cyrilzakka/clinical-trials huggingface dataset:
Pathophysiology and Clinical Relevance of Endotoxin Tolerance in Humans

A number of diseases lead to a so called systemic inflammatory response syndrome (SIRS). This excessive response is self-destructive and leads to major complications of the initial disease: dysfunction of the microcirculation, systemic vasodilation, and increased capillary leakage and oedema. Animal studies have shown that pre-treatment with endotoxin (lipopolysaccharide or LPS) suppress the excessive immune response and when rechallenged, the animal survive a normally lethal dose of endotoxin.

Besides a diminished cytokine response, an increased production of leucocytes in the bone marrow and an increased phagocytosis after pre-treatment with endotoxin is seen. The combination of these factors: diminished systemic inflammatory response and increased cellular immunity makes that endotoxin tolerance is a useful tool for preventing the complications after an excessive inflammatory response.

Further, the presence of cross-tolerance has also been shown: Endotoxin tolerant mice survive more after induction of a normally lethal fungal infection. Endotoxin tolerance is also protective for ischemia/reperfusion injury in kidneys, heart and liver. Little data is known about endotoxin tolerance in human.

The purpose of this study is to induce a state of tolerance through 2 different administration schedules and monitor the effect of tolerance on pro- and anti-inflammatory cytokines, other inflammatory parameters and different proteins involved in the signalling pathway. The effects of tolerance on vascular reactivity will be determined. Finally, the effect of tolerance on ischemia-reperfusion injury will be investigated.

See protocol

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* drug-, nicotine-, alcohol abuses
* tendency towards fainting
* BMI \< 18 kg/m2
Study of [68Ga]FAPI-46 PET in Patients with Pancreatic Ductal Carcinoma

This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of \[68Ga\]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The \[68Ga\]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second \[68Ga\]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection. This will be followed by histopathology and IHC analyses and comparison to resected PDAC tumor specimens.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed pancreatic ductal adenocarcinoma
2. Treatment-naïve
3. Staged as resectable or borderline-resectable
4. Planned to undergo surgical resection or to receive neoadjuvant therapy (i.e., chemotherapy, radiation therapy, or combination) and subsequent possible surgical resection
5. Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent
6. Age ≥ 18 years
7. Completed informed consent as determined per the IRB of record

Exclusion Criteria:

1. Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
2. Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
3. Need for emergent surgery that would be delayed by participation
4. Bacterial, viral, or fungal infections requiring systemic therapy
5. Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise patient safety and/or protocol objectives.
6. Known diagnosis of autoimmune disorders
7. Patients receiving any other investigational agent within the past 28 days
8. Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \[68Ga\]FAPI-46 injection.
9. Known hypersensitivity to any excipients used in \[68Ga\]FAPI-46:

trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid
Flapless Emdogain in the Treatment of Periodontal Residual Pockets

48 adult patients participated in a single-centre randomized clinical trial with split- mouth design. They had presented at re-evaluation after initial non-surgical periodontal therapy (steps 1 and 2 of periodontal therapy) for generalized periodontitis with at least 2 teeth with residual probing pocket depths (PPD) ≥5 and ≤8 mm, with bleeding on probing (BOP). Two teeth with similar PPD were randomized to receive re-instrumentation either with (test) or without (control) adjunctive flapless administration of EMD. Differences in the changes of PPD and BOP from baseline to 6 and 12 months will be analysed, and the frequencies of pocket closure (PPD ≤4 mm and no BOP) will be compared


Eligibility Criteria:
Inclusion Criteria:

* at least two residual pockets with probing pocket depth (PPD) ≥5 and ≤8 mm,
* bleeding on probing (BOP),
* mobility ≤degree 1 and
* no furcation involvement.

Exclusion Criteria:

* full mouth plaque score \>20%,
* uncontrolled systemic disease,
* history of malignant disease in the oral cavity or previous radiotherapy in the head or neck area,
* pregnant or lactating females,
* drug and alcohol abuse,
* smoking \>10 cigarettes per day and
* inadequate restorative therapy or malocclusion.
Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)

Pilot randomised trial to assess recruitment for a larger trial to compare the efficacy and adverse effects of the subcutaneous and transvenous ICD in patients with hypertrophic cardiomyopathy (HCM) and indication for ICD therapy, with no requirement for pacing

This study aims to test the feasibility of conducting a trial to investigate the use of subcutaneous implantable defibrillator (SICD) in patients with hypertrophic cardiomyopathy (HCM) and to determine whether SICD produces more complications than conventional, transvenous implantable defibrillator (TV ICD).

The primary analysis for the main trial is designed to test whether the S-ICD is non-inferior to the TV-ICD with respect to the primary endpoint of inappropriate shock treatment and complications. For the incidence of the primary endpoint statistical significance and 99% confidence intervals are calculated using Cox' proportional hazards model. Non-inferiority is considered to be established if the upper boundary of the one-sided 99% confidence interval did not exceed 1.92 (absolute difference \< 12%).

Participant duration is expected to be 14 months. (12 months follow up post device implant) Recruitment duration expected to be 6-10 months.

Eligibility Criteria:
Inclusion Criteria:

* Hypertrophic Cardiomyopathy and a referred for ICD therapy with no pacing requirement.

Exclusion Criteria:

* Patients with sustained ventricular tachycardia less than 170 bpm
* Patients having an indication for pacing therapy. E.g. sick sinus syndrome.
* Patients failing appropriate QRS/T-wave sensing with the automated S-ICD ECG automated patient screening provided by Boston Scientific
* A minimum of 1 sensing vector passing in supine, standing.
* Patients with incessant ventricular tachycardia
* Patients who have had a previous ICD implant
* Patient who receives cardiac contractility modulation therapy or are likely to receive cardiac contractility modulation therapy
* Patients with a serious known concomitant disease with a life expectancy of less than one year
* Patients with circumstances that prevent follow-up (no permanent home or address, transient, etc.)
* Patients who are unable to give informed consent
* Patients who are not suitable for TV-ICD implantation, according to the discretion of the physician, are not screened for enrolment (SVC occlusion).
A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants

The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations. Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSafe Passive Delivery System \[PFS-U\] or with a prefilled syringe facilitated injection device \[PFS FID\]) following a single subcutaneous (SC) administration of 100 mg guselkumab in healthy participants.

This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel study (each group of participants will be treated at the same time) of guselkumab in healthy participants. Approximately 140 participants will be randomly assigned in the ratio 2:2:2:1 in to 4 treatment groups: Group 1 (SC injection of lyophilized formulation), Group 2 (subcutaneous \[SC\] injection of liquid formulation with PFS-U), Group 3 (SC injection of liquid formulation with PFS-FID), and Group 4 (IV infusion of liquid formulation). The study consists of 3 phases: screening (up to 4 weeks), open-label treatment and inpatient follow up (1 week) and outpatient follow up (11 weeks). Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, injection-site reactions, and clinical laboratory tests. The total duration of the study for each participant will be approximately 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participant with no clinically significant abnormalities
* Have a weight in the range of 60 kg to 90 kg for male participants; have a weight in the range of 50 kg to 80 kg for female participants
* Have a body mass index (BMI) of 18.5 kg/m2 to 29.0 kg/m2
* Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

* Participant has a history of any clinically significant medical illness including liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, ophthalmological disorders, neoplastic disease, urinary tract diseases, or dermatological disease
* Currently have any known malignancy or have a history of malignancy
* Participant has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins to monoclonal antibodies or antibody fragments
* Have had a Bacillus Calmette-Guérin (BCG) vaccination within 12 months of screening
Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer

The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Participants with metastatic breast cancer
* Measurable disease
* Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. There is no timeframe for prior paclitaxel in the metastatic setting.
* Human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib
* Eastern Cooperative Oncology Group Performance status of 0-1
* Age younger than 18 years
* Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products

Exclusion Criteria:

* More than 1 chemotherapy regimen for the treatment of metastatic breast cancer
* Prior treatment with any epothilone, capecitabine, or docetaxel
* Prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. There must be at least 1 week between focal/palliative radiation and administration of study medication.
* Any current or previous history of brain and/or leptomeningeal metastases
* Neuropathy greater than Grade 2
* Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
* Uncontrolled diabetes mellitus
* Chronic hepatitis
* HIV-positive status
* Administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. Hormonal anticancer agents must be discontinued at least 14 days prior to study medication. Hormonal replacement therapy is acceptable
* Biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry
Effects of Epidermal Growth Factor Receptor Inhibitor Therapy in the Skin of Cancer Patients

RATIONALE: Studying samples of tissue and blood in the laboratory from patients with cancer receiving epidermal growth factor receptor (EGFR) inhibitors may help doctors understand the effects of EGFR inhibitor therapy in the skin.

PURPOSE: This laboratory study is looking at the effects of EGFR inhibitors in the skin of cancer patients.

OBJECTIVES:

* Determine the effects of EGFR inhibitors on the EGFR pathway in the skin of cancer patients prior to and after receiving EGFR inhibitors (i.e., tyrosine kinase inhibitors and monoclonal antibodies).
* Compare the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin of these patients.
* Compare changes in the EGFR pathway with grade of rash in these patients.
* Compare changes in EGFR pathway effectors in the skin with serum TGFα levels in these patients.

OUTLINE: This is a pilot study.

Patients undergo skin punch biopsies and blood sample collection at baseline, within 1 week of developing skin rash, and 6 weeks after beginning treatment. Samples are analyzed by immunohistochemistry and western blot for phosphorylated MAP kinase, AKT, and EGF levels and TGFα levels. Patients also complete diagrams to indicate locations of the rash once weekly during the first 6 weeks of treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of a malignancy for which therapy on or off a clinical trial with an inhibitor of the EGFR pathway is under consideration

  * The therapy under consideration may be monotherapy or combined with other therapies as long as other therapies do not typically cause a rash

PATIENT CHARACTERISTICS:

* INR ≤ 3.0 (for patients receiving concurrent warfarin)
* No severe underlying skin disorder (e.g., toxic epidermal necrolysis or severe dermatitis) that would preclude study treatment
* No bleeding diatheses that would preclude safe biopsy
* No allergy to lidocaine or similar local anesthetics

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Sensory Synchronized Imaging and Neuromodulation

The purpose of this research study is to better understand the relationship between the type of brain stimulation used and how it changes brain activity in adult military Veterans. The goal is to use this understanding to develop new, personalized brain stimulation. The investigators evaluate brain changes from different types of transcranial magnetic brain stimulation (TMS).


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18 years and up
* English speaking
* Military Veterans

Exclusion Criteria:

* Those with a contraindication for MRIs (e.g. implanted metal)
* History of head trauma with loss of consciousness
* History of seizures or on medications that substantially reduce seizure threshold
* Neurological or uncontrolled medical disease
* Active substance abuse
* Currently pregnant or breastfeeding
Evaluation of the Safety, Efficacy, and Pharmacokinetics of Intravenous Deferiprone in HIV-Positive Subjects

This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.

This is a double-blind, placebo-controlled, randomized trial in 30 asymptomatic HIV-positive adults. There are two sequential cohorts, in which subjects will receive either one of 2 doses of deferiprone or placebo twice daily.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 positive
* HIV treatment-naïve: no previous treatment with a combination anti-retroviral therapy (cART) or highly active anti-retroviral therapy (HAART) regimen
* HIV-1 RNA \> 10,000 copies/mL
* ALT or AST ≤ 2.0 x upper limit of normal range, and bilirubin within normal range
* Body mass index (BMI) of 18.5 to 30.0 kg/m\^2
* Absolute neutrophil count at baseline of ≥1.0 x 10\^9/L (black African population only) or ≥1.5 x 10\^9/L (all other races)

Exclusion Criteria:

* Evidence of AIDS-associated illness, excluding superficial candidiasis
* CD4+ T-cell count of \< 350/mm\^3
* Positive for active or latent tuberculosis, as determined by the QuantiFERON®-TB Gold test
* Active, serious infections (other than HIV-1 infection) within the 30 days prior to screening
* Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis virus C (HCV) antibodies
* History or presence of malignancy
* A serious, unstable chronic illness during the past 3 months before screening
* A serious, unresolved acute illness at screening
Axillary Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes

This study is designed to evaluate the feasibility and safety of axillary radiotherapy for early stage breast cancer with limited positive sentinel lymph nodes.

Randomized clinical trials have demonstrated that complete axillary lymph node dissection is not necessary in patients with 1-2 positive sentinel lymph nodes who undergo breast conserving surgery, whole breast irradiation, and systemic therapy. However, whether or not the regional lymph node should be irradiated and if radiation given, whether or not all levels of axillary lymph node and internal mammary and supraclavicular lymph node should be irradiated is unknown. The purpose of this study is to evaluate the feasibility and safety of axillary level I-II areas radiotherapy for early stage breast cancer with 1-2 positive sentinel lymph nodes and no further axillary lymph node dissection.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18\~70 years old
* Pathologically confirmed invasive breast cancer
* A clinical T1-2N0M0 tumor
* Treated with breast conserving surgery and sentinel lymph node biopsy
* 1\~2 positive sentinel lymph nodes, including micro-metastases or macro-metastases.
* ECOG score 1\~2
* Written informed consent

Exclusion Criteria:

* Patients underwent complete axillary lymph node dissection
* Patients underwent mastectomy
* Patients underwent neoadjuvant therapy
* Clinically node positive pre-operative
* Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm)
* Prior history of invasive breast cancer or previous or concurrent other malignancies within the past 5 years
* Previous radiation therapy of breast or thorax
* Medical contraindication for radiotherapy
* Prior axillary surgery or radiotherapy
* Unable or unwilling to receive breast conserving surgery or sentinel lymph node biopsy
* Pregnant or nursing
PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer

The purpose of this study is to compare the concentration of four different metabolites in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different doses of Modufolin (arfolitixorin) and Levoleucovorin (Isovorin®), respectively (60 and 200 mg/m2).

The purpose of this study is to compare the concentration of \[6R\] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different does of Modufolin® and Levoleucovorin (Isovorin®), respectively (60 and 200 mg/m2).

Eligibility Criteria:
Main Inclusion Criteria:

* Operable colon cancer amenable to curative surgery.
* Performance status of 0 to 1
* Informed consent form
* Patients must be at least 18 years of age.

Main Exclusion Criteria:

* Any concurrent other anti-tumor therapy
* Any prohibited concomitant medication within 30 days of surgery
* Pregnancy or breast-feeding.
* Second primary malignancy
Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer

Interventional, exploratory, prospective and monocentric study which aim to study the feasibility of brachytherapy using a PET-scan

The study will proceed as follow:

* Initial check-up before the brachytherapy, including a clinical exam, collect of disease history and other informations that can be required for a good execution of the trial, and a usual patient care (chemotherapy with concomitant radiotherapy, biopsy, RMI, PET-scan and paraaortic lymphadenectomy).
* additional PET-scan exam at day 1 of the brachytherapy (with collect of informations on toxicity, clinical morphology data and biomorphological data of RMI and PET-scan, and dosimetric study of the brachytherapy)
* 4 months after the brachytherapy, additional PET-scan monitoring metabolic volumes and standardized metabolic fixation parameters

Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from a cervical cancer:
* squamous-cell carcinoma or adenocarcinoma histologically proven
* classified from FIGO 2009 IB2 to IVA stage
* Age ≥ 18 years old
* Examination by PET-scan and pelvic RMI realized at diagnosis
* Examination by negative PET-scan remotely closed and at lymph node level
* Surgical lymphadenectomy negative at paraaortic level
* Treatment by external radiotherapy (doses between 45 Gy and 50.4 Gy in 1.8 Gy/fractions) and concomitant chemotherapy (at least 4 cures per weeks using platinum salt) done
* Scheduled curative treatment by brachytherapy driven by RMI
* Affiliation to the National Social Security System
* With informed and signed consent before any procedure specific to the study

Exclusion Criteria:

* Performance status of WHO score \> 2
* Other histology than squamous cell carcinoma or adenocarcinoma
* Metastatic patient or paraaortic node positive
* Adjuvant radiochemotherapy after the first surgery
* Dementia or psychiatric history
* Kidney failure
* Diabet
* Chronic inflammatory bowel disease
* Pelvic and/or vesicoureteral surgery history
* Pelvic irradiation history
* Other active neoplasia or \< 5 years old, except for basocellular carcinoma that can be locally treated
* Contraindication to one of the following procedure : RMI, PET-scan, general anesthesia
* Radiosensitive disease (Fragile X syndrome, Huntington's chorea, Xeroderma Pigmentosum, connective tissue disease) or signs of radiosensitivity.
* Treatment with palliative intent
* Pregnant or breastfeeding women
* Patient Under guardianship or tutorship