louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01990521: Prostate Screening Study Using MRI in BRCA Carriers
Official title: Screening Male BRCA Mutation Carriers: Effectiveness of Multispectral 3T Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Toronto Sunnybrook Regional Cancer Centre
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Women's College Hospital
First posted: 2013-11-21
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset, aggressive prostate cancer compared to men in the general population.

Standard of care screening for men with a BRCA mutation includes PSA testing and digital rectal examination (DRE), the same as with men in the general population.

This study is being done to assess whether there is value in using MRI as a screening tool to detect prostate cancer at an earlier stage than may otherwise be detected using standard of care screening (PSA, DRE). It is unclear whether MRI has utility as a screening tool in this specific population at high risk for aggressive disease.

Detailed description: To determine the value of using Multispectral 3T MRI (MS3TMRI) for prostate cancer screening in men with a high risk of developing early onset aggressive prostate cancer given known BRCA1 or BRCA2 mutation carrier status, with no prior prostate cancer diagnosis, independent of baseline PSA levels.

* Determine the prevalence of prostate cancer in BRCA1 and BRCA2 mutation carriers independent of baseline PSA levels.
* To evaluate the accuracy of tumor targeting based on MRI and ultrasound (US) tumor co-localization. To evaluate the sensitivity, specificity, PPV, NPV, and accuracy of an automated computer aided diagnosis method (CAD) applied to MS3TMRI in the prediction of zonal biopsy results for the presence or absence of a significant cancer.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the Male Hereditary Cancer Research Program at Sunnybrook Health Sciences Center.
* Have positive genetic testing for a pathogenic BRCA1 or BRCA2 mutation.
* Clinically eligible for and willing to undergo ultrasound biopsy within 4 weeks after the MRI.
* Be 50 years of age or older.

Exclusion Criteria:

* Claustrophobia
* Contraindication to MRI
* Contraindication to receiving low molecular weight MRI contrast agent
* Previously diagnosed with prostate cancer

Primary outcomes:
measure: Prostate MRI in BRCA carriers
timeFrame: 2 years (January 2016)
Secondary outcomes:
measure: Prostate cancer in BRCA carriers
timeFrame: 2 years January 2016
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Danny J Vesprini, MD, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05265221: Learning Curve for Gastric Endoscopic Submucosal Dissection
Official title: Learning Curve Analysis for Endoscopic Submucosal Dissection of Gastric Neoplasm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Submucosal Dissection
Gastric Neoplasm
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 356
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who underwent endoscopic dissection due to gastric neoplasms

Brief summary: Endoscopic submucosal dissection (ESD) for early gastric cancer is a widely accepted treatment option of expanded indication worldwide.

ESD is relatively difﬁcult compared with endoscopic mucosal resection, thus, proper training is essential for the safe performance of the procedure. Thus, it is necessary to receive proper training in the procedure for safe performance of ESD. Previous studies reported that there was a learning curve in ESD training and preceptees needed to perform at least 30-40 procedures in order to master this technique. However, there is few study about the association between the clinical characteristics and competence level for gastric ESD.

Detailed description: This study aims to evaluate the clinical outcomes of ESD and to describe the learning curve for ESD of the gastric neoplasm, based on the analysis of a single endoscopist's experience.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed gastric neoplasm

Exclusion Criteria:

* Age \< 20
* History of gastric surgery
* Severe systemic disease
* Advanced chronic liver disease
* Recent history of upper gastrointestinal bleeding

Primary outcomes:
measure: Resection speed
timeFrame: 4 weeks
Secondary outcomes:
measure: Complication rate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
Study officials:
affiliation: Soonchunhyang University Hospital
name: Jun-Hyung Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01820221: Sutures vs. Staples Skin Closure After C-section in Obese Patients
Official title: Staples Compared With Subcuticular Suture for Skin Closure After Cesarean Delivery in Obese Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Pregnancy
Keywords: cesarean delivery
wound complications
skin closure methods
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized prospective clinical trial designed to determine the wound complication rates for stainless steel staples versus subcuticular suture for skin closure in the obese parturient (BMI≥ 30kg/m2) undergoing cesarean delivery.


Eligibility criteria: Inclusion criteria:

* 18 years or older
* BMI ≥ 30kg/m2 on admission to labor and delivery
* Patient is for scheduled cesarean delivery or in non-emergent labor but has an indication for cesarean delivery
* Singleton pregnancies
* Gestational age ≥ 24weeks
* Cesarean delivery performed under regional anesthesia

Exclusion criteria:

* Refusal to participate
* BMI \< 30kg/m2
* \< 24 weeks gestation
* Intrauterine fetal demise
* Chronic pain syndrome requiring chronic narcotic use
* Emergent clinical situations which preclude obtaining informed consent

Primary outcomes:
measure: Wound complication rates
timeFrame: 6 weeks postpartum
Secondary outcomes:
measure: Post-operative pain
timeFrame: 72 hours postpartum
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Mary L Racher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04333264: Clinical Analysis of Suction Drainage in Cementless Hip Replacement
Official title: Clinical Analysis of Suction Drainage in Cementless Hip Replacement - a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthropathy of Hip
Keywords: hip
arthroplasty
suction
drainage
Lead sponsor: Prof A Gruca Teaching Hospital
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of patients with or without closed suction drainage after primary total hip arthroplasty.
Primary purpose: TREATMENT

Brief summary: Randomized prospective study assessing suction drainage in total hip arthroplasty. Group without drainage, 50 hips, compared with group with suction drainage, 50 hips. Both groups will be asses clinically (ROM scale, VAS), laboratory and radiology (USG). In the actually literature there are no benefits using closed suction drainage after primary total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* age between 30-80
* primary hip osteoarthritis

Exclusion Criteria:

* secondary hip osteoarthritis
* autoimmune disease
* congenital or secondary coagulopathy
* vein or artery thrombosis
* renal or liver failure
* cemented or hybrid alloplasty,
* no consent from the patient

Primary outcomes:
measure: Hip hematoma size in USG
timeFrame: 3 days after surgery
measure: Hemoglobin levels
timeFrame: 3 days after surgery
measure: C-reactive protein levels
timeFrame: 3 days after surgery
measure: Visual Analog Scale punctation
timeFrame: 3 day after surgery
measure: Hip range of movement
timeFrame: 3 days after surgery
measure: Wound exudation
timeFrame: 3 days after surgery
measure: Soft tissue hematoma
timeFrame: 3 days after surgery
measure: Intraoperative bleeding
timeFrame: 1 day
measure: Blood transfusion
timeFrame: 14 days after surgery
Secondary outcomes:
measure: Infection
timeFrame: 30 days after surgery
measure: Deep vein thrombosis
timeFrame: 30 days after surgery
measure: Readmission
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Prof. A. Gruca Teaching Hospital in Otwock
name: Pawel Bartosz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bartosz P, Marczynski W, Para M, Kogut M, Bialecki J. Comparative study of suction drainage placement in cementless hip replacement among patients undergoing extended thromboprophylaxis: a prospective randomized study. BMC Musculoskelet Disord. 2021 Aug 13;22(1):688. doi: 10.1186/s12891-021-04583-0.
Clinical trial NCT05108064: Radiomic and Pathomic Study of Pituitary Adenoma Using Machine Learning
Official title: Machine Learning Modeling the Risk of Refractory Pituitary Adenoma Using Radiomic and Pathomic Data
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pituitary Neoplasms
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with pituitary adenoma who were not able to sign the informed consent.

Brief summary: Refractory pituitary adenoma is characterized by invasive tumor growth, continuous growth and/or hormone hypersecretion in spite of standardized multi-modal treatment such as surgeries, medications or radiations. Quality of life or even lives are threatened by these tumors. According to the 2017 World Health Organization's new classification guideline of pituitary adenoma, patients have to suffer from symptoms or complications caused by these tumors, to bear a heavy financial burden, and to accept additional therapeutic side effects when the diagnosis of "refractory pituitary adenoma" is made. If refractory pituitary adenoma could be predicted at early stage, these patients would be able to have a more frequent clinical follow-up, receive multiple effective treatment as early as possible, or even be enrolled in clinical trials of investigational medications, so as to prevent or delay the recurrence or persistent of the tumor growth. Therefore, the unmet clinical need falls into an early prediction system for refractory pituitary adenomas, which could provide accurate guidance for subsequent treatment in the early stage. The investigators have constructed a pituitary adenoma database including clinical data, radiological images, pathological images and genetic information. The investigators are proposing a study using machine learning to extract features from these multi-dimensional, multi-omics data, which could be further used to train a prediction model for the risk of refractory pituitary adenoma. The proposed model would also be validated in another prospectively collected database. The established model would be able to identify potential medication targets and provide guidance for personalized therapy of refractory pituitary adenoma.


Eligibility criteria: Inclusion Criteria:

* All patients with pituitary adenoma

Exclusion Criteria:

* Patients who were not able to sign the informed consent

Primary outcomes:
measure: The risk of refractory pituitary adenoma
timeFrame: 10 years
Secondary outcomes:
measure: Predicting Gamma Knife efficacy
timeFrame: 5 years
measure: Predicting immunostaining
timeFrame: Two weeks after surgery
measure: Predicting recurrence
timeFrame: 10 years
measure: Predicting endocrinopathy
timeFrame: 10 years
measure: Predicting surgical difficulty and complications
timeFrame: Two weeks after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00437164: A Study To Assess GW677954 Used In Combination With Insulin In Subjects Who Have Type 2 Diabetes Mellitus
Official title: A Randomized, Double-blind, Parallel, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of Oral GW677954 Capsules (15 mg) in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Keywords: NaBr
Sodium Bromide
DEXA Deuterium
Total Body Water
Insulin
D2O
GW677954
Randomized Withdrawal
T2DM
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 1
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many drugs used for the treatment of Type 2 Diabetes Mellitus cause the body to retain water. This study will assess whether or not GW677954 causes the body to retain fluid.


Eligibility criteria: Inclusion criteria:

* Have been diagnosed by a doctor with Type 2 Diabetes Mellitus at least 3 months before Screening
* Have a body mass index within range 25 to 40.0kg/m2 inclusive
* Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition)

Exclusion criteria:

* Significant weight loss or gain in the 3 months before screening
* Have used insulin to treat hyperglycemia within 3 months before screening
* Have a history of fluid retention
* Have uncontrolled high blood pressure
* Have liver disease
* Take loop diuretics (water pills), certain blood thinners, and/or St. Johns Wort. - Have or have had certain kinds of cancer

Primary outcomes:
measure: changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight
timeFrame: up to 24 weeks
Secondary outcomes:
measure: safety/tolerability, as measured by adverse events, clinical laboratory, edema & glycemic measures, ophthalmic assessments; & changes in weight, waist & hip circumference
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05015764: Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure Mechanistic Study
Official title: Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure Mechanistic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Reprieve Cardiovascular, Inc
Sponsor class: INDUSTRY
First posted: 2021-08-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Reprieve Cardiovascular System for the Treatment of Subjects with Acute Decompensated Heart Failure Mechanistic Study

Detailed description: The key objective of the trial was to provide an optimized decongestion treatment for subjects with acute decompensated heart failure and identify the critical parameters that could be incorporated into the design of the next generation of the Reprieve Cardiovascular System.

Eligibility criteria: Inclusion Criteria:

1. Hospitalized with a diagnosis of heart failure
2. Patients ≥ 18 years of age able to provide informed consent and comply with study procedures.

Exclusion Criteria:

1. Inability to place Foley catheter or IV catheter
2. Hemodynamic instability
3. Dyspnea due primarily to non-cardiac causes
4. Acute infection with evidence of systemic involvement
5. Inability to follow instructions or comply with follow-up procedures.
6. Other concomitant disease or condition that investigator deems unsuitable for the study
7. Enrollment in another interventional trial during the index hospitalization
8. Life expectancy less than 3 months

Primary outcomes:
measure: Fractional Excretion of Sodium measured during therapy
timeFrame: End of treatment, an average of 24 hours
measure: Device and Procedure related AEs and SAEs
timeFrame: Through study completion, an average of 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Israeli-Georgian Medical Research Clinic Helsicore
Study officials:
References:
Clinical trial NCT02186964: Comparison of Tension Free Primary Closure, Karydaks and Limberg Flap Methods
Official title: Randomised Prospective Comparison of Tension-free Primary Closure, Karydakis and Limberg Flap Methods in Treatment of Pilonidal Sinus Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Disease
Recurrence
Complication
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 150
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: Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life.

There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in between those methods is the closing of the defect that occurs after the excision of the sinus tract. The defect can be closed by primary sutures or it can be left for secondary healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap procedures are commonly used. However, it has been reported that there is no difference between flap procedures and tension free primary closure. This result triggered the controversy that; if the healing side is tension free, midline suturing may have no importance. The aim of this study is to compare the results of 3 different surgical procedures used in treatment of pilonidal disease.


Eligibility criteria: Inclusion Criteria:

* having pilonidal sinus disease
* desire for surgical treatment
* accept to be involved in the study

Exclusion Criteria:

* patients under age of 18
* recurrent cases

Primary outcomes:
measure: recurrence
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Training and Research Hospital
Study officials:
affiliation: Konya Meram State Hospital
name: Ömer Karahan, Professor
role: STUDY_DIRECTOR
References:
citation: Sevinc B, Karahan O, Okus A, Ay S, Aksoy N, Simsek G. Randomized prospective comparison of midline and off-midline closure techniques in pilonidal sinus surgery. Surgery. 2016 Mar;159(3):749-54. doi: 10.1016/j.surg.2015.09.024. Epub 2015 Oct 31.
Clinical trial NCT00502164: Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer
Official title: A Phase I Open-label Dose Escalation Study to Assess the Safety and Tolerability of AZD2171 Following Multiple Oral Doses in Subjects With Advanced Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Prostate Adenocarcinoma
Keywords: Advanced Prostate Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-17
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Men, 18yrs and older
* Histological or cytological confirmation of prostate adenocarcinoma (symptomatic or asymptomatic)
* Prior hormonal therapy, and/or no more than 1 prior chemotherapy regimen (including estramustine and/or corticosteroids) for treatment of prostate adenocarcinoma

Exclusion Criteria:

* Prior radiotherapy to bone metastases within 4 weeks prior to screening
* any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy
* Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable with steroid treatment for 1 week.

Primary outcomes:
measure: To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
Secondary outcomes:
measure: Explore the PK profile of AZD2171 at steady-state administration to subjects
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Research Site
state: California
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Nashville
country: United States
facility: Research Site
state: Tennessee
Study officials:
affiliation: AstraZeneca
name: Nick Botwood, BSc, MBBS, MRCP, MFPM
role: STUDY_DIRECTOR
affiliation: University of California, San Francisco
name: Eric Small, MD
role: PRINCIPAL_INVESTIGATOR
References: