cyrilzakka/clinical-trials huggingface dataset:
IV Lacosamide: The Safety of Intravenous Lacosamide

The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.

The objective of this study is to evaluate the safety of IV Lacosamide in children ages 4 years to 35 years, inclusive who are unable to take oral medications or require parenteral administration of IV Lacosamide Occasionally, patients over the age of 20 are seen at LeBonheur Children's Hospital due to the complexity of their condition, or due to a long relationship with their physician. These are exceptions which are reviewed on a case by case basis and are approved by the hospital administrator for admissions and outpatient testing.

Eligibility Criteria:
Inclusion Criteria:

* Patient or LAR must sign informed consent
* Diagnosis of partial onset currently uncontrolled
* Patient must have received anti-epileptic drug therapy prior to initiation
* Patient must have a medical condition in which parental administration is desireable
* Male or female
* Ages 4-35

Exclusion Criteria:

* Patient has participated in a study involving IV Lacosamide
* Patient has had an episode of status epilepticus in the last 3 months
* Drug history to lacosamide pregnant or lactating
* If of child bearing age, must have pregnancy test
* Patient has participated in an experimental drug study in last 30 days
* Patients with significant active hepatic or renal disease.
* Patients with known cardiac disease.
Hypnotherapy in Treating Chronic Pain in Cancer Survivors

This randomized pilot clinical trial studies hypnotherapy in treating chronic pain in cancer survivors. Hypnotherapy is a state of concentration and focused attention which can provide more control over the experience of acute and chronic pain and its impact and may provide comfort, maximize function, and improve quality of life in cancer survivors.

PRIMARY OBJECTIVES:

I. To test the feasibility (recruitment, attrition, adherence, logistical issues) of delivering the hypnosis (hypnotherapy) intervention to cancer survivors with chronic pain.

II. To evaluate the acceptability of the hypnosis intervention among cancer survivors with chronic pain.

III. To explore preliminary efficacy (estimate effect size) of hypnosis in relieving pain and improving associated anxiety and functional performance at 4 weeks and 8 weeks compared to a wait-list control.

OUTLINE: Participants are randomized to 1 of 2 groups.

IMMEDIATE INTERVENTION GROUP: Participants undergo hypnotherapy session over 20-30 minutes using a standardized script for pain reduction that contains post-hypnotic suggestions for permanence of hypnotherapy benefits. The hypnotherapy session is recorded and the participant listens to the recording daily for 4 weeks.

WAIT-LIST CONTROL GROUP: At week 5, participants undergo hypnotherapy session over 20-30 minutes using a standardized script for pain reduction that contains post-hypnotic suggestions for permanence of hypnotherapy benefits. The hypnotherapy session is recorded and the participant listens to the recording daily for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Self-report of moderate or higher pain on average during the last week (\> 3 on a 0-10 pain intensity numeric scale)
* Completed active cancer treatment other than maintenance therapy \>= 3 months ago
* Functional fluency in English
* Mentally and physically able to participate and complete surveys over the phone

Exclusion Criteria:

* Chronic pain is not cancer-related
The Effect Dialysis on the Pharmacokinetics of Fexofenadine

The Investigators recently completed and published a study that demonstrated that fexofenadine pharmacokinetics are significantly altered in dialysis patients (Thomson et al. (2015) American Journal of Kidney Diseases 65(4):574-582). In this study, patients were studied directly before routine dialysis treatment. Other published literature suggests the timing of the dose of some drugs (before or after dialysis) may have a profound impact on the drug pharmacokinetics (Nolin et al (2006) 17(9):2363-7). The hypothesis is that compounds that accumulate in the blood of patients with kidney failure impact the pharmacokinetics such that dosing before or after dialysis produces significantly different blood levels of the drug.

This will be an open, randomized pharmacokinetic study in 30 patients treated by dialysis. Patients will be asked to spend an additional 3 hours at the hospital on each of two study days separated by at least a week. At the first study visit, the patient will be randomized to receive the drug fexofenadine (120 mg, orally) either 3 hour prior to, OR at the conclusion of their regularly scheduled dialysis treatment. Three hours following fexofenadine administration, a single 4 mL (approximately 1 teaspoon) blood sample will be drawn. One week or more after the first study day, the patient will have the study repeated but with the timing of the dose altered to match the randomization. For example, if at the first study visit the patient received fexofenadine after their dialysis session, they will now receive the drug 3 hours prior to their dialysis session. The blood sample will be centrifuged immediately and plasma stored at -80 celsius until analysis. Fexofenadine concentration will be determine by liquid chromatography coupled to mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated by any dialysis modality (e.g. hemodialysis, peritoneal dialysis) for at least 90 days prior to study enrolment.

Exclusion Criteria:

* Current or recent (within two weeks) hepatic or gastrointestinal morbidity. Inability or refusal to provide written informed consent. Unable to provide a blood sample. Female patients that are pregnant will be excluded.
A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults with Multifocal Motor Neuropathy

The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and the local legal age of consent for clinical studies
* Has a confirmed diagnosis of definite or probable MMN at screening according to the EFNS/PNS 2010 guidelines
* Has responded to IVIg in the past 5 years.
* Is receiving IVIg at a treatment interval of once every 2, 3, 4, or 5 weeks, and a dose of 0.4 to 2.0 g/kg body weight per cycle
* Is receiving a maintenance regimen (no change in frequency, and no change in dose \>10%) of IVIg for at least 8 weeks before screening (or at least 10 weeks for participants receiving IVIg once every 5 weeks)
* Minimum converted weekly IVIg dose of ≥0.125 g/kg
* Has documented immunization against encapsulated bacterial pathogens (N meningitidis and S pneumoniae) within 5 years of screening or is willing to receive immunization at least 14 days before first study drug administration

Exclusion Criteria:

* Besides the indication under study, known autoimmune disease (eg, SLE) or any other medical condition that would confound the study results or put the participant at undue risk
* Clinical signs or symptoms suggestive of neuropathies other than MMN, such as motor neuron disease (eg, bulbar signs, brisk reflexes) or other inflammatory neuropathies (eg, sensory neuropathy)
DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection

Lung transplantation (LTx) , DNA-based testing.

Performance of DNA-based testing of bacterial and fungal pathogens in comparison to standard testing.

Experimental intervention: DNA-based testing of BAL fluid.

Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection.

Eligibility Criteria:
Inclusion Criteria:

* patients after lung transplantation (single, double or combined)
* suspicion of non-viral lower respiratory tract infection as defined by at least 2 out of
* new onset of malaise
* new or progressive pulmonary infiltrate
* hypoxemia (SpO2/SaO2 \<92% or need for oxygen)
* temperature of 38 o C or above within 7 days
* purulent (yellow or greenish) sputum
* CRP of 30 mg/l or above
* PCT of 0,5 µg/l or above

Exclusion Criteria:

* no informed consent
A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study

Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety and long-term efficacy of PF-06473871 one year after surgical revision and treatment with PF-06473871.


Eligibility Criteria:
Inclusion Criteria:

* Subjects previously randomized to Pfizer clinical study B5301001.
* Subjects must be able to tolerate up to a 3 hour scar revision surgery under sedation and local anesthesia.

Exclusion Criteria:

* Pregnant female subject; breastfeeding female subjects; male subjects with partners currently pregnant.
* Any previous history of intolerable adverse reactions to PF-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to AE in prerequisite study B5301001.
Rapid Sequence Intubation at the Emergency Department

All patients undergoing emergent endotracheal intubation (RSI) at the Emergency Department will be screened for inclusion in this clinical study. The indication of endotracheal intubation is an exclusively clinical decision and is not affected by this study protocol in any aspect.

If fulfilling the In- and exclusion criteria's, patient will be randomly assigned to one of two groups

1. C-MAC Videolaryngoscope in appropriate size
2. conventional endotracheal intubation using Macintosh Blade in appropriate size

Randomization (1:1) will be based on computer-generated codes maintained in sequentially numbered opaque envelopes that will be opened immediately before randomization.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring emergency Rapid Sequence Intubation at the emergency department
* Male and Female subjects 18 years to 99 years of age
* Written confirmation by a physician not involved in this study
* Written informed consent by the participant (obtained afterwards)
* Patient not showing remarkable rejection in participation in this study

Exclusion Criteria:

* Maxilla-Facial trauma
* Immobilized cervical spine
* Indication for fiberoptic guided intubation (known difficult airway)
* Ongoing Cardio-Pulmonary-Resuscitation (CPR)
* Involvement in any other clinical trial during the course of this trial, within a period of 30 days prior to its beginning or 30 days after its completion
* Severe or immediately life-treating injury requiring immediate medical treatment
Friendship Group Intervention Development in Cambodia

A Friendship Group (FG's) (n= 4) will be delivered over an 8-week period (December 2021 - January 2022) to individuals who met the clinical distress threshold as per Kessler-10 score. FG's were offered face-to-face in Phnom Penh (n= 2) and online via Zoom (n= 2). Trained, community support workers and Prosthetists' from the Cambodian School of Prosthetics and Orthotics delivered FG's each week.

Using a mixed methods design, the research team developed and implemented an 8-week peer-led intervention (known as a Friendship Group (FG) for Cambodian adults with physical disabilities using both face-to-face and online delivery methods.

Weekly Friendship Groups (n= 4) will be delivered over an 8-week period (December 2021 - January 2022) to individuals who met the clinical threshold as per Kessler-10 score (further details published elsewhere - blinded for review). FG's were offered face-to-face in Phnom Penh (n= 2) and online via Zoom (n= 2). Trained, community support workers and Prosthetists' from the Cambodian School of Prosthetics and Orthotics delivered FG's each week and followed the same four part structure described below. Prior to the first online session, each individual was asked to take part in a one-to-one orientation session to the platform to ensure that they could access the system without any issues. Participants were also reimbursed with costs for attending FG's (e.g. taxi fares for face-to-face or internet data for online groups). All those who had consented to receive communications were sent a weekly text message reminder 24 hours prior to the next FG meeting. All sessions were delivered in the local language (Khmer).

All participants in the study completed a screening survey to determine suitability. This included some basic socio-demographic information as well a series of validated psychometric scales described elsewhere.

Statistical Analysis

The data were screened for missing values and any error cases, such as extreme outliers. There were no missing values or error cases on any of the outcomes. The Wilcoxon Signed-Rank test was used to assess changes in pre-post scores for psychological distress, PTSD, worry, rumination and facets of mindfulness. With relatively small group sample sizes, differences between group allocations could confound intervention outcome measurement and it is therefore important in such circumstances to compare baseline differences between groups during the analysis

Eligibility Criteria:
Inclusion Criteria:

* Patients and prospective patients attending Cambodian School of Prosthetics and Orthotics
* Meet the clinical threshold during Stage 1 screening
* Adults over the age of 18

Exclusion Criteria:

* Actively suicidal
* In receipt of additional specialist psychological therapy
* Unable to give informed consent
L-Tyrosine Supplementation in Patients With Fibromyalgia

Patients in the study, who have a diagnosis of fibromyalgia, will be randomly assigned to take the amino acid L-tyrosine or placebo (blank pill) for 3 weeks. They will fill out questionnaires about their symptoms and see if they have any improvement. The investigators hypothesis is that taking tyrosine will help alleviate the symptoms of fibromyalgia.

Fibromyalgia is a chronic pain syndrome with few treatment options available. The amino-acid L-tyrosine is the precursor for norepinephrine in the central nervous system (CNS). Norepinephrine in the CNS has important roles in pain and mood modulation and descending inhibition of pain pathways. By giving the precursor L-tyrosine in high doses we believe that we can increase levels of norepinephrine in the CNS. To study this question we designed a randomized blinded pilot study of 30 patients. Patients are randomly assigned to one of 3 groups (placebo, tyrosine 1000mg/day, and tyrosine 2000mg/day.) for 3 weeks. Patients then complete the Brief Pain Inventory (BPI) daily and the Fibromyalgia impact questionnaire (FIQ) on day 1 and day 21. Patients also complete a drug diary. They are monitored weekly for progress during the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia
* Pain greater than 4/10
* Age greater than 18

Exclusion Criteria:

* Pregnant
* Age less than 18
Shift to Everolimus (RAD) Kidney Sparing Study

The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Heart Transplant with 1 to 4 years of follow-up
* GFR between 20 and 60 ml/min (calculated with Colkoroft-Gault formula)

Exclusion Criteria:

* Acute rejection in the previous 6 months
* Contraindications to statin therapy
* Ongoing infection
* Ongoing heart failure
* Myocardial infarction or myocardial revascularization after transplant
* Malignancy
Correlation Between Fractional Exhaled Nitric Oxide (FeNO) Levels and Asthma Exacerbation

The purpose of this study is to determine mean or median of fractional exhaled nitric oxide (FeNO) in Thai atopic asthmatic children that divided into subgroups due to asthma exacerbation according to the global initiative for asthma guideline.

From many previous studies, fractional exhaled nitric oxide (FeNO) has many benefits such as non-invasive, easily to perform, less time consume, has direct association with severity of inflammation of bronchial trees and sputum eosinophils, has benefit for diagnosis and monitoring the treatment in asthmatic patients.

In Thailand, this field of study is less extend, especially in children population. The investigators hypothesized that patients with asthma exacerbation may have high level of fractional exhaled nitric oxide (FeNO) than non exacerbation group.

It is therefore desirable to examine the association between fractional exhaled nitric oxide (FeNO) and asthma exacerbation among atopic asthmatic Thai children and will be the main objective of this research.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of atopic bronchial asthma follow up in clinic of allergy and clinical immunology, Siriraj hospital

Exclusion Criteria:

* smoker or past history of smoking
* chronic disease eg. HIV infection, pulmonary hypertension, systemic lupus erythematosus, liver cirrhosis, gastroesophageal reflux, COPD, bronchiectasis
* drink ethanol within 48 hours before enrollment
* history of upper or lower respiratory tract infection within 6 weeks before enrollment drink caffeine within day before enrollment during pregnancy history of systemic steroid use within 8 weeks before enrollment
Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia

Once a day oral administration with DCCR helps lower triglycerides

The population will consist of Statin-naive and Statin-treated subjects, all without diabetes mellitus, with fasting triglyceride levels in the range of ≥ 500 mg/dL and \< 1500 mg/dL.

Subjects will be randomly assigned to 1 of 2 treatment groups: DCCR and Placebo

Approximately 44 subjects will be enrolled in the study and stratified by Statin use at a 1:1 ratio in each treatment group,

Eligibility Criteria:
INCLUSION CRITERIA:

Fasting triglycerides

* Difference between Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit) ≤ 60% (compared to the higher value of Visit 3 or Visit 4)
* Run-in Triglycerides\* ≥ 500 mg/dL and \< 1500 mg/dL \*Run-in Triglyceride is defined as the average fasting triglycerides for Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit).

Statin use • Either Statin-naive

* Must not be on statin at Screening and remaining as such during the Run-in/Washout Period and throughout the study

  • Or Statin-treated
* Must be on Lipitor 20 mg initiated at the start of the Run-in/Washout Period and continue throughout the study

Medication washout

* All subjects must be willing to undergo washout of all other lipid-lowering medications

Glycemic status

* Fasting glucose \< 126 mg/dL at Screening Visit
* HbA1c \< 6.5% at Screening Visit

EXCLUSION CRITERIA:

Medications: recent, current, anticipated

* Administration of investigational drugs within 1 month prior to Screening Visit
* Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
* Thiazide diuretics within 2 weeks prior to Screening Visit
* Discontinuation of beta-blockers within 1 month prior to Screening Visit or planned discontinuation of beta-blocker therapy
* Anticipated requirement for use of prohibited concomitant medications

History of allergic reaction or significant intolerance to:

* Diazoxide
* Thiazides
* Sulfonamides
* Fenofibrate or fenofibric acid derivatives

Lifestyle changes

• Subjects intending to change exercise habits, quit smoking and/or quit alcohol use during the entire study

Specific diagnoses, medical conditions and history

* Known type I or III hyperlipidemia
* Known type 1 DM
* Current diagnosis of type 2 DM
* Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the study medications, according to the Investigator

Specific laboratory test results

• Any relevant biochemical abnormality interfering with the assessments of the study medications
Treating Self-criticism in Adolescents: a Study With Single-case Experimental Design

In this pilot study, the effect of a group intervention targeting self-criticism in adolescents in a clinical child- and adolescent psychiatric outpatient setting will be examined using a single-case experimental design (AB). Participants will be randomized to multiple baseline with weekly measures. Our primary outcomes, measured weekly, are self-criticism, nonsuicidal self-injury and symptoms of depression and anxiety, as well as an individually chosen behavior driven by self-criticism. Secondary outcomes are self-compassion, psychological flexibility, quality of life and functioning. In addition to the weekly administered questionnaires, before and after measures, and 3- and 6-month follow-up will be collected. After the treatment, participants will also be interviewed about their experiences of targeting self-criticism.


Eligibility Criteria:
Inclusion Criteria:

* Patient at the child- and adolescent psychiatric clinic in Linköping, Sweden.
* 15 to 18 years
* an adequate understanding of the Swedish language
* cognitively capable of giving informed consent
* scoring 26 or above on subscale "Inadequate self" and 8.5 or above on subscale "Hated Self" on questionnaire Forms of Self-Criticism and Self-Reassuring Scale (FSCRS)
* the treatment is transdiagnostic so all diagnoses are included (See exclusion criteria for exceptions).

Exclusion Criteria:

* severe anorexia, BMI ≤ 16
* ongoing substance abuse
* diagnosed intellectual disability
* needing interpreter for translation of Swedish language
* participants who cannot give informed consent
FRENCH OBSERVATORY OF ACUTE HEART FAILURE-2

In 2009, OFICA 1 provided a snapshot of the management of acute heart failure in France.

Over the past 10 years, practitioners have observed a change in the profiles of hospitalized patients and it is necessary to specify the evolution of these characteristics, especially since the recommendations concerning management have changed significantly; this is the objective of this observatory.

Like patients suffering from chronic diseases such as diabetes or asthma, heart failure patients are therefore at the center of their management. Compliance is improved when patients have understood the reason for the prescription. Ideally, compliance should not be achieved by respecting externally imposed norms, but rather by respecting norms that are understood, adapted, personalized and accepted.

A self-questionnaire will thus be given to patients on the day of inclusion in the study.

In heart failure patients with an average age of 80 years, systematic screening for cognitive disorders using a simple test recommended by the French National Authority for Health (Haute Autorité de Santé), the codex test, will make it possible to offer more appropriate care if necessary (geriatric or neurology consultation).

Finally, follow-up at 3 months and at 1 and 2 years will be carried out by matching with data from the National Health Data System (SNDS)


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized, regardless of the initial mode of admission, with acute heart failure (de novo heart failure or decompensation of chronic heart failure) of any severity and corresponding to one of the following clinical situations :

  1. Pulmonary edema, hypertensive or not
  2. Congestive heart failure (pulmonary congestion, peripheral oedema)
  3. Cardiogenic shock
  4. High output heart failure
  5. Isolated right heart failure
* Patient who agreed to participate in the study

Exclusion Criteria:

* Expressed refusal to participate in the study
* Scheduled hospitalization for assessment
* Surgical context (immediate postoperative period)
* Diagnosis of acute heart failure reversed to another diagnosis before end of hospitalization