cyrilzakka/clinical-trials huggingface dataset:
Memantine for Epileptic Encephalopathy

This study will evaluate the potential benefit of memantine hydrochloride as treatment for children with epileptic encephalopathy using a double-blind placebo-controlled cross-over design.

Memantine, a drug approved for Alzheimer's dementia, exerts its therapeutic effect through its action as a low to moderate affinity non-competitive (open channel) N-methyl-D-aspartate receptor (NMDA-R) antagonist, which binds preferentially to the NMDA receptor-operated cation channels. It blocks the effects of persistently elevated levels of glutamate that may lead to neuronal dysfunction. Memantine may also have anti-inflammatory effects. Memantine has been used off-label in children and adolescents with autism spectrum disorder, to improve the cognitive impairment.

Epileptic encephalopathy, as well as other forms of epilepsy, may occur as a result of multiple etiologies, including genetic and inflammatory pathologies. Ion channels were long considered to be implicated in genetic epilepsy. Indeed one of the many possible causes of epilepsy is NMDA receptor dysfunction.

In the present study, the investigators plan to investigate the potential benefit of memantine as a treatment for epileptic encephalopathy. A double-blind placebo-controlled cross-over design will be used, with participants receiving 6 weeks of memantine and 6 weeks of placebo, with a 2-week washout period in between.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained
* Age 6-18 years (Weight ≥ 20 kg)
* Clinical diagnosis of epileptic encephalopathy

  * Subject with epilepsy and developmental impairment;
  * Epileptic activity itself contributes to severe cognitive and behavioural impairments
  * Patients will typically have already have trialed at least two standard therapies
* Females of childbearing age:
* Negative urinary pregnancy test at screening
* Agree to use effective contraception for the duration of the study

Exclusion Criteria:

* Inability of a parent or legal guardian to give informed consent for any reason.
* Known hypersensitivity to memantine hydrochloride
* Taking concomitant Amantadine, Ketamine or Dextromethorphan, Cimetidine, Ranitidine, Procainamide, Quinidine, Quinine, Hydrochlorothiazide, Anticholinergics, L-dopa, Anticoagulant,
* Any degree of renal impairment
A Registry for the Food Allergy Community

The FARE Patient Registry will serve as a prospective, observational food allergy reporting system that stores detailed health and other basic information about patients' real-world experiences with food allergies, to encourage open sharing of de-identified data and participation in clinical trials. The FARE Patient Registry intends to make and support scientific discoveries by enabling the food allergy community to participate directly in research.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with diagnosed food allergy

Exclusion Criteria:

* Individuals without food allergy
Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain

This study is designed to discern if the use of a lumbosacral orthesis (LSO, also call a back support) improves the short-term outcome of lower back pain. participants will receive standard care (physical therapy, physician treatment), with one group also receiving an extensible LSO, and another group receiving an inextensible LSO. The inextensible LSO has been shown to increase stiffness of the trunk in individuals while wearing it. The hypothesis is that the group wearing the inextensible LSO will have improved outcomes over the other two groups (standard care or standard care plus the extensible LSO).


Eligibility Criteria:
Inclusion Criteria:

* chief complaint of lower back pain, with or without lower extremity (LE) symptoms
* 150 subjects will be recruited from patients seeking treatment for lower back pain from spine specialty orthopaedic clinics, family practice physicians, and out-patient physical therapy clinics

Exclusion Criteria:

* Exclusion criteria are:
* previous spinal surgery
* workman's compensation or litigation is involved
* neurological disease or injury
* systemic inflammatory disease
* pulmonary disease which restricts breathing capacity
* current pregnancy
* acute fracture
* tumor or metastatic disease
* infection
* neurological disease
* the presence of pathological reflexes (e.g., Babinski)
* the presence of lower extremity pain upon cervical motion and / or the presence of two or more of the following signs of nerve compression: diminished lower extremity strength in a myotomal distribution, diminished sensation, and / or absence deep tendon reflexes.
Characterization of Gastric Evoked Potentials

This is an exploratory study that will determine and standardize how best to record gastric evoked potentials (GEPs) elicited by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS), by optimizing the TMS parameters and cortical sites necessary to evoke GEPs.

The overall goal of this exploratory study is to determine the optimal conditions to elicit gastric evoked potentials (GEPs) with Transcranial Magnetic Stimulation (TMS).

Aim 1: Determine the optimal stimulation parameters and the optimal location for eliciting GEPs in cortical motor areas.

Aim 2: Determine whether various modes of repetitive TMS (rTMS) neuromodulation targeted to GEP hotspots shape gastric motor responses to a water load.

The investigators will record some clinical, demographic, and autonomic data (i.e. EKG) in our enrolled subjects. Secondary analyses will use these variables as covariates to investigate any systematic impact on the measures from Aims 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* psychosis or altered cognitive status
* history of head injury, metal in the skull, stroke, or a history of seizures, loss of consciousness or syncope
* implantable devices, such as a pacemaker or nerve stimulator
* current use of antiepileptic medications or current use of the following medications or substances which are known to lower the seizure threshold: Clozapine (Clozaril), Chlorpromazine (Thorazine), amphetamines or methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or 3 or more alcoholic drinks per day
* pregnancy
* BMI \> 30
* history of bariatric surgery such as sleeve gastrectomy or Roux-en-Y gastric bypass
* diabetes
* suffering from a neurodegenerative disorder.
San Diego Bleeding Esophageal Varices Study

In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on mortality rate, duration of life, quality of life, and economic costs of treatment of:

* Emergency portacaval shunt, and
* Emergency and long-term endoscopic sclerotherapy.

See attached Synopsis - APPENDIX 1

Eligibility Criteria:
Inclusion Criteria:

* All patients with UGI bleeding (blood in the esophagus, stomach, or duodenum) who enter the emergency room or develop bleeding while in the hospital or are transferred from nearby hospitals and are suspected of having cirrhosis and BEV will be eligible for consideration (all comers).
* Those who are shown to have the findings of cirrhosis and esophageal varices that:

  * Are seen to be actively bleeding;
  * Have an adherent clot;
  * Have no other associated lesion that could reasonably account for bleeding of that magnitude (such as large gastric or duodenal varices, GU, DU, etc)
* Require 2 or more units of blood transfusion, will be included in the study.

Exclusion Criteria:

* None
Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)

Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require complete cessation of suicidal behaviors prior to treatment. Furthermore, no integrated treatment has been innovated to deliver the active ingredients to efficiently affect the mechanisms underpinning this comorbidity. The investigators propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy, augmented with a Suicide Risk Management, i.e., (CPT+SRM) as a brief (12 sessions) and more parsimonious treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this pilot study is to 1) collect initial feasibility, acceptability, and safety data on this adapted treatment, 2) conduct a pilot randomized clinical trial evaluating the efficacy of CPT+SRM versus Treatment as Usual (TAU) + SRM, and 3) evaluate two targets (i.e, improvements in emotional intensity and cognitive dysfunction) as mechanisms leading to change in our primary outcomes. Both treatment conditions will be administered via telehealth.

Potential benefits include reduction in participants' PTSD, BPD and other mental health symptoms. Additionally, this work could benefit the community by improving the treatment repertoire for PTSD-BPD. Potential risks include emotional distress, suicidality, and/or self-harm. Participants may experience discomfort and/or distress while discussing participants trauma(s) and mental health. These risks will be mitigated using a suicide risk management protocol which therapists in the assessment of risk and protective factors of suicide, followed by documentation for the decision-making around the management of risk.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* Must reside in the Bay Area, CA
* Current DSM-5 diagnosis of PTSD and BPD
* Must be willing to be audio- or videorecorded for assessment and treatment sessions

Exclusion Criteria:

* Acute mania, acute psychosis, or intellectual disability
* Conditions requiring medical attention to a potentially life-threatening illness (e.g., severe anorexia nervosa)
* Severe impairments in written and aural comprehension
* EU individuals
P75NTR, Diagnostic Biomarker for Alzheimer's Disease: Quantification Study in Cerebrospinal Fluid

This research will be achieved by the assessment of p75NTR-ECD expression (total and linked to different species of Aβ (Aβ1-40 and Aβ-1-42)) within the cerebrospinal fluid (CSF) of patients with AD dementia, mild cognitive impairment (MCI) due to AD, frontotemporal dementia and non-neurodegenerative dementia.

Alzheimer's disease (AD) is a dementia which is clinically characterized by cognitive impairments with early memory loss and neuropathologically by two main lesions, amyloid deposits and tau protein accumulation. Presently, early diagnosis of AD relies on clinical symptoms, imaging techniques with recently introduced radio-tracers and analysis of cerebrospinal fluid biomarkers. All these tools are efficient when patients are already symptomatic and it is presently known that the lesions that might be reversible appear early in the time life of patients, several decades before the onset of clinical signs. To find a biomarker which would be detected early and tested in peripheral fluids is our challenge. According to updated physiopathology of the disease and referring to previous work on sphingolipid pathway in AD, precedent study focused attention on an original protein, p75NTR and particularly its extracellular domain (ECD). This protein is involved in the physiopathology of AD in several ways (apoptosis, survival). P75NTR-ECD interacts with Aβ, increases its solubility and accelerates its clearance.

The hypothesis of the present study is that p75NTR-ECD could be expressed differentially according to the category and stage of dementia. More precisely, this new biomarker could help for the diagnosis of AD and could also be used as an early marker of AD when tested in peripheral fluid.

Eligibility Criteria:
Inclusion Criteria:

* patients with AD
* patients with MCI due to AD,
* patients with frontotemporal dementia
* patients with non-neurodegenerative dementia, according to DSM-V and updated National Institute on Aging (NIA) recommendations

Exclusion Criteria:

* patients with Parkinson disease or Lewy body dementia
Dexmedetomidine Influence on the Level of Perioperative Blood Glucose and Insulin of Elderly Diabetes Patients

Dexmedetomidine is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, alleviate pain,and improve cardiovascular stability in the operation period. Dexmedetomidine have influence on perioperative stress response and immune function,but it is not clear.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 to 80 years old;
* Type 2 diabetes;
* Not use insulin treatment;
* Onging general anesthesia surgery;
* Surgery time 1-3 hours

Exclusion Criteria:

* ASA classification \> class II;
* Hypertension;
* Serious central nervous system diseases (acute stroke, uncontrolled seizures, -Severe dementia);
* Unstable angina and acute myocardial infarction;
* Allergy to investigational drug;
* Hepatic and renal dysfunction
Acute Psychological Effects of High Intensity Exercise With Schizophrenia

The purpose of this study is to study the acute psychological effects in patients with schizophrenia after one session of high intensity exercise.

We will examine if there is an acute effect of one high intensity session of physical exercise (4x4 intervals) on psychological variables state mood, state anxiety, well-being and psychological distress. This possible effect will be examined in three groups, one group being the main group that the other two groups will be compared up against. Group 1: Patients with schizophrenia and other psychotic illnesses. Group 2: people with non-psychotic diagnosis. Group 3: people without any psychological diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* They will be allocated into groups by their diagnoses

Exclusion Criteria:

* Not being able to complete the exercise
Respiratory Outcome at Adolescence of Very Low Birthweight Infants

EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.

EPIPAGEADO is a multicenter observational study:- to evaluate respiratory symptoms and lung function at adolescence in very low birthweight (VLBW) children, to identify perinatal risk factors for persistent symptoms or impaired lung function tests at adolescence, to assess the exercise tolerance in VLBW children and to search for genetic susceptibility markers associated to impaired lung function.

The main criteria for analysis will be the forced expiratory volume in one seconde (FEV1) The study duration will be 36 months the number of centers will be 4 centers in France (Paris-Necker, Nantes, Lille, Rouen) The number of patients to be included will be 400, including 260 VLBW children without BPD, 40 VLBW children with BPD, 100 control children with birth at term.

Eligibility Criteria:
Inclusion criteria :

* Children born in 1997, and included at birth in the French EPIPAGE cohort
* Absence of severe neurologic impairment, with impossibility of reliable lung function tests
* Acceptance of the child and his/her parents

Exclusion criteria :

* Severe neurologic impairment, with impossibility of reliable lung function tests
* Absence of child's or parents' acceptance
Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate

To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.


Eligibility Criteria:
Inclusion Criteria:

* Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and \<11.0 mg/dL at 1 week after the initiation of the washout period.
* Out-patient
* Undergoing hemodialysis three times per week for at least previous 3 consecutive months

Exclusion Criteria:

* Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after
* Corrected serum calcium level of \<7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 week after
* Serum intact PTH (Parathyroid) of ≧1000 pg/mL at the start of the washout period
* Pregnant woman, or lactating mother
* Significant gastrointestinal disorders including known acute peptic ulcer
* Liver dysfunction
* History of cardiovascular or cerebrovascular diseases
* Requiring treatment for hypothyroidism
Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes

EDS (Ehlers-Danlos syndromes) form a heterogeneous group of hereditary connective tissue pathologies, which present a characteristic triad: cutaneous hyperelasticity, articular hyperlaxity and connective tissue fragility.

The innumerable sprains and dislocations of all the joints require recurrent immobilizations and are responsible for a musculoskeletal handicap, chronic pains and a great fatigability, resounding on the quality of life of the patient.

The use of custom-made compression garments seems to provide relief from pain, especially nociceptive pain and in stabilizing joints by proprioceptive effect.

The SEDCARE study is an observational monocentric, non-comparative study. 76 patients will be followed in this study for 2 years during which they will wear compression custom-made garments (Cerecare®).The main objective of this study is to demonstrate the effectiveness of pressure garments Cerecare in the EDS, especially in terms of joint pain.


Eligibility Criteria:
Inclusion Criteria:

* Ehlers-Danlos syndrome diagnosis confirmed by a medical specialist, according to the new diagnostic criteria of 2017,
* Articular hyperlaxity,
* Have not used compression garments for at least 1 year,
* Without expected body weight change within 6 months,
* Having agreed to participate in the study

Exclusion Criteria:

* Presenting a known allergy to the components of compression garments,
* Presenting acute and unusual pain, not medically controlled,
* Pregnant woman,
* Participating simultaneously with another study or having recently participated in another study for which the exclusion period would not be completed.
Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan

The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Active rheumatoid arthritis
* Inadequate response to stably dosed methotrexate

Exclusion Criteria:

* Current therapy with any DMARD or biologic other than methotrexate
Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds

This is a Phase 2, multicenter study to evaluate APX001 for the treatment of invasive fungal infections caused by Aspergillus spp. or rare molds (eg, Scedosporium spp., Fusarium spp., and Mucorales fungi).


Eligibility Criteria:
Inclusion Criteria:

* Males or females, 18 years or older.
* Patients with proven or probable IMI caused by Aspergillus spp. Patients who present with IMI due to other filamentous fungi (eg, Scedosporium spp., Fusarium spp., and Mucorales fungi such as Mucor spp. or Rhizopus spp.) may also be enrolled.
* Have limited or no treatment options due to documented or anticipated resistance, contraindication, intolerance, or lack of clinical response to SOC antifungal therapy, as advocated by the relevant regional/country treatment guidelines.
* Patients where the Investigator considers that there is a potential advantage of using APX001 over current SOC (eg, broad spectrum of activity, emergence of IMI during antifungal prophylaxis, activity against resistant mold pathogens, IV and PO formulations, favorable DDI profile, favorable hepatic and renal safety profile, wide tissue distribution including brain), and/or where the SOC antifungal therapy carries significant risk of toxicity or treatment failure (eg, DDI risk, safety/toxicity risk, site of infection not accessible by SOC).

Exclusion Criteria:

* Refractory hematologic malignancy.
* Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
* Treatment with systemic (PO, IV, or inhaled) mold active antifungal therapy for 120 hours immediately before initial dosing. Note: patients with invasive fungal infection caused by a mold with documented resistance to or lack of coverage by the prior SOC in question, may have received \>120 hours prior treatment and remain eligible for the study.
* Evidence of significant hepatic dysfunction.
Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis

the objective of this study is to determine the incidence of peri-implant mucositis in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators. An analytical prospective observational study will be carried out, with an initial follow-up of 12 months.

Introduction: Peri-implant mucositis (PM) is an inflammatory disease induced by the accumulation of bacteria (biofilm) around dental implants, which can be modulated by individual characteristics of the patient, as well as by numerous factors related to a greater accumulation of biofilm in peri-implant tissues. Without correct regular maintenance, this entity can progress to peri-implantitis, a disease in which there is loss of bone supporting the implant. However, the strength of the association of the factors with the appearance of PM remains weak and incidence studies are limited due to their design and methodological inconsistencies. Therefore, the objective of this study is to determine the incidence of PM in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators.

Material and method: An analytical prospective observational study will be carried out, with an initial follow-up of 12 months. Patients with treated periodontitis and enrolled in periodontal maintenance will be selected, consecutively. They need to have implants placed in the Periodontics Specialist Clinic and are going to be rehabilitated at the UCM School of Dentistry. Peri-implant and periodontal clinical records, radiographic records, demographic variables, patient-based variables, and submucosal microbiological samples will be taken on the day of crown placement and after 6 and 12 months. The calculation of the sample size estimates the need to recruit 227 patients. The results will be analyzed using regression models.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age, able to comply with the protocol and comply with the established visits.
* Patients with treated periodontitis and enrolled in periodontal maintenance (last maintenance therapy received between 4 and 6 months maximum before inclusion in the study) (Chapple et al., 2018, Sanz et al., 2020).
* Patients with osseointegrated dental implants waiting for their prosthodontic rehabilitation (fixed prosthesis \[individual, partial or complete\], hybrid or overdenture).
* Physical or mental conditions that make it possible to perform appropiate oral hygiene

Exclusion Criteria:

* Patients with untreated periodontitis.
* Totally edentulous patients.
* Patients with peri-implant diseases.
* Pregnant or in lactating-period patients.
* Patients undergoing treatment with medication that affects the periodontal/peri-implant status or the immune system (phenytoin, calcium antagonists, corticosteroids or anti-inflammatories).
* Patients who have taken antibiotics in the last month.