louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05317143: Evaluation of Prostate Cancer Margins
Official title: Evaluation of Prostate Cancer Margins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 100
Sex: MALE
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: Patients with prostate cancer who undergo robotic-assisted prostatectomy

Brief summary: Pathological assessment of prostate tissue


Eligibility criteria: Inclusion Criteria:

* Diagnosed with prostate cancer
* Subject must be scheduled for robotic-assisted radical prostatectomy at the clinical site.

Exclusion Criteria:

* None

Primary outcomes:
measure: Positive Margin
timeFrame: Immediately postoperatively, expected same day as surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Gronau
country: Germany
facility: St. Antonius Hospital, Prostatazentrum Nordwest
Study officials:
affiliation: St. Antonius, Hospital, Prostatazentrum Nordwest, Möllenweg 22, 48599 Gronau, Germany
name: Jörn Hinrich Witt, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius, Hospital, Prostatazentrum Nordwest, Möllenweg 22, 48599 Gronau, Germany
name: Sami-Ramzi Leyh-Bannurah, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03046043: AF Ablation Based on High Density Voltage Mapping and CFAE
Official title: Ablation of Persistent Atrial Fibrillation Based on High Density Voltage Mapping and Complex Fractionated Atrial Electrogram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2017-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 20
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 efficacy of additional ablation targeting complex fractionated atrial electrogram area within low voltage zone identified by high resolution mapping in patients with persistent atrial fibrillation.

Detailed description: Fifty patients with persistent atrial fibrillation will be randomized a 1:1 ratio to each group. A test group includes those who undergoing ablation targeting low voltage areas which contains complex fractionated trial electrogram in addition to pulmonary vein isolation and a control group includes who undergoing pulmonary vein isolation only.

Eligibility criteria: Inclusion Criteria:

1. Age over 20 years old and under 80 years old
2. Patients with non-valvular atrial fibrillation
3. Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them
5. Patients who are available of follow-up at least for more than three months after catheter ablation

Exclusion Criteria:

1. Patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm
2. Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
3. Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
4. Patients in the subject group vulnerable to clinical study
5. Patients who had undergone a prior catheter ablation for atrial fibrillation

Primary outcomes:
measure: Free from atrial arrhythmia at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Complication rate
timeFrame: 12 months
measure: Total procedure time, ablation time and fluoroscopy time
timeFrame: 12 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Hyoung-Seob Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00724243: Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)
Official title: Remicade Treatment Registry in Rheumatoid Arthritis I
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects for this study will be patients expecting to initiate infliximab, for the first time, for the diagnoses of rheumatoid arthritis at the National Institute of Rheumatology Diseases in Piestany, Slovakia.

Brief summary: This study will gather information on the safety and efficacy of patients with rheumatoid arthritis (RA) who are starting treatment with infliximab for the first time. Patients will be treated in the usual manner according to local guidelines and normal clinical practice.

Detailed description: Local patients, diagnosed with RA at the National Institute of Rheumatic Diseases, Piestany, Slovakia, can participate, if their physicians have decided to treat the patient with infliximab. Registration for the trial will be done on a voluntary basis.

Eligibility criteria: Inclusion Criteria:

* Subject must have been given patient leaflet,
* Subject must not have ever received infliximab at the time of registration,
* Subject must be a good candidate for infliximab as per Summary of Product Characteristics
* Subject must sign the approved consent form

Exclusion Criteria:

* None

Primary outcomes:
measure: Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment
timeFrame: Baseline, Week 14, and Week 54
measure: Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria
timeFrame: Week 14 and Week 54
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00487643: Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay
Official title: Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tear Protein Lacritin in Human Tears
Keywords: Lacritin
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
Collaborators: name: University of Virginia
name: James Madison University
name: Eastern Virginia Medical School
First posted: 2007-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Military health care beneficiary between the ages of 21-55.

Brief summary: Purpose: to build a library of normal tear lacritin values by collecting tears from normal adult human subjects and to develop a non-invasive clinical assay for lacritin. Such an assay will provide more sensitive indicators of eye disease for clinicians and determine if a particular therapy, such as recombinant lacritin drops, is of benefit.


Eligibility criteria: Inclusion Criteria:

1. Military health care beneficiary between the ages of 21-55.
2. Male or female, of any race, and at least 21 years old and not older than 55 years old at the time of tear collection.
3. Appropriately aged individuals who report that their eyes are "normal" and who have no active eye illness as determined by principal investigator or sub-investigator.
4. Ability and willingness to understand and provide informed consent to participate in this study.

Exclusion Criteria:

1. Irritated eye reflected by patient statements or finding of "red" eye.
2. Individuals with any infections or inflammatory ocular condition (e.g. have "pink eye" or uveitis).
3. Individuals diagnosed with dry eye or other ocular surface condition, including but not restricted to neurotrophic keratitis, anterior basement membrane dystrophy, and recurrent corneal erosions.
4. Individuals who are on any topical eye medications.
5. Anyone who reports previous reaction or the possibility of an allergic reaction to 0.5% proparacaine.

Primary outcomes:
measure: lacritin levels in human tears
timeFrame: 2 minutes after instilling anesthetic eyedrop
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: WRAMC
name: Kraig S. Bower, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05289843: Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants
Official title: Effect of Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants on the Intensity of Post-operative Pain and Bacterial Reduction in Asymptomatic Necrotic Mandibular Premolars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrotic Pulp
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To measure the Effect of Rosmarinus Officinalis versus 2.5%Sodium Hypochlorite as Root canal Irrigants on the Intensity of post-operative pain and Bacterial Reduction in asymptomatic necrotic Mandibular premolars.


Eligibility criteria: Inclusion Criteria:

1. Systematically healthy patient (ASA I and II).
2. Age between 20 and 45 years with no sex predilection
3. Mandibular permanent premolar teeth:

   * Diagnosed clinically with pulp necrosis.
   * Absence of spontaneous pain.
   * Radiographic evidence of root and root canal.
   * Slight widening in the periodontal membrane space or with periapical radiolucency.
   * No response to cold pulp tester (ethyl chloride spray)
4. Patients who can understand and interpret Numerical rating scale (NRS).
5. Patients' acceptance to participate in the trial

Exclusion Criteria:

* 1- Medically compromised patients having significant systemic disorders. (ASA III or IV).

  2- History of intolerance to NSAIDS. 3- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.

  4- Pregnant women: Avoid radiation exposure, anesthesia, and medication. 5- Teeth with: i. Vital teeth. ii. Double canal mandibular premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.

  v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth
* Immature teeth.
* Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Primary outcomes:
measure: Postoperative pain after root canal treatment.
timeFrame: Up to 48 hours postoperative.
Secondary outcomes:
measure: Intracanal bacterial load change.
timeFrame: First as a base line and after 15 minutes ( End of the chemo-mechanical preparation).
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02305043: Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Gastric Cancer
Official title: Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Adenocarcinoma of the Stomach or Gastroesophageal Junction. A Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Neoplasms
Stomach Neoplasms
Keywords: non-interventional
advanced gastric cancer
Trastuzumab
HER2
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2014-12-02
Enrollment: 549
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 suffer from histologically proven adenocarcinoma of the stomach or gastroesophageal junction

Brief summary: The aim of this study is to identify biomarkers predicting response or resistance factors of a targeted therapy with trastuzumab in advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

* histologically proven adenocarcinoma of the stomach or gastroesophageal junction

  * stage IV
  * patient receives chemotherapy
  * signed informed consent
  * Age \> 18 years

Exclusion Criteria:

* Patient can not understand meaning and purpose of the study
* patient already received a chemotherapy treatment for advanced disease.

Primary outcomes:
measure: Percentage of Participants With Objective Response
timeFrame: 12 months
Secondary outcomes:
measure: time-to-progression
timeFrame: up to 24 months
measure: overall survival
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Cancer Center Leipzig
Study officials:
affiliation: University Cancer Center Leipzig
name: Florian Lordick, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ebert K, Haffner I, Zwingenberger G, Keller S, Raimundez E, Geffers R, Wirtz R, Barbaria E, Hollerieth V, Arnold R, Walch A, Hasenauer J, Maier D, Lordick F, Luber B. Combining gene expression analysis of gastric cancer cell lines and tumor specimens to identify biomarkers for anti-HER therapies-the role of HAS2, SHB and HBEGF. BMC Cancer. 2022 Mar 9;22(1):254. doi: 10.1186/s12885-022-09335-4.
citation: Haffner I, Schierle K, Raimundez E, Geier B, Maier D, Hasenauer J, Luber B, Walch A, Kolbe K, Riera Knorrenschild J, Kretzschmar A, Rau B, Fischer von Weikersthal L, Ahlborn M, Siegler G, Fuxius S, Decker T, Wittekind C, Lordick F. HER2 Expression, Test Deviations, and Their Impact on Survival in Metastatic Gastric Cancer: Results From the Prospective Multicenter VARIANZ Study. J Clin Oncol. 2021 May 1;39(13):1468-1478. doi: 10.1200/JCO.20.02761. Epub 2021 Mar 25.
Clinical trial NCT02510443: Observational Study on Contraception With Essure in France
Official title: Survey on Use and Characteristics of Definitive Contraception With ESsure®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Permanent contraception method
Contraceptive device
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Hôpital André Mignot Centre Hospitalier de Versailles
First posted: 2015-07-29
Enrollment: 2644
Sex: FEMALE
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: The patients concerned are adult women wishing to undergo tubal sterilization for contraceptive purposes, in accordance with legal provisions, who had given their consent for collection of the data.

Brief summary: Using a very broad survey, the objective is to confirm the effectiveness of the Essure method, and to obtain more information on the conditions of use as well as on the methods used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on patients.

Detailed description: The study is a prospective epidemiological survey to collect local real life data on patients under routine pratice

Eligibility criteria: Inclusion Criteria:

* Woman ≥ 18 years old,
* Scheduled for Essure procedure
* Patient who has been given appropriate information about the study objectives and procedures and who has given her consent.

Exclusion Criteria:

* Patients with contraindications as listed in the current Instruction For Use (IFU) will be excluded.

Primary outcomes:
measure: Number of patients being satisfied with successful Essure procedure having no complications at 5 years
timeFrame: At 5 years
Secondary outcomes:
measure: Number of patients with moderate or important pain when placement is performed
timeFrame: At initial visit
measure: Number of unsatisfied patients
timeFrame: Up to 5 years
measure: Number of satisfied patients at 3, 12 and 24 months
timeFrame: At 3 ,12 and 24 months
measure: Number of examinations by patients
timeFrame: At 3 months
measure: Number of good insert position by implant and patients with success in final result of the procedure
timeFrame: At 3 months
measure: Causes of unsatisfied patients
timeFrame: Up to 5 years
measure: Type of examinations by patients
timeFrame: At 3 months
measure: Number of patients with regrets
timeFrame: At 12 months, 24 months and 5 years
Other outcomes:
Locations:
city: Le Chesnay
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05677243: Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery
Official title: Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trigeminal Neuralgia
Keywords: Trigeminal Neuralgia
Radiosurgery
LINAC
Pain relief
Hypesthesia
Lead sponsor: Centre Hospitalier Princesse Grace
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nice
First posted: 2023-01-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with trigeminal neuralgia treated by radiosurgery on LINAC

Brief summary: This study aims to evaluate the outcome of patient treated by radiosurgery on LINAC with high dose rate for classical trigeminal neuralgia

Detailed description: This retrospective and prospective case-series hospital-based study will be conducted in all patients with trigeminal neuralgia treated by radiosurgery on LINAC at the Centre Hospitalier Princesse Grace from april 2018 to january 2028. Patients will be treated with frameless technic and receive 90 Gy delivered with high dose rate on the intra cisternal portion of the trigeminal nerve.

Eligibility criteria: Inclusion Criteria:

* Classical trigeminal neuralgia according the International Classification of Headache Disorders
* Trigeminal neuralgia resistant to the maximum tolerated medical therapy, with pain intensity according to the Barrow Neurological Institute (BNI) score IV or V.
* Patients aged \> 18

Exclusion Criteria:

* Patients suffering from secondary Trigeminal neuralgia (tumour in the cerebellopontine angle, arteriovenous malformation or multiple sclerosis)
* Previous history of radiosurgery procedure

Primary outcomes:
measure: Pain relief
timeFrame: 24 months
Secondary outcomes:
measure: Toxicity of radiosurgery
timeFrame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years
measure: Variation of quality of life
timeFrame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
References:
Clinical trial NCT04567043: Treating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention
Official title: Reating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot RCT will examine the preliminary efficacy of a telehealth version of Mindfulness-Oriented Recovery Enhancement (MORE) enriched with a smartphone-based just-in-time adaptive intervention (JITAI) for patients with chronic pain on long-term opioid therapy.


Eligibility criteria: Inclusion Criteria:

* Current chronic pain diagnosis determined by physician assessment (including but not limited to ICD-9 diagnoses 338.0, 338.21, 338.22, 338.28, 338.29, 338.4)
* Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for \>90 days
* Willingness to participate in study interventions and assessments

Exclusion Criteria:

* Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
* Active suicidality, schizophrenia, psychotic disorder
* Presence of clinically unstable systemic illness judged to interfere with treatment
* No access to internet (which will prevent telehealth-based treatment)

Primary outcomes:
measure: Change in momentary craving
timeFrame: Baseline through 1-month follow-up
measure: Change in momentary pain: numeric rating scale
timeFrame: Baseline through 1-month follow-up
Secondary outcomes:
measure: Change in momentary positive affect
timeFrame: Baseline through 1-month follow-up
measure: Change in momentary stress
timeFrame: Baseline through 1-month follow-up
measure: Change in heart rate variability
timeFrame: Baseline through 1-month follow-up
Other outcomes:
measure: Change in opioid misuse
timeFrame: Baseline through post-treatment (week 8)
measure: Change in chronic pain symptoms
timeFrame: Baseline through post-treatment (week 8)
measure: Change in opioid dose
timeFrame: Baseline through post-treatment (week 8)
measure: Change in self-transcendence
timeFrame: Baseline through post-treatment (week 8)
measure: Change in mindful reinterpretation of pain sensations
timeFrame: Baseline through post-treatment (week 8)
Locations:
city: Salt Lake City
country: United States
facility: Center on Mindfulness and Integrative Health Intervention Development
state: Utah
Study officials:
References:
citation: Garland EL, Manusov EG, Froeliger B, Kelly A, Williams JM, Howard MO. Mindfulness-oriented recovery enhancement for chronic pain and prescription opioid misuse: results from an early-stage randomized controlled trial. J Consult Clin Psychol. 2014 Jun;82(3):448-459. doi: 10.1037/a0035798. Epub 2014 Feb 3.