louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02518217: ShapeUp Empower Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 130
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: TREATMENT

Brief summary: This randomized controlled trial will evaluate patterns of use and health outcomes of the ShapeUp Empower online program with and without financial incentives for program engagement.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years
* Body mass index (BMI) between 25 and 45 kg/m2
* English speaking
* Have access to the Internet via a computer and smartphone compatible with Empower and Commercial Apps, and basic knowledge of how to use this technology.
* Agree to sharing of data entered in the Empower and Commercial Apps intervention systems.
* Agree to ShapeUp's privacy policy and user agreement.

Exclusion Criteria:

* Report health problems that make weight loss or unsupervised exercise unsafe or unreasonable
* Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
* Are currently pregnant or breastfeeding, or intend to become pregnant in the next 12 months
* Are planning to move outside of the greater Providence area within the next 12 months
* Report any cognitive or physical limitations that preclude use of a personal computer
* Have participated in a study conducted by the WCDRC in the past 2 years
* Have followed a commercial weight-loss program within the previous 6 months or who are currently following a commercial weight loss program
* Weight loss of ≥ 5% of initial body weight in the last 6 months
* History of clinically diagnosed eating disorder excluding Binge Eating Disorder.
* Previous surgical procedure for weight loss
* Currently taking weight loss medication\\
* Treatment of cancer within the last 6 months
* Have any medical or psychological condition, or life situation, that would make participation in a weight loss program inadvisable in the opinion of the principal investigator.

Primary outcomes:
measure: Body Weight (kg)
timeFrame: 6 months after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Resarch Center
state: Rhode Island
Study officials:
References:
Clinical trial NCT02692417: Surface Stimulation for Female Sexual Dysfunction
Official title: Surface Stimulation for Female Sexual Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Sexual Dysfunction
Keywords: hypoactive desire disorder
female sexual dysfunction
genital arousal disorder
sexual
dysfunction
female
arousal
electrical stimulation
transcutaneous electrical stimulation
women
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Female sexual dysfunction, including sexual arousal disorder, has a significant clinical impact, affecting millions of women in the United States alone. Peripheral nerve stimulation, such as posterior tibial nerve stimulation (PTNS) and dorsal genital nerve stimulation (DGNS) can modulate neural circuits for bladder and fecal continence. The investigators hypothesize that periodic DGNS and PTNS will modulate autonomic neural circuits and promote improvements in sexual function in women with sexual arousal disorder. Subjects will be randomized to receive one of the stimulation approaches. Subjects will have weekly 30-minute sessions across twelve weeks.


Eligibility criteria: Inclusion Criteria:

* Adult women ≥ 18 years of age
* Sexually active ≥ 1 time per month (≥ 2 times per month preferred)
* Score of 19 or less on a 6-question set of the Female Sexual Function Index (FSFI) survey
* Neurologically stable
* Ambulatory
* Capable of giving informed consent
* English speaking
* Capable and willing to follow study procedures

Exclusion Criteria:

* Men
* Women ≤ 17 years of age
* Pregnant or planning to get pregnant during the study period
* Clinically diagnosed neurological bladder dysfunction
* Prior experience with PTNS or DGNS
* Current use of transcutaneous electrical nerve stimulation (TENS) on pelvis, back, or legs
* Implanted pacemaker, defibrillator, spinal cord stimulator, or sacral root stimulator
* Taking flibanserin
* Taking any investigational drug
* History of neurologic diseases or impairments
* Any other factors that the investigators feel would place the patient at increased risk from this study

Primary outcomes:
measure: 6 Weeks - Total FSFI Score
timeFrame: 6 weeks after beginning of treatment
measure: 12 Weeks - Total FSFI Score
timeFrame: 12 weeks after beginning of treatment
measure: 18 Weeks - Total FSFI Score
timeFrame: 18 weeks after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Timothy Bruns, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Mitchell Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00527917: A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.
Official title: A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Efficacy and Safety of Uracyst® (Intravesical Sodium Chondroitin Sulfate) Versus Vehicle Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Interstitial Cystitis
Keywords: IC/PBS
Interstitial Cystitis/Painful Bladder Syndrome
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-09-11
Enrollment: 65
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 is a pilot clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period.


Eligibility criteria: Inclusion Criteria:

* Are female of male patient 18 years or older
* Have been previously diagnosed with IC/PBS.
* Are willing to provide informed consent
* Available for the duration of the study including treatment and follow-up (12 weeks)

Exclusion Criteria:

* Pregnant or lactating female.
* Are currently or have previously received investigational drugs within thirty (30) days of screening.
* Previous therapy for IC/PBS
* Have any medical condition/disease that could interfere with patient compliance or interfere with interpretation of the study results.
* Are unable or unwilling to comply with protocol requirements
* Are unable to read, understand, and provide written informed consent.

Primary outcomes:
measure: Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Adverse event assessments
timeFrame: Throughout the study, first instillation to Week 12
Other outcomes:
Locations:
city: Surrey
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Kentville
country: Canada
state: Nova Scotia
city: Barrie
country: Canada
state: Ontario
city: Brantford
country: Canada
state: Ontario
city: Guelph
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: North Bay
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Watson Pharmaceuticals
name: Keshava Kumar, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00954317: Do Epidurals Placed at a Lower Level Improve Labor Analgesia?
Official title: Do Epidurals Placed at a Lower Level Improve Labour Analgesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Analgesia
Keywords: epidural
labour analgesia
Lead sponsor: Royal Victoria Hospital, Canada
Sponsor class: OTHER
First posted: 2009-08-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators wish to compare the analgesia provided by epidurals placed high in the lumbar spine versus epidurals place low in the lumbar spine.


Eligibility criteria: Inclusion Criteria:

* women in active labor

Exclusion Criteria:

* known contraindications to epidural analgesia
* moderate to severe systemic illness as evidenced by an American Society of Anesthesiologists (ASA) score of 3 or higher.
* known abnormalities of the spinal column
* any neurologic illness
* multiple gestations, fetal abnormalities or fetal presentation other than vertex
* recent history of analgesic usage
* an inability to communicate in English or French
* Body Mass Index greater than 40
* patients in pain requesting an immediate epidural

Primary outcomes:
measure: Number of epidural medication boluses required
timeFrame: 30 minutes and 1 hour
Secondary outcomes:
measure: Labour progress
timeFrame: 24 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
References:
citation: Moore A, Villeneuve V, Bravim B, El-Bahrawy A, El-Mouallem E, Kaufman I, Hatzakorzian R, Li Pi Shan W. The Labor Analgesia Requirements in Nulliparous Women Randomized to Epidural Catheter Placement in a High or Low Intervertebral Space. Anesth Analg. 2017 Dec;125(6):1969-1974. doi: 10.1213/ANE.0000000000002076.
Clinical trial NCT02549417: Phase 3 Study of KHK7580
Official title: Phase 3 Study of KHK7580 (A Clinical Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Peritoneal Dialysis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-15
Enrollment: 39
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: This study is designed to evaluate efficacy and safety of KHK7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week extension period to evaluate long-term safety and efficacy.


Eligibility criteria: Inclusion Criteria:

* Personally submitted written voluntary informed consent to participate in the study
* Stable chronic renal disease treated with peritoneal dialysis for at least 16 weeks before screening
* Intact PTH level of \> 240 pg/ml at screening

Exclusion Criteria:

* Treatment with cinacalcet hydrochloride within 2 weeks before screening;
* Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
* Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
* Severe heart disease;
* Severe hepatic dysfunction;
* Uncontrolled hypertension and/or diabetes;
* Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;
* Primary hyperparathyroidism;
* Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.

Primary outcomes:
measure: Percentage of subjects in the evaluation period achieving a mean intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL
timeFrame: Weeks 30-32
Secondary outcomes:
measure: Percentage of subjects in the evaluation period achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline
timeFrame: Weeks 30-32
measure: Mean percent change in the evaluation period in intact PTH level from baseline
timeFrame: Weeks 30-32
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Study officials:
References:
citation: Tsuruya K, Shimazaki R, Fukagawa M, Akizawa T; Evocalcet Study Group. Efficacy and safety of evocalcet in Japanese peritoneal dialysis patients. Clin Exp Nephrol. 2019 Jun;23(6):739-748. doi: 10.1007/s10157-019-01692-y. Epub 2019 Apr 6.
Clinical trial NCT02409017: A Comparison of Insulin Drip Protocols in Labor: A Randomized Trial
Official title: A Comparison of Insulin Drip Protocols in Labor: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Pregnancy
Keywords: insulin drip
labor
Lead sponsor: WellSpan Health
Sponsor class: OTHER
First posted: 2015-04-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess which of two commonly utilized insulin drip protocols has better outcomes when used during the labor process.


Eligibility criteria: Inclusion Criteria:

* a. Pregnant patients with either pre-existing diabetes or gestational diabetes type A2 who require insulin for euglycemia during labor and delivery

Exclusion Criteria:

* a. Those patients who decline participation
* b. Patients less than age 18 at the time of enrollment will be excluded to protect this vulnerable patient population c. Those patients who cannot be consented d. Patients scheduled for cesarean delivery

Primary outcomes:
measure: Mean maternal glucose
timeFrame: Labor
Secondary outcomes:
Other outcomes:
Locations:
city: York
country: United States
facility: WellSpan York Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02727634: Ultrapower; a Minimally Invasive Tool for Evaluation of Total Cardiac Power
Official title: Ultrapower, an In-house Developed System for Instantaneous Logging of Ultrasound Based Blood Flow, Blood Pressure and ECG.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Diseases
Keywords: Hemodynamics
Echocardiography, Doppler, Pulsed
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2016-04-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The heart is essentially a hydraulic pump which ensures adequate delivery of blood through generating pressure and forward flow of blood. The energy delivered by the heart is uncommonly measured clinically, and todays gold standard involves placing a plastic catheter into the lung arteries. The investigators have developed an ultrasound based approach to calculate this energy without the need for catheters through the heart. This novel approach is called ultrapower. Ultrapower involves the instantaneous multiplication of the cardiac output and the arterial blood pressure. The study aims to use the ultrasound based approach to investigate Cardiac Power in the coronary artery bypass graft population.


Eligibility criteria: Inclusion Criteria:

• coronary artery bypass graft operation

Exclusion Criteria:

* Lack of informed consent
* Previous aortic valve replacement
* Inadequate Doppler signal on transthoracic echocardiography

Primary outcomes:
measure: The hearts energy delivery per second measured in watts (Cardiac Power), using two established methods and the ultrapower method
timeFrame: Immediately preoperatively
measure: The hearts energy delivery per second measured in watts (Cardiac Power), using two established methods and the ultrapower method
timeFrame: approximately 1 hour post operatively
measure: The hearts energy delivery per second measured in watts (Cardiac Power), using two established methods and the ultrapower method
timeFrame: 1 day after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of cardiothoracic surgery
Study officials:
affiliation: Norwegian University of Science and Technology
name: Idar Kirkeby-Garstad, md phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01061034: Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers
Official title: The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aspirin Blood Level
Proton Pump Inhiditor Treatment
Keywords: pharmacokinetics
aspirin
proton pump inhiditor
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-02-02
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Aspirin is a weak acid that crosses the gastric and intestinal mucosa by passive diffusion while in its lipophilic nature.Omeprazole, a proton pump inhibitor, inhibits gastric acid secretion.

We assumed that omeprazole inhibits aspirin absorption, thus reducing its action on platelets.

healthy volunteers, with no known peptic disease or bleeding disorders will be enrolled.

All volunteers will receive 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole 20mg twice daily for 3 days and then 20mg once daily.

Blood levels of Aspirin will be determined by High performance liquid chromatography (HPLC), 0, 1, 2, 4, 6, 10, 24 hours after the administration of Aspirin alone on day 7 and Aspirin plus Omeprazole on day 21.

Platelet function tests will be determined by platelet-rich plasma aggregometry in response to Arachidonic acid (500mg/ml), Ristocetin (1.5mg/ml) and Adenosine 5'-diphosphate (20mM) on day 0 as baseline and on day 7 and 21 of the study.


Eligibility criteria: Inclusion Criteria:

-healthy volunteers

Exclusion Criteria:

* pretreatment with aspirin
* pretreatment with non steroidal anti inflamatory drugs
* pretreatment with antacids
* history of peptic ulcer disease
* coagulation or aggregation disorder.

Primary outcomes:
measure: Aspirin Level in Blood (Area Under the Curve)
timeFrame: on day 7,on day 21
Secondary outcomes:
measure: Platelet Function Tests
timeFrame: on day 0 as a baseline and on day 7 and 21 of the study.
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: asaf-harofemedical center
name: ahuva golik, prop.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03206034: Stylistic Memory Enhancement
Official title: Stylistic Memory Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Memory
Cognition
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind placebo controlled randomized control trial
Primary purpose: TREATMENT

Brief summary: Impairments in higher level cognitive processing, such as new learning and memory, are common in Multiple Sclerosis (MS) and negatively impact multiple aspects of everyday life, including occupational and social functioning. Despite this, few studies have attempted to remediate these cognitive deficits in order to improve everyday functioning. While not applied in traditional rehabilitation protocols as of yet, many techniques from cognitive psychology significantly improve learning and memory in healthy persons. These techniques include the generation effect (GE), the spacing effect (SE), and the testing effect (TE). These techniques have recently been incorporated into an 8-session treatment protocol, Stylistic Memory Enhancement (SME), designed to teach participants about each of the techniques, train them on how to apply the techniques in daily life and practice their application to daily life memory demanding situations. The protocol includes teaching participants how to restructure a memory demanding situation in order to make optimal use of self-generation, spaced learning and self-testing. The objective of the study is to test the efficacy of the SME in an MS population.


Eligibility criteria: Inclusion Criteria:

Clinically definite MS between the ages of 18 and 59. Participants must have impairment in new learning (determined by an in-person screen) with intact language comprehension.

Exclusion Criteria:

* History of alcohol or drug abuse/dependence,
* Major psychiatric disturbance (e.g. bipolar disorder, schizophrenia) and neurological history other than MS.
* Corticosteroid use within the last month prior to the participation.
* Less than 1 month post most recent exacerbation.

Primary outcomes:
measure: California Verbal Learning Test (CVLT-II- Total learning
timeFrame: Baseline and post-intervention (5 weeks between testing sessions)
Secondary outcomes:
measure: Memory Functioning Questionnaire
timeFrame: Baseline and post-intervention ( 5 weeks between testing sessions)
Other outcomes:
Locations:
Study officials:
References: