cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Epidermal Langerhans Cell Population in AIDS / ARC Patients by the Topical Application of a Potent Contact Allergen (1-Chloro-2,4-Dinitro-Chlorobenzene) (DNCB)

To evaluate the effect of application of Dinitrochlorobenzene (DNCB) on the number, morphology, and antigen expression of epidermal Langerhans cells in AIDS and AIDS related complex (ARC) patients.


Eligibility Criteria:
Inclusion Criteria

Patients must have the following:

* Stage III or IV HIV infection.
* Provide informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Kaposi's sarcoma lesions in the proposed treatment sites.
* Liable to require radiation or chemotherapy during the course of the study.
* Not likely to survive the length of the study.
* Obvious ultra-violet-irradiated skin damage in the treatment areas and anyone with recent UV exposure or likely to have such exposure (e.g.:
* holiday tans obtained in Hawaii, members of UV box tanning salons, etc.) Allergy to lidocaine.

Concurrent Medication:

Excluded:

* Other Immunomodulators.

Concurrent Treatment:

Excluded:

* Radiation.

Patients with the following are excluded:

* Kaposi's sarcoma lesions in the proposed treatment sites.
* Liable to require radiation or chemotherapy during the course of the study.
* Not likely to survive the length of the study.
* Obvious ultra-violet-irradiated skin damage in the treatment areas.
* Allergy to lidocaine.

Prior Medication:

Excluded:

* Prior DNCB therapy.
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax works to treat AML in adult participants who are ineligible for intensive induction chemotherapy in Canada.

Venetoclax is a drug approved to treat Acute Myeloid Leukemia (AML). All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive induction chemotherapy will be enrolled. Around 200 participants will be enrolled in the study in approximately 15-20 sites in Canada.

Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 36 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 36 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute Myeloid Leukemia (AML).
* Ineligible for intensive chemotherapy, determined by the physician's assessment of age, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), comorbidities, regional guidelines, and institutional practice.
* Participant for whom the physician has decided to initiate venetoclax treatment in accordance with the local label. The decision to treat with venetoclax is made by the physician prior to any decision to approach the participant to participate in this study.

Exclusion Criteria:

- Participation in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Extracorporal Shock Wave Treatment to Improve Nerve Regeneration

This study evaluates the impact of extracorporeal shock wave treatment after microsurgical coaptation of finger nerves. Participants will be randomized into two treatment groups with different settings and a sham group. The participants will thereafter followed-up in a prospective, double-blind study design.

Extracorporeal shock wave treatment is CE certified in Austria, Europe and licensed for indications like achillodynia, epicondylitis, or tendinitis calcanea. The Orthogold 100 device by MTS Medical UG will be used for this study.

Defocused low-energy extracorporeal shock wave therapy (ESWT) has gained acceptance as a therapeutic tool in different medical settings. It has been shown, that shock waves stimulate of the metabolic activity of different cell type, including osteoblasts, tenocytes, endothelial cells and chondrocytes. Furthermore, it has proved effective in clinical applications relating to bone and wound healing and myocardial ischaemia. Until now, no studies have been performed regarding the effects of ESWT on regeneration of peripheral nerve injuries in humans.

Eligibility Criteria:
Inclusion Criteria:

* complete lossless transection of one or more digital nerves distal to the branching out of the commune median or ulnar nerves
* direct, tension-free coaptation of the nerve stumps

Exclusion Criteria:

* segment loss of the nerve
* tension after direct coaptation
* diabetic neuropathy or other peripheral neuropathies
* other disease with reduced sensibility of the fingers
* injuries in the course of the nerve (plexus brachialis, median or ulnar nerve)
* chronic inflammatory disease
* rheumatoid arthritis
* pregnancy
* patients not able to give written consent
* patients with an implantable cardiac defibrillator or pacemaker
* patients which are sensitive to electromagnetic radiance
An Osteopathic Assessment of Lower Extremity Somatic Dysfunction in Runners

Runners often experience acute/chronic pain due to pre-existing structural somatic dysfunction and/or acquired various overuse injuries of the lower extremity, specifically affecting the ligaments, tendons, muscles and bones. Common structural and function dysfunctions include but are not limited to patellofemoral pain syndrome (PFPS), Achilles tendonitis, iliotibial band syndrome (ITBS), ligamentous and muscle tears, muscle sprains/strains, stress fractures, pes planus, plantar fasciitis, and shin splints.

The purpose of this study is to assess the correlation between acute and chronic pain, overuse injuries, and observational and palpatory findings upon evaluation. With an understanding of the common trends of somatic dysfunctions and etiology of the pain/injury, modified regimen/routine and improved treatment plans can be developed and recommended for runners to better rehabilitate, minimize relapse and reduce compensatory injuries. No medical or osteopathic treatment will be provided.


Eligibility Criteria:
Inclusion Criteria:

* Self-proclaimed runners that run at least 1 mile per week consistently
* Minimum 18 years old

Exclusion Criteria:

* Non-runners
* Inconsistent runners, do not log at least 1 mile weekly
A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy

The primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in adult subjects with moderate to severe HDM allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older
* Moderate to severe persistent HDM allergic rhinitis with or without asthma
* Moderate to severe HDM allergic rhinitis symptoms during a baseline period
* Positive skin prick test response (wheal diameter ≥ 3 mm)
* Positive specific IgE ≥ IgE Class 2, ≥ 0.70 kU/l)

Exclusion Criteria:

* Previous treatment with immunotherapy with House dust mite immunotherapy
* Ongoing treatment with any allergen specific immunotherapy product
* Reduced lung function
* Clinical history of uncontrolled asthma
* Inflammatory conditions in the oral cavity with severe symptoms
* History of anaphylaxis with cardiorespiratory symptoms
* History of recurrent generalised urticaria
* A history of drug induced facial angioedema or hereditary angiooedema
* Any clinically relevant chronic disease (≥3 months duration)
* Systemic disease affecting the immune system
* Immunosuppressive treatment
* Currently treated with tricyclic antidepressants; catecholamine-Methyltransferase inhibitors and mono amine oxidase inhibitors
Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth

The investigators aim to determine the association of dietary intake on cardiovascular disease risk factors among children with overweight and obesity who are being evaluated for elevated blood pressure.

The investigators will also investigate for predictors of vascular function and determine if predictors vary by level of sodium intake.

This research is being done to determine if the food or salt eaten can cause arteries to be stiffer and/or not work as well and if it can impact blood pressure over a 24-hour period of time. The investigators also want to determine if there are any risk factors or blood tests that can predict how stiff arteries are or how well arteries function. The investigators hope that the information from this study will help the investigators prevent blood pressure-related cardiovascular disease in children. This knowledge could help shape future guidelines on how to best prevent and treat high blood pressure and heart disease in children.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese
* Elevated blood pressure
* Referred to the ReNEW Clinic at Johns Hopkins University for evaluation and treatment of elevated blood pressure.

Exclusion Criteria:

* The only children who will not be eligible for inclusion in this study are those who are non-English speaking.
Breast Cancer Recurrence Risk Counseling

The number of breast cancer survivors is growing. Women with a personal history of breast cancer worry about their risk of getting cancer again. The current study will develop counseling about breast cancer recurrence risk and will also get an estimate of the preliminary impact of this counseling. The goal is to enable women to make better decisions about their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women who (1) have a personal history of a single stage 0-2 breast cancer, (2) were recently diagnosed within the past 6 months, and (3) are treated at a participating breast oncology clinic.

Exclusion Criteria:

* Women who are unable to read/write in English.
Safety and Efficacy Clinical Study of SNS-595 in Patients With Advanced Small Cell Lung Cancer

The purpose of this study is to evaluate the objective tumor response rate to SNS-595 in patients with small cell lung cancer (SCLC).

Other objectives of this study are to assess the safety, survival rate, best response, time to disease progression, duration of tumor response, and to explore several potential biomarkers to see how these levels change after administration of SNS-595.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and willing to sign a written informed consent document
* Patients who have recurrent or refractory SCLC requiring second-line chemotherapy who previously received first-line chemotherapy
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
* Brain metastasis may be included if the patient is neurologically stable and has been off steroids and anticonvulsants for at least 4 weeks prior to Cycle 1 Day 0
* Laboratory values within the normal or reasonable reference range as specified by the protocol

Exclusion Criteria:

* Prior exposure to SNS-595
* Pregnant or breastfeeding
* Women of childbearing potential, or male partners of women of childbearing potential, unwilling to use an approved, effective means of contraception according to the institution's standards
* Other active malignancies or other malignancies within the past 12 months, other than non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostatic intraepithelial neoplasia
* Q-wave myocardial infarction or cerebrovascular accident/transient ischemic attack (TIA) within 6 months before the first SNS-595 dose
* Thromboembolic event (deep vein thrombosis or pulmonary embolus) within 28 days before the first SNS-595 dose
* Requires kidney dialysis (hemodialysis or peritoneal)
* Prior chemotherapy, investigational agents, or radiation therapy within 28 days before Cycle 1 Day 0; however, nitrosoureas, mitomycin C, and therapeutic monoclonal antibodies are not permitted for at least 42 days before Cycle 1 Day 0
* In patients with toxicities caused by prior cancer therapy, those toxicities must have returned to less than or equal to Grade 1, with the exception of alopecia.
* Prior pelvic radiation therapy or radiation to greater than 25% of bone marrow reserve; radiation to the brain is permitted up to 28 days before the first SNS-595 dose, as long as the patient does not require treatment with corticosteroids for symptom control related to brain metastases.
* Any other medical, psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety or compliance with study procedures
Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors

This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies. The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion, and to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion. Additionally, evaluation of side effects as a function of dose, and observation of any anti-tumor effects of SN2310 Injectable Emulsion will be made.

This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies who have failed conventional therapy. SN2310 Injectable Emulsion will be administered intravenously every 21 days. The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion; to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion; to evaluate side effects as a function of dose level; and, to observe any anti-tumor effects of SN2310 Injectable Emulsion.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of solid tumor with disease progression despite standard therapy and/or for which no other solid therapeutic option exists
* ANC \> 1,500 cell/mm3, platelets \> 100,000/mm3 and Hgb \> 9 g/dl
* At least one unidimensionally measurable lesion per RECIST
* Negative serum or urine pregnancy test, if female of childbearing potential

Exclusion Criteria:

* Female who is pregnant or lactating
* History of chronic diarrhea
Extension Study for Patients Who Have Participated in a BMN 701 Study

This is a Phase 2 open-label, multiple dose study of BMN 701 administered by IV infusion every 2 weeks (qow) to patients with late-onset Pompe disease.


Eligibility Criteria:
Inclusion Criteria:

* Have completed a prior BMN 701 clinical development study;
* Have provided written informed consent after the nature of the study has been explained prior to performance of any study-related procedures. Minors may participate as long as they provide written assent after the nature of the study has been explained to them and after their parent, or legal guardian has provided written informed consent, prior to the performance of any study-related procedures;
* Have been diagnosed with late-onset Pompe Disease, based on the entry criteria of a prior BMN 701 study;
* If sexually active, be willing to use 2 known effective methods of contraception from Screening until 4 months after the last dose of study-drug;
* If female, and not considered to be of childbearing potential, be at least 2 years post-menopausal, or have had tubal ligation at least 1 year prior to screening, or have had a total hysterectomy;
* If female, and of childbearing potential, have a negative pregnancy test during the Screening Period and at the Baseline visit, and be willing to have additional pregnancy tests during the study;
* Have the ability to comply with the protocol requirements, in the opinion of the Investigator.

Exclusion Criteria:

* Have received any experimental or approved therapy for Pompe disease, other than BMN 701, subsequent to completion of a BMN 701 study and prior to entry into POM-002;
* Have received, or are anticipated to receive, any investigational medication, other than BMN 701, within 30 days prior to the first dose of study-drug;
* Are breastfeeding at screening or planning to become pregnant (self or partner) at any time during the study;
* Have a medical condition or extenuating circumstance that, in the opinion of the Investigator, might compromise the patient's ability to comply with the protocol requirements or compromise the patient's well being or safety.
Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX)

Vaccines are used to prevent infectious diseases worldwide. Unfortunately, many vaccines, like the flu vaccine, are less effective in older adults.

This single-centre open label partially randomised, partially placebo-controlled trial evaluates the differences in immune response between young and older adults after vaccination with a quadrivalent inactivated influenza vaccine and an adjuvanted herpes zoster vaccination.

Exploring the underlying mechanisms between the differences in immunogenicity can provide important information for future vaccine development.

Rationale: Vaccination of the older adults is often advised as they are a high-risk population; however, vaccine efficacy generally decreases with age. This is mainly due to a decrease in adaptive immune responses known as immunosenescence, which is a factor influencing the response to influenza vaccination. On the other hand, there are vaccines that show high efficacy (more than 95%) in older adults, one of the most effective being the AS01 adjuvanted herpes zoster vaccine, Shingrix. The differential immune pathways associated with vaccine responsiveness as well as the immune mechanisms by which adjuvants overcome immunosenescence remain poorly understood. Targeting key immune pathways could be a way to improve vaccine efficacy in older adults.

Objective: To explore immunological features between young and older adults after administration of an adjuvanted herpes zoster (Shingrix) or influenza unadjuvanted (Fluarix) vaccine that could explain differences in vaccine immunogenicity.

Study design: A single centre open label, randomised, and partially placebo-controlled trial Study population: Approximately 140 healthy adults, 80 of which are between 18-35 years old, the other 60 are 60+ years old.

Intervention: Two groups of young and elderly volunteers receive recombinant zoster vaccine (Shingrix), while two other groups will receive a quadrivalent influenza vaccine (Fluarix). Two groups of young volunteers will receive a placebo.

Main study parameter: To identify immune senescence-related differences contributing to vaccine immunogenicity

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-35 years old OR age ≥60 years old
* Written informed consent

Exclusion Criteria:

* Known allergy to (components of) the influenza or herpes zoster vaccine
* Immunocompromised subjects and subjects with active malignancy within the last two years
* Previous herpes zoster vaccination in the last year
* Receipt of any vaccination 4 weeks prior to the start of the study or plans to receive any other vaccination in the first 2 months after inclusion
* Use of systemic immunomodulatory drugs:steroids, anti-inflammatory biological treatments (e.g. anti-cytokine monoclonal antibodies)
* Acute or active illness within two weeks prior to the start of the study
* Pregnant, breastfeeding or planning to become pregnant during the study period
Effects of Weight on Inflammation and Colon Cancer Risk

An observational study designed to compare colonic cytokine concentrations in lean versus obese individuals

An observational study was performed on 43 individuals undergoing routine screening colonoscopy, some of whom were lean and some who were obese. They had weight, height, and waist-hip ratio measured at the time of colonoscopy and had additional colonic biopsies to measure colonic cytokines.

Eligibility Criteria:
Inclusion Criteria:

1. Caucasian
2. undergoing clinically-indicated screening colonoscopy
3. BMI\< or = 25, or 30+

Exclusion Criteria:

1. past history of cancer (except non-melanoma skin cancer)
2. a polyposis syndrome
3. any current or chronic inflammatory disease or infection
4. incapable of providing valid informed consent
Genetic of Response to Acute Saline Load Test in Hypertension (Naload)

NHP referred to our outpatient clinic will be enrolled (150 newly recruited) in acute saline test for phenotype characterisation of PNat relationship(7). For each patient we will collect urine and blood samples for standard clinical biochemistry, including electrolytes, creatinine, EO, aldosterone, plasma renin activity, urinary uromodulin (ELISA), urinary and serum uric acid and blood samples for genetic test.

Acute salt load test: after the equilibration period and achievement of a steady state, a constant-rate i.v. infusion of 2 L of 0.9% NaCl was carried out in 2 hours. BP (mean of 3 measurements taken 3 minutes apart) was measured every 30 minutes during the 2 hours of loading and 3 times at 3-min intervals at the end of the infusion. These last 3 BP values were averaged and used in the analysis.

The results of these tests will be added to an already collected database of salt load test collected in the previous studies (already published)

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65years;
* body mass index (BMI) \<30 kg/m2;
* Na intake, evaluated as urinary Na excretion of \<300 mEq/24 hours; .office systolic BP (SBP) \>140 mm Hg and diastolic BP (DBP) \>90 mm Hg in 3 consecutive visits to their family doctors.

Exclusion criteria:

* Female patients
* history of myocardial infarction,
* stroke,
* congestive heart failure,
* liver disease, secondary cause of hypertension,
* diabetes,
* severe hypertension (\>160/110 mm Hg),
* abuse of drugs or alcohol, .creatinine clearance \< 80 mL/m.

Secondary forms of hypertension (e.g. primary aldosteronism) were ruled out with specific investigations when deemed appropriate
Monocentric Retrospective Observational Study on Patients With Macular Degeneration

Main Objective: The main objective of this retrospective observational study was to describe the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study) scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care, in terms of mean change of the Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Patients with exudative-subfove ARMD, regardless the neovessel type or the initial visual acuity; 2 - Patients treated in the department with intra vitreous injection of Lucentis ® during the study period (08/2011 and 02/2013); 3 - If both eyes are eligible, both will be analyzed;

Exclusion Criteria:

1. - Patients who received, for the studied eye, a treatment with a Vascular endothelial growth factor (VEGF) other than Lucentis ® in the three months preceding the start of the study. For those who received combination therapy, the nature of the treatment will be specified and taken into account in the subgroups for statistical analyzes;
2. - Patients with high myopia or neovessel not related to exudative-ARMD;