louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03586349: Cultural Adaptation of Sedentary Behavior Questionnaire and Reliability, Validity Research of Turkish Version
Official title: Cultural Adaptation of Sedentary Behavior Questionnaire and Reliability, Validity Research of Turkish Version
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Adults
Lead sponsor: Biruni University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2018-07-13
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults aged between 18-64 years.

Brief summary: The aim of this study is to adapt the Sedentary Behavior Questionnaire (SBQ) into the culture of Turkish and to work on the reliability and validity of it in healthy individuals between the ages of 18-64. The permission was obtained via mail from Dori Rosenberg, who is the developer of the questionnaire, for its Turkish adaptation. SPSS package programme will be used in the analysis,

Detailed description: The aim of this study is to adapt the Sedentary Behavior Questionnaire (SBQ) into the culture of Turkish and to work on the reliability and validity of it in healthy individuals between the ages of 18-64. Original form has nine questions but Spanish version of it had eleven questions so the investigators will translate Spanish version of SBQ. At first step by using a forward-backward translation method, a translation and adaptation process will be performed. At second step the validation process will be performed in a total of 200 healthy subjects aged between 18-64 years. Subjects will fill sociodemographic information form, International Physical Activity Questionnaire Short Form, and SBQ Turkish version ( at baseline and after seven days). Cronbach's alpha values, confirmatory factor analysis (CFA) will be evaluated for the reliability, construct and convergent validity.

Eligibility criteria: Inclusion Criteria:

* Being a healthy individual between the ages of 18-64.
* No problem of reading, writing or understanding Turkish.

Exclusion Criteria:

* Severe trauma in the last 6 months.
* Having orthopedic, neurological, cardiovascular problems that restricts ambulation.

Primary outcomes:
measure: Sedentary Behavior Questionnaire
timeFrame: 1 week
Secondary outcomes:
measure: International Physical Activity Questionnaire Short Form
timeFrame: Day 1
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Istanbul University
name: Ayse Zengin Alpozgen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02108249: Annex™ Adjacent Level System for Treatment of Adjacent Level Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Adjacent Level Disease
Lead sponsor: Spine Wave
Sponsor class: INDUSTRY
First posted: 2014-04-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population for both the treatment and control groups will include adult (skeletally mature) men and women who were previously implanted with rigid posterior fixation (pedicle screw/rod constructs) in the thoracolumbar spine and who later developed adjacent level disease (ALD) at a lumbar level.

Brief summary: The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of the Annex™ Adjacent Level System for the treatment of adjacent level disease of the lumbar spine. The Annex™ Adjacent Level System is a spinal fixation system intended to be used with commercially available pedicle screw fixation systems in order to extend existing pedicle screw constructs. Subjects will be evaluated over a 2 year period and compared to historical control.


Eligibility criteria: Inclusion Criteria:

* Men or women 18-85 years of age
* Single level adjacent level segment disease (ALD) in the lumbar spine (L1-S1).

Exclusion Criteria:

* trauma, tumor, pseudoarthrosis, revision, or same-level recurrent stenosis
* cervical fusion candidates
* extraspinal cause of back pain
* local or systemic infection
* pregnant / able to become pregnant and not following a reliable contraceptive method
* Severe osteoporosis or osteopenia
* Morbid obesity defined as BMI \> 40
* Anatomy or other factors that prohibit safe surgical access to the surgical site
* Allergy or sensitivity to any component of the treatment procedure
* Inadequate tissue coverage over the operative site
* Inadequate bone stock or bone quality
* Fever or leukocytosis
* Uncorrectable coagulopathy or hemorrhagic diathesis
* Cardiopulmonary conditions that present prohibitive anesthesia risk
* Neuromuscular disease or disorder
* Mental illness
* Has an active workman's compensation claim

Primary outcomes:
measure: % Improvement in Operative/Discharge parameters including surgical time and hospital stay
timeFrame: within 30 days after treatment
measure: Surgical Complication rate compared to retrospective chart review
timeFrame: Within 30 days of treatment
Secondary outcomes:
measure: % Pain reduction on VAS
timeFrame: Up to 2 years post-treatment
measure: % Improvement in Disability using ODI
timeFrame: Up to 2 years post-treatment
measure: % Improvement in Quality of Life using SF-36
timeFrame: Up to 2 years post-treatment
measure: % Patient Satisfaction with procedure
timeFrame: Up to 2 years post-treatment
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Neurosurgery and Spine
state: North Carolina
Study officials:
References:
Clinical trial NCT05960149: Use of Indocyanine Green in Robotic Prostate Surgeries
Official title: Evaluation of the Effect of Intraoperative Indocyanine Green Use on Erectile Function and Surgical Margin Positivity in Patients Undergoing Nerve-Sparing Robot-Assisted Laparoscopic Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Prostate Cancer Adenocarcinoma
Erectile Dysfunction Following Radical Prostatectomy
Keywords: erectile dysfunction and indocyanine green
radical prostatectomy and indocyanine green
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 200
Sex: MALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Imaging of the vascular nerve bundle using Indocyanine Green

Detailed description: Comparison of erectile function and surgical margin positivity after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery performed by imaging the vascular nerve bundle using Indocyanine Green with the results after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery without Indocyanine Green

Eligibility criteria: Inclusion Criteria:

* Patients with low-intermediate risk prostate cancer

Exclusion Criteria:

* Patients high risk prostate cancer

Primary outcomes:
measure: Evaluation of erectile function.
timeFrame: up to 12 months
measure: Evaluation of surgical margin positivity
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Universitry
name: Araz Musaev
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04197349: Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of ALD1910, a Humanized Anti-Pituitary Adenylate Cyclase Activating Peptide (PACAP) Monoclonal Antibody
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Alder Biopharmaceuticals, Inc.
First posted: 2019-12-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.

Detailed description: This is a first-in-humam, randomized, double-blind, placebo-controlled study in a healthy population. Up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the safety and tolerability of ALD1910. Approximately 96 healthy male and female participants are planned for the study, 64 for Part A and 32 for Part B.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or female
2. All female subjects must have a negative pregnancy test result and subjects to use of adequate contraception for the duration of the study.
3. Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive.

Exclusion Criteria:

1. Use of prescription meds, nutritional supplements, OTC medications.
2. New or unusually strenuous exercise for the duration of the trial.
3. Current or previous drug or alcohol abuse.
4. Current, or previous smoker within 12 weeks prior to screening. Causal or social smokers are allowed.
5. Previous treatment or clinical trial with a monoclonal antibody 6 months prior to screening.
6. Current participation in any clinical research study.
7. ECG QTcF greater than or equal to 450 msec.
8. Greater than 6.4% glycosylated hemoglobin (HgbA1c) at screening
9. Fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L) at screening

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events
timeFrame: From dosing to week 20
Secondary outcomes:
measure: Area under the serum concentration-time curve (AUC(0-T))
timeFrame: From dosing to week 20
measure: Peak serum concentration (Cmax)
timeFrame: From dosing to week 20
measure: Clearance (Cl)
timeFrame: From dosing to week 20
measure: Immunogenicity
timeFrame: From dosing to week 20
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT01209949: Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
Official title: Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-09-27
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, aged 16 to 25 years inclusive;
* Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3;
* A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose);
* Subjects who agree to be photographed at each visit;
* Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study

Exclusion Criteria:

* Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;
* Subjects with a wash-out period for topical acne treatment on the face less than 30 days
* Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months;
* Subjects who are currently being treated with antibiotics;
* Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, etc.);
* Subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials

Primary outcomes:
measure: Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.
timeFrame: Week 12
measure: Number of Participants With Tolerability Assessments Resulting in an Adverse Event
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Carrollton
country: United States
facility: Thomas J. Stephens and Associates
state: Texas
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01713049: 18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound
Official title: Use of 18F-FLT Positron Emission Tomography to Evaluate the Suspicious Findings on Mammography and Breast Ultrasound: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Keywords: FLT PET
breast neoplasms
mammography
breast ultrasound
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound.

Detailed description: 1. To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard, and to determine whether 18F-FLT PET can increase the specificity in breast lesion diagnosis and thus reduce the unnecessary biopsy.
2. To evaluate whether 18F-FLT PET is a cost-effective imaging modality for breast cancer diagnosis.

Eligibility criteria: Inclusion Criteria:

1. Women aged between 20 to 80 years
2. women who have localized findings on mammography and / or ultrasound and will receive biopsy.
3. The lesions on the conventional imaging measure \>=1cm
4. WBC count \>=3000/L, or platelet\>=75,000/L
5. Liver function, AST or ALT \< 78 U/L
6. Renal function, Creatinine \< 2.0 mg/dl.The laboratory examinations should be performed within 4months before our study.

Exclusion Criteria:

1. Pregnant women or who are planning to be pregnant.
2. Known cancers in other organs.
3. Women who are not able to cooperate with the PET/CT examination.

Primary outcomes:
measure: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard.
timeFrame: The biopsy procedures will be scheduled as soon as possible and should be finished within 2 months after 18F-FLT PET.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Medical Imaging NTUH
Study officials:
affiliation: National Taiwan University Hospital
name: Jane Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00858949: Costs of Postoperative Nausea and Vomiting in Ambulatory Surgery Patients
Official title: Time-Motion Study of PONV Costs in Ambulatory Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Nausea and Vomiting
Keywords: Outpatient surgery
Postoperative nausea and vomiting
Costs
Observational
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 100
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: Outpatients undergoing elective surgery with anesthesia that is expected to last one hour and to require significant postoperative opioids

Brief summary: This is an observational study with the goal of determining the costs of nausea and vomiting in ambulatory patients after surgery from the US societal perspective.

Detailed description: The direct cost between the end of outpatient surgery and discharge from the hospital will include costs of labors and supplies for any outpatient care, physician visits, laboratory tests, and prescribed medications, which may be used to treat operation side effects. Based on the time and motion study design, the timing of these healthcare activities will be collected. The study coordinator will observe the actual time taken for each activity for each patient. The observation period will begin after completion of the outpatient surgery. The start and end times for each activity performed will be recorded. Therefore, each activity and its duration will be concurrently recorded. We will also query patients daily to determine additional costs associated with PONV until the third postoperative morning.

Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 years of age or older
* American Society of Anesthesiologists (ASA) physical status 1 to 3
* Outpatients undergoing elective surgery with anesthesia that is expected to last one hour and to require significant postoperative opioids
* Patients must provide written informed consent and have at least two of the following PONV risk factors: (1) female gender, (2) history of PONV and/or currently prone to motion sickness, (3) non smoking status.

Exclusion Criteria:

* Any drug with potential antiemetic efficacy within 24 hours prior to the anesthetic procedure
* Vomiting, retching, or nausea in the 24 hours preceding anesthesia
* Body mass index \>40.

Primary outcomes:
measure: To determine the costs of PONV in ambulatory patients from the US societal perspective
timeFrame: 72 hours post op
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03042949: An Optical System for Measuring Blood Pressure
Official title: Correlation of Blood Pressure Measurements Using an Optical System for Measuring Blood Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure Disorders
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will have their blood pressure measured by standard plethysmography and with a new optical device
Primary purpose: DEVICE_FEASIBILITY

Brief summary: An assesment of an optical system that measures blood pressure on the finger -Elfor 1 device. The system is based on a small optical sensor that emits coherent light into the skin and collects the reflected light from the red blood cells in the blood vessels in the skin under the sensor. The sensor is able to detect the pulse wave and blood pressure can be measured.

The investigators plan to measure blood pressure with the new sensor in patients who are attending the Hypertension Clinic at Meir Hospital or are undergoing hemodialysis to validate the sensor.

Detailed description: If the blood flow is temporarily interrupted by inflating a small pneumatic cuff at the root of the finger, blood flow is occluded and the pulse wave disappears. As the pressure in the cuff is released, blood flow returns, the pulse wave is again detected and blood pressure can be measured. This apparatus is easy to use and will allow simplified monitoring of blood pressure contains the laser source and optical sensors that measure the reflected light.

The investigators proposed to validate the sensor by measuring the blood pressure in patients with this optical sensor and also by standard plethysmography. The investigators plan to measure participants with low, normal and high blood pressure in order to assess the accuracy and reliability of the new device.

Eligibility criteria: Inclusion Criteria:

* patients on hemodialysis or visiting the hypertension outpatient clinic at Meir Medical Hospital.

Exclusion Criteria:

-

Primary outcomes:
measure: Blood pressure reading
timeFrame: three hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05817149: Perioperative Examination of Inflammatory Markers in Relation to Sentinel Lymph Node Biopsy in Patients With Melanoma; a Pilot Study
Official title: Perioperative Examination of Inflammatory Markers in Relation to Sentinel Lymph Node Biopsy in Patients With Melanoma; a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Surgery
Keywords: Melanoma
Surgery
Neutrophil-to-lymphocyte ratio
Surgical inflammation
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2023-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients (n=20) diagnosed with malignant melanoma and scheduled for SLNB at Aalborg University Hospital were consecutively included from June 2021 to October 2021.

Brief summary: We want to test if an association between sentinel lymph node biopsy (SLBN) and a systemic inflammatory response can be made.

Detailed description: Sentinel lymph node biopsy (SLBN) is essential in staging melanoma and properly selecting patients for adjuvant immunotherapy. However, surgically induced inflammation can potentially aid in progression of remaining malignant cells and affect prognosis. The inflammatory marker neutrophil-to-lymphocyte ratio (NLR) is also a negative prognostic and predictive marker in serval malignancies, among melanoma. However, it is not yet established if SLNB induces a systemic inflammatory response.

Eligibility criteria: Inclusion Criteria:

* Adult (\>18 years of age)
* Diagnosed with invasive cutaneous melanoma
* Eligible for SLNB (Melanoma stage ≥ T1b)
* Obtained signed informed consent

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Neutrophil-to-lymphocyte ratio
timeFrame: 1 Day
Secondary outcomes:
measure: Pro-inflammatory cytokines
timeFrame: 1 Day
measure: Acute phase reactants
timeFrame: 1 Day
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: The North Denmark Region
Study officials:
References: