louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03242577: Micro-Technique Sampling
Official title: An Exploratory Comparative Pilot Study to Identify the Most Appropriate Method for Microbial Consortia Sampling From the Skin-II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatitis
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will consist of ten (10)Caucasian female adults 18-40 years of age, at 1 US site.

Brief summary: This is a single-center, exploratory comparative pilot study to identify the most appropriate method for microbial consortia sampling from the skin.

Ten subjects are expected to complete the study at one investigative site in the United States.

The study will consist of 2 visits, Visit 1 (Screening), Visit 2 (Sampling). At Visit 1, subjects will be consented and have their eligibility reviewed. Visit 1 and Visit 2 may be combined into one visit. Visit 1 will involve the informed consent process, screening, and enrollment. Visit 2 will involve sampling of eight (8) test sites on the back with three (3) different sampling methods: swabbing (2 sites/method), cup scrub (2 sites/method), and tape stripping (4 sites/method). All samples will be returned to Kimberly Clark then sent to a laboratory for analysis.


Eligibility criteria: Inclusion Criteria:

* Fluent in English, willing and able to read, understand, and sign the informed consent form (ICF);
* Ability to complete the course of the study and comply with instructions;
* Females aged 18 to 40 years, in good general health as deemed by the investigator (no physical required);
* Individuals free of any systemic or dermatological disorder, tatoos in the testing area or recent tanning bed exposure
* Anticipated ability to complete the course of the study and to comply with instructions;
* Females practicing an acceptable method of birth control
* Caucasian individuals with Fitzpatrick skin type I, II, or III

Primary outcomes:
measure: Best method for collecting skin microbiome samples
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Irving
country: United States
facility: Reliance Clinical Testing Services
state: Texas
Study officials:
affiliation: RCTs
name: Barry Reece
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02267577: Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Adult Volunteers
Official title: Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Eclampsia
Lead sponsor: William Marsh Rice University
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants enrolled in the study will have their blood pressure measured multiple times with both the GE Dinamap Procare commercial blood pressure monitor and Sphygmo, the experimental blood pressure monitoring device.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The research team has developed an automatic blood pressure monitor (Sphygmo) to be used for the monitoring and diagnosis of pre-eclampsia in pregnant women, particularly in low-resource settings where current monitoring is limited.

90 adult volunteers will be enrolled by researchers at Rice University. The participant will be seated in a comfortable chair with arm at heart level. Arm circumference will be measured and a blood pressure cuff will be placed on the arm. The cuff will be inflated and blood pressure measurements will be taken by a commercially available device and by the Sphygmo device. Blood pressure measurements from both devices will be recorded. The participant's blood pressure will be measured up to 9 times with a waiting period of 45-60 seconds between each measurement.

The results of this study will be used to optimize the blood pressure detection algorithm and thus further develop the device.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Willing and able to provide informed consent

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.
timeFrame: Blood pressure was measured an average of 9 times for each participant during their single visit and the mean of these measurements was recorded and used for analysis. The measurement period lasted approximately 30-45 minutes.
measure: Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer.
timeFrame: Blood pressure was measured an average of 9 times for each participant during their single visit and the mean of these measurements was recorded and used for analysis. The measurement period lasted approximately 30-45 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Rice University
state: Texas
Study officials:
affiliation: William Marsh Rice University
name: Rebecca R Kortum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03717077: Learned Resourcefulness Intervention
Official title: Effect of Learned Resourcefulness Intervention on Learned Resourcefulness, Caregiver Burden, Quality of Life for Older Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-Control
Caregiver Burden
Quality of Life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 94
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aimed to test the effects of a learned resourcefulness interveniton program on the learned resourcefulness, caregiver burden, quality of life for older family caregivers.

Detailed description: A quasi-experimental trail will be used to test the effects of a learned resourcefulness intervention program on the learned resourcefulness, caregiver burden, quality of life for older family caregivers. Through the use of convenience sampling strategy, one teaching medical hospital with approximately 104 older family caregivers in southern Taiwan will be recruited and simple randomly assigned based on teaching medical hospital to a Learned resourcefulness intervention program experimental group or a wait-list control group. Participants in the experimental group will receive the learned resourcefulness intervention program led by researcher, one time per week, 50 minutes for one week, 10 minutes for these weeks; participants in the wait-list control group will continue to receive their home care service. One pre-test and two post-tests, all participants will assessed for learned resourcefulness, caregiver burden, quality of life at baseline, and at 5 and 9 weeks of the study.

Eligibility criteria: Inclusion Criteria:

* aged 60 and above
* family caregivers of disabled adults who received home care service
* cognitively intact as assessed by SPMSQ score of 8 and above
* disabled adults will assessed by Barthel Index score of 60 and bellow
* able to answer questions

Exclusion Criteria:

* participants with severe mental disabilities

Primary outcomes:
measure: Self-control as the learned resourcefulness measured by Rosenbaum's self control schedule
timeFrame: 9 weeks
measure: Caregiver burden measured by caregiver burden scale
timeFrame: 9 weeks
measure: Quality of life measured by EuroQol five dimension scale (ED-5Q)
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chiayi city
country: Taiwan
facility: Meng-Chun Chen (MCC)
Study officials:
References:
Clinical trial NCT01690377: Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients
Official title: Plasmacytoid Dendritic Cells in Vaccination of Stage IV Melanoma Patients: a Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Keywords: Dendritic Cells
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As such they are currently used in clinical vaccination protocols in cancer patients, and both immunological and clinical responses have been observed. Several subsets of dendritic cells have been characterized in the peripheral blood. One such subset is referred to as plasmacytoid dendritic cells (PDC), another as myeloid dendritic cells (myDC). To date PDC and myDC have not been evaluated for their capability to induce anti-tumor immune responses in patients. For this reason the investigators will perform a safety and efficacy study with PDC and myDC in stage IV melanoma patients.


Eligibility criteria: Inclusion Criteria:

* Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH \< 2x upper limit of normal
* Histological proof of cutaneous melanoma
* Melanoma expressing tyrosinase and/or gp100 (approximately 20% of cells or more determined by immunohistochemistry staining)
* HLA Type A2
* WBC \> 3.0 \* 10E9/l, lymphocytes \> 0.8 \* 10E9/l, platelets \> 100 \* 10E9/l, serum creatinine \< 150 umol/l, serum bilirubin \< 25 umol/l, normal liver function
* Expected adequacy of follow up
* Written informed consent

Exclusion Criteria:

* autoimmune disorders, concomitant use of immunosuppressive drugs
* serious concomitant disease, serious active infections, other malignancy in the past 5 years with the exception of curatively treated carcinoma in-situ of the cervix/squamous cell carcinoma of the skin
* known allergy to shell fish (vaccine contains KLH)
* pregnancy or lactation
* clinical signs of CNS metastases, in patients with a clinical suspicion of CNS metastases, a CT scan of the brain should be performed to exclude this
* prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed

Primary outcomes:
measure: intervention-related toxicity
timeFrame: Within the first 6 months
Secondary outcomes:
measure: Immunological response
timeFrame: Within the first year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: C J A Punt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Nijmegen Medical Centre / Nijmegen Centre for Molecular Life Sciences
name: C G Figdor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02608177: Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management
Official title: Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Type 2 Diabetes
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
name: Medtronic
name: Abbott
First posted: 2015-11-18
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test whether a dipeptidyl peptidase-4 inhibitor, compared with a sulfonylurea, improves time in normal blood glucose range and reduces blood glucose variability. Blood glucose is measured using a continuous glucose monitoring device.

Detailed description: This is a proof-of-concept clinical trial testing the effects of linagliptin versus glipizide on glucose variability among people with type 2 diabetes and stage 3-4 CKD. In a cross-over design, each enrolled participant will receive 28 days of each study medication. Study medications will be provided in a randomly assigned order without blinding. The primary study outcome is glucose time in range, measured by blinded continuous glucose monitoring for the last 6 days of each 28-day treatment period. Secondary outcomes include indices of glycemic variability, hypoglycemia, and biomarkers of systemic inflammation, oxidative stress, and albuminuria. The overall goal of this research is to identify safe and effective treatments to control glycemia among patients with diabetes and CKD.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* eGFR 15-59 mL/min/1.73 m2
* Hemoglobin A1c \< 8%
* Age ≥ 18 years
* Current use of sulfonylurea

Exclusion Criteria:

* BMI \> 40 kg/m2
* Actively using CGM for clinical care
* End stage renal disease needing dialysis
* Kidney transplant
* Pregnant or nursing
* Unable to provide informed consent

Primary outcomes:
measure: Glucose Time in Range
timeFrame: last 6 days of each 28-day treatment period
Secondary outcomes:
measure: Glycemic Variability
timeFrame: last 6 days of each 28-day treatment period
measure: Hypoglycemia
timeFrame: last 6 days of each 28-day treatment period
measure: Biomarkers of Systemic Inflammation
timeFrame: last 6 days of each 28-day treatment period
measure: Biomarkers of Systemic Inflammation
timeFrame: last 6 days of each 28-day treatment period
measure: Biomarkers of Oxidative Stress
timeFrame: last 6 days of each 28-day treatment period
measure: Biomarkers of Oxidative Stress
timeFrame: last 6 days of each 28-day treatment period
measure: Biomarkers of Albuminuria
timeFrame: last 6 days of each 28-day treatment period
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ian de Boer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00503477: A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 in Solid Tumors in Japan
Official title: A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: Japan
Phase I
solid tumor
AZD2171
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase I open label dose escalation study to assess the safety and tolerability of AZD2171 following single and multiple oral doses in patients in Japan with advanced solid malignancies. In addition there will be an expanded cohort multi-centre study phase with NSCLC patient and CRC patients


Eligibility criteria: Inclusion Criteria:

* advanced solid tumors
* life expectancy is 12 weeks or longer

Exclusion Criteria:

* patient with uncontrolled brain metastases
* patient with inappropriate laboratory test values
* patient with poorly controlled hypertension

Primary outcomes:
measure: Safety and tolerability
timeFrame: Assessed at each visit for 4 weeks
Secondary outcomes:
measure: efficacy, PK
timeFrame: Assessed at each visit for 4 weeks
Other outcomes:
Locations:
city: Shizuoka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jane Robertson
role: STUDY_DIRECTOR
affiliation: National Cancer Centre Hospital, Tokyo
name: Tomohide Tamura, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00429377: Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
Official title: Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lupus Nephritis
Keywords: tacrolimus
FK506
lupus nephritis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-01-31
Enrollment: 64
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.


Eligibility criteria: Inclusion Criteria:

* Steroid refractory lupus nephritis

  * more than 10mg of steroid failed to control disease activity
  * patients who failed to reduce the amount of steroid
  * patients who couldn't increase the amount of steroid due to side effects

Exclusion Criteria:

* Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 12 weeks prior to test drug administration
* Patients who received cyclophosphamide puls within 24 weeks prior to test drug administration
* CNS( Central Nerve System) Lupus patients
* hepatic failure patients
* Serum creatinine ≧1.5mg/dL

Primary outcomes:
measure: Change of Lupus Nephritis - Disease Activity Index total score
Secondary outcomes:
measure: proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3)
Other outcomes:
Locations:
city: Chubu region
country: Japan
city: Hokkaido region
country: Japan
city: Hokuriku region
country: Japan
city: Kansai region
country: Japan
city: Kanto region
country: Japan
city: Shikoku region
country: Japan
city: Tohoku region
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT05592977: Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars
Official title: Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars Using Infra Zygomatic Mini Implants: A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Malocclusion
Keywords: Intermolar Width
Molar Inclination
Intra-oral Appliance
Infrazygomatic Mini-screws
Distalization
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 10
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is a scarcity in the current literature regarding such appliance and its effect on distalizing the first maxillary molar in absence of the second molar. Therefore, this study was made to evaluate the effect of bilateral distalization of upper first molars in a group of patients after extraction of maxillary second Molars using infra zygomatic mini implants.

Detailed description: The appliances available for distalization used to be mainly extraoral distalizing appliances which depended entirely on patient cooperation and compliance. Even after the emergence of intra-oral distalizing appliances they had adverse dentoalveolar effect such as anchorage loss and flaring of the upper anterior teeth. Thus, this study was made in order to evaluate the efficiency of our proposed appliance in the treatment of Class II patients while avoiding the adverse effects mentioned above.

Eligibility criteria: Inclusion Criteria:

* Female Patients with cervical vertebra maturation index (CVMI) 5 \& 6.
* From quarter unit to 3\\4-unit class II molar relationship.
* An overjet of an average 6mm.
* Full Set of permanent dentition except for the maxillary second molar.
* Favorable path of eruption for the maxillary third molar.

Exclusion Criteria:

* Medically compromised Patients.
* Patients under long term medications.
* Patients having sever periodontal disease.
* CVMI 3 or less
* Full unit class II cases

Primary outcomes:
measure: linear distalization of maxillary 1st molar.
timeFrame: Up until Class I Molar Relation (a maximum of 8 months regardless)
measure: Rate of maxillary 1st molar Distalization in mm/ month.
timeFrame: Up until Class I Molar Relation (a maximum of 8 months regardless)
Secondary outcomes:
measure: Changes in Intermolar width in mm.
timeFrame: Up until Class I Molar Relation (a maximum of 8 months regardless)
measure: Changes of Molar inclination in degrees.
timeFrame: Up until Class I Molar Relation (a maximum of 8 months regardless)
Other outcomes:
Locations:
city: New Cairo
country: Egypt
facility: Future University In Egypt
state: Cairo
Study officials:
affiliation: Future University in Egypt
name: Yehia Mostafa, Professr and Chairman
role: STUDY_DIRECTOR
References:
Clinical trial NCT01260077: Steady State Vestibular Evoked Myogenic Potentials
Official title: Steady State Vestibular Evoked Myogenic Potentials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Vestibular Evoked Potentials in Frequency Domain
Lead sponsor: Universidade Estadual de Ciências da Saúde de Alagoas
Sponsor class: OTHER
First posted: 2010-12-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Normal subjects.

Brief summary: Objective: At present, vestibular evoked myogenic potentials are analyzed only in the time domain. A technique to evaluate this potential in the frequency domain could provide more information, but has only been applied within the last year. Design and Study Sample: In this study we recorded vestibular evoked myogenic potential in the time domain, in 156 ears of 78 normal-hearing young adults, at frequencies of 250, 500, 1000 and 2000 Hz, with intensity of 90 dB nHL. Next, the steady state vestibular evoked myogenic potential was recorded at the same carrying frequencies, modulated at 20, 37, 40, 43, 70, 77 and 80 Hz. Results: The responses found by modulated frequency, regardless of carrier, recorded a higher presence of peaks and mean amplitudes between 20 and 70 Hz, especially at 40 Hz. Conclusions: The results show that the observation technique in the frequency domain is feasible and shows a strong association with the time domain for recording vestibular evoked myogenic potentials, at carrying frequencies of 250, 500, 1000 or 2000 Hz.


Eligibility criteria: Inclusion criteria: age between 18 and 35 years and auditory threshold less than or equal to 20 dBHL, between 0.5 and 8 kHz, with inter-ear frequency difference less than or equal to 10 dB.

Exclusion criteria were: exposure to occupational or leisure noise; otological surgery; more than three ear infections within the last year; use of ototoxic medication; buzzing in the ear, vertigo, dizziness or other cochlear-vestibular symptoms ; presence of systemic alterations that could contribute to cochlear-vestibular pathologies, such as diabetes, hypertension, dyslipidemias and/or hormonal alterations.

Primary outcomes:
measure: A technique to evaluate vestibular evoked myogenic potential in the frequency domain
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: de Oliveira AC, Pereira LD, Colafemina JF, de Lemos Menezes P. Amplitude modulated vestibular evoked myogenic responses: a study of carrier and modulating frequencies. Acta Otolaryngol. 2014 Aug;134(8):796-801. doi: 10.3109/00016489.2014.909605. Epub 2014 Jun 9.