louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00269594: An Open-Label Study Of Lamictal In Neurotic Excoriation
Official title: An Open-Label Study of Lamictal In Neurotic Excoriation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neurotic Disorders
Obsessive-Compulsive Disorder
Keywords: Skin
Picking
Pick
Neurotic Excoriation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2005-12-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the proposed study is to evaluate the efficacy and safety of Lamictal in neurotic excoriation. Twenty subjects with neurotic excoriation will receive 12 weeks of open-label treatment with Lamictal. The hypothesis to be tested is that Lamictal will be effective and well tolerated in patients with neurotic excoriation. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.


Eligibility criteria: Inclusion Criteria:

* men and women age 18-65
* current diagnosis of neurotic excoriation

Exclusion Criteria:

* unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination
* history of seizures
* myocardial infarction within 6 months
* current pregnancy or lactation, or inadequate contraception in women of childbearing potential
* a need for medication other than Lamictal with possible psychotropic effects or unfavorable interactions with Lamictal
* clinically significant suicidality
* lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder
* current or recent (past 3 months) DSM-IV substance abuse or dependence
* illegal substance use within 2 weeks of study initiation
* initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline
* previous treatment with Lamictal
* treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline
* current treatment with an anti-epileptic medication and
* patients who have previously been diagnosed with a medical condition that cause skin itchiness (e.g. liver, kidney, and blood diseases, etopic allergies)

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation
Secondary outcomes:
measure: Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jon E Grant, JD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grant JE, Odlaug BL, Kim SW. Lamotrigine treatment of pathologic skin picking: an open-label study. J Clin Psychiatry. 2007 Sep;68(9):1384-91. doi: 10.4088/jcp.v68n0909.
Clinical trial NCT06664294: The USE of ULTRASONOGRAPHY in CONFIRMING SUPRAGLOTTIC AIRWAY DEVICE PLACEMENT in PEDIATRIC PATIENTS
Official title: The USE of ULTRASONOGRAPHY in CONFIRMING SUPRAGLOTTIC AIRWAY DEVICE PLACEMENT in PEDIATRIC PATIENTS
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Airway Ultrasound
Keywords: supraglottic airway pediatric airway,airway ultrasound
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 55
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients aged 3-15 years with an operation time of less than 2 hours

Brief summary: In this study,the investigators evaluated the placement of the supraglottic airway device with ultrasonographic imaging.

Detailed description: After informing the patients about the study and possible risks, written consent was obtained from all patients. After routine anesthesia technique was applied to the patients, supraglottic airway device was inserted. The placement of the airway device was evaluated with ultrasonography. Airway pressures reflected on the anesthesia device were recorded. The correlation between airway pressures and ultrasonographic images was evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients with informed consent from their parents
* Patients with ASA I-II physical status
* Patients with appropriate fasting time
* Those with an operation time of less than 2 hours

Exclusion Criteria:

* ASA III-IV physical status patients
* Patients with respiratory tract infections
* Patients undergoing head and neck surgery
* Patients with oropharyngeal pathology
* Patients with gastrointestinal obstruction
* Patients with tracheomalacia
* Patients who need to be intubated for anesthesia applications

Primary outcomes:
measure: correlation between ultrasonography and clinical tests
timeFrame: 24 hours
Secondary outcomes:
measure: mesuring airway pressures
timeFrame: 24 hours
Other outcomes:
Locations:
city: Izmit
country: Turkey
facility: Kocaeli University
state: Kocaeli
Study officials:
affiliation: Kocaeli University
name: can aksu
role: STUDY_DIRECTOR
References:
citation: Kim J, Kim JY, Kim WO, Kil HK. An ultrasound evaluation of laryngeal mask airway position in pediatric patients: an observational study. Anesth Analg. 2015 Feb;120(2):427-32. doi: 10.1213/ANE.0000000000000551.
Clinical trial NCT01088360: Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)
Official title: An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: National Data Bank for Rheumatic Diseases (NDB)
First posted: 2010-03-17
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being treated for rheumatoid arthritis in the US

Brief summary: The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Diagnosis of rheumatoid arthritis
* \> 18 years at index treatment initiation or switch
* Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug.
* Read/write English

Exclusion Criteria:

* None

Primary outcomes:
measure: Key safety outcomes (targeted infections, malignancies, mortality)
timeFrame: Every 6 months throughout the study
Secondary outcomes:
measure: Patient-reported infusion reactions
timeFrame: Every 6 months throughout the study
measure: Multiple sclerosis, lupus, and psoriasis
timeFrame: Every 6 months throughout the study
measure: Adverse events in pregnant women who receive abatacept
timeFrame: Every 6 months throughout the study
measure: Adverse events in subjects on abatacept who receive concomitant biologics
timeFrame: Every 6 months throughout the study
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04628260: UNCOVER - a Non-interventional Study to Investigate Undiagnosed Severe Asthma
Official title: UNCOVER - a Non-interventional Study to Investigate Undiagnosed Severe Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Karl Landsteiner Institute for Clinical and Experimental Pneumology
Sponsor class: OTHER
Collaborators: name: Universitätsklinik für Innere Medizin II, Pulmologie
First posted: 2020-11-13
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female and male patients are eligible for this non-interventional study when fulfilling all criteria for inclusion and None of the criteria for exclusion. 400 patients will be enrolled.

Brief summary: UNCOVER is a non-interventional study to investigate the prevalence of difficult-to-treat and severe Asthma eligible for treatment with biologics in a cohort of patients with suspected, so far undiagnosed severe Asthma which were previously treated by General practitioners and Office-based pulmonologists.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at inclusion
* written informed consent
* currently diagnosed with Asthma fulfilling at least one of the criteria of potential severe Asthma
* willing and able to complete the study questionnaire miniAQLQ

Exclusion Criteria:

* biological Treatment for Asthma during the past 12 months
* participation in a clinical Trial within the last 3 months
* patients who are not able to read or write, who do not understand the nature of the study or the ICF or who are dependent from the investigator

Primary outcomes:
measure: The Primary objective is the Investigation of the prevalence of difficult-to-treat and severe Asthma eligible for Treatment with biologics.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Karl Landsteiner Institute for Clinical and Experimental Pneumology, Klinik Hietzing
Study officials:
affiliation: Head of Karl Landsteiner Institut for Clinical and Experimental Pneumology
name: Wolfgang Pohl, Univ. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05327660: CO Monitoring for Tobacco Cessation in Quitlines
Official title: Remote Carbon Monoxide Monitoring and Incentives for Tobacco Cessation in Quitlines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tobacco Dependence
Keywords: tobacco cessation
tobacco quitlines
carbon monoxide monitoring
incentives
Lead sponsor: Consumer Wellness Solutions
Sponsor class: INDUSTRY
Collaborators: name: Vincere Health
name: Maryland State Tobacco Quitline
First posted: 2022-04-14
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is a 3-arm randomized controlled pilot study. Participants who call the Maryland Tobacco Quitline and are eligible for study participation are randomized to receive quitline tobacco cessation treatment as usual (TAU), TAU plus remote carbon monoxide (CO) monitoring via smartphone app, or TAU plus remote carbon monoxide monitoring plus incentives vis smartphone app. The investigators hypothesize that remote CO monitoring will be feasible and acceptable to deliver in the quitline setting, will increase treatment engagement, and will increase tobacco cessation and treatment satisfaction rates.


Eligibility criteria: Inclusion Criteria:

* Daily cigarette smokers calling into participating quitlines
* 18 year or older
* Reads and speaks English
* Has a smartphone with a data plan
* Willing to download and use study app
* Willing to use CO monitor

Exclusion Criteria:

• Pregnant or breast feeding

Primary outcomes:
measure: Treatment Satisfaction
timeFrame: 60 days
measure: Treatment Engagement
timeFrame: 60 days
measure: Self-reported Tobacco Abstinence
timeFrame: 60 days
Secondary outcomes:
measure: Biochemically Verified Tobacco Abstinence
timeFrame: 60 days
measure: Engagement With CO Monitor
timeFrame: 60 days
measure: Satisfaction With CO Monitor
timeFrame: 60 days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Optum Center for Wellbeing Research
state: Washington
Study officials:
affiliation: Consumer Wellness Solutions
name: Kelly Carpenter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03411460: Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System
Official title: Satisfaction of Using a Continuous Glucose Monitoring System to Monitor Interstitial Fluid Glucose Level in Hospitalized Insulin-dependent Diabetic Patients Treated Using a Portable Sub-cutaneous Pump
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insulin-Dependent Diabetes
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to establish whether routine usage of the FreeStyle Libre™ system (Abbott) improves satisfaction and quality of sleep in patients hospitalized for poor glycemic control with an indication for external insulin pump treatment.


Eligibility criteria: Inclusion Criteria:

* Patient has given their free and informed consent
* The patient must be insured or the beneficiary of an insurance policy
* The patient is aged at least 18 years and less than 75 years old.
* Patients have a BMI between 18 and 40kg/m2
* Diabetic patient admitted for glycemic instability with indication for treatment using an external insulin pump but otherwise in a stable clinical state

Exclusion Criteria:

* The subject is participating in another study
* The subject is in an exclusion period determined by a previous study
* The patients is under judicial protection or state guardianship
* The subject refuses to sign the consent form
* It proves impossible to give the subject clear information.
* The patient is pregnant, parturient or breastfeeding
* The patient is clinically unstable
* BMI less than 18 or over 40
* Existence of a severe rapidly progressive ischemic retinopathy or proliferative retinopathy.
* Serious psychiatric problems
* Chronic cutaneous infection

Primary outcomes:
measure: Satisfaction of patient-determined hospital care at discharge in the two groups
timeFrame: at discharge from hospital; maximum Day 5
Secondary outcomes:
measure: Patient satisfaction concerning treatment for their diabetes
timeFrame: at discharge from hospital; maximum Day 5
measure: Patient quality of sleep
timeFrame: at each day of hospitalization and discharge; maximum Day 5
measure: Satisfaction of nursing staff concerning care of patient
timeFrame: at end of study; maximum Day 5
measure: Time taken by nurse to measure circulating glucose level
timeFrame: Daily over length of hospitalization until maximum Day 5
measure: Time necessary to achieve satisfactory equilibrium using insulin pump
timeFrame: maximum Day 5
measure: Number of glucose readings above 2g/l and below 0.80g/l over the hospital stay
timeFrame: maximum Day 5
measure: Number of hypoglycmic events with the corresponding glucose level
timeFrame: maximum Day 5
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
References:
Clinical trial NCT00005360: HIV Diversity and Pathogenesis in Donor-Recipient Clusters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Immunodeficiency Syndrome
Blood Transfusion
Blood Donors
HIV Infections
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To assess, in donor-recipient clusters, current models of HIV-1 genetic evolution and pathogenesis, based on the sequence diversity displayed by this lentivirus.

Detailed description: DESIGN NARRATIVE:

Based on anti-HIV-1 screening of a repository of 200,000 blood donor sera collected in late 1984, the Transfusion Safety Study identified and enrolled into ongoing followup 133 seropositive donors and 111 HIV-1-infected transfusion recipients. Included among these were 38 'transmission clusters' composed of a donor and from one to six linked, infected recipient(s), and, in four cases, infected recipients' sexual partners. Frozen cells and sera collected at six-month intervals over a six-year period from members of these clusters were available for study. Specimens were accessed such that sub-repositories of cellular DNA, PCR-amplified HIV-1 sequences, and viral isolates were generated for future investigations of these unique clusters. The studies included analysis of sequence diversity in envelope (env) V3, V4, and V5 hypervariable regions both within each infected individual over time, and between different members of each cluster and different clusters. Sequence diversity profiles from PBMC and serum were analyzed separately to discern differences in these different blood components at each sampling and over time. The pattern of turnover of specific sequence variants over time (evolution of viral genotypes) was correlated with clinical and immunological progression.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Asher M. Plantar release in the correction of deformities of the foot in childhood. J Bone Joint Surg Am. 1982 Jun;64(5):790-1. No abstract available.
citation: Diaz RS, Zhang L, Busch MP, Mosley JW, Mayer A. Divergence of HIV-1 quasispecies in an epidemiologic cluster. AIDS. 1997 Mar 15;11(4):415-22. doi: 10.1097/00002030-199704000-00003.
citation: Sabino EC, Delwart E, Lee TH, Mayer A, Mullins JI, Busch MP. Identification of low-level contamination of blood as basis for detection of human immunodeficiency virus (HIV) DNA in anti-HIV-negative specimens. J Acquir Immune Defic Syndr (1988). 1994 Aug;7(8):853-9.
Clinical trial NCT01617460: A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Official title: A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autistic Disorder
Keywords: Autistic Disorder, children and adolescents
aripiprazole
Long-term safety study
children and adolescents
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-12
Enrollment: 86
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).


Eligibility criteria: Inclusion Criteria:

* The patient meets Autistic disorder diagnostic criteria defined in DSM-IV-TR.
* The patient has completed the 031-11-002 study (the patient has visited the hospital during week8)
* Inpatient or outpatient status

Exclusion Criteria:

* The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome.
* Patients who fall under a contraindication listed in the ABILIFY package insert
* Others

Primary outcomes:
measure: Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
timeFrame: Baseline, the final administration
Secondary outcomes:
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Chugoku Region
country: Japan
city: Kanto Region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Hiroaki Ono, Mr
role: STUDY_DIRECTOR
References:
citation: Ichikawa H, Hiratani M, Yasuhara A, Tsujii N, Oshimo T, Ono H, Tadori Y. An open-label extension long-term study of the safety and efficacy of aripiprazole for irritability in children and adolescents with autistic disorder in Japan. Psychiatry Clin Neurosci. 2018 Feb;72(2):84-94. doi: 10.1111/pcn.12607. Epub 2017 Nov 8.
Clinical trial NCT01527760: Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension
Official title: Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension. One Group Pretest Posttest Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Essential Hypertension
Viscum album mother tincture
one group pretest post-test study
Lead sponsor: Fr Muller Homoeopathic Medical College
Sponsor class: OTHER
Collaborators: name: Rajiv Gandhi University of Health Sciences
First posted: 2012-02-07
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To estimate the effectiveness of Viscum album Homoeopathic mother tincture in Essential Hypertension by conducting clinical trial in moderate hypertensive patients for a period of six weeks.


Eligibility criteria: Inclusion Criteria:

* Hypertension at the range 180-120 mm of Hg for Systole \&
* 110-80 mm of Hg for Diastole

Exclusion Criteria:

* Patients who are on ACEI / ARB for Hypertension
* Diseases in which life expectancy is less than six months
* Secondary hypertension
* CHD
* Family History of Mental Illness like Anxiety or depression.
* Nasal Congestion

Primary outcomes:
measure: Change in Systolic and Diastolic blood pressure.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Serum Cholesterol
timeFrame: 12 weeks
measure: Change in Serum Triglycerides
timeFrame: 12 weeks
measure: Change in Serum LDH
timeFrame: 12 weeks
measure: Change in Serum Urea
timeFrame: 12 weeks
measure: change in Serum CKMB
timeFrame: 12 weeks and 16 weeks
Other outcomes:
Locations:
city: Mangalore
country: India
facility: Fr Muller Homoeopathic Medical College Hospital
state: Karnataka
Study officials:
affiliation: Fr Muller Homoeopathic Medical College
name: Dr Kurian P John, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poruthukaren KJ, Palatty PL, Baliga MS, Suresh S. Clinical evaluation of Viscum album mother tincture as an antihypertensive: a pilot study. J Evid Based Complementary Altern Med. 2014 Jan;19(1):31-5. doi: 10.1177/2156587213507726. Epub 2013 Nov 5.