louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02335489: A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
Official title: A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Neuropathic Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-01-09
Enrollment: 10
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: Chronic Neuropathic Pain of the Foot and/or Lower Leg

Brief summary: 14-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of neuropathic pain of the foot and/or lower limb


Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic, intractable pain in the foot and/or lower leg for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects with indwelling devices that may pose an increased risk of infection
8. Subjects currently has an active infection
9. Subject has participated in another clinical investigation within 30 days
10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
11. Subject has been diagnosed with cancer in the past 2 years.

Primary outcomes:
measure: Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
timeFrame: Baseline, 3, 6 and12-Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
Study officials:
References:
Clinical trial NCT00995189: Clinical Evaluation of the Causes of Contact Lens Related Dry Eye
Official title: A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Related Dry Eye
Keywords: contact lens wear
multi-purpose solution
corneal staining
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-10-15
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.

Detailed description: Daily wear soft contact lens wearers reporting significant contact lens-related dryness symptoms were enrolled. Late day dryness with contact lenses, intensity grade 3-5, frequency "sometimes / frequently / constantly" as evaluated by a questionnaire was considered significant.

Eligibility criteria: Inclusion Criteria:

* Reports late-day dryness symptoms with contact lens wear on questionnaire.
* Wears FDA Group 2 hydrogel, FDA Group 4 hydrogel, or silicone hydrogel lenses.
* Consistently uses either polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) contact lens care products (i.e. \>6 months including 1 month immediately before enrollment).
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Wears daily disposable contact lenses.
* Has significant symptoms related to lens fit or lens deposits.
* Requires concurrent ocular medication (rewetting drops allowed).
* Has used Restasis® in the last 3 months.
* Wears punctal plugs fitted in the last 30 days.
* Has any current systemic or ocular abnormality, infection or disease.
* Uses any current systemic medication likely to affect tear film, e.g. antihistamines, betaadrenergic blockers, steroids.
* Has a history of refractive surgery.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Subjective Dryness
timeFrame: 2 weeks, one month
Secondary outcomes:
measure: corneal staining
timeFrame: 2 weeks, one month
measure: conjunctival staining
timeFrame: two weeks, one month
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
References:
citation: Chalmers RL, Young G, Kern J, Napier L, Hunt C. Soft Contact Lens-Related Symptoms in North America and the United Kingdom. Optom Vis Sci. 2016 Aug;93(8):836-47. doi: 10.1097/OPX.0000000000000927.
Clinical trial NCT02995889: FLT-PET for Early Detection of Relapse in Patients With Irradiated Lung Cancer
Official title: FLT-PET for Early Detection of Relapse in Patients With Irradiated Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer, Nonsmall Cell
Small Cell Lung Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study investigates the feasibility of FLT-PET to improve the diagnosis of relapse in patients with irradiated lung cancer in comparison with FDG-PET/CT.


Eligibility criteria: Inclusion Criteria:

* history with lung cancer, small cell or non-small cell
* radiotherapy of lung cancer ended within the last 24 months
* radiotherapy might be normofractionated or stereotactic
* current suspicion of relapse
* written and oral consent

Exclusion Criteria:

* communication difficulties
* pregnancy or lactation

Primary outcomes:
measure: Number of patients with local and/or regional relapse
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
city: Copenhagen
country: Denmark
facility: Dept. Respiratory Medicine, Bispebjerg University Hospital
Study officials:
affiliation: Dept of Clinical Physiology, Nuclear medicine and PET, Rigshospitalet, Denmark
name: Andreas Kjær, MD phD MDSci
role: STUDY_CHAIR
References:
citation: Christensen TN, Langer SW, Persson G, Larsen KR, Loft A, Amtoft AG, Berthelsen AK, Johannesen HH, Keller SH, Kjaer A, Fischer BM. 18F-FLT PET/CT Adds Value to 18F-FDG PET/CT for Diagnosing Relapse After Definitive Radiotherapy in Patients with Lung Cancer: Results of a Prospective Clinical Trial. J Nucl Med. 2021 May 10;62(5):628-635. doi: 10.2967/jnumed.120.247742. Epub 2020 Oct 9.
citation: Christensen TN, Langer SW, Persson G, Larsen KR, Amtoft AG, Keller SH, Kjaer A, Fischer BM. Impact of [18F]FDG-PET and [18F]FLT-PET-Parameters in Patients with Suspected Relapse of Irradiated Lung Cancer. Diagnostics (Basel). 2021 Feb 11;11(2):279. doi: 10.3390/diagnostics11020279.
Clinical trial NCT05780489: Evaluation of Salivary ELISA for Hormone Monitoring in Donors
Official title: Evaluation of Salivary ELISA for Hormone Monitoring in Donors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility, Female
Reproductive Sterility
Keywords: SALIVA
DONNORS
OESTRADIOL
PROGESTERONE
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
Collaborators: name: MINT DIAGNOSTICS
First posted: 2023-03-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective multicentric study,
Primary purpose: DIAGNOSTIC

Brief summary: In donors or patients undergoing assisted reproduction treatments (ART) it is necessary to closely control ovarian stimulation to monitor the number and size of developing follicles.

Oestradiol (E2) and progesterone (P4) are products of steroidogenesis. Their concentrations increase with the diameter of the growing follicle. In order to assess treatment response and support clinical decisions, accurate and reliable methods to measure E2 and P4 are essential. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients or donors to undergo multiple blood draws. It is often a physically and emotionally painful process, and the most convenient solution is the measurement of hormones concentrations in other biological fluids, such as saliva. Salivary diagnostic tests are a less invasive, inexpensive, and stress-free alternative.

The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations in oocyte donors, and, also, evaluate the feasibility of doing saliva E2 and P4 determinations in the IVIRMA clinic labs.


Eligibility criteria: Inclusion criteria

* Informed consent form dated and signed
* Woman undergoing COS for oocyte donation
* Age 18-35, inclusive
* Regular menstrual cycles
* In good health and not suffering from any mental or medical condition(s) that would preclude participation in the study

Exclusion criteria

• Simultaneous participation in other clinical study, that at the investigator's criteria could interfere with the results of this study.

Primary outcomes:
measure: E2 and P4 on Day 1
timeFrame: 1 YEAR
measure: E2 and P4 on Day 8
timeFrame: 1 YEAR
measure: E2 and P4 on Triggering day
timeFrame: 1 YEAR
Secondary outcomes:
measure: BODY MASS INDEX
timeFrame: 1 year
measure: DONOR'S AGE
timeFrame: 1 year
measure: NUMBER OF OOCYTES
timeFrame: 1 YEAR
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ivi Madrid
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
References:
Clinical trial NCT04077489: Effects of 23-gauge Lensecotomy Combined With Anterior Vitrectomy on Macular in Children With Congenital Cataract
Official title: To Observe and Determine Macular Thickness Changes Before and After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular
Congenital Cataract
Keywords: macular thickness
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Congenital cataract is the main cause of form deprivation amblyopia in children. Current studies confirm that form deprivation amblyopia affects the macular development. However, there are different opinions about the effect of amblyopia on the macular thickness . Investigators have performed "cataract extraction with IOL implantation" on children with bilateral and unilateral congenital cataract. Investigators used OCT biometry to measure children's the macular thickness before and after surgery..Average sectional total thickness was automatically determined by the instrument's software using a modified Early Treatment Diabetic Retinopathy Study (ETDRS) circle grid (fovea, inner ring, and outer ring: 1 mm, 3 mm, and 6 mm. Investigators dynamically observed changes in macular to explore the retinal mechanism of form deprivation amblyopia and help guide the clinical correct understanding of postoperative follow-up time.


Eligibility criteria: Inclusion Criteria:

* congenital cataract

Exclusion Criteria:

-incooperative to complete the preoperative and postoperative examinations.

Primary outcomes:
measure: macular thickness
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: TianTong
Study officials:
References:
Clinical trial NCT06691789: Remote Social Support on Midwifery Students' Anxiety and Attitudes During Distance Education
Official title: Impact of Remote Social Support on Midwifery Students' Anxiety and Attitudes During Distance Education: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: anxiety
distance education
pandemics
COVID-19
social support
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 89
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this CT is to evaluate the effects of distance social support program on anxiety and attitudes towards distance education with midwifery students during COVID-19. The main questions are:

1. Does online social support has an impact on attitudes towards distance education?
2. Does online social support decrease the anxiety levels of the students?

Participants will:

- Join an online social support program and meet the researchers and friends.


Eligibility criteria: Inclusion Criteria:

* Being 2nd or 3rd grade midwifery student
* voluntarily participating

Exclusion Criteria:

* not using smartphone

Primary outcomes:
measure: Attitude Scale Towards Distance Education
timeFrame: From enrollment to the end of the study
measure: Multidimensional Scale of Perceived Social Support
timeFrame: From enrollment to the end of the study
Secondary outcomes:
measure: State and Trait Anxiety Scale
timeFrame: From enrollment to the end of the study
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University
state: Zeytinburnu
Study officials:
References:
Clinical trial NCT05711589: Zero-fluoroscopic Cryoballoon Ablation
Official title: Safety and Efficacy of Intracardiac Echocardiography-guided Zero-fluoroscopic Cryoballoon Ablation for Atrial Fibrillation : A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation Paroxysmal
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: zero-fluoroscopic and conventional fluoroscopy groups
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate safety and efficacy of intracardiac echocardiography (ICE)-guided zero-fluoroscopic cryoballoon ablation (CBA) in patients with paroxysmal atrial fibrillation.

Detailed description: Patients (n=100) undergoing de novo CBA for paroxysmal AF were randomly assigned (1:1) to zero-fluoroscopic (Zero-X) and conventional fluoroscopy groups.

Radiation exposure, procedural time, acute and long term outcome were analyzed.

Eligibility criteria: Inclusion Criteria:

* patients undergoing de novo CBA for symptomatic paroxysmal atrial fibrillation

Exclusion Criteria:

* age \< 18 years
* history of AF ablation or cardiac surgery
* contraindication to oral anticoagulants
* presence of intracardiac thrombus or significant coronary artery disease on cardiac computed tomography prior to the procedure.

Primary outcomes:
measure: Radiation exposure time
timeFrame: 1 day
measure: Radiation exposure dose
timeFrame: 1 day
measure: acute success rate
timeFrame: 1 day
measure: Recurrence rate of atrial tachyarrhythmias
timeFrame: 3 months
Secondary outcomes:
measure: Procedure time
timeFrame: 1 day
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
Study officials:
affiliation: Hallym University Medical Center
name: Hong Euy Lim, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06533189: Developing a Whole-body MRI and Diffusion-weighted Imaging State-of-the-art Protocol: a Pilot Study
Official title: Developing a Whole-body Magnetic Resonance Imaging and Diffusion-weighted Imaging State-of-the-art Protocol, a Pilot Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Whole Body Imaging
Cancer
Genetic Predisposition
Keywords: MRI
Whole Body MRI
Genetic Predisposition to Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2024-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oncologic patients (with multiple myeloma, lymphoma, melanoma and metastatic cancer, such as prostate, breast and gynecologic cancers. Another application of WB-MRI is the imaging of patients with certain cancer predisposition syndromes

Brief summary: Whole-body magnetic resonance imaging (WB-MRI) is a non-ionizing imaging method that can provide WB coverage using essential imaging contrasts with the possibility to include sequences focusing in specific body-regions as needed per case. WB-MRI is increasingly being used for the management of cancer patients, especially metastatic ones. An integral part of WB-MRI is becoming whole-body diffusion-weighted MRI (WB-DWI) which is a non-invasive tool used for staging and response evaluation in oncologic practice. WB-DWI is an inherently noisy technique, resulting in it accounting for more than 50% of the acquisition time of conventional whole-body MRI studies with overall duration at least 1-hour. Reducing acquisition times, without compromising image or diagnostic quality would facilitate the wider adoption of clinical WBDWI, reducing costs, and improving the patient experience


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old;
* Patients with diagnosis of multiple myeloma, lymphoma, lung, prostate, breast, colorectal and gynecologic cancers;
* Patients with genetic syndromes responsible for an increased predisposition to neoplasms (e.g. Li Fraumeni syndrome);
* Signed written informed consent to personal data treatment for research purposes

Exclusion Criteria:

* Age \<18 years old;
* Refusal to sign the written informed consent to personal data treatment for research purposes.

Primary outcomes:
measure: Radiologists' satisfaction of the quality of images
timeFrame: 18 months
Secondary outcomes:
measure: Diagnostic accuracy of the de-noised WB-MRI in detecting lesions
timeFrame: 18 months
measure: Diagnostic accuracy of the de-noised WB-MRI in detecting staging metastatic oncologic patients.
timeFrame: 18 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Radiologia
city: Rome
country: Italy
facility: Advanced Radiology Center
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Evis Sala
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06803589: Growth Hormone for the Treatment of Gastroparesis
Official title: Low-dose Growth Hormone for the Treatment of Gastroparesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Gastroparesis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
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 whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.


Eligibility criteria: Inclusion Criteria:

* Symptoms \> 6 months that have not responded satisfactorily to standard treatment.
* For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of \>21

Exclusion Criteria:

* Known history of GH deficiency, hypothalamic or pituitary disease
* Diabetes
* Prior use of GH therapy
* Age-adjusted low serum IGF1
* Women on oral estrogen therapy6
* Pregnancy or nursing
* History of malignant solid tumors
* Obesity (BMI \> 30)History of coronary and thromboembolic diseases.
* History of sarcoidosis
* History of pituitary surgery
* History of thyroid nodules.
* Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
* Failure to give informed consent.

Primary outcomes:
measure: Gastroparesis Cardinal Symptom Index (GCSI)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
Secondary outcomes:
measure: Complete Spontaneous Bowel Movements (CSBMs)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
measure: Gastrointestinal Patient Reported Outcomes Measurement Information System (GI- PROMIS)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Tisha Lunsford
role: PRINCIPAL_INVESTIGATOR
References: