louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04436679: INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors
Official title: INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer
Pancreatic Adenocarcinoma
Keywords: survival
prognosis
tissue
pancreas cancer
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pancreatic adenocarcinoma patients operated on between 2001 and 2016.

Brief summary: The study is particularly innovative as it will accurately analyze the microscopic characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the pancreas, using a comparative approach of long-survivor/short-survival patients.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age at diagnosis
* Primary pancreatic cancer patients operated on in one of the 4 centres between 2001 and 2016
* Histopathological diagnosis of excreto-pancreatic adenocarcinoma of the pancreas, ductal adenocarcinoma or classical adenocarcinoma
* Tissue blocks (FFPE) available (tumour/healthy tissue)
* Affiliated to a social security scheme

Exclusion Criteria:

* Absence of Primary Cancer Tissue Blocks (PCTBs)
* Paraffin block fixed in Bouin or AFA
* Patient Refusal
* Pancreatic cancer not corresponding to a conventional excretopancreatic adenocarcinoma such as: carcinoma on intraductal papillary mucinous neoplasm, endocrine tumor/carcinoma, acinar cell carcinoma, ...).
* Patient died due to post-surgical complications (death within 30 days post-surgery).
* Surgical resection of macroscopic R2 type.

Primary outcomes:
measure: Relationship between known prognostic histological markers of pancreatic adenocarcinoma and patient survival.
timeFrame: at 2 years
Secondary outcomes:
measure: Relationship between newly described histological markers for pancreatic adenocarcinoma and patient survival.
timeFrame: at 2 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Emmanuelle Leteurtre, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01821079: A Healthy Volunteer Study To Assess Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation
Official title: A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation Of Pf-05175157 And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Single dose
Relative Bioavailability
Food effect
Healthy subjects
Diabetes Mellitus Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-03-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study in healthy volunteers is to assess the relative bioavailability of PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the pharmacokinetics of the tablet formulation.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
* Women must be of non childbearing potential
* Body Mass Index (BMI) of 25 to 35 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms, optic nerve disease or retinal disease.
* History of habitual smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0 to 72 H after dose
measure: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
timeFrame: 0 to 72 H after dose
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0 to 72 H after dose
measure: Time at which maximum plasma concentration is observed (Tmax)
timeFrame: 0 to 72 H after dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0 to 72 H after dose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01866579: Early Retinal Nerve Fiber Layer Change of Ethambutol Optic Neuropathy by Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Lung Tuberculosis
Keywords: Retinal Nerve Fiber Layer Thickness, Optical Coherence Tomography, Ethambutol optic neuropathy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who diagnosed with primary lung tuberculosis

Brief summary: Ethambutol is widely used as first-line drug, but has serious side effect of optic neuropathy. As previously reported, incidence of ethambutol optic neuropathy is about 1\~2%, there was considerable screening efforts and medical cost is increasing. However, there is no effective treatment of ethambutol optic neuropathy or no definite preventable measure. Moreover, multi-drug resistance tuberculosis or extensively drug resistance tuberculosis is emerging, more toxic secondary drug is used in the long-term.

It is known that retinal nerve fiber layer is increased early stage in ethambutol optic neuropathy. So we decide to evaluate the retinal nerve fiber layer thickness measured by optical coherence tomography in longitudinal manner.


Eligibility criteria: Inclusion Criteria:

1. Primary lung tuberculosis who has not previously treated
2. Age more than 19 years and less than 70 years old

Exclusion Criteria:

1. spherical equivalent more than +6.00 diopter or less than -6.00 diopter by autorefraction
2. Closed angel or intraocular pressure more than 21 mmHg
3. Best corrected visual acuity less than 0.5 with severe cataract
4. Retinal disorder include branch retinal vein occlusion, diabetic macular edema, wet-type age-related macular degeneration
5. Age less than 20 years or older than 70 years old
6. Any intraocular surgery less than 3 months
7. Intellectual problems or illiterate whom could not obtained informed consent

Primary outcomes:
measure: Change in Retinal Nerve Fiber Layer thickness measured by optical coherence tomography
timeFrame: Early Retinal Nerve Fiber Layer change of initial before anti-tuberculosis treatment, 4 months after anti-tuberculosis treatment, 6 months after anti-tuberculosis treatmen
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT01078779: The Chloroquine for Influenza Prevention Trial
Official title: A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Prevention
Chloroquine
Randomised controlled trial
Respiratory virus infection
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 1516
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomised controlled trial to determine the efficacy of chloroquine for the prevention of influenza


Eligibility criteria: Inclusion Criteria:

* Age 18 -65
* Have the ability to provide informed consent
* If a woman of child-bearing potential, willing to use contraception for the period of the trial

Exclusion Criteria:

* Acute influenza-like illness at screening
* History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, or serious hepatic or renal disease
* Pregnancy or breast feeding
* Current use of medication with known serious hepatotoxic effects
* Current use of medication with known serious interaction with CQ: amiodarone, anticonvulsants, ciclosporin, digoxin, mefloquine, moxifloxacin
* Current severe depression (as indicated by current use of antidepressant medication)
* Known serious retinal disease
* Current or recent (within the past 30 days) participation in any other clinical intervention trial.
* Known G6PD deficiency
* Vaccination for influenza (seasonal or H1N1 strain) within the 3 months prior to screening

Primary outcomes:
measure: Laboratory-confirmed influenza-like illness
timeFrame: 12 weeks
Secondary outcomes:
measure: Serologically-confirmed influenza infection (symptomatic or asymptomatic)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Investigational Medicines Unit, National University Hospital
Study officials:
affiliation: National University of Singapore
name: Nicholas I Paton, MD FRCP
role: STUDY_CHAIR
affiliation: National University of Singapore
name: Lawrence Lee, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paton NI, Lee L, Xu Y, Ooi EE, Cheung YB, Archuleta S, Wong G, Wilder-Smith A. Chloroquine for influenza prevention: a randomised, double-blind, placebo controlled trial. Lancet Infect Dis. 2011 Sep;11(9):677-83. doi: 10.1016/S1473-3099(11)70065-2. Epub 2011 May 5.
Clinical trial NCT06287879: Function and Morphological Characteristics of Meibomian Gland in Patients With Renal Anemia
Official title: Function and Morphological Characteristics of Meibomian Gland in Patients With Renal Anemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye
MGD-Meibomian Gland Dysfunction
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Renal anemia refers to anemia in which the absolute or relative production of erythropoietin (EPO) is insufficient due to various kidney diseases, and uremic toxins affect erythropoietin production and its lifespan. Common treatment drugs for renal anemia include erythropoietin EPO and Roxadustat (FG-4592).

Medical history information was collected from patients with renal anemia who visited the ophthalmology department with dry eye symptoms.

This study will help to determine the function and morphological characteristics of meibomian gland in patients with renal anemia

Detailed description: 1. Collect medical records of patients with renal anemia who visited the ophthalmology outpatient department of Zhongnan Hospital and hospitalized patients with renal anemia
2. Patients were divided into Rosallistat group, and EPO group according to their drug use history.
3. The dry eye analysis results of all patients were collected, and the lacrimal river height, tear film rupture time and meibomian gland grade were counted. The results of dry eye examination were analyzed statistically.
4. Complete data collection, conduct statistical analysis, and evaluate the analysis results.

Eligibility criteria: Inclusion Criteria:

* long-term use of Roxadustat or erythropoietin for renal anemia

Exclusion Criteria:

* contact lens wearer, history of eye surgeries, systemic health conditions affecting ocular health and those who were unable to cooperate with examinations

Primary outcomes:
measure: Lacrimal river height
timeFrame: Immediately and six months later
measure: tear break-up time
timeFrame: Immediately and six months later
measure: tear-film lipid layer thickness
timeFrame: Immediately and six months later
measure: meibomian glands two-dimensional digital infrared images
timeFrame: Immediately and six months later
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT00641979: New Nasal Applicator / New Formulation - User Study
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Functionality of a New Nasal Device With Reformulated Rhinocort Aqua (Budesonide) Versus the Current Product and Versus Placebo in Subjects With Seasonal Allergic Rhinitis (SAR).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Keywords: Allergic rhinitis
Nasal symptoms
Congestion
Rhinorrhea
Sneeze
budesonide
Rhinocort AQUA
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).


Eligibility criteria: Inclusion Criteria:

* In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids.
* A documented history of at least one year of seasonal allergic rhinitis.
* A positive response to a skin prick test for grass allergens that must be present in the subject's environment throughout the study.

Exclusion Criteria:

* Primary or secondary adrenal insufficiency
* Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
* A diagnosis of asthma requiring treatment as specified in the protocol.

Primary outcomes:
measure: Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)
timeFrame: 2 weekly
Secondary outcomes:
measure: Durability of device
timeFrame: End of study
measure: Safety assessment via adverse events and clinical measurements
timeFrame: 2 weekly
Other outcomes:
Locations:
Study officials:
affiliation: Allergy & Asthma Consultant, NJ, USA.
name: Shaile Shah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Bertil Andersson
role: STUDY_DIRECTOR
References:
Clinical trial NCT06614179: A Pan-cancer Screening and Diagnosis Model Based on Abdominal CT Was Established
Official title: A Pan-cancer Screening and Diagnosis Model Based on Abdominal CT Was Established
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Neoplasm
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with abdominal tumors or Non-tumor population

Brief summary: Abdominal noncontrast scan and contrast-enhanced CT were used to establish a screening and diagnostic model for abdominal tumors

Detailed description: Secondary objective: To establish a grading model of abdominal tumors based on clinical indicators Exploratory Objective: To include CT scans in large-scale non-tumor populations for validation and to improve model accuracy Certainty

Eligibility criteria: Inclusion Criteria:

* Patients with abdominal tumors:
* all patients were pathologically diagnosed with abdominal tumors;
* The clinical case data of all patients were complete, and complete follow-up was obtained, with clear information on medical visits, operation time and survival status within 2 years. If the cause of death is unknown, it will be recorded as censored data;
* All patients had no history of active abdominal bleeding, no serious infection or other abdominal diseases that affected the observation of CT imaging within 3 months before surgery.
* Non-tumor population:
* all patients have complete clinical case data, complete abdominal CT, no history of malignant tumors, no serious infections or other abdominal diseases that affect the diagnosis and observation of CT imaging.

Exclusion Criteria:

* Cases in which contrast-enhanced or noncontrast CT images show unclear lesions, with significant noise and artifacts;

Primary outcomes:
measure: Whether or not there is a diagnosis of abdominal tumor questionnaire
timeFrame: first visited at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital；Cancer hospital of the university of chinese academy of sciences
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiangdong Cheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05081479: A Study of N-Acetylcysteine (N-AC) in People Receiving CAR T-cell Therapy for Lymphoma
Official title: Phase I Study of N-Acetylcysteine to Optimize Metabolic Tumor Microenvironment in CD19 CAR T-cell Therapy in Lymphoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Lymphoma
Keywords: N-AC
N-Acetylcysteine
Lymphoma
CD19 CAR T-cell Therapy
21-386
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety of N-AC when given in combination with Yescarta to people with lymphoma. This study will test different doses of N-AC to find the highest dose that causes few or mild side effects in participants.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age or older
* Patients who will receive axicabtagene ciloleucel for treatment of lymphoma
* Patients must have adequate end organ function to be eligible for this study as defined by the following criteria:

  * ECOG performance status 0-2
  * Hematologic function with ANC ≥ 1000, Hgb ≥ 8, Plt ≥ 50k unless there is disease related hematologic toxicity
  * Renal function with CrCr ≥ 40 ml/min or Cr ≤ 1.5 x ULN
  * Hepatic function with ALT/AST ≤ 2.5 x ULN, TBili ≤ 1.5 x ULN.

Exclusion Criteria:

* Patients with known allergy to N-AC

Primary outcomes:
measure: Maximum tolerated dose of N-AC
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gunjan Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02632084: Follow-up Evaluation of Photo-Dynamic Therapy for Pituitary Tumours
Official title: Follow-up Evaluation of Photo-Dynamic Therapy for Pituitary Tumours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Neoplasms
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Details of previous research participants will be extracted from the study files by the researchers, who are all members of the direct care team.

Brief summary: A study to followup patients that have previously been treated for pituitary tumours with either photodynamic therapy or placebo in a previous trial. The study aims to determine whether photodynamic therapy has any long term effect on tumour size, visual fields or endocrinological function.

Detailed description: No patients will receive any medical or procedural treatments in this study, since these have been administered in a previous trial. The previous trial participants will be contacted and asked to attend a clinic or to have a telephone interview, where they will answer a questionnaire. They will be assessed clinically for visual fields, as well as undergoing an MRI scan of their head to assess tumour size (unless they have had a scan anyway in the previous 12 months), these tests would ordinarily form part of the routine outpatient workup for patients with pituitary tumours. There is no significant risk to the physical well-being of the patients with any of the methods to be used.

Eligibility criteria: Inclusion Criteria:

* Patients who were previously included in the initial pituitary PDT trial, in addition to those who were randomised as part of the RCT arm of the study. These patients have already participated in phase I/II trials. Of note, these patients all have pituitary tumours.

Exclusion Criteria:

* Patients who were not included in the above mentioned trials. Patients included in the original trials who have subsequently died (of any cause).

Primary outcomes:
measure: Tumour size on MRI scan.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
References: