cyrilzakka/clinical-trials huggingface dataset:
Prenatal Education About Infant Immunization Pain Management

There are numerous pain management strategies available for the management of infant immunization pain. The majority of infants, however do not benefit from these interventions, which causes them to suffer pain unnecessarily. This study will assess the impact of educating parents about pain management strategies on their knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.

There is ample literature outlining effective pain management strategies for immunization including psychological, physical and pharmacological interventions; however their use in clinical practice has been limited. Teaching parents about these strategies in an enriching setting such as prenatal education classes has the potential to increase utilization of these strategies, and empower parents to take on a more active role in the management of their infant's pain during routine immunization. Educating parents about pain-management for infant immunization has not been previously investigated in this setting. The aim of this cluster-randomized controlled trial is to evaluate the effectiveness of an immunization pain-management education module added to the prenatal education program at Mount Sinai Hospital on parental knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.

Eligibility Criteria:
Inclusion Criteria:

* mothers attending weekend prenatal classes
* delivery of a healthy newborn \> 35 weeks gestational age
* available for followup for infant's 2-month immunization

Exclusion Criteria:

* mothers who do not plan to immunize their infants
* infant with major birth defect or hospitalized at time of immunization
* mothers who need to attend the prenatal class at a separate time when education not offered
Neurotropism and Neuroinflammation in COVID-19 Patients With Delirium.

Emerging evidence indicates that SARS-CoV-2, the etiologic agent of COVID-19, can cause neurological, neuropsychological and psychiatric complications. Given the global dimensions of the current pandemic, there is to consider the possible large-scale neurocognitive impact of COVID-19. Therefore, there is an urgent need for longitudinal studies to determine the acute and chronic effects that COVID-19 may have on the Central Nervous System. These putative effects include the possibility that the CNS serves as a reservoir for the virus, and that COVID-19 triggers CNS deleterious inflammatory cascades and neurodegenerative process. The public implications of these effects are very important in the long term.

The BRAINSTORM project aims at creating a proof-of-concept dataset from severe COVID-19 patients with delirium. For the first time, this longitudinal study will rely on repeated and concomitant: i) SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF), ii) systemic and central immune response characterization, associated to the assessment of CNS damage biomarkers (peripheral blood and CSF), iii) in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia), iv) structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity), v) multi-domains neurocognitive assessment. This dataset will be made FAIR to allow open data use and to prepare future studies.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (male or female \> or = 18 years)
* COVID-19 (positive respiratory track PCR test \< 30 days)
* Delirium (CAM-ICU criteria)
* informed and written consent to participate in the study by patient's surrogate.

Exclusion Criteria:

* medical decision of withdrawal of life sustaining treatments previous to patients recruitment
* former neurological or psychiatric disability
* MRI or PET scan contraindication
* pregnancy
* hemodynamic or respiratory failure precluding patient's transport / MRI or PET scanning
Chronic Ankle Instability Return to Sport

Real-life, observational, monocentric, prospective, longitudinal study, carried out at the European Center for Sports Rehabilitation (CERS), France.

The data will be collected through an electronic Case Report Form completed by the physician, and some auto-questionnaire completed by the patient.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 15 years;
* Patient treated at the European Sports Rehabilitation Center after a first arthroscopic surgery on the external lateral ligament of the ankle for chronic instability by anatomical reconstruction:

  * With tendon graft;
  * By suture with biological reinforcement;
* Non-opposition of the patient and his/her parents (if minor) to the collection of his/her personal data.

Exclusion Criteria:

- Minor patient (age \<18 years) not accompanied by one of his/her parents or legal representative during the inclusion visit;

* History of surgery on the same ankle;
* Associated complex osteochondral or internal ligament damage, syndesmosis, fracture;
* Non-anatomical reconstruction;
* Inability of the patient to understand the study protocol;
* Vulnerable person whose inclusion is not justified by the purposes of the research: pregnant woman, person undergoing psychiatric care, or adult person subject to legal protection.
Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure. Subjects will be connected to the Zynex Cardiac Monitor, Model 1500 (CM-1500) to characterize changes in the relative index during an apheresis donation procedure.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Ability and willingness to comply with the study procedures and duration requirements
* 18 years of age or older
* Consented to undergo an apheresis procedure with an automated blood component device

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Undergone an amputation of the left upper extremity
* Diagnosed with dextrocardia
* Subjects who have a pacemaker
Adjunctive Minocycline in Clozapine Treated Schizophrenia Patients

Schizophrenia is a devastating and costly illness. One-third to one-half of people with schizophrenia do not respond to the most current drugs leaving clozapine as the best alternative for treatment. However, over 60% of people treated with clozapine continue to have persistent symptoms and cognitive impairments. Little data is available to support evidence-based recommendations to guide clinicians in treating these patients. Preliminary data has suggested that adjunct treatment with minocycline may offer robust symptom improvement in patients with schizophrenia, including those taking clozapine. Minocycline has had interesting effects; including suggesting it may have a significant role in treatment of neurologic and psychiatric disorders. Minocycline is currently available generically; its side effects are well-described and minimal. The proposed double-blind treatment study seeks to demonstrate that adjunctive minocycline offers patients superior efficacy for persistent positive symptoms, cognitive impairments, and/or other components of schizophrenia pathology. This knowledge could lead to the more effective treatment of patients with schizophrenia. The research itself may lead to a better understanding of the pathophysiology of positive symptoms and cognitive impairments, which could contribute to improved treatments in the future.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* Male or Female
* Age: 18 to 65 years
* Caucasian or Non-Caucasian
* At least six months of clozapine treatment
* Clozapine treatment for incomplete symptoms response (evidence of two failed previous trials of antipsychotics)
* Current dose of 200 mg/day for at least 3 months AND a documented clozapine blood level 350 ng/ml prior to study start (maximum clozapine dose of 900 mg/day)
* BPRS total score of 45 or more on the 18 item version (scale: 1-7)
* BPRS positive symptom item total score of 8 or more
* BPRS positive symptom score of 4 or greater on at least one item

Exclusion Criteria:

* History of organic brain disease
* DSM-IV diagnosis of Mental Retardation
* DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine)
* DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine)
* Pregnancy or lactation
* Significant renal or liver impairment
* Previous known hypersensitivity to tetracyclines
* Current treatment with tetracycline or derivative
* Current treatment with lamotrigine
* Treatment with oral contraceptives
* Current known infection
* Treatment with cholestyramine or colestipol
* Treatment with Urinary alkalinizers (e.g., sodium lactate, potassium citrate)
* Treatment with warfarin
* Abnormal (considered positive) Lyme titer
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors

This study will evaluate the safety of subcutaneous (SC) epoetin beta (NeoRecormon) in adults with solid tumors being treated with platinum-based chemotherapy capable of inducing anemia. The anticipated time on study treatment is 16 weeks, and the target sample size is approximately 208 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adults at least 18 years of age
* Presence of solid tumor(s)
* Receiving platinum-based therapy capable of inducing anemia

Exclusion Criteria:

* Red blood cell transfusion within 7 days prior to study drug
* Relevant acute or chronic bleeding requiring therapy within 3 months prior to study drug
* Women who are pregnant or breastfeeding
Comprehensive Model for Evaluation of Surgical EPAs

Introduction. Competency-based medical education (CBME) frameworks have become increasingly prevalent among surgical education accreditation bodies. Medical schools, postgraduate training programs, and licensing bodies conduct assessments to certify the competence of future practitioners, and judge the adequacy of training programs.

Methods. A prospective cohort study was designed to evaluate clinical-surgical competencies in all residents of a general surgery program. All medical residents of the general surgery program of the Faculty of Medicine and Biomedical Sciences at the Autonomous University of Chihuahua, were video recorded with consent, in the field (Outpatient consultation, Surgical ward, Inpatient room, Classroom), for posterior evaluation by the professors of the program with electronic rubrics made with Google forms.

A prospective cohort study was designed to evaluate clinical-surgical competencies in residents of the general surgery program during the 2020-2021 academic year at a single, secondary care, public medical institution.

For this purpose a previously validated instrument for the comprehensive evaluation of clinical-surgical competencies was used (9), which considered five dimensions, derived from the Single Plan for Medical Specialties in terms of 1-3) Clinical-surgical care (preoperative, transoperative and postoperative management), 4) Search and transfer of knowledge, and 5) Research proficiency. Each instrument was composed of 6 to 7 items, graduated in four levels of achievement; a) responsive, b) resolutive, c) autonomous, and d) strategic.

All surgery residents were video recorded with consent, in the field (Outpatient consultation, Surgical ward, Inpatient room, Classroom) for posterior self-evaluation, co-evaluation and hetero-evaluation with electronic rubrics made with Google forms.

Eligibility Criteria:
Inclusion Criteria:

* Residents in an universitary general surgery program

Exclusion Criteria:

* Staff surgeons
* Residents from another universitary program
Genetic Etiology in Premature Ovarian Insufficiency

Premature Ovarian Insufficiency (POI), first described by Albright in 1942, is defined as an increase in Follicle Stimulating Hormone (FSH), an insufficiency of the ovarian function leading to an early menopause (\<40 years of age).Today, only 35% of POI's etiology can be explained. Causes enlightening POI may be enumerated as follows, according to their frequency: genetic mutations, autoimmune defects and abnormalities detected on the X chromosome.The purpose of the study is to determine the frequency of the genetic abnormalities and polymorphisms described above in the POI Turkish population


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosed premature ovarian failure patients
* 20-40 years old female patients

Exclusion Criteria:

* Surgical surgical menopause
* Female patients who can't meet the age range criteria
Intraocular Cytokine in Recurrence of Polypoidal Choroidal Vasculopathy

Changes of intraocular cytokines including vascular endothelial growth factor (VEGF) will be measured in recurrence of polypoidal choroidal vasculopathy (PCV) during treatment of ranibizumab.

PCV is regarded as a subtype of age-related macular degeneration (ARMD), but has several different features such as polypoidal terminal of new vessels, and relative resistance to anti-VEGF treatment. Other cytokines then VEGF are thought to be associated with development and progression of the disease. The aim of the this study is to investigate intraocular cytokines related to recurrence of polypoidal choroidal vasculopathy. Aqueous humor will be sampled from the anterior chamber at baseline, after loading injections of ranibizumab and at recurrence. The concentration of various cytokines will be measured in the aqueous humor.

Eligibility Criteria:
Inclusion Criteria:

1. Submacular PCV diagnosed based on branching neovascular networks having polypoidal dilatation in ICGA.
2. Presence of exudative changes involving the fovea in OCT
3. Decreased visual acuity to 20/320 - 20/40 to be primarily the results of PCV in the study eye.
4. Willing and able to comply with clinic visits and study-related procedures, and provide a signed informed consent form.

Exclusion Criteria:

1. Extramacular PCV.
2. Presence of pathologic changes blocking 50% or more area of the lesion in angiography.
3. Any anti-VEGF treatment in the study eye within 180 days of day 1.
4. Previous photodynamic therapy in the study eye.
5. History of intraocular surgery except uncomplicated cataract surgery performed before 90 days or more from day 1.
6. Presence of exudative ARMD requiring anti-VEGF treatment in the other eye.
7. Presence of other ocular disease that may compromise visual acuity in the study eye.
8. Uncontrolled systemic disease.
9. Active intraocular or periocular infection.
10. Active intraocular inflammation.
11. Hypersensitivity to ranibizumab or excipients.
High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

The purpose of this study is to evaluate the effects of high-dose intranasal oxytocin for treating tinnitus. The hypothesis is that high dose intranasal oxytocin can significantly reduce tinnitus severity and disability.

This is a pilot, proof of concept, placebo-controlled, parallel study. Participants will be recruited from NYU Langone Medical Center's Ear, Nose \& Throat (ENT) Department and will receive either high-dose intranasal oxytocin or a nasal spray containing Pcca Mucolox and distilled water, serving as the placebo. Long term treatment with high-dose oxytocin (45 IU four times daily) may reduce the frequency and severity of tinnitus, the burden tinnitus symptoms cause patients, and improve their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with continuous perception of subjective tinnitus for ≥ 6 months duration.
* Subjects must have had a normal otolaryngologic evaluation within the past year with no evidence of otitis media or externa, a Tinnitus Handicap Inventory (THI) of \> 16.
* Subjects must have tinnitus loudness rating of \>4/10.

Exclusion Criteria:

* Subjects who are being treated for tinnitus \< 6 months due to the acute nature of their condition
* Subjects who have a slight handicap according to the Tinnitus Handicap Inventory Severity Scale.
* Those with tinnitus of a muscular or vascular etiology
* Subjects with conductive hearing loss, history of migraine, or prior use of oxytocin nasal spray.
* Women of childbearing age will not be approached for participation due to the risk of oxytocin-induced uterine contractions.
* Subjects who suffer from migraines.
* Subjects who have history of pulmonary edema, Congestive Heart Failure, and severe renal disease.
Efficacy of a Chronic Care Model Supported by Self Monitoring of Blood Glucose With BGStar Over Usual Care in Improving Glycemic Control in Patients With Type 2 Diabetes Not Treated With Insulin

To demonstrate the superiority of a chronic care model (SINERGIA model) supported by the Self Monitoring of Blood Glucose with BGStar over usual care in improving glycemic control at 12 months in patients with type 2 diabetes not treated with insulin.

The planned study duration is 36 months (9 quarters). The estimated duration of screening/enrollment will be 12 months, followed by the 12-month experimental phase, plus the 12-month follow-up in the observational phase.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age ≥ 45 years
* Type 2 diabetes
* First access at the diabetes clinic
* Any diabetes duration
* HbA1c \>7.0 and ≤ 9.0%
* Already treated with any oral antidiabetic agent (OAD) or requiring the initiation of therapy with OAD
* Patients not using SMBG or using SMBG with a frequency ≤1 test/week
* Written informed consent

Exclusion Criteria:

Treatment with insulin or need to start insulin regimens or continuous sub-cutaneous insulin infusion at the first access; Refusal or inability to give informed consent to participate in the study;

Conditions / situations such as:

* Patients with short life expectancy;
* Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment;
* Requirement for concomitant treatment that could bias primary evaluation (i.e. corticosteroid treatment);
* Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study;
* Current addition/abuse of alcohol or drugs;
* Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study;
* Pregnant or breast-feeding women;
* Patients living too far from investigational center or other conditions reducing the adherence to the protocol; Subjects unlikely or unable to comply with the Protocol requirements (e.g. illiterate, uncooperative, unable to return for follow-up visit, unable to use BGStar unlikely to complete the study)
Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke

The specific aims of this study will be:

1. To compare the immediate and retention treatment effects of the patients receiving home-based mirror therapy combined with task-oriented training (MTOT) with a hospital-based MTOT group and a hospital conventional rehabilitation group on different aspects of outcomes.
2. To examine the feasibility, satisfaction, and safety of this novel home-based MTOT program.
3. To investigate the factors that may affect the efficacy of home-based stroke rehabilitation.

In this 3-year study project, we will design a single-blind randomized controlled trial (1) to compare the treatment effects of home-based MTOT with a hospital-based MTOT group and a hospital conventional rehabilitation group, (2) to investigate the feasibility, satisfaction, and safety of this home-based program, and (3) to identify the factors that might influence treatment outcomes. An estimated total of 90 patients with stroke will be recruited in this study. All participants will be randomly assigned to receive home-based MTOT or hospital-based rehabilitation for a 4-week training period (a total of 12 sessions). Before the first treatment session, a client-centered questionnaire will be administered to each patient for identifying individual needs and goals. Feasibility evaluation and caregiver's wellbeing will be also assessed. Outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as having a unilateral stroke
* at least 3 months after stroke onset
* from 20 to 80 years of age
* having completed acute rehabilitation care or discharged home
* a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
* able to follow the therapy instructions (cognition status will be measured by the Montreal Cognitive Assessment)
* capable of participating in therapy and assessment sessions.

Exclusion Criteria:

* neglect
* global or receptive aphasia
* major medical problems
* comorbidities that influenced UE usage or caused severe pain
12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation

The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.


Eligibility Criteria:
Inclusion Criteria:

* Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day

Exclusion Criteria:

* Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.
The ROAR Study: Reactive Oxygen Species and Reproduction

This is a prospective cohort study characterizing follicular fluid and serum levels of oxidative stress in women with various infertility diagnoses undergoing in vitro fertilization, and assessing the relationship of oxidative stress to oocyte competence as determined by embryo development outcomes. Furthermore, we will measure oxidative stress in sperm and correlate the overall oxidative stress within the couple with IVF and pregnancy outcomes of the resultant embryos.


Eligibility Criteria:
Inclusion Criteria:

1. Female age 18-43 years
2. Subjects planning blastocyst culture for preimplantation genetic screening (PGS) for aneuploidy.
3. Male partners 18 years of age or older.

Exclusion Criteria:

* Female partner age 44 or older
* Planning fresh transfer (hybrid PGS cycle)
* Cleavage stage biopsy