louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05261165: Effect of a Uterine Manipulator on the Incidence of Lymphovascular Propagation (LVSI) in Treatment of Endometrial Cancer
Official title: Effect of a Uterine Manipulator on the Incidence of Lymphovascular Propagation (LVSI) in Treatment of Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
LVSI
Lead sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 170
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women diagnosed with endometrial cancer, planned to primary surgical treatment - hysterectomy.

Brief summary: We retrospectively analyzed data and compared the impact of intrauterine manipulators on incidence of LVSI in endometrial cancer patients treated at our department.

Detailed description: Endometrial cancers are among the epithelial malignancies of the lining in the uterine cavity. Standard treatment is surgical, which includes a hysterectomy. The invasion of carcinoma into the lymphovascular space (LVSI - lymphovascular space invasion) is considered a risk factor for the course of the disease Based on the recommended procedures of ESGO-ESTRO-ESP (2020) in the management of endometrial cancer, in the event of significant LVSI positivity, the female patients are included in the upper-medium risk group. A confirmation of LVSI in the preparation is of diagnostic, therapeutic and theoretical importance. During endoscopy approach, we use two types of uterine manipulators, namely the Koh-RUMI manipulator (Cooper Surgical) and the Hegar dilatator along with the McCartney tube (LiNA Medical). We analyzed data and compared the impact of intrauterine manipulators on the incidence of LVSI. In addition, we analyzed tumor grading, invasion and primary histology obtaining methods - curettage or hysteroscopy in correlation to incidence of LVSI.

Eligibility criteria: Inclusion Criteria:

* endometrioid endometrial cancer,
* planned primary surgical treatment - hysterectomy,
* medical condition enabling anesthesia and surgery,
* pre-surgical clinically-determined affecting of the uterine according to MRI or ultrasound - cT1a or cT1b

Exclusion Criteria:

* non-endometrioid type of tumor in definitive histology,
* stage 2 of a disease and higher,
* previous chemo or radiotherapy,
* inability to adequately complete the surgery,
* uterine perforation during surgery

Primary outcomes:
measure: LVSI and intrauterine manipulator
timeFrame: oct. 2015 - jan. 2021
Secondary outcomes:
measure: LVSI and type of intrauterine manipulator
timeFrame: oct. 2015 - jan. 2021
Other outcomes:
measure: LVSI and grading of tumor
timeFrame: oct. 2015 - jan. 2021
measure: LVSI and myometrial invasion
timeFrame: oct. 2015 - jan. 2021
measure: LVSI and primary histology procedure
timeFrame: oct. 2015 - jan. 2021
Locations:
city: Banská Bystrica
country: Slovakia
facility: F.D. Roosevelt Teaching Hospital with Policlinic
Study officials:
References:
Clinical trial NCT03343665: Treatment With Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkins Lymphoma
Official title: A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed or Refractory Hodgkins Lymphoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hodgkin Lymphoma
Keywords: Nivolumab
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase I/II trial to evaluate the safety and efficacy of nivolumab at the fixed dose 40 mg in patients with relapsed or refractory Hodgkins lymphoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis: Histologically confirmed Hodgkins lymphoma
* Relapsed or refractory disease after at least two prior lines of treatment
* Age 18-70 years old
* Signed informed consent
* No severe concurrent illness

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
* Active or prior documented autoimmune disease requiring systemic treatment.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 12 months
Secondary outcomes:
measure: Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
timeFrame: 12 months
measure: Duration of Response (DOR)
timeFrame: 12 months
measure: Progression-Free Survival (PFS)
timeFrame: 12 months
measure: Overall Survival (OS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: First Pavlov State Medical University of St. Petersburg
Study officials:
affiliation: St. Petersburg State Pavlov Medical University
name: Boris V Afanasyev, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lepik KV, Fedorova LV, Kondakova EV, Zalyalov YR, Babenko EV, Lepik EE, Kotselyabina PV, Beynarovich AV, Popova MO, Volkov NP, Stelmakh LV, Baykov VV, Moiseev IS, Mikhailova NB, Kulagin AD, Afanasyev BV. A Phase 2 Study of Nivolumab Using a Fixed Dose of 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkin Lymphoma. Hemasphere. 2020 Sep 23;4(5):e480. doi: 10.1097/HS9.0000000000000480. eCollection 2020 Oct.
Clinical trial NCT01843465: Cryoablation of AF: Improving the Use of the Achieve Catheter
Official title: Improving the Assessment of Pulmonary Vein Disconnection With the Achieve Catheter During Atrial Fibrillation Cryoablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
balloon cryoablation
pulmonary veins
Lead sponsor: Clinique Pasteur
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing cryoablation of atrial fibrillation using the Achieve catheter to document pulmonary vein disconnection.

Brief summary: According to data from high volume Centres, documentation of entry block with the Achieve catheter may be possible in only about to 50% of pulmonary veins. The investigators aim to assess strategies using the Achieve catheter that can improve this performance.


Eligibility criteria: Inclusion Criteria:

* all consecutive patients undergoing atrial fibrillation cryoballoon ablation monitored with the Achieve catheter.

Exclusion Criteria:

* patients in AF at the beginning of the procedure
* patients with a previous AF ablation procedure

Primary outcomes:
measure: Real-time Documentation of Pulmonary Vein Disconnection
timeFrame: atrial fibrillation cryoablation procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Pasteur
state: Haute-Garonne
Study officials:
affiliation: Clinique Pasteur
name: Serge Boveda, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boveda S, Providencia R, Albenque JP, Combes N, Combes S, Hireche H, Casteigt B, Bouzeman A, Jourda F, Narayanan K, Marijon E. Real-time assessment of pulmonary vein disconnection during cryoablation of atrial fibrillation: can it be 'achieved' in almost all cases? Europace. 2014 Jun;16(6):826-33. doi: 10.1093/europace/eut366. Epub 2013 Dec 18.
Clinical trial NCT04534465: Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements.
Official title: A Single Center, Open-label, Parallel Arm, Phase 4 Study to Evaluate the Acceptability of a Prototype Flavor System With Ascending Levels of 2,4,6 Grams or Higher of Mannitol for PEG 3350 Laxative in Subjects Suffering With Occasional Constipation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to gather information on the acceptability of a new flavor system with increasing levels of 2, 4, 6 g or higher of the sugar alcohol Mannitol for Polyethylene glycol (PEG) 3350 a drug stimulating bowel movement to pass stool in subjects having infrequent bowel movements. The taste of the various preparations will be measured by use of a rating scale.


Eligibility criteria: Male and female subjects, aged 18 years and older, suffering with occasional constipation

Primary outcomes:
measure: Number of Participants With the Opinion of the Products' Flavor
timeFrame: 1 day
measure: Number of Participants With the Opinion of the Amount of Flavor in the Products
timeFrame: 1 day
measure: Number of Participants With the Opinion of the Products' Sweetness
timeFrame: 1 day
measure: Number of Participants With/Without Cooling Sensation in the Products.
timeFrame: 1 day
measure: Number of Participants With Different Levels of Cooling Sensation of the Products
timeFrame: 1 day
measure: Number of Participants With the Opinion of Aftertaste in the Products.
timeFrame: 1 day
measure: Number of Participants With Different Levels of Aftertaste of the Products
timeFrame: 1 day
Secondary outcomes:
measure: Number of Participants With no Bowel Movement
timeFrame: 1 day
measure: Time to First Bowel Movement (In Hours)
timeFrame: 1 day
measure: Number of Participants for Gas Rating
timeFrame: 1 day
measure: Number of Participants for Bloating Rating
timeFrame: 1 day
measure: Number of Participants for Abdominal Discomfort Rating
timeFrame: 1 day
measure: Number of Participants With no Successful Bowel Movement
timeFrame: 1 day
measure: Time to First Successful Bowel Movement (In Hours)
timeFrame: 1 day
measure: Number of Participants With Treatment Emergent Adverse Event
timeFrame: 1 day
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Merck Consumer Center
state: Tennessee
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03725865: A Clinical Study of iNSC Intervent Cerebral Hemorrhagic Stroke
Official title: A Clinical Study of Intracerebral Transplantation of Human Peripheral Blood Derived Induced Neural Stem Cells for Cerebral Hemorrhagic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Stroke, Ischemic
Lead sponsor: Allife Medical Science and Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-31
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a single centre、single arm、open-label，to investigate the safety and efficacy of induction of neural stem cells transplantation in the brain


Eligibility criteria: Inclusion Criteria:

1. Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study procedures.
2. Men and women 30-65 years old.
3. Women must have a negative serum pregnancy test, gestation age women practice an acceptable method of contraception.
4. At least 12 months but no more than 60 months from time of hemorrhagic stroke, with a motor neurological deficit.
5. Documented history of single hemorrhagic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI.
6. Modified Rankin Score of 2, 3 or 4.
7. FMMS score of 55 or less, two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 5 point change in the FMMS.
8. Two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 4 point change in the NIHSS.
9. Able and willing to undergo post-physical therapy/rehabilitation.

Exclusion Criteria:

1. Any disabling psychological or psychiatric disorders which may confound the study.
2. History of more than one hemorrhagic stroke.
3. History of another major neurological disease or injury.
4. Cerebral soften lesion size \>5cm in any one measurement.
5. Myocardial infarction within the prior 3 months.
6. History of seizures or current use of antiepileptic medication.
7. History of peripheral nerve surgery, including Selective Dorsal Rhizotomy and Contralateral Seventh Cervical Nerve Transfer.
8. Receipt of any investigational drug or device within 30 days.
9. Receipt of any cell infusion other than blood transfusion.
10. Any concomitant medical disease or condition noted below:

    1. Coagulopathy.
    2. Active or history of malignancy.
    3. Primary or secondary immune deficiency.
    4. Persistent MRI artifact or unable to undergo MRI.
11. Any condition that the Investigator or primary physician feels may interfere with participation in the study or may endanger the subject.
12. Any condition that the surgeon feels may pose complications for the surgery.

Primary outcomes:
measure: Incidence of Treatment Emergent AE
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00907465: Sedentary Behavior in African Americans
Official title: Measurement of Sedentary Behavior in African American Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2009-05-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community members of Baton Rouge, LA.

Brief summary: The study is designed to develop methods for objectively measuring sedentary behavior, assess the association between objectively measured sedentary behavior and cardiovascular disease outcomes, and develop an intervention to reduce sedentary behavior, in African American adults.


Eligibility criteria: Inclusion Criteria:

* self-classify yourself as African American
* are aged 18 years or older
* are free of serious medical condition, such as cancer, cardiovascular disease, or emphysema.
* are free of serious medical conditions that would prevent participant from engaging in physical activity.
* are willing to have a scan completed that measures your body composition
* are willing to stay in metabolic chamber for 8.5 hours (8:00am until 4:30 pm)
* are willing to wear an accelerometer for 2, one-week periods following your chamber stay. There will be one week in-between the 2, one-week periods.
* are willing to complete questionnaire related to your level of activity
* weigh less than 250 lbs.

Exclusion Criteria:

* unwilling or unable to perform activities in protocol
* on medications
* a woman who is intending to become pregnant, or who is pregnant

Primary outcomes:
measure: Sedentary behavior
timeFrame: 2009-2010
Secondary outcomes:
measure: Blood pressure
timeFrame: 2009-2010
measure: High density lipoproteins
timeFrame: 2009-2010
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Robert L Newton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05967065: Diagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone B250 Skull Vibration Protocol
Official title: Diagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Superior Canal Dehiscence Syndrome
Vestibular Disorder
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2023-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: to study the videonystagmography response to a bone conducted vibration on the mastoid by B250 bone transducer in patients affected by vestibular loss, Menieres disease and Superior Semicircular Canal Dehiscence Syndrome vs healthy control subjects


Eligibility criteria: Inclusion Criteria:

Patients affected by certain vestibular disorders.

Exclusion Criteria:

Patients with vertigo and dizziness without certain diagnosis.

Primary outcomes:
measure: measure of eye movements
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Hearing and Balance Unit
Study officials:
References:
Clinical trial NCT05986565: Study of the Families Moving Forward Website Behavioral Intervention for Teachers of Students With Fetal Alcohol Spectrum Disorder
Official title: Pilot Trial of the FMF Connect Teacher Companion Website
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if the FMF Connect Teacher Companion website is acceptable and usable by teachers. The FMF Connect Teacher Companion website is a website for teachers adapted from the Families Moving Forward (FMF) Program. The FMF Program is an evidence-based intervention for caregivers of children with FASD. The study will determine if the a web page intervention is feasible and acceptable by looking at enrollment and retention of study subjects and acceptability of assessments.


Eligibility criteria: Inclusion Criteria:

* Be an educational professional currently actively employed in a school setting in the United States
* Be above the age of 18 years old
* Have direct, consistent contact with a student with a diagnosed fetal alcohol spectrum disorder (FASD) or confirmed prenatal alcohol exposure (PAE) between the ages of 5-12, (i.e. grades K to 5) in a special or general education classroom
* Have reliable access to the Internet
* Be able to consent for themselves

Exclusion Criteria:

* They are unable to read English
* They do not have direct, consistent contact with a student with a diagnosed FASD between ages 5-12 (e.g., substitute teacher, principal)

Primary outcomes:
measure: Change in Mean Knowledge About FASD From Baseline to 6 Weeks
timeFrame: baseline to 6 weeks
measure: Change in Personal Efficacy Mean From Baseline to 6 Weeks
timeFrame: baseline to 6 weeks
measure: Change in Teaching Efficacy Means From Baseline to 6 Weeks
timeFrame: baseline to 6 weeks
measure: Mean Difference in Sensory Seeking Attributions at 6 Weeks
timeFrame: 6 weeks
measure: Mean Difference in Sensory Avoiding Attributions at 6 Weeks
timeFrame: 6 weeks
measure: Mean Difference in Task - Willful Attributions at 6 Weeks
timeFrame: 6 weeks
measure: Mean Difference in Task - Ability Attributions at 6 Weeks
timeFrame: 6 weeks
measure: Mean Difference in Disruptive Behavior Attributions at 6 Weeks
timeFrame: 6 weeks
measure: Mean Difference in Emotional Support Attributions at 6 Weeks
timeFrame: 6 weeks
measure: Mean Difference in Dysregulated Behavior Attributions at 6 Weeks
timeFrame: 6 weeks
measure: Mean Overall Quality of Website (Website Group Only)
timeFrame: 6 weeks
measure: Mean Subjective Quality of Website (Website Group Only)
timeFrame: 6 weeks
measure: Mean Perceived Impact of Website (Website Group Only)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT02329665: Data Collection in Patients Undergoing CT-Guided Needle Interventions for NeedleWays System Development
Official title: A Prospective Data Collection, Single-Center, Open Label Study in Patients Undergoing CT-Guided Needle Interventions for the Development of the NeedleWays System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tumors
Lead sponsor: NeedleWays
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 50
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: The primary objective of this study is to collect CT images of patients undergoing CT Guided Needle Intervention Procedures which will be used for the development of the NeedleWaysTM System.

Detailed description: The study will collect anonymized data in support of further development of the NeedleWays System.

The collected data will be:

1. Anonymized CT scans with Patient Reference Frame (PRF) placed upon the scanned area, outside of the sterile field.
2. Screen captures of the NeedleWays Procedure console display as the intervention needle is placed on the patients body, outside of the sterile field.

Eligibility criteria: Inclusion Criteria

* Male or female subjects, 18 years of age or older at the time of enrollment.
* Subjects meeting all medical conditions for percutaneous CT-guided needle intervention.
* INR \<1.4
* Written informed consent to participate in the study.
* Ability to comply with the requirements of the study procedures. Exclusion Criteria
* Subjects diagnosed with one or more of the following according to medical records:
* Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting,Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
* Subjects treated with Ticlopidine or similar antithrombotic medication.
* Subjects who cannot tolerate mild sedation
* Subjects with the following laboratory values, unless otherwise approved by hematologist:
* Platelet count \<60,000/ml
* APTT \>39 sec or PT \>15 sec
* Pregnancy or lactation
* Subject is unable to comply with requirements of the procedure, i.e. holding breath.
* Subject participation in an investigational trial within 30 days of enrollment
* Subjects who are uncooperative or cannot follow instructions

Primary outcomes:
measure: collect CT images of patients undergoing CT
timeFrame: procedure duration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: