louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04634630: The Influence of Cancer Stem-cells on Risk of Relapse in Patients Harboring Adenocarcinoma and Squamous Cell Carcinoma of the Lung
Official title: The Influence of Cancer Stem-cells on Risk of Relapse in Patients Harboring Adenocarcinoma and Squamous Cell Carcinoma of the Lung: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer, Nonsmall Cell
Relapse/Recurrence
CSC
Keywords: Non Small Cell Lung Cancer
Cancer Stem Cells
Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent major lung resection by lateral thoracotomy or videothoracoscopic approach for stage I, II, or IIIA adenocarcinoma or squamous cell carcinoma of the lung (tumor, node, metastasis (TNM) staging system, eighth edition)

Brief summary: The present study is a prospective cohort study. The aim is to assess the relationship between the presence of cancer stem-cells (CSC) and the risk of relapse in patients with early and locally advanced adenocarcinoma and squamous cell carcinoma of the lung


Eligibility criteria: Inclusion Criteria:

* patients with stage I, II or IIIA adenocarcinoma of squamous cell carcinoma of the lung
* age between 18 and 85
* R0 resection
* availability of formalin-fixed, paraffin-embedded surgery specimen from the primary tumor
* availability of fresh surgical specimen for cytofluorimetric analysis

Exclusion Criteria:

* incomplete resection
* unknown tumor, node or metastasis status
* synchronous tumors
* previous lung cancer

Primary outcomes:
measure: Relapse Free Survival
timeFrame: Minimum follow-up time: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
Study officials:
affiliation: Azienda Ospedaliero-Universitaria di Modena
name: Uliano Morandi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Masciale V, Banchelli F, Grisendi G, D'Amico R, Maiorana A, Stefani A, Morandi U, Stella F, Dominici M, Aramini B. Cancer Stem Cells and Cell Cycle Genes as Independent Predictors of Relapse in Non-small Cell Lung Cancer: Secondary Analysis of a Prospective Study. Stem Cells Transl Med. 2022 Aug 23;11(8):797-804. doi: 10.1093/stcltm/szac040.
citation: Masciale V, Banchelli F, Grisendi G, D'Amico R, Maiorana A, Stefani A, Morandi U, Stella F, Dominici M, Aramini B. The Influence of Cancer Stem Cells on the Risk of Relapse in Adenocarcinoma and Squamous Cell Carcinoma of the Lung: A Prospective Cohort Study. Stem Cells Transl Med. 2022 Mar 31;11(3):239-247. doi: 10.1093/stcltm/szab029.
Clinical trial NCT00313430: Urinary Concentration and Diluting Ability in Patients With Chronic Renal Disease and/ or Hypertension
Official title: Urinary Concentration and Diluting Ability in Patients With Chronic Renal Disease or Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency, Chronic
Hypertension
Keywords: Urine concentration ability
chronic renal insufficiency
hypertension
aquaporin2
Patients with chronic renal insufficiency
Patients with hypertension
Healthy volunteers
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants were recruited by advertisements in public and private institutions Patients with primary hypertension or chronic renal failure were recruited from the Out-patients' Clinic, Department of Medicine, Section of Nephrology, Holstebro Hospital

Brief summary: The investigators want to test the hypothesis that patients with chronic renal disease have a poorer ability to preserve water after being thirsty and a poorer ability to excrete water after a load of fluid. They presume that these abilities become poorer when renal insufficiency progresses. The investigators further hypothesize that patients with hypertension also have a decreased ability to concentrate and dilute urine.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic renal insufficiency, aged between 18 and 65, both men and women
* Creatinine clearance between 30-59 ml/min
* Patients with hypertension, aged between 18 and 65, both men and women; hypertension is defined as a mean arterial blood pressure in the daytime that is more than 140/90 mm Hg.
* Healthy volunteers, aged between 18 and 65, both men and women

Exclusion Criteria:

* Clinical signs or history of disease in the heart, lungs, liver, brain, and endocrine organs
* Cancer
* Alcohol abuse
* Medicine abuse
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medicine, Holstebro Hospital
state: Ringkjoebing
Study officials:
affiliation: Holstebro, Holstebro, Denmark
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
References:
citation: Pedersen EB, Thomsen IM, Lauridsen TG. Abnormal function of the vasopressin-cyclic-AMP-aquaporin2 axis during urine concentrating and diluting in patients with reduced renal function. A case control study. BMC Nephrol. 2010 Oct 5;11:26. doi: 10.1186/1471-2369-11-26.
Clinical trial NCT02050230: Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients
Official title: Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pulmonary Hypertension
Keywords: transfusion
pulmonary hypertension
intensive care medicine
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 11
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: Transfusion of stored blood has been associated with increased pulmonary vascular resistance in lambs. The investigators hypothesize that transfusion of one unit of red blood cells stored under standard conditions in intensive care patients will increase pulmonary arterial pressure and pulmonary vascular resistance to a greater extent than will one unit of fresh red blood cells.


Eligibility criteria: Inclusion Criteria:

1. The patient has a pulmonary artery catheter in place
2. Transfusion of 1 unit of packed red blood cells indicated for standard intensive care therapy
3. The patient has an arterial catheter

Exclusion Criteria:

1. Age \< 18 years
2. Clinical prediction that the patient will not survive at least 48 hours
3. Acute bleeding: \> 2 units of packed red blood cells/hour
4. Vasopressor use: noradrenalin \> 0.2 μg/kg/min or any use of adrenalin within 6 hours of inclusion into the study
5. Therapy with inhaled NO, inhaled prostacyclin, or phosphodiesterase-5-inhibitors
6. Sepsis

Primary outcomes:
measure: Pulmonary arterial pressure
timeFrame: Change from baseline to immediately after transfusion (time frame of 20 min)
measure: Pulmonary vascular resistance
timeFrame: Change from baseline to immediately after transfusion (time frame of 20 min)
Secondary outcomes:
measure: Systemic pressure
timeFrame: Change from baseline to immediately after transfusion (time frame of 20 min)
measure: Systemic vascular resistance
timeFrame: Change from baseline to immediately after transfusion (time frame of 20 min)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: General Hospital of the Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Roman Ullrich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06843330: Accuracy of Lactate Meter in GSDIa
Official title: Are Portable Lactate Monitoring Devices Accurate in Patients With Glycogen Storage Disease Ia When Compared to Blood Serum Lactates?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glycogen Storage Disease Type Ia
Keywords: Glycogen Storage Disease type Ia
Blood lactate
Glycogen Storage Disease Ia blood glucose
GSD I
GSDIa
Blood glucose
Accu chek glucometer
Lactate plus
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
Collaborators: name: Jewish Community Foundation
First posted: 2025-02-24
Enrollment: 10
Sex: ALL
Minimum age (years): 0
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of Connecticut Children's birth to age 60 years with diagnosed Glycogen Storage Disease Type Ia, that are seen in clinic between 7/2020 - 7/2024, or that present to emergency room or are admitted to Connecticut Children's for surgery, acute illness or dose titration admission.

Brief summary: The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, compared to lab serum lactate in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, in a population of patients with glycogen storage disease type 1a.

Detailed description: The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, within 20% of lab serum lactate reading 95% of the time, in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, within 20% of lab serum glucose reading 95% of the time, in a population of patients with glycogen storage disease type 1a.

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed/confirmed (by liver biopsy or genetic testing) Glycogen Storage Disease Type Ia (ICD 10 code: E74.01).
* Connecticut Children's Emergency Department visit and/or admission to Connecticut Children's during time study is active
* For pediatric participants: Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document
* For adults: Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients with Glycogen storage disease unspecified 74.00, or Ib
* Patients not meeting inclusion criteria

Primary outcomes:
measure: Home lactate meter accuracy in GSDIa compared with lab lactate
timeFrame: Every 1-3 hours for a maximum 33 hours
Secondary outcomes:
measure: Glucometer accuracy in GSDIa compared with lab lactate
timeFrame: Every 1-3 hours for a maximum 33 hours
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
References:
Clinical trial NCT06856330: Effect of Furlow Palatoplasty With Buccal Myomucosal Flap on the Speech Development
Official title: Effect of Furlow Palatoplasty With Buccal Myomucosal Flap Versus Two Flap Palatoplasty During Primary Cleft Palate Repair on the Speech Development
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cleft Palate
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 3-5 year old children with treated cleft palate

Brief summary: About 20 patient will be collected according to the eligibility criteria and grouped into Group I : 10 patients were treated with furlow with buccinators flap Group II : 10 patients were treated with 2 flap palatoplasty All patients will be examined by an expert Phoniatrician by Recording of speech samples in Arabic language for the children in a soundproof room including repeated syllables, sentences with high-pressure sounds and counting from 1 to 10. The records will be analyzed to assess the degree of hypernasality, speech intelligibility and compensatory speech errors


Eligibility criteria: Inclusion Criteria:

* 3-5 years old childreen with previous treated complete cleft lip and palate, nonsyndromic.
* lip and palate repair performed by one craniofacial surgeon

Exclusion Criteria:

* Patients with syndromic cleft lip.
* Redu cases
* Bilateral cleft lip
* Patient older 5years or younger 3 years.
* Associated Cardiac anomalies.
* Any systemic condition

Primary outcomes:
measure: speech assessment
timeFrame: through study completion, an average one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00054730: Effects of CX516 on Functioning in Fragile X Syndrome and Autism
Official title: Effects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fragile X Syndrome
Autism
Keywords: Fragile X Syndrome
Autism
Lead sponsor: Cortex
Sponsor class: INDUSTRY
Collaborators: name: FRAXA Research Foundation
First posted: 2003-02-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate whether CX516 can improve attention, memory, language, or behavior in adults with Fragile X Syndrome and/or Autism.

CX516 is an AMPAKINE® compound. AMPAKINE compounds enhance synaptic strength. There is evidence to suggest that the synapses in the brain of an individual with fragile X syndrome are immature and abnormal. It is possible CX516 may partially correct this synaptic transmission defect and lead to improvement in cognitive and behavioral functioning.

There is also reason to believe that these changes caused by CX516 could be helpful in managing cognitive and behavioral symptoms in patients with autistic disorder.

Involvement for each participant will last 28 days. Participants will be given study medication, a physical exam, and a variety of cognitive assessment tests to study potential drug effectiveness at improving disease symptoms.


Eligibility criteria: Inclusion criteria:

Fragile X group

* DNA-based diagnosis of Fragile X syndrome

Autism group

* Documented diagnosis with ADOS; ADI-R; CARS and GARS

Both groups

* 18-50 years
* Measured IQ below 85
* Measured IQ \>20
* Mental age \>30 months
* Stable medication regimen for past 8 weeks
* Normal hearing
* Vision corrected to at least 20/50
* All females of childbearing age must have a negative pregnancy test at enrollment

Exclusion criteria:

* Recent history of seizure, epilepsy, or blackouts
* Unresolved medical issue impacting performance
* Behavioral dysfunction to the point that subject cannot cooperate for testing
* History of drug-induced neutropenia
* Uncontrolled hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis-MIND Institute
state: California
city: Chicago
country: United States
facility: RUSH-Presbyterian-St. Luke's Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT02825030: Sun Protection Factor Assay (SPF Assay 18676)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment- Darkening Dose.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing.
* Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00910130: Insulin Resistance And End Stage Renal Disease: The Role Of Retinol Binding Protein 4
Official title: Insulin Resistance And End Stage Renal Disease: The Role Of Retinol Binding Protein 4
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Insulin Resistance
Diabetes
End Stage Renal Disease
Keywords: Retinol Binding Protein 4
Insulin Resistance
Diabetes
End Stage Renal Disease
Dialysis
Nutrition
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2009-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory patients or primary care clinic for "End Stage Renal Disease group;" Blood donors or primary care clinic for "Control group"

Brief summary: The purpose of this study is to determine whether Retinol binding protein 4 has a role in insulin resistance development in patients suffering from end stage renal disease on hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Hemodialysis for "End Stage Renal Disease group"
* Normal Renal Function for "Control group"

Exclusion Criteria:

* Diabetes
* Malnutrition
* Malignancy
* Acute Infection
* Chronic Active Infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Giovanni Piotti
Study officials:
affiliation: Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy
name: Giovanni Piotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy
name: Teresa Rampino, MD
role: STUDY_DIRECTOR
affiliation: Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy
name: Antonio Dal Canton, MD
role: STUDY_CHAIR
References:
citation: Yang Q, Graham TE, Mody N, Preitner F, Peroni OD, Zabolotny JM, Kotani K, Quadro L, Kahn BB. Serum retinol binding protein 4 contributes to insulin resistance in obesity and type 2 diabetes. Nature. 2005 Jul 21;436(7049):356-62. doi: 10.1038/nature03711.
citation: Graham TE, Yang Q, Bluher M, Hammarstedt A, Ciaraldi TP, Henry RR, Wason CJ, Oberbach A, Jansson PA, Smith U, Kahn BB. Retinol-binding protein 4 and insulin resistance in lean, obese, and diabetic subjects. N Engl J Med. 2006 Jun 15;354(24):2552-63. doi: 10.1056/NEJMoa054862.
Clinical trial NCT00305630: Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)
Official title: Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Choroidal Neovascularization
Age-Related Macular Degeneration
Keywords: Corticosteroids
Triamcinolone
Photodynamic therapy
Choroidal neovascularization
Age-related macular degeneration
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2006-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration (AMD). Patients undergoing PDT are randomized to either a periocular corticosteroid injection with 40 mg of triamcinolone acetonide or observation just prior to PDT. Patients are followed for 6 months. Primary outcome is leakage from choroidal neovascularization (CNV) at 3 months on fluorescein angiography.


Eligibility criteria: Inclusion Criteria:

* Active choroidal neovascularization
* Age related macular degeneration
* Visual acuity 20/20 to 20/400

Exclusion Criteria:

* Neovascular lesion \>6500 microns is greatest linear diameter
* More than one prior photodynamic therapy treatment
* Receiving systemic corticosteroids
* Intraocular pressure \> 21 mm Hg or glaucoma medication use
* History of glaucoma or history of ocular hypertension

Primary outcomes:
measure: Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.
Secondary outcomes:
measure: Safety
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Univeristy School of Medicine
state: Maryland
city: Portland
country: United States
facility: Oregon Health Science Univeristy
state: Oregon
Study officials:
affiliation: Johns Hopkins University
name: Douglas A Jabs, MD, MBA
role: STUDY_CHAIR
affiliation: Johns Hopkins Univeristy School of Medicine
name: Neil M Bressler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: David J Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: