cyrilzakka/clinical-trials huggingface dataset:
A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients

This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax exposure event. The study is designed to collect information on safety, clinical benefit (such as extent of anthrax illness and survival) and serum concentrations of AIGIV (for AIGIV pharmacokinetics) and anthrax toxins from inhalational anthrax patients treated with AIGIV.

This study is a post-marketing requirement from the FDA to evaluate safety and clinical benefit of AIGIV administered to patients as part of their medical care after inhalational exposure to Bacillus anthracis. Study information (i.e. data on safety and clinical benefit evaluation of AIGIV up to Day 30 following administration) and patient samples (for assessment of AIGIV pharmacokinetics and anthrax toxin levels) will be collected (up to Day 7 following AIGIV administration) prospectively to the extent possible; however, due to logistical complexities that will likely occur during a mass anthrax exposure event, most data for this study will be collected retrospectively (including scavenged patient samples for assessment of serum AIGIV concentration and anthrax toxin levels). Therefore, both prospective and retrospective data collection are allowed in this study to maximize the amount of information obtained from inhalational anthrax patients who have been administered AIGIV.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario.
* Treatment with AIGIV.
* Informed consent/assent (as applicable).

Exclusion Criteria:

* There are no exclusion criteria for subjects enrolling in this study.
2D Versus 3D Radiographs in the Localization of Upper Impacted Canines

Seventeen patients diagnosed with the extraction-based treatment of impacted maxillary canines will be included in this study. Each patient will undergo conventional 2D radiography including panoramic, and lateral cephalometric, in addition to 3D imaging by cone beam computed tomography (CBCT) images.

A set of variables will be evaluated on 2D and 3D images by a panel of assessors and then these results will be compared with the gold standard which will be established based on surgical detection and direct visualization of the impacted canine.

After taking the radiographic records, the impacted maxillary canines will be surgically exposed under local anesthesia where a full-thickness flap will be elevated from the buccal or palatal according to the initial radiographic diagnosis.

After cleaning the work yard to achieve good visibility, the pre-extraction parameters will be recorded which will be included labiopalatal position, mesiodistal position, and vertical position of the canine cusp, in addition to ankyloses of the impacted maxillary canine, proximity to the adjacent teeth, resorption of the adjacent incisors induced by the impacted maxillary canine, and bony coverage of the canine crown.

This will be followed by the extraction of the upper impacted canine and the recording of the post-extraction parameters, which will include the shape and the root apex development of the extracted canine. The pre- and post-extraction readings will be deemed the gold standard which will be compared to the 2D- and 3D-based assessments of the assessors.

Assessment sessions will be divided into two sessions with a one-week break in between. The first session will be devoted to the evaluation of the 2D image sets, while the second one will be to the evaluation of the 3D images.

Before beginning the assessment, the assessors will be subjected to a set of instructions and clarifications, including a set of graphs that help each assessor to accurately identify each variable, in addition to an oral explanation of some points so that the assessor will not fall into doubt when evaluating the radiographs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients from both gender (Male and female), Age range: 14-27 years.
2. Unilateral impaction of the maxillary canines requiring surgical extraction.
3. Non-syndromic patients without any pathology of the maxillofacial region (benign or malignant tumor, cleft lip or cleft palate, trauma)
4. Patients with a set of panoramic and lateral cephalometric images, in addition to CBCT radiograph (CBCT is indicated for treatment planning)
5. The time period between taking the radiological records and undergoing the surgical intervention does not exceed four weeks

Exclusion Criteria:

1. Patients who had a systemic disorder, cleft lip/cleft palate, craniofacial syndrome, traumatic injury, and congenital number anomaly.
2. Patients had previous orthodontic treatment.
Efficacy and Safety of Duloxetine

The purpose of this study is to monitor the long term safety and efficacy of duloxetine in the treatment of severe pure genuine stress incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Female out patients.
* Have a diagnosis of pure genuine stress incontinence on urodynamic study performed within 6 months prior to study entry.

Exclusion Criteria:

* Use of monoamine oxidase inhibitors within 14 days prior to study entry or at any time during the study.
* Suffer from severe constipation.
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.

This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 16-week treatment period. Vehicle looks the same as HP802-247 but contains no cells. Target wound status is evaluated at each study visit (closed, open, reopened). At wound closure or completion of treatment all subject will enter an observational safety followed up period which ends at one year after initial exposure to test article.

Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent.
* Age ≥ 18 years and of either sex.
* Willing to comply with protocol instructions, including allowing all study assessments.
* Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area \>12 cm2 to ≤ 36 cm2
* Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
* Arterial supply adequacy confirmed
* Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
* Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
* Acceptable state of health and nutrition

Exclusion Criteria:

* History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
* Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
* A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
* Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
* Refusal of or inability to tolerate compression therapy.
* Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
* History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
* Any prior exposure to HP802-247 or its vehicle.
Microvascular Ocular Changes of Systemic Lupus Erythematous

The goal of this observational study is to to assess the ocular microvascular status of SLE patients with inactive disease and without ocular involvement. The main questions it aims to answer are:

* the choroidal vascular status and thickness in SLE
* the retinal macular microvascular status and structure in SLE

Participants will be assessed with Spectral Domain Optical Coherence Tomography (SD-OCT). Researchers will compare SLE patients with healthy controls matched for age and sex.

The investigators will perform a cross-sectional evaluation of 25 SLE patients and 25 healthy controls matched for sex and age, using a Spectral Domain Optical Coherence Tomography (SD-OCT) with Enhanced Depth Imaging for choroidal assessment and with Angiography module to assess the retinal and choriocapillaris vasculature. Processing of image with external software will be performed to calculate the main outcomes: retinal vessel density, foveal avascular zone parameters and the choroidal vascular index.

Eligibility Criteria:
Systemic inclusion criteria for SLE patients:

* fulfill the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria for the diagnosis of SLE
* age between 18 and 80 years
* no disease activity (SLEDAI \<3)
* no risk factors for drug toxicity

Systemic inclusion criteria for control group:

* no systemic diseases
* age between 18 and 80 years

Systemic exclusion criteria:

* arterial hypertension (defined as systolic blood pressure higher than 140 mm Hg or diastolic blood pressure higher than 90 mm Hg) or medically treatment for hypertension
* diabetes mellitus
* nephropathy or other documented microvascular complications
* secondary Sjögren syndrome
* local or systemic inflammatory diseases (other than SLE)
* smokers of more than 20 cigarettes a day
* pregnancy.

Ophthalmological inclusion criteria:

* best-corrected visual acuity ≤ 0.3 LogMAR
* intra-ocular pressure \<21 mm Hg on diurnal testing with measurements using Goldmann applanation tonometry
* spherical equivalent refractive error between -6.0 and +4.0 diopters
* open anterior chamber angle on slit lamp examination.

Ophthalmic exclusion criteria:

* established primary ocular diseases including a history of any retinal or optic nerve disease
* presence of significant lens opacities (Lens Opacities Classification System III equal to or more stage 2)
* retinopathy
* high refractive error
* ocular hypertension
* previous intraocular surgery or trauma.
Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry

This study is a collection of data to evaluate safety and characterize progression of Paroxysmal Nocturnal Hemoglobinuria (PNH).

Collection of data to evaluate safety and characterize progression of Paroxysmal Nocturnal Hemoglobinuria (PNH).

Eligibility Criteria:
Inclusion Criteria:

* Patients of any age, including minors, with a diagnosis of PNH or a detected PNH clone, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment. Patients who are minors must have parent/legal guardian consent and must be willing and able to give assent, if applicable as determined by the Ethics Committees/Institutional Review Boards. Upon attaining adulthood, these patients must be re-consented.
* Ability to comprehend and sign consent to have data entered in the PNH Registry.

Exclusion Criteria:

* Inability or unwillingness to sign informed consent.
* Patients currently enrolled in an interventional clinical trial for treatment of PNH cannot be enrolled in the Registry at the same time.
LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)

To collect information about implant performance and patient clinical outcomes in patients undergoing primary total knee arthroplasty with the LinkSymphoKnee total knee replacement system with ultra-congruent tibial bearing surface.

The study will collect outcomes data on up to 600 patients from up to 3 sites using a legally marketed device according to its labeled intended use.

The study will collect:

1. KOOS-JR
2. Knee Society Score (KSS), 2011
3. PROMIS Global Health
4. PROMIS Physical Function
5. PROMIS Pain Interference
6. Surgery Satisfaction
7. Forgotten Joint Score
8. Radiographic findings
9. Revisions.

Radiographic evaluations will be done through postoperative year 2. Other outcomes will be evaluated up to postoperative year 5.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, and skeletally mature; and
* Undergoing a primary TKA for one or both knees using the cemented LinkSymphoKnee knee system as part of the surgeon's standard of care.
* Able to read and understand English (because patient-reported outcome questionnaires are not validated for all potential other languages).

Exclusion Criteria:

* 80 years of age or older,
* Women who are pregnant at the time of surgery,
* History of joint sepsis,
* Bone defect that requires grafting,
* Previous history of bone disease (e.g., severe osteoporosis or osteomalacia) which in the surgeon's opinion is severe enough to compromise device fixation,
* Systemic conditions affecting bone density (e.g., inflammatory arthritis or renal disease) which in the surgeon's opinion are severe enough to compromise device fixation,
* A poorly functioning contralateral total knee replacement or a contralateral revision regardless of function.
Effect of Steep Trendelenburg in Laparoscopic Surgery on IOP & RNFL Thickness

The effect of Steep Trendelenburg position used during laparoscopic surgery on intraocular pressure during surgery and on the retinal nerve fiber thickness after surgery

To measure IOP and RNFL thickness in subjects undergoing laparoscopic operations in steep trendelenburg before, during, and after the operation

Eligibility Criteria:
Inclusion Criteria:

* SUBJECTS INTENDING TO UNDERGO LAPROSCOPIC SERGURY WHICH HAVE NO EYE DISEASES

Exclusion Criteria:

* SUBJECT WITH EYES DISEASE
* PREGNANCY DURING THE STUDY PERIOD
Single-port Thoracoscopic Sympathicotomy for Treatment of Raynaud's Phenomenon, a Feasibility Study

The goal is to investigate the effect of a single-port R3 sympathicotomy on microvascular circulation in the affected fingers. This effect is analysed by performing cooling plethysmography and nailfold capillary microscopy bilaterally, following a unilateral, single-port thoracoscopic sympathicotomy.

Raynaud's phenomenon is discoloration, discomfort and numbness or pain in the fingers and toes as a result of excessively reduced blood flow due to sympathetic induced vasospasms, in response to a change in temperature or emotional stress. It usually affects multiple fingers of both hands and comes in frequent attacks, with little or no discomfort in between them. Current treatment consists of stepped-care, including preventive measures optimizing digital blood flow, oral and intravenous medical therapy aimed at improving microvascular circulation, surgical neuromodulation to achieve vasodilatation and neurostimulation.

While surgical sympathectomy is an established treatment of Raynaud's phenomenon, its more invasive nature has prevented widespread application as an initial therapy. After introduction of minimally invasive surgical techniques in recent years, the investigators have further optimized the endoscopic sympathicotomy procedure performed on hyperhidrosis patients, now needing only a single 1 cm port for a detailed, panoramic view of the sympathetic chain (1). This minimal invasive technique has proven to be a safe, efficient and reproducible treatment for several indications and seems also suitable for Raynaud's patients.

In this feasibility study, the researchers want to investigate the effect of a single-port R3 sympathicotomy on microvascular circulation in the affected fingers. This effect is analysed by performing cooling plethysmography and nailfold capillary microscopy bilaterally, following a unilateral, single-port thoracoscopic sympathicotomy.

Eligibility Criteria:
Inclusion Criteria:

* Severe form of SRP, defined as clinical need of prostacyclin analogue infusions and/or bosentan having been given in the preceding 2 years, without satisfying result.
* No concurrent neurological disease

Exclusion Criteria:

* Known Chronic Obstructive Pulmonary Disease \> Gold class 1.
* History of smoking \> 20 pack years, due to higher risk of complications following unilateral lung- deflation and re-insufflation.
* Documented substance addiction.
* Signs/symptoms of macrovascular disease, or abnormalities on Doppler/duplex studies
* Other signs/symptoms of systemic autoimmune disease
* Severe concomitant diseases of the liver (eg Liver Function tests \> three times the upper limit of normal), kidneys (creatinine \> 160 mol/l), heart (including history of myocardial infarction, heart failure or angina pectoris), lung, blood, endocrine system, gastrointestinal system, Central Nervous System.
* Previous intra-thoracic pleural drainage.
* Previous thoracic surgery (including sternotomy).
* Gross pulmonary or pleural abnormalities on chest X-ray.
* Pregnancy.
* Unsuitable anatomy (e.g. due to severe physical malformations).
A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children

To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected children who received less than 56 days of prior antiretroviral therapy. To evaluate the safety and tolerance of 3TC/AZT in this patient population. To determine other measures of diseases in response to the study regimens.

Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.

Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.

Patients are randomized to receive oral 3TC/AZT, ddI/AZT, or ddI alone for at least 24 months. PER AMENDMENT 4/29/96: NOTE: Randomization to ZDV+ddI arm was terminated in Spring of 1996 based upon the results of ACTG 152. Patients on that arm will continue on blinded study drug and will be followed until the end of the study.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* IVIG.
* Prophylaxis for opportunistic infection.
* EPO.
* G-CSF or GM-CSF.

Patients must have:

* Symptomatic HIV infection.
* Less than 56 days of prior antiretroviral therapy.
* Consent of parent or guardian.

NOTE:

* Co-enrollment on ACTG 219, ACTG 220, and certain ACTG opportunistic infection protocols is permitted.

Prior Medication:

Allowed:

* Up to 56 days of prior antiretroviral therapy.
* Prior immunomodulator therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Malignancy.
* Hypersensitivity to a nucleoside analog.
* Current grade 2 or higher amylase/lipase toxicity or grade 3 or 4 other toxicity.

PER AMENDMENT 4/29/96:

* Active opportunistic infection and/or serious bacterial infection at the time of entry.

Concurrent Medication:

Excluded:

* Any other anti-HIV therapy.
* Megestrol acetate ( Megace ).
* Probenecid.
* IV pentamidine.
* Human growth hormone ( hGH ).
* Systemic corticosteroids for more than 2 weeks.

Prior Medication:

Excluded:

* Investigational drug therapy within 14 days prior to study entry.
Reducing Unsafe Alcohol Use in HIV-Positive Individuals

The main aim of this study is to test an intervention to reduce unsafe drinking among HIV-positive primary care patients. The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system). Subjects who receive the enhanced motivational interview are expected to show greater improvements in drinking than individuals who receive the standard motivational interview or view a DVD on HIV self-care.

HIV infection is a widespread health problem in the U.S. Antiretroviral treatment has increased longevity and changed the nature of risk factors for morbidity and mortality. Alcohol consumption has become an increasingly serious health issue among HIV primary care patients. Drinking is a key factor in progression to severe liver damage (especially those co-infected with hepatitis), and liver disease is now one of the most common causes of death among those with HIV. Excess drinking is also associated with medication noncompliance, reduces the effect of antiretroviral treatment, and is linked to other health problems. Therefore, helping HIV patients reduce unsafe drinking is crucial to their long-term health. The intervention combines the brief MI, an established, evidence-based counseling approach, with an innovative procedure designed to strengthen the effects of the MI. An effective, easily implemented alcohol-reduction intervention could be incorporated into standard care in HIV clinics helping prevent or slow the progress of some medical problems in HIV-infected individuals, improve medication compliance, prolong lifespan and decrease risk behavior associated with alcohol use.

Comparison(s): Enhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes), brief motivational interview, viewing a DVD on HIV self-care.

Eligibility Criteria:
Inclusion Criteria:

* Male and females 18 years of age or older.
* Participants have had 4 or more drinks on any day in the prior 30 days assessed via standardized questions.
* Participants are referred to a study MI counselor by clinic staff as needing an intervention for drinking
* Participants agree to random assignment and provide informed consent

Exclusion Criteria:

* Participants who are currently psychotic, suicidal or homicidal.
* Participants who have definite plans to leave the greater New York metropolitan area within the study period.
* Participants who demonstrate gross cognitive impairment as evidenced on the Halstead-Reitain Trails (A).
* Participants who do not speak English or Spanish, or have hearing impairments that preclude use of the telephone.