cyrilzakka/clinical-trials huggingface dataset:
Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique

Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered a type of surgery, which involves the injection of glycerol in a nerve structure called trigeminal ganglion. The researchers will do a pilot study on 10 patients with a new surgical technique using neuronavigation. The researchers believe that this new neuronavigation-based system can improve the precision of the technique and reduce the risk for complications.


Eligibility Criteria:
Inclusion Criteria:

* Informed and written consent
* Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria
* Unsatisfactory effect of pharmacological treatment

Exclusion Criteria:

* Microvascular decompression is seen as a better alternative
* Heart or lung disease
* Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
* Psychiatric illness that hinders participation in the study
* Known pregnancy or breast feeding
* Inadequate use of contraceptives
* Overuse or abuse of opioids
* Abuse of medications, narcotics or alcohol
* Anomalies which hinder or impede the used method of injection
* Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin
Overactive Bladder Innovative Therapy Trial (OrBIT)

The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age
* Experiences OAB with a voiding frequency of at least 8 times per day
* Is ambulatory and able to use a toilet independently and without difficulty

Exclusion Criteria:

* On OAB pharmacotherapy within the previous month
* Primary complaint is stress urinary incontinence
* Has pacemaker or implantable defibrillator
* Has history of heart problems
* Has nerve damage or neuropathy
* Has gastric or urinary retention
* Has uncontrolled narrow-angle glaucoma
* Has known sensitivity to drug ingredients
* Is pregnant or planning to become pregnant during the trial
Validity and Reliability of the Modified Four Square Step Test in Multiple Sclerosis Patients

Balance disorder is common in people with MS. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. Given the prevalence and clinical significance of balance dysfunction in individuals with MS, the assessment of balance has become an important focus in MS clinical practice and research. The Four Square Step Test is a standard clinical measure used to assess dynamic standing balance. It is a timed test in which the individual is instructed to step rapidly forward, backward, and to the right and left over a low obstacle (a cane). The test assesses the ability to quickly change direction of movement and is a timed test involving the use of assistive devices.

In the modified four-square stepping test, the floor is divided into four equal squares with tape instead of a cane. Performing the test with tape, instead of patients at risk of being stuck with a cane, will ensure its applicability to a wider patient population.

The aim of the study is to examine the validity and reliability of the modified four-frame stepping test in MS patients.

Multiple sclerosis (MS) is a progressive disease of the central nervous system characterized by demyelination and destruction of motor and sensory axons. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. The prevalence of balance dysfunction in individuals with MS and Given its clinical relevance, the assessment of balance has become an important focus in MS clinical practice and research.The Four Square Step Test is a standard clinical measure used to assess dynamic standing balance.The individual rapidly forwards over a low obstacle (a cane), is a timed test in which instructed to step backward and to the right and left.The four-frame stepping test was developed to document deficiencies in stance balance, predict falls, assess self-perceived limitations in walking, and compare changes in standing balance following exercise training. Compared to other standardized tests, scoring is not dependent on the subjectivity of the examiner, can be administered by a person with minimal training, and requires minimal time, space, and equipment. In the modified four-square stepping test, the floor is divided into four equal squares with tape instead of a cane. Performing the test with tape, instead of patients at risk of being stuck with a cane, will ensure its applicability to a wider patient population.

Eligibility Criteria:
Inclusion Criteria:

* Having an EDSS score of 4 and below,
* Being between the ages of 18-65
* Willingness to participate in the study

Exclusion Criteria:

* Being pregnant or within the first 3 months after giving birth,
* Receiving corticosteroid therapy in the last 1 month,
* Using drugs that will affect walking in the last 1 month
The Effects of California Strawberries on Parameters of Cardiovascular Health

The prevalence of childhood obesity has been increasing over the past couple of decades. Similar to adults, overweight and obesity in young children and adolescents is associated with an increased number of cardiovascular risk factors including dyslipidemia, hypertension, insulin resistance and Type 2 diabetes. Epidemiological and clinical studies suggest that foods and ingredients rich in select flavonoids, such as cocoa, red grape products, tea, citrus fruits, and strawberries are protective against the development of cardiovascular disease. Strawberries are rich in flavonoids, particularly anthocyanins, flavanols, flavonols, ellagic acid and its glucose ester, ellagitanin. A number of in vitro studies have observed that these isolated compounds, as well as strawberry extracts have the potential to affect outcomes of cardiovascular health, including vascular reactivity, cellular signaling and oxidant defense6,7. We hypothesize that strawberry intake will lead to improvements in select measures of cardiovascular function in overweight and obese adolescent males.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects, age 14 - 18 years.
* BMI for age and gender \>75th percentile (based on CDC growth charts)
* Subject is willing and able to comply with the study protocols.

Exclusion Criteria:

* Inability to wear PAT probes
* Inability to remain still and remain quiet during test procedures
* BMI for age and gender ≤ 75th percentile (based on CDC growth charts)
* The use of medications that affect vascular function
* Regular use of dietary supplements during the last 6 months
* Blood pressure for age, gender and height ≥95th percentile
* Chronic/routine high intensity exercise or current participation in a sports program
* Self/Parent reported use of anticoagulation agents including NSAIDs
* Self/Parent reported use of oral cortisone or other immunosuppressive agents,
* Self/Parent reported underlying neoplasia or immunological disease
* Self/Parent reported diabetes
* Food faddists or those taking a non-traditional diet
* Allergies to fruit
* Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference
* range) if determined to be clinically significant by the study physician.
* Self/Parent reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas).
* Asthma (can be worsened by mild to moderate food allergies).
Improving the Diagnosis of Sexually Transmitted Infections in Emergency Rooms

A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of sexually transmitted infections caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC sexually infection transmitted tests .

Most sexually transmitted infections can be diagnosed from an anal swab which is not routinely performed. In this study, we suggest to test the hypothesis that anal swab in addition to the routine genital swab would increase by at least 5% the diagnosis capacity of sexually transmitted infections after the POC tests.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted for sexually transmitted infection in emergency room requiring a microbiological examination with a "Sexually Transmitted Infection POC kit"
* Patient who freely signed the informed consent form
* Patient affiliated to a social security regime

Exclusion criteria

* Pregnant or breastfeeding women
* Adult patient under guardianship
* Patient deprived with liberty under court order
* Patient refusing or unable to sign the informed consent form
Does McGRATH® MAC Videolaryngoscope Decrease the Number of People Required to Perform Intubation During Anesthesia ?

The main objective of this study is to compare the proportion of tracheal intubations for which more than one person is necessary when using the McGRATH® MAC videolaryngoscope.

Videolaryngoscopes, such as McGRATH® MAC videolaryngoscope, are used to facilitate tracheal intubations. This study is designed to evaluate the proportion of cases requiring more than one member of the anesthesiology team when the video feature of McGRATH® MAC is available during laryngoscopy in a population of patients without a predicted difficult intubation (Arne's score \<11).

General anesthesia from induction until tracheal intubation is recorded on a video for further analysis. Analysis includes characteristics of intubation, patient's monitoring and cooperation between anesthesiologists in two groups. In the control group, the screen of the McGRATH® MAC videolaryngoscope is hidden. In the experimental group, the McGRATH® MAC videolaryngoscope is used with its video feature.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old minimum
* Requiring general anesthesia and orotracheal intubation with a single lumen tube
* Having signed an inform consent form
* Having a telephone and agreeing to communicate their phone number
* Benefiting from a social insurance scheme or beneficiary

Exclusion Criteria:

* Pregnant or breast-feeding women
* Patients taken care in ambulatory surgery who could not be contacted within 24 hours following surgery
* Patients having a predicted difficult intubation (Arné's score ≥ 11) or predicted difficult mask ventilation
* patients requiring a rapid-sequence intubation
* patients for whom general anesthesia using sufentanil, propofol, atracurium or rocuronium is not suitable.
Artificial Intelligence-enabled Large-scale Electrocardiogram Feature Extraction and Exploring Association Between the Extracted Features and Mortality, Stroke or Various Health Outcome of Interest

* In this study, large-scale ECG data (Electrocardiogram data of all patients stored in the MUSE system by measuring standard 12-guided ECG at Severance Health Checkup at Severance Hospital from November 1, 2005 to October 31, 2022) are combined with electronic medical records, National Health Insurance Corporation data, and National Statistical Office death cause data, and the artificial intelligence algorithm is used to extract ECG features to analyze the association between death, stroke, and various health conditions, and to conduct external verification or transfer learning using public databases (e.g., UK Biobank data).
* Intended to use a web-based artificial intelligence platform to distribute computational loads generated during large-scale data processing and improve analysis accuracy and efficiency.

* All patient IDs obtained from the main office are replaced by research IDs (de-identified IDs), so the actual ID is not exposed and other personal identification information (name, resident registration number) is not collected.
* Research Methods:

  1. Electrocardiogram extraction based on the criteria of subjects.
  2. Combined with extracted ECG data and National Insurance Corporation data (+ National Statistical Office cause of death data).
  3. Health out of interest (HOI) definition. Includes death, stroke, etc.
  4. The defined HOI can be extracted from Yonsei Medical Center data or from National Insurance Service data or Statistics Korea's cause of death data.
  5. Artificial intelligence model training with electrocardiogram (and clinical information diagram if necessary) as input, utilizing supervised deep learning algorithms if there is a label and unsupervised learning algorithms if there is no label.
  6. Performance evaluation for supervised learning artificial intelligence models.
  7. In the case of unsupervised learning artificial intelligence models, the association/correlation between extracted features and HOI or predictability/detectability analysis.
  8. Transfer learning can be performed by adding external verification or dielectric data to the learned model using public databases.
  9. External verification can be performed using external additional data by mounting the learned model on a web-based artificial intelligence platform.
  10. Considering large-scale data, computing workloads can be distributed using web-based artificial intelligence platforms.
  11. The analysis results can be anonymized and the analysis results can be provided to researchers through a web-based artificial intelligence platform.

Eligibility Criteria:
Inclusion Criteria:

All patients stored in the MUSE system after measuring a standard 12-guided electrocardiogram at Severance Health Checkup at Severance Hospital from November 1, 2005 to October 31, 2022
Impact of Left Atrial Appendage Closure on Physical Capacity.

Closure of the left atrial appendage in patients with atrial fibrillation and risk for stroke is a increasing technology leading to exclusion of the left atrial appendage volume from the blood circulation and therefore protects from cardioembolic strokes- It is unclear if the volume reduction of the left atrium leads to a change in exercise capacity or Quality of life.

The monocentric trial deals with the endocrinological changes as a result of closure of the left atrial appendage with a internal closure device. Specially, the changes in atrial natriuretic peptide, brain natriuretic peptide and their impact on exercise capacity is on focus of the trial. The trial is planned as a all comers trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a indication for LAA closure device Implantation

Exclusion Criteria:

* Inability to perform exercise testing
Digital Storytelling in the NICU

Our long-term goal is to reduce suffering and long-term negative consequences for families in the Neonatal Intensive Care Unit (NICU). The overall purpose of this study is to test feasibility of a legacy intervention for NICU parents.

Specific aims are:

(1) To determine the feasibility of a legacy intervention for NICU parents; and (2) to determine the feasibility of psychosocial instruments for NICU parents. We will recruit parents (N = 12) of 6 infants in the NICU who have received a palliative care consultation and expected to die by 1 year of age based on provider report. We will use a one-group pre- and post-test design. The intervention will be delivered by the PI or trained study staff conducting video-taped interviews with parents in private NICU rooms to create a digital story about their infant. The videographer will use the video and music selected by parents to create a digital story about the infant. The final digital story is provided to parents on a DVD or unlisted (private) YouTube link to keep. Parents will complete electronic psychosocial measures at enrollment (baseline/pre-intervention) and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Parents of infants in the NICU who have received a palliative care consult and expected to die by 1 year of age based on provider report:

  * Parent caregivers (ages 18 years and up) of infants
  * Parents will be defined as the legal guardians who act in the role of the infant's primary and secondary parent caregivers based on parent self-report.
* Able to speak and understand English
* Absence of cognitive impairment
Bioavailability Study Of PF-06651600 In Healthy Subjects

PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed under fasting and fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Prior history of chicken pox.
* Evidence of personally signed and dated informed consent document.
* Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Screening blood pressure \>140/90 mm Hg.
* Screening laboratory abnormalities as defined by the protocol.
* Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.
Psychoeducational Videos and Digital Assessments for BPD

In this study, 100 adults who were recently diagnosed with borderline personality disorder (BPD) will be randomized to either receive educational videos about BPD or educational videos about other topics. All participants in both conditions will complete daily surveys about their emotions and social interactions, and they will respond to surveys and complete cognitive tests at 4 different time points. Some participants will receive feedback about their cognitive test performance, and others will not. The investigators are interested in learning about how accurate education about BPD and enhanced knowledge about cognitive abilities might help people manage their BPD symptoms. The investigators expect that participants who received psychoeducation about BPD will have lower levels of BPD and depressive symptoms than other participants, and that participants who received feedback on their cognitive tests will also have lower symptoms.

In this study, 100 adults who were diagnosed with BPD within the past three months will be randomly assigned to receive psychoeducational videos (4-10 minutes each) about the development, symptoms, naturalistic trajectory, and treatment of BPD (2/3 of participants) or matched-length videos about non-BPD, health-related topics (1/3 of participants). One video will be delivered every business day for two weeks. Participants will respond to 5-minute surveys on their recent social interactions, their feelings of threat, connectedness, and aloneness, and will complete a 1-minute version of the Continuous Performance Test (CPT) and Digit Symbol Matching Test, every day for 30 days. Participants will complete additional full-length surveys and cognitive tests at 4 time points: baseline (Day 1), Time 2 (day 15), Time 3 (Day 30), and Follow-up (day 60). The primary outcome is BPD symptom severity, and the secondary outcome is depressive symptom severity. The investigators expect that BPD-focused psychoeducation and personalized neuropsychological feedback will each lead to separate, measurable reductions in BPD and depressive symptom severity. The investigators also expect that the relationship between psychoeducation and symptom reduction will be mediated by increased knowledge about BPD, and that the relationship between neuropsychological feedback and symptom reduction will be mediated by increased cognitive control.

Eligibility Criteria:
Inclusion Criteria:

* reliable access to a smartphone with a data plan for the duration of the study
* ability to speak and understand English
* age 18 years or older
* diagnosis of BPD within the past 6 months
* awake and able to complete EMA surveys between 9:00am and 9:00pm on most days
* located within the United States

Exclusion Criteria:

* cognitive disability that impedes ability to participate in the study
* current psychiatric symptoms that interfere with the individual's ability to provide consent or complete the research procedures (e.g., acute mania, acute psychosis, eating disorder threatening medical stability).
CSL200 Gene Therapy in Adults With Severe Sickle Cell Disease

This is a phase 1 pilot study of CSL200 in adult subjects with severe sickle cell disease. The primary objectives of this study are to evaluate the safety of the following: collection of CD34+ hematopoietic stem / progenitor cells by apheresis after mobilization with plerixafor, reduced intensity conditioning with melphalan, and administration of CSL200.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sickle cell disease with the homozygous HbS homozygous genotype (HbSS) or an HbSβ thalassemia variant (ie, HbSβ0 thalassemia or HbSβ+ thalassemia) genotype, confirmed by hemoglobin studies.
* Fetal hemoglobin (HbF) ≤ 15%.
* Severe sickle cell disease symptomatology, defined as any one or more of the following:

  1. ≥ 2 episodes of acute chest syndrome in the last 2 years.
  2. ≥ 3 episodes of severe pain events requiring a visit to a medical facility and treatment with opioids in the last 2 years.
  3. \> 2 episodes of recurrent priapism in the last 2 years.
  4. Red-cell alloimmunization (\> 2 antibodies) during long-term transfusion therapy (lifetime history).
  5. Chronic transfusions for primary or secondary prophylaxis (lifetime history).
  6. Trans-thoracic echocardiograph evidence of tricuspid valve regurgitant jet velocity ≥ 2.7 m/sec (lifetime history).
  7. Clinically significant neurologic event (eg, ischemic stroke) or any neurological deficit lasting \> 24 hours.
* Not eligible for human leukocyte antigen (HLA)-matched hematopoietic stem cell transplantation, defined as follows: no medically eligible, available, and willing 10/10 matched HLA-identical sibling donor, unless subject has declined this treatment option (as documented in the informed consent form).
* Not eligible for, declined, or, as judged by the investigator, failed therapy with hydroxyurea and if still on hydroxyurea is able to interrupt hydroxyurea starting at the beginning of the transfusions, before mobilization and apheresis.

Exclusion Criteria:

* Hypoxanthine-guanine phosphoribosyl transferase (HPRT) deficiency.
* Thiopurine S-methyltransferase (TPMT) deficiency.
* Alpha thalassemia.
* Inadequate bone marrow function, defined as at least 1 of the following:

  1. Absolute neutrophil count \< 1000/µL.
  2. Platelet count \< 120,000/µL.