louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00897052: Gene Expression Profiles in Predicting Survival of Patients With Head and Neck Cancer
Official title: Survival Prediction in HNSCC Based on Gene Expression Profiles From FFPE Tissues
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prior patients who participated on clinical trial RTOG-9501

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict survival of patients with head and neck cancer.

PURPOSE: This laboratory study is assessing gene expression profiles in predicting survival of patients with head and neck cancer.

Detailed description: OBJECTIVES:

* Identify gene expression profiles associated with survival by DNA microarray assay analysis using RNA from formalin-fixed paraffin-embedded tissue samples from patients with squamous cell carcinoma of the head and neck treated on clinical trial RTOG-9501.

OUTLINE: Formalin-fixed paraffin-embedded tissue samples are analyzed by DNA microarray analysis for gene expression profiling.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of squamous cell carcinoma of the head and neck, including 1 of the following sites:

  * Hypopharynx
  * Larynx
  * Oral cavity
  * Oropharynx
* Stage II-IV disease
* Must have received treatment on clinical trial RTOG-9501
* Formalin-fixed paraffin-embedded tissue samples available

Exclusion Criteria:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Identification of gene expression profiles used to predict survival as assessed by DNA microarray analysis
timeFrame: at time of surgical resection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Barbara Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02811952: Measuring Urinary Nano Particles and Metallic Compounds in TCC Patients
Official title: Measuring Urinary Nano Particles and Arsenic and Comparing Them to Cystoscopic Findings and Urinary Cytology in Patients Suspected With Urinary Bladder Malignancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: bladder cancer
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with bladder cancer \& control group

Brief summary: In many of urothelial carcinoma patients, one does not find common risk factors such as smoking. The medical center is located in an industrial city with known air and water pollution. The investigators decided to check the presence of nano particles and traces of metals in urinary samples of patients known and suspected for urothelial carcinoma and compare the results to both cystoscopic and cytological findings. The patients will fill a validated epidemiological respiratory disease survey and the results will be compared to a control group.


Eligibility criteria: Inclusion Criteria:

Study group :

1. Patients that need cystoscopy due to suspicion/known bladder malignancy.
2. Patients that can read, understand and sign an informed consent form.

Control group:

1. Patients that need cystoscopy due to others reasons than malignancy.
2. Patients that present to the Department of Urology for surgery unrelated to malignancy of the urinary system ( prostatectomy, Incontinence repair, circumcision, hydrocele/ varicocele repair, ureteroscopy etc).

Exclusion Criteria:

Study group:

1. Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
2. Patients with a technically improper urine test.

Control group

1. Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
2. Patients with a technically improper urine test.

Primary outcomes:
measure: levels of nano particles and arsenic in urine
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Lady Davis Medical Center
Study officials:
References:
Clinical trial NCT06260852: Identification of Minimum Focal Points in Vision Curve Formation
Official title: Identification of Minimum Focal Points in Vision Curve Formation After Pseudophakic Presbyopia Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Presbyopia
Pseudophakia
Cataract
Refractive Errors
Keywords: pseudophakic presbyopic correction
premium monovision
trifocal diffractive intraocular lenses
extended depth of field intraocular lenses
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation

Brief summary: The primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery.

Detailed description: This is a prospective, non-inferiority trial. 80 participants that underwent uncomplicated pseudophakic presbyopia surgery with bilateral premium intraocular lenses (IOL) implantation will be recruited, and their postoperative Visual Curves (VAC) will be evaluated for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Then, using polynomial and spline interpolation methods on the measured data, the aim is to generate a unique polynomial of degree ninc -1 that satisfies all data points.

Eligibility criteria: Inclusion Criteria:

* age over 40,
* previous bilateral premium cataract surgery,
* best corrected visual acuity (BCVA) \< 0,2 logMAR

Exclusion Criteria:

* taking topical medication to reduce intraocular pressure (IOP),
* macular diseases,
* corneal diseases,
* inability to understand the procedure,
* postoperative astigmatism \>1.50 diopters,
* postoperative clouding of the posterior capsule

Primary outcomes:
measure: Visual curves interpolation
timeFrame: 6 months
measure: Area of the curve (AOC) assessment
timeFrame: 6 months
measure: Visual acuity assessment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Department of Ophthalmology, University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Democritus University of Thrace
name: Georgios Labiris, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00687752: Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of Central Nervous System (CNS) Pathology
Official title: Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of CNS Pathology? a Report on Two Cases.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hydramnios
Keywords: fetal deglutition
larynx
fetal CNS pathology
sonography
hydramnios
Lead sponsor: Hippocration General Hospital
Sponsor class: OTHER
First posted: 2008-06-02
Enrollment: 310
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: 310 singleton pregnancies (22-35 weeks) enrolled into the study. We assessed sonographically the fetal larynx in an axial plane through the mandible and observed the fetal deglutition movements .

Detailed description: 310 singleton pregnancies (22-35 weeks) enrolled into the study. We assessed sonographically the fetal larynx in an axial plane through the mandible and observed the fetal deglutition movements .We encountered two cases of hydramnios were no deglutition movements could be noted. In all other cases the deglutition was normal. The motivation to conduct the current observational prospective study was to assess whether there is a link between absence of fetal deglutition and CNS pathology of the fetus. In the first case the fetus deceased at 35 weeks of gestation; obduction was declined by the parents. In the second case caesarian section at 33 weeks was carried out recently due to fetal distress. The infant is still in uncapable of swallowing and there for is under investigation at the neonatal center of our hospital.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy(22-35 weeks)

Exclusion Criteria:

* positive toxoplasmosis screening,drug and/or antidepressants addiction.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Hippokration General Hospital
Study officials:
affiliation: 2nd dept OB/GYN ARISTOTLE UNIV. THESSALONIKI GREECE
name: THEOHARIS A TANTANASIS, ASSIST PROF
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd dept OBGYN ARISTOTLE UNIV. THESSALONIKI GREECE
name: JOHN M TZAFETTAS, PROF
role: STUDY_CHAIR
References:
Clinical trial NCT03056352: Metoclopramide for Post-Traumatic Headache. A Pilot Study
Official title: Metoclopramide for Post-Traumatic Headache. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Post-Traumatic Headache
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.


Eligibility criteria: Inclusion Criteria:

* Traumatic injury to the head has occurred
* Headache has developed within 7 days of injury to the head
* Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)
* The headache must be rated as moderate or severe in intensity at the time of initial evaluation.
* The plan of the attending emergency physician must include treatment with parenteral metoclopramide.

Exclusion Criteria:

* Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of monoamine oxidase inhibitors, and use of anti-rejection transplant medications. Patients will not be excluded for pregnancy or breast-feeding.

Primary outcomes:
measure: Number of Participants With Sustained Headache Relief
timeFrame: 2 hours thru 48 hours after treatment
Secondary outcomes:
measure: Post Concussion Symptoms Assessed by Post-concussive Symptom Scale
timeFrame: 7 days
measure: Number of Participants Satisfied With Medication; Assessed by Self-evaluation
timeFrame: 48 hours after treatment
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
Clinical trial NCT00518752: Effects of Oral Care in the Neuroscience ICU
Official title: Comprehensive Oral Care for the Intubated Neuroscience ICU Patient: A Comparison of the Safety and Efficacy Between 2 Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Associated Pneumonia
Oral Hygiene
Keywords: Ventilator Acquired Pneumonia
Oral Hygiene
Oral Care
Xerostomia
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2007-08-21
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: 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 how effective different ways of mouth cleaning are for patients in a neuroscience intensive care unit with a breathing tube in their mouth.

Detailed description: Patients with neurological dysfunction requiring intubation and ventilation are at risk for developing ventilator acquired pneumonia. Several studies have suggested that oral hygiene plays a role in the subsequent development of pneumonia for patients in the intensive care unit requiring intubation and mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

* \> or equal 18 years old
* Intubated within 24hours of admission to the Neuroscience ICU
* Intubation anticipated to continue for approximately 72 hours

Exclusion Criteria:

* Minors
* Pregnancy
* Acute cervical spinal cord injury
* Severe facial trauma
* Family not present for consent

Primary outcomes:
measure: Development of Ventilator Acquired Pneumonia
timeFrame: During the period of intubation
Secondary outcomes:
measure: Improved Oral Health
timeFrame: During the period of intubation and 48 hours following extubation
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
Study officials:
affiliation: St Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
name: Virginia C Prendergast, MSN, NP-C
role: PRINCIPAL_INVESTIGATOR
affiliation: Vardalinstitutet, University of Lund, Sweden
name: Ingalill R Hallberg, PhD
role: STUDY_CHAIR
References:
citation: Munro CL, Grap MJ. Oral health and care in the intensive care unit: state of the science. Am J Crit Care. 2004 Jan;13(1):25-33; discussion 34.
citation: Dennesen P, van der Ven A, Vlasveld M, Lokker L, Ramsay G, Kessels A, van den Keijbus P, van Nieuw Amerongen A, Veerman E. Inadequate salivary flow and poor oral mucosal status in intubated intensive care unit patients. Crit Care Med. 2003 Mar;31(3):781-6. doi: 10.1097/01.CCM.0000053646.04085.29.
citation: Prendergast V, Hagell P, Hallberg IR. Electric versus manual tooth brushing among neuroscience ICU patients: is it safe? Neurocrit Care. 2011 Apr;14(2):281-6. doi: 10.1007/s12028-011-9502-2.
Clinical trial NCT00781352: Nitrous Oxide and Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study
Official title: Nitrous Oxide Does Not Increase the Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: nitrous oxide
cancer recurrence
colorectal surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-10-29
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was developed to test the hypothesis that the risk of colorectal cancer recurrence was similar in patients who were randomly assigned to 65% nitrous oxide or nitrogen during colorectal surgery.

Detailed description: We conducted a 4- to 8-year follow-up of 204 patients with colorectal cancer who were randomly assigned to 65% nitrous oxide (n=97) or nitrogen (n=107), balanced with isoflurane and remifentanil. The primary outcome was the time to cancer recurrence. Our primary analysis was a multivariable Cox-proportional-hazards regression model that included relevant baseline variables. In addition to treatment group, the model considered patient age, tumor grade, dissemination, adjacent organ invasion, vessel invasion, and the number of nodes involved. The study had 80% power to detect a 56% or greater reduction in recurrence rates (i.e., hazard ratio of 0.44 or less) at the 0.05 significance level.

Eligibility criteria: Inclusion Criteria:

* Subjects age 18-18
* ASA status 1-3
* Informed consent

Exclusion Criteria:

* Acute bowel obstruction
* Minor colon surgery

Primary outcomes:
measure: To determine if the risk of colorectal cancer recurrence was similar in patients who were randomly assigned to 65% nitrous oxide or nitrogen during colorectal surgery.
timeFrame: 270 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Edith Fleischmann, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, M.D.
role: STUDY_DIRECTOR
References:
citation: Fleischmann E, Marschalek C, Schlemitz K, Dalton JE, Gruenberger T, Herbst F, Kurz A, Sessler DI. Nitrous oxide may not increase the risk of cancer recurrence after colorectal surgery: a follow-up of a randomized controlled trial. BMC Anesthesiol. 2009 Feb 3;9:1. doi: 10.1186/1471-2253-9-1.
Clinical trial NCT00005452: Ti PC Software for Analyzing Longitudinal Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To develop TI (pronounced 'T-sub-I'), a personal computer program to analyze time-varying data generated by periodic patient reports, repeatedly-observed disease signs, or serial biomarkers to study chronic disease.

Detailed description: BACKGROUND:

With the advent of quasi-likelihood, generalized estimating equations, and new ways to handle missing data, has come a striking increase in applicable models, perhaps more than after the 1972 introduction of the Cox model for survival data. TI provided a way to analyze the data.

DESIGN NARRATIVE:

TIl provided graphics for data exploration and model validation. TI ran under most current version of Windows, used Civilized Software's MLAB as its programming language, offered context-sensitive help, a dictionary of relevant terms, identification of file entries from their screen position, and simple animation. TI permitted the user to analyze time-varying data from the two perspectives of repeated measured using a variety of models and time series where both time and frequency domain tools were provided.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01667952: Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness
Official title: Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric or Young Adult Cancer Survivors
Keywords: Family History Questionnaire (FHQ)
Blood sample
Salvia sample
12-145
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 1068
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the Adult Long-Term Follow-Up Program, the Pediatric Long Term Follow-up Program, or Lymphoma Service will be recruited at a routine visit to MSKCC.

Brief summary: The purpose of this study is to establish a registry of survivors of cancer, tumor, or a related illness.


Eligibility criteria: Inclusion Criteria:

* English speaking
* A personal history of cancer tumor, or a related illness
* Followed in the the Adult Long Term Follow Up Program, Pediatric Long Term Follow Up Program, or Lymphoma Service at MSKCC

Exclusion Criteria:

* Evidence of active progression of disease or recurrence
* Neurocognitive deficits that impair ability to give informed consent.

Primary outcomes:
measure: establish a registry of DNA
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Danielle Friedman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: