cyrilzakka/clinical-trials huggingface dataset:
Belimumab Assessment of Safety in SLE

The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

Study participants receive standard therapy for SLE in addition to receiving the study drug, either placebo (no active medicine) or belimumab. The controlled period of the study is 52 weeks. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo. After completion of the 52-week study period, participants will be contacted by phone annually for 4 more years to assess health status.

Following the 52-week controlled period, participants who wish to continue treatment with belimumab may be able to do so by being prescribed commercially available belimumab. If belimumab is not commercially available in the participant's country, the participant may be able to receive belimumab under a separate continuation protocol.

Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
* Active SLE disease.
* Autoantibody-positive.
* On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate).

Key Exclusion Criteria:

* Pregnant or nursing.
* Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days.
* Have received a live vaccine within the past 30 days.
* Have severe active lupus kidney disease.
* Have severe active central nervous system (CNS) lupus.
* Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
Time-specific Exercise in Circadian Context

The project aims to explore the mechanisms, by which physical activity can support healthy ageing and decrease the negative impact of ageing on the circadian system, musculoskeletal system and immunity.

The main aim of the project is to examine the effect of as well as of the three-month, timely specific training intervention on the functionality of circadian organization in elderly volunteers. The additive aim is to examine the effect of lifelong endurance physical activity, along with the experimental training intervention on the body composition, bone density, and selected hormonal, biochemical, histological and molecular indicators of metabolic health.

Partial aims are as follows:n to explore the effect of morning and afternoon training on the most significant parameters, identified by the previous cross-sectional study, in sedentary elderly. Furthermore, to clarify adaptation mechanisms of experimental training protocol on selected parameters, that may explain possible differences in mechanisms of active and passive aging.

Eligibility Criteria:
Inclusion Criteria:

* no history of regular physical activity training and exercise of more than 150 minutes of moderate or 75 minutes of higher intensity per week.
* Body mass index (BMI) between 18.5 and 30 kg/m2 for all groups

Exclusion criteria for probands will be:

* Recent or current infection, physical disability,
* malignant, cardiovascular, metabolic, autoimmune diseases,
* Malnutrition and pharmacological interference (e.g., steroids, non-steroidal anti-inflammatory agents, immunosuppressive and antineoplastic drugs).

Use of performance enhancing drugs in the past and during the study period will condition exclusion.

Exclusion Criteria:

* recent or current infection, physical disabilities,
* malignant, cardiovascular, metabolic, autoimmune diseases,
* Malnutrition and pharmacological interference (e.g., steroids, nonsteroidal anti-inflammatory agents, immunosuppressive and antineoplastic drugs).

Use of performance-enhancing drugs in the past and during the study period will condition exclusion.
Bilateral Training Versus Unilateral Training in Stroke

This randomized, single-blind study compares the effectiveness of bilateral training to unilateral training for individuals with moderate hemiparesis. We hypothesize that bilateral training will be superior to unilateral in the proximal extremity but not the distal one.

Upper extremity hemiparesis is the most common post-stroke disability. Longitudinal studies have indicated that 30 to 66 percent of stroke survivors do not have full arm function six months post-stroke. Bilateral arm training has been investigated as a potential rehabilitation intervention for individuals not eligible for constraint induced movement therapy.

This training study included 24 hours of treatment over eight weeks. The protocol consisted of reaching activities with rhythmic auditory cueing emphasizing the proximal arm. Subjects assigned to the bilateral group performed bilateral symmetrical activities while subjects in the unilateral group performed the same activity with the affected arm only. The Motor Assessment Scale-Upper Limb Item and the Motor Status Scale are used as primary outcome measures. The Reaching Performance Scale and strength measures are secondary outcome measures. Assessments are administered pre-/ and post-training by a blind rater.

Eligibility Criteria:
Inclusion Criteria:

* cortical or subcortical stroke
* chronic condition (at least six months prior)
* ability to follow 2-step commands
* ability to give consent

Exclusion Criteria:

* lesion in brain stem or cerebellum
* visual field cut
* neglect
* uncontrolled hypertension
* angina
* COPD
Immersive Care - Virtual Reality(VR) 360 Pediatric Surgery Preparation.

Context: This study is part of the larger Immersive Care project which (in short) seeks the connection between technology and care by conducting feasibility studies with promising technological interventions tailored to care.

This is one of the case studies from the larger project titled: 360 ° video VR surgery preparation: feasibility, acceptability, tolerability and initial effectiveness of virtual reality for children in a Flemish hospital.

Domain: This scientific study will take place in 1 hospital on the pediatric ward. The target group consists of children between 6 and 12 years of age who will undergo an operation, the parents and the care providers involved.

Target:

1. Assess the acceptability, feasibility and tolerability of the 360 ° video VR surgery preparation.
2. Assess the effectiveness of the 360 ° video VR surgery preparation on preoperative procedural anxiety in children, comparing the intervention with care as usual (CAU \*).

   * CAU in this study is a picture book which is a kind of animated video with text to explain what will happen on the day of the operation.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained
* Inpatient or outpatient in the study site (Heilig Hart Hospital Lier): each paediatric patient who will undergo surgery during the study period (01-12-2020 and 30-09- 2021).
* Age range of ≥ 6 and ≤ 12
* Normal or corrected-to-normal vision
* Normal or corrected-to-normal hearing

Exclusion Criteria:

* Patient has a history of seizure disorders (e.g. epilepsy)
* Physical impairment that preclude VR intervention (e.g. facial burns or wounds, contagious infectious disease, need for intensive care)
* Non-Dutch/English/French speaker: Both the paediatric patient and his/her caregiver must be able to provide informed consent and assent
* Previous enrolment in this study (during a previous hospital stay)
Safety and Feasibility of eGlove

The purpose of this study is to measure how cortical signals improve in stroke participants after passive hand stretching therapy from a robotic glove.

After experiencing a stroke event, many individuals are left with life-long motor impairments in their upper extremity. However, motor recovery for stroke survivors is not fully understood. One of the challenges to understand the mechanisms behind recovery is the capability of the brain to reorganize and re-activate areas affected by the stroke. Brain computer interface (BCI) has shown promise in previous studies to improve motor capabilities of individuals with damaged nervous systems by reactivating damaged motor pathways.

In order to understand how BCI can be incorporated into upper extremity rehabilitation, investigators must first lay the groundwork of measuring neural activity and its relation to muscle activity in individuals who have experienced a stroke. While instructing participants to open and close their hand, investigators will measure (1) neural activity, called sensorimotor rhythms (SMRs), using a electrophysiological (EEG) cap, and (2) muscle activity using wireless electromyography (EMGs). What the investigators are specifically looking for is an event in the neural activity in between movement initiation and termination called event related desynchronization (ERD). The investigators of this study hypothesize that there is greater activation of ERDs in stroke's subjects SMR activity after completing finger extension and flexion.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke (6 months post stroke)
* Hemiparesis
* Some degree of hand and finger movement capability
* a moderate impairment (Fugl-Meyer score between 15-50)

Exclusion Criteria:

* Individuals under the age of 18
* Bilateral paresis
* Hand pain and/or extreme articular contractures on the finger joints (Modified Ashworth Scale of 4)
* Botox injection to the affected upper extremity within the previous 4 months
* Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment
Effects of Polarized and Pyramidal Training Combined With or Without Mindfulness in Amateur Runners

Road running in athletics has grown worldwide in recent years, which has led to an increase in the number of recreational runners. Despite this growth, research addressing this population is scarce, with major limitations and methodological weaknesses. Two of the topics of recent interest in runners are the effects of training intensity distribution (TID) and mental training using mindfulness on running time, body composition and physiological parameters related to performance in endurance sports; the maximal oxygen consumption (VO2max), maximal aerobic speed (MAS) and ventilatory thresholds (VT).

The scarce evidence found identifies the TID polarized model as the most effective in sports performance and TID pyramidal model as the most used by elite runners. For mindfulness, it is identified as an emerging program that could contribute to performance in endurance sports.

40 recreational long-distance runners will be randomly assigned into one of the following 4 TID models groups: polarized TID model group with mindfulness program (POL+), polarized TID model group without mindfulness program (POL-), pyramidal TID model group with mindfulness program (PYR+) and pyramidal TID model group without mindfulness program (PYR-). Each group will be composed of 10 subjects. The interventions will have a duration of 12 weeks.

All participants will have evaluation of 10 km running time, body composition and physiological parameters (VO2max, MAS and VT's 1 and 2) at week 0 and 13 of the study.

Eligibility Criteria:
Inclusion Criteria:

* Amateur long-distance runners
* Running time of 10 km in Bogotá, Colombia or similar altitude (2600 m above sea level) for men between 45 and 60 minutes, and for women between 50 and 65 minutes.

Exclusion Criteria:

* Smokers.
* History of cardiovascular disease.
* Arrhythmias.
* Cardiac insufficiencies.
* Hypertension.
* Musculoskeletal problems that affect their participation in the training program.
APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat

The purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).


Eligibility Criteria:
Inclusion Criteria:

* Give informed consent, assent and patient authorization
* Age 12 and over
* A clinical diagnosis of acute pharyngitis or tonsillitis
* A positive rapid Strep test
* Can swallow the oral study dosage forms
* Females must have a negative urine pregnancy test and be using acceptable birth control if sexually active

Exclusion Criteria:

* Chronic or recurrent odynophagia
* Need for hospitalization or IV antimicrobial therapy
* Pharyngitis known or suspected due to a pathogen resistant to beta-lactam antimicrobials
* Known carrier of S. pyogenes
* Allergies to penicillin or other beta-lactam antibiotics
* Any serious illness or concomitant condition that the investigator judges will preclude inclusion to the study
* Seizure disorder
* Pregnant or nursing
* Expectation of additional systemic antibacterials would be required for another condition
* Current drug or alcohol abuse
* Any experimental drug or device within the last 30 days
* Prior systemic antibiotic therapy within the last 30 days
* Hospitalization within the last month which included antibacterial therapy
* The presence of clinically significant hematologic conditions, etc
* Probenecid treatment
A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

The purpose of this study is to compare the short-term effects of two different thoracic spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in individuals experiencing neck pain.

The study will be conducted at the Musculoskeletal clinical facility in the Dept. of Physical Therapy and Athletic Training, Northern Arizona University, Flagstaff AZ. The investigators aim to test a maximum of 76 participants in this study. A phone screening will determine initial eligibility. If the participant meets the inclusion criteria and is not excluded after the phone screen, an appointment will be scheduled. Final eligibility will be determined in the initial session after the participant completes the outcome measures and is evaluated by a licensed physical therapist.

Participants will be involved in the study over a 4 week period. Each participant will be asked to attend 4 sessions, with one week in between each session as follows: Week 0 = baseline assessment and treatment 1; Week 1= treatment 2; Week 2 = treatment 3; and week 4 = follow-up assessment.

After completion of the baseline assessment, qualified participants will be randomly assigned to either a supine or prone thoracic spine thrust manipulation intervention.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 and 50 years of age (inclusive)
* Primary complaint of neck pain with or without symptoms that spread down into one arm
* Overall rating of neck pain intensity is at least 3/10; the overall rating is the average of the participant's rating of current, least, and worst pain experienced over the previous 24 hours on separate numeric pain rating scales where 0 corresponds to "no pain" and 10 corresponds to "worst possible pain"
* Neck Disability Index (NDI) score \> 10 points (measure of self-reported disability with a 0 to 50-point scale where higher scores indicate higher levels of disability)
* Proficient in speaking and reading English to complete outcome questionnaires

Exclusion Criteria:

* Neck pain related to a motor vehicle accident or other trauma within the previous 6 weeks
* Neck pain that spreads down into both arms
* Low back pain or thoracic origin of pain
* Nerve root involvement; defined as the presence of two or more neurological findings (e.g., decreased strength, diminished deep tendon reflex, or decreased sensation) at the same nerve root level
* Diagnosis of cervical spinal stenosis (narrowing of the central canal that contains the spinal cord)
* History of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
* Pending legal action related to current episode of neck pain
* Contraindications to thoracic spine thrust manipulation

  1. serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use)
  2. hyperreflexia
  3. unsteadiness during gait
  4. nystagmus
  5. loss of visual acuity
  6. impaired sensation of the face
  7. altered taste
  8. the presence of pathological reflexes
  9. pregnancy or considering pregnancy
Can the Origin of Sperm Affect Embryo Ploidy in Patients with Severe Male Factor Infertility?

There is evidence indicating that sperm plays a role in determining blastocyst ploidy status. In our study, we aim to compare the outcomes of preimplantation genetic testing for aneuploidy (PGT-A) and the subsequent clinical outcomes following transfers of euploid embryos. This comparison will be conducted between cases where ejaculated sperm and cases where testicular sperm were used for intracytoplasmic sperm injection (ICSI), specifically focusing on severe male factor infertility patients.


Eligibility Criteria:
Inclusion Criteria:

* Cases planned to have ICSI PGT-A cycles
* Males diagnosed as severe male factor infertility
* Normo responder female partners

Exclusion Criteria:

* Leukocytospermia
* Presence of varicocele.
* Known genetic abnormality
* Use of sperm or oocyte donors
* Use of gestational carrier
* Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)

This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers of either gender; Those without clinically significant cardiovascular gastrointestinal, hepatic, neurological, psychiatric, endocrine, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results, assessed according to the judgment of the Principal Investigator. A non-inclusive list which would not be exclusionary and define healthy individual for the purposes of this study are:

* hypothyroidism,
* stable hypertension except those subjects on beta blockers including ocular preparations,
* seasonal/perennial allergic rhinitis if able to wash out of antihistamines,
* stable, mild intermittent asthma (subjects using beta agonists as a monotherapy on an as-needed basis, excluding daily usage),
* migraine if not taking excluded medications,
* mild anxiety/depression if not taking excluded medications, and
* mild arthritic conditions if not taking excluded medications.

  * Willingness and ability to sign an informed consent document;
  * 18 - 80 years of age;
  * Intact skin at the forearm ;
  * Female participants are currently practicing effective birth control methods or abstinence.

Exclusion Criteria:

* Known allergy, hypersensitivity or contraindications to hyaluronidase, thimerosal, edetate disodium (EDTA);
* Use of medications within a duration considered to interfere with skin testing.
* Known dermographism which may interfere with skin testing.
* Pregnant or lactating women.
Mobile App for Heart Failure

The investigators developed a mobile health platform to self-management in HF. The aim of this study is to evaluate whether this smartphone app-based intervention can improve symptoms of HF when compared to usual care in HF patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 years or older hospitalized for acute heart failure.
* Patients who have obvious symptoms or sign of HF at admission
* N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥400 pg/mL or brain natriuretic peptide (BNP) ≥100 pg/mL.
* participants should be able to use smartphone well.

Exclusion Criteria:

* Patients who have baseline systolic blood pressure \<90 mmHg or resting heart rate \<50 beats per minutes
* Patients who cannot use smartphone
* Patients who had cardiac implantable electronic device will be excluded
MIST II PFO-Migraine Trial With BioSTAR® Bioabsorbable Septal Repair Implant

The objective of the study is to investigate the safety and effectiveness of PFO closure with the BioSTAR Septal Repair Implant System in a population of patients that have refractory migraine (with aura) and who have failed medications.

During the last five years, transcatheter and surgical closure of PFO in the cyrptogenic stroke and TIA population has grown in frequency world-wide. Observational retrospective reports, from both single and multi-center experiences of over 400 patients, suggest Patent Foramen Ovale (PFO) closure to reduce the risk of recurrent migraine events in these populations may be beneficial, particularly for those patients in the migraine with aura subgroup. Although none of these reports are from prospective, randomized, controlled trials, the reports are compelling enough in their totality to support further investigation of a well defined group in a prospective manner. The patients reported in these studies were brought to PFO closure with no expectation of their procedure having any impact on their migraine. In fact, in many cases, the discovery of a history of migraine was not made until well after the PFO closure procedure.

This clinical trial will prospectively compare the safety and effectiveness of PFO closure with the BioSTAR device to a control arm. Patients will be followed one year post-implant.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 60.
* migraine history prior to age 50
* must meet definition of refractory migraine with aura
* must have a Patent Foramen Ovale (PFO) within bubble study specifications.
* must provide informed consent. Guardian consent is not accepted.
* patient's heart structure and vasculature must be compatible with BioSTAR Septal Repair Implant System.
* patient must not be pregnant and agrees not to become pregnant during study participation

Exclusion Criteria:

* Medical conditions or medications that are not compatible with protocol or that would increase the patient's risk.
* patient must not have any cardiac or vascular anomalies, repaired or not, that would be incompatible with the delivery system or device for PFO occlusion.
* Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current trial endpoints.