cyrilzakka/clinical-trials huggingface dataset:
Femtosecond Laser Arcuate Keratotomy Versus Toric Intraocular Lens Implantation in Cataract Surgery

In modern cataract surgery, residual astigmatism continues to be one of the major factors influencing patients' visual quality and satisfaction. The goal of this study is to compare the clinical outcomes of femtosecond laser arcuate keratotomy in one eye and Toric intraocular lens implantation in the contralateral eye for astigmatism correction in patients undergoing femtosecond laser-assisted cataract surgery. The study is a prospective randomized comparative study. Patients with binocular regular corneal astigmatism ranging from 0.75 to 3.00 D will be recruited. The patient will randomly receive femtosecond laser arcuate keratotomy in one eye and receive Toric intraocular lens implantation in the contralateral eye. Long term evaluation will be performed to compare the visual acuity, subjective manifest refraction, and corneal topography between groups.


Eligibility Criteria:
Inclusion Criteria:

* cataract patients
* patients with binocular regular corneal astigmatism ranging from 0.75 to 3.00 D
* patients who plan to receive femtosecond laser-assisted cataract surgery

Exclusion Criteria:

* patients with ocular surface abnormalities such as irregular corneal astigmatism, corneal scarring, keratoconus, and pterygium)
* patients with history of ocular trauma or surgery
* patients with coexisting ocular disorders such as glaucoma, retinal vascular occlusive disease, retinal detachment, diabetic retinopathy, and any optic nerve-related pathologies
* patients with concurrent severe systemic diseases
* patients who lack of cooperation
The Combination of Low-dose Rituximab and ATRA as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and ATRA in patients with steroid-resistant/relapsed ITP.

Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of steroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. Rituximab has been shown to partly improve the complete remission rate of ITP. All-trans retinoic acid (ATRA) has an immunomodulatory effect on haematopoiesis, making it a possible treatment option.

A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to the low-dose rituximab+ATRA and the low-dose rituximab monotherapy groups. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Interim analysis was scheduled at 50% through recruitment. Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of the combination of low-dose rituximab and ATRA in patients with steroid-resistant/relapsed ITP.

Eligibility Criteria:
Inclusion Criteria:

* ITP confirmed by excluding other supervened causes of thrombocytopenia;
* Platelet count of less than 30×10\^9/L at enrollment;
* Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
* ECOG\<2.

Exclusion Criteria:

* Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
* Congestive heart failure
* Severe arrhythmia
* Nursing or pregnant women
* Aspartate aminotransferase and alanine transaminase levels ≥ 3×the upper limit of the normal threshold criteria
* Creatinine or serum bilirubin levels each 1•5 times or more than the normal range
* Active or previous malignancy
* Patients with other diseases were undergoing treatment with immunosuppressants
* Patients with ITP had received rituximab
Contribution of SA and Coma to The Total Ocular HOA Before and After FS-LASIK Using An Aspheric Ablation Profile

Laser-assisted in situ keratomileusis (LASIK) is the most frequently performed refractive surgery procedure for the correction of myopia, hyperopia, and astigmatism.

There is a continuous upgrade and development in LVC surgeries correlated with the evolution of new machines and enhancement of the ablation profiles. One of the main undesirable effects of corneal refractive surgeries using conventional ablation profiles is the increase in HOAs which is associated with haloes, glare, ghost images, starburst patterns and monocular diplopia, especially in low lighting conditions and during night driving.

Over the years many ablation profiles have been developed such as wavefront-guided, wavefront optimized, topography guided, Q- Value based and aspheric ablation profiles. These profiles aim to abolish LOAs and to prevent induction or increase of pre-existing HOAs aiming to improve the quality of vision experienced post-operative.

In spite of the vast body of research in this area, there remains a gap in the literature investigating higher-order aberrations' components in-depth. Therefore, this study aims to investigate the contribution of spherical aberration and coma to the total higher order aberration before and after femtosecond assisted laser in situ keratomileusis using an aspheric ablation profile.

This current study is a Descriptive analytical study that was conducted on 34 eyes of 17 patients who underwent corneal refractive surgery.

The results were analyzed to compare the effect of FS-LASIK surgery on corneal coma and SA, and the contribution of each of them on total ocular HOAs preoperative and post-operative.


Eligibility Criteria:
Inclusion Criteria:

1. Age: between 18 years and 45 years
2. Myopes from -1.50 D to -8.00 D
3. Astigmatism less than -4.00 D
4. Normal Corneal Tomography with a Belin Ambrosio big D value of less than 1.6

Exclusion Criteria:

1. Unstable refraction for 1 year
2. Corneal thickness less than 500 microns
3. Expected Post Lasik Residual Stromal bed less than 300 microns
4. All patients with post operative complications as epithelial overgrowth or decentered ablation.
MultipOlar Left Ventricular Electrode Instability Trial

Characterization of pacing thresholds in available pacing vectors of quadripolar leads used for cardiac resynchronization therapy in a short term follow-up.

Multipolar left ventricular leads are increasingly used in cardiac resynchronization therapy. Lead dislodgment requiring re-intervention is rare. However, data on minor lead movements which may affect pacing capabilities and application of new pacing algorithms is scarce. Aim of the study is to characterize pacing thresholds of each of the implanted electrodes on quadripolar leads in a short term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* De novo implantation of left ventricular multipolar leads.

Exclusion Criteria:

* Cardiogenic shock
* Device infection
* Revision for previously dislodged left ventricular lead
* Age below 18 years
* Pregnancy
* Patients under tutelage
Efficacy and Safety Study of Iron Sucrose and Oral Iron Acetyl-transferrin Hydroglycerin

multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs Bolgre group)study


Eligibility Criteria:
Inclusion Criteria:

* 30\~32nd weeks pregnant women aged over 18 years
* Women who have Hb level of more than 10.0g/dL a week before study initiation
* Patients who agree to participate in this study in writing

Exclusion Criteria:

* Patients who have participated in another clinical study in recent 3 months
* Patients who are prone to acute hemorrhage during pregnancy
* Patients who have shown intolerance to iron therapy
* Hemolytic anemia, hemoglobinopathies (thalassemia, sickle cell)
* Bleeding tendency, hypersplenism
* Chronic heart failure, Class II-IV heart disease, uncontrolled arterial hypertension (DBP ≥ 115mmHg), deep vein thrombosis, thrombocytosis, chronic renal disease
* Severe renal failure patients (2.5 times or more higher plasma creatinine level than high limit of normal state)
* Patients with severe liver dysfunction (2.5 times or more higher AST or ALT than high limit of normal state)
* Patients with doubled or more CK level than high limit of normal state
* Patients who are regarded as ineligible for this study by investigator
Motivational Interviewing (MI) for African Americans With Peripheral Arterial Disease (PAD) Pilot

The investigators are conducting a pilot study for a clinical research trial to establish the feasibility and acceptability of the intervention and the most effective recruitment strategies prior to the full study.

The eight week pilot will be conducted to establish the feasibility of implementing motivational interviewing as a means to counsel African Americans with peripheral arterial disease (PAD) to increase their walking. Additionally, we will determine the acceptance of culturally sensitive print material on managing PAD. Finally, we will utilize the pilot to develop best practice methods for successfully carrying out the full study.

Eligibility Criteria:
Inclusion Criteria:

* African American (determined by self-report)
* Lived most of their life in the United States
* Resting ABI \<0.95
* English Speaking
* Has a telephone

Exclusion Criteria:

* Currently walking for exercise at least 5 days per week (i.e., a PACE score ranging from 5-8)
* Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers)
* Rest pain with ABI \<0.4 and non-palpable femoral pulses without prior evaluation by a vascular surgeon, given the need for evaluation for the role of more invasive therapy prior to recommending walking therapy
* Leg revascularization within 3 months of enrollment or plans for revascularization during the study period
* Use of supplemental oxygen
* Myocardial infarction within the preceding 3 months
* Resting blood pressure \> 200/110 mmHg
* Exercise-induced coronary ischemic symptoms, or exercise-induced ST depression \> 2.0 mm
* Inability to walk for 2 minutes; the rationale being that people who cannot walk for 2 minutes would not be able to complete the necessary submaximal treadmill test, which is used to screen for coronary ischemic symptoms. We will also exclude anyone who can walk for 20 minutes or more during the submaximal treadmill test. Anyone who can complete the submaximal test would not have significant walking impairment and would not get that much out of the study.
* Short Physical Performance Battery score of 10 or higher as such persons do not have a clinically significant impairment in mobility; therefore, we will exclude anyone who scores a 10 or higher (out of a maximum of 12 points).
Assess Veinplicity Venous Access Device Safety and Effectiveness

The purpose of this study was to examine the Veinplicity Device as an adjunctive IV cannulation tool in subjects with a history of difficult to access veins. The Veinplicity Device is intended to improve venous access rates in compromised patients by taking advantage of the increased circulation that results from provoked muscle stimulation. The study collected information about the device, intravenous access, user and patient perceptions for IV access, and any device or procedural complications or other adverse events. Device use was examined with patients in both a prone and upright position.


Eligibility Criteria:
Inclusion Criteria:

* Subject ≥ 18 years of age
* Subject with history of failed venous access, venipuncture, or IV cannula placement
* Subject agreed to required follow-up
* Subject provided written, informed consent

Exclusion Criteria:

* Subject currently had compromised skin on either forearm or hand
* Subject currently on any blood thinning medication other than 81mg of aspirin
* Subject had been diagnosed with peripheral neuropathy, has had a complex fracture or surgery in the forearm, or has other condition that diminishes sensation in one or both arms, hands or fingers
* Subject had a demand type pacemaker or defibrillator
* Subject is female of child-bearing potential and had a positive urine pregnancy test
* Subject had a history of seizure, convulsions or epilepsy
* Subject had a known allergy to Epsom salts
* Subject had any other condition that may affect the ability to complete study requirements
A Comparative Assessment of Transfemoral Prosthetic Sockets

The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.

The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making. The investigators will explore a range of outcomes that have been found to be important for prostheses users and specifically assess the claims made by device manufacturers. Thirty adults with a transfemoral amputation will participate in four test sessions; one with their clinically prescribed, laminated socket, and three with different adjustable sockets. This data will be used to test the following aims: 1) does socket design impact socket comfort and prosthetic satisfaction? 2) does socket design impact of prosthetic socket on patient mobility and confidence, 3) how does prosthetic socket design influences prosthetic use in the home?, and 4) Are individual characteristics associated with benefits of specific socket designs?

Eligibility Criteria:
Inclusion Criteria:

* Unilateral lower-limb amputation
* Six months of independent ambulation
* Own and regularly wear a prosthesis with socket
* Minimum functional level of K2 on the Medicare Functional Classification Level (MFCL): corresponding to "the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator"

Exclusion Criteria:

* Pathology or injury of the intact limb
* Medication that affects their ability to walk
* Neurologic or cardiovascular disease
* Significant vision problems
* Suffer from an impaired mental capacity that negatively impacts verbal communication with the clinicians and research team, or requires a Legally Authorized Representative to facilitate communication
Biomarker for Hyaline Fibromatosis Syndrome (BioHFS)

Development of a new MS-based biomarker for the early and sensitive diagnosis of Hyaline fibromatosis syndrome from the blood

Hyaline fibromatosis syndrome (HFS) is rare autosomal recessive disease characterized by the deposition of amorphous hyaline material in skin and visceral organs. It represents a disease spectrum with infantile systemic hyalinosis (ISH) being the severe form and juvenile hyaline fibromatosis (JHF) being the mild form. Dermatologic manifestations include thickened skin, perianal nodules, and facial papules, gingival hyperplasia, large subcutaneous tumors on the scalp, hyperpigmented plaques over the metacarpophalangeal joints and malleoli, and joint contractures. ISH shows a severe visceral involvement, recurrent infections, and early death.

The lesions appear as pearly papules or fleshy nodules. The severity is variable. Some individuals present in infancy and have additional visceral or systemic involvement, which can lead to early death. These patients may show intractable diarrhea and increased susceptibility to infection. Other patients have later onset of a milder disorder affecting only the face and digits. Additional features include gingival hypertrophy, progressive joint contractures resulting in severe limitation of mobility, osteopenia, and osteoporosis. Histologic analysis of skin lesions shows proliferation of spindle-shaped cells forming strands in a homogeneous and hyaline eosinophilic extracellular material in the dermis.

New methods, like mass-spectrometry give a good chance to characterize specific metabolic alterations in the blood of affected patients that allow diagnosing in the future the disease earlier, with a higher sensitivity and specificity.

Therefore it is the goal of the study to identify and validate a new biochemical marker from the blood of the affected patients helping to benefit other patients by an early diagnose and thereby with an earlier treatment.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent will be obtained from the parents before any study related procedures.
* Patients of both gender older than 2 months
* The patient has a diagnosis of Hyaline fibromatosis syndrome or a high-grade suspicion for Hyaline fibromatosis syndrome

High-grade suspicion present, if one or more inclusion criteria are valid:

* Positive family anamnesis for Hyaline fibromatosis syndrome
* Coarse facies
* Subcutaneous nodule
* Gingival fibromatosis
* Skeletal muscle atrophy
* Progressive flexion contractures

Exclusion Criteria:

* No Informed consent from the parents before any study related procedures.
* Patients of both gender younger than 2 months
* No diagnosis of Hyaline fibromatosis syndrome or no valid criteria for profound suspicion of Hyaline fibromatosis syndrome
Effects of Fructose and Exercise on Hepatic Lipid Metabolism

8 healthy male volunteers will be studied each on 3 occasions, ie

* after 4 days on a weight maintenance diet containing 5% simple sugars + low physical activity
* after 4 days on a weight maintenance diet containing 30% fructose + low physical activity
* after 4 days on a weight maintenance diet containing 30% fructose + high physical activity At the end of each of these 3 periods, fructose induced hepatic de novo lipogenesis (13C palmitate synthesis in response to ingestion of a 13C fructose load) and plasma VLDL-triglyceride kinetics (measured with a bolus of 2H-labeled glycerol) will be measured


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 30 years
* males
* BMI between 19 and 25
* low to moderate physical activity (\< 3 sessions/week)

Exclusion Criteria:

* smoking
* consumption of alcohol\>50g/week
* consumption of drugs or illicit substances
* food allergies
An Evaluation of Interlaminar Lumbar Instrumented (ILIF™)

Patients diagnosed with single-level degenerative disc disease (DDD) of the lumbar spine undergo a posterior decompression followed by a fusion complete with a spinous process plate, graft, and a biologic.

Interlaminar lumbar instrumented fusion (ILIF™) is a compound surgical solution to spinal stenosis, combining direct neural decompression with an allograft interspinous spacer (ExtenSure® H2) to maintain the segmental distraction, and a spinous process fixation plate (Affix™) to maintain stability for eventual segmental fusion. Because this compound solution requires only a midline incision rather than the far lateral exposure necessary in posterolateral fusion with pedicle screws, it is less invasive to the patient, and therefore should result in less postoperative pain and disability, broadening the applicability of the procedure to even those advanced in age or with existing comorbidities. Subjects will be followed for 24 months following surgery to determine the changes in ODI scores from preoperative to baseline assessments. This data will be compared to published data on similar procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patient is over 40 years of age;
* Patient is diagnosed with single-level lumbar degenerative disc disease between L1-L2 and L4-L5 with evidence of disc collapse and symptomatic claudication with or without back pain and requires surgical intervention;
* Patient is unresponsive to conservative treatment greater than or equal to six month 6 months, or exhibits progressive neurological symptoms in the face of conservative treatment;
* Patient is willing and able to comply with the requirements defined in the protocol for the duration of the study;
* Patient has signed and dated Informed Consent.

Exclusion Criteria:

* Patients with lumbar pathologies requiring surgical treatment at more than one level;
* Patients with spondylolisthesis \> grade 1;
* Patients with lytic spondylolisthesis or a defect of the pars interarticularis;
* Patients with prior lumbar surgery at or adjacent to the operative level;
* Patients with spinal metastases or active spinal tumor malignancy;
* Progressive neuromuscular disease, e.g., muscular dystrophy, multiple sclerosis;
* Present chronic steroid use;
* Patients with rheumatoid arthritis or other autoimmune disease;
* Patients who are pregnant or interested in becoming pregnant within the follow-up period of the study;
* Patients with a history of substance abuse;
* Patients involved in active spinal litigation;
* Patients receiving workman's compensation for spinal conditions;
* Patients who are mentally incompetent;
* Patients who are incarcerated;
* Patients who are unwilling or unable to comply with the follow-up protocol schedule of visits and assessments.
Hormonal Factors in the Treatment of Anorexia Nervosa

The investigators are investigating whether a hormone that is naturally produced by the human body, called testosterone, can help improve weight, disordered eating, depression, and anxiety. The investigators hypothesize that testosterone will be a novel and effective endocrine-targeted therapy for patients with anorexia nervosa.


Eligibility Criteria:
Inclusion Criteria:

* Age 18- 45 years; if participating in the neuroimaging sub study, age 18-40
* Meet DSM-IV criteria for AN (restricting or binge/purge type, BMI 15-17.5) OR meet criteria for sub-threshold AN, i.e., all DSM-IV criteria except that patients can have a BMI of \<18.5 kg/m2 with or without amenorrhea.
* Free T below the median for healthy women of reproductive age
* All participants will be required to have a treatment team in place that consists of (at least) a primary care physician and a psychotherapist. Participants will need to have had regular contact with a primary care physician and be in an individual psychotherapy program. Participants will agree to continue with this treatment team and therapy throughout the active course of the study. If participants are taking psychotropic medications, the dose must be stable for 3 months before study entry

Exclusion Criteria:

* Pregnant women or women of child bearing potential who are not using medically accepted means of contraception (to include oral contraceptive, patch or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy).
* Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic
* Serious suicide risk, substance use disorder active within last 6 months, bipolar I disorder, severe current depressive symptoms (indexed by HAM-D score \>20 \[excluding 2 eating/weight loss items related to the symptoms of AN\]), or psychotic disorder
* New psychotropic drug regimen, specifically a significant dose change or change in drug class, within the last 6 weeks. A study psychiatrist will assess whether PRN medications and dose changes are clinically significant enough to defer enrollment of specific potential study subjects.
* Untreated hypothyroidism
* If receiving estrogen therapy, including oral contraceptives or transdermal estrogen therapy, significant change in dose in the prior 3 months
* Use of androgens or androgen precursors, including T, DHEA and methyl T, within 3 months
* Any investigational psychotropic drug within the last 3 months
* In the judgment of the study clinician, unlikely to be able to participate safely throughout the study period
* Alanine aminotransferase (ALT) \> 2x upper limit of normal
* Creatinine \>1.5x upper limit
* Serum potassium \< lower limit of normal
* If participating in the sub study, unable to tolerate 1 hour in MRI; contraindication to MRI (such as implanted pacemaker, cerebral aneurysm clips, extensive orthopedic hardware instrumentation); gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection); history of psychosis by SCID