cyrilzakka/clinical-trials huggingface dataset:
IgA Nephropathy Biomarkers Evaluation Study (INTEREST)

This prospective cohort study is designed to examine the association between blood and urine biomarkers (including genetic variants) and long-term kidney disease progression among 2000 Chinese IgA nephropathy patients with relatively normal kidney function (eGFR≥60 ml/min/1.73 m2).

Glomerulonephritis is the leading cause of end-stage renal disease (ESRD) in China, where IgA nephropathy (IgAN) is the most common primary glomerulonephritis among individuals undergoing renal biopsy. The outcomes of IgAN vary highly among individuals; some have the stable renal function for lifetime and some quickly progress to ESRD. No biomarker is widely applied to predict the outcomes in IgAN yet. Previous GWAS studies including ours have identified some susceptibility loci associated with the development and clinical features of IgAN. In addition, a few cohort studies have revealed several genetic loci related to the progression of IgAN. But, all of the reported GWAS studies were based on a case-control design, which may not provide the information about the effect of genetic variants on the progression of disease. Previous cohort studies which focused on certain specific candidate genes cannot unbiasedly explore the progression related susceptibility loci. Furthermore, there is no study that integrates the information from whole genomic loci and serum and urine biomarkers to predict the long-term progression in IgAN. Therefore, we design a relative large prospective cohort study to examine the association between blood and urine biomarkers (including whole genomic loci) and long-term kidney disease progression among 2000 Chinese IgAN patients with relatively normal kidney function (eGFR≥60 ml/min/1.73 m2).

Eligibility Criteria:
Inclusion Criteria:

* Male or female individuals aged 14 years or older
* Patients with biopsy-proven primary IgA nephropathy
* A renal biopsy available for reviewing must include 10 or more glomeruli.
* The first renal biopsy was performed within 3 years.
* eGFR ≥ 60 ml/min/1.73 m2 (MDRD formula);
* Individuals or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF).

Exclusion Criteria:

* Relatives were diagnosed with biopsy-proven primary IgA nephropathy;
* Individuals had secondary IgA nephropathy due to diseases such as diabetes, chronic liver disease and systemic lupus erythematosus.
Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients

Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four subjects with known or suspected ovarian cancer.

This was a single-center, open-label evaluation of a single injection of Tc 99m EC20 containing 0.1 mg EC20 labeled with 15 - 20 mCi of technetium-99m in normal volunteers and patients with known or suspected ovarian cancer. Two normal volunteers and two patients also were to receive an injection of 0.25 - 2.0 mg folic acid 1 to 2 minutes prior to the injection of Tc 99m EC20. Serial blood samples and urine were collected during the 24-hour period following each injection for pharmacokinetic evaluation. Serial whole body images were acquired during the 24-hour postdose period for dosimetry evaluations. Safety was monitored through predose and postdose physical examinations, electrocardiograms (ECGs), vital signs and clinical laboratory evaluations. Adverse events were monitored from the time of signing of Informed Consent to 24 hours postdose.

Eligibility Criteria:
Inclusion Criteria:

* All subjects were to be females 18 years of age or older who met the following criteria:

  1. The four normal subjects were to be normal, as established by medical history, physical examination, and laboratory data, including CBC, serum chemistry, and urinalysis.
  2. The two subjects with obvious advanced stage ovarian cancer were to have either histopathologically proven stage 3 or 4 disease or clinically obvious disease defined by 2 of the following 3 conditions: (1) pelvic mass (2) omental "caking", or (3) ascites.
  3. Subjects were to have newly diagnosed, treatment refractory, or recurrent disease. Subjects were to be treatment naïve or at least 2 months since last non-surgical treatment. Subjects were to have normal kidney and liver function.
  4. The two subjects with suspected ovarian cancer were to have a known mass. Subjects were to have normal kidney and liver function.
  5. Subjects were to provide informed consent prior to enrollment.

Exclusion Criteria:

* The following subjects were to be excluded:

  1. Subject was pregnant or breast-feeding.
  2. Subject was simultaneously participating in another investigative drug or device study, or had completed follow-up phase of any previous study within 30 days prior to enrollment in this study.
  3. Subject had a known history of chronic abuse of drugs or alcohol or had tested positive in the pre-study urine drug abuse screen.
  4. Subject was currently taking folic acid supplements and could not stop taking the supplements for a period of 3 days (2 days prior to the study and one day after last imaging procedure).
  5. Subject had physical condition that was unsuitable for radionuclide imaging.
  6. Subject had been administered another radiopharmaceutical that would interfere with the assessment of the biodistribution of Technetium Tc 99m EC20.
Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME)

Standard treatment for oropharynx cancer is radiotherapy by intensity modulation with only one planification before treatment. Adaptative radiotherapy integrates one or several planifications during treatment radiotherapy in order to take into account anatomic modifications that occurs.

Adaptative radiotherapy is very expensive, complex and is consuming human resources as well as equipment.

ARTIX study (NCT01874587) entitled "Phase III trial testing the benefit of intensity-modulated radiotherapy with weekly replanifications versus intensity modulated radiotherapy with only one planification in locally advanced oropharynx carcinoma for decreasing xerostomia" is completed and clinical data from this study are used to analyse if xerostomia is decreased when adaptative radiotherapy is used.

ARTOME study will assess cost-efficiency and cost utility between standard treatment (one pretherapeutic planification) and experimental treatment (weekly replanifications during treatment). Clinical data from ARTIX study will be used for ARTOME study.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced non-metastatic carcinoma of the oropharynx limited to T3 and T4 (whatever the N) and N2-N3 (whatever the T)(AJCC stage III-IV)
* Age ≥ 18 years and ≤ 75 years
* Performance status (WHO ≤ 2)
* Renal, hepatic and cardiovascular functions allowing systemic treatment administration
* Adapted stomatologic care
* Signed informed consent form
* Membership or beneficiary of a national insurance scheme

Exclusion Criteria:

* Both parotids totally included in the target volume
* Stages T1 or T2 with positive node disease N1
* Neoadjuvant chemotherapy
* Exereses of primitive tumor and/or nodes
* History of other cancer within 5 years (except for basocellular epithelioma and cervical)
* Previous neck radiotherapy
* Platinum salts, 5FluoroUracile (5FU) agents or cetuximab chemotherapy
* Unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or sclerodermia) incompatible with study participation
* Patient participating in other therapeutic trial with experimental drug, 30 days before the inclusion.
* Patient already recruited in another biomedical research ( non interventional study is authorized)
* Pregnant or breast feeding patients
* Patient deprived of liberty, under tutorship, guardianship or placed under judicial protection
* Patient is deemed incapable of giving informed consent
* Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.
Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk

This study is to evaluate whether non-surgical periodontal therapy can help to control the cardiovascular risk among patients with moderate/severe periodontitis and at risk of cardiovascular disease.

Previous studies showed that the treatment of periodontitis can partially improve the control of risk factors of cardiovascular disease (e.g. blood pressure, interleukin 6), whereas the evidence is still limited. Moreover, there is currently no study reporting the impact of periodontal treatment on the overall risk of cardiovascular disease. The prevalence of periodontitis in China was 62.4%. In clinical practice, a large number of patients with moderate/severe periodontitis and at risk of cardiovascular disease seek medical advice. However, the existing guidelines lack relevant recommendations. Therefore, this study intends to evaluate whether non-surgical periodontal therapy can help to control cardiovascular risk.

376 patients with moderate/severe periodontitis and at risk of cardiovascular disease will be randomized. Those randomized to the intervention arm will receive non-surgical periodontal therapy which includes full-mouth subgingival scaling and root planing. Those randomized to the control arm will receive supragingival ultrasonic scaling. All patients were given instructions on basic oral hygiene.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* At risk of cardiovascular disease (defined as "Framingham Score" predicted 10-year risk of cardiovascular disease ≥ 20%);
* Moderate//severe periodontitis;

Exclusion Criteria:

* Cardiovascular diseases at baseline (coronary heart disease, stroke and peripheral artery disease);
* Received periodontal treatment within the past 6 months;
* Pregnant or lactating females;
* Non residents of Guangzhou and its surrounding cities or expected to leave Guangzhou or its surrounding cities within 1 year;
* Malignant tumors or other end-stage diseases with life expectancy less than 1 year;
* End-stage renal disease;
* Patients with high bleeding risk, high blood pressures or other situations that make them unable to receive interventions;
* Refuse to provide informed consent;
A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects

PreTerm Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149 is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, the pharmacokinetics of various modified release formulations of GSK221149 will be investigated in healthy non-pregnant adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and non-pregnant female
* Between the ages of 18 and 50 years old.
* Females may be of child-bearing or non-child-bearing potential.
* Non-smokers
* BMI of between 19 and 30 kg/m2 (weight of greater than 110lbs).

Exclusion Criteria:

* History of smoking within past 6 months
* Regular alcohol consumption averaging 7 drinks or more per week
* Subject is positive for hepatitis C antibody, hepatitis B surface antigen, or HIV
* Use of prescription or non-prescription drugs within 14 days of study start
Comparisons of Serologic Response of Early Syphilis

Syphilis and HIV are prone to occur concomitantly and the two diseases share several modes of acquisition and risk factors such as men who have sex with men (MSM), sexual workers, intravenous drug users, previous history of sexual transmitted diseases (STDs), and multiple partners. HIV infection rates of up to 50% have been reported among patients diagnosed with syphilis in several regions, with higher HIV infection rates among MSM. Besides, syphilis ulcers are proposed to enhance the transmission of HIV. In Taiwan, there is also an increasing prevalence of syphilis and HIV co-infection among MSM. Therefore, to treat syphilis is an important issue for public health.

According to literature review, whether patients with HIV and syphilis co-infection had higher serologic failure rate remains controversial, especially in the era after highly active anti-retroviral therapy (HAART) was introduced since 1996. Ghanem et al recently demonstrated that the use of HAART may reduce syphilis failure rates among HIV-infected patients who have syphilis. In addition, the treatment guideline in 2006 suggested that the treatment of primary syphilis and secondary syphilis is single dose benzathine penicillin G regardless of HIV status; however, it goes on to suggest that "some specialists recommended additional treatments for HIV-infected patients", namely 3 doses, each a week apart. There is no reference and evidence of strength of the suggestion but only specialists' opinion.

In the study, we aim to compare serologic response of syphilis to penicillin treatment between HIV-infected and HIV-uninfected patients and to compare serologic response of early syphilis (primary or secondary) to 1 dose and 3 doses of benzathine penicillin G among HIV-infected patients. A longitudinal follow-up of serologic response will be conducted after syphilis treatment.


Eligibility Criteria:
Inclusion Criteria:

* persons aged ≧20 year-old, who had documented syphilis infection (RPR titer≧ 1:4 and TPPA ≧1:320)

Exclusion Criteria:

* Nil
Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy

Evaluation of the Efficacy and Safety of Deep Brain Stimulation of the Extreme Capsule (EC) for the Treatment of Drug-Resistant Epilepsy

This studyTo evaluate the efficacy and safety of deep brain stimulation of the EC for the treatment of drug-resistant epilepsy originating from EC structurally connected cortex cortex, This study aims to explore stimulation patterns and parameters that can suppress abnormal epileptic discharges at the seizure focus without impairing language function. This study aims to improve treatment challenges for these patients and promote clinical translation and application

Eligibility Criteria:
Inclusion Criteria:

* Participants are between the ages of 14 -65 years of age
* Diagnosis of drug-resistant epilepsy follows the standard of resistance to regular medication treatment for at least two years. Comprehensive preoperative epilepsy assessment, combined with individualized fiber tracking, is used to determine whether the epileptogenic zone is located in cortex regions structurally connected to the extreme capsule.
* Persistence of disabling seizures at least 3 times per month or greater,
* Informed consent signed.

Exclusion Criteria:

* Structural alterations are present in the extreme capsule.
* Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
* Psychogenic non-epileptic seizures within 12 months;
* Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
* Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
* IQ \< 55 or severe cognitive dysfunction, unable to complete the study;
* Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
* Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
* Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function;
* Pregnant, or planning to pregnant within 2 years;
* Participation in another clinical study within 3 months;
* Not suitable for enrollment as assessed by the multidisciplinary team of the center.
Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)

This is a placebo-controlled study intended to examine the effects of the neutraceutical citicholine, together with omega-3 fatty acids, on a range of measures in individuals with concussive head injury, often referred to as traumatic brain injury, or TBI. The study will consist of three visits, during which participants will complete brain scans, a thorough testing battery and a clinical interview to assess mood and other diagnostic information relevant to the study.


Eligibility Criteria:
Inclusion Criteria:

* Veteran status
* Age 18 to 55
* History of TBI
* DSM-IV-TR diagnosis of abuse or dependence disorder for either alcohol or drugs of abuse
* Multiple concussive head injuries that meet the following criteria for TBI: 1) normal structural imaging, 2) loss of consciousness (LOC) between 0-30 minutes, 3) alteration of consciousness or mental status for a moment up to 2 hours or 4) post-traumatic amnesia of 0-1 day
* Stable on current psychotropic medication regimen for ≥ 3 months

Exclusion Criteria:

* Non Veteran
* Significant medical or neurological illness with the exception of TBI, which might affect cognitive function
* Significant medical illness which has the potential to be exacerbated by ingestion of citicoline/omega-3 fatty acids, including diabetes, congestive heart disorder, hyperlipidemia and severe coronary artery disease
* Age other than 18 to 55 years old
* History of ECT treatment
* Estimated IQ \< 70
* Past or present history of bipolar disorder, schizophrenia, delusional disorder or any other psychotic disorder
* Currently taking a prescribed blood thinner (i.e., Coumadin)
* Claustrophobia
* Metal implanted within the body
* Pregnancy or lactation
* Left-handedness
* Poor vision, as subjects must have normal or corrected-to-normal vision for viewing of cognitive challenge paradigms during fMRI protocols
* Non-native English speakers (for neurocognitive tasks)
The Effect of Rapid Transcranial Magnetic Stimulation (rTMS) on Aggression in Forensic Patients

Forensic patients will undergo 30 rTMS treatments, once per day each business day using a 1Hz frequency at the right dorso-lateral pre frontal cortex, located using modified BEAM F3. Patients will be assessed before and after the study with a battery of assessments and using 2 computer tasks: a ball passing task, and the Point Subtraction Aggression Paradigm (PSAP). The investigators will also monitor and record aggressive incidents that take place on the unit.


Eligibility Criteria:
Inclusion Criteria:

1. are voluntary and competent to consent to treatment
2. are a current Forensics inpatient at St. Joseph's West 5th Campus
3. demonstrate aggressive behavior as confirmed by a psychologist or psychiatrist including verbal and physical aggression
4. are between the ages of 18 and 65
5. have had no changes in dose or initiation of any psychotropic medication in the 4 weeks prior to motor threshold
6. are willing and able to adhere to the treatment schedule
7. pass the TMS adult Safety-Screening (TASS) Questionnaire

Exclusion Criteria:

1. Withdraw consent to participate in the study
2. fail the TASS Safety Screening Questionnaire
3. have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump, or a significant history of seizures
4. have active suicidal intent
5. are pregnant as confirmed by pregnancy test completed as part of pre-study screening
6. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any significant history of seizure except those therapeutically induced by electroconvulsive therapy (ECT), cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis
7. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
8. currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) due to seizure risk or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
9. non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
Treatment of Insertional Achilles Tendinopathy by Hyaluronic Acid Injection

A pilot study of the effects of 3 retro-calcaneal hyalin G-F 20 injection on the clinical and radiological changes in 20 adult patients with changes in insertional achilles tendinopathy.

Pain of the achilles tendon commonly affects young active patients, with lifetime incidence that may be as high as 40 to 50 percent in competitive athletes. About 20% of the achilles tendinopathy injuries occur in the insertion point of the achilles tendon into the calcaneus bone1. The leading theories for the mechanism of the disorder are inflammatory response or mechanical tendon overuse. Still, the exact pathogenesis of Insertional Achilles tendinitis (IAT) is unclear, and as so the conservative management of IAT is less successful than the management of the Non-insertional tendinopathy. Previous histological description, in an unpublished data of the insertion point showed that the main pathologic features were found to be in the bone and cartilage tissues. The achilles tendon, in those studies, was almost intact. The histological features of the cartilage tissue were advanced degenerative changes, which resemble the pathologic changes of Osteoarthritis. This observation encourages to try treating IAT with management strategies that showed to be beneficial in OA( OsteoArthritis). One of the more acceptable non-surgical methods in treating osteoarthritis is intra-articular viscosupplementation injection. The investigators hypothesis, based on the histopathological finding, is that viscosupplementation may be a therapeutic option also for individuals with IAT. The purpose of this study is to show the impact of Hyalin G-F 20 injection in patients with Insertional Achilles tendinitis.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with chronic (\>6 months) posterior heel pain localized above the insertion point of the achilles tendon with evidence of IAT in ankle X-RAY and MRI.

Exclusion Criteria:

1. Previous surgical treatment.
2. Previous HA(Hyaluronic Acid), PRP (Platelet Rich Plasma) or steroids injection in the last 6 months.
3. Previous two or more steroids injection.
4. Plantaris muscle injury.
5. Posterior ankle impingement.
6. Achilles tendon rapture.
7. Previous calcaneal fracture
The Biosonographic Index

In this exploratory study we explore the use of Shear Wave Elastography to differentiate between Acute Kidney Injury after vascular surgery and among the healthy population.


Eligibility Criteria:
Inclusion Criteria:

* No history of diabetes or hypertension
* Estimated Glomerular Filtration Rate \> 60 ml/min/m\^2
* Structurally normal kidney on renal ultrasound
* BMI \< 27 kg/m\^2

Exclusion Criteria:

* Prisoners directly admitted from a correctional facility
* Children \< 19 years or under 50 kg body weight if age is unknown
* Patients with end stage renal disease or preexisting glomerular filtration rate less than or equal to 30 mL/min/1.73 m\^2 or need for dialysis
* Patients with end stage heart disease on the cardiac transplant list
* Patients undergoing procedures without vascular surgery
* All transplant patients
* Patients on ventricular assist devices
* Patients undergoing emergency procedures
* Patients with body mass index \> 27kg/m\^2
* Any condition that would impede visualization of the kidneys by ultrasound