cyrilzakka/clinical-trials huggingface dataset:
Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.

In addition to assessment of safety parameters, the objective of this study is to determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine. Specifically, the objectives of this study are to:

1. Compare the safety and tolerability of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age and naïve to smallpox vaccine. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis.
2. Determine the immunogenicity of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age by comparing: (a)the proportion of subjects at each dose level who develop a major cutaneous reaction; (b)the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between Baseline and Day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30.
3. Determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine.

Eligibility Criteria:
Inclusion criteria:

* in good general health.
* not pregnant and using effective birth control
* agreed to participate in entire study and comply with protocol requirements.

Exclusion criteria:

* military service prior to 1989.
* no previous smallpox vaccination.
* no contact with with children 1 year of age or younger
* immunodeficiency individuals or close contacts who are immunodeficient
* past history or current renal disease
* diagnosis or past history of eczema
* known allergy or past allergic reactions to latex gloves or to some antibiotics (neomycin, streptomycin, chlortetracycline, and polymyxin B).
* known allergy or past allergic to blood products.
* known allergy or past allergic reaction to cidofovir or sulfa-containing drugs.
* transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit.
* serology positive for HIV, hepatitis B or hepatitis C.
* current diagnosis or history within six months of drug or alcohol abuse disorders, psychiatric illness.
* inoculation with any other live vaccine within 30 days of Day 0 or participation in another drug or vaccine trial within 30 days of Day 0.
Syndecan-1 a Surrogate Marker for IBD

Syndecan-1 is a protein on the surface intestinal cells. previous studies proved low levels of mucosal syndecan-1 levels on the surface of intestinal cells is patients with acute and chronic inflammation due to inflammatory bowel disease.

this protein might shed from cell surface to the serum. The investigators wish to prove that elevated serum levels of syndecan-1 may be predictive of disease presence, extent and severity, that buy taking a simple blood sample from patients diagnosed with inflammatory bowel disease and comparing to normal subjects and to other markers.

One of the main hypothesis for the etiology of Inflammatory bowel disease (IBD) is an inappropriate and ongoing activation of the mucosal immune system in response to the presence of normal luminal flora. This aberrant response is most likely facilitated by defects in both the barrier function and the mucosal immune system of the intestinal epithelium. Syndecans are a class proteoglycans that take part in both cell adhesion and growth factor binding. Of the four known syndecan core proteins, syndecan-1 (CD138) and one of the best studied of this group and is also the relevant to the this study as it is expressed on the basolateral surface of columnar epithelial cells of the colon. Syndecan-1 functions as an integral membrane protein that participates in cell proliferation, cell migration and cell matrix interactions in the GI tract. Evidence for a reduction of syndecan-1 expression in the regenerating epithelium that overlies inflamed tissue was reported in both acute and chronic inflammation. This protein that is lost from the inflamed mucosal membrane might shed to the serum. Elevated serum levels of syndecan-1 may be predictive of disease presence and extent.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* no other concurrent inflammatory disease
* formal diagnosis of inflammatory bowel disease i.e Crohn's disease, Ulcerative colitis

Exclusion Criteria:

* pregnancy
* fever at time of sample taking
Expanded Access Use of Sulopenem Etzadroxil/Probenecid for Complicated Urinary Tract Infection

Sulopenem etzadroxil/probenecid is available to clinicians through an Expanded Access Program for the treatment of complicated urinary tract infections due to quinolone nonsusceptible uropathogens after an initial course of effective intravenous therapy. The investigational product may be requested by sending an email to the Sponsor (EAProgram@iterumtx.com), as listed on the Reagan Udall EAP Navigator website (https://navigator.reaganudall.org/company-directory/i).

This Expanded Access Program will allow clinicians to use sulopenem etzadroxil/probenecid for the treatment of patients with serious or immediately life-threatening complicated urinary tract infection due to quinolone-nonsusceptible uropathogens where there are no satisfactory oral alternatives to use as step-down therapy after receiving an initial course of effective intravenous therapy. The recommended dose of sulopenem etzadroxil/probenecid 500 mg/ 500 mg is one bilayer tablet orally twice daily, taken with food whenever possible. No dose adjustment is required for patients with renal impairment. Duration of therapy will be at the discretion of the prescribing clinician, depending on the type of infection being treated and the response to therapy, and is expected to be less than ten days total.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥18 years of age with complicated urinary tract infection due to a quinolone-nonsusceptible uropathogen
2. Patient or the patient's legally acceptable representative able to provide a signed written informed consent prior to any study-specific procedures.
3. Clinically documented pyelonephritis or complicated urinary tract infection for which at least one dose of effective intravenous antibiotics has been received.

Exclusion Criteria:

1. Patients who require concomitant administration of valproic acid
2. Patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs or probenecid.
3. Patients with known uric acid kidney stones
4. Patients requiring concomitant use of ketorolac tromethamine or ketoprofen
The Effects Nutrition Status and Body Composition on HD Patients' Outcome

A prospective long-term follow up of hemodialysis (HD) patients' outcome correlates with nutritional status and body composition. We will evaluate the body composition change among HD patients every three months with bioelectrical impedance analysis (BIA). The change of body composition will correlated with other clinical data including nutritional, inflammatory parameters and survival.

Wasting and malnutrition are common and serious complications in patients on hemodialysis and are strongly associated with adverse outcomes. Techniques for assessing nutrition have limitations and, due to metabolic effects and confounding effects of altered hydration and other body composition abnormalities, these limitations are greater in the context of renal failure. Bioelectrical impedance analysis is a promising method for the objective assessment and monitoring of body composition. Body composition techniques subdivide the body into compartments on the basis of differing physical properties. The different compartments reflect hydration, nutrition/wasting, body fat, and bone mineral content, which are all of great importance in patients on hemodialysis. We will conduct a prospective long-term follow up of HD patients' outcome correlates with nutritional status and body compositions. The patients will receive BIA every three months, and other routine clinical data such as dialysis adequacy and monthly biochemical data are collected to analyze. An additional blood sample of 8 ml will be collected every 3 months during the BIA survey for other inflammatory cytokines and nutritional markers such as adiponectin, leptin, ghrelin, prealbumin, fetuin A, fructosamine, IL-1, IL-6 and transferrin. The follow up period will be as long as possible and the last recruited into this study is in the Dec. 2016. These data will be used for the morbidity and mortality analysis to see if body compositions will be more useful and timely than the other nutritional parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients at National Taiwan University Hospital
* Patients who have received hemodialysis more than 3 months
* Patients who sign the informed consents

Exclusion Criteria:

* Patients who have received hemodialysis less than 3 months
* Patients who refuse to sign informed consents
* Patients who refuse to draw additional blood for research
Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Patient meets colonoscopy requirements according to the American Gastroenterological Association
* Patient meets criteria for chronic constipation including weekly bowel movement frequency requirements and reports one or more symptoms of constipation according to protocol requirements
* Patient has successfully completed study requirements with no clinically-significant findings: physical exam, ECG, clinical laboratory tests
* Patient is fluent in English

Exclusion Criteria:

* Patient reports loose or watery stools
* Patient meets criteria for IBS including protocol-defined abdominal discomfort or pain
* Patient may not take prohibited medications per protocol
* Medical diagnoses, medical conditions, or family history that would not make the patient a good candidate for the study or limit the patient's ability to complete the clinical study
Long Term Therapy With Imatinib: Development of Late Side Effects and Compliance to Treatment

Imatinib has revolutionised the treatment of chronic myeloid leukaemia (CML). The first clinical trials were conducted in 1998 in patients with advanced disease, and by 2002 imatinib was established as the standard therapy for all patients including those recently diagnosed. In spite of overwhelming evidence about its efficacy we still need to gain more knowledge about issues related to long term treatment with imatinib such as why some patients respond better than others, the development of side effects and the quality of life.

We plan to follow prospectively a cohort of CML patients in order to study their compliance to therapy,pharmacological levels of imatinib and the prevalence of side effects. We expect to be able to correlate the actual dose received, the pharmacological levels of drug in blood, with the change in the level of residual disease (measured by Q-PCR) at various time points. We also want to gain insight into the relationship between compliance to therapy and specific side effects and between compliance and duration of treatment. We will also assess the adherence to imatinib therapy after increases in the drug dose that are part of standard treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CML who have been treated with imatinib (Glivec®) within 6 months of diagnosis as first line therapy. Initial therapy with hydroxyurea is permitted.

Exclusion Criteria:

* Unable to give consent.
* Unable to communicate with the medical and nursing staff
Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment

Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we need more studies. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months. Method : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.

* Principal Objective : The first aim of the study is to value the effectiveness of botulinum toxin injection in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months..
* Secondary Objective : The second aim of this study is to document the tennis elbow history by a one year following after initial injection
* Study design : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
* Inclusion criteria : tennis elbow during more than 6 months ; signature of consent
* Exclusion criteria : Non inclusion criteria : less than 18 years old ; osteoarthritis elbow, referred cervical pain, fibromyalgia, pregnancy, myasthenia, polymyositis, SLA, anticoagulant treatment, aminosides ; diabetes, alcoholism
* Study plan: randomized parallel groups
* Number of subjects : 60

Eligibility Criteria:
Inclusion Criteria:

* Tennis elbow during more than 6 months
* Signature of consent

Exclusion Criteria:

* Less than 18 years old
* Osteoarthritis elbow
* Referred cervical pain
* Fibromyalgia
* Pregnancy
* Myasthenia
* Polymyositis
* SLA
* Anticoagulant treatment
* Aminosides
* Diabetes
* Alcoholism
* Previous botulinum toxin A injections
Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)

To collect the efficacy and safety information in subjects who have been treated with Zyvox (linezolid) for vancomycin resistance Enterococcus faecium infection for their appropriate use in daily practice.


Eligibility Criteria:
Inclusion Criteria:

* Subject to whom Zyvox (linezolid) was administered.
* Infected subject with Vancomycin resistance Enterococcus faecium.

Exclusion Criteria:

* Infected subject with MRSA and other organism.
United Kingdom (UK) Patient Preference Study of Somatuline Autogel and Treatment Administration Setting

The aim of the study is to generate real-world evidence to describe the patient experience of administration of Somatuline® Autogel® (lanreotide) in homecare and hospital settings, and the associated impact on healthcare utilisation, societal cost, work productivity and health-related quality of life (HRQoL)


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of GEP-NETs
* Patients on prescribed lanreotide Autogel®;
* Patients who have switched from hospital to homecare administration setting at least 2 months ago
* Patients judged to be on a stable dose; 120mg for tumour control or \>1 injection at same dose for symptom control

Exclusion Criteria:

* Patients who decline or lack capacity to consent to participate in the study
Phase III Expansion Trial for Determining the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A

The primary objectives of the study are to further evaluate the efficacy and safety of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in adolescent and adult patients with hemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Patients Who have Completed trial of RH-107-001 (previously treated patients) Previously received Recombinant Human Coagulation Factor VIII-Fc prophylactic.
* The patient and/or guardian or his or her legal representative must be able to read, understand, and provide signed informed consent, And voluntarily signed the Informed Consent Form.
* The compliance of patients appeared quite well.
* Patient who is considered by the investigators suitable for ongoing to accept previously treated.

Exclusion Criteria:

* Subjects who have not completed trial of RH-107-001or who have completed the Phase III clinical trial but not willing to continue receiving treatment.
* Subjects who did not participate in the Phase III clinical trial of RH-107-001.
Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.

Although the incidence of inflammatory bowel disease is stable in North American and European countries, the incidence of inflammatory bowel disease is increasing in newly industrialized countries, especially in China. The treatment drugs for ulcerative colitis include 5-aminosalicylic acid (5-ASA), glucocorticoids, immunosuppressants, and biological agents.

The aim of this exploratory Clinical Trial is to evaluate the safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* ulcerative colitis diagnosed for at least 3 mouths.
* Mayo score 6-12, Mayo endoscopic score 2-3 points
* resistant to medical treatment

Exclusion Criteria:

* Treatment-naive ulcerative colitis (no previous treatment)
* Acute severe ulcerative colitis
* Currently taking any biologicals
* Previous surgical treatment or severe colitis at imminent risk of surgery
* infective colitis
* Other systemic diseases
* Pregnancy and lactation
Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy

The goal of this clinical trial is to learn if a two month training with the Agilik powered orthosis improves the knee extension or the endurance in pediatric patients with Cerebral palsy and a crouch gait. It will also learn about the safety of Agilik. The main questions it aims to answer are:

Does the Agilik powered orthosis increase the value of the knee extension during walking? What medical problems do participants have when using the Agilik powered orthosis? Researchers will compare a group of patients using the Agilik powered exoskeleton with a group of patients treated with standard therapy.

Participants will:

Use Agilik at home or perform standard therapy for 2 months Visit the clinic at the beginning of the study, after 3 months and after 1 additional month.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CP and a crouch gait
* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.
* Body weight between 20 and 125 Kg
* Knee flexion retraction assessed in supine position by less than 10°. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.
* Subjects must not have had a tibio-tarsal arthrodesis. In addition, they must have at least 5° of passive dorsi-flexion of the ankle.
* Able to walk at least 3 m without stopping, with or without a walking aid.
* Able to understand and follow simple directions based on parent report and physician observation during historical and physical examination.
* GMFCS level I, II and III
* MAS score ≤ 2

Exclusion Criteria:

* Any severe neurological, musculoskeletal and/or cardiorespiratory involvement preventing the ability to walk;
* A history of uncontrolled seizure in the past year
* Severe spasticity
* Hip and/or knee flexion contracture of more than 20°
Calling for Care: Cell Phones for Mood Telemetry in Teens

We will modify our existing VMQ/VADIS mood telemetry software to run on a Motorola platform, and enhance it to collect information on both mood symptoms (currently covered by the VMQ/VADIS) as well as daily life stressors (currently outside the VMQ/VADIS' scope). By doing so, we will be able us to examine the role of daily stressors in the lives of teens with and without mood swings, to identify how changes in mood triggered by stressful events are similar to or different from mood changes linked to the bipolar disorder, borderline personality disorder, or other forms of affective instability.


Eligibility Criteria:
Inclusion Criteria:

* Age 14-20yrs,
* Either (i) self-reported healthy with no past / present history of substance use problems OR (ii) self-reported severe mood swings interfering with daily life.
* Fluent in English.

Exclusion Criteria:

* Inability to be trained successfully on the MHT software or to complete questionnaires without assistance.
* Unwillingness to sign / maintain a contract with a cell phone service provider.
* Lack of parental assent / willingness to act as guarantor for cell phone provider contract
Study of VTD in Waldenstrom's Macroglobulinemia

This study is a phase 2, single-arm, open-label, multi-institutional trial to evaluate the efficacy of combination therapy of bortezomib, thalidomide, and dexamethasone in patients with newly diagnosed Waldenstrom's macroglobulinemia and lymphoplasmacytic lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Age of 19 or older
* Newly diagnosed Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma
* Previously untreated with chemotherapy
* ECOG performance status of 2 or lesser
* Peripheral blood white blood cell count ≥ 3,500/uL
* Peripheral blood neutrophil count ≥ 1,000/uL
* Peripheral blood platelet count ≥ 20,000/uL
* Peripheral blood hemoglobin ≥ 6.0g/dL
* Serum total bilirubin ≤ 2.0 mg/dL
* Serum aspartate aminotransferase ≤ 2.5 x (upper normal limit)
* Serum alanine aminotransferase ≤ 2.5 x (upper normal limit)

Exclusion Criteria:

* Diagnosed with other malignancy within 5 years before enrollment
* Prior hematopoietic stem cell transplantation
* Prior organ transplantation
* Uncontrolled central nervous system involvement
* Congenital immunodeficiency
* Acquired immune deficiency syndrome (AIDS)
* Pregnancy
* Uncontrolled epilepsy
* Uncontrolled psychological disease
* Peripheral neuropathy of grade 3 or higher
Impact of HIV and Its Treatment on Reverse Cholesterol Transport

To investigate the effect of treatment of HIV infection with highly active antiretroviral therapy on individual steps of reverse cholesterol transport, endothelial function and intima-media thickness in HIV patients.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with HIV infection (3 groups of 50 patients each)
* HIV infected patients, naïve to ARV therapy and not likely to need to commence therapy for the duration of follow-up (12 months)
* HIV-infected patients, PI naïve, initiating therapy with PI-containing HAART (ARV naïve or NNRTI experienced changing to PI regimen)
* HIV-infected patients naïve to ARV therapy, initiating NNRTI-containing regimen

Exclusion criteria

* Treatment with any form of lipid lowering drugs, including fish oils.
* Body Mass Index greater than 27.