louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01235923: Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
Official title: A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preterm Infants
Keywords: anemia
transfusions
erythropoiesis
neonate
preterm
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2010-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 100
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preterm infants are a risk for multiple transfusions, and the administration of human recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements. Dosing usually occurs three times a week, but extended dosing schedules have been successful in adults. The investigators assessed weekly Epo dosing in preterm infants compared to standard three times weekly dosing.

Detailed description: Erythropoietin (Epo) increases and maintains hematocrit using once weekly dosing in adults with anemia due to end stage renal disease. Epo is used in preterm infants to treat the anemia of prematurity, but has not been studied using once weekly dosing. We compared reticulocyte responses of once weekly Epo dosing with thrice weekly dosing in preterm infants.

Infants ≤1,500 grams and ≥7 days of age were randomized to once weekly Epo, 1,200 units/kg/dose, or thrice weekly Epo, 400 units/kg/dose, subcutaneously for 4 weeks, along with iron and vitamin supplementation. Complete blood counts, absolute reticulocyte counts (ARC), transfusions, phlebotomy losses, and adverse events were recorded.

Eligibility criteria: Inclusion Criteria:

* \< or = 1,500 grams
* \< or = 32 weeks gestation
* \> or = 7 days of age
* informed consent obtained

Exclusion Criteria:

* hemolytic disease
* hypertension
* seizures
* thromboses
* major malformation

Primary outcomes:
measure: Baseline Retic Count
timeFrame: baseline
measure: Reticulocyte Count
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: UNM NICU
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Robin K Ohls, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05462223: Alucent Vessel Restoration System for AVF
Official title: A Study of the Safety and Feasibility of the Vessel Restoration System for AVF to Promote the Physiologic and Functional Maturation of Upper-extremity Autologous End-to-Side Arteriovenous Fistulas (AVF) in Patients With Chronic Kidney Disease: ACTIVATE AVF
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: AV Fistula
Lead sponsor: Alucent Biomedical
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: A prospective, single-arm, multicenter, open-label study of the VRS-AVF for use as adjunctive therapy in the surgical creation of an end-to-side brachiocephalic (BC) AVF.
Primary purpose: TREATMENT

Brief summary: Feasibility of the Vessel Restoration System for AVF

Detailed description: A study of the safety and feasibility of the Vessel Restoration System for AVF to promote the physiologic and functional maturation of a Brachiocephalic End-to-Side Arteriovenous Fistulas (AVF) in Patients with Chronic Kidney Disease Stage V (Pre-dialysis): ACTIVATE AVF

Eligibility criteria: Inclusion Criteria:

* 18 years of age and can provide informed consent
* Use birth control
* Chronic Kidney Disease

Exclusion Criteria:

* Receiving hemodialysis
* Pregnant, breastfeeding, planning to become pregnant
* Receiving immunosuppressants
* Has "Long COVID"

Primary outcomes:
measure: AVF Maturation
timeFrame: 2 weeks to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales
state: New South Wales
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital & North Shore Private
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Center
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Richmond
country: Australia
facility: Northern Health
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Lublin
country: Poland
facility: Poznan University of Medical Sciences
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medczny z Centrainym Szpitalem Klinicznym Ministerstwa Obrony Narodowej
city: Wrocław
country: Poland
facility: Lower Silesia Center of Heart Diseases MEDINet
city: Zielona Góra
country: Poland
facility: Klincznny Oddzial Chirurgii Naczyniowej Szpital Uniweryzstecki w Zielonej
Study officials:
References:
Clinical trial NCT03250923: CelAgace™ OraRinse Solution for Treatment of Candidiasis
Official title: CelAgace™ OraRinse (CAOR) Pilot Clinical Study for Management of Candidiasis Associated With Grade 0-II Mucositis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Candidiasis, Oral
Keywords: Oral Candidiasis, Thrush, Oral Moniliasis
Lead sponsor: CelaCare Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Texas A&M University
First posted: 2017-08-16
Enrollment: 15
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: CelAgace™ OraRinse (silver citrate complex and acemannan) Solution is planned to be evaluated for safety and effectiveness as a potential treatment for candidiasis, a yeast infection, commonly known as thrush, which is associated with mouth sores.

Detailed description: CelAgace™ contains two active ingredients, a silver citrate complex salt (0.01mg/ml) that has demonstrated laboratory effectiveness against yeast organisms and acemannan (4.0mg/ml), a purified extract isolated from the inner leaf gel of the Aloe vera plant that has been used as a key ingredient in other oral care products. Patients will swish and spit the product 4 times daily (after meals and at bedtime) for 14 days. Following an initial office visit, patients will be evaluated on days 7 and 14 to determine response to the product.

Eligibility criteria: Inclusion Criteria:

* Radiation induced oral mucositis with resulting candidiasis
* Chemotherapy induced oral mucositis with resulting candidiasis
* Oral mucositis due to being immunocompromised with resulting candidiasis
* Stomatitis due to other causes with resulting candidiasis
* Currently have mild to moderate mucositis

Exclusion Criteria:

Patient:

* under the age of 18
* pregnant or breastfeeding
* inability to use an oral rinse
* hypersensitivity to Aloe Vera and/or Silver
* whose candida rinse culture was performed greater than 10 days prior to study entry.
* has any sort of removable dental appliance
* with previous or current history of any cancer of the oral cavity
* who received therapy for candidiasis within the past 30 days
* who used antifungal medication in the last 30 days
* who has severe to life threatening oral muositis (Grade III-IV) oral mucositis
* with impaired renal or hepatic function
* receiving high dose chemotherapy and total body irradiation in preparation for Hemopoietic Stem Cell Transplant (HSCT) or Concomitant use of Kepivance® (palifermin or rhKGF)

Primary outcomes:
measure: Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture
timeFrame: Days 1(Baseline), 3, 7 and 14
Secondary outcomes:
measure: Reduction in Pain
timeFrame: Days 1, 3, 7, 14
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas A&M University College of Dentistry
state: Texas
Study officials:
affiliation: Texas A&M University College of Dentistry
name: Jacqueline M. Plemons, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01987323: Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension
Official title: Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ocular Hypertension
Keywords: glaucoma
raised intraocular pressure
Lead sponsor: Singapore Eye Research Institute
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim: Evaluation of a single subconjunctival injection of liposomal EggPC formulation of latanoprost in treating glaucoma.

Hypothesis: The investigators have already evaluated carrier stability, drug partitioning, in vitro drug release, tolerance, and efficacy of latanoprost-incorporated EggPC liposomes upon subconjunctival administration in both rabbit and monkey eyes. Therefore, the investigators hypothesize that this would be safe and efficacious in humans as well.

Methodology: A pilot study to assess a liposome formulation containing latanoprost. The investigators will recruit 6 study subjects with eyes that have raised IOP, for subconjunctival injection of this liposome formulation. The recruited eye will be injected and monitored for inflammation, toxicity and pain as primary end-points. Monitoring of the eye will be for the first 24 hours post-injection, week 2, months 1, 2 and 3 thereafter.

Importance: If proven safe, this method of drug delivery could potentially be used for treatment of raised intraocular pressures in blinding conditions such as glaucoma.

Detailed description: The number of recorded adverse events and intolerance to the subconjunctival injection procedure by the participants during the study period was used as a measure of safety.

Eligibility criteria: Inclusion Criteria:

Glaucoma patients who have eyes with raised IOP (baseline IOP \>21 mmHg) due to end-stage glaucoma with a poor visual prognosis.

Exclusion criteria:

1. Active or recent eye infection, endophthalmitis
2. Known hypersensitivity to latanoprost
3. Only eye
4. Previous glaucoma filtration surgeries or trabeculectomy
5. Intraocular pressure less than 12mmHg.
6. Inability to give informed consent.
7. Inability to safely administer a subconjunctival injection
8. Uncontrolled systemic hypertension, CVA or TIA within the previous month.
9. Pregnancy -

Primary outcomes:
measure: Number of participants with serious adverse events
timeFrame: 3 months
Secondary outcomes:
measure: intraocular pressure
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Singapore National Eye Centre
name: Tina T Wong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01936623: Computerized Brief Intervention vs. Delayed Computerized Brief Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Abuse
Keywords: brief intervention
computerized brief intervention
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine whether a computerized brief intervention for moderate risk drug use among adult primary care patients is more effective than providing such patients with a substance abuse assessment alone.

Detailed description: The study will enroll 80 adult primary care patients who have moderate risk drug use. Eligible participants (N = 80) will be randomly assigned to immediately receive a computerized brief intervention focused on drug use or to receive the same computerized brief intervention at 3-month follow-up. All participants will be assessed at three time points: baseline, and at 3 and 6 month follow-ups.

Eligibility criteria: Inclusion Criteria:

* (1) minimum 18 years of age
* (2) primary care or dental patients at the participating clinics
* (3) score between 4 and 26 (moderate-risk) for illicit drug and/or nonmedical use of prescription drugs on any of the single item drug use risk scores of the ASSIST.

Exclusion Criteria:

* (1) score in the high-risk range on the ASSIST for any drug (except tobacco) or alcohol use (i.e., ASSIST score \> 26)
* (2) no reported drug use within the past 3 months
* (3) drug abuse treatment within the past 12 months
* (4) a BI at the clinic with the behavioral health counselor within the past month
* (5) prior enrollment in the parent study;
* (6) plans to move out of New Mexico in the next 6 months

Primary outcomes:
measure: Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score
timeFrame: 3 month follow-up
Secondary outcomes:
measure: Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score
timeFrame: 6-month follow-up
Other outcomes:
measure: Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids.
timeFrame: 3-month
measure: Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids
timeFrame: 6-month follow-up
Locations:
city: Edgewood
country: United States
facility: First Choice Community Healthcare
state: New Mexico
Study officials:
affiliation: Friends Research Institute, Inc.
name: Robert P Schwartz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02030223: Transversus Abdominis Plane Block and Inguinal Hernia Repair
Official title: The Analgesic Efficacy of the Ultrasound Guided Transversus Abdominis Plane Block After Inguinal Hernia Repair With a Mesh.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Abdominal Wall Muscles
Regional Anesthesia
Postoperative Pain
Keywords: transversus abdominis plane block
inguinal hernia repair
acute postoperative pain
neuropathic pain
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 59
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: This prospective, randomized, double blinded, placebo-controlled study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia repair with a mesh under general anaesthesia, and how the efficiency of early postoperative analgesia achieved correlates with the risk of developing a chronic pain state, a not uncommon condition after this type of surgery.


Eligibility criteria: Inclusion Criteria:

ASA I-III patients undergoing inguinal hernia repair with a mesh

age between 18 and 75 years old

ability to read and write greek

-

Exclusion Criteria:

* Inability to consent to the study
* BMI \>40kg/m2
* Skin infection at the puncture site
* Contraindication to mono-amide local anaesthetics, paracetamol, NSAID's (parecoxib)
* Preoperative use of opioids or NSAID's for chronic pain conditions

Primary outcomes:
measure: Pain scores at rest and with movement using the numerical rating scale (NRS)
timeFrame: 3, 6 and 24 hours postoperatively
Secondary outcomes:
measure: Incidence of chronic pain
timeFrame: 6 months after surgery
Other outcomes:
measure: Morphine consumption (mg)
timeFrame: 24 hours postoperatively
Locations:
city: Athens
country: Greece
facility: Aretaieion University Hospital
Study officials:
affiliation: Aretaieion University Hospital
name: Erifyli Argyra, MD, PhD
role: STUDY_CHAIR
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milone M, Di Minno MN, Musella M, Maietta P, Salvatore G, Iacovazzo C, Milone F. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. 2013 Dec;17(6):749-55. doi: 10.1007/s10029-012-1022-2. Epub 2012 Nov 16.
citation: Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f.
Clinical trial NCT01170923: FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer
Official title: Standard Chemotherapy Strategy Versus Changing Chemotherapy Strategy as to FDG-PET Response After 1st Cycle of Standard Chemotherapy for Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: non small cell lung cancer
FDG PET
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Boryung Pharmaceutical Co., Ltd
First posted: 2010-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The usual response to chemotherapy is decided through the image change by computed tomography (CT), which is taken at least 6-9 weeks.

In order to predict the response to chemotherapy earlier, patients received FDG-PET scan at the first cycle of chemotherapy. Chemotherapy was guided by the metabolic response by FDG-PET scan.

Detailed description: Prospective, Open-label, Randomized phase II, single institution trial that compared chemotherapy guided by traditional evaluation based on RECIST versus chemotherapy guided by FDG-PET (metabolic) response.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed non-small cell carcinoma.
2. Stage IIIB (wet) or IV advanced NSCLC.
3. No evidence of prior malignancies for 3 years except treated basal cell or squamous cell carcinoma of skin and carcinoma in situ of uterine cervix.
4. Measurable disease by RECIST criteria.
5. Adequate organ function as follows.

   * Seum AST/ALT \< 2.5 x Upper normal limit (UNL) (if hepatic metastasis \< 5 x UNL)
   * Total bilirubin \< 1.5 x UNL
   * Serum creatinine \< 1.5 mg/dL
   * Absolute neutrophil count \> 1500/uL
   * Platelet \> 100,000/uL
   * Hemoglobin \> 9.0 g/dL
6. ECOG Performance status 0-1 7 Age \> 18

8. If previously treated with major surgery, it should be over at least 4 weeks. And if previously treated with radiotherapy, it should be over at least 2 weeks.

9. Written consent

Exclusion Criteria:

1. Previous chemotherapy.
2. Symptomatic brain metastasis.
3. Concurrent severe medical illness.
4. Pregnancy and lactation.
5. If there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial.

   * Uncontrolled diabetes mellitus.

Primary outcomes:
measure: change in response rate
timeFrame: within 4 cycles
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Asan Medical Center
name: Sang-We Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00207623: Evaluation of the Arthritis Basics for Change (ABCs) Self Management Program
Official title: Evaluation of the Arthritis Basics for Change (ABCs) Self Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Keywords: arthritis
self management
patient education
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: St. Louis University
First posted: 2005-09-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: ECT

Brief summary: While there are a variety of arthritis education materials available, the evidence-base on most of them is slim, so it i impossible to know what benefits they may have for the people who participate. The purpose of this project is to evaluate the effectiveness of the mail-delivered self-management education program, Arthritis Basics for Change (ABCS) with an emphasis on changes in knowledge, beliefs, behavior, self efficacy and health outcomes, and to evaluate the appropriateness, usefulness, and readibility of the program. This project will assist CDC's Arthritis Program in determining the usefulness of the ABCs program for helping people with arthritis improve their quality of life.


Eligibility criteria: Inclusion Criteria:

adults with arthritis

Exclusion Criteria:

-

Primary outcomes:
measure: Arthritis management knowledge at 6 months
measure: self management beliefs at 6 months
measure: Self management behaviors at 6 months
measure: Self efficacy for arthritis management at 6 months
measure: Health status at 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Louis University
name: Anjali D Despande, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00689923: Vertebroplasty Using Real-Time, Fluoroscopy-Controlled, Catheter-Assisted, Low-Viscosity Cement Injection
Official title: Vertebroplasty Using Real-Time, Fluoroscopy-Controlled, Catheter-Assisted, Low-Viscosity Cement Injection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Compression Fracture
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: painful vertebral compression fracture

Brief summary: Th low viscosity cement injection is safe in vertebroplasty procedure with Comparacle out come in pain relief.

Detailed description: Pain relief; Comparatle

Cement Leakage; Comparacle

Irradiation dose：less

Eligibility criteria: Inclusion Criteria:

* all painful fracture that can not be relieved by pain killer.

Exclusion Criteria:

* infection and malignancy in local region

Primary outcomes:
measure: pain relief
timeFrame: immediately after procedure
Secondary outcomes:
measure: cement leak
timeFrame: immediate after procedure
Other outcomes:
Locations:
Study officials:
References: