louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04936334: The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer
Official title: The Role of 68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer: A Prospective Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results informs treatment decisions versus the treatment decisions with only MRI knowledge.
Primary purpose: DIAGNOSTIC

Brief summary: Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard).

Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4).

Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments.

Assess quality of life changes from preoperative baseline.


Eligibility criteria: Inclusion Criteria:

* 1. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with:

  1. \> 3 cores of Gleason 3+4 or
  2. NCCN unfavorable intermediate risk or
  3. NCCN high-risk or
  4. NCCN very-high risk 3. Scheduled for standard of care MRI or has recently completed standard of care MRI (within 6 months).

Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI

Exclusion Criteria:

* 1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.

  2. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging).

  3. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.

Primary outcomes:
measure: Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension
timeFrame: The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery.
measure: Specificity of PSMA-PET and MRI
timeFrame: Pre-surgery prediction.
Secondary outcomes:
measure: 1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET
timeFrame: 60 Days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT01790334: Effects of Different Modes of Ventilation and Head Position on Size of Vena Jugular Interna
Official title: Comparing the Size of the Vena Jugular Interna Under Spontaneous Ventilation and Different Mechanical Ventilation Modes When Head is in Neutral and 30 Degree Lateral Position:Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Line Complication
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 ASA status I-II patients between 18-80 years old undergoing elective abdominal surgery under endotracheal intubation will be included in this random, prospective, clinical study.

Brief summary: It is widely known that positive mechanical ventilation increases the positive intrathoracic pressure which affects the pressure in the RIJV, resulting in an increase of the CSA. Currently, there appears to be a lack of studies in the literature that assess the effects of different modes of ventilation of this increase.

The aim of our study is to evaluate the changes in cross-sectional area and diameters of RIJV under two different mechanical ventilation modes (PCV and VCV) and spontaneous ventilation in head neutral and 30 degree rotated lateral position by using ultrasonography and to determine the ventilation mode that is most suitable for catheterization.


Eligibility criteria: Inclusion Criteria:

* 30 ASA status I-II patients between 18-80 years old undergoing elective abdominal surgery

Exclusion Criteria:

* Patients with a history of congestive heart failure, pulmonary hypertension, chronic renal failure, diabetes mellitus, rheumatological diseases, neck surgery, valvular disease, obesity or RIJV catheterization will be excluded from the study

Primary outcomes:
measure: comparing the size of right internal jugular vein in different mechanical ventilation modes
timeFrame: 1 month
Secondary outcomes:
measure: effect of different head positions on the right internal jugular vein size
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
state: Fatih
Study officials:
References:
citation: Lobato EB, Florete OG Jr, Paige GB, Morey TE. Cross-sectional area and intravascular pressure of the right internal jugular vein during anesthesia: effects of Trendelenburg position, positive intrathoracic pressure, and hepatic compression. J Clin Anesth. 1998 Feb;10(1):1-5. doi: 10.1016/s0952-8180(97)00189-x.
Clinical trial NCT02435134: Examination Chair for Hip Internal Rotation Range of Motion Measurement
Official title: Validation of a Test Protocol for Measuring the Hip Internal Rotation Range of Motion Using a Newly Developed Examination Chair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limited Hip Mobility
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants

Brief summary: Hip internal rotation range of motion (HIRROM) assessment is performed to assess the mobility of the hip. The assessment is typically done manually (manual testing), which induces large variability in the results between and within testers. An initial version of an examination chair (EC1) was recently developed with the aim to minimize the variability of testing results for HIRROM assessments. A new version of the examination chair (EC2) has been implemented in order to individualize the testing protocol and will be validated in this study.


Eligibility criteria: Inclusion Criteria:

* Participants are pain free in the lower extremity, hip and back
* Participants signed the consent form

Exclusion Criteria:

* Participant requires pain relief medication
* History of hip surgery
* Neuromuscular disorders
* Legal incompetence

Primary outcomes:
measure: Hip internal rotation range of motion angle (degrees)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Schulthess Klinik
Study officials:
References:
Clinical trial NCT05143034: the Evaluation of the Efficacy of TCI66207 on the Skin.
Official title: Evaluation of Skin Efficacy of TCI66207
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Diseases
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the evaluation of the efficacy of TCI66207 deep-sea live-face bacteria on the skin.


Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers aged above 20 years old
2. Subject has dull skin.

Exclusion Criteria:

1. .Subject with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
2. Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
3. Female who is pregnant or nursing or planning to become pregnant during the course of the study.
4. Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
5. Subjects who have large spots (area \>3 square centimeter) or abnormal acne.

Primary outcomes:
measure: The change of skin moisture
timeFrame: Subjects will be tested in the 4th week.
measure: The change of skin elasticity
timeFrame: Subjects will be tested in the 4th week.
measure: The change of skin wrinkles
timeFrame: Subjects will be tested in the 4th week.
measure: The change of skin collagen density
timeFrame: Subjects will be tested in the 4th week.
measure: The change of skin texture
timeFrame: Subjects will be tested in the 4th week.
measure: The change of skin pores
timeFrame: Subjects will be tested in the 4th week.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Research & Design Center, TCI CO., Ltd
state: Neipu Township
Study officials:
affiliation: Chia Nan University of Pharmacy ＆ Science
name: Chia-Hua Liang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00247234: Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders
Official title: Effectiveness of Group Based Schema Therapy in the Treatment of Borderline Personality Disorder and Avoidant Personality Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Personality Disorder, Borderline
Avoidant Personality Disorder
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2005-11-01
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to compare the effectiveness of schema therapy with standard psychiatric outpatient care for patients with borderline or avoidant personality disorder.


Eligibility criteria: Inclusion Criteria:

* Avoidant or Borderline personality disorders

Exclusion Criteria:

* Do not speak Scandinavian languages
* Antisocial personality disorder
* Narcissistic personality disorder
* Affective bipolar disorder I
* Schizophrenia
* Mental impairment/organic brain disorder
* Substance dependence
* Planned pregnancy
* Serious somatic illness
* Anorexia Nervosa

Primary outcomes:
measure: quality of life
timeFrame: 5 years
measure: depression
timeFrame: 5 years
measure: anxiety
timeFrame: 5 years
measure: suicidal ideation
timeFrame: 5 years
Secondary outcomes:
measure: Use of psychotropic medication
timeFrame: 5 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Department of Neuroscience, NTNU - Faculty of Medicine, MTFS, NO-7489 Trondheim, Norway
name: Are Holen, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05185934: The Effect of Dietary Intervation on Endothelial Glycocalyx in COVID-19 Patients.
Official title: The Effect of Dietary Glycocalyx Precursor Supplementation on Endothelial Function, on Markers of Vascular Function and on Cardiac Performance in Patients With COVID-19 Infection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Endothelial Dysfunction
Keywords: COVID-19
Arterial Stiffness
Endothelial Glycocalyx
Coronary microcirculation
Left ventricular myocardial deformation
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty patients with COVID-19 infection will be randomized to receive food supplement Endocalyx (n=30) or placebo (n=30) for 4 consecutive months.
Primary purpose: PREVENTION

Brief summary: The food supplement Endocalyx is considered to support the endothelial glycocalyx integrity by supplying sulfated polysaccharides, anti-oxidant enzymes and additional substrates for glycocalyx synthesis. The investigators will study the effect of Endocalyx on endothelial, vascular and left ventricular myocardial function in patients with COVID-19 infection.

Detailed description: Sixty patients who have been hospitalized due to COVID-19 infection will be randomized to receive food supplement Endocalyx (4 capsules per day) (n=30) or placebo (n=30) for 4 consecutive months.

Eligibility criteria: Inclusion Criteria:

* caucasian patients
* hospitalization for COVID-19 infection
* diagnosis of COVID-19 proven by PCR

Exclusion Criteria:

* Pregnancy and breastfeeding
* Foreseen inability to attend scheduled visits
* History of acute coronary syndrome. Coronary artery disease will be excluded by a clinical history, examination and electrocardiogram.
* Moderate or severe valve disease
* Primary cardiomyopathies
* Chronic obstructive pulmonary disease
* Asthma
* Chronic kidney disease (estimated glomerular filtration rate \[eGFR\] ≤60 ml/min/1.73 m2)
* Liver failure
* Malignancies

Primary outcomes:
measure: Endocalyx effects on endothelial glycocalyx thickness
timeFrame: four months
Secondary outcomes:
measure: Endocalyx effects on arterial stiffness
timeFrame: four months
measure: Endocalyx effects on coronary microcirculation
timeFrame: four months
measure: Endocalyx effects on left ventricular myocardial function
timeFrame: four months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Attikon" University General Hospital
state: Attiki
Study officials:
References:
Clinical trial NCT00065234: Acupuncture to Prevent Postoperative Bowel Paralysis (Paralytic Ileus)
Official title: Acupuncture to Prevent Postoperative Paralytic Ileus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ileus
Neoplasms
Keywords: Colostomy
Ileostomy
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if acupuncture is effective in preventing prolonged postoperative paralysis of the gastrointestinal tract among patients undergoing colostomy/ileostomy closure.


Eligibility criteria: Inclusion Criteria:

* Previous surgical cancer treatment with ileostomy/colostomy, now scheduled for closure
* Hospital admission must be same day as surgery

Exclusion Criteria:

* Incapacitating disease
* Concurrent herbal or laxative use
* Use of Heparin or Coumadin
* Upper or lower extremity deformities
* Chronic constipation prior to cancer diagnosis
* History of cerebrovascular accident or spinal cord injury
* Chronic pain that has been treated with any form of major opioid or weak opioids (=/\> 30mg/24 hours)
* Pacemaker or metal implants
* Concurrent alternative medicine/herbal use

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Joseph S Chiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06071234: Preoperative Evaluation of 3D Reconstruction Tool for Nipple-sparing Mastectomy
Official title: An Exploration of 3D Reconstruction Tool for Preoperative Evaluation in Reducing Ischemic Complications of Flap and Nipple-Areolar Complex (NAC) After Nipple-sparing Mastectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical study is to explore whether preoperative application of 3D reconstruction tool can reduce the occurrence of ischemic complications in the flap and nipple areola complex after surgery.

Detailed description: The 3D reconstruction tool was applied preoperatively to assess the blood supply and volume of participants' breasts and to recommend personalized prosthesis volume. Compared with electrosurgical knife separation，the flap was separated intraoperatively using a combination of cold knife and electrosurgical knife to observe whether there was a difference in the incidence of ischemic complications of participants' nipple areola complex and flap, and whether the use of the 3D tool in the preoperative assessment was effective in reducing the occurrence of postoperative ischemic complications.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed diagnosis of breast cancer
* Age: 18 to 70 years old
* No infiltration of the nipple-areola complex and negative histopathology of the nipple basal margins;
* Participants who meet the indications for breast conserving surgery require total mastectomy and reconstruction;

Exclusion Criteria:

* Inability to tolerate surgery or subjective desire not to undergo nipple-sparing mastectomy;
* Participants with clinical or imaging evidence of preoperative involvement of the nipple/areolar region, including Paget's disease, nipple spillage, inflammatory breast cancer, and/or imaging findings suggesting malignant involvement of the nipple or subareolar tissues, according to the 2023 NCCN guideline recommendations, where retaining the NAC fails to yield negative margins;

Primary outcomes:
measure: Ischemic complications of flap and nipple areola complex
timeFrame: 1 week and 2 week after surgery
Secondary outcomes:
measure: Severity of ischemic complications in the flap and nipple areola complex
timeFrame: 1 week and 2 week after surgery
measure: Duration of surgery
timeFrame: postoperative
measure: Blood loss
timeFrame: Preoperative and 2 hours postoperatively
measure: Breast-Q Satisfaction
timeFrame: Preoperative, 3 months and 1 year postoperatively
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02111434: Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment
Official title: Phase 4 Study of Effect of Testosteron Treatment on the Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadism
Keywords: visceral adiposity index
triglycerides / hdl cholesterol ratio
testosterone
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The study is designed to answer the following questions:

1. What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio in hypogonadism?
2. What is the effect of testosterone replacement on the visceral adiposity index and Triglycerides/HDL cholesterol ratio?

Detailed description: This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2007-2010.

Eligibility criteria: Inclusion Criteria:

* Men
* Congenital hypogonadism
* Treatment Naive

Exclusion Criteria:

* Previous history of androgen replacement
* Hypertension
* Diabetes mellitus

Primary outcomes:
measure: time to change of visceral adiposity index with testosteron replacement
timeFrame: baseline and 6 months
measure: time to change of TG/HDL cholesterol ratio with testosteron replacement
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine
Study officials:
References:
Clinical trial NCT01829334: Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
Official title: A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries
Keywords: dental caries
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 329
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this proposed study is to investigate the cost-effectiveness of four methods in preventing fissure caries in permanent teeth, which is the most prevalent dental disease in primary school children in China.

The four caries prevention methods are: resin fissure sealant, atraumatic restorative treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution.

The specific study objectives are:

1. to describe longitudinally the clinical outcomes of using the above four methods to prevent dental caries in the pits and fissures of permanent first molars in school children,
2. to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and
3. to compare the cost-effectiveness of the above four caries prevention methods.


Eligibility criteria: Inclusion Criteria:

* school children in good general health
* has at least one pair of sound permanent first molars with deep occlusal fissures or fissures with signs of early caries

Exclusion Criteria:

* children with major systemic disease or on long-term medication
* children not cooperative and refuse dental treatments

Primary outcomes:
measure: dental caries
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Primary schools
Study officials:
affiliation: The University of Hong Kong
name: Edward CM Lo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu BY, Xiao Y, Chu CH, Lo EC. Glass ionomer ART sealant and fluoride-releasing resin sealant in fissure caries prevention--results from a randomized clinical trial. BMC Oral Health. 2014 May 19;14:54. doi: 10.1186/1472-6831-14-54.