cyrilzakka/clinical-trials huggingface dataset:
Immune Response in Adults to PrEP and Simulated Booster PEP With a New CPRV

Pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.

After the pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 42 are 0.5 IU/ml or more.

And Simulated post-exposure rabies booster vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.

After the simulated post-exposure rabies booster vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 14 after the booster are 0.5 IU/ml or more.

Pre-exposure vaccination will be done according to standard protocol. Participants will be injected with one dose on day 0, 7 and 28. Blood samples will be taken on day 0, 28 and 42 after the first vaccination dose.

360 days later, participants will receive simulated post-exposure rabies booster vaccination one dose on day 0 and 3. Blood samples will be taken again on day 0(360 days) and 14(374 days) after the booster vaccination.

Rabies neutralizing antibody levels will be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT). And the levels of 0.5 IU/ml or more is considered acceptable protective level.

For statistical analysis, percentage of subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. The average of the titer used in this study is Geometric mean titer(GMT). 95 percent confidence interval(95% CI) of the GMT will be calculated for each study group from individual measurements of serum rabies antibody levels at each sampling time. One-way ANOVA would be used to calculated the significance of the difference between the GMT of three groups, SPEEDA® intradermal injection, SPEEDA® intramuscular injection and PVRV intramuscular injection. The primary criterion for this comparison are the rabies antibody value on day 42 (2 weeks after the third vaccine dose of pre-exposure vaccination) and on day 374(2 weeks after the first vaccine dose of booster vaccination). Results will be deemed statistically significant at p \< 0.05. Safety data (immediate, local and systemic reactions) were summarized as numbers and percentages.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Can visit according to the protocol

Exclusion Criteria:

* Fever
* Acute illness
* History of rabies vaccination
* Allergic to the vaccines' component
* Immunosuppressive conditions such as HIV infection, transplantation, chronic renal failure, received steroid or immunosuppressive drugs and anti-malarial drugs within previous two months or any blood products within previous three months
* Female participant must not be pregnant
* All female participant must have urine pregnancy test negative prior to participate the study
Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study

In this prospective study, breast capsule biopsy was performed in patients undergoing 2-stage expander-implant breast reconstruction to determine its use. Prospective clinical trial was designed for 10 consecutive patients as a pilot study and approved by IRB of Samsung Medical Center. From November 2013 to May 2015, full-thickness capsule biopsy specimen was obtained from acellular dermal matrix (ADM) capsule and from native subpectoral capsule (internal control) during expander-implant exchange. Biopsy specimens were scored for fibrosis and inflammatory reactions.

This is completed study and its specific title, study objective, method, and results will be available online after scientific journal submission.


Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 70
* planning 2-stage expander-implant breast reconstruction using acellular dermal matrix
* with no medical history such as diabetes, hypertension, or smoking
* no surgical history

Exclusion Criteria:

* pregnant
* newly detected medical or surgical condition
* acellular dermal matrix loss due to allergic reaction or prosthetic infection
* breast cancer recurrence
* transfer to other institution
* reconstruction give-up due to patient's wish
* no biopsy score
Influence of Psychological Status on the Results of Pain Treatment in Patients With Gunshot and Mine-explosive Wounds

82.1% of patients with gunshot and mine-explosive wounds and wounds during hostilities in Ukraine have negative results of pain treatment, which leads to its chronicity. Examining the effect of psychological status on pain management outcomes in these patients may improve their treatment outcomes.

The influence of the amount of damage and operative interventions on the results of pain treatment in patients with gunshot and mine-explosive wounds at the stages of treatment needs to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have its features. Since in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.

Eligibility Criteria:
Inclusion Criteria:

* availability gunshot and mine-explosive wounds

Exclusion Criteria:

* absence gunshot and mine-explosive wounds
Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial

RATIONALE: Gathering information about why patients or their guardians agree or decline to participate in the optional pharmacokinetic portion of a phase I treatment study may help doctors plan clinical trials in the future.

PURPOSE: This clinical trial is looking at decision making about participating in pharmacokinetic studies in patients enrolled in a phase I treatment clinical trial.

OBJECTIVES:

* To use a simple 2-page survey to gather preliminary information on why patients or parents/guardians (if patient is a minor) do or do not agree to participate in the optional pharmacokinetic portion of a phase I treatment study while consenting to participate in the phase I treatment study.

OUTLINE: This is a multicenter study.

Patients or parents/guardians (if patient is a minor) complete a short questionnaire on the reasons for agreeing/declining to participation in the optional pharmacokinetic sampling component of the phase I clinical trial.

Patient demographics and other relevant information are collected.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients or their parents/guardians (if patient is a minor) consented to participate in a phase I treatment clinical trial with an optional pharmacokinetic (PK) component, within the past 4 weeks

  * Must not have withdrawn consent for the phase I treatment study

    * Patients or their parents/guardians are eligible regardless of whether they initially agreed to participate in the PK sampling

      * Must not withdraw consent for PK sampling prior to completing the study questionnaire if initially agreed to optional PK sampling
    * Patients or their parents/guardians are eligible regardless of whether they actually completed PK sampling (provided reasons for not completing the sampling was not withdrawal of the initial consent to the phase I treatment study)

PATIENT CHARACTERISTICS:

* Not cognitively or physically impaired
* May participate no more than once in the study questionnaire survey

PRIOR CONCURRENT THERAPY:

* No limit on participation in the number of prior phase I trials or other studies
Post Market Surveillance for Infanrix™

The purpose of this study was to investigate the following questions through post-marketing surveillance:

* Unknown/Unexpected adverse events and the serious adverse events.
* The circumstances in which the adverse events occurred under the practical application.
* Factors considered to have influence on safety.
* Factors considered to have influence on efficacy.
* Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.


Eligibility Criteria:
Inclusion Criteria:

All children receiving Infanrix™ were eligible for this survey.

Exclusion Criteria:
Aminocamptothecin in Treating Patients With Advanced or Recurrent Kidney Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients with stage III, stage IV, or recurrent kidney cancer.

OBJECTIVES: I. Determine the response rate, duration of response, and survival of patients with advanced renal cell carcinoma treated with aminocamptothecin colloidal dispersion. II. Determine the nature and degree of toxicity of aminocamptothecin in this patient population.

OUTLINE: Patients receive aminocamptothecin colloidal dispersion intravenously for 120 hours weekly for 2 weeks followed by 1 week of rest. Courses are repeated every 3 weeks in the absence of disease progression or dose limiting toxicity. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and yearly thereafter.

PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage III, stage IV, or recurrent renal cell carcinoma Measurable disease No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1500/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL ALT and AST no greater than 2.5 times the institutional normal values Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled systemic infection No other prior or concurrent malignancies except nonmelanoma skin cancer, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast that have been curatively treated No evidence of delirium, confusion, suicidal ideation, or untreated depression

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 30 days since prior cytokines and recovered No more than 1 prior treatment with cytokines (interleukin-2 or interferons) Chemotherapy: No prior cytotoxic chemotherapy No prior aminocamptothecin No other concurrent antineoplastic agents Endocrine therapy: At least 30 days since prior hormone therapy and recovered No more than 1 prior hormone therapy (tamoxifen or medroxyprogesterone) Radiotherapy: Prior radiotherapy allowed if indicator lesion and greater than 15% of marrow producing bone have not been irradiated Surgery: Recovered from prior surgery Other: At least 30 days since other investigational agents No concurrent investigational agents
Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer

The primary objective of this study is to compare progression-free survival (PFS) of patients with metastatic triple-negative breast cancer randomised to treatment with standard chemotherapy plus moxifloxacin or placebo.

This is a multicenter, randomised, double-blind, placebo-controlled, phase 3 trial. The main purposes of this study are to examine the efficacy and safety of standard chemotherapy plus moxifloxacin or placebo as first-line treatment in patients with metastatic triple-negative breast cancer. This study is designed to recruit up to 228 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
* Histologically confirmed invasive ductal carcinoma, no specific type (NOS)
* ER negative and progesterone receptor (PR) negative (defined as \< 1% positive cells by IHC), human epidermal growth factor receptor 2 (HER2) negative (defined as IHC 0-1 staining or fluorescent in situ hybridization (FISH) negative).
* No prior therapy after first recurrence or diagnosis of metastatic disease.
* At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Neutrophil-to-lymphocyte ratios (NLR) in peripheral blood ≥ 2.
* Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve (Left ventricular ejection fraction (LVEF) by echocardiogram ≥45%).
* Compliance with the study protocol.
* Have provided written and signed informed consent.

Exclusion Criteria:

* Pregnant or breast feeding.
* Definitive breast cancer susceptibility gene (BRCA) mutation, Programmed Cell Death-Ligand 1 (PD-L1) positive, microsatellite instability-high (MSI-H), and mismatch repair deficient (dMMR).
* Patients who are receiving or will receive other biological agents or immunotherapy.
* Uncontrolled medical problems.
* Evidence of active acute or chronic infection.
* Hepatic, renal, cardiac, or bone marrow dysfunction as detailed above.
* Concurrent malignancy or history of other malignancy within the last five years.
* Known severe hypersensitivity to moxifloxacin
* Patients were unable or unwilling to comply with program requirements.
Face Photoaging: Efficacy and Tolerance Evaluation of an Intradermal Injective Treatment

Efficacy and tolerance evaluation of an intradermal injective treatment

Primary end point of the study was to evaluate clinically and by non-invasive instrumental evaluations tolerance and efficacy of SUNEKOS ® 200 injectable treatment on main sign of face skin photoaging; the micro-injections of the study product were performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of female volunteers aged 45-65 years, with photoaging of mild/moderate grade.

Eligibility Criteria:
Inclusion Criteria:

* - female sex;
* age 45-65 years;
* mild/moderate cutaneous photoaging according to a reference photographic scale (see Appendix 8)
* skin phototype I, II and III according to Fitzpatrick's classification, with a preference to grade II-III (see par. 8.1)
* agreeing to present at each study visit without make-up;
* accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products;
* accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study;
* accepting to sign the Informed consent form.

Exclusion Criteria:

* Dependent on the volunteers' characteristics
* Pregnancy;
* lactation;
* subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
* Body Mass Index (BMI) variation (± 1) during the study period;
* subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, 30 days (T4i) and 2 months (T2M) after the first biomineralizing treatment execution;
* performing skin treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 12 months prior to the study start;
* performing permanent filler in the past;
* change in the normal habits regarding food, physical activity, face cosmetic, cleansing and make-up use during the month preceding the test;
* sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
* subjects whose insufficient adhesion to the study protocol is foreseeable;
* participation in a similar study actually or during the previous 6 months.
* Presence of cutaneous disease on the tested area, as lesions, scars, malformations;
* recurrent facial/labial herpes;
* clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
* Diabetes
* endocrine disease
* hepatic disorder
* renal disorder
* cardiac disorder
* pulmonary disease
* cancer
* neurological or psychological disease
* inflammatory/immunosuppressive disease
* drug allergy.
* Anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
* assumption of drugs able to influence the test results in the investigator opinion.
Surefire Precision Infusion System Registry

This project involves the collection and analysis of retrospective and prospective data on patients diagnosed with hepatocellular carcinoma (HCC) in which the Surefire Precision Infusion System was used/will used be to deliver transarterial chemoembolization with doxorubicin-eluting beads (DEB-TACE). The purpose is to compare tumor and medical response in a real-world setting as well as identify potential areas for future clinical research.

Conventional transarterial chemoembolization with lipiodol/doxorubicin (cTACE) is known to prolong survival compared to supportive therapy in certain patients with unresectable HCC, including patients with unilateral portal vein invasion (PVI). The best results for cTACE occur when the dose is delivered in a highly targeted manner into the tumor. Dense accumulation of embolic spheres or lipiodol into the tumor as documented by computed tomography (CT) has been shown to have improved outcomes. However, with standard endhole catheters, achieving maximum delivery of embolic agents is significantly limited by the development of stasis, non-target delivery and subsequent non-target injury. Thus, when this procedure is performed with endhole catheters, there is significant variability in the delivery of the agent that is entirely dependent on the flow pattern of the target tumor. Therefore, current techniques result in various degrees of embolization with variability in dosages and angiographic endpoints.

DEB-TACE is a relatively new modality associated with favorable systemic doxorubicin exposure/toxicity and liver-specific toxicity compared to cTACE. It is currently utilized for: (1) patients who have unresectable HCC; (2) patients who meet the Milan Criteria and are currently on liver transplantation lists; and (3) downstaging patients into Milan Criteria for possible liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone or will undergo DEB-TACE for HCC delivered by the Surefire® Precision Infusion System
* Patients aged 18 years or older
* Diagnosis of HCC
* Has a discrete hepatic artery(s) feeding the vessel with diameter(s) of the vessels ≥ 1.5 mm

Exclusion Criteria:

* Contraindications for doxorubicin administration
* Vessels providing flow to the tumor that are \< 1.5 mm in diameter(s)
* Patients who are unable to provide informed consent
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

The purpose of this study is to evaluate the efficacy and safety of VX-548 for acute pain after a bunionectomy.


Eligibility Criteria:
Key Inclusion Criteria:

* Before Surgery

  * Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block)
* After Surgery

  * Participant is lucid and able to follow commands
  * All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

* Before Surgery

  * Prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot
  * History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
  * Any prior surgery within 1 month before the first study drug dose
* After Surgery

  * Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy
  * Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization

Other protocol defined Inclusion/Exclusion criteria may apply.
Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer

Many studies have been devoted to the quality of life of patients during adjuvant chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on the immediate environment (spouse, children) during this difficult time for women. Curiously, no study to date has been submitted or published about how women with a one-year treatment "extra" Herceptin ® live this period in terms of quality of life, in terms of psychological impact for themselves and their families.

The investigators have no more data on how often they return to work during this treatment or on the psycho-social parameters which underpin them. It therefore seemed interesting to "give a spotlight" on this particular period in these women HER2 + by comparing a patient population of same age receiving the same adjuvant but with no Herceptin ®.


Eligibility Criteria:
Inclusion Criteria:

* Women aged over 18
* Invasive breast carcinoma confirmed histologically
* Non-metastatic cancer
* Surgery of the primary tumor performed (mastectomy or lumpectomy) and associated with an audit axillary (sentinel node and / or axillary dissection)
* Patient should receive their last course of adjuvant chemotherapy (3 FEC and 3 Taxotere)
* Patients not receiving the third course of Taxotere because of toxicities may be included in the fifth course of chemotherapy is the second of Taxotere
* For the group Herceptin ®: HER2 overexpression without contraindication to treatment administration
* For the control group: no indication for Herceptin ®
* Radiation therapy and / or adjuvant hormonal therapy allowed
* Free and informed consent signed

Exclusion Criteria:

* Women under 18 or over 60 years
* Histology other than adenocarcinoma
* Metastatic Breast Cancer
* Chemotherapy neoadjuvant
* Surgery of the primary tumor unrealized
* Lack of adjuvant chemotherapy with Taxotere 3 FEC and 3
* Patients with a history of malignancy within 5 years, outside of a basal cell cancer or cancer of the cervix treated and cured
* Patient under guardianship or unable to give informed consent,
* Pregnant or lactating
* Patient unable to undergo a medical for geographical, social or psychopathological
Comparison of Conventional Dialysis and the Allient System

The purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the Allient System as compared to conventional hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Maintenance in-center hemodialysis
* Age greater than or equal to 18 years
* Has been on hemodialysis for at least 4 months
* Uses a standard single-pass dialysis machine with a high-flux dialyzer

Exclusion Criteria:

* Hospitalization during the 8 weeks preceding enrollment
* Infection requiring antibiotic treatment during the 8 weeks preceding enrollment
* Central venous cather as dialysis access
* Uncontrollable blood coagulation anomalies
* Smokers
* Dialysis regimen other than 3 times weekly
* In ability to understand the English language and give informed consent for participation in the study