cyrilzakka/clinical-trials huggingface dataset:
Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen

This study is conducted to assess the relative bioavailability of MTX administered subcutaneously via a prefilled pen (50mg/mL) compared with MTX administered via IM injection (25mg/mL).


Eligibility Criteria:
Inclusion Criteria:

* Is able to understand and follow instructions during the study
* Has a diagnosis of moderate to severe psoriasis based on a dermatologic evaluation
* Provides written informed consent
* Is male or female and is aged 18 to 65 years, inclusive
* Has a body mass index (BMI) within the range 18 through 30 kg/m2.

Main Exclusion Criteria:

* Is receiving concomitant treatment for psoriasis with a biologic or conventional systemic treatments (eg, cyclosporine, azathioprine, fumaric acid esters, Leflunomide), other than MTX every week
* Has used antibiotics within 14 days prior to Screening or requires use prior to study completion
* Has used any of the following medications within 14 days prior to Screening or requires use prior to study completion, unless on a stable, daily dose: Non steroidal antiinflammatory drugs (NSAIDs), Diuretics, Folic Acid, Hydrochloroquine, Probenicid, Proton-pump inhibitors
* Has, other than psoriasis, any uncontrolled cardiac disease, liver disease, lung disease, hematologic disease, gastrointestinal disease, or other systemic disease, that in the opinion of the investigator, would present an unacceptable risk if he or she were to participate in the study
* Has ongoing acute or chronic infection within 14 days prior to Screening
* Has renal insufficiency , hepatic insufficiency, impaired hematopoiesis, known severe, acute, or chronic infection, history of malignancy, history of or suspected abuse of drugs or alcohol
* allergic reactions or serious adverse reactions to the study drug
* Is a female subject who is pregnant, trying to become pregnant, or breast feeding, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
* Is a male subject with a female partner of childbearing potential, not had a vasectomy and not using a condom and/or cervical cap/diaphragm with spermicide
Social and Cognitive Online Training: the SCOT Project

Social isolation and reduced involvement in cognitive activities are associated with repercussions on cognitive well-being and health status in elderly adults. In particular, loneliness and social isolation represent risk factors in favouring cognitive decline and dementia. The Social Cognition Online Training (SCOT) project aims to evaluate the beneficial effects of an online intervention on social-cognitive functioning in healthy elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* Cognitively healthy subjects aged above 65 years old
* Montreal Cognitive Assessment (MoCA) equivalent score \> 1 (Italian normative values)

Exclusion Criteria:

* Diagnosis of dementia, based on Diagnostic and Statistical Manual of Mental Disorders, FifthEdition (DSM-V)
* History of current or previous neuropsychiatric disorders;
* History of current or previous substance abuse;
STimulation to Improve Auditory haLLucinations

Investigating the effects of non-invasive transcranial current stimulation as a treatment for auditory hallucinations in patients with schizophrenia.

The investigator's primary objective is to conduct a pilot clinical trial to establish the feasibility and to collect first effectiveness data for the use of transcranial alternating current stimulation (tACS) to re-normalize pathological alpha oscillations in dorso-lateral prefrontal cortex (dl-PFC) of patients with schizophrenia or schizoaffective disorder by comparing Auditory Hallucination Rating Scale (AHRS) scores immediately before the first stimulation session and immediately after the last stimulation session. As a secondary objective the investigators will assess the differential clinical effects of sham, 10 Hz and 2 mA transcranial direct current stimulation (tDCS) on electroencephalogram (EEG) measures of alpha oscillations.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. Duration of illness \>1 year
* 18-70 years old
* Clinically stable for at least 12 weeks, i.e. not requiring hospitalization or a change in level of care
* On current antipsychotic doses for at least 4 weeks
* Stable auditory hallucinations as demonstrated by having less than or equal to 20% change in AHRS scores across a 2 week interval during the screening period.
* Capacity to understand all relevant risks and potential benefits of the study and to provide written informed consent, OR has a legal guardian who can provide informed consent on the patient's behalf with the patient providing written assent to participate.

Exclusion Criteria:

* DSM-IV diagnosis of alcohol of substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
* Medical or neurological illness (unstable cardiac disease, AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation
* History of traumatic brain injury that required subsequent cognitive rehabilitation, or caused cognitive sequelae
* Prior brain surgery
* Any brain devices/implants, including cochlear implants and aneurysm clips
* Co-morbid neurological condition (e.g. seizure disorder, brain tumor)
* Non English speakers
* Female participants who are pregnant, nursing, or unwilling to use an adequate method of contraception during study participation for those of childbearing potential
* Positive urine test for cannabis, cocaine, amphetamine, barbiturates, benzodiazepines, opiates
Improving Embryogenesis by Adding Growth Factors to In Vitro Human Culture Media

The investigators suppose that adding growth factors that had been found in the female tubal fluid and uterus to In Vitro single step culture media for human embryos might improve the the embryogenesis In Vitro and the clinical outcome of the resulting off spring.

The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding growth factors ( Insulin-like growth factor I, Insulin-like growth factor II, transforming growth factor-beta and epidermal growth factor ) as a promoting growth factors to Lifeglobal culture media might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and the same culture condition but with one arm with growth factors and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

Eligibility Criteria:
Inclusion Criteria:

* all patients

Exclusion Criteria:

* over 40 years old
Study of Vorinostat Plus Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer: Zolinza+XP

There is scientific rationale for exploring the role of vorinostat, histone deacetylase inhibitor with capecitabine (X) and cisplatin (P), one of standard chemotherapy in patients with advanced gastric cancer. XP is a new standard of care in advanced gastric cancer (AGC) and vorinostat is a novel targeted agent that prevents tumor cell proliferation, survival and angiogenesis through histone deacetylase inhibition.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed unresectable or metastatic advanced gastric adenocarcinoma
* Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy
* Age 18 to 70 years old
* Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
* Estimated life expectancy of more than 3 months
* Presence of measurable or evaluable disease
* Adequate bone marrow function (ANC \>1,500/µL and platelets\>100,000/µL),
* Adequate renal function: creatinine \< 1 x upper normal limit (UNL) or creatinine clearance 60ml/min or less
* Adequate hepatic function: bilirubin \< 1.5 x UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels \< 2.5 x UNL (\< 5 x upper limit of normal for patients with liver involvement of their cancer), alkaline phosphatase \< 5 x UNL (except in case of bone metastasis without any liver disease)
* Written informed consent

Exclusion Criteria:

* Prior exposure to any histone deacetylase (HDAC) inhibitor (however, valproic acid would be allowed if a 30-day wash-off period is provided.)
* Previous adjuvant treatment with capecitabine or platinums
* Contraindication to any drug contained in the chemotherapy regimen
* Other tumor type than adenocarcinoma
* Presence or history of central nervous system (CNS) metastasis
* Gastric outlet or bowel obstruction
* Evidence of serious gastrointestinal bleeding
* Peripheral neuropathy \> grade 2
* History of significant neurologic or psychiatric disorders
* History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* Active human immunodeficiency virus (HIV) infection
* Viral hepatitis infections
* Other serious illness or medical conditions
Study of XL999 in Adults With Solid Tumors

The purpose of this study is to assess the safety and tolerability of XL999 in adults with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor
* Cancer that has progressed on currently available therapies
* Life expectancy of \>3 months
* Adequate bone marrow, liver, and kidney function
* Willing to use accepted method of contraception during the course of the study
* Negative pregnancy test (females)
* Written informed consent

Exclusion Criteria:

* Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
* Radiotherapy within 4 weeks of the start of treatment
* Subjects with known brain metastasis
* Uncontrolled medical disorder such as infection or cardiovascular disease
* Subjects known to be HIV positive
* Pregnant or breastfeeding women
Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility

Infertility refers to an inability to conceive after having regular unprotected sex. Infertility can also refer to the biological inability of an individual to contribute to conception, or to a female who cannot carry a pregnancy to full term. In many countries infertility refers to a couple that has failed to conceive after 12 months of regular sexual intercourse


Eligibility Criteria:
Inclusion Criteria:

* unexplained infertility, Primary or secondary.
* Absence of galactorrhoea.
* Normal serum prolactin.
* Normal hysterosalpingography.
* Normal spermogram.

Exclusion Criteria:

* Women on other line of treatment as aromatase inhibitors,gonadotrophins, or tamoxifen.
* Known hypersensitivity for cabergoline or clomiphene citrate.
* Other factors of infertility as tubal factor, uterine factor or male factor.
Bioavailability Study of Colcrys® in Apple Juice

The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast.

The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. Sixteen healthy, non-smoking, non-obese, male and female volunteers between 18-55 years of age will be randomly assigned in a crossover fashion to receive each of two dosing regimens in sequence with a 14 day washout period between dosing periods. In each of the dosing periods, after an overnight fast, subjects will receive one intact Colcrys® 0.6 mg tablet (followed by 240 mL of water) or one Colcrys® 0.6 mg tablet crushed and dissolved in 20 mL of apple juice (followed by 220 mL of water) according to the randomization schedule. Blood samples will be drawn from all participants before dosing and for 48 hours post-dose at times sufficient to adequately define the pharmacokinetics of colchicine. Vital signs (blood pressure, heart rate, respiratory rate, and temperature) will be measured prior to dosing and at 1 hour ± 30 minutes post dose. Subjects will be monitored throughout their participation in the study for adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults age 18-55, non-smoking, non- pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index of 18-30 kg/m²

Exclusion Criteria:

* Recent participation (within 30 days) in other research studies
* Recent significant blood donation or plasma donation
* Pregnant or lactating
* Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
* History of treatment for drug or alcohol addiction within the previous 12 months or use of tobacco products within 90 days of the start of the study
* Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, especially cardiovascular disorders (angina, heart failure, irregular heartbeats, heart attack, hypertension, hypotension) stroke, renal or hepatic disorders, diabetes or bleeding disorders, gastrointestinal disease or history of malabsorption within the last year
* History of or psychiatric disorders occurring within the last two years that required hospitalization or medication
* Presence of a medical condition requiring regular treatment with prescription drugs
* Use of any drugs or substances known to inhibit or induce drug-metabolizing enzymes within 30 days prior to dosing with the study drug
* Drug allergies or sensitivity to colchicine
* Positive test results for drugs of abuse at screening
Ketamine and Glutamate After Brain Injury : a Microdialysis Study

The objective of the study is to compare the effects of 48 hours ketamine infusion versus sufentanil infusion on brain glutamate concentrations measured with microdialysis after traumatic brain injury.

We hypothesize that ketamine infusion will decrease high glutamate values faster than sufentanil.

Inclusion of 20 consecutive head trauma patients. Randomization and double-blind to compare the effects of ketamine versus sufentanil on brain glutamate concentrations measured with microdialysis.

Ketamine is an anti-N-methyl-D-aspartate (NMDA) medication. It is supposed to limit excitotoxicity of amino-acids, especially glutamate. Glutamate is known to be elevated in more than 60% of the severe head trauma patients. It induces cortical spreading depression which can aggravate prognosis. It's a daily used medication in anesthesia and intensive care units for sedation and induction of anesthesia. It's the recommended medication for induction of unstable wounded soldiers on the field because of its neutrality on haemodynamic state.

Sufentanil is the reference opioid for sedation in ICU in Europe. It can induce hypotension which is deleterious for cerebral perfusion pressure after brain trauma.

In our unit, patients with severe head injury are monitored by a triple lumen access device including ICP (IntraCerebral Pressure), PtiO2 (oxygen pressure in the brain) and microdialysis. This last monitoring allows measurement of brain parenchymal concentrations of small molecules : glucose, lactate, pyruvate, glutamate, glycerol,.... It's a tool to evaluate the metabolic state of the brain divided into 4 categories : normal, hyperglycolysis, ischemia and metabolic crisis.

Then, we will detail the effects of ketamine on metabolic state of the brain, especially glutamate concentration. Normal values are below 10 micromol/ml. After head trauma it can dramatically increase to values up to 50 or even 100 micromol/ml, with normalization after 24 hours. Ketamine is expected to decrease these high values faster than described in observational studies.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Glasgow Coma Scale (GCS) \< 9
* \> 3 days of sedation expected at the arrival

Exclusion Criteria:

* pregnancy
* \< 18 years old
* estimated survival \< 48 hours post-trauma
* expected sedation \< 3 days
* coagulation impairment (platelets\<100.000/mm3 and prothrombin time (TP) \<60%)
* Cardiac arrest before ICU admission
* Admission \> 12 hours after trauma
* Multimodal monitoring implanted \> 24 hours post trauma
* Participation to the study refused by the next of kind
* No next of kind
Effects of Multiple Concussions in Retired NHL Players

To investigate long term affects of multiple concussions on the cognition, balance, proprioception, and biomarkers in retired National Hockey League players

This research study will collect data for each subject in one single visit. During the visit the subject will be asked to consent to the study which is estimated to take approximately 10 minutes. A medical history will be obtained, taking approximately 15 minutes. Blood, urine, and cheek swabs will be collected for approximately 15 minutes. The PHQ-9, Becks Depression Inventory, Connors Adult ADHD Rating Scale (CAARS™), and Montreal Cognitive Assessment (MoCA) will be administered, these assessments combined are estimated to take 50 minutes. Lastly, patients will be asked to complete a Sensory Organization Test (SOT) which takes approximately 15 minutes. There are only licensed health professionals working on this project that will respect your privacy and conduct this trial following all HIPPA and clinical research guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Retired professional NHL player
* History or reported concussion and concussion like symptoms

Exclusion Criteria:

* Any neurological condition
* Non sport related head trauma
Shock Wave Therapy for Lateral Hip Pain, Caused by Tendon Pathology

The aim of this randomized controlled study is to investigate if focal shock wave is an effective treatment, with respect to hip pain and lower limb function, in a population affected by greater trochanteric pain syndrome with gluteal tendinopathy.


Eligibility Criteria:
Inclusion Criteria:

* duration of lateral hip pain of six weeks or longer,
* normal passive hip range of movement (ROM),
* sonographic evidence of gluteal tendinopathy at their insertional site at the greater trochanter

Exclusion Criteria:

* general contraindication to extracorporeal shock wave therapy (pacemaker, pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area),
* history of rheumatologic disease,
* previous fractures or surgery in the affected limb,
* full thickness tear of the gluteal tendons,
* osteoarthritis of the hip (with ROM limitation),
* clinical signs of lumbar radiculopathy,
* corticosteroid injections or other conservative therapies (except pharmacological pain treatments) since the onset of the current pain episode.
CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks (VLA-008 CALM Ext)

This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA 007 trial. There may be patients who have benefitted from the study drug and who might benefit from further treatment. In order to accommodate those patients further treatment to complete 48 weeks of CVA21 intratumoral injections will be made available.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients must have reached Week 24 of the core protocol in immune-related complete response (irCR), immune-related partial response (irPR), immune-related stable disease (irSD), or immune-related progressive disease (irPD) (unconfirmed) with evidence of tumor inflammatory reaction.
* 2. If patient is in irPD (unconfirmed) status, they must not have had a decrease in their Karnofsky Performances Scale (KPS) score \> 10 points and to be judged to not have "rapid clinical deterioration" by the investigator since the subject's last tumor measurement leading to irPD assessment.
* 3. Patients must start treatment in the extension protocol within 8 weeks of their last injection administered in the core protocol.
* 4. Patient is able and willing to provide written informed consent to participate in the study.
* 5. Fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males.

Exclusion Criteria:

* 1. Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis.
* 2. If lesions are too small to be visualized or palpable for accurate injection.
* 3. Currently in status of irPD (confirmed) or irPD (unconfirmed) without evidence of tumor inflammatory response, or with rapid clinical deterioration, or with a decrease of 10 points or more on their KPS score since their last assessment before irPD (unconfirmed) assessment.
Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.

A long-term follow-up study to obtain safety and efficacy data in subjects who completed phase 1/2a clinical trial of NEUROSTEM® (NCT02054208), comparing NEUROSTEM and placebo groups for up to 36 months after the initial administration in patients suffering from Alzheimer's disease

The subjects will be followed up at 12-month, 24-month, and 36-month (phone call) after the initial administration of NEUROSTEM®.

Eligibility Criteria:
Inclusion Criteria:

* Assessment of safety and exploratory treatment efficacy in subjects who were enrolled and completed phase 1/2a clinical trial of NEUROSTEM®.
* Subjects who have been treated with either NEUROSTEM® or placebo at least 12 months ago.
* Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial (in case it is difficult for the participant to sign, the consent of the legal representative)

Exclusion Criteria:

* Subjects who were not enrolled in phase 1/2a clinical trial of Neurostem® for assessing safety and exploratory treatment efficacy
* Other subjects, excluding those listed above, who were deemed unsuitable by the PI
A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations

A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX022 (sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations


Eligibility Criteria:
Inclusion Criteria: The participant must have a clinically confirmed superficial/ cutaneous (visible on the skin) venous malformation (cVM), referred to as the treatment area. The treatment area may contain a minority (\<30%) lymphatic component (mixed venous / lymphatic malformation).

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Exclusion Criteria:

* The participant's treatment area is mainly in any wet mucosa or within the orbital rim. For clarification, no part of the venous malformation should be evaluated or treated if it in mucosa. External genital presentation is permitted.
* The participant has a known pervasive extension of the lesion into mucosa, bone or tissue (as determined by diagnostic or the investigator) that would impair the ability of the investigator to evaluate the cutaneous components of the lesion.