louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00627848: Rivastigmine in Mild Alzheimer's Disease, FMRI Study
Official title: Effect of Rivastigmine on FMRI in Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer' Disease
Keywords: Alzheimer's disease
fmri
face recognition
rivastigmine
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2008-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate the effect of rivastigmine given as an acute dose compared to placebo and after 1 month chronic dosing on fMRI response during a face recognition task. Furthermore, the aim is to investigate whether fMRI response is correlated with long term treatment effect at 6 months and 12 months.


Eligibility criteria: Inclusion Criteria:

* Probable Alzheimer's disease according to the NINCDS-ADRDA criteria
* mild disease, CDR 1
* the clinician is planning to start anticholinesterase treatment

Exclusion Criteria:

* cognitive impairment for other reason than Alzheimer's disease
* severe depression
* other unstable physical disease
* medal in body prevention MRI examination, claustrophobia
* cardiac pacemaker
* other significant neurologic or psychiatric disease
* contraindication for anticholinesterase treatment

Primary outcomes:
measure: FMRI response in face recognition task
timeFrame: at baseline and at 1 mo
Secondary outcomes:
measure: treatment response measured by ADAS-cog
timeFrame: at 6 month and 1 year
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Hilkka Soininen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04540848: Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?
Official title: Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: Brachial plexus block
Multimodal pain control for Distal Radius surgery
Exparel
Bupivacaine
Distal Radius Pain Control
Post operative pain Control
Supraclavicular nerve block
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 see if Exparel, used intraoperatively by injecting at the surgical site, followed by a Supraclavicular nerve block with bupivacaine in the recovery room, will provide better pain scores for patients at 24 and 48 hours post operatively than, 1)Bupivacaine Hydrochloride (HCL) injection at the surgical site, with a supraclavicular block in Post-anesthesia care unit(PACU), or 2)a supraclavicular block in PACU without any kind of injection at the surgical site.


Eligibility criteria: Inclusion Criteria:

* distal radius fractures
* undergoing Open reduction internal fixation (ORIF) at Lyndon B Johnson Ambulatory Surgical Center (LBJ ASC)

Exclusion Criteria:

* pregnancy
* history of chronic pain conditions
* currently taking opioids

Primary outcomes:
measure: Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
timeFrame: 24 hours post treatment
measure: Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
timeFrame: 48 hours post treatment
Secondary outcomes:
measure: Number of patients who presented to Emergency room following surgery for pain control
timeFrame: 24 hours post surgery
measure: Number of patients who presented to Emergency room following surgery for pain control
timeFrame: 48 hours post surgery
measure: Number of over the counter(OTC) pain medications consumed by the patient
timeFrame: 24 hours post surgery
measure: Number of OTC pain medications consumed by the patient
timeFrame: 48 hours post surgery
measure: Number of prescription opioid medications consumed by the patient
timeFrame: 24 hours post surgery
measure: Number of prescription opioid medications consumed by the patient
timeFrame: 48 hours post surgery
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Erikka L Washington, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01164748: Lymphatic Mapping After Previous Breast Surgery
Official title: Lymphatic Mapping After Previous Breast Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Sentinel Node
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2010-07-19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included patients that received BCT with SNB and/or ALND for primary breast cancer located in the upper-outer quadrant of one breast at least 3 years before this analysis. Patients were excluded if they had breast surgery for other reasons than breast cancer, had recurrent breast cancer or had a former allergic reaction to 99mTc-colloidal-albumin.

44 patients were included and were divided into two groups according to previous surgical treatment of the axilla, being the sentinel node biopsy group and the Axillary Lymph Node Dissection group

Brief summary: Rationale: Like in primary breast cancer, prognosis in recurrent breast cancer is correlated with regional lymph node status. Therefore, axillary staging may be warranted in patients with recurrent disease and intact axillary nodes, although this has not been described in guidelines yet. The lymphatic drainage pathways in the breast and/or axilla could have been changed due to prior surgery and/or radiotherapy. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy (SNB), leading to a more accurate staging.

Objective: To assess the technical feasibility of lymphoscintigraphy after prior breast surgery. A second goal is to investigate whether or not previous breast surgery (with or without radiotherapy) significantly changes the lymphatic drainage pathways of the breast.


Eligibility criteria: Inclusion Criteria:

* treatment with BCT with SNB and/or ALND for primary breast cancer
* previous primary breast cancer located in the upper-outer quadrant of one breast
* Primary breast cancer treatment at least 3 years before the analysis, with or without adjuvant chemo- or hormonal therapy.

Exclusion Criteria:

* breast surgery for other reasons than breast cancer
* recurrent breast cancer
* former allergic reaction to 99mTc-colloidal albumin.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
Study officials:
References:
Clinical trial NCT03964948: Kidney Fibrosis and MRI
Official title: Development of Novel MRI Methods for Detecting and Measuring Renal Injury/Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 37
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators plan a prospective cross-sectional study of pediatric and adult healthy volunteers and patients with chronic kidney disease that will correlate a variety of quantitative MRI biomarkers with severity of renal insufficiency and available histopathology. Over 3 years, the investigators will recruit approximately 20 healthy volunteers, 20 patients with chronic kidney disease (CKD) Stage 2-5, and 20 patients with renal transplant kidneys. The investigators also plan to assess the effect of inflammation on the quantitative MRI biomarkers by recruiting approximately 20 additional patients with active lupus nephritis.


Eligibility criteria: Inclusion Criteria:

Subjects who meet all of the following criteria will be eligible for the study:

1. ≥ 10 and ≤ 25 years of age and;
2. Kidney transplant patients, who have had a recent kidney biopsy (within 1 year) that shows interstitial fibrosis OR
3. Patients with CKD Stage 2-5 who have previously had a biopsy (within 1 year) OR
4. Lupus patients with active nephritis who will undergo biopsy evaluation before and after induction therapy OR
5. Healthy Controls

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

1. Known contraindication to MR imaging (e.g., implanted non-MRI compatible device)
2. Known or suspected pregnancy. Female subjects of child bearing potential will undergo a urine pregnancy test prior to imaging.
3. Inability to undergo MRI without sedation/anesthesia.
4. Non-English Speaking

Primary outcomes:
measure: Development of noninvasive MRI methods to measure kidney disease using MR elastography.
timeFrame: 3 years
measure: Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping.
timeFrame: 3 years
measure: Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.
timeFrame: 3 years
measure: Development of noninvasive MRI methods to measure kidney disease using T2 mapping.
timeFrame: 3 years
measure: Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging.
timeFrame: 3 years
measure: Development of noninvasive MRI methods to measure kidney disease using diffusion-weighted imaging.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT00444548: Evaluation of A Novel Methodology in the Assessment of Urethral Function Using [S,S]-Reboxetine in Healthy Volunteers
Official title: Measurement Of Urethral Function In Healthy Female Volunteers - Evaluation Of The Sensitivity of Urethral Reflectometry Compared To Urethral Pressure Profilometry, Using [S,S]-Reboxetine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Equipment
Supplies
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: \[S,S\]-Reboxetine will be used to evaluate pharmacodynamic changes in urethral function in healthy volunteers using a novel methodology


Eligibility criteria: Inclusion Criteria:

* Healthy female subjects, aged 18-65 years.
* Subjects must be non-pregnant and non-lactating, and be either post menopausal (greater than 1 year without menses), surgically sterilized, or using another acceptable form of contraception.
* Subjects of child bearing potential must have confirmed negative pregnancy tests at screening and prior to commencing all study periods.

Exclusion Criteria:

* Evidence or history of clinically significant disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing).
* Subjects with any clinically significant abnormality following review of laboratory data, urinalysis and physical examination.

Primary outcomes:
measure: Reflectometry measurements at visit 2, 3, 4 , 5, 6 and 7.
Secondary outcomes:
measure: Urethral pressure profile measurements at visit 2, 3, 4, 5, 6 and 7
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02185248: Wellness Action Plan Trial Addressing Childhood Obesity
Official title: Randomized Controlled Trial of a Wellness Action Plan to Address the Childhood Obesity Epidemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Pediatric Obesity
Body Mass Index
Weight Perception
Counseling
Health Behavior
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 181
Sex: ALL
Minimum age (years): 30
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study was to determine the effectiveness of a novel Wellness Action Plan aimed at 1) improving parent recall of diet and activity plans 2) increasing follow-through with plans and 3) aiding parents in identifying their child's weight category.


Eligibility criteria: Inclusion Criteria:

* Children between the ages of 2.5 and 14 years, regardless of baseline BMI
* Presented for a well child visit at a pediatric clinic serving primarily Medicaid-insured children in Milwaukee, Wisconsin

Exclusion Criteria:

* Patients in foster care
* Parents and patients who were non-English speaking
* Patients who were being seen by a specialist for weight management.

Primary outcomes:
measure: Diet plan recall directly after visit
timeFrame: On day of primary visit
measure: Activity plan recall directly after visit
timeFrame: On day of primary visit, directly after seeing physician
Secondary outcomes:
measure: Diet plan recall/follow-through 1 month post visit
timeFrame: 4 weeks after primary visit
measure: Diet plan recall/follow-through 3 months post visit
timeFrame: 12 weeks after primary visit
measure: Activity plan recall/follow-through 1 month post visit
timeFrame: 4 weeks after primary visit
measure: Activity plan recall/follow-through 3 months post visit
timeFrame: 12 weeks after primary visit
measure: BMI category identification directly after the visit
timeFrame: On day of primary visit
measure: BMI category identification 1 month post visit
timeFrame: 4 weeks after primary visit
measure: BMI category identification 3 months post visit
timeFrame: 12 weeks after primary visit
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Downtown Health Center
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: John R Meurer, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kharofa RY, Copeland KA, Sucharew H, Meurer JR. Randomized controlled trial of a Wellness Action Plan to promote healthy diet and activity in pediatric primary care. Prev Med Rep. 2015 Oct 21;2:899-905. doi: 10.1016/j.pmedr.2015.10.008. eCollection 2015.
Clinical trial NCT00779948: Dynamic Internal Fixation of Femoral Neck Fractures
Official title: Dynamic Internal Fixation of Femoral Neck Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Neck Fracture
Keywords: Femoral Neck Fracture
Internal Fixation
Dynamic Hip Screw
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 171
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Patients

Brief summary: Evaluation of dynamic Plate-Screw-Systems for internal fixation after femoral neck fractures. Open Registry for Comparison of 1-screw-systems (DHS) with multi-screw-system Targon FN.

Detailed description: Two implant systems are mainly used for internal fixation: canulated screws and plate-screw-systems. Regarding the latter, the dynamic hip screw systems (DHS)represent the most frequently used devices.

Targon FN (Aesculap) is a new plate-screw system and available on the market since 2007. In contrast to the DHS, which uses only one telescrew, the Targon FN provides up to four telescrews.

With this registry, we want to evaluate the results of Targon FN compared with DHS systems.

Eligibility criteria: Inclusion Criteria:

* men \>= 60 years, women \>= 55 years
* femoral neck fractures needing surgical therapy
* femoral head preserving indication
* Living in a 100 km Radius from Hospital

Exclusion Criteria:

* Patient not able to walk
* Previous fracture or surgery on ipsilateral hip
* pathological fracture
* open fracture

Primary outcomes:
measure: Cumulative Complication Rate
timeFrame: 1 year
Secondary outcomes:
measure: Course of Surgery Mobilization Radiology functional Results (SF-12, IOWA Hip Score)
timeFrame: 1 year
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
state: Baden-Wuerttemberg
city: Tübingen
country: Germany
facility: Berufsgenossenschaftliche Klinik
state: Baden-Württemberg
city: Bad Hersfeld
country: Germany
facility: Klinikum Bad Hersfeld GmbH
state: Hessen
city: Castrop-Rauxel
country: Germany
facility: Evangelisches Krankenhaus
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: Raphaelsklinik
state: Nordrhein-Westfalen
city: Schwerte
country: Germany
facility: Marienkrankenhaus Schwerte gGmbH
state: Nordrhein-Westfalen
city: Annaberg-Buchholz
country: Germany
facility: Erzgebirgsklinikum Annaberg gGmbH
state: Sachsen
city: Berlin
country: Germany
facility: Krankenhaus Bethel
city: Ludwigshafen
country: Germany
facility: BGU Ludwigshafen
Study officials:
affiliation: University Hospital Freiburg
name: Peter Helwig, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT02753426: A Trial of Doxycycline in Renal Disease
Official title: A Trial of Doxycycline in Renal Disease (ADORE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Disease
Cardiorenal Syndrome
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of this trial is to evaluate whether subantimicrobial-dose of doxycycline (20mgBID) will affect serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic kidney disease.

Detailed description: This is a Phase I, placebo-controlled, randomized crossover trial to determine the effects of 4-week treatment with subantimicrobial-dose doxycycline on serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic kidney disease (eGFR\<30ml/min/1.73m2). Doxycycline is a matrix metalloproteinase inhibitor and is approved for use as an anti-fibrotic in the setting of gum and skin disease at low doses (20mgBID). At such a dose, serum levels are too low for antimicrobial effect and chronic usage is not thought to lead to tetracycline resistance. Investigators hypothesize that doxycycline will ameliorate cardiac and renal fibrosis and thus investigators will detect a decrease in fibrotic markers during treatment with doxycycline.

Eligibility criteria: Inclusion Criteria:

* CKD pre-dialysis (eGFR\< 30 ml/min/1.73m2 not on dialysis);
* local 415/650/510 area codes;
* primary language English or Spanish

Exclusion Criteria:

* eGFR worsening by greater than 5ml/min/1.73 m2 during the last 6 months;
* Systolic blood pressure less than 100mmHg or greater than 170 mmHg;
* pregnancy;
* ejection fraction less than 45%;
* NYHA class III or IV HF;
* myocardial infarction or hospitalization for HF within 4 months;
* liver disease;
* moderate or severe chronic obstructive pulmonary disease or pulmonary fibrosis;
* current infection;
* chemotherapy;
* major surgery within last month;
* bilateral dialysis access precluding lab draw;
* self-reported use of IV drugs or cocaine within the last 6 months.

Primary outcomes:
measure: Serum markers of fibrosis
timeFrame: 3 months
measure: Urinary markers of fibrosis
timeFrame: 3 months
Secondary outcomes:
measure: Adverse effects
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ruth Dubin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01771926: Lifestyle Modification and Potato Consumption
Official title: Lifestyle Modification and Potato Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: resistant starch
lifestyle intervention
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2013-01-18
Enrollment: 107
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. We will evaluate the effects of the consumption of potatoes (high or low resistant starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and ( the extent to which potato consumption alters markers of lipid metabolism and inflammation in the context of a lifestyle intervention program.

Detailed description: Our primary objective is to compare the effects of potato consumption to those of commonly consumed carbohydrate sources on glucose tolerance and other cardiometabolic risk factors in overweight and obese, glucose intolerant men and women participating in a lifestyle intervention program. We hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. Our specific aims include: (1) to evaluate of the effects of the consumption of potatoes (high or low resistant starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and (2) to determine the extent to which potato consumption alters markers of lipid metabolism and inflammation in the context of a lifestyle intervention program.

Eligibility criteria: Inclusion Criteria:

* Men and women between 20-65 years of age.
* Overweight or obese (BMI 25 - 39.9 Kg/m2)
* Impaired Glucose Tolerance: fasting glucose between 100-125 mg/dL
* Willingness to comply with the demands of the experimental protocol
* Sedentary lifestyle

Exclusion Criteria

* Major medical condition
* Smokers
* Unable to perform moderate exercise
* Use of medications that alter glucose or lipid metabolism
* Pregnant or lactating

Primary outcomes:
measure: Glucose Tolerance
timeFrame: Days 0, 14, 28, 42, 56
Secondary outcomes:
measure: Weight Loss
timeFrame: Days 0, 14, 28, 42, 56
measure: Functional Fitness
timeFrame: Days 0 and 57
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA GFHNRC
name: Susan K Raatz, PhD, MPH, RD
role: PRINCIPAL_INVESTIGATOR
References: