louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00918671: Medication-overuse Headache: 4 Years Follow up
Official title: Treatment of Medication-overuse Headache: 4 Years Follow up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Overuse Headache
Keywords: Headache
Medication overuse
chronic
relapse
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2009-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-70 years remitted to the out-patient clinics of the neuroloical departments of five University Hospitals in Norway with probable medication overuse headache included in a 1-year open-labeled trial during 2004-2006.

Brief summary: From 1 January 2004 to 31 December 2006 64 individuals with probable medication overuse headache were included in a randomized, 1-year open-labeled, multicentre study to evaluate the effect of early introduction of prophylactic treatment compared to abrupt withdrawal and with a control group (ClinicalTrials.gov number NCT00159588). In this follow-up, randomized patients still alive 4 years after primary inclusion time will be invited to a follow up interview, evaluating the headache complaints and the proportion of recurrent medication overuse.

Detailed description: The participants will be interviewed by telephone or consult the study doctor completing a headache diary for at least 1 month before attending the visit.

Eligibility criteria: Inclusion Criteria:

* Randomized during the initial trial during 2004-2006.

Primary outcomes:
measure: Change in Headache Days/Month After 4 Years Compared to Baseline
timeFrame: Baseline and after 4 years
Secondary outcomes:
measure: Change of Medication Days/Month Compared to Baseline
timeFrame: Baseline and after 4 years' of follow-up
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian National headache Centre, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Knut Hagen, MD, PhD
role: STUDY_CHAIR
References:
citation: Hagen K, Albretsen C, Vilming ST, Salvesen R, Gronning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. Management of medication overuse headache: 1-year randomized multicentre open-label trial. Cephalalgia. 2009 Feb;29(2):221-32. doi: 10.1111/j.1468-2982.2008.01711.x. Epub 2008 Sep 24.
citation: Hagen K, Albretsen C, Vilming ST, Salvesen R, Gronning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. A 4-year follow-up of patients with medication-overuse headache previously included in a randomized multicentre study. J Headache Pain. 2011 Jun;12(3):315-22. doi: 10.1007/s10194-010-0285-1. Epub 2011 Jan 5.
citation: Hagen K, Stovner LJ. A randomized controlled trial on medication-overuse headache: outcome after 1 and 4 years. Acta Neurol Scand Suppl. 2011;(191):38-43. doi: 10.1111/j.1600-0404.2011.01542.x.
Clinical trial NCT04591171: Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease
Official title: Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Chronic Kidney Diseases
Keywords: n-of-1 trial
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-10-19
Enrollment: 9
Sex: ALL
Minimum age (years): 5
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study to test whether n-of-1 trial-guided clinical decision-making improves blood pressure control in hypertensive children with chronic kidney disease (CKD) and end-stage renal disease (ESRD).


Eligibility criteria: Inclusion Criteria:

* hypertension
* CKD stage 2-5
* requiring antihypertensive medication per clinician judgement.

Exclusion Criteria:

* renal transplant anticipated or occurred within 6 months of screening
* transfer out of our practice setting anticipated within 6 months
* unable to complete 24 hour arterial blood pressure monitoring (ABPM) due to developmental or behavioral limitations

Primary outcomes:
measure: Change in 24-hour Mean Arterial Pressure (MAP)
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Number of Participants With Target Blood Pressure
timeFrame: 6 months
measure: Number of Participants With Target Blood Pressure
timeFrame: baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas at Houston Medical School; Pediatric Nephrology and Hypertension Clinics
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Joyce P Samuel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02886871: CalFitness Smartphone-Delivered Physical Activity Intervention
Official title: Mobile Phone-Based Physical Activity Intervention on University Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Physical Activity
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 64
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: TREATMENT

Brief summary: The overall goal of this study is to test personalized mobile phone-based physical activity interventions among staff members at the University of California, Berkeley. Most physical fitness applications for smartphones and activity trackers use a constant goal for the number of steps each day. However, if the step goals are dynamically adjusted according to past behavior, then the corresponding goals may encourage individuals to increase their physical activity level. This study consists of a randomized controlled trial in which we are assessing the efficacy of two different algorithms for calculating personalized goals for the number of steps each day.


Eligibility criteria: Inclusion Criteria:

* intent to become physically active
* own an iPhone
* willing to keep the iPhone in pockets during the day
* willing to install and use the intervention app every day for 4 months
* ability to speak and read English.

Exclusion Criteria:

* known medical conditions or physical problems that require special attention in an exercise program
* planning an international trip during the next 4 months, which could interfere with daily server uploads of mobile phone data
* pregnant/gave birth during the past 6 months
* severe hearing or speech problem
* history of an eating disorder
* current substance abuse
* current participation in lifestyle modification programs or research studies that may confound study results
* history of bariatric surgery or plans for bariatric surgery in the next 12 months.

Primary outcomes:
measure: Daily Steps Taken Per Day
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
Study officials:
References:
citation: Zhou M, Fukuoka Y, Mintz Y, Goldberg K, Kaminsky P, Flowers E, Aswani A. Evaluating Machine Learning-Based Automated Personalized Daily Step Goals Delivered Through a Mobile Phone App: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jan 25;6(1):e28. doi: 10.2196/mhealth.9117.
Clinical trial NCT04619771: M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)
Official title: M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Morbid Obesity
Keywords: Insomnia
Sleep
Bariatric Surgery
Morbid Obesity
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Dartmouth-Hitchcock Medical Center
First posted: 2020-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a longitudinal clinical trial designed to assess the feasibility of sleep intervention (Cognitive Behavioral Therapy for Insomnia (CBT-I)) in individuals with insomnia following bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18-64
* Fluency with English
* Willingness to maintain an active telehealth platform account
* Daily access to wireless internet connection or sufficient cell phone service for telemedicine
* Undergone bariatric surgery (Roux-en-Y or vertical sleeve gastrectomy) within past 1-3 years
* Must have experienced \<50% excess weight loss following surgery Clinically significant insomnia (i.e., ISI score \>11)

Exclusion Criteria:

* Patient underwent revision of initial weight loss procedure
* PHQ-9 Depression score \> 15
* GAD-7 Anxiety score \> 15
* Current alcohol or substance abuse
* Current narcotic use
* Unstable major psychiatric condition
* Restless leg syndrome
* Sleep apnea with non-adherence to CPAP intervention (i.e., use of CPAP \<4 nights/week)
* Other problems at investigator discretion
* Vulnerable populations (e.g., adults unable to consent, ages \<18, pregnant women, and prisoners).

Primary outcomes:
measure: Recruitment Rate
timeFrame: Follow Up (week 15)
measure: Completion of Study Measures
timeFrame: Follow Up (week 15)
measure: ActiGraph Use
timeFrame: Follow Up (week 15)
measure: Actigraph Compliance
timeFrame: Follow Up (week 15)
Secondary outcomes:
measure: Treatment Acceptability
timeFrame: Follow Up (week 15)
measure: Change in sleep onset latency
timeFrame: Follow-up (week 15)
measure: Change in wake after sleep onset (WASO)
timeFrame: Follow-up (week 15)
measure: Change in total sleep time (TST)
timeFrame: Follow-up (week 15)
measure: Change in sleep efficiency
timeFrame: Follow-up (week 15)
measure: Change in Insomnia Severity
timeFrame: Visit 1 (Week 3), Visit 5 (Week 11), Follow up (Week 15)
measure: % Excess Weight Loss
timeFrame: Baseline (week 1), Follow-up (week 15)
measure: Change in BMI
timeFrame: Baseline (week 1), Follow-up (week 15)
measure: % Total Weight Loss
timeFrame: Baseline (week 1), Follow-up (week 15)
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Genna F Popovich Hymowitz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01837771: Epiphrenic III Pilot Trial
Official title: Uni- or Biventricular Pacing and Diaphragmatic Stimulation for Severe Heart Failure (Epiphrenic III Pilot Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The Epiphrenic III Pilot Trial investigates whether a diaphragmatic stimulation by interventionally placed electrodes may improve heart function, symptoms and functional capacity in patients with severe heart failure.


Eligibility criteria: Inclusion Criteria:

* Symptomatic heart failure (NYHA functional classes II, III or IV)
* Reduced left ventricular ejection fraction (LVEF) \<35%
* Guideline-recommended drug therapy

Exclusion Criteria:

* Patient refuses study participation
* Life expectancy presumably \<1 year
* Pregnancy

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: Four weeks
measure: NYHA functional class
timeFrame: Four weeks
Secondary outcomes:
measure: Brain natriuretic peptide (BNP)
timeFrame: Four weeks
measure: 6-minutes walking test
timeFrame: Four weeks
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Luzerner Kantonsspital
name: Paul Erne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05069571: Endoangel Withdrawal Overspeed Analysis
Official title: Explore the Relationship Between the Percentage of Overspeed of Colonoscopy Withdrawal and the Rate of Adenoma Detection:a Prospective、Multicenter、Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 1210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients need to receive the colonoscopy examination.

Brief summary: Exploring the relationship between the percentage of overspeed of colonoscopy withdrawal and the rate of adenoma detection.


Eligibility criteria: Inclusion Criteria:

1. Males or females who are over 18 years old (inclusive);
2. Enteroscopy and related examinations are needed to further clarify the characteristics of digestive tract diseases;
3. Able to read, understand and sign the informed consent form;
4. The researcher believes that the subject can understand the process of the clinical research, is willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures.

Exclusion Criteria:

1. Participated in other clinical trials, signed an informed consent form and within the follow-up period of other clinical trials;
2. Abuse of drugs or alcohol or mental disorders in the last 5 years;
3. Women during pregnancy or breastfeeding;
4. Subjects with previous history of bowel surgery;
5. The investigator believes that the subject is not suitable for enteroscopy and related examinations;
6. The investigator believes that the subject is not suitable for high-risk diseases or other special circumstances to participate in clinical trials.
7. Patients with gastrointestinal bleeding;
8. Known or highly suspected allergy to any ingredient of bowel cleansing agent;
9. Restricted activities or any mental or physical condition impairs their ability to drink intestinal cleansing preparations;
10. Known or suspected intestinal obstruction or perforation, toxic megacolon, most colectomy, heart failure (grade III or IV), severe cardiovascular disease, severe liver failure or end, renal insufficiency, etc.

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of withdrawal overspeed
timeFrame: 3 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT00878293: Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic
Official title: A Randomized Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Pain Due to Diabetic Polyneuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Polyneuropathy
Keywords: analgesic
diabetes mellitus
chronic neuropathic pain
painful polyneuropathy caused by diabetes mellitus type I or II
Lead sponsor: Tris Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine whether the new centrally active analgesic and MS Continus® are effective in the treatment of painful diabetic polyneuropathy.


Eligibility criteria: Inclusion Criteria:

* Subjects with pain at least NRS \>4 due to painful diabetic polyneuropaty.

Exclusion Criteria:

* Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
* non Caucasian or Hispanic.
* Concomitant painful disease.
* Life-long history of seizure disorder or epilepsy.
* Subjects with clinical relevant cardiac and vascular diseases.
* Subjects with impaired renal function
* Subjects with impaired hepatic function
* Female subjects who are pregnant or breastfeeding.

Primary outcomes:
measure: Average daily pain intensity
timeFrame: 5 days
Secondary outcomes:
measure: Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values
timeFrame: 5 days
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Investigator 3
city: Mainz
country: Germany
facility: Investigator 1
city: Münster
country: Germany
facility: Investigator 2
city: Manchester
country: United Kingdom
facility: Investigator 4
Study officials:
affiliation: IKFE, Parcusstr. 8, 55116 Mainz
name: Thomas Forst, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05932693: Effect of Different E-cigarette Cooling Flavors on Adults' Sensory Experience TCORS 3.0
Official title: Examine the Effects of Novel E-cigarette Constituents and Determining Appropriate Concentrations Among Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: E-Cig Use
Keywords: Cooling components
e-cigarette
menthol
WS-23
WS-3
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-07-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants are exposed to all study conditions (16 e-liquid samples).
Primary purpose: OTHER

Brief summary: This pilot sensory experiment will examine cooling from comparable concentrations of WS-3 and menthol to determine appropriate concentrations to use in the main study.

Detailed description: This pilot study will establish low and high concentrations of both WS-3 and menthol concentrations to test in the main study. An anticipated 30 adult e-cigarette users will participate in one laboratory session during which participants will be exposed to e-liquids containing five different concentrations of two different cooling flavors without nicotine (10 e-liquids total). Participants will rate "coolness" using the generalized Labeled Magnitude Scale (gLMS). Using averages of participant ratings, we will select a low concentration of each constituent that is rated as more than "barely detectable" but less than "moderate" to ensure that cooling is weak but clearly perceptible. For the high concentration of each constituent, we will select a concentration that on average falls between "strong" and "very strong" to identify a strong cooling sensation while avoiding sensations that would also be uncomfortable.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Able to read and write
* Used e-cigarettes containing nicotine
* Use e-cigs in past 30 days

Exclusion Criteria:

* Known hypersensitivity to propylene glycol
* Pregnant or lactating females
* Uncontrolled asthma
* Nut/e-liquid flavorant allergy
* Current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms

Primary outcomes:
measure: Coolness: Score change in coolness of each e-cigarette condition (16 conditions in total)
timeFrame: Following administration of e-cigarette condition 1 (at 10 minutes), then 5 minutes post administration of each e-cigarette condition, up to 85 minutes (condition 16)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Suchitra Krishnan-Sarin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim J, Wood A, Green BG. Derivation and evaluation of a labeled hedonic scale. Chem Senses. 2009 Nov;34(9):739-51. doi: 10.1093/chemse/bjp054.
Clinical trial NCT00012493: Cardiac Vulnerability in Potentially Susceptible Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease
Keywords: Cardiac event
Heart disease
Particulate Matter
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. In this project patient who have recently suffered a cardiac event are being monitored with cardiac monitors for 24 hours up to 4 times during the year following their cardiac event. Similarly a second group of patients with moderate to severe heart failure will undergo similar cardiac monitoring for 24 hours, twice a week separated by 3 months. In both sets of patients home indoor pollution measures will be continuously made and used to correlate with measures of heart rate variability.

Detailed description: Approximately 50 patients in each group will be studied. In addition to cardiac monitoring for 24 hours at each session, overnight respiratory pattern and oxygen saturation will be monitored in both groups. The exposure monitoring will include both particle mass of PM2.5 along with detailed assessment to determine that portion of the particulate exposure from outdoor vs. indoor sources.

Eligibility criteria: For the cardiac event cases patients are selected from the Brigham and Women's Hospital cardiac services at the time of discharge, aged 45-74, having suffered a cardiac event resulting in either an infarct or need for a cardiac procedure (angioplasty, stint, etc). For the CHF patients they are selected from the BWH cardiac clinics where they have been identified and classified as stage 3 or 4 CHF. For both groups residence requirements are that they reside within the Greater Boston Area as defined by an outer ring road (Route 495) and are willing to be visited at home and have the exposure assessment equipment set up in their home as well as be monitored personally.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
Study officials:
affiliation: Environmental Epidemiology Program, Department of Environmental Health, Harvard School of Public Health
name: Frank E Speizer, MD
role: PRINCIPAL_INVESTIGATOR
References: