louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04544475: A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause
Official title: A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genitourinary Syndrome of Menopause (GSM)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: JDS Therapeutics, LLC
First posted: 2020-09-10
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-hormonal alternatives for the treatment of genitourinary syndrome of menopause (GSM) are needed. In this proposed trial, patients who are diagnosed with GSM will be randomized to receive either a hyaluronic acid (HLA) vaginal insert or vaginal estrogen topical cream for 12 weeks. There will be a baseline visit and an 12 week follow up visit, at which points the patient will undergo a detailed history and physical examination including a pelvic exam, vaginal pH sampling, vaginal cell sample for microscopic analysis, and will fill out a vulvovaginal symptom questionnaire (VSQ). These study arms will be analyzed to assess the efficacy of HLA as compared to the gold standard of vaginal estrogen to treat GSM symptoms.


Eligibility criteria: Inclusion Criteria:

1. Postmenopausal status as defined by amenorrhea for \>12 months or history of bilateral salpingo-oophrectomy or if the patient has had a hysterectomy and menopausal symptoms for \>1 year or FSH \> 40
2. Symptoms of GSM
3. Negative Pap smear as per ASCCP guidelines
4. Capable of giving informed consent
5. Ambulatory
6. Capable and willing to follow all study-relation procedures

Exclusion Criteria:

1. Use of any HRT (systemic or local) or raloxifene within six weeks of proposed start date
2. History of estrogen-sensitive tumor
3. Undiagnosed vaginal bleeding in the past 12 months
4. History of thromboembolic event
5. Currently have or have had liver problem
6. Bleeding disorder
7. Impaired mental status
8. Prior pelvic irradiation
9. Active vaginal infection
10. Any medical reason the investigator deems incompatible with treatment with vaginal estrogen

Primary outcomes:
measure: Change in VSQ Score
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change in VMI
timeFrame: Baseline, Week 12
measure: Change in Vaginal pH
timeFrame: Baseline, Week 12
measure: Change in VAS Score - Dyspareunia
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lila Nachtigall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05251675: Effect of Physician Peer Coaching on Burnout in Hospital-Based Physicians: A Pilot Randomized Clinical Trial
Official title: Effect of Physician Peer Coaching on Burnout in Hospital-Based Physicians: A Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Burn Out
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The prevalence of burnout symptoms among physicians is high, especially for acute care physicians. Physician burn out is a long-term stress reaction marked by emotional exhaustion, depersonalization, and a lack of sense of personal accomplishment. The healthcare environment, due to its demanding pace and emotional intensity, puts physicians at high risk for burnout.

Detailed description: Physician-Led Professional Coaching is a one-on-one intervention between a physician coach and an individual physician that is systematic, collaborative, future-focused, goal-oriented and is meant to help coaches attain valued professional or personal development. The trial will be conducted with 25 participants in an intervention cohort and 25 participants in a control. The intervention cohort will receive 6 individual coaching sessions over 6 months. Coaching sessions will use the CHEER acronym for conducting the coaching sessions: Celebrate, Hear, Executive coaching, Engage, and Recharge. The control group will be eligible for coaching sessions after the completing of the interventional arm. Physicians randomized to the control arm will be offered the same individualized coaching sessions as those that were in the intervention group. Te Maslach Burnout Inventory survey will be used to measure burnout and will be collected at baseline, 3 months, 6 months, and 9 months. The physician coach will be blinded to all survey data as it is being collected.

Eligibility criteria: Inclusion Criteria:

* Geisinger Physician
* Practicing medicine at least 6 months in the Geisinger system

Exclusion Criteria:

* Currently seeking professional coaching sessions
* Planning to leave the Geisinger system within 1 year

Primary outcomes:
measure: Change in burnout as measured by the Maslach Burnout Inventory
timeFrame: 9 months
Secondary outcomes:
measure: Change in work environment factors contributing to burnout by Areas of Work life Survey
timeFrame: 9 months
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Prasanna Tadi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03522675: NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test
Official title: Skin Prick Test in Healthy Volunteers of Any Sex, to Investigate the Potential Allergy to NeoMatriXTM Wound Matrix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy Skin
Allergy
Dermatitis, Allergic Contact
Lead sponsor: NeXtGen Biologics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: State University of New York at Buffalo
First posted: 2018-05-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study is to investigate the potential of NeoMatriXTM Wound Matrix to cause an allergic response to healthy volunteers using a skin prick test.

Detailed description: Using a minimally invasive skin prick test, the test material, positive control, and negative control are applied to the forearm using a prick test. The test area is observed after 15 minutes, 6 hours, and again at 1-2 days after the initial prick test. The skin will be examined for a reaction such as a wheal and/or a flare, a flare alone is not clinically significant.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers aged at least 18 years.
* Completed written informed consent and receive a copy of their executed ICF.
* Volunteers must be capable of understanding and following directions in English.

Exclusion Criteria:

* Pregnancy or lactation;
* Inadequate or non-existent contraception (women of child bearing potential only);
* A current skin disease;
* Heavy alcohol consumption;
* Current use or history of repeated use of recreational drugs;
* Recent illness prior to test;
* Significant past medical history of diseases to potentially effect study results;
* Current treatment of allergy;
* A history of multiple drug hypersensitivity;
* Concurrent medication likely to affect the response to the test articles or confuse the results of the study;
* Known sensitivity to the test articles;
* Participation in a repeat insult patch test (RIPT), skin prick test (SPT) or follow-up work within the last month;
* Sensitization or questionable sensitization in a skin test;
* Recent immunization.

Primary outcomes:
measure: Wheal Formation
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
measure: Wheal Formation
timeFrame: 6 hrs
measure: Wheal Formation
timeFrame: 2 days
Locations:
city: Buffalo
country: United States
facility: University at Buffalo Clinical and Translational Research Center
state: New York
Study officials:
References:
Clinical trial NCT06295575: Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass
Official title: The Effect of Probiotics on Intestinal Barrier Function and Intestinal Flora in Infants With Congenital Heart Disease Undergoing Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Intestinal Disease
Dysbiosis
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora.


Eligibility criteria: Inclusion Criteria:

* a diagnosis of CHD requiring surgical repair with the use of CPB
* age greater than 37 weeks corrected gestational age and less than 1 year old

Exclusion Criteria:

* Patients with inherited metabolic disease, history of intestinal surgery, preexisting gastrointestinal pathology (such as NEC, IBS, inflammatory bowel disease, chronic intestinal obstruction or diarrhea), immunity dysfunction or received antibiotics, probiotics or hormone-replacement therapy within 2 months before enrollment were excluded from the study

Primary outcomes:
measure: incidence of morbidity
timeFrame: up to 1 months
measure: gastrointestinal functional recovery indicators
timeFrame: up to 1 months
measure: biomarkers
timeFrame: after anesthesia induction preoperatively and at 24 hour postoperatively
measure: microbiome
timeFrame: before surgery: within 24 hours after enrollment in the control group and within 24 hours preoperatively in the treatment group after surgery:between 48 and 72 hours in both groups
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Children's Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Nanjing Children's Hospital
name: Zhixuan Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiothoracic Surgery, Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China
name: Xiaoxu Liu
role: STUDY_DIRECTOR
References:
Clinical trial NCT06464575: Comparison of Vocal Biomarkers for Depression and Anxiety to Formal Clinical Assessments
Official title: Prediction of a Structured Clinical Assessment by Patient Reported Outcomes and Machine Learning Algorithms: A Comparative Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Depression/Anxiety
Keywords: Vocal biomarker
Depression
Anxiety
Structured clinical assessment
Lead sponsor: Ellipsis Health
Sponsor class: INDUSTRY
First posted: 2024-06-18
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: \~540 individuals aged 18 and above, of any gender, race, culture, ethnicity, sexual orientation or educational level residing anywhere in the United States.

Brief summary: Participants will be recruited to complete self reported surveys normally used as standards of care for screening and monitoring depression and anxiety symptom severity, provide a voice sample composed of an answer to open ended questions and then be assessed by a mental health professional using structured and clinically validated assessment tools for depression and anxiety. Their voice will be analyzed by machine learning models that predict the severity of depression and anxiety symptoms. The models' performance will be compared to the clinician assessments and how that correlation compares to a similar comparison between the clinician assessments with the self reported surveys. It is hypothesized that the performance of the machine learning models in assessing the severity of depression and anxiety symptoms is no worse than the self reported surveys when both are compared to clinician assessments. It is also hypothesized that presence or absence of the diagnoses of Major Depressive Disorder and Generalized Anxiety Disorder can be predicted better than chance by the analysis of the participant's voice sample using machine learning models.


Eligibility criteria: Inclusion Criteria:

* Native speaker or conversant in English
* Access to smartphone or computer with microphone
* Provision of esigned and dated informed consent form
* Willingness to adhere to the study protocol
* To participate in the subsequent clinical interview portion of this study in addition to the above inclusion criteria, a participant must provide an evaluable and qualified voice sample.

Exclusion Criteria:

* Speech impairments or other conditions that impact their ability to speak clearly
* Under the influence of recreational drugs or alcohol
* Ill or experiencing heavy allergies or temporary conditions affecting respiration, voice, or speaking.

Primary outcomes:
measure: Primary Outcome A
timeFrame: 4 days
measure: Primary Outcome B
timeFrame: 4 days
Secondary outcomes:
measure: Secondary Outcome A
timeFrame: 4 days
measure: Secondary Outcome B
timeFrame: 4 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ellipsis Health
state: California
Study officials:
References:
Clinical trial NCT04600375: Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa
Official title: Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hidradenitis Suppurativa
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being conducted to evaluate if a written action plan for hidradenitis suppurativa (HS) will help patients with hidradenitis suppurativa gain a better understanding of the condition and how to manage the condition on a daily basis compared to a routine verbal consultation.


Eligibility criteria: Inclusion Criteria:

* This study will only enroll subjects between the ages of 18-years and 89-years of age.
* Diagnosis of HS by a board-certified dermatologist
* Able to read and comprehend study materials
* No prior exposure to written HS action plans

Exclusion Criteria:

* Those who do not fit the inclusion criteria

Primary outcomes:
measure: Visits to High-cost Care Settings [ Time Frame: 1.5 Months ]
timeFrame: Through study completion, an average of 1.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Vivian Y Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson AM, Fernandez JM, Shih T, Hamzavi I, Hsiao JL, Shi VY. Improving hidradenitis suppurativa patient education using written action plan: a randomized controlled trial. J Dermatolog Treat. 2022 Aug;33(5):2677-2679. doi: 10.1080/09546634.2021.1970707. Epub 2021 Sep 27.
Clinical trial NCT02257775: Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer
Official title: Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Breast Cancer
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring systemic therapy for metastatic breast cancer

Brief summary: The objective of this study is to apply Whole-body DW imaging alongside the routine management of patients requiring systemic therapy for metastatic breast cancer to compare the time to progression of individual liver metastases within and between patients following stable disease or partial response to palliative systemic therapy for breast cancer.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years.
* First metastatic breast cancer relapse after treatment for early stage disease
* A minimum of 10 evaluable lesions in the liver on routine x-ray CT imaging
* Patient prescribed cytotoxic, endocrine or biological therapies
* Patient physically and psychologically fit enough to consider sequential WB-- - DWI imaging alongside their standard disease monitoring
* Written informed consent

Exclusion Criteria:

* Diagnosis of other cancer within the last 5 years, other than resected non-melanoma skin cancer or cervical intraepithelial neoplasia
* Diagnosis of brain metastases.
* Contraindication to magnetic resonance MR imaging

Primary outcomes:
measure: Progression rate of liver metastases
timeFrame: 3 months
Secondary outcomes:
measure: Progression rate of skeletal metastases
timeFrame: 3 months
measure: Global and local lesion Apparent Diffusion Coefficient (ADC) distributions of WB-DWI scans within individual patient
timeFrame: 3 months
measure: Patient acceptability of WB-DWI assessed from questionnaires provided between WB-DWI scans and quantified using a 5-point Likert scale
timeFrame: 3 months
measure: Comparison of patient acceptability to whole-body CT
timeFrame: 3 months
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Jill Noble
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01377675: Web-based, Interactive Professional Education for Chronic Obstructive Pulmonary Disease
Official title: Assessment of an Interactive Education Tool to Disseminate Best Practice Recommendations on Chronic Obstructive Pulmonary Disease to Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Education of Primary Care Clinicians
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: American College of Chest Physicians
First posted: 2011-06-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Third year internal medicine residents

Brief summary: This study involves the development and evaluation of a web-based, interactive education program on chronic obstructive pulmonary disease (COPD) for primary care clinicians.

The research questions that this proposal addresses include:

1. Can an interactive, web-based COPD course be developed to disseminate evidence-based, best practice recommendations to primary care clinicians?
2. Can assessment tools be developed to evaluate the impact of the program on clinician behavior in clinical practice and on patient care?


Eligibility criteria: Inclusion Criteria:

* Primary care clinicians in training
* willing to participate

Exclusion Criteria:

* Specialists

Primary outcomes:
measure: Change in clinical practice
timeFrame: 9 months
Secondary outcomes:
measure: Clinician knowledge and comprehension
timeFrame: 9 months
measure: Clinician self-confidence
timeFrame: 9 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
References:
Clinical trial NCT01362075: Pain Management After Shoulder Prosthesis: A Clinical Trial of Nerve Block and Local Infiltration
Official title: Pain Management After Shoulder Arthroplasty: A Randomised Clinical Trial of Interscalene Block and Local Infiltration Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Shoulder Arthroplasty
Local infiltration analgesia
Lead sponsor: Horsens Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Aarhus University Hospital
name: The Hede Nielsen Family Foundation
name: Central Denmark Region
name: The Danish Rheumatism Association
First posted: 2011-05-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of local infiltration analgesia as compared to 48-hour interscalene block in treating pain after shoulder arthroplasty. The investigators hypothesize a reduced pain score and use of supplemental analgesic medication during the first three postoperative days using local infiltration analgesia.


Eligibility criteria: Inclusion Criteria:

* elective primary shoulder arthroplasty

Exclusion Criteria:

* reverse or delta prosthesis
* recent fracture near the shoulder
* allergic to amid-type local analgesics
* operation not under general anaesthesia
* incompetent, pregnant, below 18 or above 90 years old
* severe chronic neurogenic pain or sensory disturbances in the shoulder

Primary outcomes:
measure: Supplemental analgesics ingested
timeFrame: First 24 hours postoperatively
Secondary outcomes:
measure: Pain score
timeFrame: First 72 hours postoperatively
measure: Supplemental analgesics ingested
timeFrame: First 72 hours postoperatively
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Aarhus Hospital
city: Horsens
country: Denmark
facility: Horsens Hospital
Study officials:
affiliation: Horsens Hospital
name: Karen T Bjørnholdt, MD
role: PRINCIPAL_INVESTIGATOR
References: