cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of CRS-207 With Pembrolizumab in Gastric, Gastroesophageal Junction or Esophageal Cancers

The purpose of this study is to determine whether CRS-207 in combination with pembrolizumab is safe and effective in adults with recurrent or metastatic gastric, gastroesophageal junction, or esophageal cancer who have received one or two prior chemotherapy regimens for advanced disease.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis with confirmed histology of one or more of the following:

   * Histologically-confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma (Siewert type II/III classification), or
   * Histologically-confirmed inoperable superior, medial, or distal third esophageal adenocarcinoma (Siewert type I classification may be included, provided there is no mixed histology)
2. Confirmed recurrent or metastatic disease
3. Received and experienced disease progression on, or following one or two prior chemotherapy regimens for advanced disease.
4. HER-2/neu negative or, if HER-2/neu positive, disease must have previously progressed on treatment with trastuzumab; prior treatment must have included a platinum and a fluoropyrimidine.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Can provide tissue for PD-L1 and mesothelin biomarker analysis
7. Adequate organ and marrow function at screening

Exclusion Criteria:

1. Diagnosis of squamous or undifferentiated gastric cancer
2. Individuals with inaccessible tumors or for whom biopsy is contraindicated
3. Participated in any other study in which receipt of an investigational new drug or investigational device occurred within 28 days of first dose of study drug
4. Receiving tumor necrosis factor (TNF) pathway inhibitors, PI3 kinase inhibitors, systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
5. Clinical evidence of ascites by physical exam
6. Prior anti-cancer monoclonal antibody within 4 weeks prior to first dose of study drug or has not recovered from adverse effects due to agents administered more than 4 weeks earlier
7. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study drug, or has not recovered from adverse effects due to a previously-administered agent
8. Subjects who have implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g. artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)) if infection occurs. Other common devices such as venous access devices (e.g. Port-a-Cath or Mediport) may be permitted as well as arterial and venous stents and dental and breast implants that were placed more than 3 months prior to first dose of study drug.
Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease

The aim of this study is to evaluate macrophaging activity and immunologic profile of patients with Gaucher 's disease. For this, one blood sampling will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age equal or above 18.
* Patients with Gaucher 's disease treated in the "Grand Ouest" competence center
* patients affiliated to social security
* Informed consent signed

Exclusion Criteria:

- Children (age\<18)
Natalizumab Treatment of Progressive Multiple Sclerosis

The purpose of this study is to study safety and efficacy of natalizumab treatment of primary and secondary progressive multiple sclerosis.

This will be done by measuring the effect of treatment on inflammation in the CNS by means of osteopontin levels in the cerebrospinal fluid (CSF). Safety measures further includes physical and neurological examination,blood samples and MRI measures of disease activity.

The study will include 12 secondary progressive multiple sclerosis patients and 12 primary progressive multiple sclerosis patients to treatment with IV natalizumab for 60 weeks. At baseline and week 60 a lumbar puncture will be performed. MRI scans will be performed at baseline week 12 and week 60.Safety blood samples will be collected every 12 week.

Eligibility Criteria:
Inclusion Criteria:

* Age between 19 and 55 years
* Progressive disease course of multiple sclerosis (primary or secondary)
* Duration of progressive phase of at least 1 year
* Progression of \> 1 EDSS point during the last 2 years (\>½ EDSS point if EDSS \> 5,5)
* EDSS \</= 6.5
* Written and informed consent

Exclusion Criteria:

* Pregnancy, breast-feeding or lack of anti.conception for fertile women.
* Attack during the last month before inclusion.
* Treatment with methylprednisolone during 3 months before inclusion.
* Treatment with interferon-beta, glatirameracetate, immunoglobulin G or other immune-modulating treatment 3 months prior to inclusion.
* Treatment with mitoxantrone, cyclophosphamide, azathioprine or other strong immunosuppressive drug 6 months prior to inclusion.
* Prior experimental treatment with strong immunosuppressive drug which the treating physician means will influence the results of the trial.
* Diseases associated with immunodeficiency.
* Treatment with other anticoagulant than aspirin.
* Current malign disease.
* Diabetes Mellitus or other autoimmune disease.
* Renal insufficiency or creatinine \> 150 μmol/l.
* Travel in tropical areas 3 months prior to inclusion.
* Acute or chronic infectious diseases, which the treating physician finds relevant (e.g.hepatitis B virus, hepatitis C virus, HIV).
* Psychiatric disease or other circumstances that may limit the patients participation in the trial.
* Contraindication for MRI scan or gadolinium contrast .
* Known hypersensitivity to natalizumab.
IMPACT (Improving Plasma Collection) Clinical Trial

Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.

Prospective, multi-center, randomized, controlled clinical trial that will be conducted at three source plasma collection centers throughout the United States. The objective of the trial is to study the safety and effectiveness of a novel plasma collection nomogram run on the bi-directionally integrated Haemonetics NexSys PCS® and Haemonetics NexLynk DMS® plasma collection system. Subjects will be randomized into an intervention and control arm. The control arm will donate plasma using the current software. The intervention arm will donate plasma using a novel software that supports a more individualized collection approach.

Eligibility Criteria:
Inclusion Criteria:

* Donors must be qualified to donate plasma per individual site's screening procedures which are in compliance with IQPP standards. If donors do not meet inclusion criteria at subsequent donations but have already been enrolled in the clinical trial, they are eligible to remain in the clinical trial and to donate plasma within the clinical trial once they meet eligibility criteria again, except if they fulfill any of the exclusion criteria listed below.

Exclusion Criteria:

* All subjects meeting any of the exclusion criteria listed below will be permanently excluded from the clinical trial.

  * Subject not able or willing to give consent to participate in the clinical trial.
  * Subject donated plasma outside of the present clinical trial after enrolling in this clinical trial.
  * Subjects are withdrawn from the clinical trial due to safety concerns by the qualified healthcare providers.
  * In addition, all donors for whom a BMI for use in the PPN feature cannot be reliably calculated will be excluded
Pediatric Parenting Support in Flint

Public health disasters have disproportionate impacts on low income communities, through pathways that add to those of poverty and associated stressors, and act over extended periods. Very young children are highly vulnerable to long-term impacts on development and mental health in the context of parenting challenges following disasters, yet frequently receive the least attention and resources. This study will test the role of universal parenting support in enhancing young children's development and mental health in Flint, Michigan following the Flint Water Crisis.

There are three specific aims of this study: Specific Aim 1: Characterize participants' experience of the FWC using ecological (neighborhood-level), geocoded STYH data, ecological indicators of water quality and parent self-report measures. These metrics will be obtained from Speak to Your Health (STYH) survey, a biennial community survey including neighborhood-level measures of stress collected before, during and after the FWC. Specific Aim 2: Assess impacts of strengths-based parenting support (VIP) after a disaster compounding chronic poverty (FWC). Specific Aim 3: Assess variation in VIP impacts in relation to FWC experience.

Eligibility Criteria:
Inclusion Criteria:

* Infant is receiving pediatric care at Hurley Children's Clinic
* Caregiver can be contacted (has a working phone)
* Infant is three months old or younger at time of enrollment

Exclusion Criteria:

* Infant very low birth weight (\<1500gm)
* Infant born in non-singleton birth (twin, triplet, etc.)
* Infant has known or suspected significant genetic syndrome or malformation
* Infant has other significant medical or developmental complication or risk (e.g., known neurodevelopmental/neuromuscular disorder likely to affect development)
* Parent/legal guardian not present with infant at visit and/or unable to provide consent
* Parent/legal guardian is not English speaking
* Parent/legal guardian with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia)
* Parent/legal guardian has previously participated in VIP intervention with another child
* Not planning to stay in Flint area for at least 3 years
Comparison of Maternal and Neonatal Vitamin D Levels in Term Neonates With and Without Early Onset Sepsis

Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life which is still an important cause of morbidity and mortality. Vitamin D is a fat-soluble steroid hormone that primarily contributes to the maintenance of normal calcium homeostasis and skeletal mineralization. In addition to its classical role in bone metabolism, vitamin D also has immunomodulatory effects on immune function. Although some studies reported a link between vitamin D deficiency and critical illness in adults, a direct relationship has not been directly shown yet. However, to the best of our knowledge, no study evaluated the association between EOS and maternal/neonatal vitamin D levels. The objective of this prospective study is to determine the possible role of maternal and neonatal plasma vitamin D levels on EOS development in term infants. We also aim to evaluate possible effect of the severity of vitamin D deficiency on EOS development in the study population.

Term infants with clinical and laboratory findings of early onset sepsis who are \>37 weeks of gestational age and will be admitted to Neonatal Care Unit of Kanuni Sultan Suleyman Training and Research Hospital will be included in this prospective study. The study group will consist of term neonates who are clinically suspected to have an early infection from the 1st day of life. Blood for neonatal and maternal vitamin D levels will be obtained from all infants and their mothers at the time of hospital admission. Only infants with high probable sepsis will consist the study group. The healthy infants who admit to our outpatient clinic for routine evaluation at postnatal day 3 with no signs of clinical and laboratory infection and are evaluated for hyperbilirubinemia will be referred to as the Control group. The Control group wll consist term infants with the same gestational and postnatal age of the infants that will be included in the study group. In both groups, maternal samples will be obtained at the postpartum period at the time of infant's hospitalization. Plasmas after separated and stored at -800C. Levels of 25-OHD were determined using Shimadzu LC-20AT model High Performance Liquid Chromatography (HPLC) system. Data will be analyzed using SPSS software and appropriate statistical analyses will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Infants \>37 weeks of gestational age and are admitted to Neonatal Care Unit of Kanuni Sultan Suleyman Training and Research Hospital
* Infants with clinical and laboratory findings of early neonatal sepsis
* Term infants without sepsis as the control group

Exclusion Criteria:

* presence of maternal clinical and/or histological chorioamnionitis,
* presence of premature rupture of membranes (PROM),
* infants with probable or possible sepsis according to criteria,
* refusal of parental consent,
* lack of laboratory data,
* major congenital abnormalities
The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy

This is a pilot study to estimate the efficacy of infliximab in inducing and maintaining healing of lesions in the mucosa of subjects with Crohn's disease involving their small bowel.

Landmark trials in Crohn's disease demonstrated the efficacy of infliximab in inducing and maintaining clinical remission. Furthermore, the endoscopic sub-studies within these trials demonstrated the ability of infliximab to rapidly induce and maintain mucosal healing as evidenced by the complete absence of mucosal breaks in the colon and terminal ileum. Unfortunately, conventional colonoscopy does not allow intestinal exploration beyond a very restricted portion of the small bowel (at most 10-15 cm of the terminal ileum). A study that systematically examines the changes in the small bowel mucosa during Crohn's disease symptomatic improvement is clearly needed.

This study consists of 20 subjects and 30 weeks of follow up. All subjects will undergo wireless camera endoscopy at three (3) visits, namely: at Screening, at Week 10 and at Week 26. Infliximab is administered at (5) visits, namely: at Baseline (week 0), Week 2, Week 6, Week 14 and Week 22. In some subjects, an ileal-colonoscopy may be performed at Week 26.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* Established diagnosis of Crohn's disease and evidence of small bowel involvement
* CDAI score between 220 and 450 inclusively
* Lewis score of at least 790 at Screening
* Colonoscopy within the last 6 months
* Successful excretion of the intact patency capsule Exclusion Criteria
* Contraindications to anti-TNF therapy (TB, cardiac impairment, etc.)
* Prior bowel resection
* Prior anti-TNF exposure
Powered Echelon Device in VATS Surgery

This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).

The European prospective observational multi-center cohort study aims to collect real-world outcomes of consecutive patients scheduled for VATS lobectomy for histologically confirmed Non-Small Cell Lung Cancer (NSCLC) or scheduled for VATS wedge resection for undiagnosed pulmonary nodule or metastasis from colorectal cancer (CRC) in accordance with their institution's Standard-of-care (SOC).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed NSCLC (up to and including Stage II) for patients undergoing VATS lobectomy. For patients undergoing wedge resection for undiagnosed pulmonary nodule or metastasis from CRC, a malignant diagnosis may be confirmed post-operatively.
* Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung
* Willing to give consent and comply with evaluation and treatment schedule
* At least 18 years of age

Exclusion Criteria:

* Active bacterial infection or fungal infection
* Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure)
* Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure
* Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
* Prior history of VATS or open lung surgery
Investigation of Neurocognitive Measures of Sport-Related Injury

The overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. The central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.


Eligibility Criteria:
Inclusion Criteria:

* 12-30 year old competitive or recreational athletes

Exclusion Criteria:

* Pre-existing condition preventing the ability to perform neck range of motion or a neck strength assessment
* Recent exposure to head lice
* Known or suspected pregnancy
Comparison of TAP (Transversus Abdominis Plane) and Ilioinguinal/Iliohypogastric Nerve Block for Analgesia of Open Inguinal Herniorrhaphy

TAP was recommended by PROSPECT for further investigation as an appropriate analgesic method after open herniorrhaphy. Ilioinguinal/iliohypogastric nerve block is one of the oldest methods of analgesia. The researchers wish to investigate whether the TAP block is as effective as the ilioinguinal/iliohypogastric nerve block?


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective primary unilateral open tension-free mesh inguinal hernia repair

Exclusion Criteria:

* Inability to consent to the study
* BMI more than 40
* Skin infection near injection site
* Chronic hepatic or renal failure
* Peripheral neuropathy
* Proven opioid dependency
* Coagulopathy
* Thrombocytopenia
* Dementia
* Lack of orientation
* Impossibility to understand VAS
* Patients suffering from chronic pain
Smart Catheter: A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection

Urinary Tract Infection (UTI) is the most common hospital acquired infection worldwide, and is most commonly associated with catheterisation of the bladder. Catheter associated urinary tract infection (CAUTI) causes increased hospital costs, increased length of stay and increased mortality. This burden of disease is, in part, mediated by a lack of diagnostic and monitoring modalities for CAUTI. Both traditional and novel UTI diagnostic tests are susceptible to false positives associated with bacterial colonisation, and correlate poorly with clinically meaningful symptomatic CAUTI. As such, the current standard of care is reliant on clinical monitoring, which is susceptible to diagnostic delays, over and under treatment.

Imperial College London have developed a wireless biosensor for continuous monitoring of catheter-urine biochemistry. This project aims to validate this biosensor and demonstrate it's potential for preemptive CAUTI diagnosis through continuous urinary biochemical monitoring.

This research project aims to demonstrate that continuous urinary biochemical monitoring using a Smart Catheter biosensor can provide rapid diagnosis of impending catheter associated urinary tract infection (CAUTI). The primary research question will then be: "Does the Smart Catheter device reduce the time to diagnosis of CAUTI?"

This will be accomplished through four studies: The aim of the first study will be to show the reliability and robustness of the Smart Catheter device through the question: "Is there any difference between the biochemical measurements from the Smart catheter device and a gold-standard laboratory measurement?"

The aim of the second and third studies aim to demonstrate the different biochemical profiles of infected and healthy urine by addressing the research question: "What is the difference in biochemical concentrations in healthy urine as compared to infected urine?" Study 3 will accomplish this by comparing infected human catheter-acquired urine as compared to uninfected human catheter-urine. Study 3 will monitor the changes in biochemical changes in an artifical bladder with artificial urine over time while an infection is induced.

The final study will demonstrate the reduced time to diagnosis in a clinical setting by addressing the research question: " What is the time difference in diagnosis of CAUTI from the CAUTI as compared to the current standard of clinical monitoring?"

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older Subjects expected to undergo catheterisation as part of their clinical care. Signed informed consent is a prerequisite for inclusion in the study.

Exclusion Criteria:

* Consent to participate not given Known sensitivity to urinary catheters or electronic products Patients undergoing urologic procedures
Follow up for Patients With Thyroid Cancer Planed for Radioiodine Scan or Treatment

The prevalence of thyroid cancer has increased in recent decades. Patients with thyroid cancer need to choose between Thyrogen® injection and Eltroxin® withdrawal before radioiodine therapy or scan. This is a prospective, observational study, aiming to observe the difference of metabolic profiles between patients choose Thyrogen® injection and Eltroxin® withdrawal.

1. Objective： To observe the difference between Thyogen® injection or Eltroxin® withdrawal on metabolic profile.
2. Background and method:： The prevalence of thyroid cancer has increased in recent decades. Patients with thyroid cancer need to choose between Thyrogen® injection and Eltroxin® withdrawal before radioiodine therapy or scan. This is a prospective, observational study, aiming to observe the difference of metabolic profiles between patients choose Thyrogen® injection and Eltroxin® withdrawal.

Inclusion ： Patient number: 500人

Inclusion criteria :

1. Patients with diagnosis of thyroid cancer。
2. Patients who need radioiodine therapy or scan。

Exclusion criteria:

1. Patients cannot cooperate with blood test.。
2. Patients cannot cooperate with radioiodine therapy。 Study design： Prospective, observational study。

Method： We will collect 20cc blood and 20 cc urine before and after radioiodine therapy during each visit (total 3 visits) and check lipid profiles, glucose profiles and inflammation markers. We will compare the difference between results of patients undergoing Thyrogen® injection and Eltroxin® withdrawal.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with diagnosis of thyroid cancer。
2. Patients who need radioiodine therapy or scan。

Exclusion Criteria:

1. Patients cannot cooperate with blood test.。
2. Patients cannot cooperate with radioiodine therapy。