cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters

The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters.

Qualifying participants underwent an in-clinic administration (Test Dose Phase \[TDP\]) of two doses of USL261 (intranasal midazolam 5 mg), separated by 10 minutes, in the absence of seizures. Eligible participants were then randomized to USL261 versus Placebo in an outpatient Comparative Phase (CP). When the participant had a qualifying seizure cluster episode, as described in an individualized patient management plan, the participant's caregiver administered the double-blind dose. An open-label USL261 dose could be administered after 10 minutes and up to 6 hours after the double-blind dose, if the participant had persistent or recurrent seizures. Initial participants could not proceed to CP until an independent data safety monitoring board (DSMB) reviewed safety data from at least the first 25 participants in TDP; the DSMB performed additional safety reviews at pre-set intervals based on enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
* Has an established diagnosis of partial or generalized epilepsy that includes the following:

  * A documented history of seizure clusters lasting a minimum of 10 minutes
  * Seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any)
  * A second seizure in the seizure cluster typically occurring within 6 hours from the time of cluster recognition
  * A seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures
  * A seizure cluster pattern established \> 3 months before Visit 1
  * A frequency of ≥ 3 seizure clusters during the year before Visit 1
  * At least 1 seizure cluster occurring ≤ 4 months before Visit 1
  * Seizure cluster pattern is confirmed by a central reviewer
* Currently on a stable regimen of anti-epileptic drugs (AEDs) with no changes in type of AEDs since Visit 1 and for ≥ 7 days before Visit 2, with or without intermittent use of benzodiazepines at a constant dose
* Weight is 40 kg to 125 kg, inclusive

Exclusion Criteria:

* Has a neurological disorder that is likely to progress in the next year
* Has severe chronic cardio-respiratory disease
* Has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
* Has a history of their stereotypical seizure cluster progressing to status epilepticus within the 2 years before Visit 1
* Has a history of acute narrow-angle glaucoma.
* Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years
* Currently using a vagal nerve stimulator (VNS) unless the device has been implanted for at least 6 months and the setting stable for 4 weeks before Visit 1
Humoral and Cellular Immunity Against SARS-COV-2 Vaccine in HIV-infected Patients Immunosuppressed

Prospective, non-equality, cohort study, where investigators propose to analyze humoral and cellular immunity after two doses of SARS-CoV-2 RNA vaccines in HIV-infected participants severely immunosuppressed.

A total of 92 HIV-infected subjects over 18 years old with ≤200 CD4/μl (experimental group; n=46) and ≥ 350 CD4/μl (as control group; n=46) who have completed two doses vaccination against SARS-CoV-2 will be included in the study.

Primary Objectives:

* To analyze the percentage of participants with SARS-CoV-2-specific IgG after 1, 6, and 12 months after vaccination in subjects with ≤200 vs ≥350 CD4/μL by electrochemiluminescence immunoassay (Elecsys® Anti-SARS-CoV-2. Roche Diagnostics).
* To analyze the percentage of subjects with specific T and memory B lymphocyte response against SARS-CoV-2 after 1, 6, and 12 months after vaccination with \<200 vs ≥350 CD4/μL. Multiparametric flow cytometry in peripheral blood mononuclear cells (PBMCs) will be performed to detect the production of cytokines (IL-2, TNF-α and IFN-γ), cytolytic (perforin and granzyme B) and degranulation (CD107a) molecules from T cells, as well as to identify memory B cells specific to SARS-CoV-2 IgG+.

Secondary Objectives: To analyze in participants with \<200 vs ≥350 CD4/μl after 1, 6, and 12 months after vaccination:

* Quantification of specific IgG titers against SARS-CoV-2
* The association of the T response to SARS-CoV-2 with humoral response parameters.
* The association of the T response against SARS-CoV-2 with other parameters of immune activation, inflammation and immunosenescence. The phenotypes of maturation (CD45RA and CD27), activation (HLA-DR and CD38), senescence (CD57+CD28-) and markers of immune exhaustion (TIGIT, LAG-3, TIM-3 and PD-1) in CD4 and CD8 lymphocytes T will be determined by multiparametric flow cytometry.


Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected subjects over 18 years old and ≤200 CD4/μl who have completed vaccination against SARS-CoV-2.
2. HIV-infected subjects with ≥350 CD4/μl who have completed vaccination against SARS-CoV-2 matched by age and sex as control group.
3. Sign the informed consent.

Exclusion Criteria:

1. Neoplastic or autoimmune disease known.
2. Treatment with steroids, immunomodulators, interferon, chemotherapy or any pathology that may impact immunological parameters after vaccination against SARS-CoV-2.
3. Active infections at the time of sampling.
DS-5565 Phase III Study for Renal Impairment in Japanese Subjects

Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal impairment.

The primary objective is the safety and tolerability of DS-5565 in Japanese subjects with moderate to severe renal impairment.

Eligibility Criteria:
Inclusion Criteria:

* At screening, creatinine clearance (using the Cockcroft-Gault equation): 15-59 mL/min
* At screening, a pain scale of ≥ 40 mm
* Type 1 or type 2 diabetes mellitus at screening (for patients with diabetic peripheral neuropathic pain DPNP only)-. Painful distal symmetric polyneuropathy (for patients with DPNP only)
* post-herpetic neuralgia PHN defined as pain present for more than 3 months after herpes zoster skin rash at screening (for patients with PHN only)

Exclusion Criteria:

* HbA1c (National Glycohemoglobin Standardization Program) \> 10.0% (for patients with DPNP only)
* Previous use of neurolytic block (for patients with PHN only)
Hormone Deficiency After Brain Injury During Combat

We would like to ascertain the prevalence of hypopituitarism after combat-related TBI. This will lead to enhanced awareness, recognition, and treatment of hypopituitarism, which can have life-saving ramifications and enhance quality of life and rehabilitation efforts in our combat veterans.

The prevalence of hypopituitarism after combat-related traumatic brain injury (TBI) is currently unknown. Recent civilian data on TBI show the prevalence of any pituitary hormone deficiency is as high as 80% after 12 months. While the military prevalence of hypopituitarism can be extrapolated from civilian data, a major limitation is the notably different mechanism of injury (i.e., blast) for military personnel compared to civilians (i.e., assaults, traffic accidents and falls). Little is known about the effect of shockwaves from a blast injury on central nervous system tissue, and due to the unique nature of blast-related TBI, the prevalence of pituitary dysfunction in affected service members may significantly differ from nonmilitary subjects in prior studies.

Eligibility Criteria:
Inclusion Criteria:

* Combat veterans who are 3 or 6 months post combat-related TBI and age 18yrs or older
* Must demonstrate capacity for informed consent
* Must be DEERS eligible (Military healthcare beneficiary)

Exclusion Criteria:

* Pregnancy (to be assessed by urine HCG)
* Use of hormonal contraceptives
* Chronic oral or intravenous glucocorticoids
* Use of hormonal therapy to include estrogen and testosterone
* Prior diagnosis of hypopituitarism prior to combat related TBI
Single Perclose Escalation Technique for Vascular Closure in TAVR

This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath.

Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the double "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath. The use of Femoseal in mild bleedings, and a second Perclose Proglide for moderate to severe bleedings. Compare this SPET technique with double Preclose technique, with two historical cohorts of patients. One cohort of patients with SPET technique since started this technique, and a second cohort with double perclose technique prior to starting SPET technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients who have undergone Transfemoral TAVI implantation

Exclusion Criteria:

* Patients who do not meet the inclusion criteria
Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis

A total of 41 adults with perennial allergic rhinitis were enrolled in a first double-blind placebo-controlled phase for six months, and treated on a weekly basis with sublingual doses of single individualized homeopathic medicines or placebo. After this closed initial phase, all patients were invited to participate in an long-term open-label controlled phase, in that they would receive homeopathic treatment for the maximum period of 36 months, and the results were compared with the improvement of initial phase. Signs and symptoms scores, rescue medication requirements and quality of life were assessed by questionnaires and personal clinical evaluation by a same independent researcher, before and after each phase. Primary and secondary clinical outcome were, respectively, specific and general allergic signs and symptoms scores. Total IgE titles were performed before and after each phase.


Eligibility Criteria:
Inclusion Criteria:

* moderate rhinitis
* to assign written informed consent

Exclusion Criteria:

* other chronic diseases
* corticosteroid use
* pregnancy
Children's Intake of Foods Reduced in Energy Density

The purpose of this research is to investigate children's responses to incorporating vegetables into selected entrees and snacks over several days. The hypothesis is that children will increase their vegetable intake by consuming foods that have been reduced in energy density through the addition of vegetables. Effects on energy intake will also be examined.


Eligibility Criteria:
Inclusion Criteria:

* enrolled in daycare centers at Penn State University

Exclusion Criteria:

* food allergies or intolerances
Prognostic Value of Non-invasive Index of Endothelial Function.

The objective of this study is to determine the prognostic performance of endothelial function assessment, using endothelial peripheral arterial tonometry (Endo-PAT), associated to TIMI risk score, in patients consulting the emergency department for non-traumatic chest pain.

To determine the sensitivity, specificity, negative and positive predictive value of this method that was not previously used for this purpose.

Chest pain is a frequent reason for consultation in the emergency room, which can be as much as 5 to 10% of consultants. Stratifying the cardiovascular risk for patients consulting for chest pain is sometimes difficult.

The endothelium plays a crucial role in maintaining the tone and vascular integrity and in particular the secretion of vasodilator and vasoconstrictor mediators. In most vascular pathologies, this equilibrium will be broken by the attenuation of the vasodilating function of the endothelium. This is called endothelial dysfunction.

Several tools for measuring endothelial function have been developed, the main characteristics of which are: noninvasive, reproducible, independent operators, predictive of the disease, safe for subjects, inexpensive and easy to use.

In this study we will be interested in digital plethysmography which has shown its effectiveness in:

* Screening for cardiovascular risk in asymptomatic subjects.
* The risk of a new cardiovascular event in the sick.
* Evaluation of the response to certain therapies.

Goal of the study :

The objective of this study is to to determine the prognostic performance of endothelial function assessment, using endothelial peripheral arterial tonometry (Endo-PAT), associated to TIMI risk score, in patients consulting the emergency department for non-traumatic chest pain.

To determine the sensitivity, specificity, negative and positive predictive value of this method that was not previously used for this purpose, hence the originality of this study.

Eligibility Criteria:
Inclusion Criteria:

* Any patient ≥ 25 years consulting for chest pain in the emergency department from 8:00 am to 8:00 pm (for the unavailability of the endopat device during the guard).

Exclusion Criteria:

* Chest pain of traumatic origin.
* Hemodynamic instability.
* Myocardial infarction requiring urgent revascularization.
* Parkinsonism: tremor problem.
* Refusal, communication problem.
Safety of 4CMenB Exposure During Pregnancy

4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January 2015 for people aged 10 through 25 years of age. 4CMenB should be used during pregnancy only if clearly needed and sometimes, inadvertent exposure during pregnancy may also occur - before the woman knows she is pregnant, for example. The objective of this study is to evaluate the safety of 4CMenB during pregnancy and to help us learn more about the health of women who have been vaccinated with 4CMenB within 30 days prior to their last menstrual period (LMP) or at any time during pregnancy, and the health of their infants. Pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to their last menstrual period or at any time during pregnancy are eligible to participate. A woman may self-enroll in the registry by calling the pregnancy registry telephone number directly or their healthcare provider (HCP) can, with their consent, enroll them on their behalf. Alternatively HCPs may report anonymous data on pregnancy exposures and outcomes occurring within their network/health maintenance organization (HMO). The health of the woman and her infant will be followed up until the end of the pregnancy.


Eligibility Criteria:
Inclusion Criteria:

Any pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to LMP or at any time during pregnancy where:

* Sufficient evidence to confirm that exposure to a meningococcal B vaccine (confirmed or possible 4CMenB exposure) occurred within 30 days prior to LMP or at any time during pregnancy
* Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (i.e., whether the outcome of pregnancy was known at the time of first contact with the registry)
* Date the pregnancy exposure is registered
* Full reporter (i.e., HCP) contact information to allow for follow-up (name, address, etc.)

Exclusion Criteria:

Pregnant women vaccinated with a different brand of Meningococcal B vaccine will not be included. (Of note: In the event that it cannot be ascertained to which meningococcal B vaccine the woman was exposed, an unknown exposure cohort will be established and analyzed separately).
The Effect of Auricular Point Stimulation on Obese Women

The aim of the study is to examine whether the ear acupoint stimulation is effective on obese women.

% change body weight, BMI, lipid profile, glucose and obese hormone.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-65 years women
* BMI\>27 kg/mm
* Signed informed consent

Exclusion Criteria:

* Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.
* Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker.
* Allergy and Immunology disease.
* High aminotransferases ( Alanine, Aspartate \> 80 IU/L) or high serum creatinine (\> 2.5 mg/dL)
* Pregnant or lactating women.
* Childbirth within 6 months.
* Stroke or otherwise unable to exercise
* Management for weight control within 3 months.
* Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.
* Endocrine disease
Efficacy of Physiotherapy on the Health and Quality of Life of the Rheumatic Patient

Despite leading cause of morbidity, treatment strategies for Rheumatic diseases are geared almost exclusively toward medical-pharmacological area away from offering the patient the possibility of an interdisciplinary approach to their disease.

Present study test whether treatment of physiotherapy reduces stiffness and pain inherent in rheumatic disease and improve their quality of life related to health.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* History of Rheumatoid Arthritis (RA) symptoms for less than 7 years
* Had RA by American College of Rheumatology (ACR) criteria
* ACR functional RA class I, II or III
* Hemoglobin more than 8g/dL without evidence of active bleeding
* Positive for rheumatoid factor (RF) or anti cyclic citrullinated protein
* standard conventional medicine were allowed within the approved dosage regimen

Exclusion Criteria:

* connective tissue disease
* any other alternative or complementary medicine with in last 3 months.
* corticosteroid, disease modifying medicines
* Poorly controlled diabetes, hypertension, hepatitis, cardiac disease, liver diseases, carcinoma, drug abuse
Structural and Metabolic Determinants of Sarcopenia and the Efficacy of Concentric vs. Eccentric Exercise Training

The first goal of this study is the follow young and older people over a period of 8 weeks to define the processes responsible for loss of muscle length and width in age-related muscle wasting (sarcopenia) and allow us to look at age-related differences in tendon. Secondly, we will assess two different exercise interventions for reversing human sarcopenia; one which involves shortening of the muscle and the other which involves lengthening, whilst also studying why these exercises work the way they do. This project will have significant implications for our understanding of the control of skeletal muscle and tendon size in humans, particularly in relation to sarcopenia and the surrounding health issues.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Body mass index 18-30 kg/m2
* Aged 18-35 and 65-75 years

Exclusion Criteria:

* Participation in a formal exercise regime,
* A BMI \< 18 or \> 30 kg/m2,
* Active cardiovascular disease,
* Taking beta-adrenergic blocking agents, statins or non-steroidal anti-inflammatory drugs,
* Cerebrovascular disease,
* Respiratory disease,
* Metabolic disease,
* Active inflammatory bowel or renal disease,
* Malignancy,
* Recent steroid treatment (within 6 months) or hormone replacement therapy,
* Clotting dysfunction,
* Musculoskeletal or neurological disorders,
* Family history of early (\<55y) death from cardiovascular disease
The Effect of Antibiotic Prophylaxis Associated With Dental Implant Surgery

The overall aim of the study is to investigate whether routine administration of antibiotic prophylaxis 1 hour prior to implant surgery may prevent postoperative infection and implant loss in healthy or substantially healthy patients (ASA Class 1 and Class 2).

The prevalence of bacteria resistant to antibiotics is increasing and there is a correlation between high consumption of antibiotics and high incidence of antibiotic resistance. It is therefore important to reduce the prescription of antibiotics. Antibiotics in dental care are used to treat oral infections as well as to prevent infections associated with surgical procedures. An example of the latter is antibiotic prophylaxis associated with dental implant surgery in order to reduce the risk of postoperative infection that can lead to loss of implant.The study will be conducted as a multicenter placebo-controlled randomized clinical trial. Eligible patients will be asked for participation and those who leave oral and written information will be included in the study. Patients included will be allocated to either active treatment (antibiotic prophylaxis) or placebo. Both clinicians and patients will be blinded to group affiliation. A total of 10 clinicians in 8 centers in the south of Sweden have agreed to participate and each clinicians will be allowed to use the implants and routines that they usually work with.

Specific aims of the study are to test the following hypotheses:

1. There is no difference in proportion of patients with early implant losses in patients receiving 2 g of amoxicillin preoperatively and patients receiving identical placebo tablets.
2. There is no difference in proportion of patients with early infections between patients receiving 2 g of amoxicillin preoperatively and patients receiving identical placebo tablets.
3. There is no difference in infections (within 3-6 months postoperatively) between patients receiving 2 g of amoxicillin preoperatively and patients receiving identical placebo tablets.

If it appears that antibiotic prophylaxis does not lead to any risk reduction, this result may provide a basis for guidelines rejecting antibiotic prophylaxis in dental implant surgery.

Eligibility Criteria:
Inclusion Criteria:

* Requirement for dental implant placement
* Over 18 years of age

Exclusion Criteria:

* Immunosuppressed or immunocompromised
* Affected by not controlled diabetes
* Serious or severe systemic disease (ASA classification \> 2)
* Previous radiotherapy to the head or neck area
* Ongoing acute or chronic infection in the oral cavity
* Ongoing treatment with antibiotics
* Hypersensitivity to penicillin
* Previous or ongoing treatment with bisphosphonates
* In need of major bone augmentation
* Planned direct loading or early loading (within 2 weeks) of the implant