louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01953159: Assessment of Paclitaxel-Induced Neuropathy
Official title: Validation of a Polygenic Neurotoxicity Risk Score in Patients With Unusually Severe Paclitaxel-Induced Neuropathy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Breast Cancer
Ovarian Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with paclitaxel

Brief summary: The purpose of this study is to collect clinical data, blood samples, and self reported symptoms from patients that experience unusually severe neuropathy after treatment with paclitaxel. This data will be used to develop predictive markers for neuropathy. Blood samples will be used to create induced pluripotent stem (iPS) cells and eventually artificial nerve cells to be used to study neuropathy in the lab.


Eligibility criteria: Inclusion Criteria (Severe Toxicity Group):

* Diagnosis of cancer (including, but not limited to, breast and ovarian cancer)
* Females aged 18 and older
* History of grade 3 or higher peripheral neurotoxicity, any neuromotor, neurocortical, or neurocerebellar toxicity, myalgias or arthralgias refractory to non-steroidal anti-inflammatory drugs and steroids, ong-term persistence (\> 6 months) of grade 2 or higher peripheral neuropathy, or other unusually severe neurotoxicity approved for inclusion in study by Principal Investigator after completion of paclitaxel chemotherapy regimen or history of peripheral neuropathy that required treatment with narcotics or grade 2 or higher peripheral neuropathy after only 1 to 2 doses of paclitaxel.

Inclusion Criteria (Control Group):

* History of no neurotoxicity (grade 0) after completion of a standard paclitaxel-containing chemotherapy regimen
* Females age 18 and older
* Matched to a specified subject with neurotoxicity based on age (within 10 years), tumor type, chemotherapy regimen or total paclitaxel dosage, race, and ethnicity

Exclusion Criteria :

* Treatment with other severely neurotoxic chemotherapy (i.e. cisplatin) prior to or concomitantly with paclitaxel. Carboplatin therapy is allowed.
* Presence of peripheral neuropathy prior to paclitaxel therapy
* Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity (alcoholism, Charcot-Marie-Tooth disease)

Primary outcomes:
measure: Validation of polygenic risk score
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Gini Fleming, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05370859: mMe: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients
Official title: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Behaviors
Cancer
Motivation
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 25
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 being seen at the study recruitment sites for cancer treatment, who have a current cancer diagnosis and who are currently smoking. Other concurrent tobacco use is also acceptable.

Brief summary: The objectives of this study are to pilot test a protocol of weekly assessments of motivation to quit and other relevant constructs combined with information about how to enroll in cessation programs, which will allow initial quantification of motivation to quit during cancer treatment and develop hypotheses about the impact of motivation on the decision to enroll in services.


Eligibility criteria: Inclusion Criteria:

* An adult (18+)
* Current smoker defined by: Has smoked 100 cigarettes in their lifetime (may be multi-tobacco users as long as they also use combustible cigarettes).
* Any type of cancer (except non-melanoma skin cancer)
* Anticipates receiving any of the following cancer treatments in the 3 months following enrollment: chemotherapy, surgery, immunotherapy, bone marrow or stem cell transplant, hormone therapy, or radiation
* Access to the Internet

Exclusion Criteria:

* Not smoked 100 cigarettes in their lifetime
* \< 18 years in age
* Diagnosed with non-melanoma skin cancer
* Not diagnosed with cancer
* Does not anticipate receiving cancer treatments in the 3 months following enrollment
* Has been previously enrolled in an existing Cancer Center Tobacco Treatment Program (TTP)
* Not comfortable reading and responding to questions in English
* No consistent access to the Internet

Primary outcomes:
measure: Number of participants who enroll in cessation services
timeFrame: 12 weeks after study start
Secondary outcomes:
measure: Level of and change in motivation and self-efficacy to quit smoking
timeFrame: Through study completion, an average of 12 weeks
measure: Level of and change in anxiety and depression
timeFrame: Through study completion, an average of 12 weeks
measure: Number of smoking quit attempts
timeFrame: 12 weeks after study start
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center and affiliated sites
state: Virginia
Study officials:
References:
Clinical trial NCT05798559: Sleep Hygiene Education in Mothers With Preschool Children
Official title: Investigation of the Effectiveness of Sleep Hygiene Education in Mothers With Preschool Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Habits
Neurodevelopmental Disorders
Keywords: Sleep Hygiene
Neurodevelopmental Disorders
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial

Mothers of children with neurodevelopmental disorders will be included in the study.

Inclusion criteria for the study:

* Having a child with a neurodevelopmental disorder
* Be over 18 years old and literate
* Having a child(s) of pre-school age (3-6 years old)
* Communicating and collaborating

Intervention and study group will be formed by simple randomization.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to gain importance of sleep routine and environment in mothers have children with neurodevelopmental disorders. The main questions it aims to answer are:

* What is the importance of sleep routine and environment in children with neurodevelopmental disorders?
* What kind of an effect does the awareness that mothers gain through sleep trainings have?

Participants will:

* Evaluations will be applied to all participants
* Divided into intervention and control groups
* The intervention group will be given "Sleep Training" and followed up for about 1 month.
* The results between the two groups will be compared

Researchers will compare intervention and control groups to see if turning a healthy sleep routine into a life habit


Eligibility criteria: Inclusion Criteria:

* Having a child with a neurodevelopmental disorder
* Be over 18 years old and literate
* Having a child(s) of pre-school age (3-6 years old)
* Communicating and collaborating

Exclusion Criteria:

* Having a neurological or psychiatric disease that prevents communication and cooperation

Primary outcomes:
measure: The Children's Sleep Habits Questionnaire
timeFrame: 1 month
Secondary outcomes:
measure: Occupational Balance Questionnaire
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
state: İ̇stanbul
Study officials:
affiliation: Bezmialem Vakif University
name: Kardelen Yıldırım, Lecturer
role: STUDY_CHAIR
affiliation: Bezmialem Vakif University
name: Gülşah Zengin, Lecturer
role: STUDY_DIRECTOR
affiliation: Bezmialem Vakif University
name: Sultan Akel, Lecturer
role: STUDY_DIRECTOR
affiliation: Bezmialem Vakif University
name: Sümeyye Sarışahin, Researcher
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University
name: Beyzanur Demirci, Researcher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00612859: Study to Assess the Efficacy and Safety of Levetiracetam for the Treatment of Social Anxiety Disorder (Generalized Type)
Official title: A Multicenter, Randomized, Double-Blind, PBO-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Levetiracetam Versus PBO for the Treatment of Social Anxiety Disorder (Generalized Type)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety Disorders
Keywords: Levetiracetam
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-02-12
Enrollment: 217
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: TREATMENT

Brief summary: Preclinical and clinical findings indicate that LEV has some anxiolytic potential. There is reason to believe that compounds with anxiolytic activity may have broad clinical utility across the anxiety spectrum. This trial was intended to explore LEV's utility in adults with social anxiety disorder.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients between 18 and 70 years old inclusive;
* symptoms of social anxiety disorders (generalized type) present for at least 1 year prior to Selection Visit;
* had a score of \>=60 on the LSAS at the Selection Visit and at the Randomization Visit. Additionally, the clinician's gloal impression of change score must have been \>= 2 at the Randomization Visit;
* had a telephone where they could be directly contacted.

Exclusion Criteria:

* History of autism or Asperger's Disease;
* had another primary axis I disorder or fulfilled diagnostic and statistical manual of mental disorders-4th edition (DSM-IV) criteria in the 6 months prior to Screening;
* major depression as measured by a Hamilton Depression Rating Scale (HAM-D-17 items) total score of \> 17 and/or a suicide subscale score on the HAM-D-17 items of \> 2 at the Selection or Randomization Visit;
* history of electroconvulsive therapy within the prior 3 months;
* history of psychotherapy which was not stable and ongoing for at least 6 months prior to Visit 1;
* clinical history of significantly impaired renal function with an estimated creatinine clearance below 80 mL/min;
* clinically significant medical condition;
* history of any clinically significant allergic condition or allergy to LEV or pyrrolidone derivatives;
* neutrophil count of less than 1800/µL.

Primary outcomes:
measure: change in Liebowitz Social Anxiety Scale (LSAS) score from Visit 2 to the last Evaluation period visit attended using last observation carried forward (LOCF) methods
measure: Safety: monitoring of AEs, clinical laboratory tests, physical examination and vital signs.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004359: Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epidermolysis Bullosa Acquisita
Keywords: dermatologic disorders
epidermolysis bullosa
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Northwestern University
First posted: 1999-10-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate immunomodulation with extracorporeal photochemotherapy (ECP) in patients with epidermolysis bullosa acquisita.

II. Investigate the effect of ECP on lymphocyte activity.

Detailed description: PROTOCOL OUTLINE: Oral methoxsalen (8-MOP) is administered 90 minutes prior to leukapheresis. Blood mononuclear cells are exposed to ultraviolet A light for 3 hours, then returned to the patient. The process is repeated on 2 successive days.

Patients are re-treated every 3 to 4 weeks for a total of 6 treatments or until the skin has cleared.

Eligibility criteria: * Active epidermolysis bullosa acquisita

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Kenneth B. Gordon
role: STUDY_CHAIR
References:
Clinical trial NCT02335359: Tranexamic Acid in Major Vascular Surgery
Official title: Tranexamic Acid in Major Vascular Surgery. A Randomized Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Loss, Surgical
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair


Eligibility criteria: Inclusion Criteria:

* Age \> 50
* Able to give written informed consent
* Undergoing open abdominal aortic aneurysm repair

Exclusion Criteria:

* Patients participating in a pharmaceutical clinical trial in the last 3 months
* Urgent/emergent surgery
* Allergy/intolerance to tranexamic acid
* History of seizures
* Acute Venous or Arterial Thrombosis
* Fibrinolytic conditions due to consumption coagulopathy
* Disseminated intravascular coagulation
* Haematuria
* Visual disturbances

Primary outcomes:
measure: Blood loss (milliliters)
timeFrame: intraoperative (from skin incision to skin closure)
Secondary outcomes:
measure: Number of packed blood red cells transfused
timeFrame: hospital stay (an average of one week)
measure: Occurrence of thromboembolic events (of any nature)
timeFrame: 28-days and one year after surgery
measure: Mortality
timeFrame: 28-days and one year after surgery
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
References:
citation: Monaco F, Nardelli P, Pasin L, Barucco G, Mattioli C, Di Tomasso N, Dalessandro G, Giardina G, Landoni G, Chiesa R, Zangrillo A. Tranexamic acid in open aortic aneurysm surgery: a randomised clinical trial. Br J Anaesth. 2020 Jan;124(1):35-43. doi: 10.1016/j.bja.2019.08.028. Epub 2019 Oct 10.
Clinical trial NCT01903759: Kinetics of Inflammation Markers in Maternal Plasma: Study of the Correlation With the Diagnosis of Chorioamnionitis in Women Hospitalized for Spontaneous Rupture of the Fetal Membranes
Official title: Kinetics of Inflammation Markers in Maternal Plasma (Interleukins, Matrix Metalloproteinases -MMP): Study of the Correlation With the Diagnosis of Chorioamnionitis in Women Hospitalized for Spontaneous Rupture of the Fetal Membranes (SPROM) Before 34 Weeks of Amenorrhea (WA) With no Modification in the Usual Therapy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patients With Spontaneous Rupture of the Fetal Membranes
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The principal aim of this study is to help obstetricians to diagnose chorioamniotic infection early, in cases of premature rupture of the fetal membranes before 34 WA, by proposing earlier and more specific markers of infection than FBC and CRP. The aim is to reduce vital and functional risk of acute chorioamnionitis for the mother, the fetus or the newborn,.

If the kinetics profile of one or several markers correlates strongly with the diagnosis of chorioamnionitis, it could be used in clinical practice, possibly in the context of another clinical study.

The results of the study presented here are destined to be published in obstetrics journals.


Eligibility criteria: Inclusion Criteria:

* Term between 24 and 34 WA
* Spontaneous rupture of the fetal membranes
* Singleton pregnancy
* Age \> 18 years

Exclusion Criteria:

* Delivery within the hour following admission
* Hospitalisation before 24 WA or after 34 WA
* Hemorrhagic placenta previa or retroplacental hematoma, known auto-immune or inflammatory disease
* Infection with human immunodeficiency virus (HIV)
* Refusal to provide consent.
* Patients provided for in articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g.: minors, adults under guardianship, etc...)

Primary outcomes:
measure: determination of plasma cytokines
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
References:
Clinical trial NCT04391959: Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
Official title: A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Azura Ophthalmics
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2020-05-18
Enrollment: 31
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: AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

Detailed description: AZ202001 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 years of age or older
* Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye
* Evidence of meibomian gland obstruction
* Reported dry eye signs and symptoms within the past 3 months

Exclusion Criteria:

* Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease
* Glaucoma, ocular hypertension, or intraocular pressure (IOP) in either eye at screening ≥24 mm Hg or has planned insertion/removal of glaucoma filtration shunts/devices during the study
* Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity
* BCVA worse than 20/40 in either eye
* Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye

Primary outcomes:
measure: Meibum Gland Secretion Score (MGS)
timeFrame: Month 3
Secondary outcomes:
measure: Total OSDI
timeFrame: Day 14 to Month 3
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Fiona Stapleton
state: New South Wales
city: Brisbane
country: Australia
facility: Scott A Read
state: Queensland
city: Maroochydore
country: Australia
facility: Susan Thackwray
state: Queensland
city: Auckland
country: New Zealand
facility: Jagrut Lallu
city: Auckland
country: New Zealand
facility: Jennifer P Craig
Study officials:
affiliation: School of Optometry and Vision Science, University of New South Wales
name: Jacqueline Tan-Showyin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04820959: Validation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers
Official title: Validation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Valvulopathy
Heart Surgery
Procollagen C-Proteinase Enhancers
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Heart failure is characterized by cardiac fibrosis linked to extracellular collagen deposits. Collagens are synthesized as soluble precursors, procollagens, which must undergo proteolytic maturation to assemble into fibres. This step is under the control of two extracellular proteins, procollagen C-proteinase enhancer 1 and 2 (PCPE-1 and -2). The mechanism of action of these highly effective and specific activators was recently elucidated by one of our partners. Preliminary results, as well as data from the literature, indicate a strong correlation between the expression rates of PCPEs and cardiac fibrosis. The aim of this study is to validate in humans, by analysis of endomyocardial tissue biopsies, the hypothesis that PCPEs contribute to the anarchic accumulation of collagen during cardiac fibrosis and to evaluate the interest of developing new diagnostic and therapeutic strategies for cardiac fibrosis using PCPE agonists.


Eligibility criteria: Inclusion Criteria:

* Person who has given written consent
* Patient aged 18 to 85 for men and 60 to 85 for women
* Patient requiring cardiac surgery for aortic valve replacement or aortic plastic surgery or aortic plasty or ascending aorta replacement more or less associated with aortic valve surgery

Exclusion Criteria:

* Person not affiliated or not benefiting from national health insurance
* Person subject to a measure of legal protection (curatorship, guardianship)
* Person deprived of liberty, by judicial or administrative decision
* Major incapable or incapable of giving consent
* Minor
* Pregnant or breastfeeding woman
* Emergency Surgery
* Acute Infectious Endocarditis

Primary outcomes:
measure: Myocardial fibrosis rate
timeFrame: Through study completion, an average of 1 year
measure: Rate of PCPE-1/2
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: