louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04418778: The BEAR Therapeutic Program for Women
Official title: The Building Empowerment and Resilience Therapeutic Program for Women With a History of Trauma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Trauma, Psychological
Depression, Anxiety
PTSD
Keywords: empowerment
therapeutic intervention
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have experienced interpersonal violence broadly defined

Brief summary: The current study aims to test a novel therapeutic intervention for women who have a history of interpersonal trauma. The Building Empowerment and Resilience (BEAR) Therapeutic group incorporates psychological skills, psychoeducation, and physical empowerment training, all within a therapeutic process. It will be implemented iwith women who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect). The investigators aim to understand how this program effects one's self-efficacy and whether the program can reduce rates mental health problems (such as depression and anxiety) and reduce the rates of revictimization. Women who participate in the BEAR group must be able to attend in-person sessions. The control group can be remote.


Eligibility criteria: Inclusion Criteria:

1. Women ages 18-70
2. History of physical, sexual, and/or emotional abuse/neglect/violence, with subsequent interpersonal or psychological distress (e.g., depression or anxiety) related to this history.

Exclusion Criteria:

1. Active, significant substance abuse
2. Significant medical conditions that would preclude safe participation in the study
3. High levels of depression with significant suicide risk
4. Psychiatric instability
5. History of assaultive behavior or is judged to be at potential risk to assault others.

Primary outcomes:
measure: Change in Coping Self-Efficacy Scale (CSES)
timeFrame: baseline to post-group (3 months)
measure: Trauma Symptom Inventory-II (TSI-2).
timeFrame: baseline to post-group (3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
Clinical trial NCT05701878: COVID-19 Self-testing Study
Official title: Field Test of COVID-19 Self-testing With Rapid Antigen Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
self-testing
mobile-app
SMARTest
randomized control trial
RCT
antigen test
mobile health
digital health
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will either be given access to the self-testing mobile app or not.
Primary purpose: SCREENING

Brief summary: The goal of this clinical trial is to understand how the introduction of an app-based intervention changes knowledge, attitudes, and practices on COVID-19 self-testing.

Detailed description: Rapid diagnostic testing has been shown to be an important tool in controlling the spread of the COVID-19 pandemic by identifying people when they are likely to be most contagious and reducing crowding at testing sites. In addition to employer-mandated testing, rapid antigen tests are becoming increasingly used by individuals. A method to promote frequent self-testing would help break the chain of viral transmission, slow the spread of disease, slow the spread of vaccine-resistant variants, and improve pandemic management.

The ubiquity of smartphones along with their data connectivity capabilities and onboard sensors make them an attractive tool to complement rapid diagnostic tests and an important component of decentralized testing. Smartphone-based tools have shown high acceptability among healthcare workers for the real-time tracking of rapid test results.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* 18 years old or older
* Owns a smartphone running either Android or iOS operating systems
* Willing to download a COVID-19 self-testing app
* Willing to receive and send text messages for the study (and fill out surveys linked from text messages)

Exclusion Criteria:

* Not willing to self-test themselves with COVID-19 rapid tests

Primary outcomes:
measure: COVID-19 Self-Testing Knowledge, Attitudes, and Practices Questionnaire Score - study initiation
timeFrame: Baseline
measure: COVID-19 Self-Testing Knowledge, Attitudes, and Practices Questionnaire Score - study completion
timeFrame: At study completion (About 1 month after enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: ICAP Harlem Prevention Center
state: New York
Study officials:
affiliation: Columbia University
name: Yael Hirsch-Moverman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Samuel K. Sia, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05790278: Purpose in Life Survey
Official title: Evaluating the Prevalence of Purpose-related Existential Distress Among 2 Clinical Populations Compared to a Normative Sample
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancer
Traumatic Brain Injury
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who are either (1) healthy controls, (2) individuals with a qualifying cancer diagnosis, or (3) individuals with a qualifying Traumatic Brain Injury

Brief summary: At present, there is no empirical data that specifies the likely prevalence of purpose in life disruption among various clinical populations. Between one-third and one-half of cancer survivors report some degree of existential distress during or after their treatment, but these findings are not specific to the domain of purpose in life.

To address the aforementioned gap, we propose to conduct a survey study to determine the prevalence of purpose disruption in two clinical populations and determine if the prevalence of purpose disruption in these populations is different from that of a normative population.


Eligibility criteria: Inclusion Criteria:

* Age 18+
* Stage 1, 2, 3 cancer
* Cancer types: breast cancer, non-Hodgkin's lymphoma; colorectal cancer
* Receiving oncology services or treatment through AHCI
* Have completed primary cancer treatment within the past 12 months
* Able to communicate in English;
* Able to see and read (with or without assistive devices);
* Has access to a device (computer, phone, tablet) and an email address;
* Access to an internet connection.
* Has a known email address (in EPIC) and/or home telephone number
* Adults who sustained a traumatic brain injury within the past 12 months.
* Attending the 2022 MN State Fair

Exclusion Criteria:

* Have declined consent for use of medical records in research during admission to AH facility

Primary outcomes:
measure: Purpose Status Question
timeFrame: Through Study Completion, about 15 minutes
Secondary outcomes:
measure: Work and Adjustment Scale
timeFrame: Through Study Completion, about 15 minutes
measure: Meaning in Life Questionnaire
timeFrame: Through Study Completion, about 15 minutes
measure: Life Engagement Test
timeFrame: Through Study Completion, about 15 minutes
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Allina Health - Courage Kenny Rehabilitation Institute
name: Mary V Radomski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04209478: Transversus Abdominis Plane Block and Quadratus Lumborum Block in Pediatric Patients
Official title: Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Pediatric Patients; a Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: quadratus lumborum block
pediatric anesthesia
transverse abdominal block
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2019-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In the pediatric age group, postoperative pain is very important for the children to have a comfortable and problem-free postoperative period.

In the present study, it was aimed to compare the postoperative analgesic efficacy of Transversus abdominis plane (TAP) Block, and quadratus lumborum block (QLB) Type 1 on the pediatric patients

Detailed description: Patients included in the study were randomly divided into 2 groups. Cases were assessed ultrasonography-guided TAP block (Group B, n=20) or ultrasonography-guided QL Block. Total analgesic amounts in 24 hours and first analgesic requirement times recorded.

Eligibility criteria: Inclusion Criteria:

* The study included 40 cases undergoing lower abdominal surgery aged from 3 to 16 years with American Society of Anesthesiologist I-II level.

Exclusion Criteria:

* Cases with American Society of Anesthesiologist III-IV health level and those with a history of allergy to local anesthetic medications were not included in the study

Primary outcomes:
measure: the analgesic use of the groups in 24 hours
timeFrame: how many times in 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Döndü Genç Moralar
Study officials:
References:
Clinical trial NCT06580678: A Study to Evaluate Physiologic Dentin Regeneration and Safety of KH001 in the Administration of Erupted Wisdom Tooth With Dentin Caries
Official title: A Clinical Study to Evaluate Physiologic Dentin Regeneration When KH001 Was Administration to Erupted Wisdom Tooth With Dentin Caries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Dentin Caries
Keywords: Wisdom Tooth
Dentin Caries
Lead sponsor: Seoul National University Dental Hospital
Sponsor class: OTHER
Collaborators: name: HysensBio Co., Ltd
First posted: 2024-08-30
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate physiologic dentin regeneration and safety of KH001 in the administration of erupted wisdom tooth with dentin caries

Detailed description: The design is a single site, double-blind, randomized study. Phase 2 study to evaluate physiologic dentin regeneration and safety of KH001. The total duration of the study will be approximately 5 to 9 weeks.

Eligibility criteria: Inclusion Criteria:

* Is between 19 and 35 of age by the time of the screening
* Has signed written informed consent in the study
* Subject who either have no pain in the affected tooth, or can endure pain until the day of tooth extraction

Exclusion Criteria:

* Is allergic to the active ingredient or other ingredients used in the investigational product
* Have participated in another clinical study within 30 days from screening visit and have a history of administration/application of investigational product/device
* Is judged by the investigator as ineligible for participation for other reasens

Primary outcomes:
measure: Evaluation of physiological dentin formation
timeFrame: Week 5
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to 9 weeks
measure: Oral soft/hard tissue examination
timeFrame: Up to 9 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Dental Hospital
Study officials:
References:
Clinical trial NCT02030678: A Phase II Study of Irinotecan in 3 Line or More Therapy in Local Recurrence or Metastatic Breast Cancer
Official title: To Evaluate the Clinical Effect of Irinotecan Monotherapy in Treatment of Local Recurrence or Metastatic Breast Cancer Patients Who Accepted at Least 2 Kinds of Chemotherapy Regimens Including Antharcycline or Taxanes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer
Lead sponsor: Liaoning Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic breast cancer. Evaluate the effect and safety of irinotecan in local recurrence or Metastatic breast cancer patients who recieved anthracycline or taxane drugs. The primary endpoint is Disease Control Rate and Progression free survival. The second endpoint is 3 or 4 grade Adverse Events 、overall survival.All the patients will recieve this therapy till disease progress or other occurrence of withdrawal standards.

Detailed description: A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic breast cancer. Evaluate the effect and safety of irinotecan in local recurrence or Metastatic breast cancer patients who recieved anthracycline or taxane drugs. The primary endpoint is Disease Control Rate and Progression free survival. The second endpoint is 3 or 4 grade Adverse Events 、overall survival. irinotecan 100mg/m2,iv,day1,day8,every 3cycles.If no AE happens, increase irinotecan dose to125mg/m2 at the second cycle.All the patients will recieve this therapy till disease progress or other occurrence of withdrawal standards.

Eligibility criteria: Inclusion Criteria:

* Mestatic breast cancer patients whose disease recurrent after using anthracycline or taxane drugs

Exclusion Criteria:

* Heart Disease.etc

Primary outcomes:
measure: Disease Control Rate
timeFrame: 3cycles (21days/cycle)
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: SunTao
state: Liaoning
Study officials:
affiliation: Liaoning Cancer Hospital & Institute
name: Tao Sun, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04412278: Impact of COVID-19 Pandemic on Perceived Exercise Benefits and Barriers
Official title: Impact of COVID-19 Pandemic on Perceived Exercise Benefits and Barriers: Cross Sectional Study on Turkish Society and Interpretation With Physical Activity Level
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Isolation, Social
Keywords: Covid 19
Physical activity level
Exercise benefits and barriers
Turkish Society
Social Isolation
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 392
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the individuals between 15 - 65 ages in Turkey is 56.391.925 people. It is calculated that there are 42.463.119 individuals cover the criterion as universe of the study.

Brief summary: It is aimed to determine the physical activity level and exercise benefits and barriers caused by Covid-19 pandemic and reveal the relationship between them.

Detailed description: Study hypothesis that people are tend to be physically inactive while Covid-19 pandemic. It is aimed to determine the exercise benefits and barriers caused by Covid-19 pandemic and reveal the relationship among gender, age, marial status and physical activity level.

Eligibility criteria: Inclusion Criteria:

* being Turkish
* understanding Turkish
* being between the age of 15 - 65
* being literate
* have internet access

Exclusion Criteria:

* having a disable condition to exercise
* having missing value on outcome measures
* giving incomprehensible answering

Primary outcomes:
measure: Exercise Benefits and Barriers Scale
timeFrame: three months after Covid 19 recognised as pandemic
measure: Sociodemographic information
timeFrame: three months after Covid 19 recognised as pandemic
Secondary outcomes:
measure: International Physical Activity Questionairre
timeFrame: three months after Covid 19 recognised as pandemic
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Okan University
Study officials:
References:
Clinical trial NCT02367378: Minimally Invasive Surgery (MIS) for Spine Metastases
Official title: Minimally Invasive Surgery for Spine Metastases - A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Metastases
Keywords: Minimally invasive surgery
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chart review of patients having undergone minimally invasive surgery of spine metastases, 18 years and older.

Brief summary: The purpose of this study is to collect information on the effect of minimally invasive spine tumor decompression on treated patients. This treatment option is less invasive that the standard surgical decompression and is expected to result in better wound healing, decreased tissue trauma, and decreased pain after surgery.

Detailed description: This is a prospective study designed to analyze the impact that minimally invasive spine tumor decompression has upon quality of life, neurological morbidity, pain, and mortality. Prospective findings will be compared with historical controls to determine whether the minimally invasive approach offers better outcomes than traditional treatment methods.

Eligibility criteria: Inclusion Criteria:

* undergone minimally invasive surgery
* over 18 years of age

Exclusion Criteria:

* unable to give consent

Primary outcomes:
measure: Survival time
timeFrame: up to 2 years
Secondary outcomes:
measure: Ambulation Index
timeFrame: up to 2 years
measure: Cobb Angle
timeFrame: up to 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Arthur Jenkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06273878: From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy
Official title: From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Università degli Studi dell'Insubria
First posted: 2024-02-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is represented by patients with endometrial cancer who have undergone, or who have will undergo surgery

Brief summary: Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients.

Detailed description: The picture of precisely coordinated immune adaptations over time at the maternal-fetal interface level and altered in pregnancy complications, could reveal a specific "immune clock" in tumors. The study aims to decipher mechanisms of immunodeficiency by helping to predict recurrence in patients with endometrial cancer and identify molecular pathways that are turned on or off in progression from lesions early to advanced neoplasia. This will allow the discovery of potential immunotherapy targets to interfere with the immune escape activation process or to reactivate/re-educate the immune response.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years;
* Histological diagnosis of endometrial hyperplasia with and without atypia, carcinoma of the endometrium histotype endometrioid at any stage of the disease (FIGO I-IV), patients subjected to hysterectomy for benign extra-endometrial pathology, patients with recurrence/metastasis from endometrioid endometrial carcinoma that are subjected to surgery;
* Adequate biological material to be able to carry out the analyzes previously described;
* Written informed consent (only for patients in the prospective part and/or in follow-up);
* For the retrospective part: availability of samples adequately stored at the Institute biobank and availability of follow-up data.

Exclusion Criteria:

* Comorbidities not controlled with adequate medical therapy;
* Infections of the endometrial cavity (pyometra);
* Synchronous tumors;
* Neoadjuvant treatments;
* Previous radiation treatments on the pelvic region.

Primary outcomes:
measure: Validate the differential expression of LOX-1 and NALP3 receptors.
timeFrame: 36 months
Secondary outcomes:
measure: Characterize phenotypic alterations.
timeFrame: 36 months
measure: Evaluate the predictive and/or prognostic value.
timeFrame: 36 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: National Cancer Institute - IFO -
state: RM
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References: