cyrilzakka/clinical-trials huggingface dataset:
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)

This (DEEp SEA Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DS must fulfill all of the following criteria:

  1. Participants with seizure onset age \>1 and \<20 months
  2. The participant has a history of at least 1 of the following seizure type(s): prolonged generalized tonic-clonic, hemiclonic, myoclonic, tonic, atonic, atypical absence, focal impaired awareness, nonconvulsive status epilepticus
* The participant has a current occurrence of at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (including hemiclonic), and focal to bilateral tonic-clonic
* The participant has demonstrated an average of at least 4 countable motor seizures per month for the 3 months prior to Screening.
* The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening.
* The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study.
* The participant must be willing and able to provide written informed consent.

Exclusion Criteria:

* The participant has a history of infantile/epileptic spasms.
* The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening.
* The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing.
* The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures.
* The participant is receiving exclusionary medications.
* The participant has used any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC).
* The participant has unstable, clinically significant neurologic (other than the disease being studied, eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
* The participant is unwilling to comply with any of the study requirements or timelines.
MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and the reference product - MabThera® (rituximab) and to demonstrate comparative safety and tolerability of a single course of treatment of MabionCD20® and MabThera® in patients with moderate to severe active rheumatoid arthritis.

Subjects who meet the criteria for participation in this study receive 2 intravenous infusions of MabionCD20® or MabThera® with two weeks interval in combination with methotrexate and folic acid. After the treatment period, patients are followed for 24 weeks, in order to continue checking safety. Therefore, the total study lasts 48 weeks. There is a possibility to repeat treatment after 6 months of the first infusions if subject meets the retreatment criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active rheumatoid arthritis with disease duration minimum 6 months prior to screening visit
* Patients who are naive to tumor necrosis factor (TNF) antagonists or any other monoclonal antibody therapies
* Patients who have had an inadequate response to an adequate regimen of methotrexate

Exclusion Criteria:

* History of current rheumatic autoimmune disease other than RA and current inflammatory joint disease other than RA
* Contraindications according to the MabThera SmPC and every serious coexisting diseases which, in the Investigator's opinion, would preclude subject participation
* Positive tests for HIV, hepatitis B surface antigen (HBsAg) Anti-HBc antibody, hepatitis C antibody
* Prior treatment with rituximab, other anti-CD20 mAb, anti-TNF-alpha drug or any other monoclonal antibodies
* Pregnancy or lactation or women planning to get pregnant during the course of the study and/or within 12 months post last study drug infusion
* Allergic reaction or intolerance to rituximab, MabionCD20 or any of their components
* Severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or previous treatment of any lymphocyte-depleting therapies
Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension

To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants.

The Neo Non-Randomized Hypertension Study is a non-randomized, open-label, verification study in participants diagnosed with drug resistant hypertension, defined as medical treatment failure for hypertension defined as office cuff systolic blood pressure (SBP) ≥ 140 mmHg despite being prescribed to at least three antihypertensive medications, including a diuretic, in accordance with the AHA guidelines.

Participants should remain on their prescribed anti-hypertensive medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.

All (Canadian) participants are now in long term follow-up and are required to have at least one annual visit.

Parameters assessed during long-term follow-up visits:

* Physical Assessment
* Office Cuff Blood Pressure
* Subject Medications
* Serious adverse events

Eligibility Criteria:
Inclusion Criteria:

* Actively participating in the Neo Non-Randomized Hypertension Study.
* Have signed a revised approved informed consent form for continued participation in this study.

Exclusion Criteria:

* Treating physician decision that the subject should not continue with therapy.
Comparison of the Efficacy of Conventional Landmark, Ultrasound-Assisted, and Real-Time Ultrasound-Guided Techniques in Spinal Anesthesia for Obese Patients

Spinal anesthesia is frequently administered using the conventional landmark technique. Ultrasound is a non-invasive and safe approach. Neuroaxial anesthesia procedures can be conducted using two different ultrasound techniques; Real-Time Ultrasound Guided (USRTG) and Ultrasound-Assisted (USAS). The primary objective of this study is to compare the successes of spinal anesthesia applications using USRTG, USAS, and conventional landmark techniques on the first attempt in obese patients undergoing orthopedic surgery.

Patients included in the study will be those undergoing lower extremity orthopedic surgery, with a body mass index (BMI) 30 kg/m² and above, and classified as American Society of Anesthesiologists (ASA) class I-III. Patients will be randomized into 3 groups. In the Conventional Landmark group, spinal anesthesia will be administered using the conventional technique. In the Ultrasound-Assisted group, the spinal space will be marked with ultrasound before proceeding. For the Real-Time Ultrasound-Guided group, the spinal space and the advancement of the needle for the injection will be visualized simultaneously with ultrasound during the application of spinal anesthesia. The primary outcome is to compare the success rates on the first attempt. The secondary outcomes are to compare the number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Patients who will undergo lower extremity orthopedic surgery
* ASA I-II-III patients
* BMI 30 kg/m² and above

Exclusion Criteria:

* BMI \< 30 kg/m²
* ASA IV-V patients
* Severe cardiovascular disease
* Patients with a known or suspected allergy to local anesthetics
* Contraindications of spinal anesthesia (eg, coagulopathy, puncture site infection)
Acute Dose Response of Korean White Ginseng in Metabolic Syndrome or Type 2 Diabetes

The study is a Phase-I like double blind randomized placebo controlled crossover design trial. The objective is to assess the dose response relationship on glycemic and vascular effects of an acutely administered Korean White Ginseng (KWG)(Panax C.A. Meyer) in individuals with metabolic syndrome or type 2 diabetes . Twenty seven subjects with Type 2 Diabetes (Key inclusion criteria: HbA1c ≤8.5%)or metabolic syndrome (Key inclusion criteria: as defined by The US National Cholesterol Education Program Adult Treatment Panel III)will be recruited for the study.

This study hypothesizes that KWG will dose dependently lower postprandial area under the curve compared to negative control, as well as will dose dependently decrease postprandial glycemia. It also assumes that use of KWG will dose dependently decrease aortic and brachial blood pressure, aortic augmentation index, and mean arterial pressure, and improve left ventricular ejection duration(ED) and subendocardial viability ratio (SEVR) compared to control. Finally, it expects to notice an effect on subjective satiety levels and have no significant adverse effects compared to control.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* 18-75 years old
* BMI 25-35 kg/m2
* Presence of type 2 diabetes (as defined by HbA1c ≤8.5%),treatment with diet or oral hypoglycemic medication) OR
* Presence of Metabolic Syndrome as defined by The US National Cholesterol -Education Program Adult Treatment Panel III (NCEP III). As per NCEP III criteria, at least three of the following must be present:
* central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 36 inches(female)
* dyslipidemia: TG ≥ 1.7 mmol/L (150 mg/dl);
* dyslipidemia: HDL-C \< 40 mg/dL (male), \< 50 mg/dL (female) blood pressure ≥ 130/85 mmHg; fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl)

Exclusion Criteria:

* BMI \>35 kg/m2
* Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg)
* Pregnant women, or those at risk of pregnancy, or breastfeeding at the time of the study.
* Women of childbearing age that do not use acceptable method of birth control (ie. abstinence, implants, injectables, oral contraceptives, IUDs etc).
* Chronic conditions including: liver disease, cancer, heavy alcohol use, bleeding disorders, history of angina, congestive heart failure, coronary revascularization, peripheral vascular disease, retinopathy, kidney disease or coronary/cerebrovascular event; chronic use of medications including blood-thinners, SSRIs, MAO inhibitors, medications affecting NO synthesis (eg. Viagra)
* Allergy or sensitivity to the placebo (wheat bran), ginseng or gelatin used in the capsules.
* Use of any ginseng products within three days preceding the study and during the study.
* Allergies to Panax species, their constituents or to other members of the Araliaceae family.

The use of additional NHPs that may affect blood pressure or blood glucose Individuals suffering from glucose-galactose malabsorption syndrome.
Effects of Sertraline on Brain Connectivity in Adolescents With OCD

The investigators will examine how treatment with sertraline for 12 weeks impacts frontal-striatal-thalamic circuitry (FSTC) in this OCD sample.

To examine FSTC using advanced multi-modal imaging techniques, including resting-state functional magnetic resonance imaging (R-fMRI) and high angular resolution diffusion imaging (HARDI), in 25 medication-free adolescents youths with OCD (ages 8-17) in comparison with 25 matched healthy controls.

Hypotheses: (A) Based on the pilot data, adolescents youths with OCD will show lower functional connectivity in FSTC at baseline when compared with controls, and , lower functional connectivity in FSTC will correlate with greater severity on CY-BOCS. (B) Adolescents Youths with OCD will also show abnormalities in structural connectivity in FSTC at baseline when compared with controls, and structural and functional connectivity will be related. (C) The investigators will explore relations between OCD dimensions and functional connectivity measures, and predict that the repeating/ordering dimension will correlate with orbitofrontal cortex (OFC) connections, hoarding will correlate with rostral anterior cingulate cortex (ACC) connections, and forbidden thoughts will correlate with caudal ACC connections.

To investigate how sertraline impacts functional connectivity in FSTC in adolescents with OCD.

Hypothesis: After 12 weeks of sertraline treatment, functional connectivity measures within FSTC for the OCD group will (on average) increase compared to baseline and will no longer be significantly different when compared with controls. Non-responders may show a different pattern (i.e. failure to show these changes).

Eligibility Criteria:
Inclusion Criteria (OCD):

* OCD as the primary Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis based on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV, Child Version
* Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) score of greater than 15

Exclusion Criteria (OCD):

* lifetime diagnosis of bipolar disorder, schizophrenia, or substance abuse/dependence on ADIS
* Intelligence Quotient (IQ) \< 80 on Wechsler Abbreviated Scales of Intelligence (WASI)
* positive urine drug screen
* MRI-incompatible features (e.g., metal implants, claustrophobia)
* current or recent trial of psychotropic medication (within the past 4 8 weeks or past 6 12 weeks for fluoxetine)
* non-response in \> 2 selective serotonin reuptake inhibitor (SSRI) trials of adequate dose/duration
* positive pregnancy test
* history of seizure disorder or serious head injury

Inclusion Criteria (Controls):

* Healthy 8-17 year olds

Exclusion criteria (controls):

* No psychiatric diagnoses
* No immediate family history of OCD
Switched Memory B-cells as a Marker for Humoral Immune System Recovery in Patients With Secondary Antibody Deficiency Due to Hematological Malignancies

Current treatment for patients with secondary antibody deficiency (SAD) is Immunoglobulin replacement therapy (IGRT). There are currently no clinical guidelines for IGRT discontinuation in patients with SAD. This study will examine the IGRT discontinuation success rate and IGRT discontinuation rate in patients.

Immunoglobulin replacement therapy (IGRT) is a mainstay treatment for SAD and has been shown to reduce the risk of infection and increase quality of life in patients with SAD. Current guidelines recommend that patients with severe hypogammaglobulinemia (IgG \<4 g/L) or patients with a history of recurrent or severe infections should be offered IGRT, which can be administered intravenously on a monthly basis or more frequently by subcutaneous infusions. There are currently no clinical guidelines for IGRT discontinuation. Although research conducted at the Ottawa Hospital indicates successful discontinuation of IGRT, clinicians need a tool to predict the recovery of humoral immunity and the risk of infection in these patients in order to determine whether IGRT may be safely discontinued.

Eligibility Criteria:
Inclusion Criteria:

1. History of leukemia, lymphoma, or plasma cell disease
2. Receiving IGRT for SAD for at least 12 months
3. Over 18 years of age
4. Able to provide informed consent
5. Able to speak English or French
6. Available for ongoing follow-up as required

Exclusion Criteria:

1. Receiving chemotherapy or immune-oncology treatment during the study period
2. Severe infection within the last 6 months
3. Pregnancy
Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes

The purpose of this investigation is to examine the role of oxidative stress in aberrant microvascular function in otherwise healthy women with a history of GDM.

Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.

The purpose of this investigation is to examine the role of oxidative stress in mediating vascular dysfunction in women who have had gestational diabetes.

In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had GDM. As a compliment to these measures, the investigators also collect endothelial cells from an antecubital vein and measure markers of oxidative stress and insulin-mediated eNOS phosphorylation in these cells.

Eligibility Criteria:
INCLUSION CRITERIA:

* female sex
* 18 -50 years old
* pregnancy history within 5 years of the study visit
* had gestational diabetes diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes
* or without a history of gestational diabetes

EXCLUSION CRITERIA:

* skin diseases
* current tobacco/e-cigarette use
* diagnosed or suspected hepatic or metabolic disease including diabetes
* statin or other cholesterol-lowering medication
* current antihypertensive medication
* history of preeclampsia or gestational hypertension
* current pregnancy
* body mass index \<18.5 kg/m2
* allergy to materials used during the experiment.(e.g. latex), known allergies to study drugs.
Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells

Brief summary: Allogeneic γδT cells from healthy donor will be administrated intravenously to patients with the MDR-TB，and then the safety and efficacy of γδT cells will be evaluated.

All patients with multi-drug resistant pulmonary tuberculosis will be assigned into 2 groups(study group and control group)，both groups will receive conventional treatment. Allogeneic γδT cell will be administrated intravenously to patients in the study group (but not the control group) every two weeks for 6 months

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-50 years old, male or female;
2. Informed consent;
3. Patients with multidrug-resistant tuberculosis diagnosed by positive sputum smear and tubercle bacillus culture.

Exclusion Criteria:

1. AIDS, hepatitis B and other viruses, bacterial infections;
2. Patients with other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system diseases, mental diseases, neurological diseases, and vascular circulatory diseases;
3. Others After being evaluated by clinicians participating in this project, it is not suitable to participate in immune cell therapy;
4. Those who do not agree to be included.
Arithmetic Training With the Kumon Method for Cognition in Schizophrenia

A randomized placebo-controlled trial of arithmetic training (with the Kumon Method) as an errorless learning method for improvement of cognition in schizophrenia. Outpatients were included after signing an informed consent. The trial consisted of 48 sessions of arithmetic training (twice a week, for 6 months) or placebo (nonspecific recreation, 48 sessions). The patients were evaluated with a neuropsychological battery at baseline, after 6 months (end of intervention) and after 12 months after baseline. The Positive and Negative Syndrome Scale (PANSS) and the Personal and Social Performance scale (PSP) were applied at baseline, after 6 months (end of intervention) and 12 months after baseline. Primary outcome was the performance on three cognitive domains (attention, executive functions and working memory).


Eligibility Criteria:
Inclusion Criteria:

* Literate (≥5 years of formal education).
* Diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR).
* Clinically stable, with constant antipsychotic medication regimen for ≥8 weeks before screening
* No hospitalizations in the last 6 months.

Exclusion Criteria:

* Other Axis I psychiatric disorders, substance abuse or dependence.
* History of head trauma or other neurologic diseases.
* Severe or uncontrolled medical diseases, history of mental retardation or attendance in special-education classes,
* Suicide risk
* Participation in any other kind of psychosocial intervention.
Nutritional Risk for Hospitalized Patients With Neurology Disorders in China

Neurology disorders are one of the major public health problems that seriously threaten human health. It often accompanied by various nutritional problems, which can aggravate the primary disease, lead to serious complications, prolong the hospitalization, lead to poor prognosis, and increase family and social economic burdens. According to the previous studies, the risk of malnutrition was approximately 58.5% of stroke patients, and 6% had moderate to severe malnutrition in China. Another study conducted in Beijing showed that the risk of malnutrition of elderly patients in the department of neurology was significantly higher than in other departments (28.5% vs. 26.4%). Strengthening nutritional supervision of patients with neurology disorders will benefit to improve patients' prognosis. Therefore, the aim of this study is to investigate the nutritional status of inpatients with neurology disorders in China, evaluate the impact of different nutritional status on patients' health outcomes, and establish a high-quality, standardized nutrition and health cohort database for neurology disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. The primary diagnosis was neurological disorders;
3. Written informed consent.

Exclusion Criteria:

1. Life expectancy is \< 3 months;
2. Researchers think other ineligible participant for the study.