louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06125431: Factors That Affect Trust Between Physicians and Patients
Official title: Factors That Affect Trust Between Physicians and Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trust
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized internal medicine patients, 18 years and older, with English or Spanish as primary language.

Brief summary: The goal of this study is to evaluate patient perception and preference in physician attire. Eligible subjects admitted to medical-surgical hospital unit will complete a survey expressing perceptions and preference regarding physician attire.

Detailed description: Hospitalists (internal medicine physicians) work in one week rotations. Each hospitalist will serve as a control.

During one week rotation, the hospitalist will wear surgical scrubs throughout the rotation. At the end of the rotation (or prior to subject discharge, whichever occurs first), the hospitalist will ask subjects seen during that rotation to complete the survey regarding the hospitalist attire.

During a second week of rotation, the hospitalist will wear professional attire with a white coat throughout that rotation. At the end of the rotation (or prior to subject discharge, whichever occurs first), the hospitalist will ask subjects seen during that rotation to complete the survey regarding the hospitalist attire.

Eligibility criteria: Inclusion Criteria:

* Subjects 18 years of ages or older
* Admitted to LLUMC medical surgical unit, under care of internal medicine physician
* Primary language is English or Spanish

Exclusion Criteria:

* Less than 18 years of age
* altered mental status or severe dementia
* Hearing or vision impairment that would preclude subject from completing survey

Primary outcomes:
measure: Patient Preference for Type of Physician Attire
timeFrame: At the end of hospitalist rotation or prior to subject discharge, whichever occurs first, not to exceed one week from study enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
References:
Clinical trial NCT00701831: Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control
Official title: Assessment of Forced Titration to Reach the Effective Dose for Good Glycemic Control in Lantus Treated Type 2 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective:

* To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients

Secondary objectives:

* To assess the forced titration on physician and patient satisfaction
* To evaluate the impact of training tools by means of patient profile


Eligibility criteria: Inclusion Criteria:

* T2 insulin naïve patients
* Patients whom their physician is considering initiation of Lantus treatment
* Poor glycemic control 7,5 %10 %
* T2 treatment with OADs more than 3 months
* BMI\<40 kg/m2

Exclusion Criteria:

* Impaired renal function (Cr\>2mg/dl or current renal dialysis)
* Acute or chronic metabolic acidosis
* Active liver disease or serum ALT or AST \>2,5 than normal
* History of hypoglycemia unawareness
* Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry
* Pregnancy, breast feeding

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: HbA1c, FBG
timeFrame: after treatment end (6 months)
measure: Final dose
timeFrame: after treatment end (6 months)
measure: Number of dose adjustment
timeFrame: after treatment end (6 months)
measure: Time to dose titration
timeFrame: after treatment end (6 months)
Secondary outcomes:
measure: Hypoglycemia
timeFrame: after treatment end (6 months)
measure: Noctural hypoglycemia
timeFrame: after treatment end (6 months)
measure: DTSQ
timeFrame: after treatment end (6 months)
measure: Physician Satisfaction Questionnaire
timeFrame: after treatment end (6 months)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Zeynep Cetin
role: STUDY_DIRECTOR
References:
Clinical trial NCT03538431: Improving Driving in Young People With Autism Spectrum Disorders
Official title: Improving Driving in Young People With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
ASD
Anxiety
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
First posted: 2018-05-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will examine the effects of treatment with the anti-anxiety medicine buspirone on driving performance (eye tracking) in individuals with high-functioning autism spectrum disorder (HF-ASD).

The study consists of an Assessment Visit at Massachusetts General Hospital (MGH), as well as two Driving Simulation visits that will take place at Massachusetts Institute of Technology (MIT). Subjects will be given buspirone and asked to take the medication for the two days preceding the Driving Simulation Visit.


Eligibility criteria: Inclusion Criteria:

* Males and females, ages 18-24, with a diagnosis of DSM-V Autism Spectrum Disorder
* Has a valid Driver's License

Exclusion Criteria:

* Major sensorimotor handicaps (e.g. deafness, blindness)
* Individuals who have never held a valid driver's license
* Intellectual Deficiency (Verbal Comprehension Index \< 80)
* Inadequate command of the English language
* Subjects with any clinically meaningful medical or psychiatric condition as determined by the investigator
* Individuals who are currently taking a monoamine oxidase inhibitor (MAOI) for any reason
* Pregnant

Primary outcomes:
measure: Driving Performance - Measured by Mean Off-Road Glance Duration
timeFrame: Up to 6 weeks
measure: Heart Rate
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00684931: Cerebellar Loops and Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Alterations of Fronto-Cerebello-Frontal Loops in Attention Deficit Hyperactivity Disorder (ADHD) : A Study Using Magnetic Resonance Imaging (MRI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention
Deficit
Disorder
Hyperactivity
cerebellum
alteration
fronto-cerebello-frontal loops
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2008-05-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the integrity of connectivity between the neocortex and the cerebellum in the Attention Deficit Hyperactivity Disorder (ADHD). Fibers integrity will be measured using magnetic Resonance Imaging Techniques.

Detailed description: ADHD is a neurodevelopmental trouble characterized by attentional deficits, impulsivity and motor hyperactivity. Morphological neuroimaging studies in ADHD children have revealed cerebellar abnormalities, however data in adults regarding cerebellum alterations are scarce. In this study we will analyse the conectivity of the cerebellum of adults ADHD patients. We will use diffusion tensor imaging (DTI) technique, and morphological data will be compared with the neuropsychological status.

Eligibility criteria: Inclusion Criteria:

Patient with ADHD :

* Diagnosis of ADHD
* 18 - 35 years old

Healthy volunteer :

* 18 - 35 years old
* no ADHD diagnosed

Exclusion Criteria:

* Associated neurological or psychiatric pathologies
* Pregnant woman
* MRI counter indication

Primary outcomes:
measure: Fractional anisotropy coefficient if fronto-cerebello-frontal loops.
timeFrame: visite 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Charles Perrens Hospital
city: Bordeaux
country: France
facility: University Hospital Bordeaux
Study officials:
affiliation: Charles Perrens Hospital
name: Manuel BOUVARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04825431: Mass Balance Study of [14C] TAS-205 in Healthy Volunteers
Official title: A Phase 1 Open-label Study Evaluating the Pharmacokinetics and Mass Balance of [14C] TAS-205 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 6
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of \[14C\]TAS-205 following oral single doses.


Eligibility criteria: Key Inclusion Criteria:

1. Healthy adult male who provided written informed consent to participate in the study
2. Aged 20 years or older and younger than 40 years at the time of informed consent
3. Capable of oral intake.
4. Body weight of 50 kg or more and body mass index of 18.5 or more and less than 25.0

Key Exclusion Criteria

1. Had current or previous hypersensitivity or allergy to drugs
2. Had current or previous drug abuse (including use of illicit drugs) or alcoholism
3. Had any concurrent disease (including symptoms and signs; however, diseases that do not affect valuations in the study such as asymptomatic pollinosis and wart are excluded)
4. Consumed foods or beverages containing the St. John's Wort within 28 days before study drug administration
5. Had blood pressure, pulse rate, and body temperature meeting any of the following at screening:

Systolic blood pressure: \<90 mmHg or ≥140 mmHg, Diastolic blood pressure: \<40 mmHg or ≥90 mmHg, Pulse rate: \<40 beats per minute (bpm) or ≥100 bp, Body temperature: 35.0°C or ≥37.1°C

Primary outcomes:
measure: Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205
timeFrame: Day 1 to Day 8
measure: Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate into urine and feces.
timeFrame: Day 1 to Day 8
measure: Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate in all excreta (urine and feces).
timeFrame: Day 1 to Day 8
measure: Plasma, urinary, and fecal metabolite profiles of TAS-205 , and structural estimation.
timeFrame: Day 1 to Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
Study officials:
affiliation: Taiho Pharmaceutical Co., Ltd.
name: Taiho Pharmaceutical Co., Ltd.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05721131: NC Thermometer (Gen 3) ISO 80601-2-56 Validation
Official title: NC Thermometer (Gen 3) ISO 80601-2-56 Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Febrile Illness
Healthy
Fever
Lead sponsor: Natural Cycles
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 105
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be asked to participate and enrolled during standard visits to the medical clinic or office location.

Brief summary: The purpose of this clinical validation is to evaluate the the clinical bias, the limits of agreement, and the clinical repeatability of measuring oral temperature using a new thermometer, NC° Thermometer (Gen 3), compared to a reference clinical thermometer.

Detailed description: The purpose of this clinical study is to validate the clinical accuracy of the NC° Thermometer (Gen 3) according to the requirements of ISO 80601-2-56:2017. The NC° Thermometer (Gen 3) (the device under study (DUT)) is a predictive thermometer that operates in adjusted mode. The Welch Allyn oral thermometer (Welch Allyn Spot Vital Signs 420 SureTemp temperature module, Welch Allyn, San Diego, CA) with a measurement accuracy of ± 0.1 °C in monitor mode will be used the reference clinical thermometer (RCT). During the clinical study, subjects will be asked to perform three consecutive oral measurements with the DUT, and one oral measurement with the RCT.

Eligibility criteria: Inclusion Criteria:

* They are more than 5 years old
* They have not taken any antipyretic in the preceding 120 minutes
* They have no medical conditions which might impact the clinical accuracy validation results, such as inflammation at the measuring site (the mouth)
* They are not taking medications such as barbiturates, thyroid preparations, antipsychotics, and recent immunizations

Primary outcomes:
measure: Clinical Bias
timeFrame: Up to 1 hour
measure: Limits of agreement
timeFrame: Up to 1 hour
measure: Clinical repeatability
timeFrame: Up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Choice Health Network- Reyes Health Center
state: California
city: New York
country: United States
facility: Natural Cycles
state: New York
Study officials:
References:
Clinical trial NCT05641727: Plyometric Training Versus Strengthening Exercise On Children With Hemiplegia
Official title: Plyometric Training Versus Strengthening Exercise On Muscle Strength, Selective Motor Control And Quality Of Life In Children With Hemiplegia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Children With Hemiplegic cp
Effect of Plyometic Exercises
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: children with hemiplegic cp aged from 8 - 10 years.

Brief summary: The aim of the study is to evaluate the effect of plyometric training versus strengthening exercise on quadriceps and hamstring muscles and quality of life and selective motor control of lower limb of children with hemiplegia.

Detailed description: The aim of the study is to evaluate the effect of plyometric training versus strengthening exercise on quadriceps and hamstring muscles and quality of life and selective motor control of lower limb of children with hemiplegia.

Hand-Held dynamometer is used to assess the muscle strength of quadriceps and hamstring Selective control assessment of lower extremity scale is used to assess selective motor control of lower limb.

Peds Ql scale is used to assess quality of life of the children. The methods of assessment are valid and reliable.

Eligibility criteria: Inclusion Criteria:

* Their age will be ranging from 8 to 10 years.
* They will be on level (1 : 1+) according to Modified Ashworth scale
* They will be on level I according to Gross Motor Functional Classification System
* They can understand and follow instructions.

Exclusion Criteria:

* Child undergoes orthopedic surgery past one year.
* Visual or auditory problems that interfere with rehabilitation programs.
* Botox injection past 6 months.
* Cardiac problems or uncontrolled seizures.

Primary outcomes:
measure: Muscle strength
timeFrame: three months
measure: Quality of life of children
timeFrame: three months
measure: Selective motor control of lower limb
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient Clinic of Faculty of Physical Therapy
state: Giza
Study officials:
affiliation: assisstant professor of pediatric physical therapy
name: Walaa Abdel-Nabie, phd
role: STUDY_CHAIR
affiliation: lecturer
name: Amira Ibrahim, phd
role: STUDY_CHAIR
References:
Clinical trial NCT05622227: 68Ga PET/CT Imaging in Breast Cancer Patients
Official title: 68Ga-P16-093 PET/CT Imaging in Primary and Recurrent Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including breast cancer. This makes it a potentially imaging target for the detection and grading of breast cancer. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG in the same group of breast cancer patients.

Detailed description: PSMA has been confirmed to be over expressed in vascular endothelial cells of various malignant solid tumors, such as breast cancer and renal cancer, which can provide growth advantages for various cancers by cutting the signal molecules involved in angiogenesis. Positron emission tomography (PET) imaging using radiolabeled molecules targeting PSMA can detect a variety of non prostate cancer solid tumors such as breast cancer and glioma. According to previous studies, PSMA can detect primary and metastasis lesions of breast cancer patients, and has a higher uptake value in triple negative breast cancer and HER2 overexpressed patients. The uptake may be related to tumor grade.

Eligibility criteria: Inclusion Criteria:

* breast cancer patients highly suggested by ultrasound or histologically confirmed;
* 68Ga-P16-093 PET/CT and 18F-FDG within two weeks;
* signed written consent.

Exclusion Criteria:

* known allergy against PSMA;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Primary outcomes:
measure: Diagnostic performance
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: standardized uptake value (SUV) of tumor
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhaohui Zhu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06685627: Core Temperature in Open Water Wetsuited Swimming.
Official title: Core Temperature in Open Water Wetsuited Swimming: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temperature
Keywords: Core temperature
water
swim
wetsuit
cold
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Norwegian Armed Forces Medical Service
name: SINTEF MiNaLab
First posted: 2024-11-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trained and highly trained swimmers were recruited from local swim clubs and via social media

Brief summary: Swimming in cold water is intrinsically unsafe. One of the threats is a fall in core body temperature (Tcore), which adversely affects all body systems and increases the risk of death. Wetsuits mitigate, but do not negate this threat. Environmental conditions may confound findings from laboratory studies or computer models, thus necessitating open water studies.

This study was designed to investigate the effects of open water wetsuited swimming on core body temperature at a range of different water temperatures between 8.4oC and 24.5oC.


Eligibility criteria: Inclusion Criteria:

* Trained and highly trained swimmers.

Exclusion Criteria:

* a history of cardiovascular disease, arrhythmias, or gastrointestinal abnormalities precluding the use of rectal temperature measurement.

Primary outcomes:
measure: Core temperature
timeFrame: The thermistor was inserted 15 minutes prior to immersion and measured the core temperature until 30 minutes after egress from the water.
Secondary outcomes:
Other outcomes:
Locations:
city: Olso
country: Norway
facility: Institute of Clinical Medicine, University of Oslo, Oslo, Norway
Study officials:
affiliation: Institute of Clinical Medicine, University of Oslo, Oslo, Norway
name: Jonny Hisdal, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00535327: Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography
Official title: A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 2. Women Undergoing Diagnostic Mammography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Mammography
mammogram
breast
Abnormal and normal breast tissue
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 220
Sex: FEMALE
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: Women referred for diagnostic mammogram

Brief summary: Comparison of the ability of DBT and FFDM to detect breast cancer.


Eligibility criteria: Inclusion Criteria:

* Women ≥18 years or older and has underwent screening mammography and is now referred for diagnostic mammography
* Able and willing to comply with study procedures, and have signed and dated the informed consent form
* Surgically sterile or postmenopausal

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Has signs or symptoms of breast cancer
* Has been previously included in this study
* Has breast implants
* Has a history of breast cancer and is in active treatment
* Has breasts too large to be adequately positioned for the DBT examination

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GE Healthcare
name: Amy Longcore
role: STUDY_DIRECTOR
References: