louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01049269: Validation and Evaluation of a Portable Body Scanner for Determination of Obesity
Official title: Validation and Evaluation of a Portable Body Scanner for Determination of Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Body Scanning
Body Fat
Body Volume
Obesity
No Conditions
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-01-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject will be 18-60 years old, BMI 18.50 to 39.99 kg/m3, and free of known diseases, who are Hispanic and Not Hispanic or Latino Whites.

Brief summary: The objective of this study is to validate a portable 3D human body measurement system which will improve approaches in obesity assessment.

Detailed description: Obesity has become an epidemic in the United States. A new technique of three-dimensional (3 D) photonic scanning will be used to create and validate a portable instrument that rapidly assesses obesity in clinical and field settings. This new portable body scanner will be a safe and easy method to help determine the incidence and type of obesity.

Eligibility criteria: Inclusion Criteria:

* 18-60 years old
* BMI between 18.50 to 39.99 kg/m3
* Free of known diseases
* Hispanic and Not Hispanic or Latino Whites

Exclusion Criteria:

* Women who are pregnant, could be pregnant, or lactating

Primary outcomes:
measure: Body volume
timeFrame: 3 hours
Secondary outcomes:
measure: Validating body imaging as an indicator of central obesity
timeFrame: 3 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: The Uniersity of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Jeanne H. Freeland-Graves, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05193669: Clinical Validation of Molecular Triage in HR-HPV Positive Women
Official title: VALidation of Tests Usable as a First Step TRIage to Manage Women Positive to High-risk Papillomavirus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Carcinoma
Keywords: molecular HPV test
Pap-test
Triage
Lead sponsor: Hiantis Srl
Sponsor class: INDUSTRY
Collaborators: name: European Commission
name: Sciensano
name: University of Milano Bicocca
First posted: 2022-01-18
Enrollment: 23941
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women accessing the HPV-based screening programme 'Prevenzione Serena', for primary screening, supported by a comprehensive follow-up registry.

Brief summary: Women accessing the HPV-based screening programme for primary screening, will undergo cervical sampling and clinical data recording. Samples from high-risk HPV positive women (around 2000 expected) will be aliquoted for testing with new HPV molecular test, that will allow full genotyping and viral load quantification.


Eligibility criteria: Inclusion Criteria:

* women participating in a cervical cancer screening program using an HPV assay as primary screening test
* positivity to hrHPV;
* written informed consent given.

Exclusion Criteria:

* total hysterectomy;
* diagnosis of CIN2+ in the last two years;
* hrHPV negative or inadequate.

Primary outcomes:
measure: Sensitivity of the index triage test: Pap-test
timeFrame: Baseline
measure: Sensitivity of the index and comparator triage test: HPV molecular test
timeFrame: Baseline
measure: Specificity of the index and comparator triage test
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino S.S.D. Epidemiologia, Screening- CPO
Study officials:
affiliation: AOU Città della Salute e della Scienza di Torino, Itay
name: Paola Armaroli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sciensano - Brussels, Belgium
name: Marc Arbyn, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01866969: Quality of Life in Caregivers of Hospitalized Older Patients With Cancer
Official title: Physical, Emotional and Social Stressors and Their Impact on Quality of Life of Caregivers of Hospitalized Older Adults With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic/Lymphoid Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-06-03
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial studies quality of life in caregivers of hospitalized older patients with cancer.

Detailed description: PRIMARY OBJECTIVES:

I. Identify patient and caregiver factors associated with increased caregiver burden and decreased quality of life in caregivers of older adults with cancer.

SECONDARY OBJECTIVES:

I. Determine characteristics of informal caregivers of older adults with cancer admitted to hospital.

II. Determine type and amount of care informal caregivers provide for older adults with cancer admitted to hospital.

III. Determine quality of life in informal caregivers of older adults with cancer admitted to hospital.

IV. Identify caregiver needs, both informational and resource related. V. Explore the association between re-admission to the hospital within 30 days and caregiver burden.

VI. Explore whether feedback of information attained from the assessment of the caregiver influences services implemented by the health care team.

VII. Determine reasons for non-participation.

OUTLINE:

Caregivers complete a questionnaire about their sociodemographics, physical health, social supports, social activity, mental health and caregiver burden. They will also provide an assessment of the person they care for.

Eligibility criteria: Inclusion Criteria:

* PATIENT: Age \>= 65 years old
* PATIENT: Diagnosis of cancer (solid or hematologic malignancy)
* PATIENT: Be able to provide informed consent
* PATIENT: Unplanned admission to hospital
* CAREGIVER: Primary caregiver (person who provides all of the majority of the unpaid care for the care recipient)
* CAREGIVER: Be able to provide informed consent

Exclusion Criteria:

* PATIENT: Planned admission to hospital for treatment (chemotherapy, transplant)
* CAREGIVER: Not fluent in English (because not all questionnaires have been validated in other languages)
* CAREGIVER: Paid and trained to care for the patient

Primary outcomes:
measure: Caregiver burden and caregiver quality of life as measured by the Caregiver Quality of Life-Cancer Index
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Arti Hurria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02227069: Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers
Official title: A Phase 1, 21-Day, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Irritation Potential of M518101 in Healthy Volunteers, Using a Cumulative Irritant Patch Test Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Maruho North America Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a single center, randomized, controlled, within-subject comparison, multiple dose study to determine the irritation potential of M518101 on normal skin under occlusive patch condition.

The study drug will be applied for 21 days under occlusive patch condition. The irritation potential of M518101 will be compared with positive, negative control and M518101 vehicle. The study duration is 21days and there will be at least 23 visits to study center including screening visit.


Eligibility criteria: Inclusion Criteria:

* Health male or female subjects age 18 years or older
* Signed and dated Informed Consent Form obtained prior to any study-related activities
* Subjects are free of any systemic or dermatologic disorder
* For Female, females of non-childbearing potential or who agree to use a highly effective method of birth control during the study and have a negative urine pregnancy test.
* Subjects must be able to communicate with the investigator and understand and comply with the requirements of the study and visit schedule

Exclusion Criteria:

* Have any visible skin disease at the application site which will interfere with the evaluation of the test site reaction
* Have damaged skin in or around the test sites
* Have a history of sensitivity to adhesive tape
* Have a known sensitivity to constituents present in the material being evaluated
* Have a history of, or are currently being treated for skin cancer
* have used any study drug and/or participate in any clinical study within 60 days prior to Randomization
* to engage in any type of strenuous exercise (swimming, running, etc.) or who intended to use hot tubs or saunas during the study
* Are pregnant, breastfeeding, or of childbearing potential and who wish to become pregnant during the study
* Are deemed to be ineligible by the investigator

Primary outcomes:
measure: Inflammatory skin responses
timeFrame: 21 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL research
state: New Jersey
Study officials:
References:
Clinical trial NCT00698269: An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment
Official title: Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 5926
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A non-randomized sample of Type 1 or Type 2 diabetics

Brief summary: This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.


Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes
* Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
* Selection will be at the discretion of the individual physician

Exclusion Criteria:

* Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
* Previous enrolled in this study
* Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Primary outcomes:
measure: Incidence of major hypoglycaemic events reported
timeFrame: during 24 weeks of treatment
measure: Change in HbA1c
timeFrame: during 24 weeks of treatment
Secondary outcomes:
measure: Percentage of subjects achieving HbA1c below 7.0%
timeFrame: at 12 & 24 weeks
measure: Change in FPG
timeFrame: at 12 & 24 weeks
measure: Change in PPG
timeFrame: at 12 & 24 weeks
measure: Body weight
timeFrame: at 12 & 24 weeks
measure: Change in number of hypoglycaemic events in the last 4 weeks before routine visits
timeFrame: at 12 & 24 weeks
measure: Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits
timeFrame: at 12 & 24 weeks
measure: Number of adverse drug reactions (ADR)
timeFrame: at 12 & 24 weeks
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02864069: Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI
Official title: Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2016-08-11
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Vast evidence supports use of physical exercise and cognitive stimulation for lowering risk for cognitive decline and dementia, with combinations of non-pharmacological interventions providing greatest promise for impacting cognitive aging. This, paired with limited cognitive benefits from pharmacological interventions in dementia, has shifted focus to non-pharmacological interventions administered earlier in the disease course. This application, therefore, proposes a randomized controlled trial (RCT; 12-week active intervention, 3- and 6-month follow-up) comparing 3 conditions: walking program (guided progressive increases in weekly step counts), computer-based cognitive training program (Brain HQ, Posit Science), and combination of the exercise and cognitive program, on cognitive, functional, and diagnostic outcomes in 60 sedentary, community-dwelling adults with mild cognitive impairment (MCI).


Eligibility criteria: Inclusion Criteria:

* MCI diagnosis (can be self referral, will determine eligibility at baseline)

Exclusion Criteria:

* Dementia diagnosis
* Head trauma
* Neuro/psychiatric disorders
* Current substance dependence
* Sensory/mobility deficits
* No more than 1 hour of purposeful, aerobic activity/week
* Currently engaging in any other brain-stimulating computer program (No more than 1 hour a week)

Primary outcomes:
measure: Rivermead Behavioral Memory Test
timeFrame: 12 weeks
measure: Everyday Cognition Scale
timeFrame: 12 weeks
measure: Older Peoples Quality of Life Questionnaire
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD
state: California
Study officials:
affiliation: University of California, San Diego
name: Amy Jak, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02418169: Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations
Official title: Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injuries
Skull Fractures
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2015-04-16
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe traumatic brain injury, patients with craniofacial fractures

Brief summary: This study evaluates the association between traumatic brain injuries and craniofacial or/and skull fractures. Purpose is to find out the amount of missed diagnoses and improve primary diagnostics of trauma patients.

Detailed description: A part of mild TBIs remains undiagnosed. Therefore the primary diagnostics of trauma patients needs to be improved. According to some studies, a part of trauma patients' concomitant injuries weren't diagnosed in the emergency room (ER) but were diagnosed later in the clinics. In addition to difficult diagnostics the treatment of these patients demands close co- operation between many specialities.

The aim of this study is to evaluate the association between TBIs and facial fractures. The real amount of facial fractures in patients with severe TBI and the clinical significance of these fractures are evaluated. Also the number of patients with facial fractures and a concomitant TBI is evaluated. The aim is to find out the amount of patients with missed diagnoses. Other aims of are to determine the effect of the type or location of a facial fracture on the in- cidence and severity of TBI. With the help of the results it would be possible to improve the comprehensive diagnostics and early treatment of patients with a facial fracture or a TBI.

The retrospective and prospective data on patients with TBI and/or facial fracture are collect- ed at Turku University Hospital. The comparison of the two groups will give information on the amount of patients with missed diagnosis of TBI or facial fracture. The results can be utilised in planning strategy for comprehensive diagnostics and treatment of the patients. In the research group the investigators have specialists in the fields of oral and maxillofacial surgery, neurol- ogy and otorhinolaryngology.

Eligibility criteria: Inclusion Criteria:

* Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture

Exclusion Criteria:

* Died before admitted to hospital

Primary outcomes:
measure: survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03116269: The Effect of Cilostazol Compared to Aspirin on Endothelial Function in Acute Cerebral Ischemia Patients
Official title: The Effect of Cilostazol Compared to Aspirin on Endothelial Function Measured by Flow Mediated Dilatation in Acute Cerebral Ischemia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Endothelial Dysfunction
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients presenting with acute cerebral ischemic events are randomly assigned into aspirin (n=40) or cilostazol (n=40) group in a double-blinded manner. FMD is measured as a primary outcome at baseline (T0) and 90 days (T1). Serious and non-serious adverse events were described.

Detailed description: This investigator-initiated, randomized, double-blind trial is prospectively conducted with two-arm parallel treatment groups and a single dose scheme: 100 mg aspirin daily and cilostazol placebo twice daily versus aspirin placebo daily and 100 mg cilostazol twice daily.

A total of 80 eligible patients is planned to be recruited.

All included patients undergo diagnostic studies including routine blood tests and cardiologic work-ups. The primary outcome is differences in endothelial function in the two groups measured by means of FMD on admission and at 3 months. According to previous studies, the adverse effects in two groups are investigated.

Eligibility criteria: Inclusion Criteria:

1. acute ischemic stroke confirmed by diffusion weighted imaging
2. transient ischemic attack (TIA) within 7 days

Exclusion Criteria:

1. there is intracranial hemorrhage on imaging study
2. patients is previously taking antiplatelets, vitamin K antagonists, factor Xa antagonists, or chronic treatment with systemic steroidal and non-steroidal anti-inflammatory drugs
3. patients who received fibrinolytics within the previous 48 hours
4. cognitive impairment interfering with the possibility of obtaining informed consent
5. pregnancy
6. participation in another pharmacological study
7. peptic ulcer disease or hematological abnormality
8. initial modified Barthel index \<30 points
9. liver function tests exceeding a 2-fold upper range value.

Primary outcomes:
measure: flow mediated dilation
timeFrame: 3 month change
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
state: Gyunggido
Study officials:
affiliation: 82 31 219 5174
name: Ji Man Hong
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee SJ, Lee JS, Choi MH, Lee SE, Shin DH, Hong JM. Cilostazol improves endothelial function in acute cerebral ischemia patients: a double-blind placebo controlled trial with flow-mediated dilation technique. BMC Neurol. 2017 Aug 29;17(1):169. doi: 10.1186/s12883-017-0950-y.
Clinical trial NCT03733769: A Novel Approach for Transmuscular Quadratus Lumborum Block
Official title: A Novel Approach for Transmuscular Quadratus Lumborum Block for Peri-operative Analgesia in Hip Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transmuscular Quadratus Lumborum Block Hip Surgery
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: a novel approach for TQL (anterior Q.L) block aiming mainly for terminal branches of lumbar plexus. The technique is described as Para-Spinous Saggital Shift Q.L block, done at L4 transverse process level in saggital orientation.

Detailed description: With this approach, we think it has advantages of easy identification, better caudal LA spread till under fascia iliaca, with the psoas major muscle provides a better protective barrier against accidental needle entry into the peritoneal cavity, the endpoint is injection within a fascial plane, rather than a specific motor response contact where the lumbar plexus stimulation is not sought, so there is minimal risk of nerve injury, inadvertent dural cuff puncture and intrathecal spread of local anesthetic. And finally optimal insertion of catheter in long axis of Q.L and psoas major if continuous analgesia is planned.

Eligibility criteria: Inclusion Criteria:

* Orthopaedic patients, American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral hip surgery.

Exclusion Criteria:

* History of neurological/neuromuscular, psychiatric disease, dementia preventing proper comprehension.
* Patients with Body Mass Index (BMI) \<18.5 or \>30 kg/m2.
* Coagulation disturbances (INR\>1.4, platelet count\<100 000).
* History of opioid dependence (opioid use within the last 4 weeks).
* History of allergies to study medications.

Primary outcomes:
measure: peri-operative analgesia in hip Surgery
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Medicine
Study officials:
affiliation: Alexandria faculty of medicine
name: Emad A Abdelmonem
role: STUDY_CHAIR
References:
citation: Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.
citation: Adhikary SD, El-Boghdadly K, Nasralah Z, Sarwani N, Nixon AM, Chin KJ. A radiologic and anatomic assessment of injectate spread following transmuscular quadratus lumborum block in cadavers. Anaesthesia. 2017 Jan;72(1):73-79. doi: 10.1111/anae.13647. Epub 2016 Oct 12.
citation: Carline L, McLeod GA, Lamb C. A cadaver study comparing spread of dye and nerve involvement after three different quadratus lumborum blocks. Br J Anaesth. 2016 Sep;117(3):387-94. doi: 10.1093/bja/aew224.