louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00078143: Motivational Enhancement Therapy to Improve Treatment Utilization in Pregnant Substance Users - 1
Official title: Motivational Enhancement Therapy (MET) to Improve Treatment Utilization in Pregnant Substance Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Substance-Related Disorders
Keywords: behavioral intervention
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-02-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Motivational Enhancement Therapy (MET) with standard drug abuse treatment among pregnant women.


Eligibility criteria: Inclusion Criteria:

* Pregnancy \<30 weeks
* Have not attended drug treatment in past 28 days
* Not needing residential treatment (except detox)
* Not at risk for suicide/homicide
* Have no pending legal charges (except drug treatment)

Primary outcomes:
measure: Treatment Utilization
measure: Substance Abuse
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Midtown Community Mental Health Center
state: Indiana
city: Louisville
country: United States
facility: Jefferson Alcohol & Drug Abuse Center
state: Kentucky
city: Detroit
country: United States
facility: Eleonore Hutzel Recovery Center
state: Michigan
city: Albuquerque
country: United States
facility: Milagro Clinic
state: New Mexico
city: Albuquerque
country: United States
facility: Milagro
state: New Mexico
city: Wilmington
country: United States
facility: Coastal Horizons Center, Inc.
state: North Carolina
Study officials:
affiliation: University of Cincinnati
name: Theresa Winhusen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Osterman R, Lewis D, Winhusen T. Efficacy of motivational enhancement therapy to decrease alcohol and illicit-drug use in pregnant substance users reporting baseline alcohol use. J Subst Abuse Treat. 2017 Jun;77:150-155. doi: 10.1016/j.jsat.2017.02.003. Epub 2017 Feb 21.
citation: Winhusen T, Lewis D. Cigarette smoking in pregnant substance users: Association with substance use and desire to quit. J Addict Dis. 2017 Jan-Mar;36(1):88-91. doi: 10.1080/10550887.2016.1254992. Epub 2016 Nov 1.
Clinical trial NCT01813643: A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis
Official title: A Multiple-Center, Randomized, Double-Blind Study of Comparison of Risperidone and Aripiprazole for Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Methamphetamine Dependence
Keywords: Methamphetamine-Associated Psychosis
Aripiprazole
Risperidone
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms), response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic neurotransmission) of both conditions. Both risperidone and aripiprazole are second generation antipsychotics，but have different pharmacological effects of antipsychotic treatment.This study was designed to examine the acute efficacy, safety, and tolerability of risperidone and aripiprazole for patients with MAP.

Detailed description: Methods:A Multiple-Center, Randomized, Double-Blind.

Eligibility criteria: Inclusion Criteria:

1. Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine-Associated Psychosis.
2. Must sign a Information consent form.
3. Required to provide detailed address and phone number

Exclusion Criteria:

1. Serious organic disease.
2. Suicide ideation or hurt others.
3. Taking antipsychotic within two weeks before.
4. drug allergy to Risperidone or Aripiprazole.
5. pregnancy and breastfeeding women.

Primary outcomes:
measure: The severity of psychosis
timeFrame: up to 4 weeks. participants will be followed for the duration of hospital stay
Secondary outcomes:
measure: adverse drug reaction
timeFrame: up to 4 weeks. participants will be followed for the duration of hospital
measure: Clinical general status
timeFrame: up to 4 weeks. participants will be followed for the duration of hospital stay
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central University
state: Hunan
Study officials:
affiliation: Central South University
name: Wei Hao, MD., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05224843: Feasibility of VOICES Elder Abuse Intervention in Primary Care Setting (VOICES-PC Feasibility)
Official title: The Feasibility of the VOICES Digital Health Tool for Elder Mistreatment Screening in the Primary Care Setting (VOICES-PC Feasibility)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Elder Abuse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-02-04
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: VOICES Elder Abuse Intervention
Primary purpose: PREVENTION

Brief summary: To test an interactive intervention to screen for Elder Abuse and Mistreatment (EM) in the Primary Care (PC) setting to promote self-identification and self-disclosure of EM.

Detailed description: The aim of this study is to perform a feasibility evaluation (N=80) of the VOICES screening tool among older adults in the primary care setting. If VOICES is feasible for identifying suspicion of EM in primary care setting, then it will be able to connect more victims of EM to necessary services and potentially prevent a multitude of poor EM outcomes

Eligibility criteria: Inclusion Criteria:

* Age 60 years or older
* Alert and oriented to person and place
* Abbreviated Mental Test (AMT-4) score of 4
* Able to consent and communicate in English
* Agrees and able to use the iPad

Exclusion Criteria:

* subjects who live in nursing homes or other long-term care sitting and do not reside in community setting
* patients will be excluded if they cannot safely undergo the studies required for participation
* subjects with clear signs of EM
* Patient or clinician refusal to participate
* severe hearing and vision impairment
* COVID-19 positive

Primary outcomes:
measure: Participation
timeFrame: 5-10 minutes before VOICES intervention use.
measure: Usage
timeFrame: 5-10 minutes directly following VOICES intervention.
Secondary outcomes:
Other outcomes:
measure: Acceptability
timeFrame: 5-10 minutes directly following VOICES intervention use.
measure: Demand
timeFrame: 5-10 minutes directly following VOICES intervention use.
measure: Practicality
timeFrame: Actual time duration is assessed during VOICES use by the computer program (the actual duration of the patient's time using VOICES). Estimation of completed time is completed 5-10 minutes directly following VOICES intervention use.
measure: Efficacy of the Brief Negotiation Interview
timeFrame: Measure collected 5-10 minutes directly following VOICES intervention.
measure: Accuracy
timeFrame: Measure collected up to directly following VOICES intervention to 1 week following VOICES intervention.
Locations:
city: New Haven
country: United States
facility: Yale Internal Medicine Associates
state: Connecticut
Study officials:
affiliation: Yale University
name: Fuad Abujarad, PhD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00982943: The Epidemiological Study on Psychiatric Disorders and Psychotropic Drugs
Official title: The Epidemiological Study on Psychiatric Disorders and Psychotropic Drugs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychiatric Disorders
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 1000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the health insurance data from persons who had diagnoses of ICD: 290-319 or were prescribed with antidepressant agents during the period from 1998 to 2006

Brief summary: During the past decade, the dramatic change in patterns of both psychiatric diagnoses and prescription of psychotropic agents has been noted since the introduction of newer antidepressant drugs. In the meantime, suicide has been recognized as a major public health problem all over the world. Research efforts have hence been spent in exploring the interrelationships between suicide rates and prescription of antidepressant drugs (as a proxy for the treatment of depression). However, most available studies came from developed countries despite that the majority of countries with rising suicide rates during the past decade were developing countries. Both suicide rates and prescription of antidepressant agents have been rising in Taiwan during the past decade; with a reliable mortality registrar and nationwide health insurance covering 99% of its population, Taiwan is distinctive in realizing a large-scale analysis on these interrelationships between suicide and prescription of antidepressant drugs. However, there has been no study in Taiwan exploring these potential associations up to now.

This study aims at examining the interrelationships between suicide rates and prescription of antidepressant agents based on the health insurance data from persons who had diagnoses of ICD: 290-319 or were prescribed with antidepressant agents during the period from 1998 to 2006. The investigators plan to first perform correlation analyses between the trends of suicide rates and prescription of antidepressants during the study period after taking into accounts potential confounding factors; analyses by age, gender groups and by administrative regions will also be performed. Besides, the investigators plan to analyze the change in the prescription pattern of psychotropic agents in Taiwan during the study period, with the particular focus on that of newer antidepressant drugs. The prescription of psychotropic agents in both psychiatric and non-psychiatric diagnoses will be explored.


Eligibility criteria: Inclusion Criteria:

* psychiatric disorders

Exclusion Criteria:

* without psychiatric disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei County
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References:
Clinical trial NCT05605743: Alternate Nostril Breathing Training in Geriatrics With Glaucoma and High Blood Pressure
Official title: Ocular Hypertension Response to Alternate Nostril Breathing Training in Geriatrics With Glaucoma and High Blood Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Open Angle Glaucoma
Hypertension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypertension, particularly if poorly controlled, appears related to an increased risk of open angle glaucoma, (the high tension type of glaucoma is characterized as optic nerve degeneration with ocular hypertension). so this study will search response of glaucoma to breathing exercise

Detailed description: Hypertension, particularly if poorly controlled, appears related to an increased risk of open angle glaucoma, (the high tension type of glaucoma is characterized as optic nerve degeneration with ocular hypertension). With a random assignment, sixty hypertensive geriatric with high tension type primary open angle glaucoma will be assigned to breathing exercise (alternate nostril breathing) group (n=30 geriatrics) or waiting list geriatrics. the daily breathing exercise will be performed by the geriatrics in evening (for half an hour) and morning (for half an hour).

Eligibility criteria: Inclusion Criteria:

* hypertensive elderly
* primary open angle glaucoma in both eyes
* ocular hypertension in both eyes

Exclusion Criteria:

acute or chronic eye inflammation cataract eye surgeries mental ill patients patients who will refuse to participate in the study other systemic /cardiovascular problem

Primary outcomes:
measure: intraoccular pressure
timeFrame: It will be measured after 4 weeks of training
Secondary outcomes:
measure: systolic blood pressure
timeFrame: It will be measured after 4 weeks of training
measure: diastolic blood pressure
timeFrame: It will be measured after 4 weeks of training
measure: heart rate
timeFrame: It will be measured after 4 weeks of training
measure: respiratory rate
timeFrame: It will be measured after 4 weeks of training
measure: hospital anxiety and depression scale
timeFrame: It will be measured after 4 weeks of training
measure: short form 36 survey
timeFrame: It will be measured after 4 weeks of training
measure: glaucoma quality of life-15 questionnaire
timeFrame: It will be measured after 4 weeks of training
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00603343: Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence
Official title: Treatment With Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence: Results of a Randomized Placebo-Controlled Phase III Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Urinary Incontinence
Children
Keywords: antimuscarinics
children
overactive bladder
propiverine
urinary incontinence
urotherapy
Lead sponsor: APOGEPHA Arzneimittel GmbH
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 303
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic overactive bladder and urinary incontinence.

Detailed description: This clinical trial showed superior efficacy of propiverine over placebo and convincing tolerability for the treatment of children suffering from OAB and urinary incontinence.

Eligibility criteria: Inclusion Criteria:

* voiding frequency 8 or above per day
* at least one incontinence episode per day
* age between 5-10 years
* body weight between 17 and 45 kg

Exclusion Criteria:

* normal age expected bladder capacity
* PVR more than 10 ml
* dysfunctional voiding
* neurogenic disorders
* UTI, constipation

Primary outcomes:
measure: voiding frequency
timeFrame: before therapy and at end of therapy
Secondary outcomes:
measure: voided volume
timeFrame: before and at end of treatment
measure: incontinence episodes per day
timeFrame: before and at end of therapy
measure: safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate
timeFrame: before and at end of treatment
Other outcomes:
Locations:
Study officials:
affiliation: urologist
name: Daniela Marschall-Kehrel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marschall-Kehrel D, Feustel C, Persson de Geeter C, Stehr M, Radmayr C, Sillen U, Strugala G. Treatment with propiverine in children suffering from nonneurogenic overactive bladder and urinary incontinence: results of a randomized placebo-controlled phase 3 clinical trial. Eur Urol. 2009 Mar;55(3):729-36. doi: 10.1016/j.eururo.2008.04.062. Epub 2008 May 7.
Clinical trial NCT03303443: Empirical Mode Decomposition in the Electroencephalogram
Official title: Empirical Mode Decomposition in the Electroencephalogram During General Anesthesia Between Generations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depth of Anesthesia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20-40y/o patients or over 60y/o patients without severe systemic disease who were scheduled for general anesthesia.

Brief summary: Bispectral index (BIS), a standard monitor for perioperative monitor of patient's conscious level, is a noninvasive medical technique for monitoring and recording the electrical activity of brain.

Detailed description: The electroencephalogram and BIS data have lots of information. Fourier transformation to decompose EEG was first applied on the EEG signaling until now. The disadvantages of Fourier transformation is hard to deal with physical signals, which was modulated by autonomic system and factors. The Hilbert-Huang transform (HHT) was proposed to decompose EEG signal into intrinsic mode functions (IMF) since 2004. HHT can obtain instantaneous frequency data and work well for data that is nonstationary and nonlinear. HHT have been applied for wild ranges, not only in the analysis of arrhythmia for medical and public health fields, but also in the earthquake detection and earth physics detection...etc.

The relationship between frontal EEG patterns and general anesthesia remain poorly understood. It can only say that the increase in frontal EEG power and shift power to lower frequencies during general anesthesia from publications. The investigators are going to compare the EEG signal between generations, try to find the difference in aging using empirical mode decomposition method.

Eligibility criteria: Inclusion Criteria:

1. 20-40y/o or over 60y/o
2. Scheduled for low risk general anesthesia
3. Suitable for surgery after interviewed by anesthesiologist

Exclusion Criteria:

1. Not suitable for general anesthesia
2. High risk patient
3. Allergic to the EEG sensor

Primary outcomes:
measure: EEG power calculation
timeFrame: During the operation time.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Feng-Fang Tsai
Study officials:
affiliation: National Taiwan University Hospital
name: Feng-Fang Tsai, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01163643: Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
Official title: A Randomized, Double-Masked, Parallel-Group, Vehicle Controlled, Multicenter, Exploratory Study Assessing the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndrome
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-07-16
Enrollment: 356
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: The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.


Eligibility criteria: Inclusion Criteria:

* Subjects who have a diagnosis of dry eye disease.
* Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
* Subjects who are willing and able to refrain from using contact lenses during the study.

Exclusion Criteria:

* Subjects with known hypersensitivity or contraindication to any component of the study medication.
* Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter).
* Subjects who are expected to require treatment with corticosteroids during the study.
* Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
* Subjects who have undergone any type of ocular surgery within three months prior to screening.
* Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit.
* Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.

Primary outcomes:
measure: Mean Corneal Staining Score
timeFrame: 12 weeks
measure: Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Tuyen Ong, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01024543: Role of Angiotensin II in Insulin-induced Microvascular Activity
Official title: Role of Angiotensin II in Insulin-induced Microvascular Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Microcirculation
Keywords: Angiotensin II
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study we hypothesize infusion of Angiotensin II improves the insulin-induced microvascular dilatation and therefore insulin-mediated glucose uptake. Objectives: Does infusion of Angiotensin II increase insulin-mediated glucose uptake via enhanced insulin-mediated microvascular function in healthy subjects?


Eligibility criteria: Inclusion Criteria:

1.18-60 years 2.Caucasian 3.Blood pressure \<140/90 mmHg.

Exclusion Criteria:

1. Obesity (BMI\>27kg/m2)
2. Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
3. Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA
4. Smoking
5. Alcohol use \>4U/day
6. Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs)
7. Pregnancy
8. Wearing contact lenses

Primary outcomes:
measure: functional recruitment of capillaries in the skin
timeFrame: January 2009
Secondary outcomes:
measure: perfused capillary density in the nailfold
timeFrame: January 2009
measure: Endothelium- (in)dependent vasodilatation of finger skin microcirculation
timeFrame: January 2006
measure: Insulin sensitivity
timeFrame: January 2009
Other outcomes:
Locations:
city: Maastricht, P.o. Box 5800, Netherlands
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical Centre
name: CDA Stehouwer, Prof
role: STUDY_CHAIR
References: