cyrilzakka/clinical-trials huggingface dataset:
A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors

APT-008 is an open-label, Phase I/Ib, dose escalation and expansion cohort study to evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and preliminary efficacy of EOS301984 as monotherapy and in combination with other anticancer therapies in participants with advanced solid tumors.


Eligibility Criteria:
INCLUSION CRITERIA

* Provide a signed written informed consent before any study-specific evaluation.
* Be at least 18 years old on the day of signing informed consent.
* Have a histologically confirmed advanced solid tumor for which no standard approved treatment is available, or are ineligible for, or did not tolerate standard approved treatment.
* Have at least one tumor lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Have adequate organ and marrow function.
* Agree to use adequate highly effective method of contraception during the study is mandatory, if Women of Childbearing Potential (WOCBP) or male.

EXCLUSION CRITERIA

* Have received prior systemic anticancer treatment including investigational agents within 4 weeks before the first dose of study treatment.
* Have major surgery planned or have had a major surgery within 5 weeks before the first dose of the study treatment.
* Have received prior radiotherapy within 2 weeks before the first dose of study treatment.
* Have allergy to study treatment(s) or any of its components.
* Have a history or current evidence of uncontrolled or significant cardiovascular disease. Unable to comply with the requirements of the study or who, in the opinion of the Investigator, should not participate in the study.
* Pregnant or breastfeeding women.
The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment

This study is examining the effects of growth hormone releasing hormone (GHRH) on mild cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects with MCI as well as healthy controls.

Subjects with MCI as well as healthy controls will be given GHRH at a dose of 1mg/day for 10 weeks.

This study is designed to investigate the effects of GHRH on the following things: 1) cognitive function as measured by our neuropsychologist with a series of short tests; 2) brain activity as measured by fMRI 3) lean and fat mass of your body as measured by DEXA; 4) physical function as measured by a walking test.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 55 to ≤ 85 years
* Ability to sign consent form (score ≥ on the Mini Mental State Examination, MMSE)
* MCI group: MMSE scores of 23 - 26
* Normal Control Group: MMSE scores of 27 - 30

Exclusion Criteria:

* Diabetes
* A neurologic condition other than MCI which might cause cognitive impairment
* Baseline serum IGF-1 concentration greater than the midrange for healthy young adults (300ng/ml)
* Presence of a pacemaker or metal implant
* Heart Failure
* Edema
* Active malignancy
* Carpal tunnel syndrome
* Disruption of the hypothalamic pituitary axis such that the pituitary is expected to be insensitive to growth hormone secretagogues such as GHRH
* Known allergy to tesamorelin or mannitol
* Pregnancy
* Significant heart, liver, kidney, blood or respiratory disease
* Active cancer
* Recent (within 6 months) treatment with anabolic steroids, GHRH or corticosteroids
* Alcohol or drug abuse
* MMSE \< 23
* Less than 12 years of education
* Significant findings on screening tests, including but not limited to, blood counts, blood biochemistries, urinalysis, drug screening, HIV test, hepatitis panel, electrocardiogram
* Other medical conditions deemed exclusionary by the study investigators
Effects of Preconditioning With Sevoflurane During Organ Procurement From Brain Dead Donors: Impact on Early Function of Liver Allografts

The aim of the investigators study is to investigate the effects of anaesthetic preconditioning with sevoflurane during organs harvesting in brain dead donors. More particularly, the investigators will investigate whether sevoflurane preconditioning protects against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of cold ischaemia and whether this protection translates in a better clinical functional recovery of these allografts.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive brain dead donors in the Belgian university hospitals of Leuven, Brussels, Louvain and Liège eligible for organs harvesting followed by organs transplantation in the Eurotransplant area. There is no age limitation for eligibility

Exclusion Criteria:

* haemodynamic instability that precludes safe administration of 2% sevoflurane.
A Phase II Study of an Anti-Tumor Immunotherapy Regimen Comprised of Pegylated Interferon-Alpha 2b and HyperAcute Melanoma Vaccine for Subjects With Advanced Melanoma

The purpose of this study is to determine the safety of giving subjects with advanced, recurrent or refractory melanoma the HyperAcute® Melanoma vaccine with a variant of a drug, called Interferon (PEG-Intron®) that is specially formulated to be given on a weekly basis (instead of daily). The study vaccine (HyperAcute®-Melanoma) is made from three types of human melanoma cell lines (grown in the laboratory) in which the genes have been slightly changed. This clinical study will try to discover the safety of the study vaccine combined with PEG-Intron®, its side effects and the potential benefits, if any.

This study will look at the anti-tumor vaccine effect, side effects and toxicity of the HyperAcute® Vaccine with PEG-Intron®. It is hoped that the immune system's response to these genetically engineered melanoma cells and PEG-Intron® will cause a reaction that will make it react to and attack and kill the melanoma cells and keep it from growing, possibly causing the tumors to shrink.

Patients that are eligible are 19 years or older and have been diagnosed with advanced, treatment resistant or recurrent melanoma, an aggressive usually pigmented form of skin cancer.

Eligibility Criteria:
Inclusion Criteria:

* 19 years or older
* Histological diagnosis of melanoma
* AJCC Stage IIIC (any T, N1b, N2b, N3, M0) or Stage IV (any T, and N, M1), metastatic, progressive, refractory, recurrent or high risk of recurrence melanoma.
* Expected survival of more than 6 months
* Adequate organ function
* Measurable or non-measurable disease
* Must have negative serologies for Hepatitis B and C and HIV prior to entering study
* Must be more than 4 weeks since major surgery, radiotherapy, chemotherapy or biotherapy/targeted therapies
* Male and female subjects of child producing potential must agree to use contraception or avoidance pregnancy measures while enrolled on the study and for one month after the last immunization.

Exclusion Criteria:

* Active CNS metastases or carcinomatous meningitis
* Hypercalcemia
* Pregnant or nursing women
* Other malignancy within five years
* History of organ transplant or current active immunosuppressive therapy
* Subjects taking systemic corticosteroid therapy
* Active infection or antibiotics within 1-week prior to study
* Uncontrolled or significant congestive heart failure, myocardial infarction, ventricular arrhythmias or pulmonary dysfunction
* Autoimmune disease
* A known allergy to any component of the HyperAcute vaccine or PEG-Intron
* Patients having undergone splenectomy
* Patients with sickle-cell anemia or thalassemia major.
A Long-Term Follow-up Study of Subjects With Gaucher Disease Who Previously Received AVR-RD-02

This is a multicenter, multinational long-term follow-up study to assess the long-term safety and durability of effect of AVR-RD-02 treatment in subjects who previously received AVR-RD-02 treatment (single dose administration).

Subjects who received AVR-RD-02 in the preceding treatment study and who meet all eligibility criteria may participate in the AVRO-RD-02-LTF01 study. For individual participating subjects, the Baseline visit for the AVRO-RD-02-LTF01 study will coincide with the subject's last visit in the preceding treatment study, whenever feasible. Subjects will be asked to return for study visits at approximately 6-month intervals for the first 4 years of the study and then annually thereafter for 10 years (for a total follow-up of 14 years in this study), during which time periodic safety and efficacy assessments will be performed to assess measures of safety, engraftment, and clinical response after AVR-RD-02 treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have been enrolled and received AVR-RD-02 as single dose administration
* Subject must be willing and able to provide written informed consent for the AVRO-RD-02-LTF01 study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures.

Exclusion Criteria:

* Subject is currently enrolled in an AVROBIO-sponsored AVR-RD-02 treatment study.
Opportunities in Outpatient Care

The purpose of this research study is to determine whether there are things that Intermountain can do to break down barriers to helping patients see their primary doctors or other outpatient clinics. To do this we will develop and test a classification scheme to help us understand how we might reduce some avoidable emergency department and InstaCare visits.

The study will develop a first-pass taxonomy that classifies the causes and effects of challenges and opportunities of outpatient care leading to potentially avoidable ED and urgent care center visits.

The study will quantify the proportion of ED and urgent care center visits that result from a challenge or opportunity in outpatient care and classify the causes and outcomes according to the taxonomy. It will also define the 30 and 90 day episode costs of ED and urgent care center visits associated with a challenges and opportunities of outpatient care beginning the day of the ED or urgent care center visit.

Eligibility Criteria:
Inclusion Criteria:

* All Emergency Department/IC patients who can consent, including children.

Exclusion Criteria:

* Unable to give consent
* Prisoners
A Study Evaluating the Effect of Formulation on the Bioavailability of Ipatasertib in Healthy Volunteers

This Phase I, open-label, randomized, 2-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy adult volunteers. Participants will be randomized to one of two treatment sequences to receive a single oral administration of ipatasertib in tablet or capsule formulation followed, after a washout period, by a single oral administration of ipatasertib in the second formulation. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers aged 18 to 55 years, inclusive
* Body mass index (BMI) from 18.5-29.9 kg/m2, inclusive

Exclusion Criteria:

* Clinically significant findings from medical history or screening evaluations
Echinocandins Versus Azoles for Candidemia Treatment

Candidemia is the most frequent invasive fungal disease in intensive care units (ICUs). It remains a major health concern, considering its attributable mortality up to 40% in critically ill patients. Successful clinical outcome requires early diagnosis and effective antifungal therapy. Guidelines for the treatment of candidemia were published by the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). According to these guidelines, echinocandins are the preferred first-line therapy for candidemia in critically ill patients. Considering the bibliography supporting this statement, the place of triazoles still needs to be defined in candidemia therapeutic arsenal. In this context, we are setting up a retrospective cohort study using Hospital database to compare the efficacy of echinocandins and azoles for the treatment of candidemia in intensive care units.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had a diagnosis of candidemia during ICU stay and were treated with echinocandins or azoles

Exclusion Criteria:

* Patients with neutropenia
* Patients without antifungal treatment
* Patients who received antifungal therapy for more than two days before candidemia diagnosis
* Patients receiving liposomal amphotericin b or multiple antifungal agents as first-line therapy
* Patients who received less than 4 days of antifungal therapy after candidemia diagnosis
The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada

This study will assess the safety, tolerability and efficacy of canakinumab treatment in Canadian patient diagnosed with cryopyrin-associated periodic syndrome over a period of 18 months.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients at least 4 years of age at the time of the screening visit
2. Patient's informed consent for \> or = 18 years of age before any assessment is performed
3. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients \< 18 years of age.
4. Patients with a diagnosis of CAPS: FCAS/FCU, MWS, or NOMID/CINCA
5. Body weight \> or = 15 kg
6. Able to communicate with the investigator and comply with the requirements of the study (for children the parent can assist when necessary)

Exclusion Criteria:

1. Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at baseline
2. Patient of childbearing potential (man or woman) and unwilling to use double barrier method of contraception. It is required that double barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients of childbearing potential (man or woman) regardless of whether a hormonal agent is also used as a method of contraception.
3. Participation in any clinical investigation within 4 weeks prior to dosing
4. Live vaccinations within 3 months prior to the start of the trial, during the trial and up to 3 months following the last dose.
5. History of significant medical conditions, which in the Investigator's opinion would exclude the patient from participating in this trial (this can be discussed with Novartis on a case by case basis in case of uncertainty).
6. History of drug or alcohol abuse within 12 months prior to dosing
7. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes

"Other protocol-defined inclusion/exclusion criteria may apply"
Comparison of Somatosensory Versus Endurance-strength Exercise in Patients With Chronic Neck Pain

Aim: To compare the effects of somatosensory exercise vs endurance-strength exercise on the deep cervical flexor muscles on pain and perceived disability in patients with chronic neck pain.

Study design: Protocol of a clinical trial, controlled, parallel and a blinded assessor.

Population: Subjects aged 18 to 65 years with neck pain of 3 or more months of evolution.

The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 60 subjects with nonspecific chronic neck pain will be selected and randomly assigned into two intervention groups. The first group will perform a somatosensory exercise program and a second group will perform activation and endurance-strength exercises of the deep cervical flexors. The duration of the intervention will be 8 weeks, with 6 sessions of physical therapy and daily home exercise. The variables pain, pressure pain threshold, disability, endurance-strength, proprioception, quality of life, kinesiophobia, quality of sleep and depression will be analyzed. Measurements will be taken pre-treatment, post-treatment and a follow-up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of age between 18 and 65 years
* Neck pain of 3 or more months of evolution

Exclusion Criteria:

* Cervical Disability Index less than 15/50
* Infection
* Oncological processes
* Neck or arm surgery
* Neck or arm trauma
* Positive neurological signs
* Rheumatic diseases
Surgical Treatment of High Perianal Fistulas

Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the third and fourth decade of life. According to Parks classification fistulas have been divided into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. Simple fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high (transsphincteric) fistulas it may affect anal continence seriously.

Therefore sphincter preserving procedures should be preferred in these cases. Rectal advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication with high success rate in cryptoglandular fistulas. However, this technique is technically demanding and results can be expert depended with wide spread of healing rates (24-100%) in individual studies as referred in recent systematic review.

Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple sphincter preserving technique. The success rate varies between 40-95% with low overall incontinence rate (6%).

The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment of high perianal fistulas.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years old or older
* Diagnosis of simple intersphincteric or transsphincteric fistula
* Patients able to comply with the study protocol as per investigator criteria
* Signed and dated informed consent by the patient
* Absence of any exclusion criteria

Exclusion Criteria:

* Recurrent anal fistula
* Suprasphincteric, low subcutaneous fistula
* Multiple fistulas
* Posttraumatic fistula
* Perianal hidradenitis
* Fistula arises from other than cryptoglandular origin
* Previous anal surgery except of abscess
* Inflammatory Bowel Disease
* History of fecal incontinence
* Rectal prolapse
* Malignant disease and life expectancy of less than 1 year, or chemotherapy and radiotherapy less than six months prior enrolment
* HIV infection
* Pregnancy
* Participation in another clinical trial less than one month prior to enrolment, or involvement in another trial
Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)

This study aims to evaluate the effect of red meat intake on occurrence of non-transferrin bound iron (NTBI)

During Visit 1, blood samples will be collected to assess iron status. During Visit 2, after an overnight fast, participant will be given a standardized meal (rice and potatoes) with a portion of cooked beef (200 g). Blood samples will be collected right before and 2 hour after the meal for NTBI analysis.

NTBI concentration before and after meal consumption will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy male volunteers (21 - 45 years old)
* C-reactive protein (CRP) \< 5 mg/L

Exclusion Criteria:

* Blood donation or significant blood loss (e.g. surgery) within the past 4 months
* Regular intake of iron and other nutrient supplements within the past 4 months
* Regular intake of medication except oral contraceptives
* Acute or recent inflammatory or infectious symptoms
* Chronic gastrointestinal disorders or metabolic diseases
* Smoking
* Coeliac disease or gluten-related disorders
* Iron deficiency anemia (Hb \< 14 g/dL for males) with serum ferritin concentration \< 30 ng/mL)
* Non-iron deficiency anemia (serum ferritin concentration within normal range (30 - 300 ng/mL for males) but low hemoglobin (\< 14 g/dL for males)
* Iron overload conditions (serum ferritin concentration \> 300 ng/mL for males)
* Known hereditary disorders of iron metabolism
Quality of Life and Health Economic Measurements in Allergic Patients Treated With Immunotherapy

Grass pollen and house dust mites (HDM) are the most common allergens causing allergic rhino-conjunctivitis (RC) and/or asthma (A). Subcutaneous allergen specific immunotherapy (SCIT) reduces symptoms and use of medication. The purpose of SABAL is to assess the effect of SCIT on disease severity classifications in terms of number of days affected- and sick days on patients with grass pollen and/or HDM induced disease. These outcome measures will be gathered in one single measure: Quality Adjusted Life Years (QALY)


Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 16 years) and allergic to grass pollen and/or house dust mites.

Exclusion Criteria:

* Allergic patients who had been immunotherapy treated before.
Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial

A randomized double-blind controlled trial will be carried out in which young, nulliparous (having never given birth) women will be randomly assigned to receive weekly supplementation with either iron and folic acid or folic acid alone. Women will be followed-up weekly up to 18 months. Women who become pregnant will be followed-up until delivery. Malaria risk in both groups will be compared by assessing the prevalence of peripheral parasitaemia at the first antenatal clinic visit for pregnant women and at the end of the first malaria transmission season for non-pregnant women. The incidence of clinical malaria will be assessed by active and passive case detection throughout the follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Female
* At least 15 and less than 25 years old at enrolment
* Never given birth
* Resident within the Demographic Surveillance System (DSS) area
* Willing to adhere to the study requirements (including weekly observed drug intake)
* Provision of written informed consent (if non emancipated minor by guardian/parent with minor's assent

Exclusion Criteria:

* No menses for \>3 months and/or palpable uterus or positive pregnancy test if history unclear
* Concurrent enrolment in another study
* Intention to move out of the study area for more than 2 months within the next 18 months
* Any significant illness at the time of screening that requires hospitalization, including clinical signs of severe anaemia (conjunctival or mucosal pallor, tachycardia, respiratory distress)
* History or presence of major clinical disease likely to influence pregnancy outcome (sickle cell disease, diabetes mellitus, severe renal or heart disease, open tuberculosis, epilepsy)