louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03206554: Local Infiltration Analgesia in Total Knee Arthroplasty
Official title: Local Infiltration Analgesia in Total Knee Arthroplasty: A Randomized, Prospective, Placebo Controlled, Double Blinded Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Total Knee Arthroplasty
Analgesia
Lead sponsor: Asklepieion Voulas General Hospital
Sponsor class: OTHER_GOV
First posted: 2017-07-02
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 40 patients ASA I-III, undergoing total knee arthroplasty were randomly assigned, into one of two groups, namely group LIA (n=20), where local infiltration analgesia would be administered intraoperatively; and group sham LIA (n=20), where sham injections of normal saline would be administered. All patients received a standardized multimodal approach, including pregabalin, adductor canal peripheral nervous blockade, spinal anaesthesia, paracetamol, and PCA with morphine. Morphine consumption during the first 24 hours postoperatively was measured and additionally the investigators recorded: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 6 hours, 12 hours, 18 hours and 24 hours postoperatively, complications, patient satisfaction and duration of hospitalization.


Eligibility criteria: Inclusion Criteria:

* Physical status according to American Society of Anesthesiologists (ASA) I-III
* Patients scheduled for total knee arthroplasty

Exclusion Criteria:

* Contraindication for central and/or peripheral nervous blockade
* Reoperation on previous total knee arthroplasty
* History of allergic or other adverse reactions on the agents used in the study
* Chronic opioid or gabapentinoid use
* Serious psychiatric, mental and cognitive disorders
* Language barrier
* Difficulty in understanding or using a patient controlled analgesia device

Primary outcomes:
measure: Morphine consumption
timeFrame: 24 hours
Secondary outcomes:
measure: NRS scores
timeFrame: 24 hours
measure: Complications
timeFrame: 24 hours
measure: Patient satisfaction
timeFrame: 24 hours
measure: Duration of hospitalization
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
citation: Tziona D, Papaioannou M, Mela A, Potamianou S, Makris A. Local infiltration analgesia combined with a standardized multimodal approach including an adductor canal block in total knee arthroplasty: a prospective randomized, placebo-controlled, double-blinded clinical trial. J Anesth. 2018 Jun;32(3):326-332. doi: 10.1007/s00540-018-2476-x. Epub 2018 Mar 5.
Clinical trial NCT00817154: Individually Based Psychosocial Rehabilitation for Older People With Serious Mental Illness (SMI)
Official title: Individually Based Psychosocial Rehabilitation for Older People With SMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depression
Keywords: Older persons with SMI
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-01-06
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The major goal of this project is to adapt an existing group-based psychosocial program to enhance community functioning in older people with serious mental illness (SMI). The focus of the adaptation is designing and evaluating an individually based rehabilitative program for older people with SMI who either cannot or choose not to access a group program.


Eligibility criteria: Inclusion Criteria:

1. Age 50+;
2. ability to provide voluntary informed consent or assent, with formal consent by a legal guardian;
3. Axis I Disorder of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression;
4. Functional impairment based on New Hampshire state eligibility criteria for services to people with SMI;
5. Enrollment in treatment for at least three months.

Exclusion Criteria:

1. residence in a nursing home or assisted living facility;
2. Terminal illness expected to result in death within one year or less;
3. Diagnosis of dementia, or significant cognitive impairment as indicated by a Mini Mental Status Evaluation (MMSE) score \<24;
4. Current active substance abuse or dependence;
5. Past Participation in HOPES-G

Primary outcomes:
measure: To develop an individually based psychosocial rehabilitation program for older adults with SMI. The program will be specified in treatment manuals and will match relevant skills training modules to the functional needs and preferences of consumers.
timeFrame: baseline, 9 months and 12 months, 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: Riverbend Community Mental Health Center
state: New Hampshire
city: Nashua
country: United States
facility: Community Council of Nashua
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Sarah I Pratt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00609154: Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates
Official title: Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Insulin
biosynthesis
Non diabetic control
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-02-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood.

Detailed description: We will measure the rate of new insulin production in subjects with Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2 diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes
* Non diabetic

Exclusion Criteria:

* Currently taking medication such as thiazolidinediones, metformin, Exenatide, or sitagliptin
* Chronic condition such as chronic heart failure CHF), Coronary Artery Disease (CAD), or chronic renal failure (CRF)
* Anemia

Primary outcomes:
measure: Insulin Biosynthesis Rate
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicinie
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Daniel T Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04847154: Endometrium Microbiome Alterations in Cesarean Section Diverticula Before and After Transvaginal Repair Surgery
Official title: Endometrium Microbiome Alterations in Cesarean Section Diverticula Before and After Transvaginal Repair Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Section Complications
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 Healthy women with cesarean section without Cesarean Section Diverticula 30 Healthy women with cesarean section with Cesarean Section Diverticula

Brief summary: The study compares the microbiome differences in the endometrium between normal people and patients with uterine diverticula after cesarean section and aims to discover the essential microbes and their metabolites that highly associate with the repair of myometrium through metagenomics and metabolomics. It verifies that flora disorder in the endometrium is the important cause of poor uterine repair after cesarean section. Then these patients with uterine diverticula receive the transvaginal repair surgery. Through the follow-up with them, we gain the microbiome differences of the endometrium before and after the surgery and show the validity of transvaginal repair surgery in the level of microbiome and metabolism.


Eligibility criteria: Inclusion Criteria:

have one cesarean delivery, have intermenstrual spotting after the cesarean section or Residual muscle thickness was less than 3.0 mm at the preoperative stage underwent magnetic resonance imaging and transvaginalultrasound to evaluate the size of the defect and the Residual muscle thickness before surgery have vaginal repair of Cesarean Section Diverticula write consent for operation.

Exclusion Criteria:

have a history of endocrine disorders have coagulation disorders use of intrauterine devices have sub-mucous myoma have endometrial diseases have endometrial cysts, uterine fibroids, and adenomyosis

Primary outcomes:
measure: Change of Endometrium Microbiome
timeFrame: In the 7th day of the period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00667654: Safety and Tolerability of 4975 in the Treatment of Moderate to Severe Knee Pain Due to Osteoarthritis (OA)
Official title: A Phase 2, Open-label Study to Evaluate Safety and Tolerability, and to Explore the Efficacy, of Dosing Regimens of Intraarticular 4975 in Patients With Chronic Moderate to Severe Pain of the Knee Associated With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis, Knee
Lead sponsor: Centrexion Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.

Detailed description: This is a single site study. The study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks. Pain in the treated knee will be assessed before, during and after administration of the study drug.

Eligibility criteria: Inclusion Criteria:

* Male or female patients aged 40 years or over.
* Body mass index (BMI) of 35 or less.
* History of OA of the knee for at least 1 year and has experienced pain in the target area for at least six months.
* X-Ray of the target knee.
* Willing and able to complete the study procedures.

Exclusion Criteria:

* Female patients who are pregnant or lactating or who plan to get pregnant.
* Clinically significant form of joint disease other than OA.
* Medical condition that could adversely impact the patient's participation, safety or affect the conduct of the study.
* Prior major trauma in the target knee or major surgeries such as partial or total knee arthroplasty.
* Arthroscopic surgery on the target knee within 6 months.

Primary outcomes:
measure: To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times
timeFrame: 12 Weeks
Secondary outcomes:
measure: Evaluate analgesic efficacy, as measured by the PGIC, following IA injection of CNTX-4975
timeFrame: 12 Weeks
measure: Change from baseline to Week 12 in WOMAC subscale score
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Worcester
country: United States
facility: Clinical Phamacology Study Group
state: Massachusetts
Study officials:
affiliation: Anesiva, Inc.
name: William C Houghton, MD
role: STUDY_DIRECTOR
affiliation: Anesiva, Inc.
name: Shaun Comfort, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT02465554: Imaging and Omics for Cardiovascular Risk During NASA Deep Space Missions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for clinically-indicated CT coronary angiography.

Brief summary: The purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions.

Detailed description: The purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions. In this protocol, two different forms of imaging will be used to evaluate coronary plaque development (CT coronary angiography) and microvascular function (myocardial contrast echocardiography) to stratify CV risk. Based on this stratification, "omic" patterns (targeted metabolomics, lipidomic, and whole genome sequencing) will be assessed to determine whether there are any patterns that can add to existing predictive models. Outcomes measures will involve correlation of "omic" patterns to incremental risk scaling from lowest (no plaque and normal endothelial function) to highest (+ plaque and endothelial dysfunction).

Eligibility criteria: Inclusion Criteria:

* Patients referred for clinically indicated CT coronary angiography within 6 months
* No obstructive coronary plaque and an Agatston score of 0 or At least one obstructive coronary plaque \<50% diameter and one other high risk feature on CT-A (positive remodeling, scattered calcification, low Hounsfield units, or "napkin ring" sign.

Exclusion Criteria:

* Known CAD or other atherosclerotic disease
* Valvular heart disease (moderate or more) and congenital heart disease
* Heart failure
* Pregnancy
* Allergy to ultrasound contrast agent.
* Right to left shunt

Primary outcomes:
measure: Omic patterns of atherosclerosis
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT02426554: Dietary Supplementation of of DHA, Vitamin D3 and Uridine in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
name: Helene Elsass Center, Denmark.
First posted: 2015-04-27
Enrollment: 16
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The feasibility of combining a motor and cognitive exercise program with dietary supplementation (DDU: Vitamin D, DHA and Uridine or Placebo) is tested in a smaller group of prepubescent children.


Eligibility criteria: Inclusion Criteria:

- age 8 to 11 yrs.

Exclusion Criteria:

* history of neurological or psychiatric disorders.

Primary outcomes:
measure: Compliance to cognitive and motor training program (Move It To Improve It: MiTii)
timeFrame: 6 weeks
measure: Dietary compliance
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NEXS
name: Jens Bo Nielsen, Professor
role: STUDY_DIRECTOR
References:
citation: Hansen SL, Ritterband-Rosenbaum A, Voigt CB, Hellgren LI, Sorensen AM, Jacobsen C, Greve LZ, Jorgensen KD, Bilde PE, Kiens B, Nielsen JB. Supplementation of docosahexaenoic acid (DHA), vitamin D3 and uridine in combination with six weeks of cognitive and motor training in prepubescent children: a pilot study. BMC Nutr. 2017 Apr 17;3:37. doi: 10.1186/s40795-017-0155-1. eCollection 2017.
Clinical trial NCT01341054: Use of Chamomilla Recutita in Mucositis
Official title: Chamomilla Recutita Use of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mucositis
Keywords: mucositis
chamomilla
therapeutics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 40
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: To determine the Chamomilla recutita solution dose needed to reduce the intensity and evolution time of oral mucositis in adult subjects submitted to HSCT.

Detailed description: Population: adult subjects, submitted to hematopoietic stem cell transplantation (HSCT) at a cancer hospital in the interior of São Paulo State. The following inclusion criteria were adopted for sample selection purposes: subjects over 18 years of age, candidates for allogeneic HSCT and with intact oral cavity on the first day of conditioning. Subjects will be excluded if they present any adverse reaction to the active principles of Chamomilla recutita; receive oral or intravenous anticoagulation therapy; use oral or systemic topical anti-inflammatory medication; receive any other type of intervention for mucositis not included in the standard oral care protocol.

Eligibility criteria: Inclusion Criteria:

* subjects over 18 years of age;
* candidates for allogeneic HSCT;
* with intact oral cavity on the first day of conditioning.

Exclusion Criteria:

* present any adverse reaction to the active principles of Chamomilla recutita;
* receive oral or intravenous anticoagulation therapy;
* use oral or systemic topical anti-inflammatory medication;
* receive any other type of intervention for mucositis not included in the standard oral care protocol.

Primary outcomes:
measure: Oral mucositis intensity
timeFrame: The measurement will be held on the first day of the conditioning regimen to bone marrow grafting. In an expected average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Fernanda TM Braga, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Emilia C Carvalho
role: STUDY_DIRECTOR
References:
citation: Braga FT, Santos AC, Bueno PC, Silveira RC, Santos CB, Bastos JK, Carvalho EC. Use of Chamomilla recutita in the Prevention and Treatment of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized, Controlled, Phase II Clinical Trial. Cancer Nurs. 2015 Jul-Aug;38(4):322-9. doi: 10.1097/NCC.0000000000000194.
Clinical trial NCT04596254: Detection of Gut Metabolites in Mother's Milk Following Juice Intake
Official title: Prospective Human Specimen Collection for Medical Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Diet
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 7
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the biological sample collection is to assess the presence of gut metabolites in human breast milk (BM) samples obtained prospectively from healthy lactating mothers and after consumption of fruit juice.


Eligibility criteria: Inclusion Criteria:

* 20-40 yrs. female subjects with no lactation problems
* Healthy and term delivery
* Healthy dietary intake (vegetarian or omnivore)
* Agree to donate breast milk (not colostrum)
* First 6 months of lactation
* Subjects agree to consumer 8oz. of pomegranate juice for a week prior to 2nd collection

Exclusion Criteria:

* \<20 yrs or \>40 yrs. of age
* Subjects with lactation problems
* Preterm delivery
* Colostrum samples
* Lactation\>6 months
* Subjects fail to drink juice for at least a week

Primary outcomes:
measure: Change in levels of gut metabolites in breast milk following juice intake
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valleywise Health Biobank
state: Arizona
Study officials:
affiliation: Amazentis SA
name: Anurag SIngh, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00644254: The Prognostic Impact of Extracapsular Lymph Node Involvement in Ductal Pancreatic Adenocarcinoma
Official title: The Prognostic Impact of Extracapsular Lymph Node Involvement (ECLNI) in Ductal Pancreatic Adenocarcinoma (DPAC).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasms
Pancreatic Adenocarcinoma
Keywords: Prognosis
Extracapsular lymph node involvement
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2008-03-26
Enrollment: 145
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Resected ductal pancreatic adenocarcinoma

Brief summary: Extracapsular lymph node involvement (ECLNI) has been identified as a pathological variable associated with worse outcome in esophageal, gastric and colorectal cancer. No studies so far have studied its prognostic impact in ductal pancreatic adenocarcinoma (DPAC). The goal of the investigators is to determine the prognostic value of ECLNI in a prospective consecutive series of 145 patients with DPAC, who underwent resection of their primary tumor between 1998 and 2005.

Detailed description: Presence and extent of extracapsular lymph node involvement (ECLNI) will be scored by reviewing all original pathological slides.

ECLNI is defined as metastatic adenocarcinoma extending through the nodal capsule into the perinodal fatty tissue.

Observers: 1 experienced board-certified GI pathologist, blinded for follow-up results.

Follow-up data are obtained by reviewing patients charts and by a telephone survey of the patient's GP/gastroenterologist in November 2007.

Statistical analysis:

* Common closing date: 1/11/2007
* Kaplan-Meier survival analysis (Log-Rank, Wilcoxon)
* Cox logistic regression (uni/multivariate)

Eligibility criteria: Inclusion Criteria:

* DPAC
* Primary resection

Exclusion Criteria:

* Positive section margins
* non DPAC, other tumor
* Postoperative mortality
* Neoadjuvant chemo/radiotherapy

Primary outcomes:
measure: Overall cancer-specific survival
timeFrame: 11/2007
Secondary outcomes:
measure: Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables
timeFrame: 11/2007
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Abdominal Surgery
state: Vlaams-Brabant
Study officials:
affiliation: Catholic University Leuven (KULeuven), Belgium
name: Baki Topal, MD, PhD
role: STUDY_DIRECTOR
affiliation: Catholic University Leuven, Belgium
name: Gregory Sergeant, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University Leuven, Belgium
name: Nadine Ectors, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: