cyrilzakka/clinical-trials huggingface dataset:
An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects

An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects

An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects (6 to \< 18 Years Old) With Severe Plaque Psoriasis

Eligibility Criteria:
Inclusion Criteria:

1. Subject's parent(s) or legally acceptable representative has provided informed consent, using an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved Informed Consent Form (ICF), when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated, or when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
2. Males and females ages 6 to \<18 years of age, inclusive, at the time of screening
3. Subjects must have up-to-date immunizations according to the relevant local country guideline. Subjects must not be scheduled to be vaccinated while on study.
4. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test at Baseline (Day 1). A female of childbearing potential is defined as a female who is fertile, following menarche.

Exclusion Criteria:

1. Received conventional systemic therapies or phototherapy for treatment of psoriasis within the last 4 weeks. Topical corticosteroids are allowed.
2. Female subjects who have reached puberty and are sexually active and are unwilling to use acceptable methods of effective birth control for the duration of the study and continuing for 5 weeks after receiving the dose of study drug. Acceptable methods of effective birth control include sexual abstinence (males and females); double barrier method (male condom with spermicide in combination with one female barrier method \[diaphragm, cervical cap, or contraceptive sponge)\]; or hormonal birth control; or intra-uterine device.
3. Female subjects who are lactating/breastfeeding or who plan to breastfeed while on study through 5 weeks after receiving the dose of study drug.
4. Female subjects with a positive pregnancy test.
5. Female subjects who are pregnant or planning to become pregnant while on study through 5 weeks after receiving the dose of study drug.
A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer

Treatment adaptation to biological and anatomical changes occurring during treatment can increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer patients. This trial investigates the feasibility of using repetitive per-treatment \[18F\]FDG-PET acquired during treatment in adaptive \[18F\]FDG-PET-voxel intensity-based intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT) for head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx.
* Primary unresectable tumor and/or patients refused surgery.
* Stage T1-4; T3-4 N0 or Tany N1-3 for cancer of the glottis.
* Multidisciplinary decision of curative radiotherapy or radiochemotherapy.
* Karnofsky performance status ≥70%.
* Age ≥ 18 years old.
* Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria:

* Treatment combined with brachytherapy.
* Prior irradiation to the head and neck region.
* Distant metastases.
* Second primary tumors that are not under control
* Pregnant or lactating women.
* Creatinine clearance (Cockcroft-Gault) ≤ 60 mL/min before treatment.
* Allergy to the CT-contrast agents.
* Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
* Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During Exercise

This study compared the blunting effect of aliskiren and valsartan monotherapies on exercise-induced rises in systolic blood pressure in patients with mild to moderate essential hypertension.


Eligibility Criteria:
Inclusion criteria:

* Mean sitting systolic blood pressure ≥ 140 mmHg and \< 180 mmHg measured at rest
* Patients able to exercise and to reach 85% of their predicted heart rate during a standard exercise test on a treadmill according to the Bruce Protocol

Exclusion criteria:

* Patients not confident in exercising or not able to exercise
* Absolute contraindication to exercise
* Mean sitting systolic blood pressure ≥ 180 mmHg and/or mean sitting diastolic blood pressure ≥ 110 mmHg measured at rest

Other protocol-defined inclusion/exclusion criteria applied to the study.
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy

The purpose of this study is to explore the effect of treating actinic keratoses of the face with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone

Actinic keratoses are common skin lesions associated with solar ultraviolet radiation exposure. Some actinic keratoses may develop into skin cancers.

Imiquimod 3.75% cream is an approved treatment for actinic keratoses that utilizes a regimen of application to the entire face or balding scalp of up to 2 packets of cream daily for two 2-week cycles, separated by a 2-week no treatment interval.

Photodynamic therapy with aminolevulinic acid (ALA) 20% topical solution is also an approved treatment for actinic keratoses. ALA is applied to actinic keratoses, and after an incubation period, is excited with light. Although approved as a lesion-directed treatment for actinic keratoses, treatment of a field (e.g. face) with photodynamic therapy is commonly performed.

Treatment with photodynamic therapy followed by imiquimod 5% cream has been reported in patients with actinic keratoses, basal cell carcinoma and Bowen's disease, and treatment with imiquimod 5% cream followed by photodynamic therapy in patients with vulvar intraepithelial neoplasia. There are, however, no prior studies on the safety and/or efficacy of using topical imiquimod 3.75% in conjunction with photodynamic therapy in the treatment of actinic keratoses.

This study will use an open-label parallel cohort design in which all patients will received treatment with imiquimod 3.75% cream, and subsequently will be randomized to either photodynamic therapy or observation.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults; 18 and over
* At least 10 and no more than 30 clinically typical actinic keratoses on the face

Exclusion Criteria:

* Hypertrophic actinic keratoses or other skin lesions on the head that might required excluded treatment during the study
* Known contraindication to treatment with imiquimod or photodynamic therapy
* Condition that would limit compliance, be a potential safety risk, or require therapy with an excluded treatment
* Systemically immunocompromised
* Pregnant or nursing
* Dermatologic disease and/or condition in treatment area that might exacerbated by treatment with imiquimod, cause difficulty with examination, or require therapy with an excluded treatment
* Participation in another clinical study
* Treatment within the past 60 days with:

  * Ultraviolet therapy
  * Systemic immunomodulators
  * Chemotherapeutic or cytotoxic agents
  * Investigational agents
* Treatment on the head within the past 60 days with:

  * Imiquimod
  * Photodynamic therapy
  * Red or blue light source therapy
  * Cryotherapy or chemotherapy
  * Surgical excision or curettage
  * Topical corticosteroids
  * Laser
  * Dermabrasion
  * Chemical peel
  * Topical retinoids
  * Topical 5-fluorouracil
  * Topical pimecrolimus or tacrolimus
  * Topical diclofenac
* Treatment for actinic keratoses on the head within the past 60 days
Clinical and Laboratory Characteristics of Polycythemia Vera

The study is observational, longitudinal, retrospective and prospective, on patients with PV. Patients with PV diagnosed from 2000 to 2023 according to WHO2017 criteria will be considered. The main purpose of the study is to determine the impact of clinical and laboratory characteristics of Polycythemia Vera on patients' prognosis, understood as long-term survival

The structured collection of data necessary for the evaluation of the objectives will take place through the creation of a specific electronic archive with an expected duration of 7 years, possibly extendable. The electronic archive may be used to review case histories and to obtain or confirm new scientific evidence on Polycythemia Vera. Patients will be followed and treated within the care pathway provided by normal clinical practice.

The following elements will be considered in each patient: age, recent and remote pathological history, characteristics of PV onset, histological, cytogenetic and molecular investigations of diagnostic definition, medical therapies performed, type of response to the therapies performed, complications of these therapies and pathology. All useful data will be collected exclusively through consultation of outpatient medical records.

The planned enrollment period is 60 months (January 2019-December 2023). The observation period of enrolled patients is at least 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PV according to WHO 2017 criteria,
* Obtaining informed consent for data collection and processing

Exclusion Criteria:

* None
The Effect of Monoclonal Vascular Endothelial Growth Factor (VEGF) Antibody (Bevacizumab) on Pituitary Function

The purpose of this research is to determine whether the drug, Bevacizumab (a monoclonal anti VEGF-A antibody), which is approved to treat patients with metastatic colon cancer induces hyperprolactinemia (increased prolactin secretion) in humans with intact pituitary function. Past studies have shown Bevacizumab to shrink tumor size and also increase prolactin levels. The mechanism of the hyperprolactinemia might be inhibition of pituitary portal vein transport, suggesting that Bevacizumab induces prolactin secretion from normal lactotrophs in the pituitary gland.

Patients who have been treated with Bevacizumab for at least one month will be recruited to participate.

The subjects who are being treated with Bevacizumab by Dr. Stephen Wolin (a sub-investigator) will be screened by him for study eligibility. Dr. Wolin will approach eligible patients with all the information and background of the study and see if they have an interest in being consented.

If consented, there will be 2 blood draws for the research that is not part of their standard care in which 10 ml of blood is collected and prolactin, growth hormone, IGF-I, TSH, thyroxine, ACTH, and cortisol will be measured. One 5ml blood draw will occur before the administration of Bevacizumab and the second 5 ml blood draw will occur after the administration of the Bevacizumab. The investigators will then review the laboratory results. The blood tests are of the hormones of the pituitary gland to test pituitary function and see if there are any abnormalities with the secretions of the gland. Pituitary function abnormalities and hyperprolactinemia are diagnosed by looking at hormone levels in the blood and comparing them to the normal reference ranges.

This study will only involve 10 subjects and will be conducted entirely at Cedars-Sinai Medical Center.


Eligibility Criteria:
Inclusion Criteria:

* Patients with colorectal cancer, lung cancer, breast cancer, and glioblastoma patients that have been treated with Bevacizumab for at least 1 month
* Adults (18 years of age or older)

Exclusion Criteria:

* Patients who are taking medications known to affect serum prolactin levels
* Patients who are pregnant
* Patients who have pituitary disease
* Minors (Under the age of 18)
HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants

The goal of this clinical trial is to learn how a mixture of human milk oligosaccharides impacts the development of the infant microbiota, the immune maturation and how the interaction between the microbiota and immune maturation may impact both short and long term health of the infant.

The participants will:

* Consume the investigational products (active/placebo) for 6 months
* Legal guardians/parents to the participant to collect stool samples from the diapers at home
* Legal guardians/parents to the participant to report gastrointestinal symptoms, signs of infections in an electronic questionnaire
* Visit the clinic for checkups and dried blood sample collection

For reference, a group of breastfed infants will be included. They will undergo the same procedures apart from consuming the investigational product (active/placebo). 230 participants (115 in each intervention arm) will be randomized to an intervention and 104 participants will be recruited for the reference group, giving a total sample size of 334 participants.

The intervention trial will be reported in two steps, first step covering the intervention phase from birth to 6 months; and step two includes both the intervention phase (0-6 months) and the follow-up period from 6-12 months. Informed consents for the possibility to preform long-term follow-up will be obtained.


Eligibility Criteria:
Inclusion Criteria:

• All infants which parents has decided mode of feeding

Exclusion Criteria:

* Premature birth
Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA

2000 international units (IU) vitamin D, 1 gram (gm) calcium, or both given to children with Juvenile Rheumatoid Arthritis (JRA) may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.

Supplementation With 2000 IU Vitamin D, 1 gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.

Eligibility Criteria:
Inclusion Criteria:

* Juvenile Rheumatoid arthritis

Exclusion Criteria:

* Steroid use
A Study of Pregnenolone in the Treatment of Individuals With Autism

This study will assess the tolerability and effectiveness of pregnenolone in the treatment of behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone found in the body which has been shown to help with the function of nerve cells. It is also shown to modulate the activity of certain brain receptors implicated in autism. We hope to examine the tolerability of pregnenolone in adults with autism.

This study will assess the tolerability and effectiveness of pregnenolone in the treatment of behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone found in the body which has been shown to help with the function of nerve cells. It is also shown to modulate the activity of certain brain receptors implicated in autism.

Pregnenolone has been used safely in research studies involving individuals with schizophrenia. In the proposed trial, we hope to examine the tolerability of pregnenolone in adults with autism. We hope to see improvement in behavioral outcomes as measured by standardized behavioral measures. Further, we will measure concentrations of pregnenolone and related neuroactive compounds in the blood. The use of pregnenolone has been studied in a number of mental disorders but not autism. Thus, we hope the study will identify new avenues of research for the treatment of autism.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatients 18-45 years of age;
2. Males and females who are physically healthy;
3. Diagnosis of autism based on Diagnostic and Statistical Manual (DSM-IV-TR) criteria, the Autism Diagnostic Interview-Revised, and expert clinical evaluation;
4. Total Aberrant Behavior Checklist (ABC) greater then 21;
5. Care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis;
6. Ability of subject to swallow the compound;
7. Stable concomitant medications for at least 2 weeks; and
8. No planned changes in psychosocial interventions during the open-label pregnenolone trial.

Exclusion Criteria:

1. Diagnostic and Statistical Manual (DSM-IV-TR) diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder, not otherwise specified;
2. Prior adequate trial of pregnenolone;
3. Active medical problems: unstable seizures, significant physical illness (e.g., serious liver or renal pathology);
4. Pregnancy or sexually active females (as determined by a urinary pregnancy test in the beginning of the study); and
5. Subjects taking oil or fat based nutritional supplements will be excluded from the study unless they have been off these compounds for at least 4 weeks
Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study

Impulse control disorders (ICDs) (such as pathological gambling, hypersexuality, compulsive shopping ...) are an increasingly recognized psychiatric complications in Parkinson's disease (PD). Therapeutic management of these disorders is important since they have an impact on patient quality of life. Dopamine agonists play a key role in the emergence of ICD.

Animal models and imaging underline the implication of opioid system in the genesis of ICD.

An opioid antagonist, the naltrexone, has been studied to treat ICDs in PD. Papay and al 2014 have found that patients treated by naltrexone showed an interesting decrease of their ICDs measured by the QUIP RScale. Nevertheless, naltrexone has shown adverse effects such as increasing hepatic liver enzymes. Nalmefene has no known hepatic adverse effects. Nalmefene is an opioid antagonist that has an antagonist action on μ and δ receptors, but also an agonist action on κ receptor. Grant and al 2006 has shown significant reduction of the severity of pathological gambling in patients treated with nalmefene.

The primary purpose is to evaluate the efficacy and the safety of nalmefene in the treatment of ICDs in PD.

In this open study, 30 patients with ICDs, will be treated with 18 mg per day of nalmefene during 3 months.

Patients will be evaluated 2 times: at inclusion visit (J0) and 3 months after (at the end of the study, +3months).

At each time, patients will have :

* a clinical and neurological evaluation
* neuropsychological tests for cognitive, depression and TCI evaluations.
* blood sample to test hepatic and renal functions
* tolerance evaluation with a list of adverse events/effects

Patients will be contacted 3 times by phone: 2 weeks after inclusion, 1 month after inclusion and 2 months after inclusion, to note the presence of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patient suffering of Parkinson's disease
* Male or Female aged from 18 to 80 years old
* Diagnosis of ICDs with the Ardouin Scale of Behavior in Parkinson's Disease (ASBPD) with a score of at least 2 on one of the Item of hyperdopaminergic symptoms
* No modification of the treatments for PD since 3 months
* No modification of parameters of deep brain stimulation since 6 months
* Patients who understood and signed the consent form
* Patients having a social security

Exclusion Criteria:

* Contraindication to nalmefene (Patients receiving opioid antalgics, antecedent of opioid dependence, dopamine agonist withdrawal syndrome, opioid consumption, patient receiving methadone or buprenorphine, severe hepatic failure, severe renal failure, antecedent of alcohol withdrawal, galactose intolerance, lactose deficit or glucose malabsorption, pregnant women)
* Cognitive impairment with Mini Mental Score \< 26
* Psychiatric comorbidities (bipolar disease, schizophrenia)
* Patient participating in another therapeutic study
Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

Patients with pancreatic cancer often suffer from chronic abdominal pain, weight loss and decreased quality of life. The patients also often need pancreatic enzyme supplements. In this prospective study the aim is to see whether patients undergoing palliative pancreatic duct drainage will experience less chronic abdominal pain and a higher quality of life than patients with the same diagnosis without the procedure. The study also investigates whether the nutritional state of the patients with palliative stents remains better than in the control group.

In this prospective study all patients have inoperable pancreatic cancer. In these patients the pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm. Patients also suffer from chronic abdominal pain caused by pancreatic cancer. The strength of the pain the patients are experiencing is evaluated with visual analogue scale (VAS). Patients in this study report experiencing chronic abdominal pain at least the strength of VAS 4 at the time of recruitment.

In this pilot study a total of 40 patients are recruited. Patients are divided into to two 20 patient groups. First group will receive a pancreatic duct stent followed by pain medication if needed and the control group will go with conventional pain relief methods only. All patients are asked to evaluate the strength of experienced pain with visual analogue scale at the time of recruitment, and then every 4 weeks up to 24 weeks. The patients will also be asked to evaluate their quality of life with a standardized EORTC-QLQ C30 version 3 quality of life questionnaire at the time of recruitment and then every 4 weeks up to 24 weeks. The patients are also asked to report their body weight, and the amount of pancreatic enzyme supplements needed at every point of survey.

Eligibility Criteria:
Inclusion Criteria:

* Patients have inoperable pancreatic cancer.
* Pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm.
* Patients in this study report experiencing chronic abdominal pain at least the strength of VAS 6 (Visual Analogue Scale) at the time of recruitment.

Exclusion Criteria:

* Patients are not fit enough to undergo ERCP
Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy

The investigators planned to research the effect of vitamin D supplementation on the incidence of contrast-induced nephropathy in patients undergoing coronary angiography.

Vitamin D is primarily generated in the skin, in response to direct absorption of ultraviolet B radiation. Vitamin D can also be obtained through fortified foods and oral supplements. Contrast-induced nephropathy (CIN) is a generally reversible form of acute kidney injury that occurs mostly within 2-3 days of exposure to contrast medium (CM). The estimated incidence of CIN ranges from 2%-50%, and coronary angiography (CAG) or percutaneous coronary intervention (PCI), or both, are associated with CIN in about half of cases. Recently low vitamin D status has been shown to be associated with increased risk of CIN. However, its effects on CIN patients remain unclear. The investigators planned to determine the efficacy of vitamin D on the incidence of contrast-induced nephropathy in patients undergoing coronary angiography. This study may shed light as to whether oral vitamin D supplementation can be an adjunct therapy in CIN patients.

Eligibility Criteria:
Inclusion Criteria:

* The main inclusion criteria were patients who underwent coronary angiography.

Exclusion Criteria:

* The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders.
* Patients were also excluded if they were taking vitamin D3 tablets or other lipid-regulating drugs.