louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06350656: Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)
Official title: Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebrospinal; Disorder
Keywords: Cerebrospinal compliance
Intracranial pressure.
Head injury
Pulse waveform
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sedated patient on mechanical ventilation with continuous intracranial pressure monitoring

Brief summary: Despite the massive use of intracranial pressure in neuro-resuscitation, there is still no cerebral compliance evaluation index used in current practice to guide therapy.

In treatment guidelines for intracranial hypertension, patients are placed in a prone position at about 30 degrees. Several times a day, during nursing care, patients are flattened, which corresponds to a cerebral compliance test by adding a volume of cerebrospinal fluid to the cranial box.

Detailed description: This study aims to analyse the shape of the different components of the intracranial pressure waves (P1, P2, and P3) when the patient is flattened to determine an index to define the level of cerebral compliance.

Eligibility criteria: Inclusion Criteria:

* Continuous intracranial pressure monitoring
* Sedated patient on mechanical ventilation

Exclusion Criteria:

* Craniectomy
* Major hemodynamic failure

Primary outcomes:
measure: Intracranial pressure (mmHg)
timeFrame: Year : 1
Secondary outcomes:
measure: Correlation between ICP (Intra Cranial Pressure) doses and cerebral compliance
timeFrame: Year : 1
Other outcomes:
Locations:
city: Chaponnay
country: France
facility: CENTRE HOSPITALIER Charponnay
city: Grenoble
country: France
facility: CENTRE HOSPITALIER UNIVERSITAIRE Grenoble
city: La Tronche
country: France
facility: HOPITAL NORD La Tronche
city: Paris
country: France
facility: APHP
city: Paris
country: France
facility: Hopital Lariboisiere - Ahph
city: Rennes
country: France
facility: CENTRE HOSPITALIER UNIVERSITAIRE Rennes
city: Saint-Étienne
country: France
facility: CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne
Study officials:
affiliation: CHU DE SAINT-ETIENNE
name: LAURENT GERGELE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00204256: Intravenous Iron in Patients With Anemia of Chronic Kidney Disease
Official title: Open Randomized Phase IV Study on Intravenous Iron in Anemic Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Keywords: chronic kidney disease
anemia
intravenous iron
recombinant human erythropoetin
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 50
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: The objective of this study is the evaluation of the efficacy and safety of intravenous iron sucrose in anemic patients with chronic kidney disease not on renal replacement therapy.

Detailed description: This is a randomized, open label, phase IV study in anemic predialysis patients (Hb between 8 and 11.5 g/dl) who require iron supplementation. The duration of the study for each patient will be approximately 6 months. Patients will be randomized to one of two treatment arms and admitted to the anemia correction phase (days 1-43). Treatment will be intravenous iron sucrose alone versus iron sucrose plus rhEPO. The main treatment evaluation will at the end of the correction phase: The primary end-point will be the change of hemoglobin during correction phase. Secondary end-points will be the change of ferritin and transferrin saturation from baseline to day 43. Safety assessments will include recording of adverse events, vital signs, physical examinations and clinical laboratory tests. Incidence and severity of adverse events will be compared between the two different treatment arms.

Eligibility criteria: Inclusion Criteria:

Chronic kidney disease Anemia (Hb 8 - 11.5 g/dl) Age above 18 years Signed informed consent

Exclusion Criteria:

Rapid progression of kidney disease Need for dialysis Uncontrolled hypertension

Primary outcomes:
measure: Change in hemoglobin from baseline to day 43
Secondary outcomes:
measure: Change in ferritin and transferrin saturation from baseline to day 43; incidence and severity of adverse events
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University Hospital Muenster
state: Westphalia
Study officials:
affiliation: University Hospital Muenster
name: Roland M Schaefer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01034956: Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections
Official title: Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhytids
Wrinkles
Keywords: Soft tissue filler
Dermal filler
Complications
Patient satisfaction
Lead sponsor: The New York Eye & Ear Infirmary
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
First posted: 2009-12-18
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by Principal Investigator with facial soft tissue filler within the past 2 years

Brief summary: Purpose of the study:

The overall goal of this study is to better understand patient experience with injectable facial fillers so that the investigators may provide the best results for their patients. To do this, the investigators are administering surveys to approximately 50 patients who have been treated by Dr. Anthony P Sclafani, MD, FACS.

Participation:

Participants will be asked to complete a brief questionnaire regarding their most recent treatment by Dr. Sclafani with a facial injectable filler. All responses will be analyzed anonymously.

Detailed description: Patients previously treated by the PI with dermal fillers will be mailed questionnaires about their experience with the treatment. These questionnaires will be deidentified prior to recording answers on a computer based spreadsheet.

Eligibility criteria: Inclusion Criteria:

* Patients treated by Principal Investigator with facial soft tissue filler within the past 2 years willing to complete the research survey.

Exclusion Criteria:

* Any patient not treated by Principal Investigator with facial soft tissue filler within the past 2 years.

Primary outcomes:
measure: Satisfaction with treatment with facial soft tissue fillers
timeFrame: 0-24 months
Secondary outcomes:
measure: Social and behavioral effects of facial soft tissue filler treatment
timeFrame: 0-24 months
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Eye & Ear Infirmary
state: New York
Study officials:
affiliation: The New York Eye & Ear Infirmary
name: Anthony P Sclafani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03281356: Text Messaging Pilot Study
Official title: Text Messaging Pilot Study to Encourage Shared Reading Among a Sample of Urban Parents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Literacy
Keywords: Pilot Study
Early childhood development
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This pilot study aims to assess the acceptability, feasibility, and preliminary effectiveness of text messages designed to encourage shared reading among urban parents. We hypothesize that parents will report reading more often to their children after receiving the text messages.

Detailed description: This is a single arm, pilot study. The participants enrolled will receive two text messages per week for a 4 week period (a total of 8 messages). At the end of the study period we will assess change in number of reading occurrences using a validated measure. Parents will also complete a brief acceptability survey.

Eligibility criteria: Inclusion Criteria:

1. Preferred language either English or Spanish,
2. Parent or legal guardian,
3. Age ≥ 18,
4. Willing to accept text messages

Exclusion Criteria:

1. Individuals unable to provide consent
2. Individuals who do not meet inclusion criteria

Primary outcomes:
measure: Acceptability Survey
timeFrame: Visit 2 (1 month)
Secondary outcomes:
measure: Stim Q Survey
timeFrame: Visit 2 (1 month)
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
Study officials:
References:
Clinical trial NCT06056856: Anatomical and Functional Outcome of PSG Vs BMG for Urethral Substitution in Long Segment Anterior Urethral Strictures
Official title: Anatomical and Functional Outcome of Penile Skin Graft Versus Buccal Mucosal Graft for Urethral Substitution in Long Segment Anterior Urethral Strictures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Urethral Stricture, Male
Keywords: urethral stricture
urethroplasty
BMG
PSG
penile skin
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 60
Sex: MALE
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel assignment. The first arm will be operated using penile skin grafts, The second arm will be operated using buccal mucosal grafts.
Primary purpose: TREATMENT

Brief summary: This study aims to compare the penile skin graft and buccal mucosal graft for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.

Detailed description: Since previous studies were:

* Retrospective and very few were prospective randomized studies
* Some studies were done on lichen sclerosis cases that have an adverse effect on the PSG outcome.
* The follow-up duration was longer for PSG patients.
* Stricture length was usually longer for PSG cases.

This study aims to compare the PSG and BMG for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.

The investigators hypothesize that:

❶ Conducting a well-designed prospective, randomized study can help identify which technique is better than the other.

❷ Using the one-side dorsal approach can improve the outcomes of both techniques and identify their advantages and disadvantages.

Eligibility criteria: Inclusion Criteria:

* The study will include patients with long segment anterior urethral stricture (\>2 cm).

Exclusion Criteria:

* Urethro-cutaneous fistula, urethral abscess or diverticulum.
* A scarred and unsalvageable urethral plate or scarred perineum.
* Lichen sclerosis (Balanitis xerotica obliterans).
* Unhealthy/unavailable buccal mucosa.

Primary outcomes:
measure: The degree of urethral lumen patency.
timeFrame: through study completion, an average of 1 year.
Secondary outcomes:
measure: Lower urinary tract symptoms improvement
timeFrame: 6 months
measure: Erectile function assessment
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar urology department, Al-Azhar university hospitals
Study officials:
affiliation: Urology department, Al-Azhar university, Cairo, Egypt
name: Ahmed Fahim, professor
role: STUDY_DIRECTOR
affiliation: Urology department, Al-Azhar university, Cairo, Egypt
name: Mostafa Ezzeldein, professor
role: STUDY_CHAIR
References:
Clinical trial NCT02600156: Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors
Official title: A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Prostate Cancer Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Localized Prostate Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 7
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.

Detailed description: The study is being done to evaluate the safety and effectiveness of Magnetic Resonance Imaging (MRI)-guided focal laser therapy with the Visualase Thermal Therapy System to treat low-risk prostate cancer tumors. Unlike surgery or radiotherapy which affects a large portion of the prostate or the entire organ, localized or focal therapy is intended to treat a small portion of tissue in which the cancer has been found by biopsy.

Eligibility criteria: Inclusion Criteria

* Male, 45 years of age or older.
* Diagnosis of prostate adenocarcinoma.
* Clinical stage T1c or T2a.
* Gleason score of 7 (3+4 or 4+3) or Intermediate risk Gleason 6
* PSA less than or equal to 20 ng/mL
* Three or fewer biopsy locations with prostate cancer which correlate with MRI findings.
* No lesion \> or = 2cm
* One, two, or three tumor suspicious regions identified on multiparametric MRI
* No definite radiographic indication of extra-capsular extension.
* Estimated survival of 5 years or greater, as determined by treating physician.
* Tolerance for anesthesia/sedation.
* Ability to give informed consent.

Exclusion Criteria

* Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
* History of other primary non-skin malignancy within previous three years.

Primary outcomes:
measure: Success rate
timeFrame: 3 years
measure: Incidence of treatment emergent adverse events
timeFrame: 3 years
Secondary outcomes:
measure: Short- and mid-term ablative success
timeFrame: 3 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Woodrum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06700356: Thalamus Seizure Detection With a Deep Brain Stimulator System
Official title: Seizure Detection With a Deep Brain Stimulation System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy; Seizure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the feasibility of chronic ambulatory thalamus seizure detection. The sensitivity, specificity, and false alarm rate of thalamus seizure detection will be calculated using recordings from a deep brain stimulation system, assessed relative to concurrent gold-standard video-EEG monitoring collected in the in-patient setting (epilepsy monitoring unit), in 5 patients with drug resistant epilepsy.


Eligibility criteria: Inclusion Criteria:

Participants must meet all of the inclusion criteria to participate in this study:

* 18 years of age and older.
* Implanted with a clinical DBS system for epilepsy with brain recording capabilities (Medtronic Percept™ DBS).
* Subject or legally authorized representative is able to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria:

All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation:

* Health status or any clinical conditions (e.g., life expectancy, co-existing disease) that, in the opinion of the site investigator, would pose undue risk to undergo epilepsy monitoring unit evaluation for the purpose of seizure characterization.
* Women will verify not pregnant, and if applicable, have urine pregnancy test.
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Primary outcomes:
measure: Thalamic seizure detection in the epilepsy monitoring unit
timeFrame: 2 years
Secondary outcomes:
measure: Ambulatory thalamus seizure detection with constrained DBS recordings
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nicholas Gregg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04457115: Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Pain Control in Modified Radical Mastectomy
Official title: Comparison of Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Intra and Postoperative Pain Control in Modified Radical Mastectomy: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Surgery
Thoracic Paravertebral Block
Post-operative Pain Control
Erector Spinae Plane Block
Opioid Use
Keywords: breast surgery
Thoracic paravertebral block
Erector spinae plane block
Mastectomy
post-operative pain control
Lead sponsor: AUSL Romagna Rimini
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effectiveness of the Erector spinae plane (ESP) block versus thoracic paravertebral (TPV) block in the post-operative pain control after radical mastectomy.

Detailed description: Primary outcome of our study is to compare the effectiveness of two regional anesthesia techniques, ESP block and TPV block, in the post-operative pain-control after radical mastectomy.

We will also evaluate both intra and post-operative opioid consumption, the incidence of PONV, the length of hospital stay, patient satisfaction with the anesthesiology technique and the incidence of chronic pain 6 months after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 85
* American Society of Anesthesiologists classification I - III
* Signature of consent to participate in the study

Exclusion Criteria:

* Coagulopathies and / or use of antiplatelet / anticoagulant drugs
* Infections and/or lesions at the puncture site,
* BMI ≥40
* allergies and / or contraindications to the administration of the drugs used in the study,
* use of chronic opioid therapy

Primary outcomes:
measure: Post-operative pain assessment
timeFrame: 12 hours
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 3 days
measure: Evaluate the incidence and severity of persistent pain 6 months after surgery
timeFrame: six months
measure: Opioid use
timeFrame: 36 hours
measure: Incidence of PONV
timeFrame: 36 hours
measure: Assessment of patient satisfaction with the anesthesiological technique
timeFrame: 36 hours
Other outcomes:
Locations:
city: Cesena
country: Italy
facility: Domenico Pietro Santonastaso
state: Emilia Romagna
Study officials:
affiliation: AUSL Romagna, M. Bufalini Hospital, Cesena
name: Domenico P Santonastaso, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00711815: A Study to Identify Markers in Blood and Tissue of HPV Clearance
Official title: Biomarkers of HPV Clearance: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV Infections
Keywords: Women of the state of Alabama
CIN 1
negative biopsy
normal colposcopy
HPV
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 197
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HPV-positive women with biopsy-confirmed CIN 1 or negative biopsies or normal colposcopic findings

Brief summary: This is a research study looking at gene characteristics in blood and Pap smear samples in hopes of identifying markers that will predict if the HPV infection is present or not.

Detailed description: Because infection with high-risk human papillomavirus is a necessary cause of cervical cancer, HPV testing has many potential uses in cervical cancer screening. Unfortunately, like cytology, it suffers from a lack of specificity when used for population-based screening. Given that HPV testing detects more cases of CIN3+ than cytology and that it would probably be more practical in developing regions, finding a biomarker that would increase specificity has been the goal for much research on HPV and cervical cancer. The goal of this study is to explore potential predictors of viral clearance, specifically RNA levels of candidate genes in cervical swabs and host genetic polymorphisms, in the context of genotype-specific infection data.

Eligibility criteria: Inclusion Criteria:

* HPV positive

Exclusion Criteria:

* Negative for HPV

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Warner K Huh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: