louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04122521: Radiogenomic and Prognosis Analysis in Glioma
Official title: Prospective Observational Study of Imaging-based Prediction for Genomic Mutations and Prognosis in Glioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of tertiary hospital center

Brief summary: This study aims to evaluate whether MRI can be used to predict genomics and prognosis in glioma. Given the profound prognostic significance of genetic mutations seen in glioma, there have been increasing attempts to correlate imaging characteristics with genetic, mutational and expression patterns. To be able to predict genomics and prognosis based on imaging alone will prove useful in patients with involvement of glioma in delicate areas of the brain and better reflect tumor and molecular heterogeneity.

Detailed description: Previous studies have proposed certain imaging characteristics correlating with genetic, molecular and expression patterns. Advanced imaging provides additional clues but no studies have examined its added value particularly in a prospective setting. The investigator's aim to evaluate preoperative MRI for patients suspected of glioma to predict IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status using imaging characteristics such as margin, patterns of contrast enhancement and edema as well as diffusion and perfusion characteristics. This will be confirmed pathologically and further correlated with patients' long term outcome.

Eligibility criteria: Inclusion Criteria:

* Patients suspected of glioma undergoing MRI examination prior to surgery
* MRI including advanced imaging such as cerebral blood volume, apparent diffusion coefficient and amide proton transfer imaging
* Signed informed consent

Exclusion Criteria:

* Pathologic confirmation as tumors other than glioma
* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
* Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential

Primary outcomes:
measure: Time to progression
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Genomics including IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status
timeFrame: 2 months
measure: Progression free survival
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Ho Sung Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Ji Eun Park, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01189721: Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery
Official title: Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hyperalgesia
Keywords: remifentanil
hyperalgesia
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2010-08-27
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that propofol infusion during surgery can affect the remifentanil hyperalgesia compared to sevoflurane inhalation.The outcome will be measured by a verbal numerical rating score (VNRS) and mechanical punctuating pain by electronic von frey filament.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing thyroidectomy
* Age 20-65
* American Society of Anesthesiologists physical status classification I or II

Exclusion Criteria:

* History of chronic pain, Regular use of analgesic, antiepileptic or antidepressive drugs
* History of drug \& alcohol abuse
* Psychiatric disorder
* Use of opioids within 24hrs
* Renal disease with decreased glomerular filtrate ratio
* Neuromuscular disease, Severe cardiac disease

Primary outcomes:
measure: Tactile pain thresholds adjacent to the surgical wound assessed by von Frey hair before the induction and at postoperative 24 & 48 hrs
timeFrame: postoperative 48 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gang Nam Severance Hospital, Yonsei University, Anesthesia and Pain Medicine Department,
Study officials:
affiliation: Gangnam severance hospital, Yonsei university, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute
name: yuen hee shim, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06124521: Community Based Treatment for (ComBaT) Glaucoma
Official title: Increasing Eye Care Utilization in Black Americans At High Risk For Glaucoma Using A Community-Engaged and Faith-Based Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Keywords: Eye Care
Care utilization
Community-based
Faith-based
Glaucoma
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-11-09
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research is to evaluate if intervention and education can change the behavior of someone's willingness to see an eye care provider to prevent blindness and glaucoma. The researchers are investigating if adding additional resources improves participant access to care.

Detailed description: Outcome measures related to acceptability and feasibility are exploratory. They will not be registered or results reported.

Eligibility criteria: Inclusion Criteria:

* Black or African American
* Participated in the screening examination portion of the study

Exclusion Criteria:

* Current eye pain (\> 8 out of 10)
* Sudden decrease in vision (within 1 week)
* Double vision that doesn't stop when you blink and stops no matter what eye you cover (not blurred, but seeing 2 objects)
* Pregnant women
* Prisoners
* Cognitive impairment- unable to give an ocular and social history
* Moving outside of Michigan or driving distance to the church within 6 months

Primary outcomes:
measure: Eye care utilization
timeFrame: Up to 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Historic King Solomon Baptist Church
state: Michigan
Study officials:
affiliation: University of Michigan
name: Angela Elam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05423821: Non-operating Room Anesthesia Experiences in Pediatric Magnetic Resonance Imaging Cases
Official title: Out Patient Anesthesia Experiences in Pediatric Magnetic Resonance Imaging Cases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Magnetic Resonance Imaging Contrast Media Adverse Reaction
Sedation Complication
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 350
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases under the age of 18 who received anesthesia outside the operating room (MRI) in our clinic between 2020-2022 will be screened retrospectively.

Brief summary: In recent years, out patient anesthesia applications have been increasing for diagnostic and interventional procedures for pediatric patients. In this study, we aimed to retrospectively analyze the anesthesia applications performed in pediatric MRI cases in our hospital.

It is a retrospective study

Detailed description: In recent years, applications with sedation and/or general anesthesia for diagnostic purposes in pediatric cases with Magnetic Resonance Imaging (MRI) method have been increasing. Although imaging methods are useful in diagnosis and treatment, they carry minimal risk for patients. As the demands for anesthesia increase during Magnetic Resonance Imaging, questions have arisen about what can be done safely in anesthesia management. The type of anesthesia applied for Magnetic Resonance Imaging is called non-operating room anesthesia.

Cross-sectional imaging techniques such as MRI require pediatric patients to remain calm for up to one hour, and thus these patients need anesthesia. In the induction of anesthesia with agents used in anesthesia outside the operating room, the patient sleeps quickly, the vital functions are stable in its maintenance, the patient recovers quickly after anesthesia, the physical and mental activities return to normal as soon as possible after recovery, and there are no side effects such as nausea, vomiting, dizziness and pain that will delay the discharge. is necessary. Sedation or general anesthesia carries risks and can have unintended consequences if poorly managed.

Eligibility criteria: Inclusion Criteria:

* Elective cases under the age of 18 will be included in the study between 01.01.2020 and 01.01.2022.
* Patients to undergo elective magnetic resonance imaging

Exclusion Criteria:

* Magnetic resonance without anesthesia will not be included. Over the age of 18 will be excluded from study

Primary outcomes:
measure: The type of anesthesia we trust most in magnetic resonance
timeFrame: two hour
Secondary outcomes:
measure: reducing complications in magnetic resonance
timeFrame: two hour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01613521: Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer
Official title: Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Cancer
Keywords: DCE-MRI
18F-FMISO PET
11-174
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 3
Sex: FEMALE
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 is to assess how patients respond to their treatment for cervical cancer. This research does not involve a specific treatment for the cancer that will be recommended by the doctor and may include radiation therapy and/or chemotherapy. This is a separate research imaging study designed to assess how patients respond to their treatment for cervical cancer.


Eligibility criteria: Inclusion Criteria:

* Biopsy-documented, newly-diagnosed primary cervical cancer of all histopathology types.
* Clinically visible gross lesion (International Federation of Gynecology and Obstetrics (FIGO) stage IB1 and above).
* Treatment (chemoradiation), DCE-MRI and 18F-FMISO PET studies will be at MSKCC.
* Patients must be an adult female 18 years of age or older.

Exclusion Criteria:

* Patients who because of general medical or psychiatric condition, or physiologic status cannot give an informed consent.
* Patients who received prior radiation treatment to pelvis.
* Patients with contraindications to DCE-MRI (non-compatible cardiac pacemakers or intracranial vascular clips, allergy to Gadolinium, end-stage renal disease) and/or 18F-FMISO PET.
* Patients who do not fulfill the screening criteria for safe DCE-MRI or 18F-FMISO PET as per the Department of Radiology guidelines.
* Pregnant patients; and or patients who are breast-feeding their babies.

Primary outcomes:
measure: predict tumor response
timeFrame: 2 years
Secondary outcomes:
measure: predict disease-free survival
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Oguz Akin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02702921: Powered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies
Official title: A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in VAT Lobectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2016-03-09
Enrollment: 201
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 prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current Standard Of Care stapler (for Pulmonary Artery/Pulmonary Vein transection) and powered vascular stapler.


Eligibility criteria: Inclusion Criteria:

* Subjects with a confirmed or suspected diagnosis of stage IA to stage IIIA non-small cell lung cancer scheduled for a lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)5;
* Subjects scheduled for VATS lobectomy in accordance with their institution's Standard Of Care;
* Performance status 0-1 (Eastern Cooperative Oncology Group classification);
* American Society of Anesthesiologists (ASA) score \</= 3;
* No prior history of VAT or open lung surgery (on the lung in which the procedure will be performed);
* Willing to give consent and comply with study-related evaluation and treatment schedule; and
* At least 18 years of age.

Exclusion Criteria

* Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment);
* Pregnancy;
* Physical or psychological condition which would impair study participation; or
* The subject is judged unsuitable for study participation by the Investigator for any other reason.

Primary outcomes:
measure: Incidence of Intra-Operative Hemostatic Intervention
timeFrame: Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours
Secondary outcomes:
measure: Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding
timeFrame: Post-Op through 4 Week Followup
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
References:
Clinical trial NCT05092321: Aquatic Therapy for ASD
Official title: Exploration of Aquatic Therapy in Children With Autism and Their Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Franklin County Board of Developmental Disabilities
First posted: 2021-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an aquatic occupational therapy group for children between the ages of 3-12 that have an autism diagnosis. Intervention will focus on increasing the child's safety swim skills.

Detailed description: Information will be collected from participants' guardians during an intake visit regarding a child's sensory processing deficits, movement abilities and exposure to swim skill instruction prior to the group. The group will provide swim instruction using the Halliwick approach to learning swim skills as well as other occupational therapy techniques such as shaping, therapeutic relationship and behavior management. Groups will have a minimum ratio of 1 staff to every 2 children, with the possibility of 1:1 ratio most days. There will be a certified lifeguard present at all times. Qualitative interviews and a follow up survey will be conducted with parents (ages 18+) to determine impact on families and individual participants. Swim skills will be tracked at each session via goal attainment scaling and daily documentation. Descriptive and correlational statistics will be completed as well as coding of interview and survey data. Participants can participate for one, 10 week session, or will have the option to participate in additional 10 week sessions until child participants top out on the WOTA or plateau in progress of swim skills.

Eligibility criteria: Inclusion Criteria:

* pre-existing diagnosis of autism spectrum disorder from a medical professional
* family interest in swimming

Exclusion Criteria:

* ventilation system for breathing such as trachea not capped

Primary outcomes:
measure: Change in swim skills
timeFrame: baseline, pre-intervention; immediately after the intervention
measure: Change in individualized goals
timeFrame: immediately after the intervention
measure: Change in parent comfort
timeFrame: baseline pre-intervention; immediately after the intervention
measure: Parent perspective
timeFrame: one time after 8 hours of intervention have been provided to the child participant
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Erika Kemp
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05633121: Retrospective Study Evaluating the Contribution of Rheopheresis in the Treatment of Uremic Calciphylaxis (RHEO-CUA)
Official title: Retrospective Study Evaluating the Contribution of Rheopheresis in the Treatment of Uremic Calciphylaxis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheopheresis
Calcifying Uremic Arteriolopathy
Uremic Calciphylaxis
Lead sponsor: Association ECHO
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
name: Elsan
First posted: 2022-12-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient on chronic hemodialysis and suffering from uraemic calciphylaxis.

Brief summary: Calcifying uremic arteriolopathy (or uremic calciphylaxis) is a rare disease (prevalence \<1% of dialysis patients), but the prognosis is often catastrophic. The main non-modifiable risk factors are age, female gender, diabetes, obesity and length of time on dialysis. Today, there is no specific treatment for this pathology, and the therapeutic management is poorly codified. However, it is commonly accepted that the treatment is based on the control of risk factors, local care, and the possible addition of treatment with sodium thiosulfate. Hyperbaric oxygen therapy has also been proposed by some authors, but remains not very accessible in practice.

Recently, it has been proposed to use Rheopheresis as an adjuvant treatment for severe forms of uraemic calciphylaxis. It is a technique of apheresis in double filtration, allowing the extraction of molecules of high molecular weight, and thus the improvement of the rheological conditions of microcirculation. The expected effect is the improvement of tissue oxygenation and the acceleration of the healing of skin lesions, with the consequent reduction of infectious complications.

The aim of this study is to propose a large national retrospective study, studying the evolution of patients with uremic calciphylaxis and treated by rheopheresis, compared to a control group. This will allow to have a more precise idea of the contribution of Rheopheresis in this indication.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Chronic hemodialysis
* Uraemic calciphylaxis (clinical or histological diagnosis) diagnosed between January 2010 and December 2022,
* Rheopheresis treatment initiated within one month of calciphylaxis diagnosis (for the exposed group)
* Patient informed and not opposed to the use of their health data.

Exclusion Criteria:

* minor patient,
* Advanced cognitive disorders.

Primary outcomes:
measure: Proportion of patients fully recovered 6 months after diagnosis.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: ECHO - Pole Santé Sud
Study officials:
References:
Clinical trial NCT04451421: Effects of Standing at Different Angles on Transpulmonary Pressure
Official title: Effects of Standing at Different Angles on Transpulmonary Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Effects of standing at different angles on transpulmonary pressure

Detailed description: Objective: To study the effect of different standing angles on cross-lung pressure.Background: Long-term bed rest in ICU patients leads to upward movement of diaphragm and increased intrathoracic pressure in mechanically ventilated patients, resulting in lower cross-lung pressure. If the end-expiratory cross-lung pressure is negative, lung tissue compression and atelectasis will occur.Standing can lower the diaphragm, improve the pressure across the lungs, and improve ventilation.Selection methods: patients with invasive mechanical ventilation in the ICU, on the premise of stable hemodynamics, with the aid of electric bed training in standing in different angles, start from 20 degrees, 5 degrees up every five minutes, the largest up to 80 degrees, each Angle across the pulmonary pressure, die cavity ratio, tidal volume and breathe out carbon dioxide at the end of the record, and record whether low blood pressure, an accident in the process of take off the tube and other adverse reactions.

Eligibility criteria: Inclusion Criteria:

* The age is ≥ 18 years old;
* the hemodynamics is stable;
* 50 \< heart rate \< 120 beats / min ;
* 90 \< systolic blood pressure \< 200mmHg ;
* 55 \< mean arterial pressure \< 120mmHg;
* do not increase the dose of pressor drugs for at least 2 hours;
* intracranial pressure is stable and there are no seizures within 24 hours;
* the respiratory state is stable;
* the patient's finger pulse oxygen saturation ≥ 88%;
* 10 \< respiratory frequency \< 35 beats / min.

Exclusion Criteria:

* Pregnancy;
* acute cardio-cerebrovascular events;
* spinal or limb fractures;
* active bleeding.

Primary outcomes:
measure: transpulmonary pressure
timeFrame: 5 minutes
measure: Esophageal pressure
timeFrame: 5 minutes
measure: Dead space rate
timeFrame: 5 minutes
measure: tidal volume
timeFrame: 5 minutes
measure: partial pressure of carbon dioxide in endexpiratory gas
timeFrame: 5 minutes
Secondary outcomes:
measure: adverse reaction
timeFrame: an hour
Other outcomes:
Locations:
Study officials:
affiliation: The First Medical Center of PLA General Hospital
name: xin li xie, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: