cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy

Childhood absence epilepsy (CAE) is a form of generalized epilepsy syndrome. Clinically these seizures are manifest with a sudden, brief (3-15 second) loss of awareness followed by a quick recovery to baseline. Keppra (levetiracetam) is approved by the U.S. Food and Drug Administration (FDA) to treat partial seizures in adults. It is currently being studied in children with partial seizures. Absence seizures can be difficult to detect clinically, therefore the response to therapy will be determined both by clinical observation and by 24 hour EEG recordings. The researchers hope that with this information they will learn how well it works for the treatment of childhood absence epilepsy and at what dose. This is an open-label, dose-ranging pilot study of levetiracetam in subjects with newly diagnosed childhood absence epilepsy. Approximately 20 patients will be needed to study effectiveness and dose requirements. Subjects must not be on any antiepileptic medication at the time of entry into the study. Male and female subjects from the ages of 4 to 10 years of age may participate.

This is a 12 week ( 12 week treatment phase), dose ranging pilot study on the effectiveness of levetiracetam for the treatment of childhood absence epilepsy. It consists of 1 phase. The treatment phase where the optimal medication dose will be defined. Absence seizures are often brief and subtle with no postictal manifestations. As a result, clinical observation alone is inadequate to assess the seizure Therefore, both subjective clinical response (parental/caregiver assessment) and EEG recordings are an important part of evaluation of treatment response. A 6 hour outpatient video-EEG study (including 3 minutes of hyperventilation), followed by an 18 hour ambulatory EEG recording - for total 24 hour EEG recording will be done before treatment and every 2 weeks after each dose plateau is reached )

Eligibility Criteria:
Inclusion Criteria:

* CAE by EEG criteria
* Naive to antiepileptics
* Onset 3 to 10 years old
* A history of daily seizures
* Age between 4 and 10
* Weight at least 5th percentile for age
* Be able to take oral medications
* Be willing to return for diagnostic testing and visits and adhere to medication regime

Exclusion Criteria:

* An EEG with any of the following abnormalities
* Focal epilepsy
* Slow spike and wave discharges
* Photoconvulsive response
* Slow background rhythms for age
* Currently being treated with an antiepileptic drug (AED)
* History of MR
* A history of myoclonic, atonic,tonic or astatic seizures
* A clinically unstable disease
A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).


Eligibility Criteria:
Key Inclusion Criteria:

Core Treatment Period:

* Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (feeder studies).
* Has one care partner who, in the Investigator's opinion, has adequate contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities.

LTE Treatment Period:

* Participant must have completed the Core study period (Week 102) and adequately tolerated 10 mg/kg of aducanumab during the Core study period in the opinion of the Investigator.
* Has one informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities.

Key Exclusion Criteria:

Core Treatment Period:

* Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the participant's cognitive impairment.
* Stroke or any unexplained loss of consciousness within 1 year prior to Screening.
* Clinically significant unstable psychiatric illness in past 6 months.
* History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening.
* A seizure event that occurred after the last visit of the feeder study and before Screening for this study.
* Evidence of impaired liver function as shown by an abnormal liver function profile at Screening.
* History of or known seropositivity for HIV.
* Clinically significant systemic illness or serious infection within 30 days prior to or during Screening.
* Contraindications to having a brain magnetic resonance imaging (MRI).

LTE Treatment Period:

* Any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the Investigator, will substantially increase the risk associated with the participant's enrollment in and completion of the study.

Note- Other protocol defined Inclusion/Exclusion criteria may apply.
Subtypes and Prognostic Factors in Erdheim-Chester Disease

Erdheim-Chester Disease (ECD) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. The causes of the pathology are still unknown. Although the disease typically affects adult individuals, cases of pediatric-onset ECD have been described. However, there is a lack of detailed information on the phenotypic characteristics of these patients, and reliable data on response to specific therapies and long-term outcomes are missing. Three patients referred to our reference center for Histiocytosis present a concomitant BRAF-mutated neoplasm. Such an association could be due to the presence of mosaicisms for the BRAF V600E mutation. Mosaicism is a biological event defined as the presence of more than one genetically dissimilar cell population in the same organism and is an increasingly studied field, both in normal and pathological conditions. If proven in ECD as well, this mechanism could contribute to providing answers to the still open questions regarding the development of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Prevalent and incident patients (adults and pediatric), with histologically confirmed diagnosis of Erdheim-Chester Disease according to the latest diagnostic recommendations;
* Signing of informed consent for study participation.

Exclusion Criteria:

* Patients for whom clinical and imaging data are not available and for whom it is not possible to retrieve histological samples."
A Study of Prevalence of EGFR Mutations in Participants With NSCLC

This is a non-interventional, local, multicenter, cross-sectional study to determine the prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed with non-squamous non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent form signature
* Jordanian male and female participants greater than or equal to (\>=) 18 years of age
* Histologically confirmed NSCLC
* Not participating in a study that involves an investigational agent within 30 days prior to enrollment

Exclusion Criteria:

* Other primary malignancy
* Fine needle aspiration samples
Is Auriculotherapy Responsible for Improvements on Anxiety Students' Prior and After Examinations?

As the investigators have shown before, there was a tendency for a reduction of anxiety levels on university students after 30 minutes, with auriculotherapy treatment before examinations have started. However, the effect was effective and clinically significant after 48 hours comparing auriculotherapy with placebo and no treatment. In this sense, the investigators intend to perform a new study with a large sample and introduce a new hypothesis. So, this study aims to detect the clinical effect of two auriculotherapy techniques on the anxiety levels of university students.

To treat anxiety, conventional medicine relies on medicines such as benzodiazepines, antidepressants, barbiturates, and antihistamines. However, several authors have reported western medicine cannot resolve all anxiety diseases and the risk of side effects, resistance to pharmacological treatments affects approximately one in three patients with anxiety disorders.

Alternatively, auriculotherapy is a technique similar to reflexology. It is speculated the technique might work in anxiety because groups of pluripotent cells contain information from the whole organism creating regional organization centres representing different parts of the body, through the recruitment of more cortex cells dedicated to specific body areas. Thus reflex points in the ear can incite body responses by the stimulation of reticular formation and the sympathetic and parasympathetic nervous systems. The information that comes from the thermal, Algic and proprioceptive stimuli are transmitted from the auricular pavilion by the fibres of the nerves: trigeminal; Auricular magnum and minor occipital (sensitive branch of the cervical plexus) and the vagus nerve. The vagus nerve is responsible for the parasympathetic innervation of the lung, heart, stomach, and small intestine, as well as the pharynx and larynx muscles and it also sends information to important brain regions (e.g., locus coeruleus, orbitofrontal cortex, hippocampus and at amygdala) in the regulation of anxiety. In turn, the trigeminal nerve controls, mainly, the mastication muscles and the facial sensitivity while the cervical plexus nerve is responsible for neck muscles, diaphragm, and thorax.

Eligibility Criteria:
Inclusion Criteria:

* University students
* Unfamiliar with auriculotherapy,
* No psychological disorders measured through Brief Symptom Inventory scale.

Exclusion Criteria:

* Students having any neurological disease, cardiovascular disease, renal disease or any chronic disease, such as diabetes or hypertension.
* Pregnants.
* Under psychiatric medication.
Assessment of Endothelial Function, Apolipoproteins and Adiponectin

The overall hypothesis is that endothelial function, apolipoprotein levels and adiponectin levels are accurate predictors of underlying cardiovascular disease in patients with end-stage liver disease, in whom standard tools for the diagnosis of and screening for cardiovascular disease are of limited utility.

This study is looking at using a noninvasive test called a reactive hyperemia peripheral artery tonometry (RH-PAT) to check endothelial dysfunction. Endothelial dysfunction is thought to be an indication of future heart disease or metabolic disorders. Adiponectin is a hormone associated with heart disease. Apolipoprotein levels, are established risk factors for coronary artery disease in the general population. Our group would like to see if there is a link between endothelial function, adiponectin, apolipoprotein levels and posttransplant heart disease complications. The study would be taking these results to find new clinical procedures for patients that are at potentially higher risk of heart problems during and after their liver transplant procedure.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 21 years of age.
* Cirrhotic end-stage liver disease
* Pre-transplant

Exclusion Criteria:

* Dialysis shunt
* non-cirrhotic liver disease
* fulminant hepatic failure
Postpartum Sexual Function in Pregnant Women With COVID-19

The aim of this study is to identify women with postpartum sexual dysfunction and dyspareunia risk in the early period and to use the treatment and care services they need effectively. Our secondary aim is to reveal the difference in sexual life in the postpartum period between healthy pregnant women and pregnant women diagnosed with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant Patient with COVID-19

Exclusion Criteria:

* Those with known sexual dysfunction disorder
Telerehabilitation in Multiple Sclerosis

The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS, Khymeia) compared to usual care treatment for patients with MS at home.

The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with a comparison group receiving usual care training. The investigators will assess the effect of VRRS system on the quality of life, motor, and cognitive abilities. (Phase I) In the second phase of the present study we aim to evaluate the effects induced by the treatment of active (anodal) transcranial Direct Current Stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (lDLPFC) combined with VRRS compared to placebo tDCS stimulation combined with VRRS. The effects of the intervention patient-relevant outcomes will be assessed using a randomized controlled trial design with four groups. The investigators will assess the effect of VRRS system on patient-relevant outcomes motor, cognitive and participation. (Phase II)


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Multiple Sclerosis (RR and SP) based on McDonald criteria
* Education ≥ 8 ages
* Italian mother language
* Right-handedness
* Use of corticosteroids for three months prior to the study, having and no acute exacerbations of symptoms within three months of the study.

Exclusion Criteria:

* Existence of visual acuity and acoustic perception problems, to prevent performance of VRRS activities
* Relapses next to the time of enrolment (3 months)
* EDSS \> 6.5.
Validity of Mediastinal Blood Pool SUV Ratio

-Validity of blood pool SUV ratio in identification of malignancy in case of diseased liver.

PET/CT is the functional imaging tool that can measure increased glucose metabolism in cancer tissues by using flourine 18 FDG which is FDA approved and used routinely in identification of malignant lesions , staging and restaging of many malignancy like lymphoma, breast cancer, lung cancer and cancer colon.

In clinical routine, SUV is often used to determine the glucose metabolism in tumours by 18F-FDG PET/CT. And can be further normalised to SUVs in reference regions resulting in a SUV ratio (SUV ratio).in routine work SUV of the lesion is normalised to SUV of the liver , but this not used if the liver is diseased like as liver cirrhosis or liver metastases , so SUV ratio of lesion to mediastinal blood pool and SUV ratio of the lesion to liver will be measured in correlation to pathology to assess validity of SUV of mediastinal blood pool.

Eligibility Criteria:
Inclusion Criteria:

* This study will include cancer pt who did PET/CT scan who presented to nuclear medicine unit during the period from 2021 until the end of the study.

Exclusion Criteria:

* Severely ill patient
* Pt with glucose level above 200
A Study of Two Anti-HIV Drug Combinations

The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs.

Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.

It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor.

Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection documented by a licensed antibody ELISA assay and confirmed by Western blot, positive HIV blood culture, positive HIV serum antigen, or plasma viremia.
* CD4+ cell count of at least 300 cells/mm3.
* HIV-1 RNA less than 10,000 copies/ml by Roche Amplicor PCR assay.
* CDC Category A or B Classification for HIV infection (no clinical diagnosis of AIDS).
* Compliance with dosing schedule and protocol evaluations.

Prior Medication:

Required:

* 3TC at 150 mg bid, ZDV at 600 mg/day (200 mg tid or 300 mg bid), plus a marketed protease inhibitor (ritonavir, saquinavir, indinavir, or nelfinavir) at its recommended dose for at least 10 weeks.

Allowed:

* Inhaled corticosteroids for the treatment of asthma.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Malabsorption syndromes affecting drug absorption (e.g., Crohn's disease and chronic pancreatitis).
* Enrollment in other investigational protocols.

Concurrent Medication:

Excluded:

* Cytotoxic chemotherapeutic agents.
* Nonnucleoside reverse transcriptase inhibitors.
* Other investigational agents.

Concurrent Treatment:

Excluded:

Radiation therapy.

Prior Medication:

Excluded:

* Cytotoxic chemotherapeutic and immunomodulating agents such as systemic corticosteroids, IF-2, alpha-IFN, beta-IFN, or gamma-IFN (except for inhaled corticosteroids for the treatment of asthma) within 4 weeks of study entry.
* HIV immunotherapeutic vaccine within 3 months of study entry.

Prior Treatment:

Excluded:

Radiation therapy within 4 weeks of study entry.
Dresden Corneal Disease and Treatment Study

The purpose of this study is long-term follow up of patients with corneal diseases to analyze the quality of surgical interventions and diagnosis. Corneal ectasia, especially keratoconus, is a corneal disease that leads to an irreversible loss of visual acuity while the cornea becomes steeper, thinner and irregular. For these patients, surgical intervention (e.g. corneal cross-linking) is performed, in case of disease progression. Overall, a long-term follow up is needed to evaluate an early disease progression as well as corneal stability after surgical intervention.

Corneal ectasia (e.g. keratoconus) is a corneal disease that is characterized by irregular steepening of corneal curvature, stromal thinning and reduced biomechanical properties. As a result of this, visual acuity is reduced and can improved by spectacles in early state or with rigid gas permeable contact lenses in mild as well as advanced stage of the disease. Furthermore, in moderate and advanced cases stromal scarring occurs that affected the vision negatively. Therefore, a corneal transplantation is needed. Since the introduction of corneal cross-linking, the amount of corneal transplantations has been reduced. It is necessary to perform closely examinations to detect the progression of the disease as well as post-operatively follow-ups to confirm treatment success.

Parameters being analyzed are:

Age, sex, refraction, family history, known duration of ectasia, previous ocular surgery, systemic diseases, systemic and topical medication;

biomicroscopy, anterior optical coherence tomography (OCT), Scheimpflug-based tomography (Pentacam), Biomechanical assessment (Ocular Response Analyzer and Corneal Visualization with the Scheimpflug Technology), optical biometry, confocal microscopy, endothelium cell count.

Eligibility Criteria:
Inclusion Criteria:

* corneal disease
* corneal ectasia

Exclusion Criteria:

* pregnancy
* age under 18 years
Harmony & Health: Feasibility of a Movement Intervention to Improve Psychosocial Wellbeing in Black Adults in Northeast Texas

To test the feasibility and acceptability of a program that combines yoga practices and Christian spirituality (called Harmony \& Health) amongst insufficiently active Black adults.

Objectives

Primary Objective:

The primary objective of this 2-arm randomized controlled pilot study is to test the feasibility and acceptability of HH in Black adults residing in rural areas surrounding Tyler in Northeast Texas. Black adults who are insufficiently active will be randomized to the HH intervention or an attention control group. We hypothesize that we will meet our recruitment goal of 50 participants over 5 months, ≥80% of participants will be retained at post-intervention and follow up, and ≥80% will adhere to sessions.

Secondary Objectives:

The secondary objectives of this study are:

2.a. To explore the effects of HH on sitting time and LPA in Black adults who are insufficiently active. Participants will complete assessments at baseline (week 0), post-intervention (week 9), and follow-up (week 24), and changes in measured sitting time and LPA from week 0 to 9 will be assessed.

2.b. To evaluate acceptability of the intervention and assessment protocols via in-depth interviews. After follow-up, we will conduct interviews with community partners (n=2), delivery agents (n=2), and participants (n=16) to assess acceptance and refine training and implementation protocols in preparation for a future large-scale randomized controlled efficacy trial.

Eligibility Criteria:
Inclusion criteria:

1. Men and women ≥18 years of age
2. Self-identify as Black or African American
3. Able to read, speak, and write in English
4. Primary residence in the Northeast Texas area (Public Health Region 4/5N)
5. Insufficiently active (self-report \<75 minutes/week of physical activity)
6. Sedentary (self-report ≥6 hours/day of sitting time)
7. Body mass index \[BMI\] ≥25 kg/m2
8. Able to pass the Physical Activity Readiness Questionnaire (PARQ) or provide physician's clearance to participate
9. Able to provide written informed consent without assistance

Exclusion criteria:

1. \<18 years of age
2. Do not self-identify as Black or African American
3. Unable to read, speak, and write in English
4. Primary residence falls outside of the Northeast Texas area or Public Health Region 4/5N
5. Physically active or self-report doing ≥75 minutes/week of physical activity
6. Not sedentary or self-report \<6 hours/day of sitting time
7. BMI \<25.0 kg/m2
8. Absolute contraindications to unassisted physical activity based on the PARQ (e.g., acute MI, orthopedic and musculoskeletal limitations)
9. Planning to move from the Northeast Texas during the 6 month study period
10. Pregnant or planning to become pregnant during the 6 month study period
11. Currently participating in another program to increase physical activity, reduce sedentary behavior, or manage weight
Evaluation of the Preparation of Runners and the Impact of an Ultra-trail Event in a Hot and Humid Environment

Human beings are characterized by their extraordinary ability to thermoregulate. During a physical exercise, only 25% of the energy provided by the substrates is converted into muscular mechanical work. The remaining 75% is released as heat.

In fact, thermoregulation has always been an integral part of exercise's physiology.

Due to current climate change, study and understand the mechanisms of thermoregulation and the practices of runners to cope with these constraints becomes increasingly necessary in order to optimize the sports performance and protect the health of athletes of all levels.

Heat stroke is responsible for more deaths than any other environmental disaster and is the second leading cause of sport mortality after heart problems.

The exercise-related hyperthermia and malignant hyperthermia, dehydration and hyponatremia problems have been relatively well studied in several sports. For ultra endurance disciplines, the data remains very fragmentary.


Eligibility Criteria:
Inclusion Criteria:

* All major runners participating in one of the 3 individual races of the "Grand Raid" 2019 in Reunion Island

Exclusion Criteria:

* Refusal to participate
* Runners who do not understand French