cyrilzakka/clinical-trials huggingface dataset:
Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas

The purpose of this access protocol is to allow patients with brain tumors who had previously received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor begins to grow, they develop side effects to the treatment, or their medical condition changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV) or develop another cancer).


Eligibility Criteria:
Inclusion Criteria:

* 18 Years or Older
* Previous treatment with at least one course of 125I-MAB 425 (one course = 3 infusions)
* Karnofsky performance status \> 70%
* Hemoglobin \> 10.0 g/dL, White Blood Cells \> 4,000/mm3, Platelets \> 100,000/mm3, BUN \< 25 mg/dL, Creatinine \< 1.5 mg/dL
* Signed informed consent
* Pathologic confirmation of GBM or AAF
* A negative beta hCG test for women of childbearing potential
* Negative HAMA test

Exclusion Criteria:

* Metastases or Second Primary Cancer
* Iodine allergy
* Inability to tolerate oral intake of Lugol's solution
* HIV Infection
* Positive HAMA test
* Pregnancy
* Uncontrolled Seizures
Pilot Study of the Osteo-Fluidic-Sensitive (OFS) in Tension-type Headache.

The hypothesis of the study is the Osteo-fluidic-Senstive is effective for lowering headache pains (Reduction of the number of days of headaches per month) for patients having frequent episodic tension-type headache. The OFS method will improve quality of life and will reduce the consumption of crisis treatments.

Compare the efficacy of the Osteo-Fluidic-Sensitive method versus a placebo method on patients with tension type headache for the reduction of the number of days of headaches per month after 3 months of treatment at Centre Hospitalier Universitaire de Poitiers.


Eligibility Criteria:
Inclusion Criteria:

* 18 and 75 years' old
* Person having highly frequent episodic tension type headache (between 2 and 14 days of headaches per month) associated or not to headache with characteristic of a migraine per International Classification of Headache Disorders 3rd edition criteria
* Person who completed his headache agenda the month before the study.
* Patient who understands and accepts the effects of the study
* Signed consent
* Person with health insurance coverage

Exclusion Criteria:

* Person having secondary or primary headaches (chronic tension type headache, migraines only, Cluster headaches, Neuralgias ...)
* Person on treatment of venlafaxine, gabapentine, duloxetine, clomipramine et toxine botulique.
* Concomitant participation to another clinical research
* Pregnant or lactating women, women of child-bearing age who do not have effective contraception.
* People with reinforced protection (juvenile), people deprived of liberty per justice or administrative decision, people living in a sanitary and social establishment, adults under legal protection and people in critical medical conditions
Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV)

Individual patient expanded access requests may be considered for patients who have no other treatment options and are not eligible for an ATEV clinical study

Procedure for Requesting Expanded Access:

The treating physician requesting expanded access must contact Humacyte directly with the basis for the request. Please include your contact information so that Humacyte may follow up with you directly.

General Criteria:

We will evaluate and respond to each expanded-access request that we receive on a case-by-case basis. Humacyte will consider the nature of the request, the patient's health, the available medical and scientific information about the investigational product, the balance of risk and potential benefit to the patient, the availability of investigational product, and the potential regulatory impact.

Anticipated Timing:

If you contact Humacyte as described above, Humacyte anticipates that we will acknowledge receipt within ten (10) business days or less.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: PEAGE

The treatment of the venous thromboembolic disease, including pulmonary embolism (PE), is based on anticoagulants. During the last decade, all the randomized clinical trials evaluating these anticoagulants have included PE patients with an average age below 60 years. But in clinical pratice, approximately 50% of PE patients are older than 75 years.

So the investigators want to perform a french multicentre prospective cohort of consecutive patients receiving an anticoagulant treatment for a symptomatic and confirmed PE. All the validated and available anticoagulant treatments are authorized in this cohort (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants).

This cohort will provide data regarding the bleeding risk and the risk of PE recurrences and regarding the pharmacokinetic (PK) and pharmacodynamic (PD) properties of these anticoagulants in this older population. Using population approach modelling , the investigators will pay particular attention to the sources of PK/PD variability PK / PD such as genetic polymorphisms of P-glycoprotein and cytochrome P450.

Using all these data , the investigators will try to identify significant risk factors for bleeding and venous thromboembolic events.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic pulmonary embolism confirmed by objective paraclinical examination with or without DVT associated
* confirmation of pulmonary embolism within 3 days
* Administration possible according to the recommended dosages of anticoagulant treatment : (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants)
* Indication of anticoagulant treatment for at least 6 months

Exclusion Criteria:

* on therapeutic dose of anticoagulant treatment over 72 hours
* indication to therapeutic dose of anticoagulant treatment for another reason.
* Inability for whatever reasons, to prescribe recommended anticoagulant treatment
* PE treatment on heparin-induced thrombocytopenia requiring argatroban, lepirudin or danaparoid treatment,
* ongoing bleeding
* PE occurring despite well conducted anticoagulant treatment
* Contraindications to recommended dose of anticoagulant treatment
Exhaled Breath Aerosol for the Etiological Diagnosis of Respiratory Tract Infections: a Pilot Study

Pilot study for the evaluation of the feasibility of pathogen detection in exhaled breath aerosols (XBAs) samples using the AveloCollect device.

The aim of the study is to evaluate the feasibility of XBA collection and molecular detection of respiratory pathogens using the AveloCollect BlowTube device (index test) in subjects with a clinical presentation consistent with a respiratory infectious disease, compared to the same molecular assays performed on nasopharyngeal secretions (using commercially available swabs) and sputum (comparator tests).

Respiratory infections have a significant impact in terms of morbidity and mortality, both in the EU and globally and were responsible for the majority of pandemics in the last centuries. Human breath is an attractive sample type, given the ease of sample collection via non-invasive methods, its direct link to the route of transmission, and its potential role as an indicator of infectiousness. In particular, recent studies have focused on the exhaled breath aerosols (XBAs). Aerosol transmission was demonstrated for many respiratory infections, including pandemic influenza, respiratory syncytial virus (RSV), tuberculosis (TB) and COVID-19. Pathogen detection in XBA samples has shown a good sensitivity, but currently available research tools are highly technical and resource demanding. New and simplified XBA collection devices (Face masks, AveloCollect Blow tube device) are currently under evaluation, and further clinical studies are needed in order to assess their feasibility for pathogen detection in clinical practice, especially for etiological diagnosis in patients with unspecific respiratory symptoms.

The objective of this study is to evaluate the feasibility of XBAs collection and analysis (index test) using the molecular tests currently in use at San Raffaele Hospital for the detection of respiratory pathogens in clinical samples, compared to upper respiratory secretion and sputum samples, that will be collected using standard procedures and analysed using the same kits (comparator tests).

Eligibility Criteria:
Inclusion Criteria:

* Adult age (≥18 years)
* Subjects with one or more symptoms of respiratory tract infection (fever, cough, sore throat, dyspnea, conjunctivitis and/or rhinitis).
* Samples collected within 3 days from symptom onset.
* No antibiotic drug taken during the previous 3 days

Exclusion Criteria:

* Pregnancy
* Samples collected after 3 days from symptom onset.
* Antibiotic drug taken during the previous 3 days
FCN-159 in Adult Patients with Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas

A study to evaluate the efficacy of FCN-159 in adult patients with symptomatic, inoperable neurofibromatosis type 1-related plexiform neurofibromas.

This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of FCN-159 in adult patients with symptomatic, inoperable neurofibromatosis type 1-related plexiform neurofibromas.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old and ≤ 70 years old.
2. Patients must be diagnosed with symptomatic NF1-related plexiform neurofibromas (PNs) and require systemic therapy at the investigator's discretion.
3. Presence of measurable lesions, defined as ≥ 3 cm in length in at least one dimension, which can be evaluated for efficacy by MRI.
4. Karnofsky performance status score ≥ 70.
5. Patients with adequate organ and bone marrow functions.

Exclusion Criteria:

1. NF1-related malignancies requiring chemotherapy, radiotherapy, or surgery, such as medium to high grade optic glioma or malignant peripheral nerve sheath tumor.
2. Patients with a history of or concurrently with other malignancies (excluding cured non-melanoma skin basal cell carcinoma, breast cancer in situ or cervical cancer in situ, and other malignancies without evidence of disease within 5 years).
3. Patients who cannot undergo MRI and/or have contraindications to MRI.
4. Patients with previous or current retinal vein obstruction (RVO), retinal pigment epithelial detachment (RPED), glaucoma, and other abnormal ophthalmic examination with clinical significance.
5. Interstitial pneumonia, including clinically significant radiation pneumonia.
6. Cardiac function or combined diseases meet one of the following conditions:

   1. QTcF value of \> 470 milliseconds; patients with risk factors for QTcF prolongation or patients receiving drugs that prolong the QTcF interval.
   2. Congestive heart failure per New York Heart Association (NYHA) classification ≥ Class 3.
   3. Arrhythmias with clinical significance.
   4. Known concurrent clinically significant coronary artery disease, cardiomyopathy, and severe valvular disease.
   5. LVEF \< 50%.
   6. Patients with a heart rate of \< 50 beats/min.
Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion

To evaluate the incidence of adrenal insufficiency after surgery in Primary aldosteronism patients concurrent with or without autonomous cortisol secretion.

This study is a prospective, single-center research. Primary aldosteronism patients concurrent with or without autonomous cortisol secretion who underwent adrenalectomy and completed the ACTH stimulation test will be included. To evaluate the incidence of adrenal insufficiency after surgery in these patients.

Eligibility Criteria:
Inclusion Criteria:

* PA conccurent with or without autonomous cortisol secretion
* complete adrenalectomy
* complete ACTH stimulation test on the one day after surgery
* complete follow-up at 6，12 months after surgery

Exclusion Criteria:

* Patients underwent partial adrenalectomy
* Suspicion of familial hyperaldosteronism or Liddle syndrome. \[i.e., age \<20 years, hypertension and hypokalemia, or with family history\]
* Suspicion of pheochromocytoma or adrenal carcinoma.
* Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; Severe anemia (Hb\<60g/L); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) \>3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG≥13.3 mmol/L); Obesity (BMI≥35 kg/m2) or Underweight (BMI≤18 kg/m2); Untreated aneurysm; Other comorbidity potentially interfering with treatment;
* Patients with actively malignant tumor.
* Long- term use of glucocorticoids.
* Suspected PBMAH or PPNAD;
Apicoectomy Longterm Results

The purpose of the study is to evaluate the longterm treatment results after micro-surgical root resection of teeth with post and core and crown.

All 73 patients, who have been treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.

The patients will have a clinical and radiologic examination. The investigators will examine if new periapical lesions, bone loss, fracture of teeth or loss of teeth exist.

Eligibility Criteria:
Inclusion Criteria:

* All 73 patients, who were treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.

Exclusion Criteria:

* Pregnancy
* Patients who do not want to participate in clinical and radiological follow up.
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are:

* What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs?
* Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor?
* What happens to KQB198 in the body?

Participants will:

* Take KQB198 daily, alone or in combination with another anti-cancer drug
* Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that


Eligibility Criteria:
Inclusion Criteria:

* PART 1: Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations: EGFR, RAS, PTPN11, or SOS1 mutations, or inactivating mutations of NF1.
* PART 1 (Osimertinib arm) and Part 2 Cohort A: Histologically confirmed diagnosis of NSCLC with activating EGFR mutation and progression on osimertinib
* Part 3 Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function
* Measurable disease per RECIST 1.1.

Exclusion Criteria:

* Prior therapy with a similar mechanism of action to KQB198
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
* History of interstitial lung disease
* Cardiac abnormalities
Prostate Adaptive Radiation Therapy

Prostate ART is a two phase study looking at using adaptive radiotherapy to help reduce toxicity for prostate cancer patients.

Adaptive radiotherapy is a new technology that provides the ability to account for daily changes in anatomy. Adaptive radiotherapy also provides a foundation for which radiotherapy margins might be safely reduced.

Phase 1 of this study is looking to see if a radiation therapist centred adaptive workflow can be implemented. If phase 1 of this study is safe and feasible, the study will proceed to phase 2.

Part 2 of the study looks at using adaptive technology to reduce radiation treatment margins. The primary aim of this study is to see whether margin reduced treatment using adaptive radiotherapy can reduce side effects for prostate cancer patients.

Despite major technological advancements in the delivery of pelvic radiation therapy including the use of dynamic therapy, image guidance, integrated boosting and stereotactic techniques, toxicity from pelvic radiation remains a significant issue impacting on patient's quality of life and preventing the delivery of higher (and more curative) doses of radiation. Although evidence showed that adaptive radiotherapy demonstrating promising reduction of acute toxicity, the uptake of adaptive radiotherapy remains poor as adaptive radiation therapy is very labour intensive, time consuming and usually requires a radiation oncologist (RO) and Medical Physicist in attendance to review/modify target contours. These practices of daily multi-disciplinary team (MDT) in person attendance is not sustainable in the long term.

Since 2021, Royal North Shore Hospital has been treating patients with cancer in the pelvic with Adaptive Radiation Therapy (ART) and Radiation Therapists (RT) at the site have undergone a rigorous University based Advanced Practitioner training programme.

This study aims to evaluate RT-led ART in a randomised trial to assess the safety and feasibility of ART in a two stage phase 3 randomised controlled trial. If this study can prove safety and feasibility in the first phase, it will proceed to the second phase of the study which will look at using adaptive radiotherapy to safely reduce CTV and PTV margins.

The primary aim of the study will be to measure the difference in combined acute patient reported gastrointestinal (GI) and genitourinary (GU) toxicity between ART with margin reduction versus standard radiotherapy. Secondary aims will be to look at differences in biochemical failure, the time efficiency of ART, the radiation dosimetric differences between the treatment arms and patients' perception of ART.

Eligibility Criteria:
Inclusion Criteria:

1. - Age \> 18
2. Biopsy proven prostate malignancy
3. Definitive treatment is radiotherapy to the prostate alone
4. ECOG performance status 0-2
5. Ability to understand and the willingness to sign an informed consent

Exclusion Criteria:

1. Hip prosthesis
2. Patient separation from prostate centre to skin edge \> 24cm, measured on diagnostic scan-
The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms

Dental plaque is a well known etiologic factor for gingivitis. Recently, herbal extracts are a matter of scientific interest to inhibit plaque accumulation on teeth. The purpose of this study was to evaluate the effects of pistacia Mutica (PM) mouth wash on de novo dental plaque plaque formation, gingival inflammation indices and oral microorganisms.


Eligibility Criteria:
Inclusion Criteria:

* had merely gingivitis (pocket depth≤3 mm, no attachment loss)
* without any fixed or removable oral appliances

Exclusion Criteria:

* Individuals who had a history of any relevant systemic diseases
* Individuals who had a history of any drug usage
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users

This study aims to determine if a standardized approach including counselling and Nicotine Replacement Therapy (NRT) can help e-cigarette users quit vaping. Current e-cigarette users will be randomly assigned to either to counselling and NRT or counselling only group. Self-reported rates of vaping cessation will be measured throughout the year in both groups. The use of e-cigarettes has grown substantially among non-smokers, particularly among youth and young adults. These devices deliver high levels of nicotine, far greater than is possible with conventional cigarettes. Currently, they are not approved for smoking cessation or any purpose by Health Canada. Nonetheless, there is some evidence that e-cigarettes may be of assistance in smoking cessation. Conversely, there is evidence that using cigarettes and e-cigarettes together may result in increased cigarette consumption. E-cigarette use among youth also serves as a gateway to regular use of conventional cigarettes. Clinicians and patients are seeking guidance on vaping cessation. However, to date, there are no strong evidence-based interventions to support e-cigarette users in quitting. NRT is approved for smoking cessation by Health Canada. However, it is not approved for vaping cessation and thus its use to support e-cigarette users to quit by managing their nicotine withdrawal is considered "off-label". This represents a significant gap and opportunity, which this project will address.

The study hypothesizes that the OMSC approach, which includes the use of nicotine replacement therapy, will result in higher rates of vaping cessation compared to usual care.

Participants will all complete an initial counselling session to discuss vaping cessation and receive tips to help achieve cessation. They will all be asked to track their smoking/vaping behaviour and the amount of tobacco in their e-cigarette for 7 days. After 7 days, all participants will be randomly put into one of two groups (either the intervention or control group). They will have follow-up assessments with the research team at 1, 3, 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age or older
* Ontario resident
* Ability to speak English or French
* Regular use of e-cigarette (vaping at least once per week for the past four weeks)

Exclusion Criteria:

* Cognitive impairment or acute psychiatric illness that would alter their ability to participate
* Being institutionalized at a retirement home, nursing home or long-term care facility
* Participating in another smoking or vaping cessation program
* Allergy or intolerance to NRT
Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Normal platelet count and clotting parameters
* Adequate renal and hepatic function
* If female and of child-bearing potential, negative serum pregnancy test within 21 days of enrollment and a negative urine pregnancy test on admission to the clinical research unit
* If a sexually active male or a sexually active female of child-bearing potential,agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
* Negative drug and alcohol screens

Exclusion Criteria:

* Known antibodies or hypersensitivity to FXIII
* Known bleeding or hematologic disorder
* Known allergy to yeast
* Receipt of blood products within 30 days of screening
* Donation of blood within 30 days prior to enrollment
* Any surgical procedure in the 30 days prior to enrollment
* Previous history of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus
* Receipt of treatment with any experimental agent within 30 days of study enrollment
Pressure Course in the Tube Cuff During Swallowing

Leakage of fluid from the subglottic space to the lungs occurs along the longitudinal folds within the wall of endotracheal tube (ETT) cuffs. In this project the researchers investigate the possible effect of swallowing on the pressure course in the ETT cuff.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* general anaesthesia or intensive care medicine treatment

Exclusion Criteria:

* refusal of written informed consent