louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04983706: Optimization of the Core Number and Location for Targeted Prostate Biopsy
Official title: An Exploratory Study of Optimizing the Core Number and Location for MRI/Ultrasound Fusion Targeted Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.

Detailed description: This is a single-center prospective study. The investigators perform MRI/US image fusion targeted saturation biopsy on prostate lesions with PI-RADS score 4, to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.

Eligibility criteria: Inclusion Criteria:

1. Men more than 18 years old with clinical suspicion of prostate cancer;
2. Serum PSA ≤ 20 ng/ml within the previous 3 months;
3. No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
4. mpMRI PI-RADS V2.1 score ≥4, diameter of ≤2.5 cm；
5. Able to provide written informed consent.

Exclusion Criteria:

1. Prior prostate biopsy or prostate surgery;
2. Prior treatment for prostate cancer;
3. Contraindication to MRI (e.g. claustrophobia, pacemaker);
4. Contraindication to prostate biopsy;
5. Men in whom artifact would reduce the quality of the MRI.

Primary outcomes:
measure: The significant prostate cancer detection rate with different combinations of core number and location in the targeted saturated biopsy area
timeFrame: When histology results available, at an expected average of 3 days post-biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References:
Clinical trial NCT01901406: Change of Retinally-Induced Aniseikonia in Patients With Epiretinal Membrane After Vitrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epiretinal Membranectomy
Keywords: epiretinal membrane, stereopsis, aniseikonia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with epiretinal membrane who had metamorphopsia or had imparied vision, therefore planned to undergo vitrectomy

Brief summary: Epiretinal membrane is common disease, affecting 5\~10 % incidence over 60 years old population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but nowadays with technical improvement and surgical instrument renovation, it seems to have been changed the surgical indication. Therefore, we plan to evaluate the changes of binocular visual acuity, aniseikonia in patients with epiretinal membrane.


Eligibility criteria: Inclusion Criteria:

* Idiopathic epiretinal membrane who had impaired vision or metamorphopsia, want to undergo vitrectomy
* Age more than 20 years and less than 90 years old

Exclusion Criteria:

* secondary epiretinal membrane due to retinal surgery,
* impaired visual acuity less than 20/40 in the normal eye(Snellen chart) due to severe cataract
* glaucoma patients
* complication during vitrectomy (ex. Retinal tear, silicone oil injection, ...)
* other retinal disease except epiretinal membrane
* other ocular surgery history within 3 months
* intellectual problems or illiterate whom could not obtained informed consent

Primary outcomes:
measure: Changes of Stereopsis tested by TNO test (arc of second)
timeFrame: from Initial screening day before surgey to postoperative 6 months
measure: Titmus test (arc of second)
timeFrame: from Initial screening day before surgey to postoperative 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Institute of Vision Research, Department of Ophthalmology, Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT05059249: Effects of Mechanical Versus Manual Traction in the Management of Low Back Pain.
Official title: Effects of Mechanical Versus Manual Traction in the Management of Low Back Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Low Back Pain, Mechanical
Disc Degeneration
Disc Prolapse
Disc Prolapse With Radiculopathy
Lumbar Radiculopathy
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compared the effects of mechanical and manual traction on pain, disability and lumbar spinal curvature in patients with discogenic low back pain


Eligibility criteria: Inclusion Criteria:

* Patients with discogenic low back pain,
* Patients of both genders
* Age ranges from 20 to 60 years
* NPRS \> 5

Exclusion Criteria:

* Patients with non-mechanical back pain
* Patients with known metabolic diseases,
* Osteoporotic patients,
* Recent history of spinal trauma or surgery,
* Lumbar myelopathy,
* Cauda equine syndrome.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 6 weeks
measure: Oswestry disability index
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Institute of Rehabilitation Sciences.
state: Federal
Study officials:
affiliation: Foundation University Islamabad
name: Furqan Yaqoob, PhD*
role: PRINCIPAL_INVESTIGATOR
affiliation: Foundation University Islamabad
name: Muhammad Osama, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06341049: Effect of Three Different Postcesarean Analgesic Techniques on QbsQor-10 Score: Prospective, Randomized Trial
Official title: Effect of Three Different Postcesarean Analgesic Techniques on ObsQoR-10 Score: Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Recovery
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effects of three different postsesarean analgesia techniques, including instillation of local anesthetic into the peritoneum with infiltration into all layers of the anterior abdominal wall, intrathecal morphine injection with local anesthetic, and quadrotus lumborum type 1 block, on the postoperative recovery of women using the ObsQoR-10 score..

Detailed description: This study will be planned on women who will undergo elective cesarean section surgery with neuraxial anesthesia, after obtaining ethics committee approval and written informed consent from the patients.Parturients will be randomized by the statistician using a computerized random numbers table and divided into 3 equal groups: Group IPLA + LWI, Group QLB 1 and Group M.Postoperatively, patients' ObsQoR-10 scores will be evaluated and recorded at the 24th and 48th hours.

Eligibility criteria: Inclusion Criteria:

* Elective cesarean section under spinal anesthesia
* Full-term singleton pregnancy
* Agree to participate in the study
* American Society of Anaesthesiology Score of II

Exclusion Criteria:

* Contrindication for neuraxial anesthesia
* ASA≥3, diabetes, preeclampsia, cardiovascular disease, chronic pain and neuropathic pain
* Age\< 18 or \> 50
* Multiple pregnancy
* Presence of psychiatric diseases
* Gave a history of allergic to any medication in the study protocol
* Gave a history of chronic pain
* Unable to consent
* BMI\>35 kg/m2
* Those who were given opioids during the operation due to intraoperative pain
* Those who have had previous abdominal surgery
* Patients who failed spinal anesthesia and switched to general anesthesia
* Those who have excessive bleeding or uterine atony during the operation
* Does not understand VAS
* Those who have a drain placed in the area to be infiltrated
* Gave a history of drug addiction

Primary outcomes:
measure: obstetric quality of recovery-10 (ObsQoR-10) scores of parturient at the 24th and 48th postoperative hours
timeFrame: Postoperative 24th and 48th hours
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: Palandoken
Study officials:
affiliation: Ataturk University
name: Aysenur Dostbil
role: STUDY_DIRECTOR
References:
Clinical trial NCT06447649: Investigation of Factors Affecting Shoulder Pain in Stroke Survivors
Official title: Investigation of Factors Affecting Shoulder Pain in Stroke Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Functionality
Hemiplegic Shoulder Pain
Stroke
Muscle Tone
Rehabilitation
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: stroke patients treated in the Physical Therapy and Rehabilitation Unit of Pamukkale University Faculty of Medicine Hospital. We conducted patient selection through screening using the Probel system, and randomly assigned patients who met the inclusion criteria and agreed to participate in the study using a random number table.

Brief summary: The aim of this study was to examine the factors affecting shoulder pain in stroke survivors and to determine how much the factors affect shoulder pain

Detailed description: The study included 62 stroke patients who got stage 3 or more from the Brunnstrom upper limp stage. We assessed shoulder pain using the Visual Analog Scale, evaluated muscle tone using the Modified Ashworth Scale, identified myofascial trigger points by manual palpation, and measured range of motion using a universal goniometer. We employed the Fugl-Meyer Upper Extremity Assessment to assess the functional status of the upper extremities. We also used the Neer Impingement, Apprehension, Acromioclavicular Shear, and Speed Tests to evaluate the soft tissue condition.

Eligibility criteria: inclusion Criteria:

* having received a diagnosis of hemiplegia following a cerebrovascular accident (CVA)
* having experienced a first-time stroke
* having unilaterally affected, having stage 3 or above Brunnstrom upper limb stage
* not having any other neurological/orthopedic problems in addition to hemiplegia
* not having any shoulder problems on the same side (affected side) before the stroke
* not having any shoulder problems on the same side (affected side) before the stroke

Exclusion Criteria:

* having a history of shoulder injury (affected side)
* neurological and orthopedic diseases other than stroke
* prior stroke
* bilateral involvement
* non-cooperation

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 1 year
measure: Modified Ashworth Scale (MAS)
timeFrame: 1 year
measure: Fugl Meyer Motor Assesment Scale (FMMAS)
timeFrame: 1 year
measure: Neer Impingement Test
timeFrame: 1 year
measure: Speed Test
timeFrame: 1 year
measure: Acromioclavicular Shear Test
timeFrame: 1 year
measure: Apprehension Test
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT01014949: Microcirculation Assessment in Diabetes and Metabolic Syndrome
Official title: Invasive Coronary Microcirculation Assessment in Diabetes and Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Microvascular Dysfunction
Metabolic Syndrome
Diabetes
Lead sponsor: S.M. Misericordia Hospital
Sponsor class: OTHER
First posted: 2009-11-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Abnormal coronary microvascular vasodilation has been demonstrated in patients with diabetes and metabolic syndrome, but the role of insulin resistance in its pathogenesis is not clear. The aim of this study is to invasively assess coronary microcirculation and to investigate the relationship of insulin resistance with coronary microvascular dysfunction.

A pressure temperature-sensor-tipped coronary wire will be advanced in coronary arteries without significant lumen reduction. Thermodilution-derived coronary flow reserve (CFR) will be calculated as resting mean transit time (Tmn) divided by hyperemic Tmn (obtained with a 5-min i.v. infusion of adenosine 140 mg/kg/min). An index of microvascular resistance (IMR) will be calculated as the distal coronary pressure at maximal hyperemia divided by the inverse of the hyperemic Tmn. FFR will be calculated by the ratio of Pd/Pa at maximal hyperemia. Insulin resistance (IR) will be assess by the homeostasis model assessment (HOMA) index and plasma IL-6 and TNF-alpha levels will be measured in addition to routine blood examinations before the procedure.


Eligibility criteria: Inclusion Criteria:

* Patients with stable angina or inducible myocardial ischemia
* Coronary arteries without high-grade epicardial stenoses (angiographic stenosis \< 50% and fractional flow reserve \[FFR\] \> 0.75)

Exclusion Criteria:

* Significant renal insufficiency (serum creatinine \> 1.5 mg/dL), a recent (\< 1 week) acute coronary syndrome, heart failure, severe valvular disease, or hypertrophic cardiomyopathy.

Primary outcomes:
measure: Coronary Flow Reserve and Index of Microvascular Resistance values
timeFrame: Outcome measures will be assessed at the end of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Grosseto
country: Italy
facility: Interventional Cardiology Unit, Misericordia Hospital
Study officials:
References:
citation: Picchi A, Limbruno U, Focardi M, Cortese B, Micheli A, Boschi L, Severi S, De Caterina R. Increased basal coronary blood flow as a cause of reduced coronary flow reserve in diabetic patients. Am J Physiol Heart Circ Physiol. 2011 Dec;301(6):H2279-84. doi: 10.1152/ajpheart.00615.2011. Epub 2011 Oct 7.
Clinical trial NCT01765049: Breast Density Change Predicting Response to Adjuvant Aromatase Inhibitor
Official title: Prospective Study Analyzing Value of Breast Density Change Predicting ENdocrine Therapy Response in Postmenopausal Women Taking Adjuvant ARomatase Inhibitor
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Invasive Breast Cancer
Estrogen Receptor Positive Breast Cancer
Keywords: breast density change
endocrine therapy response
aromatase inhibitor
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 260
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women with ER positive invasive breast cancer taking adjuvant endocrine therapy with aromatase inhibitor

Brief summary: Breast density change after short term use of aromatase inhibitor in postmenopausal ER positive breast cancer would predict endocrine responsiveness

Detailed description: Inclusion criteria ER positive breast cancer Postmenopause women Older than 60yr S/P bilateral salphingo-oophorectomy No menstruation history within 1yr and FSH\>30mIU/mL Ipsilateral invasive breast cancer Undergone curative resection No evidence of distant metastasis Capable of breast MRI

Eligibility criteria: Inclusion Criteria:

* ER positive invasive breast cancer Postmenopause women age 60yrs or older s/p bilateral salphingo-oophorectomy No history of menstruation and FSH\>30mIU Planned for aromatase inhibitor Unilateral breast cancer Curative resection No evidence of distant metastasis

Exclusion Criteria:

* Bilateral breast cancer Male breast cancer Acceptable for breast MRI Pregnancy or lactation

Primary outcomes:
measure: disease free survival
timeFrame: 5 year
Secondary outcomes:
measure: breast density change
timeFrame: 6mos, 1yr, 2yr
Other outcomes:
measure: overall survival
timeFrame: 5 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: SNUH
name: Wonshik Han, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04569149: Primordial Dwarfism Registry
Official title: Primordial Registry at Nemours/A. I. duPont Hospital for Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MOPDII
RNU4atac-opathy (e.g. MOPDI/III, Lowry-Wood Syndrome, Roifman Syndrome)
Meier-Gorlin Syndrome
Saul-Wilson Syndrome
Ligase 4 Syndrome
Microcephalic Primordial Dwarfism
Keywords: microcephalic primordial dwarfism
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: Potentials Foundation
name: Walking with Giants Foundation
First posted: 2020-09-29
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual at any age with microcephalic primordial dwarfism or a closely related condition

Brief summary: The goal of this registry is to collect information on individuals with forms of microcephalic primordial dwarfism. The study team hopes to learn more about these conditions and improve the care of people with it by establishing this registry.

Detailed description: The goal of this registry is to collect information on individuals with forms of microcephalic primordial dwarfism. The registry will enable detailed natural history studies of MOPD II and associated conditions. The study team hopes that identification of risk factors will allow for preventative treatments and thus a better quality of life for individuals with these diagnoses.

This study is limited to chart review, after signed informed consent obtained. There will be no additional visits or time in clinic because of participation in this registry. This study involves only the collection and storage of data extracted from the medical record. Records that may be requested and reviewed as a part of this study include but may not be limited to: specialist evaluations, surgical reports, results of blood and urine tests, genetic testing, x-rays, CT/MRI/MRA imaging. There are no special procedures, visits, or expectations of the individual as a result of participation in this registry. No one will be asked to have any specific testing for the sole purposes of this research.

Eligibility criteria: Inclusion Criteria:

* Individuals with MOPDII, MOPDI/III, Meier-Gorlin syndrome, or unclassified or closely related types of microcephalic primordial dwarfism as diagnosed by a medical provider are eligible for this registry.

Exclusion Criteria:

* individuals without microcephalic primordial dwarfism or closely related conditions

Primary outcomes:
measure: Characterization of the natural history of various forms of primordial dwarfism
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours
state: Delaware
Study officials:
affiliation: Nemours
name: Angela Duker, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06443749: Closure of the Appendiceal Stump
Official title: Closure of the Appendiceal Stump With a Polymer Clip Versus Intracorporeal Ligation With a Single Instrument in Laparoscopic Appendectomy; Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Appendectomy
Keywords: Appendectomy
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 48
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: Laparoscopic appendectomy is a well-defined surgical technique. However, concerns remain about whether closure of the appendiceal stump should be done with clips, endoloops, staples, or other techniques. If tying is to be used in the closure of the appendiceal stump, there is no consensus on which technique (intracorporoyal, extracorporoyal, etc.) should be used for ligation. For this reason, there is a need for studies on different binding techniques and instruments currently used. The aim of this study was to compare the use of unilateral intracorporeal knot and polymer endoclip closure during laparoscopic appendectomy.

Detailed description: Patients who are scheduled to undergo laparoscopic appendectomy after the ethics committee approval will be included consecutively. Patients will be randomized into 2 groups: those who will be closed with a polymer endoclip (Group 1) and those who will be closed with an intracorporeal node with a single instrument (Group 2). Data such as age, gender, body mass index, comorbidities, previous abdominal surgeries, medications used by the patients, as well as the presence of ileus, perforation, and diffuse peritonitis will be recorded. After laparoscopic dissection, the appendiceal stump will be closed with a polyper homologous clip in Group 1 and the stump will be closed with an intracorporial node with a single instrument in Group 2. The operation times of the patients, the time elapsed after the end of the dissection until the pathology specimen comes out of the skin (to be determined as the closure time), complications such as ileus, intra-abdominal abscess, bleeding and fistula related to stump closure problems encountered in the postoperative period will be recorded and compared. Patients will be followed by the corresponding author In both surgical methods, it is routinely used to close the appendiceal stump and in the polymer clip application, a clip with a locking mechanism is used when the stump is tightened with an applicator. In the intracorporial node with one hand, the surgical node is made by circulating the tip of the suture material around the appendix with a single instrument (the other end is kept fixed outside the abdomen)

Eligibility criteria: Inclusion Criteria

* Patients who are diagnosed with acute appendicitis

Exclusion Criteria:

* bleeding diathesis
* cirrhotic acid,

Primary outcomes:
measure: operation time
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: