cyrilzakka/clinical-trials huggingface dataset:
Monitored vs Standard Supplementation of Vitamin D in Preterm Infants

The purpose of this study is to determine wheather the monitored vitamin D (vit D) therapy is safer and more effective than standard therapy in pretrem infants.

Vitamin D (vit D) deficiency is a risk factor of osteopenia of prematurity, which leads to rickets or decreased bone mass mineral density. Recently multiple studies have been published on vit D adjust biological functions. Dosage, safety and effectiveness of vitD supplementation in preterm infants still remains a controversial topic. We hypothesize that monitored supplementation of vit D is more effective and safer than standard therapy 500IU in preterm infants. The study will be carried out in 138 preterm infants, born at 24-32 week of gestational age (GA) at the Princess Anne's Hospital in Warsaw, Poland. We will determine if monitored supplementation of vit D decreases the incidence of vit D deficiency and/or overdosing at 40 week (GA). For secondary objective we shall assess if monitored therapy reduces the incidence of vit D deficiency and/or overdosing at 35, 52 week (GA), prevalence of osteopenia, low bone mass, nephrocalcinosis and nephrolithiasis.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born between 24 and 32 weeks of gestation (estimated by ultrasound)
* In born or admitted to the unit within 48hours from birth.
* Randomization within 7 days from birth.
* Parental consent.
* Mothers willing to return for follow up visits.

Exclusion Criteria:

* Preterm delivery \>=33 weeks of gestation or term delivery (estimated by ultrasound).
* Major congenital abnormalities.
* Participation in another trial.
* Severe illness at birth deemed incompatible with survival.
* Congenital HIV infection.
* Total parenteral nutrition \> 14 days.
* Cholestasis
Telemedicine Education for Rural Children With Asthma

The investigators will implement an interactive school-based telemedicine education program for rural low-income, minority children with asthma, their caregivers, and school nurses in the Delta region of Arkansas.

Specific aims:

1. The investigators will examine changes in asthma symptoms control and other health outcomes such as activity levels and family/child emotional health in the intervention group compared to a usual care group.
2. The investigators will examine changes in asthma knowledge, self-efficacy, and quality of life in the intervention participants and their caregivers compared to a usual care group.

The investigators will conduct a prospective study to examine the impact of an interactive, telemedicine asthma intervention among children living in the rural Delta region of Arkansas.

Eligibility Criteria:
Inclusion Criteria:

* Study participants will be English-speaking children ages 7-17 years with physician-diagnosed asthma and/or active symptoms in the previous 12 months.
* Active symptoms include one or more of the following:

  * experience daytime wheezing, shortness of breath, and/or coughing two or more times a week for the last 4 weeks;
  * nighttime wheezing, shortness of breath and/or cough more than once a week;
  * take asthma medication more than two days a week;
  * have been treated in a hospital or emergency department two or more times in the last two years for asthma symptoms;
  * have been treated in a hospital or emergency department two or more times in the last two years for asthma symptoms have episodes of asthma-like symptoms when playing/exercising.
* Potentially eligible participants will be screened using an asthma screener to confirm eligibility.

Exclusion Criteria:

* Children with significant underlying respiratory disease other than asthma (such as cystic fibrosis) or significant co-morbid conditions (such as severe developmental delay or cerebral palsy) will be excluded from the study.
* The primary caregiver and child will be asked questions via telephone interview about how asthma affects the child every day. Children with no telephone number or contact telephone number will be excluded.
Effects Of Native Collagen Type 2 Treatment

The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint pain and function and its effects on urinary biological markers related to cartilage degeneration in patients with knee osteoarthritis.

39 patients diagnosed with knee osteoarthritis were separated into two groups. The 1st group includes 19 patients given 1500mg/day paracetamol, the 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months.Pretreatment and posttreatment Visual Analog Scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 20-m walking time and Short Form-36 (SF-36), Coll2-1, Coll2-1NO2 and Fibulin-3 levels in urine were compared.

Eligibility Criteria:
Inclusion Criteria:Patients aged 45-70 years with the diagnosis of primary knee OA according to the American College of Rheumatology (ACR) criteria, Kellgren Lawrence radiological stage II or III and knee pain -

Exclusion Criteria:Patients with intraarticular injections or physical therapy within the last year, a previous lower extremity surgery, oral treatment with glucosamine chondroitin or other natural health products within the last month, serious concomitant systemic diseases, peripheral or central neurological disorder, hypersensitivity to paracetamol or se¬vere cardiac, renal, hepatic, hematologic disease

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Theory of Mind in Preschool Children, School Children, Youths and Adults Born Preterm or Full-term

This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.

Is there any difference in the development of theory of mind between preterms and full-terms? Is there a risk group of preterms to develop a deficit in theroy of mind?

Four groups are tested: prescoolers (again two years later), youths and young adults.

All participants were tested for theory of mind, executive functions, language and cognitive abilites.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* preterm: birthweight \<1500g
* full-term: born after 38 weeks

Exclusion Criteria:

* no informed consent
Study of Physical and Mental Health of Older Patients With Newly Diagnosed Cancer

RATIONALE: Gathering information from older patients with newly diagnosed cancer may help doctors learn more about the risks of functional decline.

PURPOSE: This studying is looking at the physical and mental health of older patients with newly diagnosed cancer.

OBJECTIVES:

* To create a Geriatric-Oncology database of patients 65 years of age and older with newly diagnosed cancer who have been identified as being at increased risk of functional decline and mortality within a year.
* To enhance the Geriatric-Oncology Database by linking it to the Central Medicare Services (CMS) Database and the Ohio Death Files.

OUTLINE: This is a multicenter study.

Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care. The assessments include the Lawton's nine-item Instrumental Activities of Daily Living (IADL); the Katz's Activity of Daily Living (ADL); the Timed Up and Go Test; the Karnofsky Physician-Rated Performance Rating Scale (KPS); the number of falls in the past 6 months; the Mini Nutritional Assessment (MNA); the Body Mass Index; the percent of unintentional weight loss in the past 6 months; the Medical Outcomes Study (MOS) Social Support Subscale (emotional/information and tangible subscales); the MOS Social Activity Limitations Measures; the Charlson Comorbidity Index; the Cumulative Index Rating Scale Geriatrics (CIRS-G); the ACE-27; the Folstein's Mini-Mental State Examination (MMSE); the Geriatric Depression Scale (GDS); the Functional Pain Scale; and a list of medications.

Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years. At completion of 1 and 3 years of follow up, the Geriatric-Oncology Database will be linked to the Central Medicare and Medicaid Services (CMS) Database and the Ohio Death Files.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed newly diagnosed cancer

  * Any stage disease
* At increased risk for functional decline and mortality within the next year as per the Vulnerable Elders Survey (VES-13) screening tool (score ≥ 3)
* Seeking care at the Ireland Cancer Center (University hospitals and all other satellite sites)
* Patients with a pre-existing cancer diagnosis and a geriatric syndrome referred directly to the Senior Adult Oncology Program by their providers for a geriatric-oncology consultative evaluation are not eligible

PATIENT CHARACTERISTICS:

* Able to speak and comprehend English
* Able to understand and willing to sign a written informed consent

PRIOR CONCURRENT THERAPY:

* Not specified
Video-based Learning for Basic Surgical Skills

This is a prospective randomized study, intended to evaluate the effectiveness of teaching basic surgical techniques through video, comparing the results with those of traditional teaching


Eligibility Criteria:
Inclusion Criteria:

* Students from the 1st to 3rd years of the Integrated Master's Degree in Medicine at the University of Porto,
* Able to participate in a course of basic surgical techniques (simple suturing, X-stitches, U-stitches and Donatti points)

Exclusion Criteria:

* Participants is to have had prior contact with techniques surgical and/or minor surgery,
* Participants had contact with techniques surgical and/or minor surgery in the period between recruitment and completion of the proposed learning
A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)

A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HS for at least 1 year prior to screening
* HS lesions must be present in at least 2 distinct anatomic areas
* A total AN count (sum of abscesses and inflammatory nodules) \> 6 across all anatomical sites at both the screening and baseline visits
* Willing to use contraception for the duration of the study

Exclusion Criteria:

* Presence of other skin conditions which may interfere with study assessments
* Presence of active, chronic or latent bacterial, viral, fungal mycobacterial infection (including latent TB) or history of infection within 4 weeks of screening
* Body Mass Index (BMI) \>48kg/m2
* Breastfeeding or pregnant
Clinical Validation of DystoniaNet Deep Learning Platform for Diagnosis of Isolated Dystonia

This research involves retrospective and prospective studies for clinical validation of a DystoniaNet deep learning platform for the diagnosis of isolated dystonia.

Isolated dystonia is a movement disorder of unknown pathophysiology, which causes involuntary muscle contractions leading to abnormal, typically patterned, twisting movements and postures. A significant challenge in the clinical management of dystonia is due to the absence of a biomarker and associated 'gold' standard diagnostic test. Currently, the diagnosis of dystonia is guided by clinical evaluations of its symptoms, which lead to a low agreement between clinicians and a high rate of diagnostic inaccuracies. It is estimated that only 5% of patients receive an accurate diagnosis at symptom onset, and the average diagnostic delay extends up to 10.1 years. This study will conduct retrospective and prospective studies to clinically validate the performance of DystoniaNet, a biomarker-based deep learning platform for the diagnosis of isolated dystonia.

The retrospective studies will clinically validate the diagnostic performance of the DystoniaNet algorithm (1) in patients compared to healthy subjects (normative test), and (2) between patients with dystonia and other neurological and non-neurological conditions (differential test).

The prospective randomized study will validate the performance of DystoniaNet algorithm for accurate, objective, and fast diagnosis of dystonia in the actual clinical setting.

This research is expected to advance the DystoniaNet algorithm for dystonia diagnosis into its clinical use for increased accuracy of dystonia diagnosis. Early detection and diagnosis of dystonia will enable its early therapy and improved prognosis, having an overall positive impact on healthcare and patients' quality of life.

Eligibility Criteria:
Inclusion criteria:

1. Males and females of diverse racial and ethnic backgrounds, with age across the lifespan;
2. Patients will have at least one of the forms of dystonia, including focal dystonia (e.g., laryngeal, cervical, oromandibular, blepharospasm, focal hand, musicians), segmental dystonia, or generalized dystonia;
3. Patients will have other movement disorders (Parkinson's disease, essential tremor, dyskinesia, myoclonus) and other non-neurological conditions (tic disorders, torticollis, ulnar nerve entrapments, temporomandibular disorders, dysphonia) that mimic dystonic symptoms.

Exclusion criteria:

1. Patients who are incapable of giving informed consent;
2. Patients who are unable to undergo brain MRI due to the presence of certain tattoos and ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve) that cannot be removed or due to pregnancy or breastfeeding at the time of the study.
Assessment of an Exhaled Breath Test to Detect Bronchiectasis

To investigate whether the breath test is able to detect bronchiectasis using breathomics. This study was conducted with a prospective specimen collection, evaluator-blinded, case-controlled clinical study designed to evaluate the accuracy of breathomics to diagnosis of bronchiectasis in adults.

Bronchiectasis is a chronic airway inflammation with irreversible expansion of bronchial walls, which is characteristic by chronic cough, mucinous sputum, dyspnea and wheezing. High resolution CT (HRCT) combined with clinical manifestations is the main diagnostic method of bronchiectasis, but HRCT is expensive and radioactive. Therefore, it is urgent to develop a new technology to diagnose bronchiectasis. Exhaled breath may be a better tool for bronchiectasis detection because of its noninvasive nature. Many efforts have been made to develop breath tests for lung cancer, asthma and Helicobacter pylori infection. However, little studies pay attention to bronchiectasis. High-pressure photon ionization time-of-flight mass spectrometry (HPPI-TOFMS) is a promising tool for breath testing, because it is highly sensitive, does not require pretreatment of exhaled breath, and holds great tolerance for humidity. In our case-control diagnostic study, we investigated whether a breath test combining HPPI-TOFMS and a support vector machine (SVM) algorithm was able to distinguish patients with bronchiectasis from control individuals.

Eligibility Criteria:
Inclusion Criteria:

BE Patients were recruited according to the following inclusion criteria: (1) Age\>18 years; (2) the diagnosis of BE was according to European Respiratory Society guidelines for the management of adult bronchiectasis; (3) Willing to join in and sign the informed consent form.

Healthy control subjects were recruited according to the following inclusion criteria:(1) Age\>18 years; (2) No history of any lung disease (according to pulmonary imaging and physical examinations); (3) Willing to join in and sign the informed consent form.

Unhealthy control subjects were recruited according to the following inclusion criteria: (1) Age\>18 years; (2) The diagnosis of ILD was according to HRCT and clinical symptoms by two experts' consensus; (3) The diagnosis of Sarcoidosis (SA) was according to American Thoracic Society Clinical Practice Guideline;(4) Willing to join in and sign the informed consent form.

Exclusion Criteria:

(1) Patients combined with serious comorbidities (chronic renal failure, hepatic disease, etc.); (2) Patients who are diagnosed with asthma, pneumonia, malignant tumor, and COPD; (3) Women who are pregnant or preparing for pregnancy or breastfeeding; (4) Participated in other clinical trials within three months; (5) Refused to join in and sign the informed consent form.
Electromyographic Estimation of Neuro-muscular Coordination of Masticatory Muscles in Patients Treated With Implants (D-2012-057)

The result of the study will demonstrate that the functional activity of maxillofacial area with edentulous posterior bounded spaces recovers more effectively in patients treated with restorations on implants comparing to patients treated with fixed dentures.

All patients will be provided with electromyographic research before denture treatment, in a month and three months after the termination of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Partially edentulous bounded space in dental arch (not more that 3 teeth absent)
* Patients ages 20-45 y.o.

Exclusion Criteria:

* Chronical third-degree cardiac failure
* Connective tissue diseases
* Decompensated diabetes
* Neoplastic processes
* Strokes
A Pilot Study Analyzing Reproductive Results After IUI Using Vitrified Human Sperm

The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments.

Sperm cryopreservation is an efficient procedure widely used in fertility clinics, that provides logistical flexibility and increases the potential for success in assisted reproduction. It has been demonstrated that reproductive rates are comparable when using frozen sperm or fresh semen. However, sperm freezing using standard protocols is inevitably associated with a loss of motility, membrane integrity, and other post-thaw sperm quality parameters due to what is known as cryodamage, which involves the formation of intracellular ice crystals, osmotic shock, and dehydration.

Sperm vitrification has been recently developed as an improved alternative, where freezing occurs extremely rapidly (-20,000 ºC/min). Consequently, the formation of intracellular ice crystals is reduced, leading to improvements in sperm motility, vitality, and integrity.

However, the use of vitrified semen in fertility clinics is scarce, and no study has addressed whether vitrification could affect reproductive outcomes, such as live birth.

The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments through the analysis of clinical pregnancy (primary objective) and as secondary objectives the number of progressive sperm post-thaw, percentage of progressive sperm and biochemical pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Artificial Insemination with sperm from donor.
* Female partner's age \< 35 years
* First IUI attempt
* Caucasian phenotype

Exclusion Criteria:

* Any adverse medical condition that may significantly affect reproductive outcomes
Fast Titration in the Treatment of Schizophrenia, Taiwan

Assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent, at least 18 years old, inpatients with relapse Schizophrenia all subtypes, and with a CGI (Clinical Global Impression) score \>=4.

Exclusion Criteria:

* Pregnancy or breast-feeding, patients treated with Clozapine within 28 days of randomization, patients with a known arrhythmia, any psychotic disorders not defined in the inclusion criteria.
Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects

The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and tolerability of bosutinib in healthy subjects and subjects with liver disease.


Eligibility Criteria:
Inclusion criteria (for both study populations):

1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening.

   WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year (with follicle-stimulating hormone \[FSH\] level greater than or equal to 8 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue using it for 12 weeks after test article administration.
2. Have a high probability for compliance with and completion of the study.

Exclusion criteria (for both study populations):

1. History of clinically important cardiovascular disease.
2. Family history of QT prolongation, syncope, seizure, or unexplained cardiac-related death.
3. Presence or history of any disorder that may prevent the successful completion of the study.

Other inclusion and exclusion criteria apply.
Mazor X Stealth Versus O-arm Navigation for Pedicle Screw Insertion

The investigators would like to investigate the fluoro-registered Mazor X Stealth in terms of pedicle screw accuracy and radiation exposure in comparison with the O-arm and navigation as the institutional gold standard.

Pedicle screw insertion for spinal fusion is a surgical procedure regularly performed around the world. Surgeons use free-hand, navigation or robotic techniques. The navigation began in 1995 in spine surgery. Surgical navigation systems provide pedicle screw insertion by projecting screw trajectories on a three-dimensional (3D) image acquisition, preoperatively or during the surgical procedure. Laine et al reported better accuracy and safety in pedicle screw insertion using the navigation system. Other authors reported less irradiation with the use of computer-assisted navigation. Robotic guidance was introduced in 2006 and assists the surgeon through a mechanical guidance according to a planning of screw trajectories on 3D imaging. This technique allows stable guidance for pedicle drilling and screw insertion, leading to greater screw positioning in lumbar fusion.

Medtronic (Medtronic, Minneapolis, MN, USA) introduced the Mazor X Stealth in Europa in 2019, including the Mazor robotic device with the navigation technology within the same system. The hypothesis would be a combination of the stability of the robot during screw insertion and the accuracy of the navigation with cumulative benefit from the two techniques.

The goal of this study is to compare radiological and clinical results of the use of the new Mazor Stealth with the surgical O-arm navigation during pedicle screw insertion for posterior lumbar fusion.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* who require pedicle screw insertion for vertebral posterior stabilization

Exclusion Criteria:

* children
* participants incapable of judgment
* participants under tutelage
* vertebral fusion indication without pedicle screw implantation
* refusal to participate
* data missing for radiation exposure calculation
* unstable vertebral fracture requiring urgent fixation
* pregnancy
* refusal to participate