cyrilzakka/clinical-trials huggingface dataset:
An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients

The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.


Eligibility Criteria:
Inclusion Criteria:

* Chinese.
* Diagnosis of bacterial conjunctivitis based on clinical observation.
* Understand and sign the approved informed consent. Legally authorized representative can provide informed consent for patients less than 18 years old and/or incapable of understanding the informed consent.
* Willing to complete all required study procedures and visits.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women who are pregnant, lactating, or planning a pregnancy.
* Only 1 sighted eye or vision not correctable to 0.6 logMAR or better in either eye.
* Planned contact lens wear during the course of the study.
* Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Screening (Day 1).
* Suspected fungal, viral, or Acanthamoeba infection.
* Any systemic or ocular disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study.
* History of recent surgery.
* Presence of concomitant systemic viral infection.
* Other protocol-defined exclusion criteria may apply.
Fusion Status After ACDF

Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an important component of bony fusion in ACDF, and we aim to compare machined allograft spacers versus iliac crest allograft in a randomized controlled trial.

Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an important component of bony fusion in ACDF, and we aim to compare machined allograft spacers versus iliac crest allograft in a randomized controlled trial. We hypothesize that iliac crest allograft will improve anterior cervical discectomy and fusion arthrodesis rates and diminish the amount of intervertebral graft resorption when compared to off-the-shelf machined allografts

Eligibility Criteria:
Inclusion Criteria:

* patients 18 years of age or older
* preoperative diagnosis of cervical radiculopathy and/or cervical myelopathy.

Exclusion Criteria:

* patients undergoing a revision cervical procedure
* current smokers
* patient with surgical indications of tumor, infection, or trauma
Classification of Breast Masses Based on Visco-elastic Properties Using SAVE Method

The purpose of this research is to conduct a clinical study to evaluate the efficacy of a noninvasive and quantitative tool for classification/diagnosis of breast masses. The main objective of this proposal is to test the SAVE (Sub-Hertz Analysis of Visco-Elasticity) method on a patient population of sufficient size to determine the sensitivity and specificity for malignant-benign discrimination of breast masses.

Subject will sit or lie back on an examination bed. The investigators will use an ultrasound scanner to collect sonographic imaging data from the breast. For this purpose the investigators may use a clinical scanner such as Supersonics Aixplorer or similar or a research ultrasound machine such as Verasonics (this machine has been use in other Mayo IRB approved protocols such as IRB 11-001953). The ultrasound probe will be placed on the breast to visualize the mass. The probe will be pressed with a constant force for a period of 10-40 seconds. During this time ultrasound data will be recorded by the ultrasound scanner.

To keep the probe pressed on the breast with a constant force, the user may hold the probe by hand and press it steadily against the breast at constant force. This force is only a few Newtons (approximately half a Kg weight) which should be quite tolerable for a typical patient. Alternatively, the investigators may use an automated "actuator" to hold the probe steady and press it against the breast at a constant force to the same level. The reason for pressing the breast is to determine how the breast tissue gradually deforms; therefore this method to some extent simulates breast palpation.

The time needed to scan a subject for this study is short (a few minutes to set up, and about 10-40 seconds to scan). It will take approximately 20 minutes to complete the study. The scan can be done at the time of clinical breast sonography. The subject may be asked to hold her breath during the scan time if possible.

The investigators call this method "Sub-Hertz Analysis of Visco-Elasticity (SAVE)".

To facilitate subject access and shorten patient participation time, the investigator may station our system in the Breast Imaging area where routine clinical imaging procedures are performed.

The investigators may also use the FDA approved GE LOGIQ E9 (LE9) ultrasound system to quantify and image the stiffness of the breast lesion and compare the results to those obtained by the investigational device.

The investigators may also use the Alpinion clinical ultrasound machine, both FDA approved clinical format ECUBE 12 and non FDA approved ECUBE 12R format to acquire ultrasound images.

Eligibility Criteria:
Inclusion Criteria:

* Females in age range between 18 and up who have a breast lesion that may or may not be suspicious for breast cancer, and are referred for Radiological investigation.

Exclusion Criteria:

* No history of mastectomy or implants, or having any condition that does not allow proper use of our imaging devices.
* Only include patients with masses detectable under ultrasound.
Predicting Response Patterns to Treatment in Glioblastoma (GBM) Patients

PROPHETIC GBM - Predicting response patterns to treatment in Glioblastoma (GBM) oncology patients based on host response evaluation during anti-cancer treatments

The goal of this research study is identify new host response proteins, pathways and mechanisms that are associated with responsiveness to GBM treatment modalities.

This will serve as a tool for physicians when making treatment decisions. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide up to 5 blood samples and clinical data will be collected from their medical records.

The data obtained from the blood samples and the medical records of the patients will be used to search for potential mechanisms that are involved in response to treatment, and to identify potential targets to increase the response, and hence, increase treatment effectiveness or suggest potential new treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study-specific procedures.
2. Male or female aged at least 18 years.
3. KPS not less than 50.
4. Normal hematologic, renal and liver function:

   1. Absolute neutrophil count above 1500/mm3, platelets above 100,000/mm3, hemoglobin above 9 g/dL;
   2. Creatinine concentration not more than 1.4 mg/dL, or creatinine clearance above 40 mL/min;
   3. Total bilirubin below 1.5 mg/dL, ALT+ AST levels not more than 3 times above the upper normal limit.
5. Patients planned to receive standard of care TMZ+RT treatment; TTF therapy during RT is permitted.

Exclusion Criteria:

1. Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of surgery. Except for basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to screening, and carcinoma in situ of the cervix that have been completely excised and cured at least 5 years prior to screening.
2. Participation in another clinical trial which includes an investigational drug.
3. Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
4. Pregnancy.
Attentional Bias in Body Dysmorphic Disorder

Body Dysmorphic Disorder (BDD) participants will demonstrate greater attentional biases as compared to healthy control (HC) participants. Greater attention bias will be associated with greater distress. Greater attention bias will be associated with greater symptom severity.


Eligibility Criteria:
Inclusion Criteria for BDD and healthy control participants:

* males and females 18 years of age or older
* sufficient fluency of English to understand study staff, procedures, and questionnaires
* ability to provide informed consent

Inclusion for BDD participants only;

* primary diagnosis of Diagnostic and Statistical Manual 4th Edition (DSM-IV-TR) BDD
* BDD Yale-Brown Obsessive Compulsive Disorder score (Y-BOCS) of \> 20
* primary facial/head concern

Exclusion Criteria:

* Major medical or neurological conditions
* schizophrenia, schizoaffective disorder, or any other current lifetime DSM-IV psychotic disorder that is not attributable to delusional BDD
* current suicidality
* current homicidality

Exclusion criteria for healthy controls:

* Any current Axis I psychiatric illness
* history of BDD
Myofascial Pain Syndrome and Plantar Fasciitis Treatment

Patients with plantar fasciitis between the ages of 25-65 years who presented to the Physical Medicine and Rehabilitation clinic with the complaint of heel pain and met the inclusion and exclusion criteria will be included in the study. Demographic data (age, gender, body mass index, symptom duration) will be recorded at the beginning of the study. Then, Foot Functional Index (FFI) and Visual Analog Scale (VAS) scales will be recorded. Participants will be randomly divided into two groups. Group 1 will receive dry needling and Group 2 will receive extracorporeal shock wave therapy (ESWT). Patients in the 1st group will undergo 3 sessions of dry needling with Seirin branded 0.6\*50 mm acupuncture needles at one week intervals for the trigger point detected by manual palpation in the medial gastrocnemius, lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis brevis muscles. Patients in the 2nd group, Patients in this group received three sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 trademarked ESWT device) at an energy density of 2 bars and a frequency of 2,000 shocks/min at 12 Hz for three weeks, each session once a week. Each of the five most sensitive and painful points was given 400 pulses in the supine position


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 25-65 years with heel pain for more than 6 weeks
* tenderness on palpation in the medial calcaneal region
* aggravation of symptoms while standing and in the first hours of the morning
* who agreed not to receive anti-inflammatory treatment during the study period
* fascia thickness \>4mm measured by ultrasound.

Exclusion Criteria:

* Patients diagnosed with rheumatologic diseases
* Those diagnosed with Diabetes Mellitus (DM), those with chronic liver and kidney failure
* Anti-inflammatory-analgesic treatment within the last 1 month
* Diagnosed with inflammatory rheumatic disease
* Those with a history of foot surgery
* Those with mid or hindfoot deformity
* Previous history of central or peripheral nerve damage, lower extremity neuropathy
* Those diagnosed with Diabetes Mellitus
* Those with cognitive impairment
* Unassisted mobilization
* Those with bleeding disorders
* Pregnant women
Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures

OBJECTIVES: I. Determine whether treating head injured patients with valproate sodium will reduce the risk of developing seizures as a result of the head injury.

II. Determine the safety of valproate, the appropriate dose, and the effect valproate may have on the recovery of the brain's ability to compute numbers, solve problems, remember information, and control the movement of limbs after head injury.

PROTOCOL OUTLINE: This is a randomized, double blind trial involving 3 treatment groups.

On day 1, controls receive phenytoin IV over 1 hour. On days 2 through 7, controls receive 2 doses each of phenytoin and placebo daily, intravenously. From day 8 through 6 months, controls receive placebo IV 4 times daily, then placebo tablets are administered.

On day 1, the experimental group receives a loading dose of valproate sodium intravenously over 1 hour within 24 hours of injury. Then, patients are divided into 2 subgroups.

From day 2 through 1 month, one group of patients receives valproate IV 4 times daily over 1 hour until tablets are tolerated. Patients receive placebo tablets by mouth 4 times daily from month 2 through month 6.

On day 2, the other group of patients receives valproate IV 4 times daily and continues for 6 months until tablets (same dose) are tolerated.

If patients remain seizure free between day 8 and 6 months, the number of valproate or placebo tablets are tapered over 1 week.

Each patient receives a full neuropsychological and psychosocial examination at 1, 6, and 12 months after injury.

Untreated observation of patients continues until 2 years after injury.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Any patient developing the following conditions within 24 hour postinjury:

* Cortical contusion
* Depressed skull fracture
* Subdural hematoma
* Epidural hematoma
* Intracerebral hematoma
* Penetrating head wound
* Seizures occurring subsequent to head injury

--Prior/Concurrent Therapy--

* No antiseizure medication prior to injury or between the injury and study drug loading
* Surgery: No prior neurosurgical operation for which the skull and dura mater were opened

--Patient Characteristics--

* Age: 14 and over
* Hematopoietic: No abnormal coagulation profile
* Hepatic: No history of chronic or alcoholic liver disease Adequate liver function as indicated by ALT less than 1.5 times the upper limit of normal
* Other: Not pregnant No injuries greater than 24 hours old No history of seizures prior to injury No prior history of significant head injury or neurological condition requiring medical attention
Screening Contrast-enhanced Mammography

The main objective of this study is to compare the diagnostic performance of two diagnostic methods, namely CESM and MRI, in the evaluation of a lesion suspicious of breast cancer in 300 Quebec women referred for the investigation of breast cancer. breast lesion suspected of cancer. All suspicious lesions will be evaluated by these two diagnostic imaging and by TNM. Then, radiologists will respectively interpret diagnostic imaging, without knowing the result of the other imaging in parallel with the study. The sensitivity, specificity, positive predictive value and negative predictive value for his diagnostic imaging will then be determined. Histopathological confirmation by biopsy or surgery will be used as a standard value.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 18 and over
* At least one breast lesion with BIRADS classification 5

Exclusion Criteria:

* Refusal to perform the biopsy or surgery
* Pregnant or possibly pregnant woman
* Usual contraindication to contrast product

  * Significant kidney failure
  * Allergy to contrast medium
* hyperthyroidism
* Usual contraindications to MRI
The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"

The main objectives of CESTA are (1) to compare the efficacy of two cervical cancer screening algorithms: HPV test followed by visual inspection with acetic acid (VIA) and treatment (HPV + VIA + treat) and HPV test followed by immediate treatment (HPV + treat). The study will be conducted to address its objectives in women living with HIV (from now on called HIV positive women); and 2) To evaluate the performance of other techniques for primary screening and as triage for HPV positives WLHIV.

1,500 women living with HIV WLHIV will be recruited from HIV care clinics, also called antiretrovirals (ARV) clinics in South Africa. After giving informed consent, women will be screened with HPV testing and those that have a HPV positive test will be randomized at a 4:1 ratio into HPV + VIA + treat (Arm 1) and HPV + treat (Arm 2). Women in Arm 1 will receive VIA and only positive for VIA will be treated. In Arm 2, all HPV positive women will be treated. Women that are eligible for ablative treatment will be randomized into treatment with TA or cryotherapy in both arms. Others will be referred to colposcopy. After VIA in Arm 1 or before treatment in Arm 2, the nurses will collect 2-4 biopsies on all HPV positive women. The biopsies will be used as gold standard for disease detection. Treated women will be called by telephone after 1 week and 1 month to assess side-effects and satisfaction with the procedures. Cervical samples from women will be tested with HPV DNA test and HPV mRNA test to evaluate different screening tests for WLHIV. All women with a positive HPV test (treated or not) will be called back after 1 year for a follow-up visit. At this visit, women will be screened with HPV testing and VIA and 2-4 colposcopy-directed biopsies will be taken from all HPV positive women. Women with remaining/recurrent CIN2+ disease will receive appropriate management.


Eligibility Criteria:
Inclusion Criteria:

* Willing to disclose HIV status
* HIV negative women aged 30-54 years; HIV positive women aged 25-54 years
* Mentally competent to give informed consent
* Physically able to have a pelvic exam

Exclusion Criteria:

* Women reporting no previous sexual activity
* History of cervical cancer
* Treatment for cervical precancer in the last six months
* Hysterectomy
* Pregnancy
* Serious pre-existing medical conditions (e.g. history of bleeding disorders, serious physical or mental disease)
Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression

The investigators would like to carry out this study to measure drug levels in HIV-infected women that are taking anti-HIV medications. This study will determine the predictors of high drug levels and will assess the association of drug levels and adverse events in women.

There have been tremendous advances in the treatment of HIV by combining 3 to 4 of the 20 anti-HIV medications available. Despite these advances, there remain several important complications related to the treatment, most importantly adverse events like nausea, diarrhea, liver toxicity and lipodystrophy (fat wasting or accumulation). Some studies have found that drug levels are higher in women and that these higher drug levels are associated with the increased toxicity in women. The reasons for the higher drug levels remain unclear. It is unknown whether these relate to hormonal influences, drug metabolism, adherence, fat distribution, body size or other factors. For this reason, we would like to carry out this study to measure drug levels in HIV-infected women that are taking anti-HIV medications. This study will determine the predictors of high drug levels and will assess the association of drug levels and adverse events in women.

Eligibility Criteria:
Inclusion Criteria:

* Are HIV infected
* Are 18 years old or older
* A biologic woman
* Are taking their first combination Anti-retroviral regimen that includes a Protease Inhibitor or a Non-Nucleoside Reverse Transcriptase Inhibitor for the past three months with no changes in any part of the combination in that period
* Are taking either a Protease Inhibitor or an Non-Nucleoside Reverse Transcriptase Inhibitor but not both
* If taking a Protease Inhibitor, must be taking only one Protease Inhibitor excluding low dose ritonavir used as boosting
* Have a viral load \< 50 copies/mL on two occasions at least 1 month apart including a value at least three months before the baseline visit
* Have signed and dated a full informed consent

Exclusion Criteria:

* Have difficulty participating in a trial due to non-adherence or substance abuse
* Pregnant or breast-feeding
* Have malignancy receiving systemic chemotherapy
* Have end-stage organ disease
* Have another significant non-HIV underlying disease that might impinge upon disease progression or death
MRI Sequence and Imaging Protocol Development

The purpose of this study is to develop imaging protocols when using cardiovascular magnetic resonance (CMR) to assess cardiac functions, morphology and tissue characterization. The National Heart Research Institute Singapore (NHRIS) houses two dedicated CMR scanners to support the numerous investigator initiated projects in patients with various cardiac pathologists. By optimizing novel CMR sequences used in these studies, scanning time can be shortened for patients with underlying cardiac diseases.

In medical research, there is a continuous need to develop new imaging techniques such as cardiovascular magnetic resonance (CMR) imaging. This will allow us to visualize and study the function and structure of the heart in greater detail so as to improve the diagnosis and treatment of patients with various cardiac conditions. The aim of the study is to optimise new CMR sequences, allowing the development of imaging protocols in future research studies.

This study will hence recruit 800 subjects for each of the following sub-studies:

1. Sub-study 1: Normal CMR protocols for assessment of cardiac function and morphology
2. Sub-study 2: Exercise stress protocols with a CMR-compatible supine bike.

For the first sub-study, 400 healthy volunteers and patients with cardiac conditions or suspected to have cardiac conditions will be recruited. The testing and optimising of CMR sequence settings are crucial to ensure the accuracy and robustness of the scan before using the scan as a clinical diagnostic tool.

For the second sub-study, 400 healthy volunteers of different fitness levels and and patients with cardiac conditions or suspected to have cardiac conditions will be recruited. An exercise stress protocol will then be developed for future studies in patients with suspected coronary artery diseases. For this protocol, participants will be asked to cycle on a supine exercise bike to assess the effects of exercise and free breathing on the stability of the CMR imaging sequences.

Eligibility Criteria:
Inclusion Criteria:

* Has no known significant medical history
* Is able to give informed consent

Exclusion Criteria:

* Has contraindications to CMR implantable devices, cerebral aneutysm clips and cochlear implants
* Has claustrophobia
* Females who are pregnant
* Is unable to comply with study protocols