louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00682903: Use of a Bearable Continuous Interstitial Glucose Monitoring Device (GuardianR) During Teaching Sessions to Functional Insulin Therapy Concept in Patients Suffering From Type 1 Diabetes: Evaluation at 6 and 12 Months
Official title: Use of a Bearable Continuous Interstitial Glucose Monitoring Device (GuardianR) During Teaching Sessions to Functional Insulin Therapy Concept in Patients Suffering From Type 1 Diabetes: Evaluation at 6 and 12 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Complications
Keywords: glucose
diabetes
glycemia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-05-23
Enrollment: 64
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: DIAGNOSTIC

Brief summary: The objective of the project is to evaluate advantages from the use of a bearable continuous interstitial glucose monitoring device (GuardianR) during educative sessions of diabetic patients dedicated to functional insulin therapy teaching. This concept of intensified treatment is based on testing and explanation of simplified decision making algorithms to adapt insulin dose to every true life conditions. As self monitoring of capillary glucose level is needed to validate those algorithms, we postulate that using a device able to permanently control interstitial glucose readable by both medical team and patient himself (during the session and the 5 following days after discharge) could significantly improve safety and efficiency of such educative session.

Detailed description: Two groups of 60 patients (experimental and control groups) will be followed and evaluated at 6 and 12 months. We do think that this new tool would facilitate education of patients and lead further to a better glycemic control.

Eligibility criteria: Inclusion Criteria:

* Subject major, from 18 to 70 years old
* Diabetes of type 1 defined according to the criteria of American Diabetes Association
* Insulinic treatment for at least 12 months
* Understood HbA1C enters 6,5 and 9,5 %

Exclusion Criteria:

* Minor subjects or under guardianship
* Unbalance kétosis current or recent
* Pregnancy
* Incapacitated to participate weekly complete educational in the functional insulin-therapy,
* Evolutionary severe general disease
* Psychiatric confusions
* Unbalance chronic (HbA1c \> 9,5 %) connected to an absence of adapted coverage or to abnormal behaviors
* Pathology making not interpretable the rate of HbA1c (hemoglobinopathy, anemia)

Primary outcomes:
measure: The HbA1c, the witness of the quality of the metabolic balance, in 6 and 12 months. We shall compare the deltae of HbA1c between the period of inclusion and 6 and 12 months following the training course in the "fonctional" insulin therapy
timeFrame: glycemia
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: CHU timone
state: Bouches du Rhone
Study officials:
References:
Clinical trial NCT02593903: Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair
Official title: Prophylactic Antibiotics Following Distal/Mid-shaft Hypospadias Repair: Are They Necessary?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypospadias
Keywords: Antibiotic Prophylaxis
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2015-11-01
Enrollment: 67
Sex: MALE
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of prophylactic antibiotics following distal or mid-shaft hypospadias repair in influencing the rate of postoperative urinary tract infection and complications.

Detailed description: The rationale for using prophylactic antibiotics after hypospadias surgery is to decrease the occurrence of urinary tract infections (UTIs) and complications. However, even though prophylactic antibiotics are used by some pediatric urologists, to date there has been no evidence supporting the role of prophylactic antibiotics in decreasing UTIs or complications. This is a prospective, randomized trial involving children undergoing distal or mid-shaft hypospadias repair. Subjects randomized into a group taking prophylactic dosages of antibiotics and a group not receiving post-operative antibiotics.

Eligibility criteria: Inclusion Criteria:

* all children between ages 6 months to 2 years under going distal or mid shaft hypospadias repair
* children of parents who give informed consent
* English speaking
* participant must be available for follow-up 3 and 12 months post-surgery

Exclusion Criteria:

* all proximal hypospadias and redo hypospadias repairs
* children who are allergic to sulfa medications
* patients who have UTI at time of surgery (proven by culture)

Primary outcomes:
measure: Number of Participants With Urinary Tract Infection
timeFrame: 4-8 days post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Travis W Groth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meir DB, Livne PM. Is prophylactic antimicrobial treatment necessary after hypospadias repair? J Urol. 2004 Jun;171(6 Pt 2):2621-2. doi: 10.1097/01.ju.0000124007.55430.d3.
citation: Roth EB, Kryger JV, Durkee CT, Lingongo MA, Swedler RM, Groth TW. Antibiotic Prophylaxis with Trimethoprim-Sulfamethoxazole versus No Treatment after Mid-to-Distal Hypospadias Repair: A Prospective, Randomized Study. Adv Urol. 2018 Mar 26;2018:7031906. doi: 10.1155/2018/7031906. eCollection 2018.
Clinical trial NCT00000303: Rapid Evaluation of Baclofen for Treatment of Cocaine Abuse/Dependence - 6
Official title: Rapid Evaluation of Cocaine Pharmacotherapies (Baclofen)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: Cocaine dependence
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. In this study, baclofen is tested.

Detailed description: 16-week participation plus a 2 week lead in period. Participants are assigned randomly to placebo or baclofen. Participant attend group meetings 3 x/week.

Eligibility criteria: Inclusion Criteria:

M/F ages 18-65. cocaine dependence according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on ethanol (ETOH) or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Primary outcomes:
measure: Retention
measure: Cocaine use
measure: Cocaine craving
measure: Psychosocial progress
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04733703: Impact of Postanesthesia Care Unit Delirium on Postoperative Quality of Recovery
Official title: Impact of Postanesthesia Care Unit Delirium on Postoperative Quality of Recovery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Neurocognitive Disorders
Delirium
Postoperative Recovery
Anesthesia
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who are scheduled for elective non-cardiac surgery and who will receive general anesthesia, are eligible for study participation.

Brief summary: Postanesthesia care unit (PACU) delirium is subtype of postoperative delirium that occurs early after anesthesia and surgery during the recovery period. The consequences of PACU delirium have not been investigated thoroughly. So far it is unknown, whether patients with PACU delirium experience impaired postoperative quality of recovery.

The aim of this observational study is to assess the impact of PACU delirium on quality of recovery 24 hours after general anesthesia for elective non-cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* elective non-cardiac surgery
* general anesthesia
* fluency in German

Exclusion Criteria:

* expected postoperative ICU stay

Primary outcomes:
measure: postoperative quality of recovery
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
name: Marlene Fischer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02635503: Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer
Official title: A Prospective Randomized Controlled Trial Comparing Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) Versus Conventional Laparoscopic Surgery for Sigmoid Colon or Rectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: colorectal cancer
laparoscopic surgery
natural orifice specimen extraction
Inflammatory response
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 366
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 compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.

Detailed description: Further study details as provided by Chinese Academy of Medical Sciences.

Eligibility criteria: Inclusion Criteria:

* 18 years \< age \< 80 years
* Tumor located in rectosigmoid (defined as 8- to 30-cm from the anal verge)
* Pathological rectosigmoid adenocarcinoma
* Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual
* Tumor size of 6 cm or less;
* Eastern Cooperative Oncology Group (ECOG) score is 0-1
* American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
* Informed consent

Exclusion Criteria:

* Body mass index (BMI) \>30 kg/m2
* Pregnant woman or lactating woman
* Severe mental disease
* Previous abdominal surgery
* Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
* Requirement of simultaneous surgery for other disease

Primary outcomes:
measure: Early morbidity rate
timeFrame: 30 days
Secondary outcomes:
measure: Duration of the intervention
timeFrame: 1 day
measure: Peritoneal bacterial contamination
timeFrame: 1 day
measure: Pain score
timeFrame: 14 days
measure: 3-year disease free survival rate
timeFrame: 3 years
measure: 5-year overall survival rate
timeFrame: 5 years
measure: Plasma levels of several cytokines after colorectal cancer surgery
timeFrame: 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
state: Beijing
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
name: Zhixiang Zhou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03751943: NanoFUSE® PL Gutter PMCF
Official title: Clinical Investigation of NanoFUSE® Bioactive Matrix and Autogenous Bone in Posterolateral Spinal Fusion (Nonloadbearing)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Degenerative Disc Disease
Keywords: Demineralized Bone Matrix
Primary Lumbar Fusion
Autograft Lumbar Fusion
Lead sponsor: NanoFUSE Biologics, LLC
Sponsor class: INDUSTRY
First posted: 2018-11-23
Enrollment: 50
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: This study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal fusion.

Detailed description: NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis.) These defects may be surgically created osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine. This product provides a bone graft substitute that remodels into the recipient's skeletal system. Radiographic success will be the primary judgement of success. All patient's achieving fused or probably fused status will be judged as a success.

Eligibility criteria: Inclusion Criteria:

* Grade I or II (less than 50% slip f the cephalic vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L5
* Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of nonsurgical treatment, or such patients with worsening neurological condition
* Patients who are medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix is consistent with product labeling
* Patients who have consented for surgical treatment
* Patients able to provide informed consent for the study and complete the questionnaires

Exclusion Criteria:

* Lytic spondylolisthesis
* Non degenerative stenosis (example: tumor, trauma, epidural, lipomatosis)
* Segmental kyphosis at the level of the spondylolisthesis
* Rheumatoid arthritis
* Active infection
* On long term disability or workers compensation claim

Primary outcomes:
measure: Radiographic Success
timeFrame: 12 months
Secondary outcomes:
measure: Overall patient success
timeFrame: 12 months postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04317443: A Prospective Observational Comparison of SMP and ESWL for the Treatment of Renal Stones ≥20 mm in Children (IAU-04)
Official title: A Prospective Observational Comparison of Super-mini Percutaneous Nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the Treatment of Renal Stones ≥20 mm in Children: An IAU Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Stone
Keywords: percutaneous nephrolithotomy
pcnl
miniperc
smp
children
Lead sponsor: The International Alliance of Urolithiasis
Sponsor class: NETWORK
First posted: 2020-03-23
Enrollment: 250
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients undergoing SWL and SMP

Brief summary: ESWL and PNL are the two treatment modalities for kidney stones greater than 20 mm in the pediatric population. ESWL is non-invasive, does not require anesthesia and inexpensive, but its success rate may be lower, and require multiple treatment sessions. On the contrary, PNL has a higher success rate, does not require multiple sessions but is an invasive method. Compared to standard PNL, miniaturized PNL systems have been shown to decrease complications with comparable success rates. SMP is a unique miniaturized PNL system with integrated active irrigation and suction systems. The current literature lacks studies comparing SMP and ESWL prospectively in the pediatric population. In this study, the effectiveness, reliability, and reusability of ESWL and SMP will be compared.

Detailed description: To compare the success and complication rates of super-mini-percutaneous nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the treatment of renal stones ≥20 mm in children.An international multicentre, prospective, observational study. Pediatric cases with renal Stones ≥20 mm who undergo ESWL or SMP will be evaluated and compared proespectively. The total number of departments planned to be included in the study is 10 and the number of cases is 180.

Eligibility criteria: Inclusion Criteria:

* Children ≤14 years old with renal Stones ≥20 mm
* Willing and able to sign informed consent
* Normal renal function
* No stone-related surgical history
* American Society of Anesthesiology (ASA) score 1-2

Exclusion Criteria:

* Congenital renal anomalies (horseshoe kidney, ureteropelvic junction obstruction)
* Uncorrected UTI
* Abnormal coagulation function
* Morbid obese children (BMI≥35）

Primary outcomes:
measure: Stone free rate
timeFrame: 3-months
Secondary outcomes:
measure: blood loss
timeFrame: Postoperative day 1
measure: auxiliary procedures
timeFrame: Postoperative month 3
measure: hospital stay
timeFrame: Postoperative month 3
measure: complications
timeFrame: Postoperative month 3
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02073643: Study of Household Purchasing Patterns, Eating and Recreation
Official title: Delay Discounting and Household Food Choices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Habits
Adiposity
Blood Pressure
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: University of Illinois at Chicago
First posted: 2014-02-27
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chicago households

Brief summary: This project examines behavioral and household characteristics associated with food purchasing patterns.


Eligibility criteria: Inclusion Criteria:

1. Adult individual who reports making at least 75% of household food purchases
2. Resides in City of Chicago, Illinois or surrounding suburbs

Exclusion Criteria:

1. Inability to provide informed consent in English
2. Living in transitional housing or on a college campus
3. Lack of a cellular or land line phone
4. Gang presence or illegal activity in the immediate vicinity of the home, or other factors jeopardizing researcher safety during home visits (e.g., extreme unsanitary conditions)
5. Having a household member, including the primary shopper, with a medical condition or food allergy that substantially influences household food choices (e.g., phenylketonuria, celiac disease)

Primary outcomes:
measure: Diet Quality of Household Food Purchases
timeFrame: 2 weeks
Secondary outcomes:
measure: Diet Quality of Dietary Intake
timeFrame: 2 weeks
measure: Home Food Environment
timeFrame: 2 weeks
measure: Percentage of Total Energy Purchased From Non-store Sources (e.g., Fast Food and Take-out/Delivery, Restaurants)
timeFrame: 2 weeks
Other outcomes:
measure: Change From Baseline in Systolic Blood Pressure at 12 Months
timeFrame: 12 months
measure: Change From Baseline in Body Mass Index at 12 Months
timeFrame: 12 months
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
citation: Appelhans BM, Tangney CC, French SA, Crane MM, Wang Y. Delay discounting and household food purchasing decisions: The SHoPPER study. Health Psychol. 2019 Apr;38(4):334-342. doi: 10.1037/hea0000727.
citation: French SA, Tangney CC, Crane MM, Wang Y, Appelhans BM. Nutrition quality of food purchases varies by household income: the SHoPPER study. BMC Public Health. 2019 Feb 26;19(1):231. doi: 10.1186/s12889-019-6546-2.
citation: Appelhans BM, French SA, Tangney CC, Powell LM, Wang Y. To what extent do food purchases reflect shoppers' diet quality and nutrient intake? Int J Behav Nutr Phys Act. 2017 Apr 11;14(1):46. doi: 10.1186/s12966-017-0502-2.