louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03062267: Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness
Official title: Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizoaffective Disorder
Schizophrenia
Bipolar Disorder
Major Depressive Disorder
Keywords: mhealth
texting intervention
mobile health
mobile mental health
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Testing an mHealth mobile interventionist texting program on illness management.

Detailed description: The ultimate objective is to evaluate a validated mHealth intervention that can be realistically integrated into community mental health settings to increase the availability, reach, and broad impact of illness management approaches for people with serious mental illness (SMI).

Eligibility criteria: Inclusion Criteria:

1. Chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder;
2. 18 years or older;
3. A rating of "3" or higher on one of three Patient Activation items;
4. Ownership of a mobile phone with call/text plan (research staff will offer assistance in accessing the Federal Lifeline Assistance Program to people who do not have a mobile phone and/or call/text plan if they are otherwise eligible);
5. Receiving community based treatment services.

Exclusion Criteria:

1. Hearing, vision, or motor impairment that make it impossible to operate a mobile phone (determined using the individual's device for screening);
2. English reading level below 4th grade (determined using the reading section from the Wide Range Achievement Test - 4th Edition (WRAT-4).

Primary outcomes:
measure: Psychiatric Symptoms
timeFrame: Change from baseline to 3 months and 6 months
measure: Psychiatric Symptoms
timeFrame: Change from baseline to 3 months and 6 months
Secondary outcomes:
measure: Recovery
timeFrame: Change from baseline to 3 months and 6 months
Other outcomes:
measure: Satisfaction With Treatment
timeFrame: 3 months
Locations:
city: Chicago
country: United States
facility: Thresholds
state: Illinois
city: Spokane
country: United States
facility: Frontier Behavioral Health
state: Washington
Study officials:
affiliation: University of Washington
name: Dror Ben-Zeev, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04353167: Examination of the Relationship Between Foot - Body Posture and Balance and Gait in Duchenne Muscular Dystrophy
Official title: Examination of the Relationship Between Foot - Body Posture and Balance and Gait in Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foot Posture
Balance
Gait Disorders, Neurologic
Body Posture
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 38
Sex: MALE
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population include just patients with Duchenne Muscular Dystrophy

Brief summary: Foot and body postures of patients with DMD will be evaluated. Foot structure characteristics such as foot length, metatarsal width, calcaneal valgus angle will be calculated for the foot posture. Also, the Foot Posture Index (FPI-6) scale will be used. The body posture will be evaluated with the New York Posture Scale. Many gait characteristics such as step length, cadence, support surface of the patients will be determined with GaitRite instrumented walkway. Patients' balance assessment will be evaluated with Bertec Balance Advantage. The statistical analysis method will determine the relationship between foot and body posture and gait and balance.


Eligibility criteria: Inclusion Criteria:

1. To be between 5-13 years old
2. Being at level I or II according to Brooke Lower Extremity Functional Classification Scale
3. In the balance assessment, there should be at least 90 degrees of joint range of motion in the ankle to provide base contact on the force platform.
4. Agree to participate in the research voluntarily

Exclusion Criteria:

1. Having serious mental and psychological problems,
2. Failure to cooperate adequately with the physiotherapist making the evaluations,
3. Severe contracture in lower extremities,
4. Any injury and / or surgery of the lower extremities in the past 6 months.

Primary outcomes:
measure: Gait instrumented walkway (GaitRite)
timeFrame: 10 minutes
measure: Bertec Balance System (Bertec)
timeFrame: 10 minutes
Secondary outcomes:
measure: Foot Posture Index - 6
timeFrame: 10 minutes
measure: NewYork Posture Scale
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
affiliation: Hacettepe University
name: Güllü Aydın Yağcıoğlu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aydin Yagcioglu G, Yilmaz O, Alemdaroglu Gurbuz I, Bulut N, Karaduman A, Ozkal O, Topuz S. Examination of the relationship between foot-body posture and balance and gait in Duchenne muscular dystrophy. Ir J Med Sci. 2023 Aug;192(4):1883-1888. doi: 10.1007/s11845-022-03178-5. Epub 2022 Oct 7.
Clinical trial NCT01101867: Prandial Insulin Dosing in Hospitalized Patients
Official title: Prandial Insulin Dosing Using the Carbohydrate Counting Technique in Hospitalized Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Admitting Hospital
Non-critically Ill
Keywords: diabetes
glucose
hospital
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2010-04-12
Enrollment: 126
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 determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Detailed description: The purpose of this study is to determine whether mealtime insulin, dosed to match the intake of carbohydrates (starches or sugars) results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Eligibility criteria: Inclusion Criteria:

* general medical or minor surgical hospitalized patients
* type 2 diabetes
* blood glucose 150-400 on at least 2 occasions within 24 hours or requiring at least 20 units of insulin/day in the 24 hours prior to enrollment

Exclusion Criteria:

* • Major surgery, occurring within the previous 2 weeks or planned within 72 hours of study entry, including cardiothoracic, neurosurgical, and open intra-abdominal procedures (in particular, any surgery lasting over 2 hours).

  * Patients receiving glucocorticoids, total parental nutrition (TPN), or tube feeds.
  * Pregnancy (glucose targets differ in pregnancy). Premenopausal women not on pharmacologic contraceptives, inrauterine device (IUD), or surgical menopause will undergo pregnancy testing.
  * Patients currently on IV insulin (must wait to enroll) or with planned surgical procedures in the next 72 hours for whom intravenous insulin will be likely
  * Prolonged (\>24 hour) strict nil per os (NPO-nothing by mouth) status (eg. small bowl obstruction). Liquid or modified consistency diets are acceptable.
  * Patients for whom expected length of stay will be less than 48 hours
  * Patients using subcutaneous insulin pumps
  * Diabetic ketoacidosis
  * End-stage renal disease on dialysis
  * End-stage liver disease with cirrhosis
  * Mental conditions precluding informed consent
  * Potentially sensitive admissions: prisoners, HIV, suicidality
  * Unable to give consent in English

Primary outcomes:
measure: Mean Glucose
timeFrame: day 3
Secondary outcomes:
measure: Postprandial Glucose
timeFrame: day 3
measure: Hypoglycemia
timeFrame: 72 hour
measure: Change in Glucose
timeFrame: 72 hour
measure: Treatment Satisfaction
timeFrame: day 3
measure: 1,5-anhydroglucitol Change
timeFrame: day 1 to day 3
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Kathleen M Dungan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03436667: Perioperative Factors Impacting Surgical Risk and Outcomes in Children
Official title: Perioperative Factors Impacting Surgical Risk and Outcomes in Children
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Surgery
Orthopedic Disorder
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing ambulatory orthopedic surgery at Nationwide Children's Hospital.

Brief summary: This prospective study will measure various factors in children coming in for ambulatory surgery and attempt to create a scoring system that would be able to predict post-operative outcomes.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged 6-18 years old having ambulatory orthopedic surgery with or without planned postoperative admission.
* Patients need to be cooperative to under spirometry testing and reaction time measurement. If unable to perform, we will assess why they were not able (non-cooperative, inability, etc)

Exclusion Criteria:

* Spinal fusion

Primary outcomes:
measure: Post-anesthesia care unit (PACU) length of stay
timeFrame: Immediately post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Vidya Raman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001367: Diagnosis and History Study of Patients With Different Neurological Conditions
Official title: Diagnosis and Natural History Protocol for Patients With Different Neurological Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nervous System Disease
Healthy Volunteer
Keywords: Healthy Volunteer
Nervous System Disease
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 3813
Sex: ALL
Minimum age (years): 2
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The following population groups may participate: - Subjects with neurological disorders who are 2 years old or older, - Family members who are 2 years old or older of people with a neurological disorder, - Healthy volunteers who are 18 years old or older.

Brief summary: This protocol is a screening and natural history protocol, which allows for evaluation of

patients and families where neurological conditions are present for enrollment into other

studies and will also be used to screen healthy volunteers to create a pool of potential future HV matches for HMCS protocols. Through diagnostic evaluations, data will be collected for research use in this study.

Detailed description: This protocol is a screening and natural history protocol, which allows for evaluation of

patients and families where neurological conditions are present for enrollment into other

studies and will also be used to screen healthy volunteers to create a pool of potential future HV matches for HMCS protocols. Through diagnostic evaluations, data will be collected for research use in this study.

Eligibility criteria: * INCLUSION CRITERIA:
* Patients with neurological disorders and subjects with a family history of neurological conditions OR
* Healthy volunteers: People age 18 or older who are generally in good health.

EXCLUSION CRITERIA:

* Patients \<2 years old.
* Employees of HMCS in NINDS.

Primary outcomes:
measure: to screen patients with neurological conditions and family members of patients with neurological conditions for enrollment in additional research protocols
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
name: Debra J Ehrlich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01005667: Study to Determine if Monitoring of Labor Shortens the Time to Delivery
Official title: Management of Labor Using the BirthTrack Computerized Labor Monitoring System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pregnancy
Keywords: Nulliparous women in spontaneous labor
Lead sponsor: Barnev, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
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 test the hypothesis that using the BirthTrack for management of labor shortens the time to delivery and thus improves both maternal and perinatal outcomes.


Eligibility criteria: Inclusion Criteria:

* The patient must be ≥ 18 years old
* Nulliparous
* Singleton fetus in vertex presentation
* Gestational age 36-0/7 or more
* Reassuring fetal heart tracing

Exclusion Criteria:

* Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
* Low lying placenta (edge 3cm or less from cervix)
* Known or suspected fetal or maternal infection
* Maternal thrombocytopenia (platelet count \<100,000)
* Maternal bleeding disorder
* Women with previous uterine surgery
* Known major fetal malformation
* Suspected fetal growth restriction (EFW\<10th percentile)
* Subjects with significant psychiatric history
* Major maternal morbidity (e.g. major cardiac disease)
* Subjects with indication for immediate delivery
* Limit on cervical dilation (e.g., up to 7 cm.)
* Prolonged rupture of membranes (i.e., \> 24 hours)

Primary outcomes:
measure: Shortened time to vaginal delivery
timeFrame: Length of labor until delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Barak M Rosenn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Dan Farine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05342467: Gemeprost Versus Dinoprostone in First Trimester Miscarriages
Official title: Gemeprost Versus Dinoprostone in the Medical Management of First Trimester Miscarriages: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Missed Abortion
Medical; Abortion, Fetus
Incomplete Abortion
Keywords: miscarriages
first trimester
medical treatment
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison between intravaginal gemeprost and dinoprostone.
Primary purpose: TREATMENT

Brief summary: Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

Detailed description: Women who are diagnosed with first trimester missed miscarriages are invited to participate in the study. They will be randomised to either gemeprost or dinoprostone.

Eligibility criteria: Inclusion Criteria:

* missed miscarriages
* incomplete miscarriages
* first trimester

Exclusion Criteria:

* coagulopathy
* Rhesus negative
* suspected ectopic pregnancy or pregnancy of unknown location
* on anticoagulation drug
* septic miscarriages
* hemodynamically unstable

Primary outcomes:
measure: Percentage of women who achieved complete evacuation
timeFrame: from recruitment until up to one week after commencement of treatment
Secondary outcomes:
measure: Percentage of women who experienced side effects
timeFrame: from recruitment until up to one week after commencement of treatment
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: UKM Medical Center
state: W.Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: UKM Medical Centre
state: W.Persekutuan
Study officials:
affiliation: National University of Malaysia
name: Rahana Abd Rahman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00515567: Explanted Lung Tissues With Pulmonary Fibrosis
Official title: Utilization of Explanted Lungs for Isolation of Tissue Samples and Primary Cell Lines to Study Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Fibrosis
Keywords: explanted lungs
pulmonary fibrosis
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2007-08-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects listed for lung transplant

Brief summary: The goal of this study is to use the tissues from the explanted lungs in order to better study the cause of pulmonary fibrosis at a cellular level.

Detailed description: Pulmonary Fibrosis involves scarring of the lung. Gradually, the air sacs of the lungs become replaced by fibrotic tissue. The most current thinking is that the fibrotic process is a reaction to tiny injury to the lung. When the scar forms, the tissue becomes thicker causing a permanent loss of the tissue's ability to carry oxygen into the bloodstream.

We need to obtain lung tissue from patients without pulmonary fibrosis and compare it to lung tissue from patients with pulmonary fibrosis.

Eligibility criteria: Inclusion Criteria:

* all patients awaiting lung transplant

Exclusion Criteria:

* all who will not give consent

Primary outcomes:
measure: assess fibroblasts and cytokines associated with pulmonary fibrosis
timeFrame: 12/2013
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Nickolai Dulin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01857167: Effect of Omega-3 Fatty Acids on Insulin Sensitivity in Chinese Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Insulin Resistance
Keywords: omega-3 fatty acids
randomized controlled trial
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2013-05-20
Enrollment: 185
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is to examine the change of fasting insulin, glucose, insulin sensitivity and related traits in response to the six month treatment of omega-3 fatty acids, including fish oil and flaxseed oil, in Chinese type 2 diabetic patients. Corn oil, rich in omega-6 fatty acids, will be selected as a controlled oil. The investigators hypothesize that omega-3 fatty acids could improve insulin sensitivity and glucose metabolism in Chinese type 2 diabetic patients.

Detailed description: The insulin resistance will be estimated by a homeostatic model assessment model of insulin resistance (HOMA-IR)

Eligibility criteria: Inclusion Criteria:

1. Fasting glucose \> 7.0 or have diabetes medication;
2. Male, 35-80 years; female, postmenopausal to 80 years;
3. Agree to participant in the trial.

Exclusion Criteria:

1. Deny to sign the informed consent;
2. type 1 diabetes;
3. Family history of hypertriglyceridemia or fasting triglyceride\>4.56 mmol/L;
4. Have severe liver disease, kidney disease or cancer;
5. Participating in the other clinical trial within 30 days;
6. Other diseases or conditions, for which the doctor of the patients do not agree his or her participating.

Primary outcomes:
measure: insulin resistance
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang University
state: Zhejiang
Study officials:
References:
citation: Zheng JS, Huang T, Yang J, Fu YQ, Li D. Marine N-3 polyunsaturated fatty acids are inversely associated with risk of type 2 diabetes in Asians: a systematic review and meta-analysis. PLoS One. 2012;7(9):e44525. doi: 10.1371/journal.pone.0044525. Epub 2012 Sep 11.
citation: Zheng JS, Lin M, Fang L, Yu Y, Yuan L, Jin Y, Feng J, Wang L, Yang H, Chen W, Li D, Tang J, Cai W, Shi M, Li Z, Wang F, Li D. Effects of n-3 fatty acid supplements on glycemic traits in Chinese type 2 diabetic patients: A double-blind randomized controlled trial. Mol Nutr Food Res. 2016 Oct;60(10):2176-2184. doi: 10.1002/mnfr.201600230. Epub 2016 Jul 12.
Clinical trial NCT06437704: Effects of Brain Training Games on Cognitive Function and Quality of Life in MCI
Official title: The Effects of Brain Training Games on Cognitive Function and Quality of Life Among Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Cognition
Aging
Quality of life
Brain training games
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to determine the effects of brain training games on cognitive function and Quality of life among older adults with MCI.

Detailed description: The study aims to determine the effects of brain training games on cognitive function and Quality of life among older adults with MCI.This study will assess the efficacy of Brain training games. Lumosity on the cognitive function and Quality of life among older adults with MCI .Beyond cognitive rehabilitation, this intervention holds promise as a cost-effective approach to delay, maintain, or even improve cognitive decline associated with the aging process.

Eligibility criteria: Inclusion Criteria:

* Older adults of age \>50 years and above
* Both male and female
* Education level matriculation at least
* Mild cognitive impairment ( MOCA score of 18-25)
* Active independent individuals with normal hearing and normal or corrected-to-normal vision.

Exclusion Criteria:

* Moderate to severe cognitive impairment
* Diagnosed case of dementia, depression or other mental issues.
* Current plans to move to another city.

Primary outcomes:
measure: Montreal Cognitive Assessment Scale
timeFrame: 6 weeks
measure: Trail Making Test A and B
timeFrame: 6 weeks
measure: World Health Organization Quality of Life Brief Version (WHO-QOL BREF) Questionnaire:
timeFrame: 6 weeks
measure: International Physical Activity Questionnaire (IPAQ);
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University, Gulberg Green Campus
state: Punjab
Study officials:
affiliation: Riphah International University Islamabad
name: Arshad Nawaz Malik, PhD
role: PRINCIPAL_INVESTIGATOR
References: