louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00527137: NESP Pediatric Study
Official title: An Open-label, Randomized, Non-inferiority Study of Novel Erythropoiesis Stimulating Protein (NESP) and Recombinant Human Erythropoietin (rHuEPO) for the Treatment of Anemia in Pediatric Subjects With Chronic Renal Insufficiency (CRI) or End-stage Renal Disease (ESRD) Receiving Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pre-dialysis
End Stage Renal Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open-label, randomized study of NESP in pediatric subjects 18 years of age or younger. Subjects will receive study drug (NESP or rHuEPO) for 28 weeks after a 2 week screening and baseline period. During the study, procedures include bloodwork for laboratory assessments and vital signs. Dose titration determined by hemoglobin values taken weekly during the study. Antibody samples taken at baseline and during the end of study assessments. A physical examination and laboratory tests will conclude the study.


Eligibility criteria: Inclusion Criteria:

* 1 to 18 years of age
* ESRD receiving dialysis or CRI with eGFR less than 30 mL/min
* Baseline hemoglobin 9.5 - 12.5 g/dL and iron replete
* Stable rHuEPO therapy for 8 weeks

Exclusion Criteria:

* Scheduled for a living-related kidney transplant
* Uncontrolled blood pressure
* seizure activity
* Hyperparathyroidism
* Major surgery within 12 weeks or active inflammatory disease
* Currently receiving antibiotics
* Clinical evidence of malignancy
* Pregnant or breast-feeding

Primary outcomes:
measure: To demonstrate that NESP is comparable (not inferior) to rHuEPO for the treatment of anemia in pediatric subjects with CRI or ESRD receiving dialysis
timeFrame: Entire Study
Secondary outcomes:
measure: To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD
timeFrame: Entire Study
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Warady BA, Arar MY, Lerner G, Nakanishi AM, Stehman-Breen C. Darbepoetin alfa for the treatment of anemia in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2006 Aug;21(8):1144-52. doi: 10.1007/s00467-006-0071-0. Epub 2006 May 25.
Clinical trial NCT00375037: A Multifaceted Intervention to Improve Hand Hygiene
Official title: Cluster Randomized Controlled Trial of a Multifaceted Intervention to Improve Hand Hygiene Among Healthcare Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Handwashing
Infection
Keywords: hand washing
cluster randomized trial
performance feedback
healthcare workers
Hand hygiene
hand washing adherence
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2006-09-12
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled trial will evaluate the effect of a multifaceted intervention including performance feedback on adherence to hand hygiene among healthcare workers. A key component of the study is to demonstrate whether improved adherence to hand hygiene leads to a reduction in rates of infection.

Detailed description: A cluster randomized controlled trial of the intervention will be conducted where hospital units (wards) in three hospitals will be allocated to either the intervention or usual practise. We will stratify by hospital site in order to minimize confounding by hospital-level factors. The unit of allocation, intervention, and analysis will be at the level of the hospital unit. Thirty hospital units will be randomized to either the intervention or comparison arm. We will compare adherence to hand hygiene, MRSA rates, and other outcomes between the two study arms.

Eligibility criteria: A. Study units Inclusion: Medical and subspecialty units, surgical units, critical care units

Exclusion: pediatric units, neonatal intensive care units

B. Healthcare workers

Inclusion: any hospital staff with direct patient care who are affiliated with a single unit (includes registered nurses, nursing assistants, environmental aides, allied health professionals (occupational, physical, and respiratory therapists), and some physicians

C. Patients Clinical outcomes will be measured in patients on study units.

Primary outcomes:
measure: Incidence of MRSA
timeFrame: 12 months
measure: Adherence to hand hygiene
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of multi-resistant bacteria other than MRSA
timeFrame: 12 months
measure: Catheter-related blood stream infections
timeFrame: 12 months
measure: Clostridium difficile related diarrhea
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: Henderson Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences- McMaster University
name: Mark B Loeb, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03942237: Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy
Official title: Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Nerve Block
Laparoscopic Adrenalectomy
Keywords: transmuscular quadratus lumborum block
adrenalectomy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 72
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: This prospective, randomized control study aims to compare the analgesic effect, satisfaction with anesthesia and analgesia between single-injection QLB (quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo laparoscopic adrenalectomy
* Informed consent

Exclusion Criteria:

* a known allergy to the medications being used for anesthesia
* coagulopathy or on anticoagulants
* chronic opioid therapy or history of substance abuse
* participating in another RCT
* inability to properly describe postoperative pain to investigators (e.g., language barrier, neuropsychiatric disorder).

Primary outcomes:
measure: the NRS pain scores on activity 12-hours after surgery
timeFrame: 12-hours after surgery
Secondary outcomes:
measure: the pain scores at rest determined by the numeric rating scale (NRS, 0-10)
timeFrame: At 2,4, 8, 12, 24 ,48,72 hours after the surgery
measure: incidence of postoperative nausea and vomiting (PONV)
timeFrame: within 24 postoperative hours
measure: ambulation time
timeFrame: within 5 days after surgery
measure: time of recovery of bowel movement
timeFrame: within 5 days after surgery
measure: postoperative length of hospital stay
timeFrame: up to 2 weeks after surgery
measure: patient's satisfaction of anesthesia and analgesia
timeFrame: 48 hours after surgery
measure: the NRS pain scores on activity after surgery
timeFrame: At 2,4, 8, 24 ,48,72 hours after the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: PUMCH
name: Yuguang Huang
role: STUDY_CHAIR
References:
citation: Yuan Q, Lu S, Cui X, Zhang Y, Xie Y, Zhang Y, Yan W, Ji Z, Huang Y. Transmuscular quadratus lumborum block for postoperative pain and recovery after laparoscopic adrenalectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Nov 9;21(1):274. doi: 10.1186/s12871-021-01494-4.
Clinical trial NCT06446037: Assessment of Gesture Accuracy of a Prosthesis Control System
Official title: Assessment of Gesture Accuracy for a Multi-electrode EMG Sensor Array Based Prosthesis Control System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Upper Limb Amputation Below Elbow (Injury)
Keywords: Prosthesis
Upper limb amputee
Lead sponsor: Phantom Neuro Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-06
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.

Detailed description: The study will characterize the performance of Phantom X system and associated algorithms in decoding EMG signals for various hand gesture control. The EMG signals will be sensed using a non-invasive multi-electrode array applied to subjects' forearms.

Eligibility criteria: Inclusion Criteria:

1. Individuals 21 years in age and older
2. Individuals with amputation of one or both arms at transradial level (applies to amputees only)
3. Ability to follow study directions
4. Willingness and ability to sign Informed Consent

Exclusion Criteria:

1. Individuals with previously diagnosed muscle pathologies
2. Individuals with impaired muscle function and/or impaired ability to perform normal hand movements (normal participants) or ability to perform normal phantom hand movements (amputees)
3. Individuals with transhumeral or higher amputation of both arms (applies to amputees only)
4. Cognitively impaired to follow study instructions
5. Allergies to skin adhesive materials necessary for cutaneous electrode placement
6. Excessive hair growth on arms and inability to shave off the hair for electrode placement
7. Pregnant woman
8. Arms or residual limbs with insufficient diameter to accommodate the wearing of two cutaneous sensor arrays
9. Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study

Primary outcomes:
measure: Gesture accuracy
timeFrame: Acute visit (at most 3 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Phantom Neuro Inc. Operational Headquarters
state: Texas
Study officials:
References:
Clinical trial NCT05439837: Paracoracoid Subscapularis Plane Block Versus Iso Block for Shoulder Surgery for Shoulder Surgery
Official title: Paracoracoid Subscapularis Plane Block Versus Infraclavicular and Subomohoid Block for Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Shoulder surgery is the second orthopedic operation cause post operative pain Interscalene block is the standard block for shoulder surgery but it cause phrenic nerve block and diaphragmatic hemipareses Iso block is the block used to block the brachial plexuses cord and suprascapular nerve And paracoracoid subscapularis block supra scapular nerve in supra scapular fosa and axillary nerve as it curves around humeral head

Detailed description: Two groups Group S for paracoracoid subscapularis block Group I for iso block Twenty patients for para coracoid subscapularis block with ultra sonography 50 mm 22G needle inserted anterior to the fascia and 15ml o.5% bupivicaine injected another twenty patients for iso block a linear probe of ultrasound is placed in the infraclavicular region to identify the cords the needle is inserted 2-3cm superior to the clavicle and advanced in.plane posterior to the clavicle toward the cods and 25ml local anaesthesia is injected

Eligibility criteria: Inclusion Criteria:

* male or female patient \>20year for shoulder surgery American Society of anaesthesiologist physical state 1 to2

Exclusion Criteria:

* refusal of patient Systemic infection Local infection Neurological or respiratory disease

Primary outcomes:
measure: Pain assessment by VAS score
timeFrame: At 48 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University hospital
state: Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt
Study officials:
affiliation: Fayoum university hodpital
name: Mohammed A Shawky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eygpt fayoum university
name: Joseph M Botros, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fayoum universty hospital
name: Maged L Bolus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garrett WE Jr, Swiontkowski MF, Weinstein JN, Callaghan J, Rosier RN, Berry DJ, Harrast J, Derosa GP. American Board of Orthopaedic Surgery Practice of the Orthopaedic Surgeon: Part-II, certification examination case mix. J Bone Joint Surg Am. 2006 Mar;88(3):660-7. doi: 10.2106/JBJS.E.01208. No abstract available.
Clinical trial NCT03302637: Oral Microbiome and Pancreatic Cancer
Official title: Oral Microbiome and Pancreatic Cancer: a Prospective Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 732
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 361 incident adenocarcinoma of pancreas and 371 matched controls from two prospective cohort studies, the American Cancer Society Cancer Prevention Study II and the National Cancer Institute Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial.

Brief summary: This is a prospective population based study to examine the relationship of oral and pancreatic microbiome, and their functions, to pancreatic cancer risk.

The identification of specific oral bacteria and their functional relationship to pancreatic cancer will advance scientific knowledge on the etiology of pancreatic cancer. This could provide a new microbially-based research paradigm, possibly leading to new drug targets for this disease. Second, the oral bacteria may serve as a readily accessible, non-invasive biomarker for subsequent pancreatic cancer risk, which help to identify people at high risk of this disease. Finally, the identified oral bacteria may lead to microbial prophylactic preventions, with antibiotic therapy aimed at eradicating the specific species associated with increased cancer risk or, alternatively, combined with probiotics to introduce species that are associated with a decreased cancer risk. Thus, the study outcomes will lead to actionable means for pancreatic cancer prevention.

Detailed description: A history of periodontal disease and the presence of circulating antibodies to selected oral pathogens have been associated with increased risk of pancreatic cancer; however, direct relationships of oral microbes with pancreatic cancer have not been evaluated in prospective studies. Investigators examine the relationship of oral microbiota with subsequent risk of pancreatic cancer in a large nested case-control study.

Eligibility criteria: Inclusion Criteria:

* DNA extracted from oral wash samples from NIH-PLCO and ACS-CPS cohorts

Exclusion Criteria:

-

Primary outcomes:
measure: Presence or absence of bacterial taxa will be compared in oral and pancreatic samples.
timeFrame: 4 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jiyoung Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02456337: Xenogenous Collagen Matrix Graft With or Without Enamel Matrix Proteins Derivative for Root Coverage
Official title: Xenogenous Collagen Matrix Graft Associated or Not With Enamel Matrix Derivative Proteins in the Treatment of Gingival Recession Class I and II of Miller: Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingival Recession
Keywords: Gingival Recession
Coronally advanced flap
Periodontal regeneration
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2015-05-28
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the reduction of gingival recession of single Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen matrix graft and / or enamel matrix proteins.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Presence of at least one Class I or II Miller gingival recession ≥ 2.5 mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep non-carious cervical lesions (\< 0.5 mm): A +(Pini-Prato et al. 2010).
* Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.
* Full-mouth visible plaque index ≤ 20% (Ainamo \& Bay 1975).
* Full-mouth sulcus bleeding index ≤ 20% (Mühlemann \& Son 1971).

Exclusion Criteria:

* Smoking.
* Pregnancy.
* Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery).
* Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair).
* Previous periodontal surgery in the area.

Primary outcomes:
measure: Recession Reduction
timeFrame: 6 months
Secondary outcomes:
measure: Complete root coverage
timeFrame: 6 months
Other outcomes:
measure: Keratinized tissue thickness
timeFrame: 6 months
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School, State University of Campinas
state: São Paulo
Study officials:
affiliation: University of Campinas
name: Enilson A Sallum, PhD
role: STUDY_CHAIR
References:
citation: Sangiorgio JPM, Neves FLDS, Rocha Dos Santos M, Franca-Grohmann IL, Casarin RCV, Casati MZ, Santamaria MP, Sallum EA. Xenogenous Collagen Matrix and/or Enamel Matrix Derivative for Treatment of Localized Gingival Recessions: A Randomized Clinical Trial. Part I: Clinical Outcomes. J Periodontol. 2017 Dec;88(12):1309-1318. doi: 10.1902/jop.2017.170126. Epub 2017 Jul 28.
Clinical trial NCT00499915: NICU Asthma Education and Secondhand Smoke Reduction Study
Official title: Preventing Respiratory Illness Among Premature Infants: An Asthma Education and Secondhand Smoke Reduction Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Illness
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Halcyon Hill Foundation
First posted: 2007-07-12
Enrollment: 165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Premature infants have a significantly increased risk for developing respiratory illnesses and asthma. Secondhand smoke (SHS) also is clearly associated with increased breathing problems in children, thus exposure to smoke makes it substantially more likely for a premature infant to develop wheezing. The overall goal of this study is to test whether comprehensive asthma education combined with a home-based secondhand smoke reduction program can reduce exposure to smoke and prevent respiratory illness among premature infants. Our hypotheses are:

* More premature infants whose families receive asthma education combined with a SHS reduction intervention will live in smoke-free environments compared to infants receiving only asthma education (control group).
* Caregivers receiving the SHS reduction program will have higher rates of quit attempts and less relapse into smoking compared to caregivers in the control group.
* Infants whose families receive the combined intervention will experience less respiratory illness compared to infants in the control group.


Eligibility criteria: Inclusion Criteria:

* ≤32 weeks gestation
* Planned discharge to home from the Neonatal Intensive Care Unit
* Parent or caregiver must consent to the intervention
* The first sibling discharged, for twins or infants from a multiple birth pregnancy

Exclusion Criteria:

* Inability to speak and understand English
* No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate home)
* Family residence outside the greater Rochester area (more than 30 miles away)
* Children in foster care or other situations in which guardian consent cannot be obtained
* The child having significant medical conditions, including serious heart disease, cystic fibrosis, or other conditions that could interfere with the assessment of respiratory-related outcome measures

Primary outcomes:
measure: Infants Living in Smoke-free Environments.
timeFrame: 5 months post baseline
Secondary outcomes:
measure: Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.
timeFrame: 2, 5, and 7-9 months post baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Jill S. Halterman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01343615: Study of Blood Flow Changes and Microemboli During Carotid Surgery
Official title: Hemodynamic Alterations in Middle Cerebral Artery and Intraoperative Microemboli During Carotid Endarterectomy and Angioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carotid Endarterectomy
Percutaneous Transluminal Angioplasty
Cognitive Aspects
Diffusion Weighted MRI
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the clinical and radiologic implications of the intraoperative microemboli during carotid revascularization.


Eligibility criteria: Inclusion Criteria:

* acoustic window for transcranial Doppler
* surgical criteria proposed by the NASCET and ACAS studies
* postoperative follow-up for at least six months
* patient consent

Exclusion Criteria:

* carotid restenosis
* combined surgery
* emergency surgery

Primary outcomes:
measure: Hemodynamic alterations in middle cerebral artery and intraoperative microemboli during carotid endarterectomy and angioplasty
timeFrame: 6 months
measure: Number of ischemic areas detected by magnetic resonance
timeFrame: 6 months
measure: Neuropsychological changes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Hospital de Clínicas da Unicamp
state: SP
Study officials:
References: