louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05919563: LTFU Study of Subjects Who Received GRNOPC1
Official title: Long Term Follow-up of Subjects Who Received GRNOPC1
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spinal Cord Injuries
Lead sponsor: Lineage Cell Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who received administration of GRNOPC1 under clinical study protocol CP35A007

Brief summary: This is a LTFU study for thoracic SCI subjects that were administered GRNOPC1 cells in the main study CP35A007.

Detailed description: Study CP35A008 is a Phase 1, multi-center long term follow-up (LTFU) study for five (5) subjects with complete thoracic SCI that were administered 2 million GRNOPC1 cells in the main study CP35A007. The purpose of this study is to monitor long-term safety in subjects for 15 years post GRNOPC1 administration.

Eligibility criteria: Inclusion Criteria:

* Subjects who received administration of GRNOPC1 under clinical study protocol CP35A007.

Exclusion Criteria:

* There are no exclusion criteria for this LTFU study.

Primary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: Up to 15 years after GRNOPC1 injection
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Evanston
country: United States
facility: Northwestern Medical Group
state: Illinois
Study officials:
affiliation: Lineage Cell Therapeutics, Inc.
name: Gary Hogge, DVM, MS, PhD
role: STUDY_CHAIR
References:
citation: McKenna SL, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth E, Fessler RG. Ten-year safety of pluripotent stem cell transplantation in acute thoracic spinal cord injury. J Neurosurg Spine. 2022 Apr 1;37(3):321-330. doi: 10.3171/2021.12.SPINE21622. Print 2022 Sep 1.
Clinical trial NCT03233763: Laboratory Studies Into the Pathology of Leukaemia
Official title: Laboratory Studies Into the Pathology of Leukaemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is an exploratory laboratory study using stored tissue where consent has already been given.

Brief summary: Ongoing laboratory work into the pathology of Leukaemia:

Detailed description: The investigators will test AML samples sent to the diagnostic laboratory from participants with newly diagnosed or relapsed/refractory AML. Samples will be sent from district general hospitals and teaching hospitals.

Results will be returned to referring clinicians in the same way investigators currently return results for samples sent for standard tests. The service will be advertised through the Royal Marsden Website with visibility to both participants and HCPs). The investigators will also inform all the clinicians involved in the AML working party (Dr Taussig is a member of the AML working group).

In addition we are looking at diagnostic approaches to IDH 1 and 2 mutation identification.

An initial comparison of 50 samples by three analysis methods will be conducted.

IDH1 and IDH2 variant discovery will first be performed using an established standard in house SOP (SOP: SMD103) for CE-SSCA

Eligibility criteria: Inclusion Criteria:

18 \& Over Diagnosis of AML Generic Research consent given

Exclusion Criteria:

Under 18 No generic research consent

Primary outcomes:
measure: Pathology of Leukaemia cells
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Department of Haematology, the Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: David Taussig
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04758663: The Role of Naps and Overnight Sleep on Cognitive Learning in Preschoolers
Official title: The Role of Naps and Overnight Sleep on Cognitive Learning in Preschoolers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 40
Sex: ALL
Minimum age (years): 33
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Within subject comparison of nap/overnight and wake/overnight conditions in habitual and non-habitual nappers
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this research is to understand the role of sleep on memory function in early childhood. Specifically, we seek to examine how promoted naps vs. promoted waking in habitual and non-habitual napping children may impact overnight sleep physiology and subsequent memory consolidation.

Detailed description: With time spent awake, sleepiness increases (i.e., sleep pressure; Borbely, 1982). In young adults, naps following sleep deprivation have significantly elevated slow wave activity (SWA; 1-4 Hz) relative to naps following normal overnight sleep (Werth et al., 1996). Similarly in preschool children, overnight sleep following nap deprivation yields significantly greater SWS relative to when a nap was taken earlier in the day (Lassonde et al., 2016). This impact on subsequent sleep physiology suggests that naps may be an extension of overnight sleep. How napping status (i.e., habitual and non-habitual napping) impacts overnight sleep physiology and subsequent memory consolidation is unknown. Thus, this study aims to investigate how napping vs. staying awake in habitual and non-habitual napping children may impact overnight sleep physiology and subsequent memory consolidation.

Eligibility criteria: Inclusion Criteria:

* Family lives within 30 miles of UMass Amherst
* Is 33-71 months at the time of enrollment
* Meets the definition of a habitual (5+ naps/week) or non-habitual (\<2 naps/week) napper
* Normal or corrected-to-normal vision and hearing
* Access to a computer with an internet connection for online sessions with the research team.

Exclusion Criteria:

* Diagnosis of any sleep disorder (other than mild parasomnia which is routine at this age) past or present
* Current use of psychotropic or sleep-altering medications
* Traveling beyond 1 time zone within 1 month of participation
* Fever or symptoms of respiratory illness at the time of participation
* Diagnosed developmental disability

Primary outcomes:
measure: Overnight sleep physiology
timeFrame: 9-11 hours of sleep overnight
Secondary outcomes:
measure: Change in memory accuracy
timeFrame: 2-3 hours/24 hours
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Amherst
name: Rebecca M Spencer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04193163: Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device
Official title: Prospective Observational Clinical Study Conducted Over a 10-year Period on Patients Who Received the ESOP 2 Stem to Restore Joint Function, in Order to Confirm Security and Performance of the Device
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Disease
Hip Fractures
Keywords: Arthroplasty
Hip replacement
Lead sponsor: FH ORTHO
Sponsor class: INDUSTRY
First posted: 2019-12-10
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from participating hospitals will be enrolled as part of their clinical routine care.

Brief summary: This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real life conditions according to the instructions for use.

Detailed description: The primary objective of this study is to evaluate the security of the ESOP 2 stem by calculating the survival rate up to 10 years of follow-up.

The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score and quality of life score up to 10 years of follow-up.

Eligibility criteria: Inclusion Criteria:

* Subject implanted with ESOP 2 stem in one of the following indication according to the instructions for use: hip disorders; femoral neck fracture
* Subject who received an information form and is willing to participate in the study

Exclusion Criteria:

* Contraindications described in the instructions for use
* Usual surgical contraindications
* Subject who is not able to express his/her non-opposition

Primary outcomes:
measure: Survival rate
timeFrame: 10 years post-op
Secondary outcomes:
measure: Radiographies evaluation
timeFrame: immediate post-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
measure: Rate of complications
timeFrame: per-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
measure: Functional outcomes such as pain, mobility
timeFrame: pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
measure: Quality of life evaluation
timeFrame: pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Tivoli Ducos
city: Bordeaux
country: France
facility: Nouvelle Clinique Bel-Air
city: Colmar
country: France
facility: CH Pasteur
city: Garches
country: France
facility: CH Raymond POINCARE
city: Haguenau
country: France
facility: CH de Haguenau
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière
city: Écully
country: France
facility: Clinique du Val d'Ouest
Study officials:
References:
Clinical trial NCT06161363: Description of Compliance With Hydroxychloroquine Treatment in Patients With Systemic Lupus Erythematosus
Official title: Description of Compliance With Hydroxychloroquine Treatment in Patients With Systemic Lupus Erythematosus in a Hospital Internal Medicine Consultation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lupus Erythematosus
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with systemic lupus erythematosus

Brief summary: The project focuses on non-compliance in patients with systemic lupus erythematosus taking Plaquenil. More than half of patients with chronic illness are not or only poorly compliant with their treatment and lupus is one of them.

The investigators want to use an already validated existing questionnaire in English, the Morisky Medication Adherence Scale 8 (MMAS 8). These results will make it possible, after a multivariate study with reference to the gold standard which is hydroxychloroquinemia, to see which exact questions in the questionnaire can be used in general medicine practices in order to detect less or non-compliant patients as early as possible.


Eligibility criteria: Inclusion Criteria:

Age \>18 years

* Patient with systemic lupus erythematosus
* Treatment with PLAQUENIL for \> 6 months with dosage of hydroxychloroquinemia planned during the consultation.

Primary outcomes:
measure: Non-compliance with hydroxychloroquine treatment
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse Hospital
Study officials:
References:
Clinical trial NCT01274663: A Study Of PF-05175157 In Healthy Volunteers
Official title: A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-05175157 After Administration Of Single Escalating Oral Doses Under Fasted And Fed Conditions In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Single Ascending Dose
Phase 1
Safety and Tolerability
PK
Healthy Subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 45 years (inclusive).
* Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
* In addition, subjects must have normal chest x-ray, normal pulmonary function tests and normal ophthalmological examination.
* Body Mass Index (BMI) of 17.5 to 29.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
* Evidence or history of any chronic ongoing or current pulmonary disease.
* History of 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.
* Active ocular disease including infection, glaucoma, seasonal allergies, dry-eye symptoms or retinal/optic nerve disease.
* Evidence or history of 'dry eye-syndrome', Meibomian gland disease, ocular inflammation (eg, uveitis, iritis), chronic blepharitis, any eye surgery including Lasik, any mechanical injury or chemical exposure to the ocular surface, use of ocular lubricants, or use of contact lenses.

Primary outcomes:
measure: Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects
timeFrame: 5 months
measure: Single dose pharmacokinetics of PF-05175157
timeFrame: 5 months
Secondary outcomes:
measure: Exploratory pharmacodynamic biomarkers
timeFrame: 5 months
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03739463: Pro-omega-3, Reduction of Inflammation and Modulation of Prematurity
Official title: Pro-omega-3, Reduction of Inflammation and Modulation of Prematurity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PPROM
Keywords: Pro-omega-3
Inflammation
Prematurity
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Laval University
First posted: 2018-11-13
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the project is to decrease the inflammatory status of pregnant women with preterm premature rupture of membranes to delay the initiation of labour that would inevitably lead to premature delivery. The main objective is to measure the mean duration between the initiation of the treatment and delivery in the two groups treated either with MAG-DHA or with the placebo.

Detailed description: This randomized controlled trial will be conducted in two hospitals in the province of Quebec (CHUS, CHUQ- Site mère-enfant Soleil).

Patients between 24 and 33 weeks of gestation with a diagnosis of preterm premature rupture of membranes (PPROM) who meet all inclusion and none of the exclusion criteria will be approached to participate. Once they have signed the IFC, participants will be randomized and begin a supplementation with either MAG-DHA or the placebo until delivery or for up to 2 weeks (14 days). A total of 70 patients will be recruited.

Principal outcome: To compare the difference in duration between the start of treatment and delivery between the group receiving MAG-DHA and the group receiving placebo.

Secondary outcomes: 1) Evaluate the difference in neonatal outcome between children in the MAG-DHA group and those in the placebo group. 2) Determine the inflammatory status of the patients associated with the exposure to either MAG-DHA or the placebo.

This regimen could potentially represent an innovative approach in the management of women with a diagnosis of PPROM.

Eligibility criteria: Inclusion Criteria:

* PPROM diagnosis, gestational age between 24 and 33 weeks of gestation.

Exclusion Criteria:

* multiple pregnancy, placenta previa, preeclampsia, retroplacental hematoma, chorioamnionitis, intrauterine growth retardation, severe fetal malformations

Primary outcomes:
measure: Duration latency period
timeFrame: From PPROM through delivery
Secondary outcomes:
measure: Composite neonatal score
timeFrame: From birth through the first 28 days of life
measure: Inflammatory status
timeFrame: Every 2-3 days from PPROM until delivery or a maximum of 14 days, whichever happens first
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06325735: Combined Systemic Inflammatory Indices and Birth Weight
Official title: Combined Systemic Inflammatory Indices and Their Impact on Birth Weight: A Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Inflammation Markers
Birth Weight
Combined Systemic Inflammatory Indices
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 199
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprised full-term pregnant women. These participants were likely to represent a diverse range of ages and backgrounds, typical of a general pregnant population at a second-level University Hospital.

Health Status: The women included were in generally good health, with full-term, uncomplicated pregnancies. This was ensured by the rigorous exclusion of any pregnancies affected by significant health issues such as diabetes, hypertension, and other specified conditions.

Brief summary: The study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight

Detailed description: The research was structured as a prospective observational study. It was conducted at a second-level University Hospital over the period from December 2019 to February 2021.

Participants:

Blood samples were collected at hospital admission. These samples were used for a complete blood count, focusing specifically on deriving systemic inflammatory indices.

The primary inflammatory indices studied were Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), and Monocyte-to-Lymphocyte Ratio (MLR).

The birth weight was registered.

Eligibility criteria: Inclusion Criteria:

* physiological Full-term pregnancies

Exclusion Criteria:

* gestational diabetes
* pregestational diabetes
* Chronic Hypertension
* Gestational Hypertension
* Preeclampsia
* Eclampsia
* Intrauterine Fetal Growth Restriction
* Preterm Delivery
* Multiple Pregnancies
* Fetal malformations

Primary outcomes:
measure: Systemic inflammatory indices and birth weight
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -
state: Italia
Study officials:
References:
Clinical trial NCT04829435: Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
Official title: A Phase I Randomized, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperuricemia
Gout
Lead sponsor: Allena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase I study is to evaluate the safety and tolerability of ALLN-346 in in normal healthy volunteers, in an ascending dose design.

ALLN-346 is an (oral) enzyme that specifically degrades urate in the intestinal tract.

Detailed description: This is a Phase I, 7-day, randomized, double-blind, placebo-controlled, multiple ascending dose study of orally administered ALLN-346 in normal healthy volunteers. Study will take place at a clinical pharmacology unit (CPU). Two sequential cohorts will be dosed and followed for safety through Day 28.

The study will evaluate safety and tolerability (including inflammation and immunogenicity), and pharmacodynamics of ALLN-346.

Eligibility criteria: Inclusion Criteria:

* Male or female, age 18 to 55 years
* Incapable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation
* Good general health as determined by medical history and physical examination
* Normal clinical laboratory test results and ECG

Exclusion Criteria:

* Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurological, psychiatric disease or history of hyperuricemia
* Any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines
* Positive screen results for drugs of abuse, alcohol, or cotinine or recent history of drug or alcohol abuse, or positive COVID-19 test
* Clinically significant abnormal findings on physical examination, vital signs or on electrocardiogram (ECG)
* Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody
* Received treatment with or exposure to an Investigational drug or device within 30 days prior to or during Screening
* Prior dosing in ALLN-346 clinical study
* Per Investigator judgment, is not an ideal clinical study candidate

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: 28 days
Secondary outcomes:
measure: Serum ALLN-346
timeFrame: 8 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology
state: Ohio
Study officials:
affiliation: Allena Pharmaceuticals, Inc.
name: Christine Tosone, MS, RAC
role: STUDY_DIRECTOR
References: