louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04761302: Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures
Official title: Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Femur Fracture
Tibial Fractures
Keywords: Opioid use
Post-operative pain
Analgesic use
Femur fracture
Tibia fracture
Intramedullary Nailing
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures treated with intramedullary nailing. This study will explore an alternative for opioid medications for patients undergoing intramedullary nailing of tibial and femoral shaft fractures.

Detailed description: The data analysis for the study will be performed separately for patients with femoral fractures and for patients with tibial fractures. Therefore, the data analysis will compare patients with femoral fractures receiving the experimental treatment to patients with femoral fractures receiving the control treatment (Group 1 vs. Group 2). Likewise, patients with tibial fractures receiving the experimental treatment will be compared to patients with tibial fractures receiving the control treatment (Group 3 vs. Group 4).

Eligibility criteria: Inclusion Criteria:

1. Patients with tibial and femoral shaft fractures
2. Patients undergoing intramedullary nailing
3. Willing to participate in the protocol

Exclusion Criteria:

1. Chronic pain disorder (daily use of oral opioids)
2. Allergy or hypersensitivity to non steroid anti-inflammatory drug
3. Impaired renal, cardiac, or hepatic function
4. History of gastrointestinal bleeding or substance abuse

Primary outcomes:
measure: 12hrs VAS Pain Scores
timeFrame: Measured at postoperative hour 12
measure: 24hrs VAS Pain Score
timeFrame: Measured at postoperative hour 24
measure: 36hrs VAS Pain Scores
timeFrame: Measured at postoperative hour 36
measure: 48hrs VAS Pain Scores
timeFrame: Measured at postoperative hour 48
measure: 12hrs MME
timeFrame: Measured at postoperative hour 12
measure: 24hrs MME
timeFrame: Measured at postoperative hour 24
measure: 36hrs MME
timeFrame: Measured at postoperative hour 36
measure: 48hrs MME
timeFrame: Measured at postoperative hour 48
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: Determined by discharge date
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University District Hospital
Study officials:
affiliation: Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
name: Luis F. Lojo-Sojo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00724802: Oral Glyceryl Triacetate (GTA) in Newborns With Canavan
Official title: Oral Glyceryl Triacetate (GTA) in Newborns With Canavan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Canavan Disease
Keywords: babies with canavan disease
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2008-07-30
Enrollment: 1
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Canavan disease is caused by Aspartoacylase deficiency. There is no treatment for the disease, but there is a food additive that includes acetate . We suggest an early treatment with acetate and a neurologic evaluation, including MRI, after 4 months of treatment. In any case the treatment will be stopped at the age of 22 months, when myelinization is ended.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Canavan disease

Exclusion Criteria:

* Age above 18 months

Primary outcomes:
measure: brain MRI at the end of the study
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Gheona Alterescu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Segel R, Anikster Y, Zevin S, Steinberg A, Gahl WA, Fisher D, Staretz-Chacham O, Zimran A, Altarescu G. A safety trial of high dose glyceryl triacetate for Canavan disease. Mol Genet Metab. 2011 Jul;103(3):203-6. doi: 10.1016/j.ymgme.2011.03.012. Epub 2011 Mar 15.
Clinical trial NCT03487302: White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study
Official title: Assessment of White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging, Premature
Congenital Heart Disease
White Matter Hyperintensities
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 146
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not;
* for the control group, being an healthy subject.

Brief summary: The study aims at investigating the role of cyanotic congenital heart disease (cCHD) on brain aging. The investigators assume that due to congenital and acquired cardiovascular abnormalities, cCHD patients could show radiologic (and clinical) signs of precocious brain aging and eventual cognitive decline.

Detailed description: White matter hyperintensities burden will be quantified through a semi-autamated software (ITK-SNAP)

Eligibility criteria: Inclusion Criteria:

* for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not.
* for the control group, being an healthy subject.

Exclusion Criteria:

* any contraindication to magnetic resonance imaging;
* any pathological condition and/or symptomp that could alter the white matter hyperintensities burden, among which:

  * inflammatory, infectious, demyelinating or dysmyelinating diseases of the CNS;
  * ischemic, haemorrhagic or traumatic brain events and eventual gliotic and malacic or lacunar sequelae;
  * genetic diseases (whether mendelian or mitochondrial) of the CNS;
  * cerebral amyloid angiopathy;
  * CADASIL;
  * cerebral arteriovenous malformations;
  * primary or metastatic brain neoplasms which cause neurological symptoms and/or brain parenchymal sequelae from surgical excision;
  * patent oval foramen;
  * being pregnant;
  * migraine with aura (Bashir, Lipton, Ashina, \& Ashina, 2013).

Primary outcomes:
measure: White matter hyperintensities volume expressed in mm^3
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milano
Study officials:
affiliation: IRCCS Policlinico S. Donato
name: Francesco Sardanelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yushkevich PA, Piven J, Hazlett HC, Smith RG, Ho S, Gee JC, Gerig G. User-guided 3D active contour segmentation of anatomical structures: significantly improved efficiency and reliability. Neuroimage. 2006 Jul 1;31(3):1116-28. doi: 10.1016/j.neuroimage.2006.01.015. Epub 2006 Mar 20.
Clinical trial NCT01862302: Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium
Official title: Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium: A Randomized Placebo-Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Confusion
Keywords: Prevention delirium
Cardiac surgery
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce the incidence, duration, and severity of post cardiotomy delirium?

Detailed description: Pilot study for feasibility and safety, n = 40, haloperidol 1mg vs. placebo BID administered night before and day of surgery, then continued for total 72hrs post-op, if delirium occurs study drug is stopped and usual standard of care implemented by MRP.

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 70 years of age, undergoing a median sternotomy OR 60-69yrs of age with one or more of the risk factors:

  * TIA/Stroke;
  * Euroscore greater than or equal to 5;
  * abnormal clock draw.

Exclusion Criteria:

* Parkinsonism,
* on any antipsychotic medications pre-op,
* active delirium,
* emergent surgery,
* Haloperidol allergy,
* schizophrenia,
* prolonged QTc.

Primary outcomes:
measure: Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery
timeFrame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days.
measure: Safety monitoring of low dose Haloperidol use in patients post cardiac surgery
timeFrame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
Secondary outcomes:
measure: The incidence of delirium
timeFrame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
measure: Delirium severity
timeFrame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
measure: Total length of stay (LOS), with breakdown for intensive care unit (ICU) days and ward days
timeFrame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
measure: Duration of delirium
timeFrame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
Other outcomes:
measure: An economic analysis will be completed to determine if Haloperidol prophylaxis resulted in any cost savings
timeFrame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Site
state: Ontario
Study officials:
affiliation: McMaster University
name: Andre Lamy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02912702: L-DEP as an Initial Treatment for EBV-HLH
Official title: A Randomized Controlled Trial of L-DEP as an Initial Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hemophagocytic Lymphohistiocytosis
Keywords: Pegaspargase
hemophagocytic lymphohistiocytosis
Epstein Barr virus
initial treatment
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the efficacy and safety of Pegaspargase together with liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as an initial treatment for Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.


Eligibility criteria: Inclusion Criteria:

1. Patients were older than 14 years of age
2. Diagnosed as EBV-Hemophagocytic Lymphohistiocytosis (HLH)
3. Patients did not receive any treatment for HLH before
4. Informed consent

Exclusion Criteria:

1. Heart function above grade II (NYHA)
2. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2
3. Pregnancy or lactating Women
4. Allergic to Pegaspargase, doxorubicin or etoposide
5. Active bleeding of the internal organs
6. uncontrollable infection
7. history of acute and chronic pancreatitis
8. Participate in other clinical research at the same time

Primary outcomes:
measure: Overall response(complete response+ partial response) rate of Participants
timeFrame: Change from before and 2,4,6 and 8 weeks after initiating L-DEP or HLH-94 therapy
Secondary outcomes:
measure: Compare survival between two arms
timeFrame: from the time patients received L-DEP or HLH-94 therapy up to 12 months or September 2019
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: through study completion, an average of 1 years
measure: Change of Epstein-Barr virus(EBV)-DNA before and after therapy
timeFrame: Change from before and 2, 4, 6 and 8 weeks after initiating L-DEP or HLH-94 therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
References:
citation: Wang Y, Huang W, Hu L, Cen X, Li L, Wang J, Shen J, Wei N, Wang Z. Multicenter study of combination DEP regimen as a salvage therapy for adult refractory hemophagocytic lymphohistiocytosis. Blood. 2015 Nov 5;126(19):2186-92. doi: 10.1182/blood-2015-05-644914. Epub 2015 Aug 19.
Clinical trial NCT02841202: The Effect of Oral Contraceptive Pills On Eyes
Official title: The Effect of Oral Contraceptive Pills On Macula, Retinal Nerve Fiber Layer and Choroid Thickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adverse Effect of Oral Contraceptives, Subsequent Encounter
Keywords: optical coherence tomography
oral contraceptive pills
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-07-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators aimed to evaluate the effect of oral contraceptive pills(OCP) on macula, retinal nerve fiber layer and choroid thickness by using Optical Coherence Tomography (OCT). The present clinical study is the first research reported in the literature which is investigating the posterior ocular segment changes in women using OCP by using OCT.

Detailed description: Spectral-domain optical coherence tomography (OCT) which is used to evaluate retina both qualitatively and qualitatively is a non invasive process. And also OCT makes it possible to perform retinal exams repeatedly without eye drops and dilatation.

Eligibility criteria: Inclusion Criteria:

* All the participants in the study group were Caucasian origin and the ages of them ranged from 18 to 48 in the reproductive period

Exclusion Criteria:

* None of the women in the study was pregnant. Women who reported histories of any medical problems such as thyroid disorders, hypertension, thromboembolic disease, diabetes mellitus, cardiovascular events, Cushing disease, positive malignancy, congenital adrenal hyperplasia, liver disease, psychotic disorders and neither did they use antidepressants nor steroidal hormone drugs and mood stabilizers (lithium, valproic acid, cocaine, antiandrogens, and insulin sensitizers, etc) were excluded from the study. Subjects were also excluded if they used caffeine or tobacco. The investigators also excluded from the study those women who had ocular surgery, ocular trauma or any ocular diseases such as glaucoma, cystoid macular edema, macular degeneration, optic atrophy, intraocular pressure 421 mmHg, cataract, best corrected visual acuity worse than 20/30, high spherical4± 3 dioptre or cylindrical42 dioptre refractive errors and uveitis at the time of OCT measurement.

Primary outcomes:
measure: Adverse Events on Eyes That Are Related to Treatment
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kayseri Education and Research Hospital
name: YUSUF MADENDAG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02130102: ModuLAAr - A Module Based and Scalable System for Silver-ager in Austria
Official title: Evaluation of ModuLAAr - a Module Based and Scalable System for Silver-ager Located in Assisted Living Homes in Austria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: technology acceptance
ambient assisted living
independent living
quality of life
socioeconomic impact
usability of information and communication technologies
Lead sponsor: AIT Austrian Institute of Technology GmbH
Sponsor class: OTHER
Collaborators: name: Samariterbund Burgenland Rettung und Soziale Dienste GmbH
name: University of Applied Sciences Technikum Wien
name: Austrian Research Promotion Agency
name: Austrian Federal Ministry of Transport, Innovation and Technology (BMVIT)
First posted: 2014-05-05
Enrollment: 38
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly residents of assisted living homes aged 60 and above

Brief summary: In this research project a module based Ambient Assisted Living solution will be provided to elderly living in assisted living homes. Those products and services seek to impact quality of life of the elderly and have positive effects on their environment.


Eligibility criteria: Inclusion Criteria:

* 60 years and older
* informed consent
* resident of an assisted living home of the Samariterbund Burgenland Rettung und Soziale Dienste GmbH

Exclusion Criteria:

* relevant health threatening event or death
* mini mental state score \<17

Primary outcomes:
measure: Changes of quality of life and subjective health
timeFrame: 4 and 1 months before intervention. 1, 4 and 12 months after intervention
Secondary outcomes:
measure: Changes in technology acceptance and usability
timeFrame: 1, 12 and 18 months after intervention
measure: Impact and changes on socio-economic parameters
timeFrame: 4 months before intervention. 4 and 12 months after intervention
Other outcomes:
Locations:
city: Wiener Neustadt
country: Austria
facility: AIT Austrian Institute of Technology GmbH
state: Lower Austria
Study officials:
affiliation: AIT Austrian Institute of Technology GmbH
name: Barbara Prazak-Aram, Mag.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siegel C, Prazak-Aram B, Kropf J, Kundi M, Dorner T. Evaluation of a modular scalable system for silver-ager located in assisted living homes in Austria--study protocol of the ModuLAAr ambient assisted living project. BMC Public Health. 2014 Jul 21;14:736. doi: 10.1186/1471-2458-14-736.
Clinical trial NCT01061502: Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds
Official title: Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Burns
Wound Healing
Keywords: Burns
Wounds and Injuries
Skin Grafts, Bioelectric
Grafting, skin
Lead sponsor: Vomaris Innovations
Sponsor class: INDUSTRY
First posted: 2010-02-03
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds.


Eligibility criteria: Inclusion Criteria:

* Wounds resulting from skin graft
* Split thickness wound
* Wound size greater than 2x2 cm
* Wounds must be ≥5 cm away from all other wounds
* Participant agrees to participate in follow-up evaluation
* Participant must be able to read and understand informed consent, and sign the informed consent

Exclusion Criteria:

* Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
* Participant is to receive another topical antimicrobial agent other than the study dressing
* Participant with sensitivity or adverse reactions to silver or zinc
* Pregnancy or nursing an infant or child
* Immunosuppression
* Active or systemic infection
* Peripheral vascular occlusive disease
* Collagen vascular disease
* Connective tissue disease
* Participant undergoing active cancer chemotherapy
* Chronic steroid use
* Decision impairment

Primary outcomes:
measure: To compare epithelialization over time
timeFrame: 3 months
Secondary outcomes:
measure: To compare patient reported perception of pain
timeFrame: 3 months
measure: To compare scarring
timeFrame: 3 months
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Blodgett Hospital
state: Michigan
Study officials:
affiliation: Blodgett Hospital
name: Andrew L Blount, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Blodgett Hospital
name: Richard Wilcox, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01346202: Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes
Official title: Influence of a Multimodal Day-unit Pain Therapy on Pain Experience, Pain-related Disability and Depression in Patients With Chronic Pain Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: multi-modal pain therapy, chronic pain
Lead sponsor: Klinikum St. Georg gGmbH
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 260 consecutive patients with chronic pain syndromes

Brief summary: Complex and chronified pain syndromes requires a specialized therapeutic concept. From patients with chronic low back pain the investigators know, that an interdisciplinary multi-modal approach may improve the therapeutic success. In this observational study the investigators investigated if the multi-modal pain therapy is also effective in patients with mixed chronic pain syndromes.

Detailed description: The multi-modal pain therapy includes:

* specific drug therapy
* pain education
* psychological therapy
* physical therapy
* behavioral therapy
* work hardening
* bio-feedback
* ergotherapy

Eligibility criteria: Inclusion Criteria:

* age \>= 18 years and \<= 65 years
* verified chronic pain for more than 6 month

Exclusion Criteria:

* application for a pension
* non-accordance with multi-modal pain therapy
* dominant geriatric symptoms
* dominant psychiatric symptoms

Primary outcomes:
measure: intensity of pain
timeFrame: Change from Baseline in intensity of pain at 1 year
Secondary outcomes:
measure: pain disability index
timeFrame: Change from Baseline in pain disability index at 6 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Klinikum St. Georg, Pain Center
state: Sachsen
Study officials:
affiliation: Klinikum St. Georg
name: Armin R Sablotzki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: