cyrilzakka/clinical-trials huggingface dataset:
Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

In the past many neonates with respiratory distress syndrome would require intubation, but over the years these rates have declined as the capabilities of non-invasive ventilation (NIV) have vastly improved. Despite these improvements, the decrease in pressure transmission due to factors such as resistance from tubing or air leaks around the nostrils and mouth, continues to be one of the major drawbacks when using nasal NIV. Current ventilators measure the set pressures at the circuit but do not capture the delivered pressure at the patient's nares. Recently, Medtronic PB980 ventilators feature NIV plus and leak sync software that can be calibrated to measure the pressures provided at the nostrils. Optimum pressures received at the nostrils to provide safe and effective therapy in neonates is currently unknown. In the prospective portion of the study, we aim to evaluate safety and efficacy of the software by comparing the average pressure difference between the circuit and delivery pressure at the nares, the incidence of apnea, bradycardia, desaturations as well as escalation and de-escalation of ventilator support in newborns who are receiving NIV admitted to NICU


Eligibility Criteria:
Inclusion Criteria:

* Gestation Age of 23-41 weeks
* Born at LAC+USC Medical Center and admitted to NICU
* Received NIPPV or nasal CPAP

Exclusion Criteria:

* Infants with any congenital anomalies
* Infants receiving only comfort care measures.
* Infants receiving invasive mode of mechanical ventilation (intubated)
* Non-inborn neonates
* Re-admissions to the NICU
The ChAMP (Chondral Lesions And Meniscus Procedures) Trial

The purpose of this randomized controlled trial is to determine the effectiveness of treating cartilage lesions found during knee arthroscopy.

Normal wear-and-tear on the knee can cause tissue, or cartilage, in the knee to soften over time forming chondral lesions. Worn out cartilage is often found during knee surgery for other conditions. Typically, surgeons will remove any worn out cartilage that is found using a procedure called debridement. However, the investigators do not know if surgically treating the worn out cartilage is better than leaving the tissue untreated, so it is necessary to compare the two. Patients who are found to have worn out cartilage during arthroscopy, will be randomly assigned to either receive treatment (debridement) or non-treatment (observation) of their cartilage. Patients without worn out cartilage will also be included in this study and observed postoperatively.

The primary objective of this study is to examine the effects of treatment of worn out cartilage (versus non-treatment of worn out cartilage and versus patients without worn out cartilage), on self-reported knee pain following arthroscopic meniscectomy using a double-blinded randomized controlled trial design. Secondary objectives of this study include examining the effects of treating worn out cartilage on other outcomes (subjective knee and general health scores and knee measurements including range of motion, presence of effusion and quadriceps circumference) and also to calculate the intra-operative costs associated with treatment, including the amount of time and instruments needed for debridement.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo a meniscectomy
* Patients with chondral lesions found during meniscectomy
* Patients without chondral lesions are not eligible for randomization to one of the study arms, but will still be included in the study and observed after surgery

Exclusion Criteria:

* Osteochondritis dissecans
* Large chondral flaps judged to be impending loose bodies
* Joint space loss of affected compartment greater than 50% compared to opposite side
* Visible osteophytes of the medial or lateral compartment
* Previous knee surgery on the affected side
* Previous major knee trauma
* History of inflammatory joint disease, gout, or chondrocalcinosis
* Presence of worker's compensation claim
* Patients undergoing meniscal repair
* Patients undergoing microfracture for contained grade IV chondral lesions
* Presence of significant ligamentous instability in the operative knee (i.e., complete acruciate ligament (ACL) or posterior cruciate ligament (PCL) tear, grade III medial or lateral side instability)
* Major neurologic deficit
* Serious medical illness with limited life expectancy or that poses high intraoperative risk
* Pregnancy
SI Joint Stabilization in Long Fusion to the Pelvis

The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.

This is a multicenter randomized controlled, postmarket clinical study to determine the differences between subjects undergoing standard MLF surgery with S2AI fixation in the pelvis vs the additional placement of iFuse 3-D in the bedrock configuration during MLF surgery. Subjects will be monitored for sacroiliac (SI) joint pain and at two years post surgery a CT scan will be taken to assess S2AI screw loosening or any other findings.

Eligibility Criteria:
Inclusion Criteria:

1. Age 21-75 at time of screening
2. Patient scheduled for multilevel (\>3 levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
3. Patient has signed study-specific informed consent form
4. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion Criteria:

1. Indication for multilevel spine fusion surgery is any of the following:

   1. Congenital neuromuscular disease
   2. Prior pelvic fixation (i.e., patient already has S2AI or iliac bolts in place, current surgery indicated to revise this hardware)
   3. Grade IV spondylolisthesis
2. Prior sacroiliac joint fusion/fixation on either side
3. Presence of spinal cord stimulator
4. Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery
5. Surgeon plans to use iliac screw for pelvic fixation
6. Any known sacral or iliac pathology
7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
8. Known metabolic bone disease
9. Severe osteoporosis
10. Known allergy to titanium or titanium alloys
11. Use of medications known to have detrimental effects on bone quality and soft-tissue healing
12. Neurologic condition that would interfere with postoperative physical therapy
13. Current local or systemic infection that raises the risk of surgery
14. Patient currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the SI joint or low back pain.
15. Currently pregnant or planning pregnancy in the next 2 years
16. Prisoner or a ward of the state.
17. Known or suspected drug or alcohol abuse
18. Uncontrolled psychiatric disease that could interfere with study participation
19. Fibromyalgia
HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults

The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205).

Healthy adult volunteers are assigned randomly to either a vaccine or placebo group. Injections are received either intramuscularly, intradermally, or by delivery under the skin of the volunteer's own white blood cells which have had dendritic cell reinfusion. Volunteers are vaccinated at 0, 1, 3, and 6 month time points. Volunteers are closely monitored for 1 hour after vaccination and keep a diary of symptoms for 1 week post-immunization. Volunteers undergo leukopheresis at the start of the study and after the last vaccination at Walter Reed Army Medical Center. Volunteers receive compensation benefits.

Eligibility Criteria:
Inclusion Criteria

Volunteers may be eligible for this study if they:

* Are legal US residents.
* Are healthy adults from 18 to 55 years of age.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

* Are HIV-positive.
* Are at highest risk for HIV infection.
* Are pregnant or breast-feeding.
* Are allergic to eggs or neomycin.
* Use certain prescription medications.
Pharmacokinetics of rFVIIIFc at Two Vial Strengths

The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months for a continued treatment period.

This is a randomized, open-label, crossover study during which each participant receives a single injection of rFVIIIFc from 2 different vial concentrations (PK assessment). After the PK assessment, participants are provided with rFVIIIFc for either prophylactic or episodic (on-demand) treatment for up to 6 months.

Eligibility Criteria:
Key Inclusion Criteria:

* Have severe hemophilia A
* Previously treated subject, defined as having at least 150 documented prior exposure days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products (other than any use of rFVIIIFc- study drug or commercial product) at Day 1. Fresh frozen plasma treatment must not be considered in the count for documented exposure days.
* No history of a positive inhibitor test or clinical signs of decreased response to FVIII administrations. Family history of inhibitors will not exclude subjects.
* No measurable inhibitor activity using the Nijmegen-modified Bethesda assay at Screening.
* Platelet count ≥100,000 platelets/μL at screening
* CD4 lymphocytes \>200 mm3 if known as HIV antibody positive at screening.
* Viral load of \<400 copies/mL if known HIV antibody positive at screening.

Key Exclusion Criteria:

* Subject is at high risk of bleeding during the 5-day period between the first and second injections for PK analyses, as per Investigator discretion.
* Previous treatment with rFVIIIFc as study drug or commercial product.
* Other coagulation disorder(s) in addition to hemophilia A.
* History of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration.
* Currently taking (or likely to require during the study) acetylsalicylic acid (ASA), except for low-dose ASA as prophylaxis (other nonsteroidal anti-inflammatory drugs are permitted).
* Concurrent systemic treatment with immunosuppressive drugs within 12 weeks prior to Day 1. Exceptions to this include: ribavirin for treatment of hepatitis C virus (HCV), and/or systemic steroids (a total of 2 courses of pulse treatments lasting no more than 7 days at a dose of ≤1 mg/kg within 12 weeks prior to Day 1) and/or inhaled steroids.

NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply
New Non-invasive Modalities for Assessing Retinal Structure and Function

This study investigates a new technology to assess the structure and function inside the eye. Retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal structure and function compared to other visual function tests.


Eligibility Criteria:
Controls:

Inclusion:

Normal eye exam in last 2 years

Exclusion:

Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay. Any abnormalities of the retina or optic nerve that could affect metabolism of the retina outside of normal.

Subjects with Inner Retina Defect:

Inclusion:

Defined structural defect to include those with Ischemic optic neuropathy, branch retinal artery occlusion (BRAO), hemianopia or visual field defect that respects the vertical meridian, inherited mitochondrial optic neuropathies such as Leber's and Dominant Optic Neuropathy, other retinopathies or optic neuropathies.

Exclusion:

Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.

Subjects with Outer Retinal Defect:

Inclusion:

AZOOR (acute zonal occult outer retinopathy) or other focal or diffuse outer photoreceptor loss of function

Exclusion:

Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.

The 450 total is to allow for exclusion of some subjects or in the event that the enrolled subject blinks too much or cannot fixate on a visual target adequately to maintain the same eye position during the short imaging interval. We hope to have a total of 450 (50 controls and 400 patients)
Dose Response to Topical Glyceryl Trinitrate in Patients With Raynaud's Phenomenon

The purpose of this study is to evaluate the blood flow response to topical Glyceryl Trinitrate when applied to the skin of patient's fingers with Raynaud's Phenomenon.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers aged between 18 and 50 inclusive
* Subject has idiopathic RP (patient may have undifferentiated connective tissue disease with positive ANA) diagnosed for more than two (2) years
* If a female, subject must be non-pregnant and non-lactating
* The subject has provided written informed consent prior to admission to this study

Exclusion Criteria:

* History of clinically relevant medical illnesses (not considering RP) that in the Investigator's opinion may jeopardize subject's safety or interfere with participation in the study, including but not limited to hemoglobinopathy, hemophilia, clinically significant retinal abnormalities, unstable hypertension, liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, psychiatric or psychological disorders, CNS trauma or active seizure disorders, allergic or immunologically mediated disorders
* History in the past five (5) years of drug or alcohol abuse
* History in the past five (5) years of vascular migraine or other chronic severe headache
* History in the past five (5) years of autonomic neuropathy or postural hypotension
* Unwilling or unable to comply with the restrictions outlined in the protocol
* Current use of smoking cessation treatment, including nicotine patches
* History of drug allergies, anaphylaxis or laryngeal oedema, including allergy to GTN, propylene/ethylene glycol or common moisturizing creams
* Use of any nitrate medication or any phosphodiesterase inhibitor within three (3) days prior to or intended use one (1) day following each dosing with study drug
* Currently treated for hypertension
* Currently receiving treatment for prevention and/or treatment of RP
* Use of any investigational medication within 30 days prior to dosing with study medication or scheduled to receive an investigational drug other than during the course of this study
* Open skin lesions or pathological condition (including, but not limited to, infection) in the area where the study medication is to be applied
* Use of topical corticosteroid to the hand or fingers within 10 days of treatment with study drug
* Withdrawal of consent at any time during the study
* Any condition, which compromises ability to give informed consent or to communicate with the investigator as required for the completion of this study
* Previously enrolled in the study
Efficacy and Safety Study of Kinerase® for Treatment of Cutaneous Facial Photodamage

The purpose of the K.I.S.S. study is to evaluate the efficacy of Kinerase® Cream (Kinetin 0.1%) in Thai patients, on the basis of the severity and clinical signs of facial photodamage.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects older than 35 years of age and less than 65 years of age.
2. Subjects with mild, moderate or severe facial photodamage as assessed by a 10-point scale.
3. Subjects willing to sign an informed consent and adhere to all protocol requirements.

Exclusion Criteria:

1. Male and female subjects with suspected porphyria, systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug-induced photosensitization.
2. Subjects with chronic or recurring skin disease or disorder.
3. Subjects with any active infectious skin disorder (Herpes simplex, molluscum contagiosum, and facial warts).
4. Subjects with skin cancer of the facial tissues.
5. Subjects who have received any laser/ intense pulsed light (IPL) / chemical peel in the 2 months preceding the screening visit.
6. Subjects with a history of topical and/or oral isotretinoin use, 6 months prior to the screening visit.
7. Subjects who have been on topical Retin-A or Renova in the 2 months prior to the screening visit.
8. Subjects who have used topical alpha-hydroxy acid skin care products in the month preceding the screening visit.
9. Subjects currently on any anti-aging products and who wish to continue use of their products.
10. Subjects requiring concurrent treatment that would interfere with the study assessments.
11. Pregnant or lactating female subjects.
Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

The purpose of this study is to describe alterations of serum ferritin, transferrin saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes, reticulocyte hemoglobin content after iron loading in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* hemodialysis for three months minimum
* stable epoetin dose for two months minimum
* serum ferritin concentration \< 1000 ng/ml
* transferrin saturation \< 50%
* parathormone concentration \< 800 pg/ml

Exclusion Criteria:

* hemoglobin concentration \> 13g/dl
* serum ferritin concentration \< 20 ng/ml
* vitamin B12 and/or folic deficiency
* other hematologic disease than anemia
* cancer
* hypothyroidism
* infectious disease
Safety Evaluation of Gene Therapy in Leber Hereditary Optic Neuropathy (LHON) Patients

The purpose of this study is to evaluate the safety and tolerability profile of ascending doses of GS010 in Leber Hereditary Optic Neuropathy (LHON) patients.


Eligibility Criteria:
Inclusion Criteria:

Documented diagnosis of LHON based on a genetic test confirming the presence of the G11778A mutation in the mitochondrial ND4

Age 18 years old or older at the time of study entry (informed consent signature)

Visual acuity ≤ 1/10 of the less functional eye

Exclusion Criteria:

Any known allergy or hypersensibility to one of the product used during the trial

Contraindication to IVT surgery (anaemia Hb \<8g/dl, severe cardiovascular disease, severe coagulopathy...)

Disorder of the ocular humors and of the internal retina involving visual disability

Glaucoma

Presence of other pathology whose symptoms or associated treatments might affect the retina or the optic nerve Vascular retinal occlusion

Narrow angle contra-indicating pupillary dilation

Other cause of optic neuropathy (inflammatory conditions or exposure to toxins...)

Patients presenting known mutation of other genes implicated in pathological retinal conditions
LCI-HEM-SPEC-001: Tissue Collection for Genetic Analysis of Acute Myelogenous Leukemia

The purpose of this study is to obtain high quality specimens for molecular studies for the identification and characterization of genetic mutations involved in the pathogenesis of familial myeloid malignancies. Specimens obtained will be de-identified, linked to basic clinical data, and sent to Washington University (Division of Oncology, St. Louis, MO) for molecular analyses. Some specimens sent to Washington University may also be used for quality control analyses.

This is a specimen collection study for patients receiving standard of care treatment for AML. Specimens collected will be 1) bone marrow biopsy and aspiration, 2) peripheral blood, 3) skin punch biopsy, and 4) oral rinse. Collection of these specimens will be at timepoints determined by the patient's standard of care and their physician Investigator.

Eligibility Criteria:
Inclusion Criteria

* Patients must have a diagnosis of acute myelogenous leukemia.
* Family members of patients with acute myelogenous leukemia may be enrolled.
* Informed consent must be provided by the patient or his/her legal guardian in accord with the practices of Levine Cancer Institute and Atrium Health.

Exclusion Criteria

* Known infection with Hepatitis B or C, HTLV, or HIV.
Pounce™ Thrombectomy System Retrospective Registry

The PROWL registry is an open-label retrospective, multi-center, US study of the Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature.


Eligibility Criteria:
Inclusion Criteria:

* Subject underwent an endovascular intervention where the Pounce Thrombectomy System was attempted
* Subject is willing and able to provide informed consent prior to the collection of study data or a consent waiver is in place

Exclusion Criteria:

* Subject is under the age of 18 years
Universal Exercise Unit Therapy With Sling Exercise Therapy on Lower Limb Kinematics in Chronic Stroke Patients

Stroke occurred when blood supply to brain or a part of brain is disturbed due to clot (ischaemic stroke) or due rupture of small vessels (hemorrhagic stroke) in brain and causes bleeding in brain cells. The prevalence of stroke was 1.2 % (1200/100,000) in Pakistan, 3.1% in China and it is 44.29 to 559/100,000 in different parts of the world. Leading cause of stroke is hypertension. The aim of study will be to compare universal exercise unit therapy with sling exercise therapy on lower limb kinematics, disability, balance and quality of life in chronic stroke patients.

This will be randomized controlled trial. Study will be conducted at Khawaja Arshed Hospital Sargodha. Duration of intervention will be 08 weeks, 5 sessions in a week, total 40 sessions. Duration of single session will be one hour. A convenient sample of n patients fulfilling the inclusion and exclusion criteria will be selected from in-patient settings of various hospitals from the city Sargodha and will be allocated randomly into three groups equally after taking informed consent. Group A will obtain Universal Exercise Unit Therapy. Group B will obtain Sling Exercise Therapy and Group C will be control and will receive routine physical therapy. Outcome will be measured at baseline, 04 weeks and 08 weeks. Outcome measurement tools will be Berg balance scale, Barthel index, Short form 12 (SF-12), Trunk impairment scale, functional reach test and smart phone motion analysis for lower limb kinematics. Scores will be measure in mean and SD. Results of intervention will be comparing by using one way ANOVA by using IBM SPSS version 21.0

Eligibility Criteria:
Inclusion Criteria:

* Patient with chronic (course of disease at least six month)
* Recently discharge from in-patients setting with in 06 month of onset
* Hemiplegia (either right or left)
* Both gender
* Age between 30 to 70
* Medically stable
* No balance disorders before this stroke.
* History of mental
* illness or severe cognitive impairment (MINI-MENTAL SCALE SCORE \> 25)

Exclusion Criteria:

* Stroke Patient with complication like shoulder hand syndrome, adhesive capsulitis or shoulder partial dislocation
* Stroke patients with behavioral issue, significant cognitive deficit
* Patients with arthritis and fracture
* Chronic stroke with deformities
* Serious viscera dysfunction, such as cardiovascular system,
* Lung, liver and kidney
* History of mental
* Illness or severe cognitive impairment (MINI-MENTAL SCALE SCORE \> 25)
* Audio-visual understanding
* obstacle, unable to cooperate with instructions;
* Infection and ulcer skin