louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05045963: Impact of Aminoglycosides in Hypotensive Septic Oncology Patients
Official title: Evaluating the Impact of Aminoglycosides in Hypotensive Septic Oncology Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Septicemia
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 319
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: Oncology patients with sepsis and hypotension treated at The University of Texas MD Anderson Cancer Center from January 1, 2019 to December 31, 2019

Brief summary: This study evaluates the impact of aminoglycosides in hypotensive septic oncologic patients. In the oncologic patient population, sepsis is a major health concern due to high mortality rates and healthcare costs. Prior research shows aminoglycosides antibiotics are frequently used to treat sepsis, but their clinical impact in hypotensive oncology patients upon the progression of sepsis is not known.

Detailed description: PRIMARY OBJECTIVE:

I. To assess the impact of beta-lactam (BL) + aminoglycoside (AG) combination therapy in hypotensive septic oncology patients.

OUTLINE:

Patients' medical charts are reviewed retrospectively.

Eligibility criteria: Inclusion Criteria:

* Adult patients (age \>= 18 years) with a diagnosis of sepsis during the index hospital admission identified by International classification of diseases (ICD)-10 codes (as specified below) receiving BL antibiotics within 6 hours prior to or following the onset of hypotension
* To be included in the AG group, patients must have received at least 1 dose of intravenous (IV) tobramycin or amikacin in addition to the BL therapy within the above time period

Exclusion Criteria:

* Age \< 18 years
* Receipt of IV AG outside of the above time frame in the AG group or receipt of IV AG within 48 hours prior to or following the onset of hypotension in the BL backbone group
* Pregnancy
* Patients not receiving therapy with BL antibiotics

Primary outcomes:
measure: Time to resolution of hypotension
timeFrame: Within 7 days from hypotension onset
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jeffrey J Bruno
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00468663: Ambient Air Pollution, Preeclampsia, and Preterm Delivery
Official title: Ambient Air Pollution, Preeclampsia, and Preterm Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Preterm Delivery
Keywords: preeclampsia
preterm delivery
lipid peroxidation
inflammation
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2007-05-03
Enrollment: 4200
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE

Brief summary: An epidemiologic study of pregnant women in western Washington to measure the relationships between exposure to air pollutants and risks of preeclampsia and preterm delivery.

Detailed description: We will design models that use local traffic, weather, and population characteristics to predict monthly ambient concentrations of fine particulate matter (PM2.5) and carbon monoxide (CO). These models will be used to estimate study participants' PM2.5 and CO exposures during and before pregnancy. We will test whether these air pollutant exposures are associated with subsequent risk of preeclampsia and preterm delivery. Additionally, we will test biological markers of maternal lipid peroxidation (thiobarbituric acid reactive substances) and inflammation (high sensitivity C-reactive protein) in maternal blood samples drawn during early pregnancy. We will also examine carboxyhemoglobin measured in early-pregnancy maternal blood samples as a marker of CO exposure.

Eligibility criteria: Inclusion Criteria:

* English speaking
* enrolled in parent study
* pregnant at \<20 weeks gestation and attending prenatal care clinics affiliated with Swedish Medical Center and Tacoma General Hospital

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Swedish Medical Center, First Hill
name: Carole Rudra, Ph.D, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Swedish Medical Center
name: Michelle A Williams, Sc.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03765463: Extinction Learning in Youth With Tourette Syndrome
Official title: Extinction Learning in Youth With Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourette Syndrome in Children
Tourette Syndrome in Adolescence
Habit Reversal Training
Tic
Keywords: Extinction learning
Behavior Therapy
Tourette's Disorder
Habit Reversal Training
Comprehensive Behavioral Intervention for Tics
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aversive sensory phenomena such as premonitory urges play a central role in the behavioral treatment model of tics. Extinction learning and extinction recall are learning processes implicated within this model, but have not been directly evaluated in youth with Tourette syndrome (TS). This study examines extinction learning and extinction recall in youth with TS using an experimental task. This study will also explore the relationship between extinction processes (i.e., extinction learning and extinction recall) and treatment outcomes with behavior therapy. Findings from this investigation will be used to update the behavioral treatment model, which serves as the basis for evidence-based behavioral interventions.


Eligibility criteria: Youth with TS will be eligible for participation if they meet the following inclusion criteria:

* age 8-17 years (inclusive)
* have moderate tic severity or greater as evidenced by a YGTSS Total Tic Score greater than 13 (\>9 for youth with motor or vocal tics only)
* have not received more than 4 previous sessions of HRT
* be fluent in English.
* Medication free or on a stable dose of psychiatric medication for 8 weeks prior to enrollment.

Exclusion criteria for youth with TS:

* An inability to complete rating scales
* Attend study visits.

Primary outcomes:
measure: Tic severity as assessed by the Hopkins Motor and Vocal Tic Scale (HM/VTS)
timeFrame: Within 1 week after completion of HRT
Secondary outcomes:
measure: Tic severity as assessed by the Yale Global Tic Severity Scale-Revised (YGTSS)
timeFrame: Within 1 week after completion of HRT
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Joseph F McGuire, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06634563: Effect Of Adding Mindfulness Meditation To Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia
Official title: Effect Of Adding Mindfulness Meditation To Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: Mindfulness Meditation
cognitive behavioral training
fibromyalgia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mindfulness Meditation and cognitive behavioral training
Primary purpose: TREATMENT

Brief summary: this study will be conducted to investigate The Impact Of Adding Mindfulness Meditation to Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia.

