louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03792438: Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound
Official title: Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septum; Uterus
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary infertility or recurrent abortion attending to Early Cancer Detection Unit at Ain Shams Maternity Hospital

Brief summary: This study aims to assess the relation between the vascularity of uterine septum and obstetric performance with Transvaginal 3D Power Doppler Ultrasound

Detailed description: Research hypothesis:

In women with uterine septum vascularity of the septum may affect obstetric performance.

Research question:

In women with uterine septum does vascularity of the septum affect obstetric outcome?

Eligibility criteria: Inclusion Criteria:

* Patients with septate uterus diagnosed by office hysteroscopy

Exclusion Criteria:

* Women with previous uterine scar.
* Women with suspected or confirmed pregnancy.
* Women with active pelvic infection or old one.
* Women with abnormal uterine bleeding.
* Fibroids, adenomyosis or ovarian swelling.

Primary outcomes:
measure: Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium
timeFrame: About 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Professor
name: Mohamed I Amer, MD
role: STUDY_CHAIR
affiliation: Assistant Professor
name: Nashwa E Hassan, MD
role: STUDY_DIRECTOR
affiliation: Lecturer
name: Mortada E Ahmed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06145438: Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery
Official title: Comparing the Safety and Efficacy in the Use of Dienogest, Leuprolide Acetate, DMPA and Combined Oral Contraceptive Pills (Microgynon) on Endometriosis Patients After Conservative Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis Ovary
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare safety and efficacy in endometriosis patient after conservative surgery. The main question\[s\] it aims to answer are:

1. Health-related quality of life (HRQoL)
2. VAS score
3. Beta estradiol
4. TNF Alpha
5. Adnexal mass recurrence

Participants will be randomized into 4 groups, each group will receive:

1. Leuprolide Acetate injection/month
2. Dienogest 2 mg/day
3. COC (mycrogynon)/day
4. DMPA injection 150mg/month Researcher will compare the efficacy and safety in the assigned group.

Detailed description: 1. Beta estradiol level is measured in the serum, before and after treatment
2. TNF alpha is measured in the serum, before and after treatment
3. Evaluation of HRQoL using the Endometriosis Health Profile-30 (EHP-30)
4. VAS score will be recorded before and after treatment
5. Adnexal massa recurrence evaluation using USG

Eligibility criteria: Inclusion Criteria:

Patient post surgical removal of endometriosis cyst Willing to participate

Exclusion Criteria:

1. Use of any hormonal therapy for endometriosis within the previous 16 weeks.
2. History of severe adverse drug reactions or hypersensitivity to steroid hormones.
3. Failure of previous treatment with COC, DMPA used in this study.
4. There are contraindications to the use of Leuprolide Acetate, COC, DMPA or Dienogest, such as a history or complications of thrombosis/embolism, stroke, Diabetes Mellitus, liver cirrhosis or other liver function disorders, breast, ovarian and endometrial malignancies.
5. Smoker.

Primary outcomes:
measure: beta estradiol level
timeFrame: 0 and 12 weeks of treatment
measure: TNF alpha level
timeFrame: 0 and 12 weeks of treatment
Secondary outcomes:
measure: VAS score
timeFrame: 0 and 12 weeks of treatment
measure: health-related quality of life (HRQoL)
timeFrame: 0 and 12 weeks of treatment
measure: Mass recurrence
timeFrame: 0 and 12 weeks of treatment
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Kariadi Hospital
state: Central Java
Study officials:
affiliation: Diponegoro University
name: Yuli Trisetiyono, SpOG (K)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03945838: Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema
Official title: Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema Arm
Lymphedema; Surgical
Keywords: Lymphedema
Hand grip strength
Breast cancer related lymphedema
Complete decongestion therapy
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 74
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: Patients between 18-70 years old with a history of mastectomy or breast conserving surgery and lymphedema

* Having a certain diagnosis of lymphedema

Brief summary: This study aims to find whether complete decongestive therapy used in breast cancer-related lymphedema has an effect on muscle strength in the affected arm, while assessing the efficacy of the therapy itself. 74 patients with breast cancer related lymphedema were included in this study. Patients were taken their demographic and clinical history and were evaluated with measurements of extremity volumes and hand grip strengths using a hand dynamometer before and after the complete decongestive therapy. Data were then assessed using relevant statistical methods.


Eligibility criteria: Inclusion Criteria:

* Having had mastectomy or breast conserving surgery
* Having a certain diagnosis of lymphedema with a difference in arm circumferences more than 1 cm

Exclusion Criteria:

* The subjects with active infection or cancer with metastases, the ones who didn't accept the complete decongestive therapy, patients with vascular disease, rheumatic disease, upper limb deformity, any upper limb surgery history, bilateral lymphedema or a history of transplantation were excluded

Primary outcomes:
measure: Hand grip strength
timeFrame: 3 weeks
measure: Extremity volume
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege university school of medicine
Study officials:
References:
Clinical trial NCT01444638: Evaluation of Ultrasound (US) Assistance for Anesthesia Trainees for Caesarean Section Spinal Placement
Official title: Evaluation of US Assistance for Anesthesia Trainees for Spinal Placement in Parturients Having Caesarean Section: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: pregnancy
Caesarian
section
spinal
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2011-10-03
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Parturients receiving spinal anesthetic for Cesarean section will be randomized to have/not have pre-spinal ultrasound examination of their back.

Detailed description: Parturients receiving spinal anesthetic for elective Cesarean section will be randomized to have/not have pre-spinal ultrasound examination of their back, prior to spinal insertion by anesthesia trainees.

The hypothesis is that ultrasound visualization of the patient spinal spaces will allow junior residents to correctly place the spinal needle with fewer attempts.

The null hypothesis is that there is no difference in the primary outcome (number of attempts). i.e. the investigators hypothesize that the number of attempts is not affected by ultrasound assistance. The control group will undergo spinal anesthesia with manual palpation, the standard of care.

Eligibility criteria: Inclusion Criteria:

1. Parturient scheduled for elective spinal anesthetic for caesarean section.
2. Resident level PGY1 or PGY2.
3. Resident experience between 2-25 spinal anesthetics.
4. ASA 1-3 scheduled for elective sections

Exclusion Criteria:

1. Parturient BMI \> 40.
2. Emergency C-section.
3. Previous spinal surgery or scoliosis.
4. Parturient refusal
5. Resident refusal
6. Multiple gestations

Primary outcomes:
measure: Number of attempts at intrathecal needle tip placement during spinal anesthesia.
timeFrame: Day 1
Secondary outcomes:
measure: 1. Time to place spinal anesthetic (seconds), measured from introducer placement to confirmation of cerebral spinal fluid (CSF).
timeFrame: Day 1
measure: Space used for 1st attempt, as estimated by palpation or U/S
timeFrame: Day 1
measure: Number of spaces used
timeFrame: Day 1
measure: Dural depth (cm)
timeFrame: Day 1
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
Study officials:
affiliation: UWO
name: Timothy P Turkstra, M. Eng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01345838: Acetabular Labral Tear in Dysplastic Hips
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Dysplasia of the Hip
Labrum
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with developmental dysplasia of hip and who is scheduled for PAO

Brief summary: A prospective case-control study of the clinical and radiographic outcome of periacetabular osteotomy in patients with and without preoperative acetabular labral tears.


Eligibility criteria: Inclusion Criteria:

* Developmental dysplasia of the hip

Exclusion Criteria:

* contraindication for magnetic resonance arthrography
* severe deformities of the femural head

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Orthopaedic department, Aarhus Universityhospital
Study officials:
affiliation: Orthopedic Research Unit, Aarhus University Hospital
name: Kjeld Soballe, Prof. D.Msc
role: STUDY_CHAIR
affiliation: Orthopedic Research Unit, Aarhus University Hospital
name: Charlotte Hartig-Andreasen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03921138: Opportunistic Salpingectomy at the Time of Benign Laparoscopic Hysterectomy
Official title: Opportunistic Salpingectomy at the Time of Benign Laparoscopic Hysterectomy : Assessment of Possible Complications and Histopathological Tumor Protein 53 (p53)-Signatures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Laparoscopic Hysterectomy
Systematic Salpingectomy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy

Brief summary: In this prospective study, patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy were included. The aim of this study is to assess the prevalence of tubal histopathological abnormalities such as Serous Tubal Intraepithelial Carcinoma (STIC) and tumor protein 53 (p53) signatures) as well as the prevalence of perioperative and postoperative complications related to opportunistic laparoscopic salpingectomy in a low risk population. The hypothesis is that prophylactic salpingectomy during benign laparoscopic hysterectomy is both feasible and innocuous. Peri- and postoperative complications, duration of salpingectomy and post-salpingectomy blood loss, histopathological and immunohistochemical analysis with anti-p53 antibody were evaluated.


Eligibility criteria: Inclusion Criteria:

* patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy

Exclusion Criteria:

* Hysterectomy in a context of gynecologic cancer
* Hysterectomy not carried out using laparoscopy
* Fimbriated end missing or damaged or impossible for pathologist to analyze

Primary outcomes:
measure: Histopathologic tube anomalies
timeFrame: day 1 of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon (Hôpital Femme Mère Enfant)
name: Gautier Chene, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01634438: Heparin Dose for Radial Angiography
Official title: Low Versus High Dose Unfractionated Heparin in Patients Undergoing Angiography Via the Radial Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Angiograph
Keywords: coronary angiography
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At present, coronary angiogram is usually performed either through an artery in your groin or wrist. An important limitation of the wrist approach is an increase rate of blockage of the wrist artery. It is possible that the dose of blood thinner (i.e. heparin) may decrease the risk of blockage. Early studies seem to suggest that higher dose is required to reduce the risk of this important complication. However, to date there has not been a definitive study to determine the most appropriate heparin dose for the prevention of this complication. The main goal of this study is to determine the appropriate heparin dose to prevent wrist artery blockage and to determine risk factors for developing such a complication.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years of age who were referred for either urgent or elective cardiac catheterization were eligible for the study if a normal Allen's test was demonstrated

Exclusion Criteria:

* myocardial infarction with shock,
* ST-elevation myocardial infarction,
* patients undergoing planned percutaneous coronary intervention, and
* patients in whom transradial approach is contraindicated such as hemodialysis patients

Primary outcomes:
measure: radial artery occlusion
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institute
state: Alberta
Study officials:
References:
Clinical trial NCT05217108: A Mobile Phone Text-based Intervention to Reduce Sedentary Behavior and Engage Communities on the Importance of Healthy Lifestyles: the TEXT2MOVE Study
Official title: A Mobile Phone Text-based Intervention to Reduce Sedentary Behavior and Engage Communities on the Importance of Healthy Lifestyles: the TEXT2MOVE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Life Style
Healthy Lifestyle
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To learn if an 8-week, phone-based texting intervention program will reduce sedentary (non-mobile) behavior.

Detailed description: Primary Objective: To test the effect of two text messaging strategies, responsive texts and standard scheduled texts, on sedentary behavior in a racially and geographically diverse sample of adults.

Secondary Objective: To assess participant engagement with the program and with the educational content delivered via text messaging.

Exploratory Objective: To determine whether two text messaging strategies, responsive texts and standard scheduled texts, increases physical activity in a racially and geographically diverse sample of adults.

Exploratory Objective: To determine whether two text messaging strategies, responsive texts and standard scheduled texts are associated with changes in corresponding patient attitudes as assessed by surveys of exploring sedentary behavior, readiness for exercise change, and physical functioning.

Eligibility criteria: Inclusion criteria:

1. \>18 years old
2. owns a smart phone
3. has access to WiFi or willing to use mobile data
4. has an email address or willing to create an email address
5. able to read and understand English;
6. able to give informed consent;
7. willing to receive text messages and complete brief questionnaires on their smart phone
8. self-reports sedentary behavior (\> 6 hours/day of sitting time).

Exclusion criteria:

1. unwilling to have sedentary behavior and activity tracked
2. unable to walk without ambulatory assistance device (i.e. cane or walker) or due to underlying medical condition
3. MD Anderson employees that report to the Principal Investigators of this study
4. family or household member already enrolled into study
5. not sedentary based on \< 6 hours/day of sitting time, and (6) currently participating in a weight management or exercise study or program

Primary outcomes:
measure: Daily minutes in sedentary behavior based on Fitbit data.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen Basen-Engquist, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05365308: EHR-based Patient Identification and Panel Management of Patients With Iron Deficiency Anemia
Official title: EHR-based Patient Identification and Panel Management of Patients With Iron Deficiency Anemia, a Pragmatic Primary Care Physician Randomized Trial of a Quality Improvement Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency Anemia
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stratified physician-randomized controlled quality improvement intervention study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective is to determine if a set of clinical supports that includes computer-assisted identification, an EHR registry, facilitated GI referral, and an EHR tool for documentation improves the timely referral and completion of bidirectional endoscopy in men aged 18 years and older and women aged 40 years and older with iron deficiency anemia.


Eligibility criteria: Inclusion Criteria:

Northwestern Medical Group primary care physician (internal medicine, family medicine or geriatrics)

Exclusion Criteria:

No primary care office practice within Northwestern Medical Group

Primary outcomes:
measure: Bidirectional endoscopy completed
timeFrame: 120 days
Secondary outcomes:
measure: Endoscopy completed or scheduled
timeFrame: 120 days
measure: Gastroenterology consultation completed
timeFrame: 120 days
measure: GI referral provided or completed
timeFrame: 120 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Division of General Internal Medicine
state: Illinois
city: Chicago
country: United States
facility: Stephen D Persell
state: Illinois
Study officials:
References:
Clinical trial NCT05802108: Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
Official title: Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Adverse Effect of Cardiovascular Medications (Diagnosis)
Lead sponsor: Zibo Central Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with coronary heart disease who were treated with PCSK9 inhibitor evolocumab for intensive lipid-lowering therapy, the changes of retinal microvessels were measured with OCTA (Optical Coherence Tomography Angiography)before and after the treatment. The specific indicators included retinal microvessel diameter, macular area，optic disc vascular density and FAZ(Foveal Avascular Zone)area, etc., to clarify the effect of evolocumab on retinal microvessels after intensive lipid-lowering therapy.


Eligibility criteria: Inclusion Criteria:

1. Age 50-75 years old, gender unlimited;
2. Diagnosed as coronary atherosclerotic heart disease
3. The informed consent for the study has been signed

Exclusion Criteria:

1. Those who are unable to cooperate with the examination;
2. Poor imaging quality of refractive interstitial opacity;
3. Macular edema or complicated with macular membrane and senile macular degeneration;
4. Have a history of previous fundus surgery;
5. Those with eye diseases that can cause changes in the microvessels of the fundus;
6. Abnormal elevated intraocular pressure;
7. Moderate or above refractive error (≥ ± 3 diopters)
8. People with cognitive impairment, material dependence, and serious mental illness;
9. Those who do not cooperate with follow-up;
10. Those who participate in other clinical trials at the same time

Primary outcomes:
measure: the main indicator
timeFrame: Up to 12 months
Secondary outcomes:
measure: the secondary indicator
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Zibo
country: China
facility: Zibo Central Hospital
state: Shandong
Study officials:
References: