cyrilzakka/clinical-trials huggingface dataset:
Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

Islet transplantation for type 1 diabetes results are still improving, and actually Insulin-independence with normal HbA1c is obtained in 50% of patients after 5 years, 80% of c-peptide positive patients. In addition to the need of 2 or 3 surgical or radiological interventions to inject islets, an immunosuppressive regimen is needed, which can be deleterious, particularly on kidneys. Moreover, long term beneficial effects of islet transplantation on stabilization or prevention of macro and micro vascular complications of diabetes has not been evaluated. In a preliminary work, it was observed a stabilisation or improvement of microvascular complications when compared to pre-transplant data.

The aim of this study is to compare the evolution of diabetes complications, especially nephrologic, 10 years after islet transplantation and to compare it to patients with a brittle diabetes, 10 years after evaluation for islet transplantation, finally not performed.

This case-control study will evaluate nephrologic parameters (creatinine, MDRD creatinine clearance, microalbuminuria, proteinuria) and other micro and macro-vascular complications of type 1 diabetes) before islet transplantation and 10 years after the transplantation or after the first evaluation in patients who finally did not underwent islet transplantation for various non nephrologic reasons


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetic patients, with or without previous renal transplantation who benefit at least 5 years before the inclusion of clinical evaluation in order to perform an islet transplantation
* Who either benefit of islet transplantation or did not and treated with optimized insulin therapy

Exclusion Criteria:

* C-peptide positive diabetes
* Type 1 diabetic patient non-grafted of islets due to albuminuria\> 300mg / 24h or MDRD \<50 ml / min during the pre-transplant evaluation (exclusion criterion for islet transplantation)
* Patients that can not receive clear information
* Refusal to sign the consent
* Psychiatric Pathology
* Participation in another study excluding the possibility of participating in another protocol.
* Pregnant or breast feeding women
* Patients under guardianship, persons deprived of freedom
* Lack of coverage by the social security system
Four Models of Telephone Support for Stimulant Recovery

The overall objective of this research is to develop and refine empirically supported continuing care interventions that promote healthy behavior and sustained abstinence from illicit drug use.

For treatment interventions to provide the desired result of long term abstinence, it is important to develop strategies to enhance the effectiveness of continued care approaches. We plan to conduct a prospective, randomized comparison of four models of counselor-provided telephone support as strategies to promote patient aftercare attendance and sustained abstinence from stimulant use. To this end, we will develop and compare the efficacy of four low-cost telephone support protocols for patients who have completed the intensive phase of a structured, outpatient stimulant abuse treatment program. Some 500 participants completing a 4-month Matrix Outpatient Model of stimulant abuse treatment will be randomly assigned to one of four counseling groups (n=100 per group): (1) unstructured/non-directive, (2) structured/non-directive, (3) unstructured/directive, or (4) structured/directive telephone counseling, or (5) a control group consisting of standard referral to Matrix aftercare, for a total sample size of 500. The two structured conditions will be based on the behavioral "prompts" identified by Farabee et al. (2002)\* as being associated with drug avoidance. In the non-directive conditions, subjects will be allowed to state their own goals and how they intend to achieve them. In the directive conditions, the counselor will provide specific recommendations to help the subject adopt as many of the drug-avoidance activities as possible. Outcomes will be tracked for 12 months following completion of primary treatment (a total of 16 months after treatment admission) and will include measurement of participation in drug-avoidance activities (including aftercare participation) as well as self-reported and objective measures of substance use and related behavior change.

\*Farabee, D., Rawson, R.A., \& McCann, M. (2002). Adoption of drug avoidance activities among patients in contingency management and cognitive-behavioral treatments. Journal of Substance Abuse Treatment, 23, 343-350.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, 18-65 years of age.
* Meet DSM-IV criteria (at the time of treatment admission) for cocaine or methamphetamine abuse/dependence.
* Have completed the primary phase of treatment at a Matrix outpatient clinic.
* Have telephone access throughout the study procedures.
* Be able to understand and complete rating scales and to follow instructions.
* Be willing to sign an informed consent form.

Exclusion Criteria:

* Have participated in a treatment-related study conducted by the PI and colleagues during the previous 3 years and/or is currently enrolled in a treatment-related study.
* Have any medical, legal, housing or transportation problem which would preclude either safe or consistent participation.
* Have dropped out of the primary phase of treatment prior to completion.
18F-FET PET/CT in the Management of Glioma

O-(2-\[18F\]-fluoroethyl)-L-tyrosine (FET) is a tracer for positron emission tomography (PET). The Response Assessment in Neuro-Oncology (RANO) working group has officially recommended 18F-FET PET in the management of patients with brain glioma. Recently, the utility of 18F-FET PET in the diagnosis of fresh and residual gliomas has been reported by several investigators. But clinical usefulness of radiomics parameters has not been explored thoroughly in glioma patients. 18F-FET PET has been widely used in clinical studies or routine service in Europe, America, Mainland China, or Japan. However, 18F-FET PET is still not available in Taiwan. In this context, the investigator propose this study to explore the role of multiparametric 18F-FET PET imaging for glioma in Taiwan, with the emphasis in radiomics analysis.

Study background:

O-(2-\[18F\]-fluoroethyl)-L-tyrosine (FET) is a tracer for positron emission tomography (PET). The Response Assessment in Neuro-Oncology (RANO) working group has officially recommended 18F-FET PET in the management of patients with brain glioma. Recently, the utility of 18F-FET PET in the diagnosis of fresh and residual gliomas has been reported by several investigators. But clinical usefulness of radiomics parameters has not been explored thoroughly in glioma patients. 18F-FET PET has been widely used in clinical studies or routine service in Europe, America, Mainland China, or Japan. However, 18F-FET PET is still not available in Taiwan. In this context, the investigator propose this study to explore the role of multiparametric 18F-FET PET imaging for glioma in Taiwan.

Materials and methods:

1. During the pre-treatment work-up, the study participants undergo an 18F-FET PET/CT scan. In addition, other routine examinations, including MRI with and without contrast enhancement, are performed.
2. After a definitive diagnosis of primary/recurrent glioma is confirmed, subjects begin treatment (surgery, radiation therapy, chemotherapy, etc.). Within 3 to 6 months after completing treatment, the study subjects undergo a second 18F-FET PET/CT scan for response evaluation, along with a follow-up MRI.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary or recurrent brain tumors confirmed by pathological examination or imaging studies.
2. The ability to provide written informed consent and receive the scheduled scan.

Exclusion Criteria:

1. Woman with pregnancy or during lactation.
2. Unsuitable for PET scans, such as those with claustrophobia or inability to lie flat.
3. Unable to sign the informed consent form.
4. Patients with a second primary tumor.
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of RD01 (Pegerythropoietin) in Healthy Chinese Volunteers

A first-time in human study to investigate the safety, tolerability and pharmacokinetics of RD01 in healthy Chinese subjects

A Phase 1, Randomised, Double-blind, Single-centre, Placebo-controlled, Dose-Escalation study to evaluate the Safety, Tolerability and Pharmacokinetics of single S.C. doses of RD01 (Pegerythropoietin) in Healthy Chinese Subjects. Doses were escalated from 0.2μg/kg up to 4.8μg/kg with 12 subjects (randomized to 5:1 for test or placebo) in every cohort.

Eligibility Criteria:
Inclusion Criteria:

* Age 18\~60, both male and female
* Healthy adults without obvious organic diseases and nervous/mental diseases
* BMI 19\~26 kg/m2, inclusive
* Subject is willing and able to provide written informed consent, and would complete the whole study procedures
* Serum ferritin level is within the reference range at screening within 4 weeks before enrollment
* Should be fully recovered, when has received surgical treatment

Exclusion Criteria:

* Has allergy history or past drug allergy history, or allergy history to polyethylene glycol
* Has taken any drug within 5 half-time or 4 weeks before enrollment
* Has taken any drug known to harm organ within 12 weeks before enrollment
* Participated in other clinical trials within 12 weeks before enrollment
* Donated blood or received blood transfusion, or received therapy of recombinant erythrocytogenetic stimulating protein or rHuEPO within 12 weeks before enrollment
* Female subject receives therapy of hormone after menopause
* Subject with clinically significant abnormal of lab tests determined by the investigator (subjects with Hb or Rtc level outrange the up-limit of reference were suggested to be excluded)
* Subject with HBsAg, HBeAg, HCV-Ab, HIV-Ab or Treponema pallidum antibody positive
* Clinically diagnosed as vitamin B12 or folic acid deficiency
* Previous history of coronary heart disease or congestive heart failure, or ECG shows clinical significance of abnormalities
* With history of malignant tumors or suspicious
* Subject with active infection
* History of autoimmune disease, or being treated with immunosuppressive agents
* With severe, progressive or uncontrolled diseases of liver, kidney, blood, gastrointestinal tract, endocrine, heart, lung, nerves or brain
* Pregnant or lactating women, or subject planning to has descendants during trial or within 12 weeks after dosing
* Drug abusers, drug addicts, or smokers (5 or more cigarettes per day), alcoholics (14 or more units per week, 1 unit = 360 mL of beer or 150 mL of wine or 45 mL of alcohol 40% or more)
* Other factors that might influence the attendance determined by investigators, including poor compliance (long-term travel, planned relocation, mental illness, lack of motivation, etc.)
Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine (BM-SOP Study)

The aim of the study is to develop robust analytical protocols for first-void urine sample preparation and biomarker assays to analyze a panel of biomarkers in first-void urine for improved diagnosis of cervical (pre)cancer lesions.

In total 100 women will be included in this trial, women diagnosed with abnormal cytology results and/or high risk HPV (Human Papillomavirus) infection scheduled for a colposcopy exam. These women are asked to collect a first-void urine sample with the Colli-PeeTM device, prior to their colposcopy exam at the clinic. The collected urine samples will be used for the development and optimisation of robust analytical protocols for first-void urine sample preparation and biomarker assays.

During colposcopy, the cervix will be visually inspected, whether or not combined with a biopsy for histological confirmation. Colposcopy is a procedure to identify abnormalities by using a colposcope that gives an illuminated, magnified view of the cervical region. It often includes rinsing the cervicovaginal region with 50 ml acetic acid (5%). Here, this fluid will be collected and serve as the intermediate step between biomarkers in cervicovaginal secretions and urine.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 25-64 year old
* Women scheduled for a colposcopy exam due to abnormal cytology result according to the Bethesda classification 2001 (NILM, AGC (Atypical Glandular Cells), ASC-US (Atypical Squamous Cells of Undetermined Significance), ASC-H (Atypical Squamous Cells - cannot exclude HSIL), LSIL (Low-grade Squamous Intraepithelial Lesion), HSIL (High-grade Squamous Intraepithelial Lesion), invasive carcinoma), and/or positive for hrHPV infection. NILM (Negative for Intraepithelial Lesion or Malignancy) are only included when positive for hrHPV infection.
* Signing informed consent form (ICF).
* Giving consent to the research team (CEV) to contact his/her general practioner and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in ICF).

Exclusion Criteria:

* Participating in another clinical study at the same time of participating in this study.
* Not able to understand the information brochure/what the study is about.
* Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
A Multi-center Study to Determine the Prevalence and Influence of Pertussis on COPD Exacerbation in Shenzhen

A prospective, multi-center, observational clinical trail. Aim to evaluate the real incidence of chronic obstructive pulmonary disease (COPD) pertussis and the impact of pertussis on COPD exacerbation.

1. Investigate the incidence and epidemiological characteristics of pertussis infection in COPD population.
2. To explore the relationship between pertussis infection and COPD exacerbation.

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of acute COPD

Exclusion Criteria:

- Major diseases except COPD; Significant abnormality in laboratory examination; Clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis or other simple restrictive ventilation dysfunction; Patients with a history of asthma, allergic rhinitis, or a blood eosinophil count of 2600/mm3 (0.6x10\^9/L) within 4 weeks; Currently suffering from active tuberculosis; Patients with life-threatening pulmonary embolism, or al-antitrypsin deficiency, or cystic fibrosis; Patients who have undergone lung resection.
Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort

The purpose of this study is to assess the "late" immune response to further doses of pneumococcal conjugate vaccine more than 10 years after primary immunization with Prevnar (7vPnC) in infancy, as compared with individuals who did not receive Prevnar in infancy (the Prevnar naive cohort which received MnCC). The study will take place at a single study center. Study participants must have participated previously in a specific Wyeth Prevnar study (Study D118-P8) and must still be enrolled in the Northern California Kaiser Permanente (NCKP) health plan.


Eligibility Criteria:
Inclusion Criteria:

* Fully vaccinated per-protocol (4 doses of vaccine given at 2, 4, 6, and 12-15 months of age) subjects enrolled in the Prevnar arm of Study D118-P8, OR
* Fully vaccinated per-protocol subjects from the control arm of the same study that did not receive Prevnar after the close of Study D118-P8, or at any time following the study, AND
* Still enrolled in NCKP health plan.
* Subjects included in either group above must be in good health as determined by medical history, physical examination, and clinical judgment.

Exclusion Criteria:

* Previous receipt of pneumococcal polysaccharide vaccine.
* History of documented recurrent pneumococcal otitis media or any occurence of pneumonia within past 12 months
* History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
* Known or suspected disease or dysfunction of the immune system, including:
* HIV infection
* Malignancy
* Receipt of immunosuppressive therapy
* Sickle cell hemoglobinopathy
* Concomitant vaccination during the study period.
* Known hypersensitivity to any component of Prevnar.
* Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study, or could preclude the evaluation of the subject's response.
* Receipt of immune globulin within the past 3 months.
* Positive pregnancy test for menarchal female subjects.
* Females who are breastfeeding.
* For control subjects, previous receipt of Prevnar at any time.
A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral cataract surgery
* Avoid disallowed medications throughout study

Exclusion Criteria:

* Contraindications to the use of the test agents
* Known allergy or sensitivity to the test agents or components
* History of steroid response following topical administration of corticosteroids in the eye
* Wore contact lenses 48 hours prior to Visit 1
* An intraocular pressure that is greater than 22 mmHg or less than 5 mmHg in either eye
* Any significant illness that could be expected to interfere with study
* Used ophthalmic, topical or systemic corticosteroids or an immunomodulator for 7 days prior to surgery
An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis

This study is an extension trial of 0881A3-312-EU and is designed to provide information on the safety and efficacy of etanercept in patients with ankylosing spondylitis for up to 3 additional years.


Eligibility Criteria:
Inclusion Criteria:

* Completed study 0881A3-312-EU
* Agreeable to utilize medically acceptable form of contraception
* Able to reconstitute and self-inject or have a designee

Exclusion Criteria:

* Withdrawn from study 0881A3-312-EU
* Abnormal hematology or chemistry profiles
* Clinically relevant medical conditions including: congestive heart failure, multiple sclerosis or other central demyelinating diseases, blood dyscrasias, cancer or serious infection
Acupuncture for Chronic Pain

Chronic pain is a significant public health problem, associated with impairments of physical and psychological functioning. While a third or more of the general population may suffer from chronic pain, it is often under recognized and under treated in health care settings. Low income and minority samples experience disparities in the prevalence of chronic pain, in perceived access to effective pain treatment, and in consultations for pain. A great deal of literature suggests that acupuncture offers potential benefit in the management of chronic pain, but it is rarely available to low income patients. The Acupuncture to Decrease Disparities in Outcomes of Pain Treatment (ADDOPT) project will introduce and evaluate the addition of acupuncture to the management of chronic pain for ethnically diverse, low-income primary care patients. The project represents a collaboration between the New York City Research and Improvement Networking Group (NYC RING), a practice-based research network dedicated to decreasing health disparities through primary care research, the Continuum Center for Health and Healing,The Swedish Institute School of Acupuncture, and Pacific College of Oriental Medicine. Our intervention will involve addition of weekly acupuncture sessions at 3 urban primary care practices. During training sessions at each practice, primary care providers will become familiar with acupuncture and indications for referral. Patients will be eligible if they experience chronic pain due to neck pain, back pain, or osteoarthritis. Our process evaluation, guided by Glasgow's REAIM framework, will assess barriers to implementation and adoption of the intervention in busy urban practices and acceptability to patients and providers. The investigators will employ a quasiexperimental design to assess primary outcomes (pain and quality of life) and obtain preliminary estimates of secondary outcomes (health care utilization and costs) of the intervention at each health center. This design will permit comparison across sites to discern practice level differences in uptake and outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain due to osteoarthritis, back pain or neck pain; English or Spanish speaking

Exclusion Criteria:

* Active substance abuse; cognitive impairment; coumadin therapy
Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Anastrozole Tablet under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to anastrozole or any comparable or similar product.
A Study of Brivanib (BMS-582664) in Patients With Liver Cancer and Mild, Moderate or Severe Liver Dysfunction

The primary purpose of this protocol is to determine the effect of BMS-582664 on patients with hepatocellular carcinoma with varying levels of hepatic impairment


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a biopsy proven advanced solid tumor
* Subjects with a biopsy proven diagnosis of hepatocellular carcinoma conforming to child pugh classifications A, B, or C