louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02543801: A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty
Official title: A Prospective, Randomized Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Hip and Knee Arthroplasty
Lead sponsor: Kootenai Health
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 239
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates two routinely used drug combinations for periarticular injection following total hip and knee arthroplasty for pain control. One group will receive liposomal bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive ropivacaine, clonidine, epinephrine and ketorolac.

Detailed description: A key component of the multimodal approach to pain management is the intra-operative surgical site injection of a local anesthetic or drug cocktail. There are many formulations used for this purpose. A formulation documented in the literature was implemented by this institution which has dropped the average length of stay dramatically. Concern over the limited half-life of the administered anesthetic and the continued need for opioid administration has led to a search for better drug formulations and administration vehicles. Recently, the FDA approval of an extended release bupivacaine called liposomal bupivacaine was thought to extend the effective half-life of the anesthetic agent and thereby prolong post-operative anesthesia. Use of liposomal bupivacaine in total joint surgery was almost universally adopted after its recent approval and has been an integral part of the "same day total joint" movement.

Studies have suggested improvement in pain control and shortened hospitalizations with the use of liposomal bupivacaine. Other studies have raised questions about the effectiveness of this agent. Recently a randomized double blind study was performed with total knees which demonstrated no improvement in pain management with the addition of liposomal bupivacaine to the multimodal pain management protocol. This study has not been performed in the hip arthroplasty population.

Eligibility criteria: Inclusion Criteria:

* Hip Arthritis (osteoarthritis, post traumatic, inflammatory, and avascular necrosis)

Exclusion Criteria:

* Current use of opioid drugs
* Revision surgery
* Surgical complication (femoral fracture with implant insertion)
* Inability to provide Informed Consent

Primary outcomes:
measure: Pain Score
timeFrame: Starting post operatively and then every four hours up to 48 hours
Secondary outcomes:
measure: Narcotic Consumption
timeFrame: Starting immediately post operatively up to 48 hours
measure: Length of Stay
timeFrame: Start of surgery to hospital discharge up to 140 hours
Other outcomes:
Locations:
Study officials:
affiliation: Kootenai Health
name: Joe Bowen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02762201: Clinical Evaluation of Implant-secured Removable Partial Denture
Official title: Clinical Evaluation of Therapeutic Efficiency of Implant-secured Removable Partial Denture: A Randomized, Controlled, Prospective Multicentric Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tooth Loss
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the therapeutic efficiency of implant-secured removable partial denture (PASI) with the therapeutic efficiency of the metalic standard removable partial denture (PAC) in the treatment of intermediate extended-gap (4 adjacent teeth). The therapeutic efficiency will be assessed by the 5 years-prosthetic success rate.


Eligibility criteria: Inclusion Criteria:

* Patients with at least a 4 to 6 adjacent teeth intermediate extended-gap (excluding wisdom teeth) in the upper or lower jaw.
* Patients with at least 4 conservable teeth by dental arch, without major occlusal trouble.
* Patients with healthy periodontium, allowing metalic standard removable partial denture delivery : bleeding on periodontal probing for a duration less than 30 seconds, Osteolysis of the alveolar ridge less or equal to 50%, attachment loss less or equal to 5mm
* Patients with a sufficient bone volume for implant placement, without prior bone supply.

Exclusion Criteria:

* Patients with general counter-indications for implant placement.
* Patients suffering from a titanium allergy.
* Patients with an insufficient oral and dental hygiene - Patients smoking ten or more cigarettes per day.
* Patients with teeth extended-gap, which could be corrected by a fixed tooth-supported denture.
* Patient with an insufficient available bite level to deliver an attachment system (\< 7mm).
* Patients with a severe generalized chronic periodontitis , an aggressive periodontitis or a periodontitis unresponsive to treatment.
* Women who have reported to be pregnant.
* Patients deprived of liberty

Primary outcomes:
measure: prosthetic success rate
timeFrame: 5 years after prosthesis delivery
Secondary outcomes:
measure: prosthetic success rate
timeFrame: 6 months, 1 year, 2 years, 3 years and 4 years after prosthesis delivery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT03123367: Evaluation of the Nella Women's Care Line
Official title: An Evaluation of the Safety and TechnIcal Feasibility Of the NelLa Women's Care Line for Female Gynecological ExaminaTions and Procedures (VIOLET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GYN Disorders
Lead sponsor: Ceek Enterprises
Sponsor class: INDUSTRY
First posted: 2017-04-21
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluation of the Nella Women's Care Line

Detailed description: The Nella Women's Care Line is being studied in women undergoing a gynecological exam and other gynecological procedures that require visibility and access to the cervix.

Eligibility criteria: General inclusion criteria (applies to all study groups):

* Subject is female
* Subject is 18 - 65 years of age, inclusive, at the time of consent
* Subject is undergoing a gynecological examination (as defined above) as part of their regular clinical care
* Subject has undergone one or more prior gynecological exams
* Subject is willing and able to provide written informed consent
* Subject is able and willing to perform the functions required by the study protocol

General exclusion criteria (applies to all study groups):

* Subject has undergone hysterectomy
* Subject has a known history of allergies to latex or plastics
* Subject is pregnant
* Subject is post-partum (≤ 12 weeks)
* Subject has had an induced or spontaneous abortion in the prior 12 weeks
* Subject has an active gynecologic complaint that, in the opinion of the clinician, would confound study results
* Subject has dyspareunia
* Subject has a known history of vulvodynia such as vulvular vestibular syndrome
* Subject has a known history of vaginismus
* Subject has a planned surgical procedure along with the gynecological exam
* Subject is under incarceration
* Subject is unable to provide written informed consent

Device specific inclusion criteria:

In addition to the general inclusion, the subject must meet all device specific criteria associated with their assignment group. Below are device-specific criteria. There is no device-specific exclusion criterion.

Nella VuSleeve (Group 1) inclusion:

• Subject has a BMI ≥ 30 and/or 3 or more vaginal births

NellaSpec (Group 2), Nella NuSpec (Group 3), and Nella Insert (Group 4) inclusion:

• Subject has a BMI \< 35

Primary outcomes:
measure: Technical Feasibility
timeFrame: Day of Exam or Procedure
Secondary outcomes:
measure: Safety
timeFrame: Day of Exam or Procedure
Other outcomes:
Locations:
city: Portland
country: United States
facility: Research Site
state: Oregon
Study officials:
affiliation: Ceek Enterprises
name: Ceek Clinical Research
role: STUDY_DIRECTOR
References:
Clinical trial NCT02449967: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Cancer
Official title: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Cancer: Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
HepaSphere
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction Angiography（DSA）for pancreatic cancer.

Detailed description: By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction Angiography（DSA）for pancreatic cancer.

Eligibility criteria: Inclusion Criteria:

1. Age:18-80
2. Karnofsky performance status \>60
3. Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except pancreatic cancer
2. History of coagulation disorders or anemia

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of lesions that show no sign of recurrence 12 months after interventional therapy
timeFrame: 1 year
measure: Progress free disease (PFS)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Central laboratory in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Liu, PhD
role: STUDY_CHAIR
References:
citation: Niu L, Chen J, Yao F, Zhou L, Zhang C, Wen W, Bi X, Hu Y, Piao X, Jiang F, Zeng J, Liu W, Li J, He L, Mu F, Zuo J, Xu K. Percutaneous cryoablation for stage IV lung cancer: a retrospective analysis. Cryobiology. 2013 Oct;67(2):151-5. doi: 10.1016/j.cryobiol.2013.06.005. Epub 2013 Jun 24.
Clinical trial NCT00930267: Infections in Pediatric Cancer Patients
Official title: Epidemiology and Etiology of Infections in Pediatric Cancer Patients: A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infections
Keywords: fever
children
cancer
leukemia
stem cell transplantation
infections in pediatric cancer patients presenting with fever during or following chemotherapy.
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-06-30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All newly diagnosed pediatric cancer patients age 0-18 years admitted with fever during or following chemotherapy

Brief summary: A prospective epidemiological study conducted in pediatric hematology oncology center in Hadassah medical center. The study will include all newly diagnosed pediatric cancer patients age 0-18 years admitted with fever during chemotherapy.

In each event of febrile episode during chemotherapy, the following data will be collected using a patient data form and computerized software.

Demographic data: age, gender, ethnicity. Clinical data: Underlying disease, immunizations, prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy, duration of fever, duration and severity of neutropenia, diagnosis of present event.

Imaging data Microbiological data Outcome The statistical analysis will be performed by an epidemiologist and statistician using the SPSS 12.0 software.


Eligibility criteria: Inclusion Criteria:

* Pediatric cancer patients age 0-18 years admitted with fever during or following chemotherapy

Exclusion Criteria:

* No exclusions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Dan Engelhard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Diana Averbuch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00254267: Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors
Official title: An Open-label Phase 2 Study of AMG 706 in Japanese Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Gastrointestinal Stromal Tumor
Keywords: Gastrointestinal Stromal Tumor, Imatinib Mesylate Resistance, Phase2 study, AMG 706
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Takeda
First posted: 2005-11-16
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of histological confirmed GIST
* Had prior imatinib mesylate therapy
* Has at least 1 measurable leasion by modified RECIST

Exclusion Criteria:

* Central nervous system tumor involvement requiring treatment
* History of myocardial infraction
* Uncontrolled hypertension

Primary outcomes:
measure: The objective response rate as assessed by modified RECIST
timeFrame: Every 8 weeks
Secondary outcomes:
measure: Duration of response, progression-free survival, time to response, overall survival, PK and safety profile
timeFrame: imaging, every 8 weeks; survival, every 6 months; PK, Days 1,15, 29, 43, 57, every 2 weeks in week 9 to 16, and every 4 weeks thereafter;
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Benjamin RS, Schoffski P, Hartmann JT, Van Oosterom A, Bui BN, Duyster J, Schuetze S, Blay JY, Reichardt P, Rosen LS, Skubitz K, McCoy S, Sun YN, Stepan DE, Baker L. Efficacy and safety of motesanib, an oral inhibitor of VEGF, PDGF, and Kit receptors, in patients with imatinib-resistant gastrointestinal stromal tumors. Cancer Chemother Pharmacol. 2011 Jul;68(1):69-77. doi: 10.1007/s00280-010-1431-9. Epub 2010 Sep 14.
Clinical trial NCT02293967: Mass Balance Study of MT-1303
Official title: An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 After a Single Oral Dose to Healthy Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsing-remitting Multiple Sclerosis
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2014-11-19
Enrollment: 8
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Caucasian male aged 30 to 65 at Screening.
* Body weight of ≥60 kg, and a BMI ranging from 18.0 to 32.0 kg/m2 at Screening and Day -1.
* Normal or not clinically significant ECG as defined by a HR between 50 and 100 bpm inclusive at Screening, Day -1 and pre-dose.
* Vital signs within the following ranges at Screening and Day -1,Body temperature: 35.0 to 37.5 °C,SBP: 90 to 140 mmHg,DBP: 50 to 90 mmHg.
* Regular daily bowel movements.

Exclusion Criteria:

* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
* Previous medical history of tuberculosis, or in the opinion of the Investigator, a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections or fungal infections.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case or participation in the study. The investigator should be guided by evidence of any of the following:

  * history of inflammatory bowel syndrome,gastritis, ulcers, gastrointestinal or rectal bleeding;
  * history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection

Primary outcomes:
measure: Total radioactivity in urine and faeces
timeFrame: up to 10 weeks
Secondary outcomes:
measure: PK of total radioactivity in plasma
timeFrame: up to 10 weeks
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Investigational site
state: Nottingham
Study officials:
affiliation: Quotient Clinical
name: Pui Leung
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kifuji T, Inoue S, Furukawa M, Perez Madera B, Goto T, Kumagai H, Mair SJ, Kawaguchi A. Absorption, disposition and metabolic pathway of amiselimod (MT-1303) in healthy volunteers in a mass balance study. Xenobiotica. 2019 Sep;49(9):1033-1043. doi: 10.1080/00498254.2018.1525508. Epub 2018 Dec 21.
Clinical trial NCT02422667: iCORE: Collaborative Orthopedics Outcomes Registry
Official title: iCORE: Collaborative Orthopedics Outcomes Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Keywords: Orthopedics
Outcome Assessment
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18 years and older who undergo hip and/or knee arthroplasty. Patient must have the ability to understand the nature of the registry and give written informed consent.

Brief summary: The goal of this registry is to review the data collected and research ways to improve patient safety, quality of care, and medical decision-making, reduce medical spending, and help advance orthopedic science and bioengineering.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Patients requested to be seen by an orthopedic surgeon participating in the iCORE Registry.
* Patient must have the ability to understand the nature of the registry and give written informed consent.

Exclusion Criteria:

* There are no exclusion criteria for this Outcomes Registry.

Primary outcomes:
measure: Quality Improvement
timeFrame: 10 years
measure: Treatment Patterns
timeFrame: 5 years
measure: Healthcare Utilization
timeFrame: 5 years
Secondary outcomes:
measure: Humanistic Outcomes
timeFrame: 10 years
measure: Economic Outcomes
timeFrame: 10 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: SCRI
state: Tennessee
Study officials:
affiliation: SJRI/SCRI
name: David K DeBoer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00822367: Blood Sugar Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes
Official title: Assessment of Glycemic Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
First posted: 2009-01-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the study is to determine which of the commonly used meal supplements is the best product for patients with DM. This is important because meal supplements are becoming more popular as meal replacements in the United States. Peak blood sugar occurs about 2 hours later after a meal. Therefore, the best product would be the one that produces a smallest rise in blood sugar.

Detailed description: The purpose of the study is to determine which of the commonly used commercial nutritional supplements are preferential for patients with Diabetes Mellitus (DM). We will compare the post-prandial blood glucose (BG) responses in response to 3 different nutritional supplements each containing 50 grams of carbohydrate in adult patients with type 2 diabetes mellitus and relate these responses to one of the two well-recognized indices of insulin sensitivity - HOMA-R and QUICKI.

Eligibility criteria: Inclusion Criteria:

* Ages 18-75 years
* Type-2 diabetes mellitus for over 3 months
* A1c of 7.0 - 10.0% within the past 3 months
* Controlled with diet /exercise and/or on oral anti-diabetic agents which are non-insulin secretatgogues, i.e. Metformin and/or Pioglitazone
* Able to give informed consent
* Expected to be in the DC metropolitan for the duration of the study
* Fasting blood glucose between 70 and 250 mg/dl

Exclusion Criteria:

* Patients with type 2 diabetes mellitus treated with insulin secretagogues (sulfonylurea and non-sulfonylurea), pramlintide (Symlin), GLP-1 analogs (Byetta), insulin, or alpha-glycosidase inhibitors
* A1c under 7.0% or over 10.0%
* Fasting blood glucose \< 70 or \> 250 mg/d
* Gastrointestinal disorders affecting digestion and absorption of nutrients such as lactose intolerance, chronic diarrhea, pancreatic insufficiency.
* Clinical history of documented gastroperesis.
* Patients on hemodialysis or peritoneal dialysis
* Pregnancy
* Inability to read and/or speak English

Primary outcomes:
measure: To determine the nutritional supplements glycemic response in patients with DM, defined as the maximum glucose excursion, area under the curve, and 2 and 3 hour BG levels fol
timeFrame: BG will be tested by finger sticks before (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after drinking the supplement.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Walter Reed Army Medical Center
name: Robert A Vigersky, COL. MC. MD.
role: STUDY_DIRECTOR
References: