louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01292629: Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
Official title: Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Cataract
Keywords: intraocular lens
IOL
cataract
Hoya
surgical
optics
ocular
visual acuity
Lead sponsor: Hoya Surgical Optics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-09
Enrollment: 125
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.

Detailed description: This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.

Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
* Have clear intraocular media
* Have potential Best Corrected Visual Acuity of 20/40 or better
* Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse

Exclusion Criteria:

* Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
* Are monocular
* Have current ocular infection
* Are taking systemic steroids or other anti-metabolites
* Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study

Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.

Primary outcomes:
measure: Visual Acuity
timeFrame: 4 to 6 months
Secondary outcomes:
measure: Complications and Adverse Events
timeFrame: 4 to 6 months
Other outcomes:
Locations:
city: E. Shea Blvd, Suite C101
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: Boynton Beach
country: United States
facility: Katzen Eye Care and Laser Center
state: Florida
city: Miami
country: United States
facility: Center for Excellence in Eye Care
state: Florida
city: Indianapolis
country: United States
facility: Eye Surgeons of Indiana
state: Indiana
city: North Dartmouth
country: United States
facility: Eye Health Vision Centers
state: Massachusetts
Study officials:
affiliation: Hoya Surgical Optics
name: Kees den Besten
role: STUDY_DIRECTOR
References:
Clinical trial NCT01234129: Stem Cell Transplant and Zoledronic Acid Improve Outcome in Previously Untreated Patients With Multiple Myeloma
Official title: Results of Phase III Study to Assess if Zoledronic Acid Have Antumor Activity in Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: multiple myeloma
stem cell transplant
zoledronic acid
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2010-11-04
Enrollment: 320
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: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with multiple myeloma previously untreated

Brief summary: Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.

Detailed description: Assess if the use of zoledronic acid can improve outcome in patients with multiple myeloma whose are treated with cytoreductive therapy and stem cell transplant.

Eligibility criteria: Inclusion Criteria:

Diagnosis of multiple myeloma No previous treatment Symptomatic High risk (ISS) or stage III ( Durie-Salmon) No severe comorbidities -

Exclusion Criteria:

Pregnancy HIV + Refuse treatment

-

Primary outcomes:
measure: progression-free disease and overall toxicity in myeloma multiple
timeFrame: 3 years
Secondary outcomes:
measure: skeletal event
timeFrame: 3 years
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Tertiary reference oncology center
state: Distrito Federal
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Agustin Aviles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01654029: Patient Centred Communication Intervention
Official title: Patient Centred Communication Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke
Keywords: Stroke
Communication impairments
Nurse-patient communication
Patient-centred care
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-07-31
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The most frequent consequence of a stroke is a communication impairment. When patients cannot articulate their needs, frustration and agitation are frequent responses, often resulting in poor optimization of post-stroke function. Staff's lack of knowledge of communication strategies exacerbates the problem. A key component of patient-centred care is the ability of staff to communicate in such a way that allows them to understand the patient's needs. Members of our team developed the patient-centred communication intervention (PCCI) targeting registered and unregulated staff caring for complex continuing care (CCC) patients with communication impairments post stroke. The purpose of the study is to examine if the PCCI results in improved patients' quality of life and in improved staff attitudes and skills in caring for patients with communication impairments.


Eligibility criteria: Patients:

Inclusion Criteria

* diagnosis of stroke related to cerebral infarct
* presence of a communication impairment
* ability to speak and understand English before the stroke
* ability to consent

Exclusion Criteria:

* global aphasia or severe Wernicke's aphasia

Staff:

Inclusion Criteria

* directly involved in providing care
* employed full or part-time
* ability to consent
* ability to speak and write English
* work with patients who have communication impairments

Exclusion Criteria

* unwilling to provide informed consent

Primary outcomes:
measure: Stroke and Aphasia Quality of Life (SAQOL)
timeFrame: Change in SAQOL from baseline to 1 month and from baseline to 3 months
Secondary outcomes:
measure: Communication-Impairment Questionnaire (CIQ)
timeFrame: Change in CIQ from baseline to 1 month and from baseline to 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute, E.W. Bickle Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Katherine S McGilton, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGilton KS, Sorin-Peters R, Sidani S, Boscart V, Fox M, Rochon E. Patient-centred communication intervention study to evaluate nurse-patient interactions in complex continuing care. BMC Geriatr. 2012 Oct 11;12:61. doi: 10.1186/1471-2318-12-61.
Clinical trial NCT03091829: Chest Pain Unit II Register
Official title: Chest Pain Unit II Register - CPU II Register
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 4829
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Basic register:

All patients who are admitted to a CPU.

Scientific Protocol:

All patients who are admitted to a CPU and have their consent to participate in a follow-up (in patients with leading cardiac diagnosis).

Brief summary: Multicentric, prospective, non-interventional observational study with two parts:

1. A register of quality assurance within the recertification of clinics
2. An extended register with scientific protocol.

Detailed description: 1. Quality assurance

   As a quality-assuring basic register, the CPU II register checks the extent to which certified Chest Pain Units fulfill the criteria published by the DGK. In particular, the following quality dimensions are evaluated:
   * Indication quality
   * Diagnostic quality
   * Therapeutic quality
   * Structural quality / networking
2. Platform for projects with a scientific focus

The CPU II register and the infrastructure provided are a platform for further projects with scientific questions (scientific protocol = WP):

WP: Clinical history after CPU (PCI data / discharge / 12-month FUP) in patients with leading cardiac diagnosis

Eligibility criteria: Inclusion Criteria:

* CPU patient
* \> 18 years
* Written consent of the patient

Exclusion Criteria:

* Denied consent

Primary outcomes:
measure: Fulfillment of DGK criteria
timeFrame: 12 months
measure: Clinical progress after CPU
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Munchen
country: Germany
facility: Städtisches Klinikum Neuperlach
state: Bayern
city: Mainz
country: Germany
facility: Klinikum der Johannes-Gutenberg-Universität, 2. Med. Klinik
state: RLP
city: Bremen
country: Germany
facility: Klinikum Links der Weser Bremen
Study officials:
References:
Clinical trial NCT01590329: Use of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds
Official title: A Proof of Concept Cases Series on the Use of the Epidermal Expansion System to Harvest and Place Suction Blister Epidermal Grafts on Hypopigmented Skin and Surgical Wounds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Wound
Hypo-pigmented Skin
Keywords: Skin surgery
Micrografting
Hypo-pigmentation
Lead sponsor: Momelan Technologies
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This case series will assess the use of suction blister epidermal grafts harvested by a novel device on select patients with hypo pigmented skin or surgical skin wounds.

Detailed description: This study evaluates a novel micrografting technique to determine how it will influence the repigmentation of selected areas of hypopigmentation, and how it will influence the healing and pigmentation of surgical skin wounds. The Epidermal Expansion System (designed by MoMelan Technologies) will generate an array of small microblisters and transfer the micrografts to a sterile FDA cleared wound dressing for application to the subject's acute wound or prepared recipient site. The sponsor hypothesizes that applying expanded micrografts to target sites will result in rapid healing of acute wounds and in repigmentation of hypopigmented skin as well as and provide improved cosmetic outcomes.

Eligibility criteria: Inclusion Criteria:

* Male or female adult subject between 18 and 99 years of age
* Subject having an area of hypopigmentation or surgical wound considered appropriate by physician to receive epidermal micro grafting
* Willingness to participate in study by evidence of informed consent

Exclusion Criteria:

* Female subjects self-reported to be breastfeeding, pregnant or planning to become pregnant during the course of the study.
* Subject showing clinical signs of infection
* Subjects currently on immunosuppressive medications, chemotherapy or cytotoxic agents
* Subject participation in another interventional study with potential exposure to an investigational drug or device within the past 30 days or planned entry into another investigational study within 90 days after entrance into this study

Primary outcomes:
measure: Wound healing/pigmentation
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 6-12 weeks
measure: Physician Satisfaction
timeFrame: 6-12 weeks
measure: Incidence of adverse events
timeFrame: 6-12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Laser and Skin Surgery Center of New York
state: New York
Study officials:
affiliation: Laser and Skin Surgery Center of New York
name: Roy Geronemus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02257229: Prospective Evaluation of Treatment for Clubfoot
Official title: Prospective Evaluation of Treatment for Clubfoot
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clubfoot Deformity
Keywords: Clubfoot, deformity, correction, management, gait
Lead sponsor: Texas Scottish Rite Hospital for Children
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 2500
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: Specific aim:

To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions

Detailed description: PURPOSE: The purpose of this project is to help orthopaedic surgeons better understand and treat patients with a diagnosis of clubfoot. This proposed research will establish a protocol for the collection of relevant clinical and functional outcome measures on our patients with a diagnosis of clubfoot.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of clubfoot deformity
* Spanish speaking patients will be eligible to participate in the study.

Exclusion Criteria:

* All patients without a diagnosis of clubfoot

Primary outcomes:
measure: Degree of correction at initial brace wear
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Scottish Rite Hospital for Children
state: Texas
Study officials:
affiliation: Texas Scottish Rite Hospital for Children
name: Anthony I Riccio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01763229: The Practical Use of Transthoracic Echocardiography for Obtaining an Optimal Depth of Internal Jugular Venous Catheters in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insertion Depth of Central Venous Catheter
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 108
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To test if transthoracic echocardiography is useful for correct positioning of central venous catheters in infants with congenital heart disease

Detailed description: Patients scheduled for surgery for congenital heart disease younger than 12 months were studied. Following successful catheter insertion, the insertion depth was determined using transthoracic echocardiography. The long axis or short axis images were used.Chest X-ray images were taken postoperatively and distances from the tip to the carina level were measured.

Eligibility criteria: Inclusion Criteria:

* scheduled for surgery under general anesthesia

Exclusion Criteria:

* anomaly of the internal jugular vein
* thrombus in the internal jugular vein

Primary outcomes:
measure: the distance between the catheter tip and the carina
timeFrame: After opearation (about 4-6 hour after insertion of the catheter)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03095729: Cognitive Consequences of an Activation of the Cortical Drive to Breath (VENTIPSY)
Official title: Cognitive Consequences of an Activation of the Cortical Drive to Breath
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ondine Syndrome
Healthy
Amyotrophic Lateral Sclerosis
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
Collaborators: name: Association Française du Syndrome d'Ondine
name: Fonds de Recherche en Santé Respiratoire
First posted: 2017-03-30
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients and healthy volunteers

Brief summary: The purpose of the study is to measure the negative cognitive consequences of the ventilation under pathological or experimental cortical drive to breath.

Detailed description: Cognitive capacities are measured on healthy subject submitted to inspiratory threshold loading, patients treated by chronic mechanical ventilation due to suffering Ondine syndrome or amyotrophic lateral sclerosis. The spontaneous breathing is compared to NIV breathing or inspiratory threshold loading.

Eligibility criteria: Inclusion Criteria:

* Adults and non-vulnerable adults
* Fluent in French

Exclusion Criteria:

For patients:

* Total ventilatory dependency
* Coexistence of an other respiratory disease
* Alcohol and /or psychotropic consumption during the last 24 hours
* One or more episodes of acute respiratory failure during the past 6 months
* Serious cognitive deficiency or presence of fronto temporal dementia
* End-stage disease
* No affiliation to social security

For healthy volunteers:

* Existing respiratory disease
* Alcohol and /or psychotropes consumption during the last 24 hours
* Tobacco smoking more than 2 pack-years
* Sleep deprivation
* Serious cognitive deficiency
* No affiliation to social security

Primary outcomes:
measure: Score at PASAT (Paced Auditory Serial Addition Test)
timeFrame: 3 hours
Secondary outcomes:
measure: Oxygen saturation changes
timeFrame: 3 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière
Study officials:
References:
Clinical trial NCT01039129: Hybrid Transvaginal-Transabdominal Endoscopic Surgery
Official title: Hybrid Transvaginal-Transabdominal Endoscopic Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gallstones
Appendicitis
Pelvic Pain
Keywords: Gallstones
Appendicitis
Pelvic pain
Peritoneal mass
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.


Eligibility criteria: Inclusion Criteria:

* Chronic or early appendicitis
* Symptomatic gallstones
* Suspicious abdominal mass/nodule
* Female
* Age 18-60 years
* ASA Class I or II

Exclusion Criteria:

* Pregnant women
* History of previous abdominal, pelvic, or vaginal surgery
* History of previous abdominal or pelvic radiation therapy
* History of fibroid uterus
* History of endometriosis
* History of large ovarian cyst
* History of unexplained vaginal bleeding or dyspareunia

Primary outcomes:
measure: Technical success
timeFrame: intra-operative
measure: Complication
timeFrame: 1 month
Secondary outcomes:
measure: Operative time
timeFrame: intra-operative
measure: Sexual function
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center, Department of Surgery
name: Julio Teixeira, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00976729: NOX-E36 First-in-Human (FIH) Study
Official title: NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Inflammatory Diseases
Type 2 Diabetes Mellitus
Systemic Lupus Erythematosus
Keywords: monocyte chemoattractant protein-1 (MCP-1)
L-oligonucleotide aptamer
Spiegelmer
Lead sponsor: TME Pharma AG
Sponsor class: INDUSTRY
First posted: 2009-09-14
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is the first time NOX-E36 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous (IV) and subcutaneous (SC) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses, dosage regimen and route of administration suitable for multiple dose administration to healthy volunteers, followed by the studies in the patient population.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects
* Body mass index (BMI) between 19.0 and 29.0 kg/m2 inclusive
* Body weight between 50 and 100 kg inclusive
* Creatinine clearance of greater than 80 mL/min

Exclusion Criteria:

* Male and female subjects who are not or whose partners are not willing to use appropriate contraception methods
* Intake of any prescribed systemic or topical medication within 14 days prior to dosing
* Intake of any non-prescribed systemic or topical medication (including herbal remedies) within 7 days prior to dosing (with the exception of vitamin/mineral supplements)
* Supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, as confirmed by a repeat assessment
* History of any clinically significant neurological, dermatological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders

Primary outcomes:
measure: Safety and tolerability of NOX-E36 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment
timeFrame: throughout the entire study
Secondary outcomes:
measure: Pharmacokinetic parameters in plasma and urine
timeFrame: throughout the entire study
measure: Pharmacodynamic profile
timeFrame: throughout the entire study
Other outcomes:
Locations:
Study officials:
affiliation: Noxxon AG
name: Grit Landgraf, PhD
role: STUDY_DIRECTOR
References: