cyrilzakka/clinical-trials huggingface dataset:
IL15 Dendritic Cell Vaccine for Patients With Resected Stage III (A, B or C) or Stage IV Melanoma

The purpose of the study is to gather data on feasibility as well as immune and clinical efficacy of of a dendritic cell vaccine using IL15 in patients with resected stage III or stage IV melanoma

IL15 is a T cell growth factor that pre-clinical data overwhelmingly suggests could have a very important role in cancer immunotherapy. A desirable property for a dendritic cell vaccine directed against cancer is the ability to efficiently prime naïve, tumor associated antigen specific T cells into potent CTLs. Results of studies in healthy volunteers have shown that IL15 DCs are particularly efficient at priming functional melanoma specific CD8+ T cells. The use of IL15 in the manufacture of the DC vaccine could result in an improved immunotherapy product.

Eligibility Criteria:
Inclusion Criteria:

* HLA A201 + phenotype
* Biopsy-proven melanoma, Stages III (A, B and C) or stage IV.- no evidence of disease at study entry
* Age: 21-75 years
* ECOG performance status 0-1
* Adequate marrow function
* Adequate hepatic function
* Adequate renal function
* Written informed consent

Exclusion Criteria:

* Subjects with measureable non-resectable melanoma
* Subjects who have had chemotherapy less than 4 weeks before starting trial
* Subjects who received IFN-a or GM-CSF less than 4 weeks before starting trial
* Subjects who received IL2 less than 4 weeks before starting trial
* Subjects with a baseline LDH greater than 1.1 times the ULN
* Subjects who are HIV positive
* Female subjects who are pregnant
* Subjects who have received corticosteroids or other immunosuppressive agents less than 4 weeks before starting trial
* Subjects who have asthma and/or are on treatment for asthma
* Subjects with angina pectoris
* Subjects with congestive heart failure
* Subjects with history of autoimmune disease including lupus, rheumatoid arthritis or thyroiditis
* Subjects with active infections including viral hepatitis
* Subjects with a history of neoplastic disease othe than melanoma within the last 5 years
* History of neoplastic disease within the last 5 years except for carcinoma in situ of the cervix, superficial bladder cancer or basal/squamous cell carcinoma of the skin.
* Subjects who present with open wounds
Hypercapnia to Prevent Secondary Ischemia in SAH

Delayed cerebral vasospasm and secondary ischemic infarction are feared complications after aneurysmal subarachnoid hemorrhage (aSAH). To date, there is no effective therapy to prevent these ischemic complications. The arterial partial pressure of carbon dioxide (PaCO2) is one of the main determinants of cerebral blood flow (CBF) in healthy subjects. It is yet largely unknown, if and to what extent modulations of PaCO2 can influence CBF in patients after aSAH. The trial is a phase 1 study in which the feasibility of hypercapnia in SAH patients is tested. PaCO2 is gradually raised to 60 mmHg in 10 mechanically ventilated aSAH patients. Cerebral oxygen saturation measured by NIRS and CBF determined by an intracerebral thermodilution probe are the primary end points. If the feasibility is confirmed, this trial will be followed by a phase 2 dose finding study.

The course of aneurysmal subarachnoid hemorrhage (aSAH) is determined by the sequence of several ischemic episodes. Immediately after aSAH, an increase of ICP causes an increase of CBF. It is followed by an acute vasoconstriction over the next hours and days. Typically between day 4 and 10 after aSAH, delayed arterial narrowing and a decrease of CBF occurs in approximately 50 % of aSAH patients and may result in cerebral ischemia and infarction. After the failure of the CONSCIOUS-trial to improve outcome after aSAH, there is no specific treatment in sight to effectively prevent cerebral ischemic events after aSAH. Under physiological conditions, the arterial partial pressure of carbon dioxide (PaCO2) is one of the main determinants of cerebral blood flow (CBF). An elevation of PaCO2 may also be a useful treatment on aSAH patients. This trial is designed as a phase 1 study to test the feasibility of controlled hypercapnia in mechanically ventilated aSAH patients with poor-grade SAH. Monitoring is performed by an external ventricular drainage (ICP), near infrared spectroscopy (tissue oxygenation) and a thermodilution probe (CBF). The latter monitoring tools represent the primary end points of this study. In case of affirmed feasibility, a dose finding study will be launched as a next step.

Eligibility Criteria:
Inclusion Criteria:

* aneurysmal SAH
* SAH Hunt/Hess Grade 3-5
* SAH Fisher Grade 2-4
* Mechanically ventilated
* external ventricular drainage/ICP measurement

Exclusion Criteria:

* Age under 18
* ICP \> 25 mmHg for \> 2 minutes
* pH \< 7.250
Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.

This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 \& 5 months of age, in terms of safety and immunogenicity.


Eligibility Criteria:
Inclusion Criteria:

* A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,
* written informed consent obtained from the parent or guardian of the subject

Exclusion Criteria:

* Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
* Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.
Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

A study to evaluate the safety and efficacy of multiple doses of etokimab in adults with chronic rhinosinusitis with nasal polyps.

This study is a randomized, placebo controlled, double-blind, multi-dose study to assess the efficacy of two different dose regimens of etokimab compared to placebo in adults with moderate-to-severe chronic sinusitis with nasal polyposis (CRSwNP).

During the screening period, all subjects will undergo evaluation for eligibility. A centralized reader will be used to confirm the diagnosis of CRSwNP as assessed by nasal endoscopy, computed tomography (CT) scan of sinuses, and symptom scoring to reduce the risk of interpretation variation.

Participants will also be provided mometasone furoate nasal spray (MFNS) for use during the trial and are required to undergo a minimum run-in period of 20 days prior to Day 1 with approximately 80% compliance.

Participants will be randomly assigned on Day 1 to one of the three treatment arms in a 1:1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed diagnosis of CRSwNP
* Nasal polyp score (NPS) ≥ 4 out of a maximum score for both nostrils (with at least a score of 1 for each nostril).
* 22 Item Sino-Nasal Outcome Test (SNOT-22) score \> 15.
* Presence of at least two of the following symptoms prior to screening: nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell
* Body mass index (BMI) of 18 to 42 kg/m\^2 (inclusive) and total body weight \> 50 kg (110 lb). BMI=weight (kg)/(height \[m\^2\]).

Exclusion Criteria:

* Use of investigational drugs or prohibited therapy for this study within 8 weeks before screening or 5 half-lives, whichever is longer.
* Have experienced severe life threatening anaphylactic reactions.
* Participation in any interventional study for the treatment of CRSwNP in the 3 months before screening.
* If female, is pregnant or lactating, or intend to become pregnant during the study period.
* History (or suspected history) of alcohol or substance abuse.
* Current smokers or former smokers with a smoking history of ≥ 10 pack years. If a patient has less than 10 pack years smoking history, he or she should have quit smoking at least 2 months before screening to enroll in the study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis

The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
* Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
* Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
* Subjects that are on anti-Parkinson's medication must be on a stable dose for 1 month prior to Study Day 1 (Baseline) and during the trial
* Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
* The subject is willing and able to provide consent
* Caregiver is willing and able to accompany the subject to all visits
* Subject and caregiver are willing and able to adequately communicate in English for the purposes of the primary assessment

Exclusion Criteria:

* Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
* Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
* Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
* Subject has had a myocardial infarction in last six months
* Subject has any surgery planned during the screening, treatment or follow-up periods

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).
Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplantation

By doing this study, researchers hope to learn the following:

* The safety of hyperbaric oxygen administration in the setting of the autologous transplant
* The effects of hyperbaric oxygen administration on neutrophil count recovery and engraftment

The post stem cell transplant complications of neutropenic fever and mucositis, related to the chemotherapy and/or radiation on hematopoietic tissue administered prior to peripheral blood stem cell transplant, are reversible upon neutrophil count recovery. The investigators will investigate the use of hyperbaric oxygen as an intervention to shorten neutropenia post-high-dose chemotherapy and autologous peripheral blood stem cell transplant. The idea of using hyperbaric oxygen therapy in autologous stem cell transplantation is based on the investigators pre-clinical work that supported the use of hyperbaric oxygen to improve umbilical cord blood (cluster of differentiation 34) CD34+ stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent
* Subjects with Multiple Myeloma (MM), Hodgkin's Disease (HD), and non-Hodgkins lymphoma (NHL) who are eligible for high-dose chemotherapy and autologous PBSC transplant. Subjects should be enrolled within 30 days of transplant.
* Subjects must be \>/= 18 yrs old and \</= 70 yrs old
* Karnofsky performance status of \>/= 70%
* Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include:

  * ALT (alanine aminotransferase), AST (aspartate aminotransferase): \< 4x IULN (institutional upper limit of normal)
  * Total bilirubin: \</= 2.0 mg/dL
  * Creatinine: \</= 2.0 mg/dL
  * EF (ejection fraction) measured by 2D-ECHO or MUGA (multiple gated acquisition) scan of \>/= 45%
  * FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD(diffusing capacity of lung for carbon monoxide) \>/= 50% of predicted value (corrected to serum hemoglobin)
* Women of child-bearing potential and men with partners of child-bearing potential must use adequate contraception prior to study entry and up to 30 days following treatment.

Exclusion Criteria:

* Pregnant or breast feeding
* Severe chronic obstructive pulmonary disease requiring oxygen supplementation
* History of spontaneous pneumothorax
* Active ear/sinus infection
* Claustrophobia
* HIstory of sinus or ear surgery, excluding myringotomy or ear tubes
* History of seizures
Levels of Daily Physical Activity and Sedentary Behaviour in Maastricht University's Undergraduate First Year Students

This study explores the levels of daily physical activity and sedentary behaviour in Maastricht University's undergraduate first year students. Furthermore, this study explores the correlations between the students' demographical background information with their levels of physical activity and sedentary behaviour.

Participants are randomly recruited from the student population. The participants are invited to complete a demographics questionnaire, wear an ActivPAl accelerometer for 7 days, and complete daily diaries (modified International Physical Activity Questionnaire) throughout the 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Matriculated Maastricht University 2017-2018 First Year Student

Exclusion Criteria:

* Student of Maastricht University's Maastricht Science Programme (MSP) course. This is because the MSP students are undergoing another intervention (i.e., long term use of standing desks) introduced by the same team of researchers.
Safety and Efficacy Study of DAV132 in Healthy Volunteers

The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.

The proposed study, DAV132-CL-1002, is to evaluate performances of DAV132 in healthy volunteers:

* To capture residual concentration of antibiotics in colon without interfering with their systemic pharmacokinetics parameters.
* To explore the influence of DAV132 to prevent the modification of gut flora due to antibiotic.

In addition, the security and acceptability of DAV132 used during 7 days will be evaluated.

The proposed study is prospective, randomized, controlled, four parallel groups, repeated doses, open-label study blinded to analytical and microbiological evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Normal digestive transit, with usually one daily stool.
* Females participating in the study :

must be either of non-child bearing potential (surgically sterilized at least 3 months prior to inclusion, or postmenopausal or having a negative pregnancy test and be not breastfeeding at screening, and using abstinence or a double contraception method during the treatment period and for additional period of 2 weeks after the end of investigational treatment.

* Having given and signed the written study informed consent prior to undertaking any study-related procedure.
* Covered by the French Health Insurance system.

Exclusion Criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness.
* Contra-indications to fluoroquinolones, or risk factors for adverse events associated to fluoroquinolones.
* Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency should be excluded.
* Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should be excluded.
* Contra-indications to DAV132, risk of gastrointestinal obstruction, perforation or haemorrhage, recent digestive tract surgery.
* Fecal colonisation by Clostridium difficile.
* Recent history of hospitalisation (within 3 months prior to inclusion).
* Any antibiotic administration within 3 months before inclusion.
* Any vaccination within the last 28 days.
Precedex Special Investigation (in Pediatric Patients)

Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.

To assess the data, including safety profile, of Precedex Intravenous Solution administered for "sedation during and after mechanical ventilation in the intensive care setting" in pediatric patients under actual medical practice in Japan.

Maruishi Pharmaceutical Co., Ltd. and Pfizer Japan Inc. will collect 50 subjects each.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered this drug for "sedation during and after mechanical ventilation in the intensive care setting.

Exclusion Criteria:

* No exclusion criteria is set out in this study.
ROP Screening: Comparison of Pain Using Two Eyelid Retractors

Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in this population.

Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook eyelid speculum. There is no schedule for who receives which speculum during their exam.

The objective of this study is to evaluate the pain response in the neonatal population, 32 weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for retinopathy of prematurity (ROP) screening.

The primary study aim is to compare the N-PASS pain score between neonates who received a ROP eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.

Retinopathy of prematurity (ROP) is a major cause of blindness in the world. It is a vasoproliferative retinopathy that affects premature and low birth-weight infants. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in this population.

Only two studies alluded to the impact of the eyelid speculum on the pain response and score. Specifically, Hered and Gyland, questioned whether the Alfonso, spring loaded, eyelid lid speculum due to its forceful opening of the eyelid causes more pain. However, no studies were found that included the type of eyelid speculum as a variable of study. In addition, no studies have compared the effect of different eyelid speculums on the pain response.

Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook eyelid speculum. There is no schedule for who receives which speculum during their exam. The investigators team recognizes that the insertion of the eyelid speculum causes a pain response in these infants and would like to determine if there is a difference in the level of that response between the two speculums.

The investigators study will test the difference in pain response when using either a spring loaded eyelid speculum or screw loaded speculum during an ROP exam on premature infants.

The objective of this study is to evaluate the pain response in the neonatal population, 32 weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for retinopathy of prematurity (ROP) screening.

The primary study aim is to compare the N-PASS pain score between neonates who received a ROP eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.

Eligibility Criteria:
Inclusion Criteria:

* Neonates who are born at less than or equal to 32 weeks gestation or are less than or equal to 1500 grams birth weight

Exclusion Criteria:

* Neonates who are paralyzed or have a negative pain score
* Neonates undergoing an Avastin injection
* Neonates undergoing a Retcam exam
* Neonates transferred to another unit
Role of LIDOCAINE IN Pediatric Cochlear Implant Surgery

The stapedius reflex protects the ear from the loud noise. The measurement of the intraoperative electrically evoked stapedial reflex threshold (ESRT) during pediatric cochlear implants (CIs) is used to confirm that the implant is functioning correctly and determine the maximum comfortable level . Total intravenous anesthesia (TIVA) with propofol and remifentanil is frequently used for pediatric CIs as it does not suppress the ESRT. However, high doses of remifentanil exacerbates postoperative pain and increased opioid consumption.

Total intravenous anesthesia (TIVA) with propofol and remifentanil is frequently used for pediatric CIs as it does not suppress the ESRT. However, high doses of remifentanil exacerbates postoperative pain and increased opioid consumption.

Eligibility Criteria:
Inclusion Criteria:

ASA I and II children

Exclusion Criteria:

uncontrolled hypertension, diabetes mellitus, liver disease, kidney disease, heart disease, allergy to lidocaine
Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear

Headache is a very frequent symptom among the world population, the adult population with an active headache disorder are 46% for headache in general, 11% for migraine, 42% for tension-type headache and 3% for chronic daily headache. There are different therapeutic approaches for the improvement of headache. Transcutaneous stimulation of the auricular vagal nerve is being used for the treatment of headache due to the involvement of the vagus nerve in inflammation and pain modulation. On the other hand, galvanic current has shown a measurable effect by increasing parasympathetic activity. The objective of this clinical trial is to stimulate the auricular vagal nerve with galvanic current using a needle as an electrode that will be inserted into the concha of the ear. As a tool for measuring results, infrared thermography will be used to observe changes in facial skin temperature, since patients with high sympathetic activity present a characteristic pattern of "cold nose" and/or "cold patch". In addition, variables that record changes in autonomic activity such as skin conductance and heart rate variability will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Headache with a frequency of at least one monthly episode.
* Present the "cold nose" and/or "cold patch" pattern

Exclusion Criteria:

* Do not present a "cold nose" and/or "cold patch" pattern
* Pregnant women
* Subjects with facial alterations that may affect facial vascularization (sinusitis, allergies...)
* Patients with belonephobia or allergy to metals or any material used in the procedure.