Detailed description: Fibromyalgia syndrome (FMS) is a disorder characterized by chronic, widespread musculoskeletal pain. Muscle and joint stiffness, insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, and generalized sensitivity are the main manifestations of this disease .Cognitive-behavioral training presents as an important therapeutic resource, as it is capable of modifying patient's negative thoughts and expectations, improving mood, stress, coping with pain and problem solving, including behavioral interventions that specifically deal with improving the fibromyalgia symptoms (sleep hygiene, re-laxation training, activity rhythm).Mindfulness meditation is the intentional effort to pay nonjudgmental attention to present-moment experiences and sustain this attention over time. The aim is to cultivate a stable and nonreactive present-moment awareness. Mindfulness Based Pain Management has been evaluated and showing significant positive changes in patients with chronic pain, with medium to large effect sizes on self-report measures of depression, positive outlook, pain acceptance. fifty women with fibromylagia will be assigned randomly to two groups; first one will receive mindfulness meditation for 30 minutes in addition to mobile application-based brain training program and the second one will receive mobile application-based brain training program alone

Eligibility criteria: Inclusion Criteria:

* Confirmation of a clinical diagnosis of fibromyalgia by the patient's own physician.
* Wide spread pain for at least 3 months and tenderness at a minimum of 11of the 18 specific tender point sites.
* Age between 30 and 40 years.
* Female gender.
* BMI: 25-30 kg/m2

Exclusion Criteria:

* Pregnancy
* drug addicition
* Any current psychiatric disorder that would interfere with pro-gram adherence.
* Life-threatening disease

Primary outcomes:
measure: pressure threshold
timeFrame: up to eight weeks
measure: severity of pain
timeFrame: up to eight weeks
measure: cognition assessment
timeFrame: up to eight weeks
Secondary outcomes:
measure: life disability
timeFrame: up to eight weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01877863: The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients
Official title: The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Kidney Disease
Keywords: intradialytic exercise
hemodialysis
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the impact of an intradialytic exercise program on functional capacity, aerobic capacity, strength, quality of life, depression, hospitalizations and intradialytic episodes of hypotension. The investigators would also like to look at the impact of exercise training over twelve weeks on hemoglobin levels as well as the clearance of potassium, phosphate and urea. Our hypothesis is that the above mentioned outcomes will positively improve over the twelve week intervention.


Eligibility criteria: Inclusion Criteria:

* Cardiac and hemodynamic stability
* Absence of severe musculoskeletal impairment
* Increased musculoskeletal weakness
* Vital signs within normal range for exercise
* Desire/motivated to exercise
* Clearance from nephrologist and Kinesiologist

Exclusion Criteria:

* Compromised cardiac profiles
* Hemodynamic instability
* Severe bone disease
* Medical conditions which contraindicate exercise

Primary outcomes:
measure: Functional Capacity
timeFrame: 12 weeks
Secondary outcomes:
measure: Aerobic capacity
timeFrame: 12 weeks
measure: Strength
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
measure: Hospitalizations
timeFrame: 12 weeks
measure: Hypotension
timeFrame: 12 weeks
measure: Hemoglobin levels
timeFrame: 12 weeks
measure: Potassium levels
timeFrame: 12 weeks
measure: Urea removal
timeFrame: 12 weeks
measure: Phosphate levels
timeFrame: 12 weeks
measure: Bioimpedance derived volume and body mass determinations
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Northwest Dialysis Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Jennifer MacRae
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06001463: Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis
Official title: CSMed Wound Dressing on Radiation Dermatitis Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Radiation Dermatitis
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigate the effects of CSMed® for preventing and managing radiation dermatitis in patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).

Detailed description: A prospective study was conducted at the University Hospital Medical Center. The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care. Record the difference between the part of the skin with dressing and undressed skin for each patient. The severity of acute radiation dermatitis was graded using the RTOG clinical scoring standard. From the beginning of the treatment to 4 weeks after the end of the treatment, skin pain, itching, local fever and tightness, as well as skin healing time were collected every week.

Eligibility criteria: Inclusion Criteria:

* Patients receiving radiation therapy (including undamaged skin and RTOG grade 1 dermatitis).
* Patients who voluntarily agree to participate in the trial and sign the subject's consent form.

Exclusion Criteria:

* Patients with dermatitis and burns not caused by radiation therapy.
* Involuntary patients without signed consent.
* Those who are allergic to the ingredients in this product.

Primary outcomes:
measure: Severity of acute radiation dermatitis
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
References:
Clinical trial NCT04420663: Pleural Manometry in Thoracocentesis
Official title: Pleural Manometry During Thoracocentesis in Patients With Malignant Pleural Effusion: How Much Fluid Should we Drain?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracocentesis of Pleural Effusion
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective controlled trial study will be performed between August 2019 and August 2020. We will enroll patients with large volume pleural effusion referred to our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform therapeutic thoracentesis. All the patients will sign an informed consent for pleural pressure monitoring during and after therapeutic thoracentesis.
Primary purpose: DIAGNOSTIC

Brief summary: The study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions.

Detailed description: This prospective controlled trial study will be performed between July 2019 and December 2020. the investigators will enroll patients with large volume pleural effusion referred to our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform therapeutic thoracentesis. All the patients will sign an informed consent for pleural pressure monitoring during and after therapeutic thoracentesis.

The study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions.

Eligibility criteria: Inclusion Criteria:

1. age between 18 and 85 years,
2. pleural effusion occupying at least one-third of the ipsilateral hemithorax in P-A chest radiograph (CXR)
3. no contraindications for therapeutic thoracentesis
4. general health condition allowing prolonged procedure of therapeutic thoracentesis.

Exclusion Criteria:

* patients with very small amounts of pleural effusion
* patients on mechanical ventilation
* patients using anticoagulant therapy
* patients refusing to be subjected to thoracocentesis.

Primary outcomes:
measure: the pleural pressure
timeFrame: Continous monitoring during the whole session of thoracocentesis
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cardiothoracic Surgery Hospital, Faculty of Medicine, Ain Shams University
Study officials:
References:
Clinical trial NCT00902863: Impact of a Course on Stress Reduction
Official title: The Impact of a Course on Stress Reduction Techniques on Satisfaction, Stress, Performance, and Quality of Life in Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
mindfulness
yoga
quality of life
stress
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2009-05-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project seeks to measure the effectiveness of a course in self-management strategies (including yoga, mindfulness, and breathing exercises). The course will be provided by a certified yoga instructor to patients being followed at the Pain Management Centre, Hamilton Health Sciences (HHS).

Detailed description: The Pain Management Centre at Hamilton Health Sciences is organizing a course in stress reduction techniques for patients with chronic pain. The Pain Centre has arranged for a local certified yoga instructor to lead a 6-week course that she has developed for our specific patient population. The course will include self-management strategies for pain control, such as breathing exercises, yoga poses, and mindfulness meditation. Standardized questionnaires and a semi-structured interview to record baseline and post-course outcomes. The study will involve the following questionnaires/surveys/interviews: 1) Canadian Occupational Performance Measure, 2) Perceived Stress Scale, 3) Burckhardt Quality of Life Scale, 4) Visual Analog Score, and 5) written questions concerning patient demographics, the patient's chronic pain condition, and their satisfaction with the course. The participants would be asked to fill out questionnaires at three different times: 1) baseline data collected within two weeks of starting course, 2) short-term outcome data within two weeks of completing course, and 3) long-term outcome data four to six months after the course.

Eligibility criteria: Inclusion Criteria:

* patients have a history of moderate to severe chronic pain

Exclusion Criteria:

* non-English speaking patients

Primary outcomes:
measure: Performance and Satisfaction using Canadian Occupational Performance Measure (COPM)
timeFrame: 6 months
Secondary outcomes:
measure: Pain relief using VAS and pain scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Lori Olivieri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mead K, Theadom A, Byron K, Dupont S. Pilot study of a 4-week Pain Coping Strategies (PCS) programme for the chronic pain patient. Disabil Rehabil. 2007 Feb 15;29(3):199-203. doi: 10.1080/09638280600756117.
Clinical trial NCT03080363: Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During ESWL
Official title: Is Painless ESWL Possible? Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During Extracorporeal Shockwave Lithotripsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Acute
Keywords: Extracorporeal Shockwave Lithotripsy
Quadratus Lumborum Block
bupivacaine
lidocaine
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Extracorporeal shockwave lithotripsy (ESWL) is widely used for the treatment of urinary tract calculi; however, the vast majority of patients do not tolerate the procedure without analgesia and sedation.

Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, opioids, alpha 2 agonists, transversus abdominis plane block with long-acting local anesthetics, paravertebral block, local anesthetics infiltration, lidocaine/prilocaine cream).

The quadratus lumborum block was first described by Blanco. QL block is performed as one of the perioperative pain management procedures for abdominal surgery. QL block provides anesthesia and analgesia on the anterior and lateral wall of the abdomen.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients undergoing Extracorporeal Shockwave Lithotripsy

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases

Primary outcomes:
measure: Visual Analog Pain Score
timeFrame: Intraoperative 30 minutes
Secondary outcomes:
measure: Opioid consumption
timeFrame: Intraoperative 30 minutes
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Elnabtity AM, Tawfeek MM, Keera AA, Badran YA. Is unilateral transversus abdominis plane block an analgesic alternative for ureteric shock wave lithotripsy? Anesth Essays Res. 2015 Jan-Apr;9(1):51-6. doi: 10.4103/0259-1162.150177.
citation: Hanoura S, Elsayed M, Eldegwy M, Elsayed A, Ewieda T, Shehab M. Paravertebral block is a proper alternative anesthesia for outpatient lithotripsy. Anesth Essays Res. 2013 Sep-Dec;7(3):365-70. doi: 10.4103/0259-1162.123238.