louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01059513: Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer
Official title: Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: T1c
T2a
T2b
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2010-02-01
Enrollment: 167
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level \<10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).

Brief summary: This is an observational study in which a questionnaire is used to obtain quality of life data after patients undergo a hypo-fractionated course of stereotactic body radiotherapy (SBRT) for the treatment of their prostate cancer. The SBRT itself is considered standard of care for these patients and as such, is not an official component of the study.


Eligibility criteria: Inclusion Criteria:

* Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level \<10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).
* The ability to understand and willingness to sign a written informed consent are necessary.

Exclusion Criteria:

* Patients with tumor parameters that fall outside of the inclusion criteria.
* Patients with evidence on imagining (bone scan, CT, or MRI) suggestive of disseminated disease.
* Patients who have had any form of prior prostate treatment (surgery, radiotherapy, cryotherapy, high intensity focused ultrasound, TURP).
* A prior course of hormone therapy (androgen deprivation) of greater than 3 months duration.
* The use of other concurrent investigational agents.
* There are no exclusions due to co-morbid disease or illnesses except for patients with severe inflammatory bowel disease.
* No life expectancy restrictions will apply.
* Performance status will not be considered.

Primary outcomes:
measure: To quantify patient quality of life after prostate SBRT using validated questionnaire tools
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Christopher King, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01600313: Effect of Low Calorie Diet With Rice Bran Oil on Cardiovascular Risk Factors in Hyperlipidemic Patients
Official title: Effect of Low Calorie Diet With Rice Bran Oil on Cardiovascular Risk Factors in Hyperlipidemic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperlipidemias
Keywords: rice bran oil
diet
cardiovascular disease
low density lipoprotein
total cholesterol
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of rice bran oil with low calorie diet on lipid profiles.

Detailed description: This study is parallel groups' randomized clinical trial with a pre and post test design.

The study conducted on hyperglycemia patients who were healthy in other respects and were recruited from nutrition and diet therapy clinic. All subjects received a low calorie diet for 4 weeks from registered dietitian.

Treatment group received the low- calorie diet including (30g/day) rice bran oil.

Eligibility criteria: Inclusion Criteria:

* hyperlipidemia

Exclusion Criteria:

* pregnancy and lactation
* cardiovascular disease
* diabetes

Primary outcomes:
measure: LDL, HDL, Cholesterol,Triglyceride(mg/dl)
timeFrame: 30 days
Secondary outcomes:
measure: BMI (Kg/m2)
timeFrame: Baseline and 4 weeks after intervention
measure: WHR (Ratio)
timeFrame: Baseline and 4 weeks after intervention
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin University of Medical Sciences
Study officials:
affiliation: Qazvin University of Medical Sceience
name: Mostafa Noroozi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06328413: L-PRF vs PBM on Extraction Socket Healing
Official title: Comparative Evaluation of Pain, Soft Tissue Healing and Density of Newly Formed Bone Tissue in Surgical Extraction Sockets After Leukocyte and Platelet Rich Fibrin and Photobiomodulation Applications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healing Surgical Wounds
Pain
Keywords: photobiomodulation
L-PRF
pain
bone healing
soft tissue healing
third molar
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Since the groups were formed on the same individual, only which side would be the PBM and which side would be the L-PRF group was determined by coin-flip method (simple randomization).
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare leukocyte and platelet-rich fibrin (L-PRF) and photobiomodulation (PBM) applications, which have been repeatedly reported to be superior to control groups, in terms of pain, soft tissue and bone healing in tooth extraction sockets.

Detailed description: After sample size calculation, healthy volunteers were included in the study. Both teeth of these individuals with bilaterally impacted wisdom teeth were extracted simultaneously. Photobiomodulation (PBM) or leukocyte and platelet rich fibrin (L-PRF), an autogenous blood product, was randomly applied to the right or left side extraction sockets. Volunteers were called for repeat sessions (days 2,4,7,7,11,11,14,18 and 21) for the PBM treated side. Follow-ups were performed for pain (days 2,4,7) and soft and bone tissue healing.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class-I healthy volunteers
* Between 18 and 40 years of age who had wisdom teeth (Pell and Gregory Class II, Position B) with bone retention in bilateral symmetrical position with an indication for extraction, and had second molars in the mouth,
* Not use steroids or anti-inflammatory drugs in the last 3 months.

Exclusion Criteria:

* Patients with pericoronitis,
* Smoking habits
* Active periodontal disease
* Pregnancy,
* Breastfeeding
* Unable to give personal consent, and those with missing physical examination and follow-up records were excluded.

Primary outcomes:
measure: Newly formed bone (Healing at extraction sockets)
timeFrame: Bone healing at the end of 1st and 3rd months after third molar extractions
Secondary outcomes:
measure: Soft tissue healing
timeFrame: End of 1st, 2nd week and 1st month after tooth extraction
measure: Probing depth
timeFrame: End of 1st, 2nd week and 1st month after tooth extraction
Other outcomes:
measure: Postoperative pain
timeFrame: Postoperative 2nd, 4th and 7th days
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
state: Merkez
Study officials:
affiliation: Akdeniz University
name: Cennet N Eroglu, DDS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00163813: The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care (ENTERIC) Study
Official title: The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Malabsorption Syndromes
Keywords: Mechanically-ventilated
medical-surgical critically ill patients
reduced gastric motility
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2005-09-14
Enrollment: 180
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: This is a multi-centre randomised controlled trial comparing early jejunal feeding (using a frictional nasojejunal \[NJ\] tube) and standard feeding in critical illness.


Eligibility criteria: Inclusion Criteria:

ICU patients are eligible for enrolment if they meet all of the following:

* Age \> 18 years old
* In ICU for \< 48 hours prior to enrolment
* Receiving invasive mechanical ventilation (through an endotracheal tube or tracheostomy, but NOT a facemask) with an anticipated need for \> 48 hours of mechanical ventilation
* Receiving a continuous infusion of any one of:

  * morphine \> 2 mg/hour,
  * fentanyl \> 20 mcg/hour, or
  * pethidine \> 20 mg/hour
* Either a single GRV \> 150 mls (whilst receiving EN via a NG tube) or nasogastric drainage \> 500 mls over 12 hours (whether receiving EN or not)

Exclusion Criteria:

Patients will be ineligible for enrolment if they meet any of the following:

* Previous or recent surgery which has altered the anatomy of the upper gastrointestinal tract (eg. oesophagectomy, gastrectomy, any gastric anastomosis surgery, gastroplasty, pyloroplasty, pancreaticoduodenectomy \[Whipple's procedure\])
* Known gastric malignancy
* Known oesophageal varices
* Current admission for peptic ulceration
* Current mechanical bowel obstruction
* Current gastrostomy, jejunostomy, or surgically-placed enteral tube in situ
* Contraindication to the use of the nose and mouth for enteral tube insertion (eg. recent facial trauma or surgery)
* Receiving nutritional support prior to ICU admission
* Severe coagulopathy (defined by platelet count \< 20 and/or international normalized ratio \[INR\] \> 4.0)

Primary outcomes:
measure: The amount of EN delivered during the Intensive Care Unit (ICU) stay
Secondary outcomes:
measure: Amount of EN delivered during the first 10 days of the study
measure: Daily cumulative proportion of EN delivered
measure: Ventilator-associated pneumonia rate
measure: Duration of mechanical ventilation
measure: Duration of hospitalisation
measure: Mortality at hospital discharge
measure: Success rate of placement into both the small bowel, generally, and the jejunum, specifically
measure: Complication rates (as compared to the nasogastric tube)
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Andrew Davies
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05928013: Neuropathy Evaluation Using the Vibration of a Mobile Phone
Official title: Neuropathy Evaluation Using the Vibration Function of a Mobile Phone - the NERVE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: University Hospitals Dorset NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2023-07-03
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: A single centre validation/method comparison study of the experimental NERVE device for the measurement of vibration perception threshold against the established 'Neurothesiometer' device, evaluating agreement and reliability. It will also include collecting feedback from patients, carers and clinicians on the usability of the device


Eligibility criteria: Inclusion Criteria:

* Formally Diagnosed With Diabetes

Exclusion Criteria:

* 1. Un- willing or un-able to provide free informed consent (no time limit)
* 2. Un-willing or un-able to comply with all protocol requirements including study assessments;
* 3. Bilateral foot ulcers

Primary outcomes:
measure: Vibration Perception Threshold (volts) as measured by Health Care Professionals
timeFrame: Baseline
measure: Vibration Perception Threshold (volts) as measured by Health Care Professionals
timeFrame: Follow up within baseline visit
measure: Vibration Perception Threshold (volts) as measured by person with diabetes
timeFrame: Baseline
measure: Vibration Perception Threshold (volts) as measured by person with diabetes
timeFrame: Follow up within baseline visit
Secondary outcomes:
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
Study officials:
References:
Clinical trial NCT03888313: Pretreatment Group Consultation for Patients With Colorectal Cancer
Official title: Pretreatment Group Consultation for Patients With Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasm
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with colon or rectal cancer at the Sahlgrenska University Hospital/Östra planned for surgical treatment

Brief summary: An explorative study of the patients' experience of participating at a group consultation, together with other patients with newly diagnosed colon or rectal cancer

Detailed description: The group consultation is planned to be on the Friday of the same week as the patient recieved a suggested treatment plan i.e. after MDT, at a personal consultation with his/her colorectal surgeon. During the group consultation the steps necessary for the patient to take responsability for in connection with the operation. Ample time for questions, clarifications and discussions. Appropriate clinical trials are presented

Eligibility criteria: Inclusion Criteria:

* Patients participating in the pretreatment group consultation

Exclusion Criteria:

* Not able to answer questionnaire

Primary outcomes:
measure: The patient's experience of participating in a pretreatment group consultation
timeFrame: Before start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital/Östra
state: Västra Götaland Region
Study officials:
affiliation: Sahlgrenska University Hospital
name: Eva Angenete, MD, PhD
role: STUDY_CHAIR
References:
citation: Walming S, Angenete E, Bock D, Block M, de la Croix H, Wedin A, Haglind E. Preoperative Group Consultation Prior to Surgery for Colorectal Cancer-an Explorative Study of a New Patient Education Method. J Cancer Educ. 2022 Oct;37(5):1304-1311. doi: 10.1007/s13187-020-01951-7. Epub 2021 Jan 14.
Clinical trial NCT00915213: Incidence of Antibiotic Resistant E.Coli in Patients Undergoing Repeat Prostate Biopsy
Official title: Incidence of Fluoroquinolone Resistant Enterobacteraciae in Patients Undergoing Repeat Ultrasound Guided Prostate Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infection
Keywords: E. Coli
Prostate Biopsy
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Copan Diagnostics, Inc.
First posted: 2009-06-05
Enrollment: 136
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men undergoing repeat prostate biopsy

Brief summary: The purpose of this study is to discover how often certain bacteria are found in the rectum at the time of a prostate needle biopsy to diagnose prostate cancer. Certain bacteria are of importance because they can cause serious infection. Antibiotics that urologists commonly use to prevent these bacteria from causing infection are no longer effective. Many physicians around the world are noting increased infections with antibiotic resistant bacteria. Therefore; despite treating patients who are to undergo prostate biopsy with antibiotics, certain patients are being readmitted to the hospital with a serious infection. In order to study the incidence of these particular bacteria, the best method is to culture the bacteria at the time of the biopsy. This involves one rectal culture swab just prior to needle biopsy of the prostate. Once the incidence of these bacteria is known we may take steps to prevent the serious infections that occur as a result of prostate biopsy.


Eligibility criteria: Inclusion Criteria:

* adult males
* repeat prostate biopsy

Exclusion Criteria:

* first time prostate biopsy
* minors

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Kaiser Permanente
state: California
city: Long Beach
country: United States
facility: Long Beach Veteran Affairs
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Atreya Dash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05248113: Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery
Official title: Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deafness
Keywords: vestibular schwannoma
cochlear nerve
auditory prosthesis
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Test of feasibility of electrical stimulation of the cochlear nerve with a conventional bipolar nerve stimulator
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a study of the feasibility of activating the auditory system by an electrode in direct contact with the cochlear nerve.

Detailed description: This is a feasibility study being conducted prior to development of a penetrating cochlear nerve stimulating electrode. Experiments will be conducted in patients who are undergoing surgery for resection of a vestibular schwannoma (VS). In the normal course of such a surgical procedure, the cochlear nerve is exposed and, in many cases, the cochlear nerve is resected or function of the cochlear nerve is otherwise disrupted. Typically, recording electrodes are placed on the scalp for the purpose of recording sound-evoked auditory brainstem responses (ABRs), which serve as a measure of the functional status of the cochlear nerve. In this intraoperative experimental procedure, a conventional bipolar nerve stimulating electrode will be placed in contact with the cochlear nerve and the nerve will be stimulated with electrical pulses. Activation of the auditory system by the electrical pulses will be evaluated by measurement of electrically-evoked ABRs, using the same scalp electrodes that are typically used for measurement of sound-evoked ABRs. The cochlear-nerve stimulating electrode will be in place only during the actual intraoperative test. No device will remain in the patient. The intraoperative experimental procedure is not intended to as a therapeutic measure for the patient's VS.

Eligibility criteria: Inclusion Criteria:

* Adults with the diagnosis of unilateral or bilateral vestibular schwannoma proven on radiographic imaging.
* Only patients with little or no hearing ability undergoing surgical resection of the tumor will be enrolled.

Exclusion Criteria:

* Women who are pregnant

Primary outcomes:
measure: Auditory brainstem response
timeFrame: Recorded immediately during ongoing cochlear-nerve stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Health, Pavilion II
state: California
Study officials:
affiliation: University of California, Irvine
name: Harrison M Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: John C Middlebrooks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01974713: Inflammatory Markers and Adverse Outcomes in Chronic Kidney Disease
Official title: CAN-AIM to PREVENT: CANadian Study, Assessing Inflammatory Markers to PRedict EVents in Nephrology sTudy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: CKD progression
Inflammation
FGF23
Genetic biomarkers
Lead sponsor: Institute of Kidney Lifescience Technologies
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 2530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in chronic kidney disease clinic setting

Brief summary: Longitudinal cohort of patients with chronic kidney disease followed in 3 kidney centers in Ontario. The goal is to determine whether and how rates of renal disease progression are affected by inflammatory markers, FGF23 levels, and genetic polymorphisms

Detailed description: This longitudinal cohort study will follow 2500 prevalent Chronic Kidney Disease (CKD)patients under the care of a nephrologist at 3 Southern Ontario Nephrology centres and all affiliated satellite centres with an estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min to determine the rate of their renal disease progression over a 36 months. All CKD patients older than 18 years of age may be included in this study. This study will analyze, with 6 month serial measurements, conventional biochemical, hormonal and metabolic parameters in addition to the demographics, clinical status, medications and blood and urine samples of these patients. This study will assess the influence of inflammation on FGF23 and genetic polymorphisms that may reflect the processes involved with disease progression.

Eligibility criteria: Inclusion Criteria:

* Patients referred to a nephrologist for evaluation of CKD or those currently seen by a nephrologist, with eGFR less than 60 ml/min
* Patients that are erythropoietin treatment naive
* Transplant patients with failing grafts requiring nephrologists follow-up
* Patients currently not receiving RRT consenting to be in the study
* Adults 18 years of age and older

Exclusion Criteria:

* Functioning Organ transplant
* Life expectancy less than 12 months
* Patients currently receiving RRT or who will likely initiate RRT within 6 months
* Patients unable or contraindicated to receive EPREX® as erythropoietin replacement therapy for the correction of anemia related to CKD

Primary outcomes:
measure: Renal function at study censure
timeFrame: 3 years
Secondary outcomes:
measure: Dialysis-dependent renal failure
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Kidney Life Science Institute
name: Paul Y Tam, MD
role: PRINCIPAL_INVESTIGATOR
References: