigators

Exclusion Criteria:

* Patients who underwent a thoracotomy (as large thoracotomy scars may not be adequately covered by this radiotherapy technique)
* Previous radiotherapy to the region of the chest wall intervention site
* Indwelling pleural catheter in-situ at the intervention site
* Patients currently receiving chemotherapy
Psychobiology of Stress and Alcohol Craving

In this feasibility study the investigators are using a setup of stress-related body sensors including established as well as innovative sensor-based measures to identify predictor profiles for alcohol-related behavioral and neural measures in Alcohol Use Disorder (AUD). Long-term aim is the definition of a setup of mobile sensors and their integration in a mobile infrastructure that allows the prediction of stress related alcohol intake in an ambulatory setting.

The long-term aim is the definition of a setup of mobile sensors and their integration in a mobile infrastructure that allows the prediction of stress related alcohol intake in an ambulatory setting.

In patients with Alcohol Use Disorder (AUD) stress exposure is known to affect craving, cue-reactivity and relapse risk. Here, the investigators aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological stress exposure and alcohol cue-exposure regarding their effects on alcohol craving and related markers (attentional bias to alcohol-cues, implicit association task, neural cue-reactivity). In addition to applying established stress-related markers (cortisol in saliva, heart-rate variability, systolic blood pressure and electrodermal activity), the investigators will integrate innovative measures currently under investigation (e.g. voice stress analysis) to identify whether these additional parameters increase the predictive significance.

Eligibility Criteria:
Inclusion Criteria:

* Heavy drinking, defined by alcohol consumption of at least 20g alcohol per day (at 5 days per week)
* sufficient ability to communicate with the investigators, to answer questions in oral and written form
* fully informed consent
* written informed consent

Exclusion Criteria:

* withdrawal of the declaration of consent
* positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine)
* Lifetime history of DSM-5 bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance dependence other than alcohol or nicotine or cannabis dependence.
* Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention
* History of severe head trauma or other severe central nervous system disorder (e.g., dementia, Parkinson's disease, multiple sclerosis)
* Current use of medications or drugs known to interact with the CNS within at least four half-lives post last intake
The Effect of Mindfulness Meditation During Dental Implant Surgery

The aim of this pioneer study was to evaluate the efficacy (heart rate value, blood pressure, oxygen saturation, cortisol levels, BIS monitoring, patients' anxiety) of Mindfulness Meditation as a sedative technique during dental implant surgery.

Since anxiety is a form of psychological stress, an increase in anxiety results in a surge in stress levels. The role of sedation in dental surgery cannot be overemphasised. The reduction in pain and anxiety eventually causes better cooperation and patients' satisfaction. Therefore, balancing anxiety and/or stress levels in patients would be useful to ensure patient safety during treatment.Therefore, the aim of this pioneer study was to evaluate the efficacy (heart rate value, blood pressure, oxygen saturation, cortisol levels, BIS monitoring, patients' anxiety) of Mindfulness Meditation as a sedative technique during dental implant surgery.

Eligibility Criteria:
. The inclusion criteria were:

* age between 25-65 years-old
* single tooth loss in the maxillary premolar-molar region with partial bone healing (type 3) or fully healed ridge type 4
* sufficient bony ridge for implant placement without the need for simultaneous bone grafting or sinus lift procedure
* no signs of acute oral infection,
* more than 2 mm of keratinized gingiva at the site of surgery
* periodontally healthy (or successfully treated) and otherwise healthy or had well-controlled systemic disease (ASA classification I, II).

Exclusion criteria were

* diabetes mellitus
* smoking
* pregnancy;
* diagnosis of anxiety disorders/psychiatric disorder/ depression and whether or not they were seeking any form of treatment for these conditions;
* poor oral hygiene (plaque control record \> 30%);
* history of radiation therapy at head and neck area and chemotherapy; bony pathologies; history of soft tissue grafting at the prospective implant site
Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus

The goal of this observational study is to describe the experiences of parents at the birth of a child with a large or giant congenital melanocytic nevus through semi-structured interviews, and to identify potential intervention strategies to improve their care and support.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Willing to participate in a semi-structured interview
* Has received full information about the research and has not objected to participating or to the use of their data
* Able to understand and speak French
* Parent of a child under 18 years of age

Exclusion Criteria:

* Under 18 years of age
* Not willing to participate
* Currently under legal protection (e.g., guardianship or curatorship)
* Cognitive and/or psychological impairments preventing participation in a semi-structured interview
* Poor understanding and/or expression of the French language
* Parent of a child over 18 years of age
A New Multimodal Treatment Approach for Children With Spastic Diplegic Cerebral Palsy

Combining the advantages of both Neuromuscular electrical stimulation and lower limb serial casting to a selected physical therapy program in children with spastic diplegic cerebral palsy to overcome the adverse effects during the period of casting and the long period of rehabilitative interventions, providing a new multimodal treatment approach.


Eligibility Criteria:
Inclusion Criteria:

* The children will have grade 2 or 3 on Modified Ashworth Scale.
* The children will have Level II, or III according to the Gross Motor Function Classification System.
* The children walk with equinus or jump gait patterns with spasticity of the hamstrings and hip flexors in addition to calf muscles spasticity.
* Children take their Antispastic drug use such as baclofen, diazepam or tizanidine.
* All children will be able to follow instructions.

Exclusion Criteria:

* children will be excluded from the study if they have any problems of the following:

  * Cognitive dysfunction.
  * Poor skin integrity.
  * History of or recent nonunion fracture.
  * Fixed contractures and deformities.
  * Previous surgery (tendon lengthening).
  * Received Botulinum toxin A injections in the last six months.
  * Impaired circulation.