louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01437085: A Study to Measure Needle Bending and Changes in Prostate Shape During a Prostate Seed Implant
Official title: Quantifying Needle Deflection and Tissue Deformation in Transperineal Interstitial Permanent Prostate Brachytherapy: A Basis for Development of Next-Generation Implant Technique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: Needle deflection
Prostate Deformation
Prostate Brachytherapy
Needles
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 25
Sex: MALE
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: Patients having a prostate brachytherapy implant at the Cross Cancer Institute.

Brief summary: Prostate brachytherapy is an effective treatment option for men with localized prostate cancer, with excellent cure rates and a favorable toxicity profile. With the current needle insertion technique, seed placement inaccuracy is primarily caused by needle deflection and soft tissue deformation, which both occur during the brachytherapy operation. This study will accrue 20 patients undergoing prostate brachytherapy implants and acquire a series of ultrasound images, video clips and one CT scan.


Eligibility criteria: Inclusion Criteria:

* Prostate cancer
* Treated with prostate brachytherapy at the Cross Cancer Institute
* Low and intermediate risk prostate cancer
* ambulatory patients
* stable medical condition
* Over 18 years of age
* Capable of giving informed consent

Exclusion Criteria:

* Any hormonal therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Nawaid Usmani, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03240185: Post Hemorrhoidectomy Anorectal Pain
Official title: Effectiveness of Guided Breathing Exercises on Anorectal Pain in Patients With Symptomatic Hemorrhoids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhoid Pain
Keywords: hemorrhoid
pain
deep breathing
multimodal pain control
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in colorectal surgery clinic with planed hemorrhoid surgery

Brief summary: This is a quality assurance trial to evaluate the effectiveness of guided breathing exercises on reducing the symptoms of hemorrhoidal disease in colorectal surgery patients. All patients who undergo hemorrhoid surgery are educated on breathing exercises that can be used to reduce pain and increase relaxation. These patients will be surveyed at their post-operative visit regarding pain and other symptoms and at their one month post operative visit on the any hospitalizations and emergency room visits since their surgery.

Detailed description: The effectiveness of guided breathing exercises on reducing the symptoms of hemorrhoidal disease in colorectal surgery patients will be assessed in this quality assurance trial. During the pre-operative clinic visit, patients to undergo hemorrhoid surgery are educated on breathing exercises that can be used to reduce pain and increase relaxation. In this year long study patient self-reported utilization of the breathing exercises and their level of pain, sleep quality, gastrointestinal symptoms (diarrhea, constipation, etc), emergency room visits, and hospitalizations in the month post hemorrhoid surgery will be evaluated. All patients will be asked to complete a brief survey at their pre-operative and one month post-operative visits.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective hemorrhoid surgery

Exclusion Criteria:

* Emergent/urgent hemorrhoid surgery

Primary outcomes:
measure: Pain scores
timeFrame: within ~30 days of surgery, at the time of post-operative clinic visit
measure: Utilization of breathing exercises
timeFrame: within ~30 days of surgery, at the time of post-operative clinic visit
Secondary outcomes:
measure: Admissions within 30 Days of Surgery
timeFrame: within 30 days of surgery
measure: Emergency Department visits within 30 Days of Surgery
timeFrame: within 30 days of surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Jason Hall, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02704585: Comparison of Two Pulse Oximeters in Delivery Room
Official title: Comparison of Two Pulse Oximeters in Delivery Room: A Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia
Keywords: Neonatal resuscitation
Pulse oximetry
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Time to stable reading of oxygen saturation at the delivery room will be compared between two different devices.

Detailed description: After delivery babies will be located in the radiant warmer. The probe of each pulse oximeter will be applied to one of the feet. Both probes will be simultaneously connected to the female plug of the pulse oximeter.

Heart rate will be checked

Time to get a stable reading in each device (by observation on the devices' display) will be recorded; this will be the primary study outcome. Other vital signs (oxygen saturation, heart rate) and demographics) will be recorded as well.

Paired students T test will be used for the statistical analyzes.

Eligibility criteria: Inclusion Criteria:

* Neonates in the operation or delivery room immediately after delivery whose parents agreed to enter the study

Exclusion Criteria:

* Malformation of one of the legs, not allowing sensor application. Any situation in which the study might interfere with the treatment of the newborn

Primary outcomes:
measure: Time to steady reading in the pulse oximeter
timeFrame: up to 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Ruben Bromiker
Study officials:
affiliation: Shaare Zedek Medical Center
name: Ruben Bromiker, MD
role: STUDY_CHAIR
References:
citation: Baquero H, Alviz R, Castillo A, Neira F, Sola A. Avoiding hyperoxemia during neonatal resuscitation: time to response of different SpO2 monitors. Acta Paediatr. 2011 Apr;100(4):515-8. doi: 10.1111/j.1651-2227.2010.02097.x. Epub 2011 Jan 17.
Clinical trial NCT06774885: ROLE OF FOLIC ACID IN THE MANAGEMENT OF ADJUVANT ENDOCRINE THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS
Official title: ROLE OF FOLIC ACID IN THE MANAGEMENT OF ADJUVANT ENDOCRINE THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS
Keywords: Breast cancer
Hot flashes
Endocrine therapy
Folic acid
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study's objective is to investigate the role of folic acid administration in the management of hot flashes associated with adjuvant endocrine therapy in patients with breast cancer.

Detailed description: Folic acid is one of the B vitamins that when absorbed into its active form is converted to tetrahydrofolate. Folate is an essential cofactor for the biosynthesis of norepinephrine and serotonin. Studies have also noted that folate, with a mechanism like hormone replacement therapy (HRT), can improve hot flashes by interfering with monoamine neurotransmitters called norepinephrine and serotonin .The purpose of the current study is to investigate the role of folic acid administration in the management of hot flashes associated with adjuvant endocrine therapy in patients with breast cancer.

Eligibility criteria: Inclusion Criteria:

* Females older than 18 years
* Diagnosed with confirmed breast cancer and currently treated with an adjuvant endocrine
* Experiencing bothersome hot flashes at least 14 times/week
* Taking the treatment within 6 months to two years.

Exclusion Criteria:

* Known hypersensitivity to folic acid
* Patients who have been treated with selective serotonin reuptake inhibitors (SSRIs) within the past 30 days.
* Renal impairment is defined as a serum creatinine level greater than 2 mg/ld..
* Significant liver disease: Indicated by liver enzyme levels exceeding two times the upper limit of normal.
* Metastatic breast cancer
* Taking other medication for hot flashes
* Medications inducing hot flashes such as (Clomiphene, Opioids, Nifedipine, Prednisone)

Primary outcomes:
measure: Reduction in Hot Flash Frequency and Severity
timeFrame: 3 months
Secondary outcomes:
measure: Improvement in Quality of Life
timeFrame: 3 months
measure: Correlation with Folic Acid Blood Levels
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05244785: Health and Nutrition Survey on Shenzhen Children
Official title: Investigation on Nutritional Health and Growth Status of Primary and Middle School Students in Shenzhen, 2021
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition Disorder, Child
Nutrition Disorders in Adolescence
Nutritional Deficiency
Nutrition, Healthy
Nutritional Stunting
Nutritional and Metabolic Diseases
Nutritional Imbalance
Development, Child
Development, Adolescent
Growth Disorders
Growth; Stunting, Nutritional
Lead sponsor: Shenzhen Center for Chronic Disease Control
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2022-02-17
Enrollment: 4500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Primary and secondary school students in Shenzhen.

Brief summary: 1. Master and analyze the nutritional health, growth and development status of primary and secondary school students in Shenzhen, and discover the main nutritional health, growth and development problems and influencing factors.
2. Provide basic data and evidence-based basis for the municipal government and related departments to formulate child health policies and measures.


Eligibility criteria: Inclusion Criteria:

With signed consent to be a study subject.

Exclusion Criteria:

None.

Primary outcomes:
measure: Weight
timeFrame: 6 months
measure: Height
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Vitamin concentrations in circulation
timeFrame: 8 months
measure: Mineral concentrations in circulation
timeFrame: 8 months
measure: Glucose and lipid concentrations in circulation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Center for Chronic Disease Control
state: Guangdong
Study officials:
affiliation: Shenzhen Center for Chronic Disease Control
name: Jingfan Xiong, Director
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01641185: Ion Prostate Irradiation
Official title: Hypofractionated Ion Irradiation (Carbon Ions Versus Protons) of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: prostate
IPI
hypofractionation
carbon ions
proton
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2012-07-16
Enrollment: 92
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of the prostate with carbon ions or protons using the raster scan technique.

Detailed description: as published: Habl G, Hatiboglu G, Edler L, Uhl M, Krause S, Roethke M, Schlemmer HP, Hadaschik B, Debus J, Herfarth K: Ion Prostate Irradiation (IPI) - a pilot study to establish the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan technique. BMC cancer 2014, 14(1):202.

http://www.ncbi.nlm.nih.gov/pubmed/24641841

Eligibility criteria: Inclusion Criteria:

histological proven carcinoma of the prostate with Gleason score risk of lymphe node involvement of \<15% calculated by the Yale-formula; Risk \[%\] = \[GS -5\] x \[PSA/3 + 1.5 x T\], mit T = 0, 1, and 2 for cT1c, cT2a, und cT2b/cT2c

* Karnofsky-Index ≥ 70%
* age between 40 and 80 years
* PSA

Exclusion Criteria:

Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation of the pelvis pacemaker defibrillator

Primary outcomes:
measure: proctitis and cystitis
timeFrame: 3 years
Secondary outcomes:
measure: PSA-PFS
timeFrame: 3 years
measure: OS
timeFrame: 3 years
measure: quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg, Radiooncology, HIT
Study officials:
affiliation: University Hospital of Heidelberg
name: Klaus Herfarth, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Habl G, Hatiboglu G, Edler L, Uhl M, Krause S, Roethke M, Schlemmer HP, Hadaschik B, Debus J, Herfarth K. Ion Prostate Irradiation (IPI) - a pilot study to establish the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan technique. BMC Cancer. 2014 Mar 19;14:202. doi: 10.1186/1471-2407-14-202.
citation: Habl G, Uhl M, Katayama S, Kessel KA, Hatiboglu G, Hadaschik B, Edler L, Tichy D, Ellerbrock M, Haberer T, Wolf MB, Schlemmer HP, Debus J, Herfarth K. Acute Toxicity and Quality of Life in Patients With Prostate Cancer Treated With Protons or Carbon Ions in a Prospective Randomized Phase II Study--The IPI Trial. Int J Radiat Oncol Biol Phys. 2016 May 1;95(1):435-443. doi: 10.1016/j.ijrobp.2016.02.025. Epub 2016 Feb 12.
Clinical trial NCT00306085: Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis
Official title: Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Peripheral Vascular Diseases
Keywords: Peripheral arterial disease,
blood marrow cells,
therapeutic angiogenesis.
Lead sponsor: University of Naples
Sponsor class: OTHER
First posted: 2006-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Implantation of bone marrow cells, including endothelial progenitor cells, into ischemic limbs has been shown to improve collateral vessel formation. In the present study the safety and feasibility of autologous blood mononuclear cells implantation will be investigated in patients with severe peripheral atherosclerosis.Twenty cases will be enrolled. Improvement in the ankle-brachial pressure index (ABI:\>0.1), ischemic ulcers and angiography as well as laser doppler flow will be evaluated until six months.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of third or fourth class of peripheral atherosclerosis

Exclusion Criteria:

* Insuline dependent diabetes
* Cancer

Primary outcomes:
measure: Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.
Secondary outcomes:
measure: Angiographic and laser doppler measurements after six months from treatment.
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples
Study officials:
affiliation: University of Naples
name: Vincenzo Sica
role: STUDY_DIRECTOR
References:
citation: Maione C, Botti C, Coppola CA, Silvestroni C, Lillo S, Schiavone V, Sica G, Sica V, Kumar V, Cobellis G. Effect of autologous transplantation of bone marrow cells concentrated with the MarrowXpress system in patients with critical limb ischemia. Transplant Proc. 2013 Jan-Feb;45(1):402-6. doi: 10.1016/j.transproceed.2012.10.031.
citation: Cobellis G, Botti C, Taddeo A, Silvestroni A, Lillo S, Da Ponte A, Villa ML, Sica V, Della Bella S. Successful bone marrow transplantation reveals the lack of endothelial progenitor cells mobilization in a patient with critical limb ischemia: a case report. Transplant Proc. 2010 Sep;42(7):2816-20. doi: 10.1016/j.transproceed.2010.04.047.
citation: Napoli C, Farzati B, Sica V, Iannuzzi E, Coppola G, Silvestroni A, Balestrieri ML, Florio A, Matarazzo A. Beneficial effects of autologous bone marrow cell infusion and antioxidants/L-arginine in patients with chronic critical limb ischemia. Eur J Cardiovasc Prev Rehabil. 2008 Dec;15(6):709-18. doi: 10.1097/HJR.0b013e3283193a0f.
Clinical trial NCT01954485: Adhesion of Connective Tissue Around Laser-treated Abutments for Dental Implants - Clinical Trial in Humans
Official title: Histological Differences in the Adhesion of Connective Tissue Around Laser-treated Abutments and Standard Abutments for Dental Implants - Clinical Trial in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Periimplantitis
Keywords: LaserLok, connective tissue, adhesion
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: BioHorizons, Inc.
First posted: 2013-10-01
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to demonstrate the histological differences in the connective tissue surrounding laser-treated abutments and untreated abutments in humans.

Working hypothesis: There are differences in the adhesion of collagen fibres around implant abutments with laser-produced microgrooves and standard abutments.

Detailed description: All patients will receive both abutment systems. The assignment of the abutments to each of the implants will be made randomly using SPSS 15.0 (SPSS Inc., Chicago, Il, United States) software.

Eligibility criteria: Inclusion Criteria:

* patient must have partial edentulism of at least 2 teeth
* patients that have scheduled treatment for the placement of at least 2 implants
* patients with favourable attached gingiva
* patients without systemic diseases that would prevent the emplacement of implants
* patient must accept participation in the study by signing an informed consent form

Exclusion Criteria:

* smokers of 1 or more cigarettes per day
* patients who suffer from any known condition that could be an absolute or relative contraindication to dental implant placement
* patients requiring any additional surgical technique for bone or gum graft in order to insert the dental implant
* patients who refuse to be included in the study or do not sign the informed consent form

Primary outcomes:
measure: Connective tissue adhesion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Odontològic
state: Barcelona
Study officials:
affiliation: Barcelona University
name: Monica Blazquez-Hinarejos, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Barcelona University
name: Raul Ayuso-Montero, DDS, PhD
role: STUDY_DIRECTOR
affiliation: Barcelona University
name: Jose Lopez-Lopez, MD, PhD
role: STUDY_CHAIR
affiliation: Barcelona University
name: Cristina Manzanares-Cespedes, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02345785: Evaluation of the Change of Penile Corpus Cavernosum After Caudal Block Using Ultrasonography in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Urologic Surgeries
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 6
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric patients who need urologic surgery and caudal block

Brief summary: The purpose of this study is to evaluate the change of penile corpus cavernosum after caudal block using ultrasonography in pediatric patient.


Eligibility criteria: Inclusion Criteria:

1. Twenty (ASA status I or II) children, ages 2 to 7 yr old, who were scheduled for a urologic surgery
2. Children who needed caudal block for postoperative analgesia

Exclusion Criteria:

1. if there were contraindications for caudal block including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.
2. patients scheduled for penile surgery

Primary outcomes:
measure: change of penile corpus cavernosum
timeFrame: 1 min after LMA insertion
measure: change of penile corpus cavernosum
timeFrame: 2 min after caudal block
measure: change of penile corpus cavernosum
timeFrame: 5 min after caudal block
Secondary outcomes:
measure: cavernosal arterial hemodynamics
timeFrame: 1 min after LMA insertion
measure: cavernosal arterial hemodynamics
timeFrame: 2 min after caudal block
measure: cavernosal arterial hemodynamics
timeFrame: 5 min after caudal block
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References: