louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00937911: Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
Official title: YM150 Phase III Study - An Open-label, Multi-center Study in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: YM150
Bleeding
Anticoagulant
Venous thromboembolism
FXa inhibitor
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.


Eligibility criteria: Inclusion Criteria:

* Subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture surgery
* Written informed consent obtained before screening

Exclusion Criteria:

* Subject has history of deep vein thrombosis and/or pulmonary embolism
* Subject has a hemorrhagic disorder and/or coagulation disorder
* Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
* Subject has an acute bacterial endocarditis
* Subject has uncontrolled severe or moderate hypertension, retinopacy, myocardial infarction or stroke
* Subject is receiving anticoagulants/antiplatelet agents
* Subject has a body weight less than 40 kg

Primary outcomes:
measure: Incidence of venous thromboembolism
timeFrame: Until day 12
Secondary outcomes:
measure: Incidence of deep vein thrombosis
timeFrame: Until day 35
measure: Incidence of pulmonary embolism
timeFrame: Until day 35
measure: All cause mortality
timeFrame: Until day 35
measure: Incidence of bleeding event
timeFrame: Until day 35
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT04879693: Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting
Official title: Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Needing Glucose Control
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

Detailed description: To assess the performance of the CGM System in comparison to a blood glucose comparator method in non-critically ill hospitalized patients who need glucose control.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Admitted to the hospital in a non-ICU bed or once transferred out of ICU
* Anticipate at least 48 hours of hospital stay
* On treatment for glucose control.
* Willingness to complete the study.
* Willingness to wear up to 3 CGM systems simultaneously. Two in the abdomen and one on the back of the arm or one on each arm and one on the abdomen.
* Subject and/or caretaker are able to speak, read, and write English

Exclusion Criteria:

* Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis)
* Currently in an intensive care unit (ICU) of the following type (does not apply to participants placed in an ICU bed due to space issues in the non-ICU areas)
* Known allergy to medical-grade adhesives
* Pregnancy, demonstrated by a positive test (for subjects of childbearing potential)
* Women admitted to give birth or any other admission related to pregnancy
* Patients receiving Hydroxyurea
* Bleeding disorder
* Participants that are currently being treated for malignancies, cancer
* Participant that are hospitalized to receive an organ transplant
* Require a Magnetic Resonance Imaging (MRI) scan
* End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
* Current participation in another investigational study protocol (If a subject has recently completed participation in another drug study, the subject must have completed that study at least 7 days prior to being enrolled in this study.)
* Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff (e.g., known history of hepatitis B or C)

Primary outcomes:
measure: System Performance
timeFrame: Up to 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02962193: Evaluation of Functional and Social Changes After Bariatric Surgery
Official title: Evaluation of Functional and Social Changes After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional and Social Performance
Keywords: ADL
Bariatric surgery
Daily participation
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2016-11-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight patients who are fit for surgery .

Brief summary: After bariatric surgery there are big changes in the daily functions, activities and social participation of the patients.

This is a prospective study that examine daily performance and daily participation by questionnaires, before and after bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Overweight patients who are fit for surgery .

Exclusion Criteria:

* Children, Neurological patients, amputations

Primary outcomes:
measure: The change of participation before and after surgery
timeFrame: the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
Secondary outcomes:
measure: sexuality questionnaire
timeFrame: the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
measure: activity daily questionnaire
timeFrame: the patient will answer the questionnaire before and after (3 months, 6 months) surgery.
measure: range of motion (flexion of knee and thigh in degrees)
timeFrame: measure will be taken before and after (3 months, 6 months) surgery.
measure: circumferences mesurement (knee, thigh and waist) in centimeters
timeFrame: measure will be taken before and after (3 months, 6 months) surgery.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04303793: Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.
Official title: Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare safety, efficacy and procedural outcome of percutaneous PDA closure using different approaches for better characterization of device selection criteria.


Eligibility criteria: Inclusion Criteria:

* all patients who are candidate for transcatheter PDA closure

Exclusion Criteria:

1. Patients with PDA dependent pulmonary circulation.
2. Patients with small sized PDA which is silent by auscultation
3. Patients with large sized PDA which is unsuitable for Trans-catheter closure
4. Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
5. Patients with active infection or active infective endarteritis.
6. Patients refusing the study.

Primary outcomes:
measure: Procedural safety
timeFrame: one month
measure: Procedural efficacy
timeFrame: one month
measure: Procedural outcomes
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06931093: The Effectiveness of Group-Delivered Guided Written Exposure Therapy for CPTSD Symptoms Among Adolescents : A Multi-centered Randomized Controlled Trail
Official title: The Effectiveness of Group-Delivered Guided Written Exposure Therapy for CPTSD Symptoms Among Adolescents : A Multi-centered Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CPTSD, Compelx Post-traumatic Stress Disorder
Keywords: adolescents
CPTSD
randomized controlled trial
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to examine the effectiveness of group-delivered Guided Written Exposure Therapy for Complex Post-Traumatic Stress Disorder (GWE-C) among Chinese adolescents through a randomized controlled trial. A total of 120 participants will be recruited, with 60 randomized to the GWE-C group and 60 randomized to the supportive therapy (ST) group. The GWE-C intervention will consist of 7 to 10 group sessions. The primary outcome, assessed by the International Trauma Questionnaire (ITQ), will be measured at baseline, post-treatment, 1-month follow-up, and 3-month follow-up.


Eligibility criteria: Inclusion Criteria:

* Aged between 10 and 18 years;
* Meet the diagnostic criteria or subclinical criteria for Complex PTSD (C-PTSD) , defined as missing either one symptom from the PTSD clusters, or the DSO cluster;
* Possess sufficient literacy and language skills to complete writing-based tasks;
* Be able to understand the study procedures and complete the required assessments;
* Provide written informed consent, with consent also obtained from their legal guardians.

Exclusion Criteria:

* Presence of a severe psychiatric disorder or neurodevelopmental disorder, such as schizophrenia, bipolar I disorder, autism spectrum disorder, intellectual disability, or other severe psychiatric conditions that would interfere with study participation;
* Presence of a severe physical illness that would impair the ability to engage in the intervention;
* Suicidal ideation within the past six months;
* Ongoing exposure to traumatic events;
* Currently receiving other trauma-focused psychological treatments.

Primary outcomes:
measure: CPTSD Symptom Severity (self-report)
timeFrame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
measure: CPTSD Symptom Severity(interview)
timeFrame: baseline, post treatment(2 weeks), 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
References:
Clinical trial NCT06763393: Correlation Between Adnexal Masses and Endometrial Thickness Measured With Ultrasound in Adults Women
Official title: Correlation Between Adnexal Masses and Endometrial Thickness Measured With Ultrasound in Adults Women
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometrial Disorder
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: to check the Correlation Between Adnexal Masses and Endometrial Thickness Measured With Ultrasound

Brief summary: This study explores the correlation between adnexal masses and endometrial thickness in adult women, using ultrasound as the primary diagnostic tool.

Detailed description: Adnexal masses, including ovarian cysts and other abnormalities, are common gynecological findings, while endometrial thickness is a crucial indicator for assessing conditions like endometrial hyperplasia or malignancy.

By analyzing ultrasound data, this research aims to determine whether the presence, size, or characteristics of adnexal masses have a significant relationship with variations in endometrial thickness.

Eligibility criteria: Inclusion Criteria:

* Adult women typically defined as those aged 18 and older.
* Women with diagnosed adnexal masses, which could be cysts, tumors, or other growths in the adnexa (ovaries and fallopian tubes).

Exclusion Criteria:

* Pregnant women might have different hormonal and physiological changes that can affect endometrial thickness and adnexal masses.
* Recent gynecological history.

Primary outcomes:
measure: ultrasound for Endometrial Thickness
timeFrame: 12 Months
measure: ultrasound radiopaedia for Adnexal Masses
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sadiqābād
country: Pakistan
facility: Sadiqabad
state: Punjab
Study officials:
References:
Clinical trial NCT04909593: Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial
Official title: Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial: The AIM Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Intractable Pain
Low Back Pain
Pain, Neuropathic
Pain, Back
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2021-06-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).


Eligibility criteria: Key Inclusion Criteria:

* Study candidate is undergoing a temporary SCS trial of commercially approved BSC neurostimulator system, per local directions for use (DFU).
* Subject signed a valid, EC/IRB-approved informed consent form.
* Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law when written informed consent is obtained.
* In the clinician best judgment, subject is able to distinguishably describe quality and location of sensation and pain.

Key Exclusion Criteria:

* Subject meets any contraindication in BSC neurostimulation system local DFU.
* Investigator-suspected gross lead migration during the SCS trial period which may preclude the study candidate from receiving adequate SCS therapy.
* Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that in the clinician's best judgement would limit study candidate's ability to assess and report sensation information.
* Subject is currently diagnosed with a physical impairment, or exhibits a condition that would limit study candidate's ability to complete study assessments.

Primary outcomes:
measure: Perception Threshold
timeFrame: Programming Visit (up to 15 days post-screening)
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: PCPMG Clinical Research Unit, LLC
state: South Carolina
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References:
Clinical trial NCT03545893: Overnight Pain Treatment Investigating Opioids vs. Nonopioids
Official title: A Pilot Randomized Trial of Opioids Versus Nonopioids for Pain Control After Osmotic Dilator Placement for Abortion Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion Second Trimester
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
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 compare maximum pain scores between patients seeking induced abortion and requiring cervical preparation with osmotic dilators. Patients will be randomized to receive prescription for ibuprofen alone or to receive prescription for ibuprofen + oxycodone for overnight pain management after cervical preparation with osmotic dilators. Data collected in-person and through a text-messaging platform.


Eligibility criteria: Inclusion Criteria:

* English-speaking women
* 18 years or older
* Access to cell phone with text-messaging capability/data
* Receiving cervical preparation for induced abortion
* Able to complete baseline survey on smartphone/tablet at screening visit

Exclusion Criteria:

* History of opioid or alcohol abuse
* Contraindications or allergy to ibuprofen
* Contraindications or allergy opioid medications
* Seeking uterine evacuation for premature preterm rupture of membranes or advanced - cervical dilation or intrauterine fetal demise

Primary outcomes:
measure: Maximum Pain Score
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06758193: Validity and Reliability of the MAP-Hand Scale in Patients With Carpal Tunnel Syndrome
Official title: Validity and Reliability of the The Measure of Activity Performance of the Hand Scale in Patients With Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Carpal Tunnel Syndrome (CTS)
Keywords: Carpal Tunnel Syndrome
Reliability
Validity
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who apply to the Physical Medicine and Rehabilitation Polyclinic with complaints of hand-wrist pain will be examined by a physical therapist. Patients who are diagnosed with Carpal Tunnel Syndrome through physical examination, meet the inclusion criteria, and agree to participate in the study will be included in the study.

Brief summary: The primary aim of the study was to determine the validity and reliability of the "MAP-Hand (Measure of Activity Performance of the Hand)" scale in patients with carpal tunnel syndrome. The secondary aim of the study was to evaluate the hand activity performance in patients with carpal tunnel syndrome.


Eligibility criteria: Inclusion Criteria:

1. Age 18 and above and able to read and write
2. Diagnosed with mild or moderate unilateral CTS according to electroneuromyography results at least 6 months ago
3. Motor-sensory symptoms such as numbness and loss of strength in the hand for at least three months
4. Volunteers with no history of diabetes, no medical treatment or injections, no surgery, and no cervical radiculopathy or polyneuropathy

Exclusion Criteria:

1. Those with trauma, deformity, fracture, muscle contracture and atrophy in the shoulder, forearm and hand
2. Those who have received corticosteroid injections into the carpal tunnel area within the last three months and have been included in a physiotherapy program
3. Those who have cognitive problems

Primary outcomes:
measure: Hand Activity Performance
timeFrame: 24 weeks
Secondary outcomes:
measure: Grip Strength
timeFrame: 24 weeks
measure: Pain
timeFrame: 24 weeks
measure: Hand and Finger Skills
timeFrame: 24 weeks
measure: Hand Health Status
timeFrame: 24 weeks
measure: Carpal Tunnel Symptom Severity
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kirsehir Ahi Evran University
state: Merkez
Study officials:
References:
Clinical trial NCT06091293: Narrative Intervention for Long COVID-19 (NICO)
Official title: Narrative Intervention for Long COVID-19 (NICO) Research Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long COVID
Long Covid19
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study has one arm. All participants will receive the NICO intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This T1 proof of concept trial is designed to test the Narrative Intervention for Long COVID-19 intervention.

Detailed description: People living with COVID19 Long Haul Syndrome frequently experience high symptom burden and problems performing basic activities of daily living. COVID19 has impacted mental health not only for people directly affected by the pandemic, including people who are living with COVID19 Long Haul Syndrome, but also those affected indirectly, putting further strain on the mental health system, which was already under stress.

Understanding the experience of COVID 19 Long Haul Syndrome that can inform innovative and impactful ways to improve living with COVID19. Mental health providers are in high demand with an increase in burnout. One study reported 1/3 of mental health providers have experienced severe burnout since the onset of the pandemic. There are nursing staff shortages across the US, especially in rural areas. Shortages also occur within social work staff globally. There is a need to design innovative, interdisciplinary, and less time-intensive interventions to help those living with chronic illness. More people living longer with different types of illnesses and staffing shortages make traditional talk therapy interventions more challenging to deliver to more people.

This study has two specific aims:

Aim 1: Establish the acceptability and feasibility of an asynchronous narrative intervention for people living with long haul COVID19.

Aim 2: Explore themes of illness narratives of people living with long haul COVID19

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Long COVID
* Have access to email weekly
* Between the ages of 18-89 years old

Exclusion Criteria:

* Conflicting research study

Primary outcomes:
measure: Personal Health Questionnarrie- 8 item (PHQ8)
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Generalized Anxiety Disorder- 7 item (GAD7)
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Rachel Johnson, PhD, LCSW
role: PRINCIPAL_INVESTIGATOR
References: