cyrilzakka/clinical-trials huggingface dataset:
Thymosin Alpha-1 in Combination With Peg-Interferon Alfa- 2a and Ribavirin for the Therapy of Chronic Hepatitis C Nonresponsive to the Combination of IFN and Ribavirin.

The purpose of the study was to determine safety and efficacy of 48 weeks treatment with Thymosin alpha 1 (Talpha1) in combination with pegylated interferon (PEGIFN) alpha2a and ribavirin (RBV) in adult patients with chronic hepatitis C (CHC) already treated with, and not responding to previous courses of PEGIFN alpha plus RBV combination therapy, in comparison with a concurrent group treated with PEG IFN alpha2a in combination with RBV and placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent
2. Age 18
3. Presence of HCV RNA measured by quantitative PCR
4. Non responder to previous approved doses of therapy with PEGinterferon alpha plus ribavirin. Patients must have been treated for at least 12 weeks with documented HCV RNA quantitative not showing major of 2 log10 HCV RNA reduction or patients treated for at least 24 weeks with documented HCV RNA qualitative not showing a virological response (viral RNA clearance)
5. Liver biopsy consistent with a diagnosis of chronic hepatitis C or histological cirrhosis. Biopsy will not be required if the patient can produce a biopsy performed within the year preceding the randomization day and was performed at least 6 months after the end of the latter course of therapy
6. Wash-out period of at least 6 months from previous therapy with PEGinterferon alpha plus ribavirin
7. Negative pregnancy test prior (no more than 24 hours) to first study medication dose

Exclusion Criteria:

1. Use of systemic corticosteroids within 6 months of entry
2. More than one previous course of therapy with PEGinterferon alpha plus ribavirin
3. Any other liver disease
4. Decompensated liver disease based on a history of hepatic encephalopathy, bleeding oesophageal varices, or ascites
5. Decompensate or advanced liver cirrhosis (ChildPugh B or C)
6. HIV infection diagnosed by HIV seropositivity and confirmed by Western blot
7. Insulin-dependent Diabetes Mellitus
8. Severe haemoglobinopathy
9. Positive liver and kidney microsomal auto antibodies
10. Positive anti thyroid antibodies
11. Pregnancy as documented by a urine pregnancy test
12. Alcohol or intravenous drug abuse within the previous 1 year
13. Patients who are in poor medical or psychiatric conditions, or who have any non-malignant systemic disease that, in the opinion of the Investigator, would make it unlikely that the patient could complete the study protocol
14. Any indication that the patient would not comply with the conditions of the study protocol
15. Previous treatment with thymosin alpha 1
16. Patients with known hypersensitivity to any PEGinterferon and or ribavirin
17. Patients with a history of severe depression that required either hospitalization or electroshock therapy or depression associated with suicide attempt
18. Simultaneous participation in another investigational drug study or participation in any clinical trial involving investigational drugs within 3 months before study entry
19. Presence of serious pulmonary or cardiovascular disorders
Identification of Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis

This study aims to provide new mechanistic insights into the molecular determinants of response or nonresponse to Janus Kinase inhibitor therapy and the biological heterogeneity that exists in Ulcerative Colitis. This study will include patients who are initiating Janus Kinase inhibitor therapy according to standard of care. This study consists of:

* Part 1: 8 or 10 week induction therapy followed by an 8-week maintenance therapy
* Part 2: Patients who continue Janus Kinas inhibitor therapy after part 1 will be followed further for a total of 2 years, or until discontinuation of Janus Kinase inhibitor therapy (whichever is first)


Eligibility Criteria:
Inclusion Criteria:

1.18 years of age or older.

2.Male or nonpregnant, nonlactating females.

3.Diagnosis of Ulcerative Colitis for at least 3 months prior to screening.

4.Moderately to severely active Ulcerative Colitis (total Mayo Clinic Score ≥ 6), with objective evidence of inflammation defined by a Mayo endoscopic subscore (MES) ≥ 2 and disease extending \> 15 cm from the anal verge.

5.Physician plans to administer Janus Kinase inhibitor for at least 8 weeks of induction therapy as part of Standard of Care (SOC).

6.Documentation of a negative test result for latent tuberculosis within the last 12 months, or according to routine clinical practice.

7.Able to participate fully in all aspects of this clinical trial, including collection of tissue biopsies.

8.Written informed consent must be obtained and documented.

Exclusion Criteria:

1. Diagnosis of Crohn's disease or indeterminate colitis.
2. An active, serious infection, including localized infections.
3. Concomitant administration of biological therapies for Ulcerative Colitis or potent immunosuppressants, such as azathioprine and cyclosporine. Subjects with previous exposure to these treatments should undergo an appropriate washout period according to local practice prior to starting Janus Kinase inhibitor, in keeping with routine clinical practice.
4. Hematology laboratory (e.g., absolute lymphocyte count, absolute neutrophil count, and hemoglobin that contraindicate the product label.
5. Interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
6. Serious underlying disease other than Ulcerative Colitis that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study.
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness

This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of narcolepsy
* Good general health
* Willing and able to comply with the study design and schedule and other requirements

Exclusion Criteria:

* If female, pregnant or lactating
* Customary bedtime later than midnight
* History of significant medical condition, behavioral or psychiatric disorder (including suicidal ideation), or surgical history
* Any other clinically relevant medical, behavioral or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
* History of significant cardiovascular disease
* Body mass index \>34
* Excessive caffeine use - \> 600 mg/day of caffeine or \> 6 cups of coffee/day
* History of alcohol or drug abuse within the past two years
* Nicotine dependence that has an affect on sleep
Buprenorphine and Integrated HIV Care Evaluation

The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S.

Programs that integrate medical care and drug treatment have shown great promise in improving health and substance use related outcomes. The overlap in the epidemics of HIV (with its complex medical needs) and drug abuse makes HIV-infected drug users a population likely to benefit from the integration of primary care and drug treatment. The Drug Addiction Treatment Act of 2000 and the approval of buprenorphine for the office-based treatment of opioid addiction provide a new opportunity to integrate addiction treatment and medical care for people with HIV. Research has demonstrated the effectiveness of buprenorphine in reducing illicit drug use among opioid dependent people. However, little is known about implementing such programs in HIV care settings, their cost, what effect they have on the health outcomes and substance use behavior of PLWH/A, or their broader impact on providers, institutions, and local systems.

Through this study, approximately 1,350 HIV-infected individuals who meet criteria for opioid dependence will be selected by eleven model demonstration projects located in ten HIV care centers across the U.S. Information on patients' drug use, HIV health status, service utilization, quality of life, and satisfaction with services as well as information about providers' practices and attitudes towards treating drug dependent patients will be collected through face-to-face interviews, audio computer-assisted self-interviewing, written surveys, and chart abstractions. These data will be used to help replicate effective programs that integrated HIV care and drug treatment and to improve the care of HIV-infected opioid dependent individuals.

Comparisons: All eleven programs will compare a group of patients who receive integrated buprenorphine treatment and HIV care to a group of patients who receive an alternate intervention. However, the program designs and comparison group interventions vary across the sites and are locally determined. Some sites will implement randomized control designs, while others will use observational methods.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Clinical diagnosis of opioid dependence
* Fluent in English or Spanish
* 18 years or older

Exclusion Criteria:

* Liver function tests (transaminase only) at five times or higher than normal level;
* Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for benzodiazepine abuse or dependence within the past 6 months;
* DSM-IV criteria for alcohol dependence within the past 6 months;
* Actively suicidal;
* Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic);
* Methadone dose exceeding levels allowing for safe transition to buprenorphine;
* Pregnant women and women actively trying to become pregnant;
* Clinical judgment of local site principal investigator that patient is inappropriate
Manual Wheelchair Speed, Maneuverability, and Endurance and Community Access

This is a cross-section correlational study that will examine the relationships between wheelchair speed, maneuverability, and endurance with community integration. By identifying which of these has the biggest contribution to community participation, the information will be used to justify continues therapy, to alter the focus of therapy, and to justify purchase of power or power assist wheelchairs when needed. Currently, therapists make the recommendation for a power or power assist chair based on their clinical judgement and the patient's experience, but there has been limited justification from the literature for these decisions. Finally, because the CHART measure is the gold standard in rehabilitation research for community integration, but has psychometric problems, we will use this opportunity to validate a new more psychometrically solid measure, the PART-O, against the CHART.


Eligibility Criteria:
Inclusion criteria include:

* 18 years or older
* presence of a physical disability
* use of a manual wheelchair for primary mobility
* living in the community.

Exclusion criteria would include:

* individuals who have significant expressive or receptive language deficits (i.e. aphasia, verbal apraxia, etc.)
* limb orthopedic conditions that would contraindicate speed and endurance testing, such as recent fractures or joint instability
* cardiopulmonary resting heart rate of less than 50 or over 100, resting vitals of systolic blood pressure of \> 200 or \< 90, diastolic blood pressure of \>110, resting O2 levels of less than 90 (ACSM, 205; Fletcher, et al., 1993).
* any other cardiac symptoms
Safety and Efficacy Study of IV Artesunate to Treat Malaria

The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by individuals with uncomplicated malaria infection and to determine how fast it eliminates malaria infection from the body.

This is an unblinded non-randomized phase II pharmacokinetic study of a new GMP formulation of intravenous artesunate. Artesunate has been used throughout Asia and Africa for many years. Its overall efficacy associated with the ability to lower parasitemia is well established. To date, pharmacokinetic studies have not been done in Africa using GMP (Good Manufacturing Practices)-produced drug. The objective of this study is to show that GMP IV artesunate rapidly clears parasites in Adult Kenyan populations with malaria and that the pharmacokinetic profile of the drug approximates other populations of adults tested (Asians and North Americans).

Eligibility Criteria:
Inclusion Criteria:

* Adult male \& non-pregnant females, 18-65 years
* Fever, defined as \>37.5ºC, during the current illness, or history (within the last 48 hours) of fever.
* Diagnosis of falciparum malaria, greater than or equal to 200 parasites/uL
* Able to communicate well with the investigator and to comply with the requirements of the entire study.
* Willing to be admitted for the period of drug administration and/or to follow up (return to hospital)
* Provision of the written informed consent to participate as shown by a signature on the informed consent form.

Exclusion Criteria:

* Administration of any investigational drug in the period 0 to 16 weeks before entry to the study.
* The use of any medication during the period 0 to 14 days (prescribed drugs) or 0 to 5 days (OTC) before entry to the study (including herbal or dietary supplements), except those deemed by the principal investigator / clinical investigator not to interfere with the outcome of the study.
* Existence of any surgical or medical condition that, in the judgment of the clinical investigator, might interfere with the distribution, metabolism or excretion of the drug.
* History of serious adverse reaction or hypersensitivity to study drug or follow on treatment.
* Mixed malaria infection (malaria other than falciparum malaria mono-infection as detected by screening blood smear)
* Severe falciparum malaria (as defined by the WHO; Attachment 1).
* Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study,
* Transfusion of blood within past 30 days.
* Refusal to prevent pregnancy during the 14 days of the trial
* Pregnancy as defined clinically or by a positive urine BHCG at the time of screening, or nursing mothers.
* Laboratory evidence or history of significant cardiovascular, liver or renal functional abnormality, which in the opinion of the investigator would place them at increased risk. Specifically, the following will serve as exclusionary lab values:

  * Creatinine \>1.4 x ULN (\>2.0 mg/dL)
  * Glucose \<LLN (65mg/dL)
  * AST, ALT \>3x ULN (120 U/L)
Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults

This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered.

Subjects will be randomized according to a randomization scheme.

All subjects will be followed up for 60 days post-randomization and through the influenza season. Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point. The subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Adult males or females 18 - 40 years of age in good general health

Exclusion Criteria:

* Known allergies or severe reactions to any of the vaccine components including those to adjuvants
* History of severe allergic reactions, including angioedema;
* History of asthma or recurrent wheezing; (current or within past 2 years);
* History of neurological symptoms or signs following administration of any vaccine;
The Factors Predicting Change of Peritoneal Transport Characters in Peritoneal Dialysate

Peritoneal fibrosis (PF) is one of the most serious complications after long-term continuous ambulatory peritoneal dialysis (CAPD). Human peritoneal fibroblast (HPFB) and extracellular matrix (ECM) deposition is the most possible causes leading to PF. ECM are mainly synthesized from HPFB and human peritoneal mesothelial cells (HPMC). In the PF process, there is decrement in the quantity of HPMC, loss of permeability for lower molecules, and eventually ultrafiltration failure. This phenomena will result in technique failure.

High glucose content of the dialysate and peritonitis have been claimed as major stimulants to the development of PF. In each episode of peritonitis, the number of HPMC will decrease. On the other hand, ECM production will be reinforced by the inflammatory cytokines secreted by the white cells or HPMC per se. High glucose dialysate will induce the above process with more chronic stimulation, and PF followed by technique failure is inevitable.

Peritoneal fibrosis is definitively diagnosed with peritoneal biopsy, but this is inconvenient for most patients. Besides, pathology changes will be noted only after a substantial loss of peritoneal function. The peritoneal equilibration test (PET) is usually used as the index of peritoneal function. However, in the chronic process, PET change is also slow and is unable to be a parameter for treatment outcome. In this study, the factors predicting PET change will be searched, and they could be an index for evaluation and even a marker of preventing or treating PF.

In this project, peritoneal dialysis (PD) dialysate will be collected during an annual PET in each PD patient in the National Taiwan University Hospital (NTUH). Some cytokines that will be measured include vasculoendothelial growth factor, hyaluronan, transforming growth factor-β, procollagen, and cancer antigen-125. The same test and measurement will be performed during PET in the next year. The factors which affect PET results will be analyzed such as cytokines, glucose exposure, peritonitis incidence, PD duration, gender, age. The investigators will try to find a convenient acute reactive marker for preventing or treating PF to monitor the PET change clinically.


Eligibility Criteria:
Inclusion Criteria:

* All PD patients

Exclusion Criteria:

* Peritonitis
Evaluation of Patients With Bulky GIST Using Sunitinib

The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage allowing for successful surgery. Therapy will be administered orally and the response of the tumor will be assessed using CTs or MRIs.

Gastrointestinal stromal tumor (GIST) is a rare cancer affecting primarily the digestive tract and sometimes abdominal cavity in adults. The most common site is the stomach followed by the duodenum and small intestine.

Surgery is the mainstay of therapy for GIST patients whose primary tumor is felt to be resectable. Prior to the introduction of Gleevec, patients with inoperable GIST had essentially no therapeutic options. However, sunitinib trials offer options to patients who are Gleevec resistant or have intolerant GIST. Clinical benefit has been demonstrated with positive results in several sunitinib studies of varying phases.

Eligibility Criteria:
Inclusion Criteria:

* Patients more than 19 years old with pathologically proven GIST which is bulky or marginally resectable
* Patients must have at least one bidimensionally measurable disease site of 5 cm or greater not previously irradiated. Bone lesions do not qualify.
* Patients must have an ECOG performance of greater than or equal to 2, with projected survival of at least three months.
* Patients must have adequate laboratory parameters:

Hematologic: Hb \>9.0; WBC \>3200 and platelets \>100,000/mm3; Hepatic: Bilirubin \<2.0 and AST within 4 times upper limit of normal; Renal: Creatinine of less than or equal to 1.6 or eGFR greater than or equal to 50 mL/min

* Men and women who are of childbearing potential must practice strict birth control for the duration of the study.
* Women of childbearing potential must be non-lactating and non-pregnant with a negative pregnancy test within two weeks of trial registration.
* The patient, a witness, and attending physician will have signed an IRB-approved informed consent prior to Sunitinib administration.

Exclusion Criteria:

* Known brain metastases or significant pleural effusion or ascites.
* Uncontrolled hypertension, diabetes, or other medical condition.
* Major surgery within 21 days of registration.
* Patients wtih organ grafts with the exception of prior high dose chemotherapy with autologous bone marrow (or stem cell) transplantation.
* History of seizures, central nervous system disorders, dementia, or psychosis that might preclude adequate informed consent or protocol compliance.
* Prior therapy for GIST.
* A history of HIV or hepatitis virus infection.
* Any recent medical condition which, in the opinion of the investigator, makes the patient unsuitable for study participation.
* Patients with impaired kidney function.
Involved Field Irradiation (IFI) Versus Elective Nodal Irradiation (ENI) for Esophageal Cancer

This study examines contrast advantages and disadvantages of elective or prophylactic nodal irradiation in the treatment of esophageal cancer with three-dimensional conformed radiotherapy.

Esophageal lymph node drainage area is rich, according to different sites, easy to metastasis to different regions. For patient underwent concurrent chemoradiotherapy, how reasonable design the clinical target volume of lymph node drainage area has always been controversial, one is to irradiate positive lymph nodes only, the other is to irradiate the easier involved lymph node area according to different sites, in order to contrast advantages and disadvantages of the two kind of target area design，so the study was designed.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 80
2. ECOG performance status 0-2
3. Weight is not less than 90% of it before treatment
4. Histologically proven primary thoracic esophageal squamous cell carcinoma previously untreated stage I-III
5. Chest and abdominal contrast enhanced CT within 2 weeks prior to registration(PET/CT scan is selective)
6. WBC ≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
7. Platelets ≥ 100X109/L
8. Hemoglobin ≥ 90g/L(without blood transfusion)
9. AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
10. Creatinine ≤ 1.5 x upper limit of normal
11. Sign study-specific informed consent prior to study entry -

Exclusion Criteria:

1. Multiple primary esophageal tumors
2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
3. Severe, active comorbidity, defined as follows:

   * Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months
   * Transmural myocardial infarction within the last 6 months
   * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
   * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
   * Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
4. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
5. Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy