cyrilzakka/clinical-trials huggingface dataset:
Continuity of Leg Movements in VLBW Premature Infants: From Spontaneous Kicking and Supported Stepping to Independent Walking

The purposes of this one-year follow-up study are twofold: (1) to prospectively examine the spontaneous kicking and the supported stepping movement in VLBW premature infants until attainment of independent walking; and (2) to assess factors (i.e. gross motor development, cardiopulmonary function, anthropometry, body composition and cognition) that could potentially influence walking attainment in VLBW premature infants.

Very low birth weight (VLBW) preterm infants (birth weight \< 1,500g) sustain a high risk of neuromotor disability, as exemplified by delayed walking attainment. Spontaneous kicking and supported stepping have been proposed as the early precursors to independent walking. The continuity of these early leg movements with independent walking has been established in normal term infants, but such relations remain unclear in VLBE premature infants. Therefore, the purposes of this one-year follow-up study are twofold: (1) to prospectively examine the spontaneous kicking and the supported stepping movement in VLBW premature infants until attainment of independent walking; and (2) to assess factors (i.e. gross motor development, cardiopulmonary function, anthropometry, body composition and cognition) that could potentially influence walking attainment in VLBW premature infants. This study will enroll 15 VLBW premature infants born at National Taiwan University Hospital. Infants will be scheduled for spontaneous kicking examination at 2 and 4 months of corrected age, followed by supported stepping examination at 9 and 11 months of corrected age and recorded their age of walking attainment. Age of walking attainment is defined as the time when the child is first able to move for five successive steps without support. At each visit, infants will be examined for spontaneous kicking or supported stepping movements (with three-dimensional kinematic analysis of Peak Motion Analysis System), gross motor function (with the Alberta Infant Motor Scale), cardiopulmonary function (with a pulsed oxymeter), anthropometry (with scale and tape measure), body composition (with the Pediatric Plicometric System) and cognition (with the Chinese Child Development Inventory- Cognitive Subscale). The results of this study will provide important information to help reveal the maturation process of early leg movements prior to walking attainment in premature infants. Furthermore, the identified early neuromotor markers and influencing factors for walking attainment will provide physical therapists useful guidance in making early treatment plans for those premature infants who will develop motor delays.

Eligibility Criteria:
Inclusion Criteria:

* BW below 1500 gm
* GA under 37 weeks

Exclusion Criteria:

* Existence of congenital anomalies and genetic disease
NBM-200 Clinical Study in Blood Donation Setting

The NBM-200 is a portable Hemoglobin and oximetry monitor, based on occlusion spectroscopy technology, for non-invasive spot checking of hemoglobin (Hb), estimated Hematocrit (Hct), SpO2 and pulse rate.

The NBM-200 includes a reusable ring-shaped sensor probe that fits on the patient's finger, and a portable desktop monitor that calculates and displays the measurement result.

The sensor probe consists of a multi-wavelength optical measuring system and inflatable cuff employing pneumatic tissue manipulation. Blood flow in the finger can be briefly occluded and the resulting changes in its optical behavior are analyzed to provide accurate measurements of Hb.

The proposed study plan will support a 510(k) submission for the non-invasive NBM-200 system with a blood bank indication. In accordance with the agency's suggestion, OrSense plans to use as a predicate an FDA-cleared blood analyzer with a hemoglobin test method that is traceable to the cyanmethemoglobin method or that was standardized and calibrated using the International Council for Standardization in Hematology (ICSH) hemoglobin standard, e.g., the HemoCue-301 or EKF's Hemo Control Hemoglobin Measurement System. OrSense further plans to use the cleared NBM-200 (K142209) as a reference device. Clinical data will be collected in a blood donor population using 3 methods to check hemoglobin (Hb): (1) the non-invasive NBM-200 system; (2) a point-of-care device based on finger sticks that is FDA-cleared for use in blood banks, such as the HemoCue or EKF device; and (3) a laboratory analyzer based on venous blood samples.

Participants will be recruited via email and during their visit to the designated donor rooms.

Eligibility Criteria:
Inclusion Criteria:

* Regular donors and volunteers

Exclusion Criteria:

* Pregnancy
Treating Pre-School Children at Risk for Overweight in the Primary Care Setting

The goal of this study is to test, in the primary care setting, the efficacy of an innovative intervention program for children aged 2-5 years with a BMI over the 85th percentile and one overweight parent (BMI \>27 kg/m2.


Eligibility Criteria:
Inclusion Criteria:

* 2-5 year old with a BMI greater than the 85th% for age and sex
* one overweight parent (BMI\>27kg/m2)
* child with normal developmental milestones
* history of adherence to 90% of scheduled primary care visits
* parent must be at 5th grade reading and speaking of English language or the spanish language
* no plans on moving out of the area for the 2 years subsequent to enrollment

Exclusion Criteria:

* child with a height 2 SD below the mean for age and sex and/or pathological growth velocity
* SGA
* any chronic disorders influencing energy intake and/or growth
* any orthopedic disorder preventing the child or the parent from ambulation normally and performing the activity prescribed by the program
* any medication known to have the potential of affecting weight changes
* parent or child with psychiatric and/or eating disorder
* participating mother who is pregnant or planning a pregnancy
* parent being acquainted with the parent of a previously randomized study participant
Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis

To use different starting doses of methotrexate (7.5 mg per week) versus 15 mg per week in patients with rheumatoid arthritis, followed by similar hiking up of dose (2.5 mg per 2 weeks, till max of 25 mg per week). To look at the effect on efficacy ( or speed of efficacy) versus the adverse effects.

Hypothesis: There will be no difference in the adverse effects, but better and faster control of disease when starting with a higher methotrexate dose


Eligibility Criteria:
Inclusion Criteria:

* Patients with rheumatoid arthritis fulfilling the ACR 1987 criteria
* Between 18 years to 65 year of age
* Having active disease Disease activity score (28 joints) DAS28-3 more than 5.1
* Not on methotrexate in the last 2 months
* Permitted to be on corticosteroids if the dosages stable for at least 1 weeks before randomization and if corticosteroid dosage less than 10 mg/day
* Permitted to be on other disease modifying anti-rheumatic drug (DMARD) like sulfasalazine, leflunomide and hydroxychloroquine, if dosages stable for at least 2 weeks before randomization

Exclusion Criteria:

* Pregnant/Breastfeeding
* Ongoing/Recent treatment with methotrexate (2 months)
* Chronic liver disease
* Renal failure
* Any leucopenia or thrombocytopenia
* Breast-feeding
* Desirous of pregnancy in the next 6 months
* Known Hepatitis B or C positive
* Known clinically relevant chronic lung disease: ILD
* Tuberculosis or other active infections
* Known HIV positive
Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma

Phase I/II study to evaluate TAC01-CD19 in subjects with relapsed or refractory B-cell lymphomas. TAC technology is a novel way to genetically modify T cells and to redirect these T cells to target cancer antigens by co-opting the natural T cell receptor. The dose finding portion of this study will evaluate the safety and tolerability of increasing dose levels of TAC01-CD19 to identify a Maximal Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D). The dose expansion portion of the study will further evaluate the safety, efficacy and pharmacokinetics of TAC01-CD19 at the RP2D.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed CD19+ Large B-Cell Lymphoma including Diffuse Large B-cell Lymphoma (DLBCL) not otherwise specified (including de novo and transformed lymphoma), Primary Mediastinal Large B-cell Lymphoma, High-Grade B-cell Lymphoma with MYC and BCL2 and/or BCL6 rearrangement per WHO 2016 classification.
* Relapsed or refractory disease after greater than 2 lines of therapy including anthracycline and anti-CD20 therapy and either having failed autologous stem cell transplant (ASCT) or being ineligible for ASCT.
* ECOG 0-1.
* Adequate organ function.

Exclusion Criteria:

* Prior treatment with any of the following: allogeneic bone marrow transplantation, gene therapy, adoptive cell transfer of any kind, including CAR T cells.
* Active central nervous system (CNS) lymphoma involvement.
* History or presence of clinically relevant CNS pathology.
* Active inflammatory neurological disorders, autoimmune disease, or infections.
Use of the Nasal Cannula During COVID-19

The objective of this investigation is to determine the incidence of the use of the low flow nasal cannula in suspected or confirmed cases with Covid-19

An anonymous questionnaire will be sent to a group of anesthesiologists via email which will allow to collect information about the use, or not, of the low flow nasal cannula, the type of procedure where it is used, and the type of personal protection weared.

Eligibility Criteria:
Inclusion Criteria:

* only for physicians

Exclusion Criteria:

* not physicians
Study of Polymorphisms of RAAS and MMPs in Acute Heart Failure

this study aim to investigate the:

* association of RAAS polymorphisms and AHF
* association of MMP 3 and 12 polymorphisms and AHF

Heart failure can be defined as a complex clinical syndrome that results from any structural or functional disorder of the heart, with impairment of ability to fill the ventricles or eject blood. The main event of the IC is dyspnea and fatigue, which limit exercise tolerance and induces water retention.

The renin angiotensin aldosterone system governs the salt and water homeostasis in the body. Renin is a proteolytic enzyme secreted by the juxtaglomerular apparatus of the kidney (area near the glomeruli). Renin has no direct action on the organism, but that is part of the renin-angiotensin system or the renin-angiotensin-aldosterone system is known.

To date, few published studies have examined the association between the polymorphism AGT M235T \* and cardiac dysfunction; and available results are contradictory. What is not known yet is the ratio of this polymorphism with the prognosis of heart failure.

Eligibility Criteria:
Inclusion Criteria:

* aged more than 18 year old.
* acute non traumatic dyspnea .

Exclusion Criteria:

* ECG diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours
* a history of a heart transplant, pericardial effusion, chest wall deformity suspected of causing dyspnea
* coma, shock,MV,vasopressor drugs
* arrhythmia serious and sustained,
* pace maker
* severe mitral valve disease,
Study on Pancreatic Islets in Patients Undergoing (Partial) Pancreatectomy (PRECISE)

The study investigates the mechanisms underlying the pathogenesis of diabetes by examining structural and functional properties of islets of Langerhans in pancreas specimen from patients undergoing (partial) pancreatectomy.

The study aims at elucidating the mechanisms underlying the pathogenesis of diabetes. In particular, the study focusses on detailed analyses of morphological and functional properties of pancreatic islets/insulin-producing beta cells in order to identify diabetes-associated alterations on cellular and molecular levels. To directly address the role of the endocrine (and exocrine) pancreas in the complex process of diabetes development, the examinations are performed in samples of human pancreatic tissue. To this end, biopsy specimen of pancreas and visceral adipose tissue are collected from patients with or without diabetes who undergo (partial) pancreatectomy. The samples are analysed for morphological alterations (e.g. size and distribution of pancreatic islets and beta cells, size of adipocytes) and functional changes (e.g. gene expression patterns as assessed from beta-cell derived RNA). In addition, patient characteristics such as age and disease duration are documented and clinical data including fasting concentrations of blood glucose, insulin and free fatty acids are collected. Specific diabetes-associated alterations of pancreatic islet / beta cells are assessed by associating variables of glucose- and lipid-homeostasis with parameters of beta cell function. The expected outcomes of the study will contribute to improve our knowledge of the so far largely unknown molecular and cellular mechanisms involved in the pathogenesis of diabetes.

Eligibility Criteria:
Inclusion Criteria:

ability to give informed consent

Exclusion Criteria:

denial of informed consent
Effects of System Suspended Robotic Lokomat Gait in Patients With Incomplete Spinal Cord Injury

Patients with incomplete spinal cord injury

The objective of this project is to verify the effects of suspended robotic gait training (Lokomat) in recovery of functional capacity of the lower limbs patients with incomplete spinal cord injury.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis of incomplete spinal cord injury of traumatic origin
* Injury time from 1 to 36 months
* Stability verified in clinical medical evaluation
* ASIA C or D
* Absence of severe psychiatric amendment requiring psychiatric evaluations
* Present functional recovery of the upper limb compatible with stages III and IV of Brunnstrom
* Patients cannot use a cardiac pacemaker ; have unstable angina or other decompensated heart disease; have chronic obstructive pulmonary disease; dysreflexia without having autonomic control; have some fracture of the bones of the lower limbs; tracheostomy; presenting deformity and stiffness of the hip joint, knee (20 ° or more of flexion ) and ankle ( 10 or more plantar flexion ) and pressure ulcers.
* Absence of illicit drug use
* Grant writing the informed consent to participate in the study

Exclusion Criteria:

* Lack of resistance
* Disabling fatigue
* Worsening of spasticity which prevents the movement
* Body weight in excess of 150Kg
* Risk of osteoporosis with pathological fracture
* Asymmetry in the lower limbs greater than 2 cm
* Skin lesions and / or pressure ulcers in areas where the orthosis Lokomat pressuring
Ultrasound Analysis of Suspected Long Bone Fractures in the Emergency Department - Diagnostic Performance Compared to Radiography.

Ultrasound tool in bones trauma is underused in the emergency department of the University Hospital of Saint-Etienne. This prospective non randomized monocentric study will measure how much this non irradiant method of diagnostic is sensible and specific in long bones fractures, and will evaluate it advantages versus conventional X ray examination.

This study is based on physical examination (swelling, hematoma, edema) and concerns all long bones, including benign trauma (non deforming and closed fractures). The necessary time to make an ultrasound conclusion and the operator certitude degree will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Children with low kinetic, non-deforming, non-open long bone trauma

Exclusion Criteria:

* Opened fracture, deforming trauma
Ultrasound Guided Diagnostic Lumbar Puncture in Neurology

Subjects who are having a lumbar puncture as part of their clinical care will be randomized to either a traditional landmark based lumbar puncture or ultrasound guided lumbar puncture. The primary objective of study is to compare the success rate of obtaining CSF using Ultrasound guided technique against the Traditional Landmark based approach. Secondary objectives are to evaluate factors influencing the success or failure, patient tolerance, and a safety assessment.

Seventy-two subjects will be randomized into either a traditional landmark-based lumbar puncture or an ultrasound-guided lumbar puncture for obtaining CSF. This study will be conducted in the Neurology clinic. For subjects in the traditional group, the site of needle entry will be determined through palpation of the spine. For subjects in the ultrasound group, site entry will be done using ultrasound guidance. Success and failure of these techniques will be compared along with secondary outcome measures aimed at assessing the safety and efficacy of each of these techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for LP through Neurology's LP clinic
* 18 years of age or older
* Able to understand the description of procedure and provide informed consent

Exclusion Criteria:

* Any contraindications to doing a standard lumbar puncture; which typically includes risk of bleeding from effects of anticoagulants or bleeding disorders or an infection at the potential site of entry in the back. This includes subjects with spinal cord stimulators.
Confirm the Safety and Performance of Avance Solo NPWT System

The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm safety and performance of Avance® Solo NPWT System in low to moderate exuding acute (traumatic wounds and flaps and grafts), as well as subacute (e.g., dehisced wounds) wounds when used in accordance with the Instructions for Use, for up to 28 days.

This investigation is designed as a prospective, open, non-comparative, PMCF investigation to confirm safety and performance of Avance Solo NPWT System in subjects with traumatic wounds (n=34), subacute (e.g., dehisced wounds) wounds (n=34), and flaps and grafts (n=34). This is a multi-center study that will take place in approximately 5 European countries. The eligible subjects will be both in and out patients and all will be treated with Avance Solo NPWT System, for up to 28 days.

Treatment will be stopped if the wound is considered healed, has a high enough percentage of graft take, or enough flap viability by the judgement of the clinicians before the complete treatment time (28 days).

The primary performance endpoint will include assessment of wound progress compared to last visit during a maximum 28 days investigation period. Wound progression is determined by the Investigator and will be assessed at each follow-up visit and measured by three outcomes:

* Deteriorated
* No change
* Improved

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years.
2. Signed written informed consent.
3. Low to moderate exuding acute (traumatic wound, or a flap/graft) or subacute (e.g., dehisced wounds) wounds suitable for single use NPWT according to the investigator´s judgement and Instructions for Use

Exclusion Criteria:

1. Known malignancy in the wound or margins of the wound
2. Untreated and previously confirmed osteomyelitis
3. Non-enteric and unexplored fistulas
4. Necrotic tissue with eschar present
5. Exposed nerves, arteries, veins or organs
6. Exposed anastomotic site
7. Subjects with known allergies/hypersensitivity to product components.
8. Known pregnancy or planning to become pregnant or lactation at the time of study participation.
9. Subjects not suitable for the investigation according to the investigator's judgement and Clinical Investigation Plan and IFU.
10. Participating in other ongoing clinical investigation, or during the past 30 days that may impact the outcome of this investigation based on the judgement of the investigator.
Clinical Evaluation of Lyral® Dose Response Study

The purpose of this study is to determine optimal allergen dose as the lowest concentration eliciting positive reactions in 70-90% of subjects. Frequency of positive, negative, doubtful and irritant reactions, and concordance with a corresponding reference allergens will be captured.

This is a single-center, randomized study to compare the diagnostic performance and safety of ascending doses (0.10 mg/cm², 0.20 mg/cm² and 0.40 mg/cm²) of hydroxyisohexyl 3-cyclohexene carboxaldehyde (Lyral®) in 20 adult subjects with a past positive patch test to Lyral® or Fragrance Mix 2.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females 18 years of age and older.
2. Clinical history of contact dermatitis and positive patch test (current or previous) to either Lyral® or Fragrance Mix 2; otherwise in good general health.
3. Unable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential; Inability to become pregnant would include all male subjects and female subjects who are postmenopausal for at least 1 year, or surgically sterile- have had a hysterectomy, bilateral ovariectomy, uterine ablation or bilateral tubal ligation.

   Acceptable methods of contraception include: 1) systemic birth control (the same type of birth control for at least 3 months prior to entering the study and continuation of this type of birth control throughout the study); 2) double barrier methods (condom with spermicide or diaphragm with spermicide); 3) intra uterine device; 4) vasectomized partner; or 5) abstinence from sexual intercourse.
4. Have read and signed the consent form and are able to fulfill the study requirements and make all required visits.

Exclusion Criteria:

1. Lactation or pregnancy, determined by urine pregnancy test (UPT) for females of childbearing potential. UPT must be conducted prior to patch placement.
2. Treatment with topical corticosteroids on or near the test area during the previous 7 days.
3. Treatment with systemic corticosteroids or immunosuppressives during the previous 7 days. (Inhaled treatments are permitted.)
4. Treatment with ultraviolet (UV) light, including tanning, during the previous 3 weeks.
5. Acute dermatitis outbreak or dermatitis on or near the test area on the back.
6. Participation in another clinical study involving an investigational drug, treatment or device currently or within the previous 3 weeks.
7. Unable to comply with activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
8. Unable or unwilling to comply with multiple return visits.