cyrilzakka/clinical-trials huggingface dataset:
Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Physiology

The purpose of this study is to investigate the anterior and posterior structure and functional changes and vascular alterations when performing phacoemulsification at high IOP vs low, more physiological IOP using Centurion® Vision System with Active Sentry® handpiece. These devices are approved by the US Food and Drug Administration (FDA).

To investigate the anterior and posterior physiological changes when performing phacoemulsification at high IOP vs low, more physiologic IOP using Centurion® Vision System with Active Sentry® handpiece

Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye

Operating at lower, more physiological IOP using Active Sentry® handpiece during cataract surgery will use less BSS fluid usage. (Lower IOP settings are also expected to result in less subclinical changes).

Eligibility Criteria:
Inclusion Criteria:

* No prior ocular surgery including corneal refractive surgery
* Bilateral visually significant cataract, similar in density (LOCS III grade 2+), undergoing uncomplicated cataract surgery
* Equal dilated pupil size ≥6mm, no use of pupil expansion devices
* Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension with normal OCT angiography at baseline
* A1C ≤ 8% on single monotherapy or lifestyle adjustments
* To maintain high sensitivity/specificity, patients to fall under OCT normative database:
* Axial length 22-26mm
* Refractive error between -5.00D to +5.00D
* Cylinder ≤ 3.00D
* Normal K values \<47.00D
* Axial eye length cannot vary by more than 0.4 mm in an individual patient
* Normal CCT range 540µm ± 50

Exclusion Criteria:

* H/o corneal disease or dystrophies
* Media opacification for reasons other than cataract
* Compromised zonular integrity or stability
* Retinal and retinal vascular pathologies, age-related macular degeneration
* Glaucoma
* Patients with uncontrolled systematic diseases; including hypertension, diabetes, systemic cardiovascular diseases and hematological diseases
Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis

The objective of the study is to identify and validate predictive markers of anakinra responsiveness in RA patients by a transcriptomic approach.

Patients with active RA (ACR criteria) were given subcutaneous anakinra (100mg/d) 3 associated with metotrexate. Anakinra efficacy was evaluated at week 12, using the EULAR response criteria.

A blood sample was collected just before the onset of anakinra treatment and total RNAs were extracted from the peripheral blood mononuclear cells. The \[33P\] radiolabeled mRNAs were hybridized (duplicate or triplicate) over a set of 10.000 human cDNA probes spotted at a high density on nylon membranes. Data were normalized and filtered to allow the comparison between RNA samples. Statistical analyses were performed with the R software and hierarchical clustering was performed with the Cluster and Tree View softwares.


Eligibility Criteria:
Inclusion Criteria:

* Is age 18 years old or older Satisfies the 1987 American College of Rheumatology revised criteria for Rheumatoid arthritis Has active disease at the time of randomization as indicated by a DAS28\> 5.1 Has a disease at least refractory to DMARDs whose methotrexate or leflunomide Is capable of understanding and signing an informed consent form Agrees to use a medically accepted form of contraception during the study

Exclusion Criteria:

* Is pregnant or breast-feeding or without contraception Has significant concurrent medical diseases including cancer or a history of cancer within 5 years of entering the study, uncompensated congestive heart failure, significant active infection or any underlying diseases that could predispose subjects to infections (whose tuberculosis) Has renal disease (creatinin clearance level \< 30 ml/min) Has allergy to anakinra Has leukopenia (white blood cells \< 1.5 x 109 /l
Detecting Urinary Retention After Child Birth With a Ultrasound Scanner

The purpose of this study is a systematical registration of ultrasound measurements and urinary volume after catheterization. Based on these pairs of measurements we will calculate the reliability of ultrasound compared with catheter volume.


Eligibility Criteria:
Inclusion Criteria:

* Women with suspected urinary retention
Evaluating Ultrasound, Elastometry, Minilaparoscopy and Histology for the Diagnosis of Compensated Liver Cirrhosis.

Prospective study to evaluate the dignostic value of b-mode ultrasound, elastometry and mini-laparoscopic guided liver biopsy for the diagnosis of compensated liver cirrhosis.

Up to now the gold standard for the diagnosis of liver cirrhosis is to perform liver biopsy. This invasive methode is not undisputed. Therefore there is constant effort to improve, develop and apply better diagnostic tools. This study is designed to evaluate the in our eyes now a days most promising examinations: (1) high frequency ultrasound, (2) elastometry and (3) minilaparoscopy. Patients for whom the clinical decision to perform mini laparoscopic guided liver biopsy was taken should be recruited. Successive at three time points the examiner has to decide for or against cirrhosis: (1) after conventional and high frequency ultrasound (2) after elastometry and (3) after laparoscopy.

Eligibility Criteria:
Inclusion Criteria:

* clinical decision to perform minilaparoscopic guided liver biopsy for the staging of liver disease including the assessment of the degree of fibrosis.

Exclusion Criteria:

* ascites
* decompensated liver disease
* esophageal varices
* other collateral circulations
* obstructive cholestasis
* severe heart insufficiency (NYHA III-IV)
Nursing Interventions Following Sudden Cardiac Arrest

Determine the benefits of implantable cardioverter defibrillator (ICD) patients participating in a structured, 8-week educational telephone intervention delivered by expert cardiovascular nurses post-ICD. To determine if individuals participating in a post-hospital telephone nursing intervention would demonstrate (1) increased physical functioning, (2) increased psychological adjustment, (3) improved self-efficacy in managing the challenges of ICD recovery, and (4) lower levels of health care utilization over usual care at 1, 3, 6 and 12 months post-ICD implantation.

The goal of the study was to determine if a short-term social cognitive theory intervention would improve physical functioning and enhance psychological adjustment after receiving a first time ICD. The central aim of this study was to determine if individuals participating in a telephone nursing intervention compared to usual care demonstrated (1) improved physical functioning, (2) improved psychological adjustment, 3) improved knowledge related to sudden cardiac arrest (SCA) and the ICD, and (4) lower levels of health care use over a 3-month period post-ICD.

Eligibility Criteria:
Inclusion Criteria:

* the ability to read, speak, and write English,
* having telephone access,
* willingness to be followed for 1 year.

Exclusion Criteria:

* significant clinical comorbidities that prevented their return home after hospitalization,
* younger than 21 years of age,
* Short BLESSED cognitive screening tool scores ≥10.
Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes mellitus.
* Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.
* HbA1c \>=6.5% and \<=9.0%.
* Body Mass Index (BMI) \>=25 kg/m\^2 and \<40 kg/m\^2.

Exclusion Criteria:

* Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.
* Characteristics contraindicating metformin or glimepiride use.
* Receiving drugs that directly affect gastrointestinal motility.
* Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.
* Have used any prescription drug to promote weight loss within 3 months prior to screening.
* Treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: \*insulin; \*thiazolidinediones; \*alpha-glucosidase inhibitors; \*sulfonylurea; \*meglitinides
Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet

A prospective, open, post-market study that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heel cracks, calluses and/or dry feet. The investigation will consist of approximately 48 subjects (considering a 10% drop-out/screening failure rate) fulfilling the eligibility criteria for the study. Each subject will be treated with the study product, BioCool Footcare (footbath), for 3 weeks. The study duration is estimated to 5 months including recruiting, treatment and follow-up period.


Eligibility Criteria:
Inclusion Criteria:

The subjects have to meet all of the following criteria to be eligible to participate in the clinical investigation:

1. Signed informed consent form
2. \> 18 years of age
3. Males and females
4. Tinea Pedis (Athlete's foot) confirmed with total symptom score graded between 6-16 (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis and odour) using a 4-point severity scale (0=absent, 1=mild, 2=moderate and 3=severe). NOTE! maximum total score is 24.

   - Score of 2 (moderate) of higher required in at least 1 of the following; erythema, macerations, pruritus or odur.
5. Score of at least 2 (moderate) required in at least one of the following: heel cracks (rhagades), calluses (hyperkeratosis) and dry feet using a 5-point severity scale (0=absent, 1=mild, 2=moderate, 3=advanced and 4=severe).
6. Patient with confirmed mycological culture

Exclusion Criteria:

Subjects meeting any of the following criteria will not be permitted to participate in the clinical investigation:

1. Severe tinea pedis interdigitalis (Athlete's foot) total score of severity grading \>16 (signs and symptoms)
2. Women pregnant or lactation at time of enrolment
3. Diagnosed with Diabetes Type I or II
4. Topical medicinal antifungal therapy within 4 weeks prior to study start
5. Treatment with systemic anti fungal therapy including terbinafine, itraconazole or fluconazole within 6 months prior to study start
6. Treatment with local amd/or systemic corticosteroids or immunosuppressant's within 6 weeks prior to study start
7. Any other open wounds/lesions in the area treated with the Investigational device
8. Participated in another Clinical Investigation/Trial the last 3 months
9. Any other medical condition, judged by the investigator may make follow-up or investigation inappropriate
Shock Wave Therapy Plus Exercise in GTPS

The aim of this randomized controlled study is to investigate if the sequential administration of focused shock wave therapy and of a rehabilitation program based on the strengthening of gluteal muscles is more effective than a standard shock wave treatment for greater trochanteric pain syndrome


Eligibility Criteria:
Inclusion Criteria:

* Unilateral hip pain of four weeks or longer duration
* Pain to palpation in the greater trochanteric area at physical examination
* Pain in hip end-range abduction/rotation/adduction at physical examination
* Gluteal tendinopathy, in absence of full thickness tears at a sonographic examination of the gluteal tendons
* Adult age and written informed consent

Exclusion Criteria:

* No hip osteoarthritis, diagnosed according to Altman's criteria
* No history of knee osteoarthritis
* No history of rheumatologic diseases
* No previous fractures or surgery in the affected limb
* No clinical signs of lumbar radiculopathy at physical examination
* No corticosteroid injections, since the onset of the current pain episode
* No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area)
A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis

This study is a Phase 2 multicenter, randomized, placebo controlled, single-blind study. The primary objective of the study is to compare the effect of weekly dosing of LJPC-401 (synthetic human hepcidin) versus placebo on transferrin saturation (TSAT) in an adult hereditary hemochromatosis patient population.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinical diagnosis of hereditary hemochromatosis
2. Patients who are prescribed therapeutic phlebotomy for treatment of hereditary hemochromatosis
3. Patients with serum ferritin and TSAT levels above treatment guidelines
4. Female patients of child bearing potential must have a negative pregnancy test and must be using a highly effective method of contraception during participation in the study, and for 30 days after the last dose of study drug
5. Males must be surgically sterile (vasectomy), or using a highly effective method of contraception during participation in the study, and for 30 days after the last dose of study drug
6. Patient must be willing and able to provide written informed consent

Exclusion Criteria:

1. Patients receiving iron chelation therapy within 7 days prior to the first dose of study drug
2. Patients initiating phlebotomy treatments less than 3 months prior to the first dose of study drug
3. Pregnant or lactating women
4. Patients taking an immunosuppressive agent without prior Sponsor approval
5. Patients participating in an unapproved investigational drug or investigational therapeutic device within 30 days of study drug
6. Patients who are unwilling or unable to comply with the study protocol requirements
7. Patients with type 1 or poorly controlled type 2 diabetes
8. Patients with a concomitant disease, disability or condition, including laboratory abnormality and ECG findings, which may interfere with the conduct of the study, or which would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study, including, but not limited to, clinically significant arrhythmias, alcohol dependency or abuse, drug dependency or abuse, or psychiatric disease
PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient

This is a single arm, phase 0 study to evaluate the safety and efficacy of PET-CT scans with FDG-labeled RBC in patients with breast cancer.

Cardiac ejection fraction can be calculated and monitored in breast cancer patients during chemotherapy using a FDG-RBC PET-CT scan. The purpose of this study is to determine if calculated cardiac ejection fraction shows high concordance with results from echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically confirmed breast cancer and be scheduled for neoadjuvant Trastuzumab- or anthracycline-based chemotherapy.
* Age \>18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky \>60%).
* Must be able to complete an informed consent process.
* Must have normal organ and marrow function: leukocytes \>3,000/μL; absolute neutrophil count \>1,500/μL; platelets \>100,000/μL; total bilirubin within normal institutional limits; aspartate aminotransferase (AST)\[SGOT\] / alanine aminotransferase (ALT)\[SGPT\]: less than 2.5 X institutional upper limit of normal; Creatinine within normal institutional limits - OR - creatinine clearance\>60 mL/min/1.73 m\^2 for patients with creatinine level above institutional normal.
* Echocardiogram results should be of sufficiently suitable quality (adequate acoustic window access) to provide a reliable ejection fraction range calculation. The cardiac ejection fraction on the pre-treatment echocardiogram should be 50% or higher.
* Participants should be naïve to Trastuzumab or anthracycline chemotherapy prior to enrollment.

Exclusion Criteria:

* Prior history of invasive breast cancer and treatment with anthracycline chemotherapy.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to FDG.
* Known symptomatic coagulopathies, bleeding diathesis, hemoglobinopathies, or hemolytic anemia.
* Participants should have no clinically significant heart disease such as congestive heart failure. Participants should not have other significant structural heart disease by echocardiogram, or cardiac dysrhythmia on standard of care electrocardiogram that may adversely affect the cardiac imaging results obtained with FDG-RBC PET-CT imaging.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Women who are pregnant.
* Found to have a cardiac ejection fraction less than 50% on the pre-treatment echocardiogram.
Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle

Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.

Prostate biopsy is the golden standard for prostate cancer diagnosis. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. The biopsy chamber of the Tru Cut needle is in general 19 mm. However, it is on average filled only with 13 mm of tissue. Biopsy length is strongly correlated with diagnostic accuracy of prostate cancer.

Additionally, TRUSbx has a high risk of infection due to bacteria being brought across the colon wall. The investigators have shown that a new needle design reduces this bacterial transfer in an ex vivo setting and a previous trial (NCT049091230) has shown non inferior biopsy length when compared to the standard Tru Cut needle. A further improvement of the needle has now been designed aiming to increase biopsy length and quality, with the possible potential to improve prostate cancer diagnosis. This is the first human pilot aiming to evaluate if biopsy length of the novel needle is superior to a standard Tru Cut biopsy needle in prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for prostate biopsy
* Signed informed written consent

Exclusion Criteria:

- None (other than general contraindications for prostate biopsy or patient not willing to participate)
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients

The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD for 1 month
* Men or postmenopausal women
* Spirometry values indicating reduced lung function
* Smoking history equivalent to using 20 cigarettes a day for 10 years

Exclusion Criteria:

* Any current respiratory tract disorders other than COPD
* Requirement for regular oxygen therapy
* Use of oral or parenteral glucocorticosteroids within 30 days prior to the study
Recurrence of Trigeminal Neuralgia in Patient's Undergoing Radiofrequency Ablation

This study aims to find recurrence rate of the trigeminal neuralgia after patients undergo stereotactic rhizotomy by radiofrequency ablation at 80 degrees Celsius for 90 seconds under fluoroscopic guidance, a protocol that was modified from the originally described parameters for rhizotomy by John Tew, Chad J. Morgan and Andresw Grande et al. The presumption being that the higher temperature of the probe tip would lead to a more long-lasting lesion and lesser recurrence, but at the cost of more frequent sensory and motor deficits.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients fulfilling ICHD criteria:

Recurrent paroxysms of unilateral facial pain in the distribution(s) of one or more divisions of the trigeminal nerve, with no radiation beyond, and fulfilling criteria B and C

A. Pain has all of the following characteristics:

1. lasting from a fraction of a second to 2 minutes
2. severe intensity
3. electric shock-like, shooting, stabbing or sharp in quality B. Precipitated by innocuous stimuli within the affected trigeminal distribution C. Not better accounted for by another ICHD-3 diagnosis.

2. Age: Adults of both sexes 3. MRI brain ruled out organic or structural pathologies

Exclusion Criteria:

* 1. Patient with concomitant co-morbid conditions like brain tumours, vascular pathologies or coagulopathies.

  2. Patients who had previously undergone trigeminal ganglion neurolysis with either alcohol or phenol.

  3. Patients who were lost to follow-up before the completion of 6-month period or had not visited back after the procedure 4. Patients on oral anticoagulants 5. Patients declared high risk or ASA 3 and above for general anaesthesia.
Effect of Hyperoxemia on Platelet Function in Healthy Volunteers

Prospective, controlled, randomized crossover volunteer study to investigate the effect of hyperoxemia due to inhalation of oxygen (80% inspiratory fraction) via reservoir-face-mask on blood coagulation, especially platelet function, as measured by thrombelastography. According to results of basic animal and in vitro investigations, hyperoxemia may activate platelets by means of reactive oxygen species. This study aims at investigating a possible pro-coagulant effect of hyperoxemia in healthy volunteers. Additional studies on possible mechanisms are integrated.

* Trial with medical device


Eligibility Criteria:
Inclusion criteria:

* informed consent; no coagulation disorder or other illnesses;
* non-smoker;
* women: no pharmacological contraception, negative pregnancy test;
* 25-45 years old; no medication; no acute or chronic airway problems;
* for 24 hours before study: no extreme physical activity, no polyphenol-containing food (red wine, apples, cabbage, garlic);
* for 48 hours: no caffeine-containing drinks, no dark chocolate.

Exclusion criteria:

* Lack of one of the inclusion criteria;
* allergy or incompatibility to substances/materials applied in the study;
* very thin veins/arteries.