louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01359137: An Assessment of SAFE (Swift Accountable Fair Enforcement) in Cochise County
Official title: An Assessment of Arizona's SAFE (Swift Accountable Fair Enforcement) Program in Cochise County
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Keywords: Behavior
Drug users
Criminal Justice
Probation
Lead sponsor: Pepperdine University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2011-05-24
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a Cochise County experiment with innovative probation supervision practices. Subjects are assigned to one of three supervision conditions.

Detailed description: Historically, rates of failure on routine probation have been high. The result is that large numbers of probationers are ultimately revoked from probation and sentenced to long underlying jail or prison terms. Arizona is experimenting with alternatives to routine probation with the goal of reducing the overall burden of incarceration. Cochise County in Arizona is experimenting with innovative probation supervision practices. Subjects are assigned to one of three supervision conditions: Probation-as-usual (routine supervision with no deferred jail); discretionary deferred jail in response to probation violations; and Arizona's Swift, Accountable, Fair, Enforcement, or SAFE (SAFE involves non-discretionary deferred jail in response to probation violations).

Eligibility criteria: Inclusion Criteria:

* Supervised on probation in Cochise County
* Residing in Cochise County

Exclusion Criteria:

* First-time marijuana possession cases

Primary outcomes:
measure: Revocation rate
timeFrame: 12 months
Secondary outcomes:
measure: % positive drug tests
timeFrame: 12 months
measure: Days incarcerated
timeFrame: 12 months
measure: % Missed appointments
timeFrame: 12 months
measure: New arrests
timeFrame: 12 months
Other outcomes:
Locations:
city: Bisbee
country: United States
facility: Cochise County Adult Probation Department
state: Arizona
Study officials:
References:
Clinical trial NCT01106937: Factor XIII and Pulmonary Embolism in Neurosurgical Patients
Official title: Risk Factors for Perioperative Pulmonary Embolism in Neurosurgical Patients in Respect of Factor XIII Activity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Tumor
Vascular Lesion
Factor XIII Deficiency
Pulmonary Embolism
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2010-04-20
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurosurgical patients with a postoperative occurence of pulmonary embolism in with laboratory-confirmed preoperatively low levels of Factor XIII

Brief summary: Two studies (Gerlach et al. 2000; Gerlach et al. 2002) described the impact of factor XIII on the risk of prospective hemorrhage for patients undergoing craniotomy. Since then, factor XIII is measured and substituted in various centers. Few reports support the idea of factor XIII being involved in the formation of deep venous thrombosis and pulmonary embolism. In this prospective observational study, patients undergoing craniotomy for brain tumors or vascular lesions are investigated concerning the incidence of postoperative pulmonary embolism in respect of possible risk factors (factor XIII activity levels, standard coagulation parameters, tumor entity, blood loss).


Eligibility criteria: Inclusion Criteria:

* preoperatively low Factor XIII activity
* neurosurgical procedure (craniotomy)
* substitution of Factor XIII
* postoperative occurence of pulmonary embolism

Exclusion Criteria:

Primary outcomes:
measure: Incidence of pulmonary embolisms following Factor XIII substitution
timeFrame: 38 months
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Neurosurgery, LMU
state: Bavaria
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Stefan Grau, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04291937: A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA
Official title: A Multicenter Expanded Access Treatment Protocol of Lurbinectedin (PM01183) in Previously Treated Small Cell Lung Cancer in the USA
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Small Cell Lung Cancer
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-03-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access program in the USA to enable eligible patients with previously treated small cell lung cancer to access lurbinectedin treatment prior to FDA approval. Sites must apply to participate in the program. A medical doctor must assess whether the potential benefit outweighs the risk of the investigational therapy considering the program eligibility criteria and the individual patient's medical history.


Eligibility criteria: Inclusion Criteria:

* Legally competent adult
* Confirmed and unresectable Small Cell Lung Cancer (SCLC)
* Patients must have received one prior chemotherapy containing line
* Adequate organ, hematological, kidney, metabolic and liver function
* Recovery from toxicities related to previous treatment(s)
* Pregnancy must be excluded, medically acceptable contraception method

Exclusion Criteria:

* Prior treatment with lurbinectedin
* Certain concomitant diseases/conditions
* Symptomatic, steroid-requiring or progressive CNS involvement.
* Pregnant or breast-feeding women.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04289337: Double-blind Clinical Trials of Probiotic Products in Oral Health.
Official title: Double-blind Clinical Trials of Probiotic Products in Oral Health.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Probiotics
Oral Health
Probiotic Metabolites
Lead sponsor: Glac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-02-28
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In order to evaluate the effects of supplementary probiotics and their metabolites on oral environment and oral microbiota, Taiwan FDA No. 88037803 will be used to evaluate the effects of oral probiotic candidate strains from previous research results and develop oral probiotic products.


Eligibility criteria: Inclusion Criteria:

* Adults between 20 to 40 years old.
* More than 10\^5 Streptococcus mutans (CFU/mL) of saliva.

Exclusion Criteria:

* Smoking.
* Subject has major illness.

Primary outcomes:
measure: The change from baseline colony-forming unit (CFU) of Streptococcus mutans at 4 weeks.
timeFrame: 4 weeks.
measure: The change from baseline concentration of saliva immunoglobulin A (IgA) at 4 weeks.
timeFrame: 4 weeks.
measure: The change from baseline microbiota at 4 weeks.
timeFrame: 4 weeks.
Secondary outcomes:
measure: The change from baseline CFU of total oral microbiota at 4 weeks.
timeFrame: 4 weeks.
measure: The change from baseline CFU of probiotics at 4 weeks.
timeFrame: 4 weeks.
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: Glac Biotech Co., Ltd
Study officials:
affiliation: Glac Biotech Co., Ltd
name: Hsieh-Hsun Ho, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01296737: Validation of Quantitative Ventricular Function Imaging Single Photon Emission Tomography (Spect)Using the D-SPECT Cardiac Camera
Official title: Validation of Quantitative Ventricular Function Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quantitative Validation for Ventricular SPECT Imaging
Lead sponsor: Spectrum Dynamics
Sponsor class: INDUSTRY
First posted: 2011-02-15
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who have been reffered by their physicians to the nuclear medicinew department for the preformance of quantitative SPECT venricular function study and will voluntarily participate in the study

Brief summary: The purpose of this study is to validate the use of DSPECT camera for the performance of quantitative spect ventricular function imaging by comparison to a validated procedure performed on standard nuclear cameras.


Eligibility criteria: Inclusion Criteria:

* patients who have been referred by their physician to the nuclear medicine department for the quantitative SPECT ventricular function study
* voluntarily participate in the study

Exclusion Criteria:

* voluntarily to the study without being referred to the nuclear medicine department for the quantitative SPECT ventricular function study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Nuclear Medicine Department , Sacred Heart Department
state: Oregon
Study officials:
References:
Clinical trial NCT00018837: Brief Hospitalization for Schizophrenia: Strategies to Improve Treatment Outcome
Official title: Brief Hospitalization for Schizophrenia: Strategies to Improve Treatment Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizophrenic Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL

Brief summary: The goal of this research program is to implement a series of psychoeducational training classes designed to teach individuals with schizophrenia the importance of medication treatment, how to identify and manage medication side effects, and how to make appointments and emergency plans. The skills taught to the research subjects will lead to demonstrable increases (compared to the control group) in adherence to both the prescribed medication regimen and scheduled outpatient appointments and thereby cause a decrease (again compared to the control group) in rehospitalization rates and bed-days during subsequent twelve months following the intervention. A secondary objective of this work is that if the CREP program is successful and/or illness education is effective, the data will be able to disseminated throughout the VISN 22 via the recently awarded Mental Illness Research Education and Clinical Center (MIRECC) program.


Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years of age.
2. DSM IV diagnosis of schizophrenia or schizoaffective disorder.
3. Competent to give informed consent.
4. Previously participated in "Brief Hospitalization for Schizophrenia: Strategies to Improve Treatment Outcome" Principal Investigator. Donna Wirshing, M.D.

Exclusion Criteria:

1. Physical or cognitive impairment of such severity as to adversely affect the validity of clinical ratings or impair capacity to give informed consent.
2. History of substantial substance dependence 6 months prior to the study.
3. Patients at high risk of suicide or other directed violence.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
Study officials:
References:
Clinical trial NCT00992537: Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Type 1 Diabetics
Official title: A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to compare the blood glucose lowering effect of NN5401(insulin degludec/insulin aspart (IDegAsp)) with NN1250 (insulin degludec (IDeg)) and insulin aspart (IAsp) in subjects with type 1 diabetes where the trial participant will receive one single dose of each trial product in varying order.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day).
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the glucose infusion rate curve
timeFrame: From 0 to 6 hours after single-dose administration
measure: Area under the glucose infusion rate curve
timeFrame: From 4 to 24 hours after single-dose administration
Secondary outcomes:
measure: Area under the insulin degludec concentration-time curve
timeFrame: From 0 to 120 hours after single-dose administration
measure: Maximum observed insulin degludec concentration
timeFrame: From 0 to 120 hours after single-dose administration
measure: Area under the insulin aspart concentration-time curve
timeFrame: From 0 to 12 hours after single-dose administration
measure: Maximum observed insulin aspart concentration
timeFrame: 0-12 hours after single-dose administration
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02873637: Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement
Official title: Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement: A Controlled, Randomized Study (KTSS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Keywords: total knee replacement
anesthesia
catheter
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective of this study is to show that postoperative Total Knee Replacement (TKR), an analgesic perineural catheter in position under sartorial (KTSS) best preserves motor quadriceps femoral perineural catheter that (KTF) infused with even low doses of local anesthetics, this motor being evaluated by a semi quantitative simple clinical test locking of the knee feasible at the bedside.

Patients will be randomized in two arms:

* catheter in position under sartorial (experimental group)
* femoral catheter (control group)


Eligibility criteria: Inclusion Criteria:

* Major Patient (≥ 18 years)
* Before tricompartmental benefit from knee replacement (TKR) unilateral,
* TKR programmed on one of the first three days of the week (Monday to Wednesday)
* Physical status score I-III,
* Non septic programmed surgery under general anesthesia
* Able to understand the protocol
* Written informed consent
* Social Insured
* Opportunity to be followed under the Protocol

Exclusion Criteria:

* Age ≥ 85 years
* Obesity (BMI ≥ 35)
* Revision TKR,
* Patients not cooperating or not including the French,
* Difficulties in understanding and evaluating the score pain (VAS),
* Preoperative cognitive dysfunction making unreliable interrogation
* Patient unable to read and / or write (literacy, ...)
* Known bleeding disorders,
* Vascular surgery for femoral vessels on the operated side,
* Neuropathy of the lower limb,
* Localized infection at the puncture catheters,
* Known allergy to ropivacaine,
* Renal and / or severe hepatic impairment,
* Taking opioids for more than a month before surgery,
* Intolerance to morphine,
* Rheumatic inflammatory disease,
* Patients receiving immunosuppressive therapy or long-term corticosteroid
* Allergy or against-indications to standard treatments administered intraoperative and postoperative
* Flexion deformity\> 10 ° or valgus deformity with significant
* Refused to participate
* Patient trusteeship, guardianship, deprived of liberty
* Women premenopausal who become pregnant

Primary outcomes:
measure: International clinical score Daniels and Worthingham
timeFrame: 2 day after surgery (total knee replacement)
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: CHD Vendée de la Roche sur Yon
Study officials:
References:
Clinical trial NCT04181437: Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2
Official title: A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2019-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Detailed description: pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Eligibility criteria: Inclusion Criteria:

* healthy adult subjects who signed informed consent

Exclusion Criteria:

* Subjects has a history of allergy reaction of study drug ingredient
* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision

Primary outcomes:
measure: Pharmacokinetic interaction
timeFrame: 0hours - 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Dongdeok-ro
Study officials:
affiliation: Kyungpook National University Hospital
name: Yoon Y Ran, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04158037: Don't Go There: A Geospatial mHealth App for Gambling Disorder
Official title: Don't Go There: A Geospatial mHealth App for Gambling Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gambling Disorder
Keywords: mHealth App
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: National Center for Responsible Gaming
First posted: 2019-11-08
Enrollment: 40
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 goal of this project is to develop and to test the efficacy of a novel mHealth app for gambling disorder. The app capitalizes on smartphones' global positioning software (GPS) that recognizes a user's location to within 15 feet. Users will receive an alert of this go near a gambling venue. The project will conduct a 12-week pilot randomized clinical trial to test the short-term efficacy of the app with gambling disorder individuals.


Eligibility criteria: Inclusion Criteria:

* Currently meets DSM-5 criteria for gambling disorder
* At least 4 non-online gambling episodes in past 60 days
* Wagering at least $100 total over past 60 days
* Willingness to accept random assignment
* English speaking
* Android phone user

Exclusion Criteria:

* Age \<18 years old
* Severely disruptive behavior
* Serious uncontrolled psychiatric behavior that requires acute psychiatric care
* Decline permission to collect zero permission data from smartphone.

Primary outcomes:
measure: App usage (feasibility)
timeFrame: From baseline to post-treatment (12 weeks)
measure: Patient satisfaction with the gambling app
timeFrame: From baseline to post-treatment (12 weeks)
Secondary outcomes:
measure: Gambling behavior via Timeline Followback (Weinstock, Whelan, & Meyers, 2004)
timeFrame: From baseline to post-treatment (12 weeks)
measure: Gambling-related harms (Browne et al., 2018)
timeFrame: From baseline to post-treatment (12 weeks)
measure: Quality of Life Inventory (Frisch et al., 1994). A self-reported quality of life measure assessing 17 domains of life for importance and satisfaction.
timeFrame: From baseline to post-treatment (12 weeks)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: St. Louis University
name: Jeremiah Weinstock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06661837: Teledentistry Mobile Photos Versus Conventional Clinical Examination for Dental Caries Diagnosis
Official title: Reliability Of Teledentistry Mobile Photos Versus Conventional Clinical Examination for Dental Caries Diagnosis in A Group of School Children: A Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Keywords: Teledentistry
School Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 141
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: School children at a private school in Giza, Egypt.

Brief summary: Teledentistry is an intervention that can boost chances for the new primary healthcare paradigm, bringing service delivery and accessibility to new levels. Evidence-based studies have reported that Teledentistry improves access to dental care in rural, inaccessible areas to disadvantaged populations.

Detailed description: The advantage of choosing Teledentistry as a dental caries screening tool is its viability in increasing oral health care to underserved areas, increasing equity, and reducing oral disease burdens in children. Furthermore, photographic images and prints of children's carious teeth can be used to motivate parents/guardians to seek dental treatment and institute preventive care. Only a teledental assistant is needed for the imaging, eliminating the need for highly skilled professional human resources. Instead, dental professionals can be better utilized in dental hospitals/clinics.

Eligibility criteria: Inclusion Criteria:

1. Children between 6-12 years old (mixed dentition)
2. Medically free from systematic conditions

Exclusion Criteria:

1. Uncooperative children
2. Children with orthodontic appliances at time of treatment

Primary outcomes:
measure: Accuracy and Reliability of teledentistry regarding dental caries
timeFrame: Immediately and after 48 hours
measure: Dental caries
timeFrame: immediately and after 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
Study officials:
affiliation: Cairo University
name: Fatma KI Abdelgawad, PhD
role: PRINCIPAL_INVESTIGATOR
References: