louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00234546: Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity
Official title: A 24-week Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study of Dysport® Injection for the Treatment of Upper Limb Spasticity in Early Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Spasticity
Cerebrovascular Accident
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical study is to investigate the efficacy and safety of Dysport® in patients with early onset of upper limb spasticity within 2-12 weeks after stroke.


Eligibility criteria: Inclusion Criteria:

* First-ever stroke according to the World Health Organisation criteria (previous transient ischaemic attack or clinically silent infarct on CT/MRI is not counted as previous stroke)
* CT/MRI scan required to classify ischaemic / haemorrhagic stroke
* Patient recruited 2-12 weeks after stroke
* Modified Ashworth Spasticity Score 1+ or above in either elbow or wrist joint

Exclusion Criteria:

* The patient has bleeding disturbances or having used coumarin derivatives
* The patient is currently receiving drugs affecting neuromuscular transmission
* Co-existing severe systemic illness which may adversely affect the functional outcome
* Pre-existing neuromuscular junction disease or any neurogenic disorders which can interfere with spasticity

Primary outcomes:
measure: Reduction of spasticity assessed by changes of the Modified Ashworth Spasticity Score from baseline of elbow and wrist flexors in supine anatomical position
timeFrame: week 4
Secondary outcomes:
measure: Improvement of neurologic outcome (mobility and function), evaluated by Modified Ashworth Scale, Barthel Index, Modified Rankin scale, Functional scale (Motor Assessment Scale)
timeFrame: weeks 4, 8, 12 & 24
measure: Voluntary and passive joint range of motion goniometer assessment
timeFrame: weeks 4, 8, 12 & 24
measure: Pain Assessment using visual analogue scale for pain
timeFrame: weeks 4, 8, 12 & 24
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Hospital of Malaya Medical Centre
city: Manila
country: Philippines
facility: University of Santo Tomas
city: Singapore
country: Singapore
facility: TTSH Rehabilitation Centre
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Rosales RL, Kong KH, Goh KJ, Kumthornthip W, Mok VC, Delgado-De Los Santos MM, Chua KS, Abdullah SJ, Zakine B, Maisonobe P, Magis A, Wong KS. Botulinum toxin injection for hypertonicity of the upper extremity within 12 weeks after stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2012 Sep;26(7):812-21. doi: 10.1177/1545968311430824. Epub 2012 Feb 27.
Clinical trial NCT04415346: A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
Official title: A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Post Stroke Upper Limb Spasticity
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * Investigational Product: LIZTOX inj 100unit(HU-014)
* Title : A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
* Sites and investigators : Asan Medical Center(Seoul), Min-ho Chun, M.D, Ph.D
* Objective : To evaluate the safety of LIZTOX inj in the treatment of Post Stroke Upper Limb Spasticity


Eligibility criteria: Inclusion Criteria:

* A subject who is diagnosed with Stroke at least six weeks prior to Screening.
* A subject who has Modified ashworth scale(MAS) score which Wrist Flexor is ≥ 2 and Flexor or Finger Flexor is ≥ 1.
* A subject with a Disability assessment scale(DAS)of at least ≥ 2 in one of the categories of hand hygiene, clothing, upper extremity, or pain for evaluation.

Exclusion Criteria:

* A subject who has medical history following. (Allergy, Chemodenervation(within 6 months), Tendon lengthening(within 6 months), Intrathecal baclofen.Aspiration pneumonia, etc.)
* A subject who has history of any diseases following. (neuromuscular junction disorder, NMJ, myasthemia gravis, MG, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, ALS, Skin disease, Dysphagia, etc.)
* From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks
* Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
* A subject who tend to bleed or are taking anti-coagulant drugs.
* A sugject who is undergoing rehabilitation(physical therapy, occupational therapy, exercise therapy) or Splinting in the area where medication for clinical trials is scheduled to be administered.
* A sugject who has muscle atrophy, fixed joint/muscle contracture in the area where medication for clinical trials is scheduled to be administered.
* Any condition that, in the view of the investigator, would interfere with study participation.

Primary outcomes:
measure: MAS score improvement at Wrist Flexor, Elbow Flexor, Finger Flexor
timeFrame: Week 4, 8, 12 from baseline visit(=Investigational product Injection)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Department of Physical Medicine&Rehabilitation
name: Min-ho Chun, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02599246: FiO2 in Chronic Obstructive Pulmonary Disease (COPD) Patient Normobaric O2 Versus NIV
Official title: Measured FiO2 With Nasal Canula O2 Versus Noninvasive Ventilation (NIV) With the Same O2 Flow, in COPD Patients the NIV LEAKS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Home Care
Oxygen Therapy
Keywords: Home ventilator
FiO2
O2
NIV
COPD
Lead sponsor: Breas Medical S.A.R.L.
Sponsor class: INDUSTRY
First posted: 2015-11-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive pulmonary disease. With day time oxygenotherapy and nocturnal NIV and O2 supply

Brief summary: The purpose of this study is to compare pharyngeal FiO2 in day time with nasal normobaric O2 with inhaled FiO2 in the night time with home care ventilator NIV at the same O2 flow.

Detailed description: in a prospective observational study the investigators will register FiO2 in 15 voluntaries COPD patients as following:

* Pharyngeal FiO2 (G5® Philips™ side stream FiO2) with O2 supply through nasal cannula at basal flow (flow needed by patient). In order to compare FiO2s the investigators will measure FiO2 with 150%, 75%, 50% and 25 % of basal Flow
* And FiO2 during nocturnal NIV (pressure support ventilation; Vivo 50®, Bréas™), using facial or nasal masque (Confort Gel® Respironics™). O2 flow will be basal flow.

Eligibility criteria: Inclusion Criteria:

* informed consent

Exclusion Criteria:

* acute on chronic respiratory distress

Primary outcomes:
measure: Difference in FiO2 measured during NIV compared to the FiO2 measured during day time with nasal canula at similar O2 flow
timeFrame: 18 hours
Secondary outcomes:
measure: Time spent below different O2 levels during NIV despite constant O2 flow and their correlation to day time FiO2 with nasal canula
timeFrame: 18 hours
measure: levels of O2 adjustment needed to keep FiO2 stable with NIV
timeFrame: 1 hour
Other outcomes:
Locations:
city: Toulon
country: France
facility: Military teaching hospital Ste Anne
state: VAR
Study officials:
affiliation: Military teaching hospital Ste ANNE
name: Philippe GOUTORBE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cardinale M, Cungi PJ, Esnault P, Castagna O, Nguyen C, Daranda E, Bordes J, Arnal JM, Meaudre E, Goutorbe P. In COPD, Nocturnal Noninvasive Ventilation Reduces the FIO2 Delivered Compared With Long-Term Oxygen Therapy at the Same Flow. Respir Care. 2020 Dec;65(12):1897-1903. doi: 10.4187/respcare.07570. Epub 2020 Jul 21.
Clinical trial NCT04385446: Comparative Study of Muc5ac and Muc2 Mucins in Tear Film Concentration in Surgical Treated Pterygia Patients
Official title: Comparative Study of Concentration of Muc5ac and Muc2 Mucins in Tear Film in Surgical Treated Pterygia With Amniotic Membrane Transplantation vs. Conjunctival Autograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium of Both Eyes
Keywords: pterygium, amniotic membrane, conjunctival autograft, ocular mucin
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of patients in whom Conventional Pterygium surgery was performed Each patient was randomly assigned for either received amniotic membrane transplantation or conjunctival autograft as a recovering method in the pterygium removed area after surgery. Tear film Mucins were measured in both groups
Primary purpose: SCREENING

Brief summary: To identify and compare the differences in the concentration of the Muc2 and Muc5AC mucins in tear film in patients who underwent pterygium surgery using amniotic membrane transplantation and conjunctival autograft surgery.

Detailed description: Patients with nasal, primary pterygium bigger than 1 mm of corneal invasion with residence in Mexico City and older than 18 years were included. Under informed consent, patients were divided into two groups in a random fashion. Pterygium surgery was carried out with conventional technique performing amniotic membrane transplantation for group A, and conjunctival autograft for group B. Muc2 and muc5ac mucin concentration was measure min tear film by ELISA; samples were taken before surgery, at first, third and sixth month postoperatively. BUT was also measured on the same dates. Descriptive statistics and the U-Mann Whitney test for independent groups, considering a p≤0.05 as significant were used for analysis.

Eligibility criteria: Inclusion Criteria:

* Patients with nasal, primary pterygium bigger than 1 mm.

Exclusion Criteria:

* Diabetes mellitus, single eye.

Primary outcomes:
measure: Ocular Tear film Mucin MUC5ac concentration.
timeFrame: The patients will be assed during six months
measure: Ocular tear film Mucin MUC2 concentration.
timeFrame: The patients will be assed during six months
measure: Tear film breakup time.
timeFrame: The patients will be assed during six months
Secondary outcomes:
measure: Pterygium recurrence.
timeFrame: The patients will be assed during six months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04711746: Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?
Official title: Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Hematopoiesis
Keywords: Pulmonary Embolism
hematopoiesis
genetic sequencing
endothelial dysfunction
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The clonal hematopoiesis of indetermined prognosis (CHIP) has been described as risk factor for juvenile atherosclerosis. Moreover, some of CHIP genes are responsible of myeloproliferative disorders. Venous thrombosis are frequent in these disorders. The purpose of this project is to determine if CHIP is frequent in unprovoked pulmonary embolism and could be part of the pathophysiology.


Eligibility criteria: Inclusion Criteria:

* For cases : Previous proximal unprovoked pulmonary embolism, negative thrombophilia screening.
* For control : Previous proximal provoked pulmonary embolism, negative thrombophilia screening.

Exclusion Criteria:

* Age superior to 65 years old,
* Active cancer

Primary outcomes:
measure: Variation of CHIP markers between patients groups
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT05645146: Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)
Official title: Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Cervical Cancer
High Grade Cervical Dysplasia
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: James and Esther King Biomedical Research Program
First posted: 2022-12-09
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this research study is to compare the efficacy of a treatment approach that comprises both Motivation And Problem-Solving (MAPS)-based telephone counseling and a personally-tailored SMS-delivered text-based approach to quitline-delivered smoking cessation treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.


Eligibility criteria: Inclusion Criteria:

* At least 100 cigarettes or more smoked in participants lifetime
* Speaks English
* Currently smoke 1 cigarette or more in the past 30 days
* History of cervical cancer or high grade cervical dysplasia
* Has a working smartphone
* Has a valid home address
* Reside in Florida at the time of study enrollment

Exclusion Criteria:

* Receiving behavioral or pharmacological tobacco treatment
* Household member enrolled in this study

Primary outcomes:
measure: MAPS vs Standard Treatment in facilitating long term smoking abstinence
timeFrame: at 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Jennifer Vidrine, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02225912: A Study to Evaluate the Efficacy of the Nasal Antiseptic, PrevinC, When Administered for the RiskReduction of Rhinitis in Subjects Who Work for Child Day Care Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Upper Respiratory Infections
Lead sponsor: BioHealth Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Intervention model: CROSSOVER

Brief summary: The hypothesis was to establish whether the use of PrevinC administered nasally 2-3 times a day will prevent upper respiratory infections in otherwise healthy adults working in child day care centers.


Eligibility criteria: Inclusion Criteria:

* Subject must provide written informed consent prior to the conduct of any study
* Male or female
* 18-65 years of age
* Inclusive
* Employed by one of seven selected Day Care Centers

Exclusion Criteria:

* Recent symptoms of upper respiratory infection, respiratory disease
* Received medication for colds or allergies within 3 weeks of enrolling
* Had nasal surgery within 2 months of enrolling
* Had a pierced nose or wore nose jewelry

Primary outcomes:
measure: Rhinitis
timeFrame: weekly from February 2005 to May 2005, up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Sunflower Preschool & Day Care
state: Florida
city: Miami Beach
country: United States
facility: Mt Sinai Day Care
state: Florida
city: Miami
country: United States
facility: Sunflower Preschool Childcare
state: Florida
city: Miami
country: United States
facility: Sunflowers Academy
state: Florida
city: Miami
country: United States
facility: Sunflowers Academy
state: Florida
city: Miami
country: United States
facility: Sunflowers Preschool Childcare
state: Florida
Study officials:
References:
Clinical trial NCT01013012: Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Vomiting
Keywords: highly susceptible patients following spine surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery.


Eligibility criteria: Inclusion Criteria:

* Females
* Ages 18 to 65 years old

Exclusion Criteria:

* Patients who is taking steroid or who had been treated for the gastrointestinal disease
* Patients who have troubles with the kidney or liver
* Patients transferring to the ICU after the surgery
* overfat patients
* Patients who had taken antiemetics within 24 hours before the surgery

Primary outcomes:
measure: the incidence of postoperative nausea and vomiting(PONV)
timeFrame: After spinal surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05147012: Intraoperative Hypotension Predicted by Mean Arterial Pressure
Official title: Intraoperative Hypotension Predicted by Observation of Mean Arterial Pressure : a Retrospective Cohort Preliminary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wedge Resection
Lobectomy by Video-thoracoscopies
Keywords: wedge resection
lobectomy
video-thoracoscopies
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all gender minimum age : 18 years old Healthy volunteers are not accepted

Brief summary: During general anesthesia, intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Mean arterial pressure (MAP) \< 65mmHg is the most common definition of hypotension. In order to reduce IOH, a complex method using machine learning called hypotensive prediction index (HPI) was shown to be superior to changes in MAP (ΔMAP) to predict hypotension (MAP between 65 and 75 excluded). Linear extrapolation of MAP (LepMAP) is also very simple and could be a better approach than ΔMAP. The main objective of the present study was to investigate whether LepMAP could predict IOH during anesthesia 1, 2 or 5 minutes before.

Hypothesis : the area under the ROC curves (ROC Area Under Curves) at 1, 2 and 5 minutes of LepMAP would be superior to ΔMAP


Eligibility criteria: Inclusion Criteria:

* All lobectomy including for another study (VATOFA study) with continuous invasive blood pressure monitoring per arterial line
* All pancreaticoduodenectomy or hepatectomy including for another study (CARBODAV study) with continuous invasive blood pressure monitoring per arterial line
* age 18 or over

Exclusion Criteria:

* complex hemodynamic cases (heart, lung and liver transplantation)
* using extracorporeal membrane oxygenation.
* Patient who object to take part of the study.

Primary outcomes:
measure: AUC ROC of LepMAP
timeFrame: Only during perioperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Department of Anesthesiology and Intensive Care, Louis Pradel University Hospital
Study officials:
References:
Clinical trial NCT04341012: Breath Analysis Based Disease Biomarkers
Official title: Development of a Breath Analysis Test for Disease Diagnosis and Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Liver Cancer
COVID19
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are undergoing evaluation and obtaining clinical care at Mayo Clinic in Florida will be enrolled

Brief summary: The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.

Detailed description: The study will seek to collect and analyze breath samples from a broad range of patients to develop reference ranges and to refine the testing methods. Protocols for breath sample collection and algorithms for analysis will be developed. Samples will be collected from normal volunteers, persons with documented liver disease, organ transplant or with known COVID-19 test results.

Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Breath Volatile Organic Compound Profiles
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Tushar Patel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas JN, Roopkumar J, Patel T. Machine learning analysis of volatolomic profiles in breath can identify non-invasive biomarkers of liver disease: A pilot study. PLoS One. 2021 Nov 30;16(11):e0260098. doi: 10.1371/journal.pone.0260098. eCollection 2021.