louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04625439: Personality and Cancer Care Study
Official title: Personality and Cancer Care Study: Examining the Effects of a Personality Feedback Intervention in Adults With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial will test whether giving an individualized personality feedback report to adults with a history of cancer can improve their self-awareness, confidence in managing their illness, and mood.

Detailed description: This will be a randomized clinical trial examining whether a personality feedback intervention can improve three outcomes in an online sample of adults with cancer: 1) self-awareness, 2) self-efficacy for managing aspects of their illness, and 3) mood. The study will occur in a single 30-minute online session conducted in Qualtrics, with a pre-post randomized design. Participants will respond to a baseline survey including a measurement of the Five-Factor Personality Model and measures of the 3 outcomes of interest, followed by random assignment to either an intervention group or control group. Both groups will read a brief description of the Five-Factor Model of Personality. Those randomized to the intervention group will also receive an individualized feedback report containing their personality results on each of the five personality factors and recommendations for cancer self-management based on these results. After reading the personality information, participants will respond to the outcome measures again in a post-intervention survey. Control participants will receive their individualized personality feedback reports after the study is complete.

Eligibility criteria: Inclusion Criteria:

* consent to participate
* at least 18 years old (self-reported)
* have a current or past cancer diagnosis (self-reported)

Exclusion Criteria:

* under 18 years old (self-reported)
* indicate that they have no known history of cancer (self-reported)
* unable to read or understand English

Primary outcomes:
measure: Self-Awareness Outcomes Questionnaire - Change Score
timeFrame: pre-intervention and immediately post-intervention.
Secondary outcomes:
measure: PROMIS Self-Efficacy for Managing Chronic Conditions - Change Score
timeFrame: pre-intervention and immediately post-intervention.
measure: PANAS Positive Affect Subscale - Change Score
timeFrame: pre-intervention and immediately post-intervention.
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
Study officials:
affiliation: Tulane University
name: Laura M Perry, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05317039: Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation
Official title: Evaluation of Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation Comparing Between Two Different Grafting Materials (a Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Bone Loss
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Achieving prosthetically driven implant placement is a highly predictable treatment modality with reliable long-term results. Different surgical procedures have been used as a solution for reconstructing of the alveolar ridge with deficient volume. In the present study we demonstrate a modified alveolar ridge split technique for horizontal alveolar ridge augmentation (buccal plate repositioning technique) using the piezotome surgery. Evaluation of the effect of silica-calcium phosphate nanocomposite (SCPC) graft material versus demineralized freeze dried bone allograft (DFBA) in horizontal alveolar ridge augmentation before implant insertion will be performed.


Eligibility criteria: Inclusion Criteria:

* Patients with horizontal atrophy of the posterior mandible with pristine residual alveolar crest width from 2 to 4 mm.
* Augmented area length in the mesial-distal direction of less than 20 mm.
* Adequate physically healthy condition.

Exclusion Criteria:

* A systemic disease that would contraindicate oral surgical treatment.
* Treated patients who had undergone therapy involving radiation
* Patients who had received bone resection as part of an oncological treatment after a bone augmentation procedure.
* Patients are subjected to intravenous and/or oral bisphosphonate therapy after the bone augmentation procedure.

Primary outcomes:
measure: change in alveolar ridge width
timeFrame: at baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT02351739: Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer
Official title: Randomized Phase 2 Trial of ACP-196 and Pembrolizumab Immunotherapy Dual CHECKpoint Inhibition In Platinum Resistant Metastatic Urothelial Carcinoma (RAPID CHECK Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Urothelial Carcinoma
Lead sponsor: Acerta Pharma BV
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-01-30
Enrollment: 78
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: Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Metastatic Urothelial Cancer


Eligibility criteria: Inclusion Criteria:

* Men and women ≥ 18 years of age
* Histologically or cytologically confirmed urothelial carcinoma of the bladder or mixed histology bladder cancer
* Metastatic bladder cancer with disease progression on or after platinum-based chemotherapy
* Any primary site of urothelial carcinoma including upper tract, renal pelvis, bladder, and ureters
* Prior therapy with ≥ 1 systemic chemotherapy regimens for urothelial carcinoma
* Presence of radiographically measurable disease (defined as the presence of ≥ 1 lesion that measures ≥ 10 mm \[≥ 15 mm for lymph nodes\]
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Prior malignancy (other than bladder cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years of which will not limit survival to \< 2 years.
* Known central nervous system metastases and/or carcinomatous meningitis
* Malabsorption syndrome, disease significantly affecting gastrointestinal function
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening

Primary outcomes:
measure: Number of Participants With Overall Response
timeFrame: Every 12 weeks for up to 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Durham
country: United States
state: North Carolina
city: Columbus
country: United States
facility: James Cancer Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
Study officials:
affiliation: 1-888-292-9613; acertamc@dlss.com
name: Acerta Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02415439: A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
Official title: A Phase 1 Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
tolerability
pharmacokinetics
adult
volunteers
Lead sponsor: ReveraGen BioPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-14
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the safety, tolerability, and PK of various increasing single and multiple doses of VBP15 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
* For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

* For the MAD Study: Women of childbearing potential.
* Clinically significant abnormal laboratory parameters

Primary outcomes:
measure: Number of Subjects With Adverse Effects After a Single Dose of VBP15
timeFrame: Participants will be followed for the duration of hospital stay of 4 days
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose)
timeFrame: Participants will be followed for the duration of hospital stay of 4 days
measure: Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15
timeFrame: Participants will be followed for the duration of hospital stay of 4 days
measure: Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15
timeFrame: Participants will be followed for the duration of hospital stay of 15 days
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose)
timeFrame: Participants will be followed for the duration of hospital stay of 15 days
measure: Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15
timeFrame: Participants will be followed for the duration of hospital stay of 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences
state: Kansas
Study officials:
References:
Clinical trial NCT03031639: Khon Kaen University's Thyroidectomy Registry
Official title: Khon Kaen University's Thyroidectomy Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Nodule
Thyroid Neoplasms
Thyroid Cancer
Keywords: endoscopic
thyroidectomy
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who underwent thyroidectomy at Khon Kaen University

Brief summary: The endoscopic thyroidectomy approach is gaining popularity in the surgical field. This registry tries to collect the outcomes including quality of life and complication for both endoscopic and conventional thyroidectomy methods.


Eligibility criteria: Inclusion Criteria:

* The patients who underwent thyroidectomy at Khon Kaen University

Exclusion Criteria:

* None

Primary outcomes:
measure: Change from Baseline of QOL Score at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change of the symptoms score
timeFrame: At 2, 6, 12, and 24 weeks after surgery
measure: Complication rate
timeFrame: At 2, 6, 12, and 24 weeks after surgery
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Department of Otolaryngology, Khonkaen University
state: Khonkaen
Study officials:
affiliation: Khon Kaen University
name: Patorn Piromchai, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piromchai P, Vatanasapt P, Reechaipichitkul W, Phuttharak W, Thanaviratananich S. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study. BMC Ear Nose Throat Disord. 2008 Mar 20;8:1. doi: 10.1186/1472-6815-8-1.
citation: Piromchai P, Wijakkanalan P, Teeramatwanich W, Kasemsiri P, Laohasiriwong S, Ratanaanekchai T. Postauricular-submental approach endoscopic thyroidectomy. Clin Otolaryngol. 2018 Apr;43(2):767-769. doi: 10.1111/coa.12791. Epub 2016 Nov 27. No abstract available.
Clinical trial NCT03208439: Neuromuscular Electrical Stimulation Cycling
Official title: Interactive Cycling System Using Electromyography (EMG)-Driven Neuromuscular Electrical Stimulation (NMES) for Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 20
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: A new electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-cycling system is introduced to stroke survivors for lower-limb rehabilitation. The system will generate NMES to targeted muscle according to the user's voluntary intention, represented by the EMG signal during cycling.


Eligibility criteria: Inclusion Criteria:

1. diagnosis of ischemic brain injury or intracerebral hemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
2. sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;
3. significant gait deficit (Functional Ambulatory Category, FAC, scale \<4 \[person cannot walk independently\]).

Exclusion Criteria:

1. any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopedic or chronic pain condition, major post-stroke depression;
2. severe hip, knee or ankle contracture that would preclude passive range of motion of the leg;
3. implanted cardiac device (e.g. pacemaker and internal defibrillator).

Primary outcomes:
measure: Lower-Extremities Fugl-Meyer Assessment
timeFrame: 3-month follow up
Secondary outcomes:
measure: Elderly Mobility Scale
timeFrame: 3-month follow up
measure: Berg Balance Scale
timeFrame: 3-month follow up
measure: 6-Minute Walking Test
timeFrame: 3-month follow up
measure: 10-Meter Walk Test
timeFrame: 3-month follow up
measure: electroencephalography
timeFrame: 3-month follow up
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Biomedical Engineering, CUHK
name: Raymond Kai-yu Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu C, Wang T, Leung KWC, Li L, Tong RK. Muscle Electrical Impedance Properties and Activation Alteration After Functional Electrical Stimulation-Assisted Cycling Training for Chronic Stroke Survivors: A Longitudinal Pilot Study. Front Neurol. 2021 Dec 15;12:746263. doi: 10.3389/fneur.2021.746263. eCollection 2021.
Clinical trial NCT05331339: Real-life Efficacy of Insulia® Tool in Patients Living with Type 2 Diabetes Treated with Basal Insulin Therapy As Part of a National Telemedicine Program (ETAPES)
Official title: Effectiveness in Real Life of the Insulia® Digital Tool in Patients with Type 2 Diabetes Treated with Basal Insulin Therapy As Part of a National Telemedicine Program (ETAPES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Single-center diabetes department of a French public hospital.

Brief summary: The purpose of this study was to evaluate the INSULIA digital tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a French national telemedicine experimentation program (ETAPES) in a single-center study.

The assumption is that a better metabolic control with this tool.

Detailed description: Basal insulin titration in people with type 2 diabetes is of major importance to obtain the optimal dose to regulate fasting blood glucose without hypoglycemia.

Significant inertia in treatment optimization has been observed among both general practitioners and diabetologists.

The INSULIA tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a French national telemedicine experimentation program (ETAPES) has been supported by the health authorities.

The data collected are of a single-center cohort of adult patients with type 2 diabetes who used this tool between 2018 and 2021.

It is supposed that a better metabolic control with this tool and aimed to understand factors associated with better results.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old.
* Patients with type 2 diabetes.
* Initiation or adjustment of basal insulin.
* Prescription of Insulia® for more than 6 months (between august 2018 and june 2021)
* Informed patient not opposed to the research

Exclusion Criteria:

Patient opposed to the research

Primary outcomes:
measure: HbA1c
timeFrame: at 6 months
Secondary outcomes:
measure: Insulin
timeFrame: at 6 months
measure: HbA1c objective
timeFrame: at 6 months
measure: Mean fasting glucose
timeFrame: at 6 months
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
References:
Clinical trial NCT00494039: I-125 Versus Pd-103 for Low Risk Prostate Cancer
Official title: I-125 Versus Pd-103 for Low Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate
cancer
radiation
brachytherapy
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
Collaborators: name: Schiffler Cancer Center
First posted: 2007-06-29
Enrollment: 602
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy).

Detailed description: Objective: To test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy).

Methodology: Patients will be randomized by the method of random permuted blocks.

Cancer status will be monitored by serial serum PSA at 6, 12, 18 and 24 months and yearly thereafter. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months. Patients with serum PSA above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy.

Eligibility criteria: Inclusion Criteria:

* Males age 40-80
* PSA 4-10
* Gleason score 5-6

Exclusion Criteria:

* Lymph node positive

Primary outcomes:
measure: Cancer control (biochemical and survival)
timeFrame: final analysis 2008(?)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Puget Sound VA
state: Washington
Study officials:
affiliation: Puget Sound Health Care system
name: Kent E Wallner, MD
role: STUDY_CHAIR
References:
citation: Wallner K, Merrick G, True L, Sutlief S, Cavanagh W, Butler W. 125I versus 103Pd for low-risk prostate cancer: preliminary PSA outcomes from a prospective randomized multicenter trial. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1297-303. doi: 10.1016/s0360-3016(03)01448-2.
citation: Wallner K, Merrick G, True L, Cavanagh W, Simpson C, Butler W. I-125 versus Pd-103 for low-risk prostate cancer: morbidity outcomes from a prospective randomized multicenter trial. Cancer J. 2002 Jan-Feb;8(1):67-73. doi: 10.1097/00130404-200201000-00012.
Clinical trial NCT02947139: Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers
Official title: A Randomized, Open Label, Crossover Study to Explore Drug-drug Interaction Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-10-27
Enrollment: 53
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

* Accepts healthy volunteers

Exclusion Criteria:

* Who has allergy to investigational product

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 0~24 hours
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 0~24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gyunggi
country: Korea, Republic of
facility: Bundang CHA Medical Center
Study officials:
References: