louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01876004: Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy
Official title: Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ectopic Pregnancy
Keywords: ectopic pregnancy
methotrexate
human chorionic gonadotropin beta subunit
expectant management
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 25
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: Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy if the complementary use of Methotrexate could provide better results. We evaluate the success of treatment and the time required for titers of β-hCG to become negative. Methods: A double-blind randomized study, held at the Department of Obstetrics UNIFESP. The patients will be divided into two groups: in one patients will be administered a single intramuscular dose of 50 mg/m2 of Methotrexate and in the other patients will be prescribed Placebo intramuscularly. The monitoring will be done by measurement of β-hCG in the 4th and 7th day. When the decline of beta-hCG titers was \> 15% in this interval, the patient was followed with weekly dosing of β-hCG until the titers become negative. The criterion of success is when the β-hCG was negative. The treatment failure occurs when surgery was necessary.


Eligibility criteria: Inclusion Criteria:

* Hemodynamic stability
* Initial β-hCG \<2000 mIU / mL
* Titers of β-hCG in decline in 48 hours before treatment
* Adnexal mass \<5.0 cm
* Desire for future pregnancy

Exclusion Criteria:

* Alive embryo
* Ectopic pregnancy other than in tubal location
* Pregnancy of unknown location

Primary outcomes:
measure: success of treatment
timeFrame: 6 months
measure: Time required for titers of β-hCG to become negative
timeFrame: 6 weeks
Secondary outcomes:
measure: Blood tests before treatment with Methotrexate and Placebo
timeFrame: 6 months
measure: Blood tests after treatment with Methotrexate and Placebo
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Julio Elito Junior
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Luiz Camano
role: STUDY_DIRECTOR
References:
Clinical trial NCT06286904: Sleep Position Pattern Recording
Official title: Sleep Position Pattern Recording - A Validation Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnant Women
Keywords: sleep
wearable electronic devices
Pregnant Women
Posture
Lead sponsor: Myant Medical Corp.
Sponsor class: INDUSTRY
Collaborators: name: McMaster University
First posted: 2024-02-29
Enrollment: 52
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women admitted in the antenatal in-patient clinic at McMaster University Medical Centre for greater than 24 hours.

Brief summary: The main goal of this study is to validate the accuracy of the body position detection by non-invasive wearable monitors (Skiin garments, Myant Medical Corp) during sleep in pregnant participants. This is a first step towards examining the association between maternal sleep position and fetal growth.

Detailed description: Individuals who are eligible to the study and provided consent to participate will be asked to:

1. Wear the Skiin Garment system for the duration of their time in the hospital (minimum 1 nights until they are discharged from hospital).
2. Complete a study completion questionnaire about their experience with the device and the study.

The Skiin Garment system is composed by biosensing garments presented in different form factors (bra, chest band, or underwear). It captures physiological metrics and relay information from a pod to local hub with Bluetooth.

The true body position will be obtained using visual observations and cameras.

Eligibility criteria: Inclusion Criteria:

* Assigned female at birth
* Currently pregnant
* Admission to MUMC Antenatal Clinic with anticipation of being admitted for greater than 24 hours
* Able and willing to provide informed consent to participate

Exclusion Criteria:

* Unestablished gestational dating (based on first-trimester ultrasound)
* Known maternal cardiac or pulmonary disorder
* Known sleep disorders (i.e., sleep apnea, periodic limb movement disorder, etc.)
* Known fetal chromosomal or structural abnormalities
* Known highly sensitive skin/skin sensitivities to textile electrodes

Primary outcomes:
measure: Accuracy of Skiin Garment system for detecting sleep position of pregnant women
timeFrame: Recorded during the night, during 6 to 8 hours.
Secondary outcomes:
measure: Questionnaire on wearable device invasiveness and satisfaction
timeFrame: One time point, on the morning after one night wearing the Skiin Garment system
measure: Participant recruitment rate
timeFrame: From the beginning to the end of the recruitment, up to 1 year.
measure: Participant retention rate
timeFrame: From the beginning to the end of participation, up to 1 year.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Eran Ashwal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06643104: 3D Imaging Assessment of Scoliosis: Back Height Difference vs. Trunk Rotation Angle
Official title: Assessment of Adolescent Idiopathic Scoliosis Based on 3D Imaging With Depth Cameras: A Comparative Study of Back Height Difference and Angle of Trunk Rotation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study focuses on adolescents aged 10-18 diagnosed with adolescent idiopathic scoliosis, defined by a Cobb angle of ≥10°.

Brief summary: This study focuses on adolescents with idiopathic scoliosis, employing 3D imaging technology with depth cameras to measure back height difference (BHD) and angle of trunk rotation (ATR) before and after conventional treatments such as massage, exercise therapy, and bracing. Statistical analyses are conducted to verify the correlation between BHD and ATR and to assess the sensitivity of BHD in evaluating short-term treatment effectiveness.


Eligibility criteria: Inclusion Criteria:

(1) Adolescents aged 10-18 years, diagnosed with adolescent idiopathic scoliosis (AIS) with a Cobb angle ≥10°; (2) No history of spinal surgery or other corrective treatments; (3) Able to undergo short-term inpatient treatment (5 days) and comply with study procedures.

Exclusion Criteria:

(1) Patients with congenital, neuromuscular, or other secondary scoliosis; (2) Presence of major comorbidities affecting spinal structure or muscle tone (e.g., spinal cord injury, muscular dystrophy); (3) Patients unable to complete standardized assessment procedures.

Primary outcomes:
measure: Back height difference
timeFrame: Day 1 of Admission and Day 5 of Admission
Secondary outcomes:
measure: Angle of trunk rotation
timeFrame: Day 1 of Admission and Day 5 of Admission
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital of Zhejiang Chinese Medical University
Study officials:
References:
Clinical trial NCT01402804: NSAIDs in Coronary Artery Disease Patients
Official title: Non-steroidal Anti-inflammatory Drugs Impair the Platelet Inhibiting Effect of Acetylsalicylic Acid in Coronary Artery Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CAD
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a stable CAD undergoing coronary angiography in the Universitätsklinik Düsseldorf.

Brief summary: Introduction:

Different groups already showed in retrospective subgroup analyses, that there is an increased risk for cardiovascular events in patients on a simultaneous ASA/NSAID treatment.

Methods:

Light-Transmission aggregometry

Hypothesis:

Simultaneous administration of different NSAIDs and ASA impair the platelet inhibiting effect of ASA.


Eligibility criteria: Inclusion Criteria:

* Patients on a simultaneous ASA, NSAID treatment
* \> 18 years

Exclusion Criteria:

* unconsciousness, not able to consent
* reanimation, cardiac shock

Primary outcomes:
measure: Thromboxane-levels and light-transmission aggregometry in response to arachidonic acid
timeFrame: During hospital stay
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-University
state: NRW
Study officials:
affiliation: Klinik für Kariologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf
name: Amin Polzin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Kardiologie, Pneumologie und Angiologie
name: Tobias Zeus, MD
role: STUDY_CHAIR
affiliation: Institut für Pharmakologie und Klinische Pharmakologie, Heinrich-Heine-Univerität Düsseldorf
name: Thomas Hohlfeld, MD
role: STUDY_CHAIR
affiliation: Heinrich-Heine University, Duesseldorf
name: Malte Kelm, MD
role: STUDY_DIRECTOR
References:
citation: Achilles A, Mohring A, Dannenberg L, Piayda K, Levkau B, Hohlfeld T, Zeus T, Kelm M, Polzin A. Analgesic medication with dipyrone in patients with coronary artery disease: Relation to MACCE. Int J Cardiol. 2017 Jun 1;236:76-81. doi: 10.1016/j.ijcard.2017.02.122. Epub 2017 Feb 27.
Clinical trial NCT05629104: Prediction of Long-term Outcome in Aortic Stenosis After Valve Intervention
Official title: Biological Valve Prosthesis in Aortic Stenosis - Imaging, Biomarkers, Physical Performance and Patient Related Factors Predictive to Long-term Outcome (Bio-AS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients accepted for aortic valve intervention due to aortic stenosis

Brief summary: Patients with severe aortic stenosis accepted for transcatheter intervention or open surgery are included before the intervention, and then followed up with clinical visits during the first year after intervention. Imaging with echocardiography and computed tomography (CT) are performed together with additional imaging with magnetic resonance imaging (MRI) and Positron emissions tomography (PET)-CT in a subgroup of the study population. Blood samples, physical performance and questionnaires with focus on frailty and heart failure are also collected at each visit. A follow up with information of the outcomes after 2-5 years will be performed through national registries.


Eligibility criteria: Inclusion Criteria:

* Accepted for aortic valve intervention

Exclusion Criteria:

* No able to follow the study protocol

Primary outcomes:
measure: Semiquantitative assessment of protein levels associated with myocardial performance
timeFrame: One year after intervention.
measure: Imaging parameters associated with clinical outcome after intervention
timeFrame: One year after intervention
measure: Semiquantitative assessment of protein levels associated with myocardial performance associated with clinical outcome after intervention
timeFrame: Two years after intervention
Secondary outcomes:
measure: Imaging parameters associated with clinical outcome after intervention
timeFrame: Two years after intervention
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of cardiology Uppsala University Hospital
Study officials:
affiliation: VO hjärt-lungmedicin och klinisk fysiologi Akademiska Sjukhuset
name: Christina Christersson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04483804: Application of Radiomics in Breast Cancer
Official title: Application of Radiomics in Correlation Between Ultrasound Characteristics and Pathological Prognostic Factors in Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Ultrasound
Elastography
Pathology
Radiomics
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with breast cancer

Brief summary: Little is known about the correlation between ultrasound characteristics (conventional, elastography and contrast enhanced ultrasound (CEUS) )and pathological prognostic factors in breast cancer. The aim of this study was to explore the correlation between ultrasound characteristics and pathological prognostic factors using radiomics.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of breast cancer

Exclusion Criteria:

Missing pathology Missing follow-up results Missing data

Primary outcomes:
measure: metastasis
timeFrame: through study completion, an average of 1 year
measure: death
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: the Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: pintong Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02402504: PERFECT Project - Part 1 - Study 1
Official title: Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 1 - Acute Effects of Pulse Ingredients in Snack Products on Appetite, Blood Glucose, and Food Intake in Adults - Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Prevention
Obesity Prevention
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Saskatchewan Pulse Growers
name: Alberta Pulse Growers
First posted: 2015-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objectives are to test the acute effects of different extruded pulse snacks on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products.

The investigators hypothesize that snack products containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse snack products.


Eligibility criteria: Inclusion Criteria:

* Normoglycemic (\<5.6 mmol/L) and normotensive (systolic blood pressure \<140 mm Hg and diastolic blood pressure below \< 90 mm Hg)
* BMI of 18.5-29.9 kg/m2

Exclusion Criteria:

* Restrained eaters
* Regularly skip breakfast
* Smokers
* Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year
* Competitive sports or athletic training at a high intensity
* Those unable to walk for an hour continuously

Primary outcomes:
measure: Plasma Glucose and Insulin Concentrations
timeFrame: 0 - 200 min
measure: Food Intake
timeFrame: at 120 min
measure: Subjective Appetite
timeFrame: 0-200 min
Secondary outcomes:
measure: Palatability of treatments
timeFrame: at 5 minutes
measure: Palatability of meal
timeFrame: at 140 minutes
measure: Energy and Fatigue
timeFrame: 0-200 min
measure: Physical Comfort
timeFrame: 0-200 min
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
affiliation: University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
name: Peter JH Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnston AJ, Mollard RC, Dandeneau D, MacKay DS, Ames N, Curran J, Bouchard DR, Jones PJ. Acute effects of extruded pulse snacks on glycemic response, insulin, appetite, and food intake in healthy young adults in a double blind, randomized, crossover trial. Appl Physiol Nutr Metab. 2021 Jul;46(7):704-710. doi: 10.1139/apnm-2020-0572. Epub 2020 Dec 21.
Clinical trial NCT04505904: Oxytocin and Approach-avoid in Grief
Official title: A Pull to be Close: the Differentiating Effects of Oxytocin and Grief Stimulus Type on Approach Behavior in Complicated Grief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Grief Disorder
Bereavement
Keywords: Oxytocin
Approach/Avoid
Older adults
Complicated Grief
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 44
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a completed project which was initiated prior to January 18,2017

Background: Theoretical models of complicated grief (CG) suggest that maladaptive approach (e.g., perseverative proximity-seeking of the deceased) or avoidance (e.g., excessive avoidance of reminders) behaviors interfere with a person's ability to integrate the loss and recover from their loved one's death. Due in part to conflicting evidence, little mechanistic understanding of how these behaviors develop in grief exists. We sought to (1) identify behavioral differences between CG and non-CG groups based on implicit bias for grief-, deceased-, and social-related stimuli, and (2) test the role of the neuropeptide oxytocin in shaping approach/avoidance bias.

Methods: Widowed older adults with and without CG completed an approach/avoidance task measuring implicit bias for personalized, non-specific, grief-related, and other stimuli. In a double-blinded, randomized, counterbalanced design, each participant attended both an intranasal oxytocin session and a placebo session. Aims were to (1) identify differential effects of CG and stimulus type on implicit approach/avoidance bias \[placebo session\], and (2) investigate interactive effects of CG, stimulus type, and oxytocin vs. placebo on approach/avoidance bias \[both sessions\].


Eligibility criteria: Inclusion Criteria:

• Adult individual experiencing death of a spouse or partner between 6 and 36 months prior to enrollment

Exclusion Criteria:

* Inability to comprehend English;
* medical contraindications for other components of the study,
* active suicidality
* active homicidality
* active psychotic symptoms
* ongoing major health conditions such as cancer; uncontrolled hypertension; and medications likely to impact the oxytocin system (e.g., systemic corticosteroids).
* pregnant status or suspected pregnant status
* premenopausal status

Primary outcomes:
measure: Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task.
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
References:
Clinical trial NCT04845204: Relaxation Treatment in Total Knee Arthroplasty
Official title: Effects of Progressive Muscle Relaxation Techniques on Pain, Sleeping Quality and Functional Levels After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relaxation; Joint
Total Knee Arthroplasty
Exercise
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgical techniques and treatment methods of the arthroplasty have been improved and the results after total knee arthroplasty (TKA) are generally good. However, some patients have suboptimal postoperative results with respect to pain and physical functioning and may not be satisfied with the results of their TKA. Psychological symptoms were found to be associated with these suboptimal results. The aim of the present study is to determine weather relaxation techniques had beneficial effects on pain, sleeping quality, functional status and physiological symptoms in TKA patients during their hospital stay.


Eligibility criteria: Inclusion Criteria:

* primary knee osteoarthritis, Female Patients who are scheduled for unilateral Total Knee Arthroplasty surgery, were included in the study.

Exclusion Criteria:

* having a previous knee or hip surgery or fracture, diagnosis of rheumatoid arthritis, severe obesity (BMI\>40 kg/m2), sensory and motor disorders in the operated limb, inability to understand pain assessment.

Primary outcomes:
measure: Pain Level Change
timeFrame: Mean change from Postoperative day 1 to day 4 recorded
Secondary outcomes:
measure: Sleep Quality Change
timeFrame: Mean change from Postoperative day 1 to day 4 recorded
measure: Functional Outcomes Change
timeFrame: Mean change from Postoperative day4 to 6 weeks following surgery recorded
measure: Functional Outcomes Change
timeFrame: Mean change from Postoperative day4 to 6 weeks following surgery recorded
measure: Knee Range of Motion Change
timeFrame: Mean change from Postoperative day4 to 6 weeks following surgery recorded
Other outcomes:
Locations:
Study officials:
References:
citation: Koken M, Guclu B. The Effects of Total Knee Arthroplasty on Sleep Quality. Malays Orthop J. 2019 Jul;13(2):11-14. doi: 10.5704/MOJ.1907.002.
citation: Schache MB, McClelland JA, Webster KE. Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial. BMC Musculoskelet Disord. 2016 Jun 13;17:259. doi: 10.1186/s12891-016-1104-x.