louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01189877: Characterization of Rectal Cancer Hypoxia Using pO2 Histography and Immunohistochemistry for Hypoxia-Related Proteins
Official title: Characterization of Rectal Cancer Hypoxia Using pO2 Histography and Immunohistochemistry for Hypoxia-Related Proteins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: Direct pO2 Measurements
10-121
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if the cells in rectal cancer are oxygen-starved, or hypoxic. We know that as cancers grow bigger, parts of them are cut off from the oxygen supply and they become hypoxic, basically, lacking oxygen. Research has shown that cells that are oxygen-starved respond differently to treatment such as chemotherapy and radiation when compared to cells that are oxygen rich.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven adenocarcinoma of the rectum. If a biopsy was taken at an outside hospital, the slides and diagnosis will be reviewed and confirmed by a pathologist at MSKCC.
* Mid to distal rectal tumors not requiring pre-op radiation or chemotherapy
* Age ≥ 18
* Age \< 90
* Karnofsky performance status ≥ 60
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Current pregnancy
* Uncontrolled intercurrent illness that would limit compliance with study requirements.

Primary outcomes:
measure: Measure pO2 in rectal cancers
timeFrame: 2 years
Secondary outcomes:
measure: Correlate immunohistochemical analysis of endogenous markers of hypoxia
timeFrame: 2 years
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: José Guillem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03980977: Unusual Toxicity Induced by Radiotherapy
Official title: Collection of Biological Samples for Stydy of Unusual Toxicity Induced by Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: unusual toxicity
radiosensitivity
radiotherapy
fibroblast cell
indirect immunofluorescence test
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In order to evaluate the physiopathological knowledge of the different pathological manifestations associated with individual radiosensitivity, it seems essential to carry out this pilot study. It has agglomerated homogeneous tissue samples to identify new biomarkers for patient diagnosis and follow-up, and may predict the therapeutic response. These knowledge will help to treatment customization.


Eligibility criteria: Inclusion Criteria:

* Child or teenager aged 2 to \<18
* Man, Woman\> 18 years old
* Patient with one of these situations:

  * Unusual toxicity in progress or after radiotherapy
  * Indication of radiotherapy and suspicion of abnormal pathways of response to ionizing radiation - constitutional (genetic disease) or acquired (systemic disease) - which may generate unusual radioinduced toxicity
* Patient information and informed consent signed by the patient. For children and teenager : information to parents and obtaining informed consent
* Affiliation to a social security scheme.

Exclusion Criteria:

* Contraindication for skin and / or tumoral biopsy
* Contraindication for blood sample of 2.5 ml
* Persons deprived of liberty or under supervision

Primary outcomes:
measure: skin fibroblast radiosensitivity
timeFrame: 2 to 3 months after skin biopsy
Secondary outcomes:
measure: tumor cells radiosensitivity
timeFrame: 2 to 3 months after tumor biopsy
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
References:
Clinical trial NCT03327077: Music in Urgent and Emergent Settings
Official title: Music in Urgent and Emergent Settings (MUES) Trial: Phase Three
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Endowment for the Arts, United States
First posted: 2017-10-31
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to study the impact of Live Preferential Music on the patient perception of pain and management of pain syndromes in the ED.

Detailed description: The purpose of this study is to study the impact of Live Preferential Music on the patient perception of pain and management of pain syndromes in the ED. This study follows a prospective experimental design where patients will be assigned to two groups: one that receives the music intervention and one that does not receive music intervention.

Eligibility criteria: Inclusion Criteria:

1. Age: ≥18
2. Chief complaint of musculoskeletal pain
3. Gender: Male or Female
4. Ethnicity: Any
5. Physical ability: Any
6. Language: English
7. Cognitive skill/education: grade 2 reading level or above
8. Physically and cognitively able to participate in study procedures

Exclusion Criteria:

1. Patients who are unable to participate in the informed consent process
2. Prisoners

Primary outcomes:
measure: Pain reduction
timeFrame: 60 to 90 minutes
Secondary outcomes:
measure: Cost of care
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Unversity of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Joseph Tyndall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03151577: Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent
Official title: Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Glaucoma, Open-Angle
Glaucoma, Angle-Closure
Glaucoma, Primary Open Angle
Lead sponsor: Swiss Vision Network
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intraocular pressure, adverse events, complications, number of medications in mild to moderate glaucoma patients who underwent XEN® Gel Stent implantation were recorded.

Data were collected in a 2 years follow-up.
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.

Detailed description: To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.

Follow-up period is 2 years.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate glaucoma patients
* Have given written informed consent
* Aged 18 years or older of either sex

Exclusion Criteria:

* Patients not able to understand the character of the study
* Participation in other clinical research within the last 4 weeks
* Patients with end-stage glaucoma
* Patients with glaucoma surgery done before

Primary outcomes:
measure: Intraocular pressure
timeFrame: Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2
Secondary outcomes:
measure: Number of needlings
timeFrame: 2 years
measure: Number of antiglaucomatous medications
timeFrame: Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2
Other outcomes:
Locations:
Study officials:
References:
citation: Gillmann K, Bravetti GE, Rao HL, Mermoud A, Mansouri K. Bilateral XEN Stent Implantation: A Long-term Prospective Study of the Difference in Outcomes Between First-operated and Fellow Eyes. J Glaucoma. 2020 Jul;29(7):536-541. doi: 10.1097/IJG.0000000000001520.
citation: Mansouri K, Gillmann K, Rao HL, Guidotti J, Mermoud A. Prospective Evaluation of XEN Gel Implant in Eyes With Pseudoexfoliative Glaucoma. J Glaucoma. 2018 Oct;27(10):869-873. doi: 10.1097/IJG.0000000000001045.
Clinical trial NCT02222077: Central Blood Pressure in Adolescents and Young Adults
Official title: Diurnal Variation of Central Blood Pressure in Adolescents and Young Adults and Association With Indices of Asymptomatic Target-organ Damage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Hypertension
Keywords: Central blood pressure
Ambulatory blood pressure monitoring
Target-organ damage
Adolescents and young adults
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and subjects referred to the Hypertension Clinic for the assessment of elevated blood pressure

Brief summary: This study aims to investigate in adolescents and young adults:

* the 24h diurnal variation of ambulatory central blood pressure
* the association of central compared to peripheral blood pressure with indices of asymptomatic target-organ damage


Eligibility criteria: Inclusion Criteria:

* Adolescents and young adults (age range 12-25 years)

Exclusion Criteria:

* Subjects with any acute or significant chronic disease, with evidence of secondary hypertension, or on regular drug treatment will be excluded

Primary outcomes:
measure: Correlation coefficients (r) between 24h ambulatory central blood pressure and indices of target-organ damage
timeFrame: Assessment of each individual will require up to 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hypertension Center, 3rd University Department of Medicine, Sotiria Hospital
state: Attica
Study officials:
References:
Clinical trial NCT01871077: Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers.
Official title: Phase I Clinical Trial to Assess the Safety and Tolerability of the Ophthalmic Solution PRO-156 Over the Ocular Surface of Ophthalmologically Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution PRO-156 over the ocular surface of ophthalmologically healthy volunteers

Detailed description: A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of the ophthalmic solution PRO-143 over the ocular surface of ophthalmologically healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female.
* Age between 18 and 40 years old at screening visit.
* Signed informed consent

Exclusion Criteria:

* Patient with one blind eye.
* Any ocular or systemic condition.
* Visual acuity of 20/100 in any eye.
* Use of ocular or systemic medication.
* Contraindications or sensitivity to any component of the study treatment.
* Contact lens users.
* Ocular surgery within the past 3 months..
* Pregnant, nursing or childbearing potential women who were not using effective contraception.
* Participation in any studies of investigational drugs within 90 days previous to the inclusion.

Primary outcomes:
measure: Visual Acuity (VA)
timeFrame: 11 days
Secondary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 11 days
measure: Number of Eyes With Epithelial Defects
timeFrame: 11 days
measure: Number of Cases With Adverse Events
timeFrame: 11 days
Other outcomes:
Locations:
Study officials:
affiliation: Independent Clinical Research Center
name: Mauricio Casillas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04595877: Double-blind, Randomized Controlled Study to Assess the Analgesic Effect of 2 g of Magnesium Dipyrone (Metamizol) and Changes in Plasma Beta-endorphin Immunoreactivity Values in Patients Undergoing Elective Inguinal Herniorrhaphy Under Epidural Anesthesia.
Official title: Double-blind, Randomized Controlled Study to Assess the Analgesic Effect of a Single Intravenous Dose of 2 g of Magnesium Dipyrone (Metamizol) and Changes in Plasma Beta-endorphin Immunoreactivity (Beta-EPIr) Values in Patients Undergoing Elective Inguinal Herniorrhaphy (Bassini Operation) Under Epidural Anesthesia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Beta-endorphin
Dipyrone
Hernia Surgery
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A double-blind, randomized controlled study is designed to assess the analgesic effect of a single intravenous dose of 2 g of magnesium dipyrone (metamizol) and whether the administration of the active drug will be associated with changes in plasma beta-endorphin immunoreactivity values in patients undergoing elective inguinal herniorrhaphy (Bassini operation) under epidural anesthesia. Participants, care givers, and those assessing the outcomes will be blinded to group assignment. Participants will be randomized to receive dipyrone or a placebo. The active drug or placebo will be administered as an intravenous infusion over 10 min. Pain will be evaluated by the patient according to a 100-mm visual analogue scale. Assessments will be carried out the day before surgery, immediately after operation, at the time of drug administration, and 60 and 180 min after treatment. At the same time as pain will be evaluated, blood samples will be drawn for plasma beta-endorphin immunoreactivity measurement (immunoradiometric assay).


Eligibility criteria: Inclusion Criteria:

* 18-70 years, elective surgery, routine laboratory tests (blood cell count, biochemical profile, urinalysis), chest radiography, twelve-lead electrocardiography, body mass index (BMI), blood pressure, pulse rate normal or abnormal values without clinical relevance and a mental status sufficient to be able to complete efficacy tests.

Exclusion Criteria:

* Patients who had taken other analgesics or anti-inflammatory drugs 24 h before surgery, as those with known hypersensitivity to the drug or with any other disorder contradicting the administration of dipyrone. Patients with hypersensitivity to non-steroidal anti-inflammatory agents.

Primary outcomes:
measure: Analgesic efficacy-Pain relief
timeFrame: 30 seconds
Secondary outcomes:
measure: Beta-endorphins levels.
timeFrame: 1 minute
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Nursing and Physiotherapy Department
state: Alcalá De Henares
Study officials:
References:
Clinical trial NCT04448977: Examining Effects of Ocrevus on Cognitive Fatigue Using fMRI
Official title: A Biomarker for Cognitive Fatigue Using Functional Imaging in MS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
cognitive fatigue
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Hackensack Meridian Health
First posted: 2020-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals who have Relapsing remitting Multiple Sclerosis and Healthy Volunteers

Brief summary: The purpose of this research study is to investigate the effectiveness of MS Disease modifying medications on cognitive fatigue in persons with relapsing remitting multiple sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.

Detailed description: The researchers aim is to investigate the effects of disease modifying treatments on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with Multiple Sclerosis (MS). The researchers will investigate the effects on the cognitive fatigue that develops during the performance of a demanding task, and also on how cognitive fatigue changes as a function of duration of treatment.

Eligibility criteria: Inclusion Criteria:

* Age between 18-64.
* Relapsing remitting multiple sclerosis
* Been newly prescribed a new disease modifying medication for MS (either Ocrevus or Copaxone)
* or healthy volunteer who can speak English fluently.

Exclusion Criteria:

* History of head injury, stroke, seizures, or any other significant neurological event other than MS
* Flare up of MS symptoms within the past month.
* History of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder.
* Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids \[cochlear implants\]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments.
* left handed.
* Not able to have an MRI

Primary outcomes:
measure: Brain activation (BOLD signal)
timeFrame: Measured for change at 3 time points (before, six months and 12 months after intervention)
Secondary outcomes:
measure: Fatigue onset
timeFrame: Measured for change at 3 time points for change (before, six months and 12 months after intervention)
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: John DeLuca, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03662477: Effect of NK Cell Immunotherapy on Advanced Lung Adenocarcinoma Adenocarcinoma With EGFR Mutation
Official title: Effect of Autologous NK Cell Immunotherapy on Advanced Lung Adenocarcinoma With EGFR Mutation: a Preliminary Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: NK Cell Mediated Immunity
Lead sponsor: Shenzhen Fifth People's Hospital
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was attempted to investigate the efficiency of NK cells immunotherapy on non-small cell lung cancer with and without EGFR mutation, and evaluated response rate (RR) and the progression-free survival (PFS).

Detailed description: Investigators will enrolle 100 patients who met the enrollment criteria. 50 patients were clinically confirmed EGFR mutation positive. They were divided into two groups (group A and group C according to if accepted NK therapy) in accordance with the principles of randomized. The rest 50 patients which were EGFR mutation negative were also divided into two groups (group B and group D) in accordance with the principles of randomized to be paired respectively with group A and group C. Comparison of lymphocyte number, serum tumor related biomarkers, circulating Tumor Cell (CTC), KPS and survival curves was carried out before after NK cell immunotherapy. The safety and short-term effects were evaluated followed by the median PDA, response rate assessment.

Eligibility criteria: Inclusion Criteria:

The criteriaof the enrollment are as following: (1) expected survival\>6 months; (2) age between35-75 years old; (3) KPS \>45; (4) platelets\>80 × 109/L, WBC\>3 × 109/L, hemoglobin\>90g/L, prothrombin time-international normalized ratio (0.8-1.5), adequate hepatic function (bilirubin \< 20 μM, aminotransferase\<60 U/L) and renal function (serum creatinine \< 130 μM, serum urea \<10 mM); (5) All patients confirmed by pathology and/or imaging;

Exclusion Criteria:

The absence of level 3 hypertension, severe coronary disease, myelosuppression, respiratory disease, acute or chronic infection, and autoimmune diseases. -

Primary outcomes:
measure: Clinical response
timeFrame: Calculated the sum area of all tumors 3 months after NK treatment
Secondary outcomes:
measure: Detection of immune function
timeFrame: Before and 3 months after NK cell therapy
measure: Analysis of tumor biomarker CEA and CA125 levels in serum
timeFrame: Before and 3 months after NK cell therapy
Other outcomes:
measure: The endpoints of interest were progression-free survival (PFS).
timeFrame: The KPS scores were collected pre-treatment and at 12 months post-treatment.
Locations:
city: Shenzhen
country: China
facility: Shenzhen Luohu Hospital
state: Guangdong
Study officials:
References: