cyrilzakka/clinical-trials huggingface dataset:
Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients with Advanced Colorectal Cancer

This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) for treatment of patients with Advanced Colorectal Cancer,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
2. Age 18 to 70 years old;
3. Advanced Colorectal Cancer that progresses after first-line chemotherapy；
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
5. Expected survival time of ≥ 12 weeks;
6. Good function of vital organs;
7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

1. Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
2. Known mental illness, alcoholism, drug use or substance abuse;
3. Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
4. Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
5. The investigators determine that other conditions that make the patient not suitable for enrollment
Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis

This is a Phase I/II, multi-center, open-label proof-of-concept study of vamorolone. Twenty participants with a flare of mild or moderately active Ulcerative Colitis (defined as a Pediatric Ulcerative Colitis Activity Index \[PUCAI\] 10-60) will be enrolled and receive vamorolone 6 mg/kg/day orally once daily for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent/Health Insurance Portability and Accountability Act (HIPAA) authorization prior to any study-related procedures;
* Subject has current mild to moderately active ulcerative colitis, defined as a PUCAI score of 10-60.
* Subject is ≥ 4 years old and \<18 years old at the time of enrollment.
* Subject has had 1) a colonoscopy demonstrating endoscopic and histologic inflammation, and/or; 2) a fecal calprotectin \> 250 mcg/g, in the preceding 1 month.
* Subject is willing and able to comply with scheduled visits, study drug administration plan, and study procedures.
* Subject has not started a new immunomodulator or biologic in the preceding 2 months.
* If subject is taking an immunomodulator and/or biologic, the dose has not been changed in the last 2 months
* Subject has a positive varicella IgG titer, or history of at least 2 documented varicella vaccines

Exclusion Criteria:

* Subject is currently being treated or has received previous treatment with oral or rectal glucocorticoids (including budesonide) in the past month
* Subject has an allergy or hypersensitivity to the study medication or to any of its constituents
* Subject has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow-up will be correctly completed or impair the assessment of study results, in the opinion of the Investigator
* Subject is taking any other investigational drug currently or has taken any other investigational drug within 3 months prior to the start of study treatment
* Clinically significant abnormal biochemical and hematological parameters, including:

  * Neutrophil count \< 1000 cells/mm3
  * Platelet count ≤ 130 cells/mm3
  * Creatinine ≥ 1.2 x the upper limit of normal
  * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2x the upper limit of normal
  * Conjugated bilirubin greater than 1.2. mg/dL
* Has active infection with enteric pathogens (including C. difficile)
* Has a positive PPD, Quantiferon Gold, or Interferon-gamma assay
* Is pregnant or breast-feeding
Recycling Potential in Endoscopy - a Multicentre Prospective Observational Study

The present trial is an observational prospective trial. The aim of the present study is to analyse the recycling potential in endoscopy units in hospitals and outpatient facilities. For this purpose, waste is collected for four weeks each at four locations (two inpatient and two outpatient facilities). Questions such as quantity and quality of garbage will be addressed and compared between the different facilities.

Current considerations by various professional societies are developing theoretical concepts with the goal of greenhouse-neutral endoscopy operation. However, the scientific data situation here is expandable. One study calculated an extrapolation for the US based on the mean value of weight and volume of a total of 278 endoscopies in five days at two hospitals. However, a differentiated consideration of various parameters such as examination type and the location of the endoscopy (outpatient vs. inpatient) was missing here.

In different endoscopic departments waste will be weighed. Those are two hospitals (university and non-university) and two outpatient endoscopy units, each for four weeks. The waste will be divided into residual waste, paper and plastic in order to record the possible recycling potential. In addition, it will be investigated how great the savings potential is by avoiding disposable products (gowns, endoscopes).

The present study addresses the following end points:

* Parts of waste per examination in g (residual waste, plastic, paper).
* Savings potential through reusable items (e.g. gowns)
* Comparison of disposable vs. reusable endoscopes
* Descriptive description of the amount of waste at the different locations
* Statistical comparison of the amount of waste in the different locations
* Statistical comparison of the amount of waste per examination
* Statistical comparison of the amount of waste between out-patient and in-patient

Eligibility Criteria:
Inclusion Criteria:

* Endoscopic examination (gastroscopy, colonoscopy, combined gastro and colonoscopy, ERCP, EUS, bronchoscopy)
* Type of examination (interventional vs diagnostic)
* Known multi-resistant germs (yes vs no)

Exclusion Criteria:

none
Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury

The goal of this pilot clinical trial is to find out how well low dose naltrexone works for people with pain due to spinal cord injury. The main questions it aims to answer are: will low dose naltrexone reduce pain, and increase the quality of life for people with central neuropathic pain due to spinal cord injury.

Hypothesis 1: LDN will decrease the severity of CNP in adult patients with SCI as measured by the Neuropathic Pain Scale (NPS) Hypothesis 2: LDN will improve quality of life of patients with SCI as measured by various validated clinical tools

There is no comparison group. This study is being completed to give investigators more information for how to best run a larger clinical trial.

Participants will be asked to take an oral dose of 4.5mg of naltrexone, daily, for 12 weeks.

This study is being completed to provide the first evidence that low dose naltrexone may be able to lower pain and improve quality of life for people with pain due to spinal cord injury. Data from this study will be used to plan a larger, randomized control trial. If eligible, participants will take a daily low dose naltrexone pill (4.5mg) by mouth for 12 weeks. Study participants will keep a daily medicine log and a daily sleep log. The study team will check in regularly (virtual visits) with the participants and give questionnaires verbally.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of a traumatic cervical or thoracic spinal cord injury
2. Age ≥18
3. \>6 months from time of injury
4. Central neuropathic pain related to SCI, based on evaluation of a Physical Medicine \& Rehabilitation Physician
5. DN4 questionnaire ≥ 4
6. English speaking

Exclusion Criteria:

1. Adjustment in pain medications within the previous month
2. Chronic opioid treatment
3. Current treatment with naltrexone or other opioid antagonist
4. Allergy to naltrexone
5. Central neuropathic pain attributed to other etiology
6. Neuropathic pain attributed to the peripheral nervous system
7. PHQ9 ≥15 indicating moderately severe or severe depressive symptoms
8. Documented traumatic brain injury that would affect study participation, in the opinion of the investigator
9. Scheduled elective surgery during the duration of the study
10. Pregnant or breastfeeding
11. Illicit substance use per Wisconsin law
Understanding and Appraising the New Medicine Service in England

About 25% medicines prescribed for long term conditions are not taken as directed, and approximately 15% people receiving a new medicine take few, if any, doses. The New Medicine Service (NMS) is a community pharmacy service that started in England in October 2011 which involves the pharmacist providing additional support to patients starting a new medicine for some breathing problems (asthma \& COPD), high blood pressure, adult onset diabetes or medicines which reduce blood clotting. It aims to improve the way patients take their medicines improving outcomes and reducing costs to the National Health Service (NHS).

The investigators will assess the effectiveness and cost effectiveness of the NMS using a research study where some people will receive the NMS, and some won't, so The investigators can look at the effect of the NMS on problems with their medicines, medicines taking and use of the NHS in general. Data will be collected in the East Midlands, South Yorkshire and London areas.

The investigators will recruit 500 patients from a range of different pharmacies and follow them up at six, ten and twenty six weeks after starting their new medicine to assess effects on medicines taking behaviour, patients' reported problems with medicines, referrals to their General Practitioner (GP) and use of NHS resources. The investigators will compare the data gathered from this study with that being collected routinely by all pharmacies in England to provide wider estimates of cost effectiveness.

The investigators will also explore how the NMS service is being implemented by pharmacies. A sample of patients from the main study will be followed in more detail. This will involve recording the consultations with the pharmacist and also interviewing patients about their experience of the service. The investigators will interview the patients GP to investigate their views of the service. The investigators will also try to understand why people decline the invitation for the NMS


Eligibility Criteria:
Inclusion Criteria:

* Community dwelling patients eligible for NMS (aged from 14 years starting a new medicine for asthma/COPD, diabetes (Type 2), antiplatelet/anticoagulation or hypertension).

Exclusion Criteria:

* Patients collecting a repeat prescription for a medicine (i.e. not new) for asthma/COPD, type 2 diabetes mellitus (T2DM), antiplatelets/anticoagulants or hypertension
* Patients collecting a medicine where the only change from the previous medicine involves a dosage or formulation change only
* Participants who are unable to understand patient/participant study documents
* Participants who are unable and unwilling to provide written consent / assent
What Embryoselection for What Chance of Success ? EmbryoSelect Study

The aim of the research is to evaluate the results of the first in vitro fertilization (IVF) attempt according to the type of embryo culture. From the fertilization to the day 2 transfer, embryos are cultured in standard incubator or in a time lapse technology (TLT). TLT offers an uninterrupted culture environment with a morphokinetic evaluation, whereas culture in standard incubator involves discontinuous morphological embryo evaluation. The principal objective is to compare the live birth rate after the fresh embryo transfer, in a cohort of women less than 39 years-old.

Embryo evaluation and selection is fundamental in clinical IVF in order to obtain a live birth in a shorter delay as possible, but minimizing the risk of multiple pregnancies. TLT was introduced few years ago in clinical practice and allows the continuous follow up of the embryo development. In IVF centers, embryos are preferentially cultured in TL system with undisturbed environmental conditions. This provides information about the development of the embryos in time intervals of 15min and adds kinetic criteria for embryo evaluation and selection. In conventional incubator, the follow up of embryo development consists in 3 static time point observations. Many reviews and observational studies have discussed the value of time-lapse monitoring but it is as yet unclear, however, whether the TLT improves the results of IVF. It has been suggested that the clinical benefits of applying new technologies should be verified and documented by randomized controlled trials. Moreover, the cumulative live birth rate and the delay for conception were rarely reported. The study aims to evaluate the results of the first IVF attempts comparing classical embryo culture in standard incubator and embryo culture and follow up in TLT. The hypothesis is that the undisturbed culture and the selection based on continuous time-lapse images improve the results of the single embryo fresh transfer and increase the cumulative live birth rate. Patients will be randomized the day of the puncture for the type of culture: standard incubation or TLT. The results of the fresh and successive vitrified-warmed embryo transfer will be prospectively collect and patients will be followed until live birth. The attempt will be considered ended after a live birth, if all the frozen embryos are transferred, after 24 months follow up or after surrender.

Eligibility Criteria:
Inclusion Criteria:

* first IVF/ICSI attempt with fresh transfer,
* women ≥18 years-old and \<39 years-old,
* signed informed consent

Exclusion Criteria:

* attempts with donor,
* comprehension problem,
* frozen gametes,
* BMI\>35 kg/m2,
* history of 3 or more miscarriages,
* uterine pathology,
* serodiscordant patients
Oocyte Cryopreservation

The purpose of this investigation is to offer the opportunity for young women to cryopreserve (freeze) their oocytes (eggs) for use with IVF at a later point in time.


Eligibility Criteria:
Inclusion Criteria:

* women between the ages of 18 and 42
* election to preserve fertility by freezing eggs

Exclusion Criteria:

* women over the age of 43
* patient unwilling to sign informed consent
Hospital-based Surveillance of Rotavirus Gastroenteritis in Young Taiwanese Children

Rotavirus remains among the leading causes of pediatric gastroenteritis requiring hospitalization in the world. Surveillance studies revealed that more than 90% of the global circulating rotavirus strains were predominated by several major genotypes. Clinical trials and post-marketing studies have demonstrated that the currently available rotavirus vaccine can provide sufficient protection against strains of the prevalent genotypes. However, the emerging strains with new genotypes were increasingly reported in the past decade, an ongoing surveillance of the strain changes is needed in the regions where the pediatric population is either fully or partly immunized. In this project, the investigators will setup a hospital-based gastroenteritis surveillance network by incorporating 8 major hospitals in northern, central, southern and eastern Taiwan. From 2013 to 2015, children aged 5 years or younger hospitalized to one of the 8 sentinel hospitals due to acute gastroenteritis will be screened for rotavirus infection, and viral proteins 7 \[VP7\] (G type) and viral proteins 4 \[VP4\] (P type) genotypes of rotavirus will be determined for each infected case. The demographics and clinical manifestations of study subjects will also be collected and analyzed. Through this project, the investigators will be able to detect emerging genotypes of rotavirus and delineate the strain distribution during the two years of study in Taiwan. The investigators can also have more comprehensive understanding of the epidemiology of rotavirus regarding to the incidence, disease characteristics, temporal and geographic variations of severe rotavirus gastroenteritis in Taiwanese children. Results from this project will provide valuable information for future implementation of mass immunization against rotavirus in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* aged less than 60 months,
* hospitalized in 1 of the 8 hospitals,
* having diarrhea not caused by any known underlying diseases.

Exclusion Criteria:

* No
Cone-beam vs Multidetector Computed Tomography (CT) for Arthrography of the Wrist, Ankle, Elbow and Knee

ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging. Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for an analysis of the limbs distal joints. Our hypothesis is that the cone-beam scanner could detect and characterize chondral lesions the cartilage similarly to a multidetector CT (MDCT). 100 patients over 18 years requiring arthroscanner of the wrist, ankle, elbow or knee will be enrolled The primary endpoint based on the ability of cone-beam scanner to detect cartilage lesions. Secondary endpoints will concern the depiction of the joint lesions, quality of the images, tolerability of the exams and inter- intra-operator reproducibility. After arthrography, patients will have a MDCT considered as the reference exam, and a CBCT on a randomized order. Exams will be anonymized and read twice by two trained radiologists with 3-6 week intervals. The inter-observer agreement for the diagnosis of cartilage lesion type between the two techniques will be evaluated by a kappa coefficient. The evaluation of diagnostic performance will be achieved by studying the sensitivity, specificity, negative predictive value and positive predictive value, and its likelihood ratio. Kappa test will be performed to evaluate the consistency of the depiction of the lesions. A Student t test will be performed for paired data if distributions are normal, a Wilcoxon test if not. To assess patient's tolerance, the percentages of (painful, not painful) will be calculated for each technique and will be compared using the Chi2 test (or Fisher's exact test if the chi can not apply).


Eligibility Criteria:
Inclusion Criteria:

* Patient age 18 years old or above, weight ≤ 160 Kg
* Patient require knee or ankle or elbow or wrist arthroscanner
* French spoken an read
* Free and informed consent signed
* Being affiliated to a French social security system or similar.

Exclusion Criteria:

* Patients already included in the ARCOBE study
* Patient with severe pain and reduced spontaneous mobility that could prevent proper positioning for the cone-beam
* Lack of effective contraception (risk of pregnancy) or pregnancy proven data on interrogations
* Patient on protection of the court, under supervision or trusteeship
* Inability to express a consent
* Patients already enrolled in a study with a conflict of interest with this study.
Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease

The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry.

The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry. The investigators' hypothesis is that repeated oral dosing of NAC will result in increased brain and red blood cell GSH concentrations in individuals with Parkinson's disease (PD) and healthy controls. The specific aims are to 1.) measure plasma and blood (red blood cell) glutathione (GSH) and ratio of reduced GSH to oxidized glutathione (GSSG) in individuals with PD and healthy controls at baseline and after four weeks of repeated high doses of oral NAC (6000 mg/day) and 2) measure cortical GSH levels (as ascertained through MRS) in those with PD and healthy controls at baseline and four weeks during repeated high doses of oral NAC (6000 mg/day) simultaneously with Aim 1. This study will combine information from a medical history, a physical examination, and disease rating scales with results obtained using Magnetic Resonance Spectroscopy (MRS) brain scans and pharmacokinetic studies from blood samples. This research will require 2 visits, one at baseline and one after approximately 28 days of therapy. Participants will provide their medical history during the first visit, and undergo a physical examination and rating scale each visit (duration: 1 hour). The first visit including the brain scans and blood collection will require approximately 3 hours of time. The brain scan and pharmacokinetic studies for the second visit will require approximately 8 hours of time. In total the second visit will take roughly 9 hours.

Eligibility Criteria:
Inclusion Criteria:

1. All participants must be 18 years or older
2. All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent
3. Individuals with medically stable Parkinson's disease (in the opinion of the investigator)
4. All participants must not have taken antioxidants NAC, glutathione, coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study
5. Absence of dementia in all subjects

Exclusion Criteria:

1. Inability to undergo MRI scanning without sedation and other MRI counterindications, such as metal in the body (see section 7.3)
2. Medically unstable conditions as determined by the investigators
3. Pregnant or lactating or those women of child-bearing age that are not using acceptable forms of contraception
4. Diagnosis of asthma that is presently being treated with any medication, or past history of asthma/bronchospasm resulting in an emergency room visit, hospitalization or treatment
5. Unable to adhere to study protocol for whatever reason
The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis

PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18-60 years allergic to ragweed pollen.
* Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit.

Exclusion Criteria:

* Subjects with significant diseases other than allergic rhinitis that may interfere with the safety or efficacy of PF-03654764.
* Subjects with significant symptoms of allergic rhinitis within the 2 weeks prior to screening.