louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05408741: A Pilot Study Assessing the Effectiveness of Use of Guided Imagery for Treatment of Pain and Symptom Management in Women With Post-mastectomy Pain Syndrome
Official title: A Pilot Study Assessing the Effectiveness of Use of Guided Imagery for Treatment of Pain and Symptom Management in Women With Post-mastectomy Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Syndrome
Pain
Symptom Management
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To learn if using guided imagery and deep breathing techniques can help with pain management in patients who have post-mastectomy pain syndrome.

Detailed description: OBJECTIVES:

Primary objective:

-To evaluate the effectiveness of use of Guided imagery and deep breathing techniques in pain management compared to control arm in patients with post-mastectomy pain syndrome who don't receive intervention and only receive standard care.

Secondary objective:

To evaluate effectiveness of Guided imagery and deep breathing techniques in symptom cluster management including fatigue, sleep, depression, and anxiety and in general quality of life compared to control arm who don't receive intervention and only receive standard care.

Eligibility criteria: Inclusion Criteria:

1. Breast Cancer patients who were performed mastectomy in previous 12 months
2. Post-mastectomy pain syndrome \>4 weeks.
3. Patients who report 2-10 on the baseline pain severity score or 2-10 on the baseline pain interference score
4. Patients ≥ 18 years old and ≤ 70 years old
5. Must understand and read English, sign a written informed consent, and follow protocol requirements
6. If on medication for anxiety or depression, stable dose of medications for management of anxiety or depression symptoms for at least six weeks prior to enrollment with no plans to change medications in the subsequent four weeks. Increases or decreases allowed within drug class, but changing drug class will make patient in-evaluable

Exclusion Criteria:

1. Pending surgery during treatment
2. Suicidal ideation
3. Diagnosis of a formal thought disorder (e.g., schizophrenia)

Primary outcomes:
measure: The change in pain severity score and the change in pain interference score, measured by brief pain inventory short form. Brief Pain Inventory: 0-10 No Pain-0 Worst Pain-10
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Uzondu Osuagwu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02836041: Sleep in Hospitalized Children at MSKCC
Official title: A Pilot Study: Sleep in Hospitalized Children With Cancer and Related Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Cancer Patients
Keywords: assess sleep
Sleep Deprivation
16-866
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Weill Medical College of Cornell University
First posted: 2016-07-18
Enrollment: 66
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients admitted to the pediatric floor at MSK.

Brief summary: The investigators want to better understand how children sleep at night at MSKCC, so that the investigators can learn how to improve the sleeping environment.


Eligibility criteria: Inclusion Criteria:

* Parent/Patient must provide written consent
* Patient must be between the ages of: Newborn - ≤ 18 years of age
* Patient is expected to be admitted to the Pediatric floor at MSK for at least 2 nights (patients/parents will not be approached for consent on day of admission or day of discharge)
* Patient/parent must be English speaking

Exclusion Criteria:

* Expected length of stay of fewer than 2 nights (for example.: if admitted Monday and discharged Tuesday, patient/parent will not be eligible).
* Patient /Parent unable to complete questionnaire due to education or language barriers.
* Patients admitted to the PICU. (Only children on M9 will be included. It is known that sleep in the PICU is highly disordered; as such, we will be excluding PICU patients from this study).

Primary outcomes:
measure: quality of sleep
timeFrame: 3 nights
Secondary outcomes:
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: Chani Traube, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04810741: Retrospective Study of Clinical Practice and Management of Imported Schistosomiasis in France
Official title: Retrospective Study of Clinical Practice and Management of Imported Schistosomiasis in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schistosomiasis
Keywords: schistosomiasis, retrospective
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 532
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: Patients over 18 years-old with a diagnosis of schistosomiasis in France

Brief summary: Schistosomiasis is a major public health issue. Clinical guidelines for the management of imported schistosomiasis are heterogeneous. The objective of this study is to describe the clinical management of schistosomiasis imported cases in France, regarding diagnosis, treatment and follow-up.

Detailed description: Schistosomiasis is a major public health issue. Clinical guidelines for the management of imported schistosomiasis are heterogeneous. The objective of this study is to describe the clinical management of schistosomiasis imported cases in France, regarding diagnosis, treatment and follow-up. It is a multicentric, retrospective, descriptive study. Inclusion criteria are an age ≥ 18, a positive western blot and / or a positive microscopy exam. Data concerning clinical presentation, biological samples, imaging, treatment and follow-up will be assessed. A descriptive analysis will be performed.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18, positive schistosomiasis immunoblot and / or positive microscopy examination for schistosomiasis eggs

Exclusion Criteria:

* - patients under guardianship

Primary outcomes:
measure: Describe the management of patients with chronic schistosomiasis in France, in terms of diagnosis, assessment, management and follow-up.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: hospital BICETRE
Study officials:
affiliation: APHP
name: Stephane Jareguiberry, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06008041: Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations (PHYCO)
Official title: Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Coronary Microvascular Dysfunction
Keywords: Coronary Artery Disease
Coronary Physiology
Index of Microcirculatory Resistance (IMR)
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Diabetes mellitus
* High blood pressure
* Aortic stenosis
* Hypertrophic cardiopathy
* Dilated cardiopathy
* Stress cardiopathy
* Elderly people \> 75 years old
* Acute coronary syndrome
* Preserved heart failure
* Cardiac amyloidosis

Brief summary: When performing coronary angiography in a stable situation, the identification of an intermediate coronary lesion (between 50 and 70%) is common, and requires additional functional evaluation. The gold standard for this evaluation is Fractional Flow Reserve (FFR). FFR is a flow ratio transformed into a pressure ratio by simplification, neglecting some parameters, especially microcirculatory resistance.

The aim of this study is to investigate hemodynamic and structural assessment induced in specific conditions, and their repercussion on functional assessment by FFR to implement the diagnostic approach and personalize it for each patient.


Eligibility criteria: Inclusion Criteria:

* Intermediate coronary lesion (between 50 and 70%)

Exclusion Criteria:

* Hemodynamic instability
* Adenosine hypersensitivity
* Asthma
* Severe chronic obstructive pulmonary disease
* Long QTc
* Wolff parkinson white
* High degree atriovenricular block
* Left-right shunt
* Carotid artery stenosis with hemodynamic insufficiency
* Pregnancy

Primary outcomes:
measure: Index of Microcirculatory Resistance (IMR)
timeFrame: During coronary angiography
Secondary outcomes:
measure: Fractional Flow Reserve (FFR)
timeFrame: During coronary angiography
measure: Coronary Flow Reserve (CFR)
timeFrame: During coronary angiography
measure: Resting Full cycle Ratio (RFR)
timeFrame: During coronary angiography
measure: Quantitative Flow Ratio (QFR)
timeFrame: During coronary angiography
measure: Angio-IMR
timeFrame: During coronary angiography
measure: Death
timeFrame: 12 months
measure: Angina pectoris (CCS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT01478919: Risk Factors for Residual Neoplasia After Endoscopic Mucosal Resection
Official title: Risk Factors for Local Residual Neoplasia After Convetional Endoscopic Mucosal Resection of Laterally Spreading Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Endoscopic Mucosal Resection
Laterally Spreading Tumor
Local Residual Neoplasia
Colonoscopy
Therapy
Lead sponsor: Vitkovice Hospital
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for Endoscopic Mucosal Resection (EMR) of Laterally Spreading Tumors (LST.)

Brief summary: Laterally Spreading Tumors (LST) are important precursosrs of invasive colorectal cancer. Endoscopic treatment has replaced surgery in most of the cases. Nevertheless, after conventional Endoscopic Mucosal Resection (CER), Local Residual Neoplasia (LRN) is an issue. Therefore, endoscopic follow-up and treatment are necessary. To decrease its occurrence, the risk factors of LRN shoudl be identified. Thereafter, in high-risk patients, other modalities of initial treatment including Endoscopic Submucosal Dissection (ESD) and surgical treatment, could be considered. The purpose of this prospective study is to identify risk factors associated with the presence of LRN after CER of LSTs.


Eligibility criteria: Inclusion Criteria:

* all consecutive patients referred for EMR of LST

Exclusion Criteria:

* polyposis syndromes
* previous therapeutic attempt

Primary outcomes:
measure: Occurence of Local Residual Neoplasia (LRN)
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of Selected Risk Factors for Local Residual Neoplasia (LRN)
timeFrame: 3 months
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: Vitkovice Hospital
Study officials:
References:
citation: Urban O, Kijonkova B, Kajzrlikova IM, Vitek P, Kliment M, Fojtik P, Falt P, Reiterova K, Horava V Jr. Local residual neoplasia after endoscopic treatment of laterally spreading tumors during 15 months of follow-up. Eur J Gastroenterol Hepatol. 2013 Jun;25(6):733-8. doi: 10.1097/MEG.0b013e32835eda96.
Clinical trial NCT00771719: Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia
Official title: Open-Label Exploratory, Multiple-Dose Study of Ceftobiprole to Evaluate the Pharmacokinetics and Broncho-Alveolar Penetration in Adults With Ventilator-Associated Pneumonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ventilator Associated Pneumonia
Keywords: VAP
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 1
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: TREATMENT

Brief summary: The purpose of this research study is to measure the levels of ceftobiprole in the blood, urine and tissues of the lungs during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.

Detailed description: Patients will receive a intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of Ceftobiprole in the blood. Bronchoalveolar lavage (BAL) samples will be collected to determine the concentration of ceftobiprole in the BAL fluid. The penetration of the drug into the lung will be calculated. Four 1000mg administered every 8 hours

Eligibility criteria: Inclusion Criteria:

* Informed Consent
* Between 18 and 75 years of age inclusive
* VAP - 48 hours after onset of mechanical ventilation
* BMI 18 - 35 inclusive
* Albumin \< 3.3 g/dL or clinical evidence of edema
* Negative Pregnancy test
* Expected survival of at least 7 days

Exclusion Criteria:

* Renal impairment (CrCl \< 80 mL/min)
* Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)
* History of seizures
* Sustained shock, unresponsive to sympathomimetics
* Conditions that may have jeopardized adherence to the protocol (NYHA Class 4 cardiac disease, \>15% total body burn or significant third degree burn)

Primary outcomes:
measure: Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine and tissues of the lungs) during dosing and 24 hours after last dose infused
timeFrame: 2 days
Secondary outcomes:
measure: Safety will be evaluated throughout the study.
timeFrame: Study Duration
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT06364319: Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD
Official title: Study on the Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease (cGVHD) of the Liver Following Allogeneic Hematopoietic Stem Cell Transplantatio
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: cGVHD
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 118
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will be randomly assigned to either the Anti-CD25 rhMAb treatment group or the traditional treatment group. The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver.


Eligibility criteria: Inclusion Criteria:

1. Age 16 and 65 years
2. Received allogeneic hematopoietic stem cell transplantation
3. Developed chronic GVHD in the liver after transplantation
4. Ineffective prednisone treatment prior to screening
5. Received ≤4 lines of systemic therapy prior to screening
6. After informed consent, the patient agreed to receive anti-CD25 rhMAb treatment

Exclusion Criteria:

1. Elevation of bilirubin, ALT, or alkaline phosphatase due to reasons other than chronic GVHD
2. No prior treatment with prednisone
3. Overlap syndrome
4. Uncontrolled active infection
5. Organ failure
6. Early progression or recurrence of hematologic diseases
7. Allergy to anti-CD25 rhMAb
8. Received other interleukin-2 receptor monoclonal antibody treatment due to various reasons within one month after transplantation
9. Participated in other clinical studies within one month

Primary outcomes:
measure: overall response rate (ORR)
timeFrame: 56 days
Secondary outcomes:
measure: duration of response（DOR）
timeFrame: 1 year
measure: patient-reported outcomes (PRO)
timeFrame: 1 year
measure: disease-free survival (DFS)
timeFrame: 1 year
measure: failure-free survival (FFS)
timeFrame: 1 year
measure: non-relapse mortality (NRM)
timeFrame: 1 year
measure: overall survival （OS）
timeFrame: 1 year
measure: adverse drug reactions (ADR)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04322019: Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study
Official title: Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amikacin Treatment
Keywords: Amikacin
intensive care
renal replacement therapy
prescription strategy,
monitoring strategy
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care patients on renal replacement therapy with Amikacin treatment

Brief summary: Amikacin is the aminoglycoside of choice for treatment of severe infections in intensive care. An achievement of its objectives in pharmacokinetics and pharmacodynamics is difficult in intensive care patients because of modification of their volume of distribution and renal clearance. Acute renal failure requiring renal replacement therapy is frequent in intensive care. Extrarenal purification modalities (continuous versus intermittent, type of dialysis membrane), which can influence amikacin clearance, are multiple and teams dependent. Guidelines of good practice for Amikacin in intensive care patients do not exist.

Detailed description: The aim of this study is to describe strategies of prescription and monitoring of Amikacin in intensive care patients on renal replacement therapy.

Eligibility criteria: inclusion criteria :

* patients in intensive care
* patients on extrarenal replacement
* patients with Amikacin treatment
* patients accepting to participate in the study

exclusion criteria :

* patients less than 18 years old
* pregnant women
* patients with Amikacin treatment in the previous 7 days

Primary outcomes:
measure: Measurement of maximum concentration observed
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT04432441: Effects of Neuromuscular Electrostimulation on Scapular Stability
Official title: Effects of Neuromuscular Electrical Stimulation (NMES) Plus Therapeutic Exercise Combination on Scapular Stability in Female Professional Handball Players With Scapular Dyskinesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Female Handball Player
Keywords: "Electric Stimulation Therapy"
"Resistance training"
"Overhead sports"
"Risk factors"
"Scapular anomalies"
Lead sponsor: University of Extremadura
Sponsor class: OTHER
Collaborators: name: Luis Espejo Antúnez
name: Antoni Morral
First posted: 2020-06-16
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups. Experimental group realizes a therapeutic physical exercise program for scapulo-humeral stabilitation, and the other group (control group) the same program with electrostimulation. The programme consisted of a two-part sequence of isometric prone push-up, being it an optimal position for periscapular stability exercises.
Primary purpose: PREVENTION

Brief summary: Injuries and shoulder pain are common problems in handball, more often among female athletes. The impact on performance and participation shows the need to work on the risk factors to minimize the damage. It has been found an association between scapular dysfunction and pain in the shoulder. Currently there are many exercise programs, but few with electrotherapy implemented. The aim of the study is to assess the effect of a therapeutic physical exercise program for scapulo-humeral stabilitation with and without electrotherapy on scapular stability, glenohumeral internal rotation and external rotation strength.


Eligibility criteria: Inclusion Criteria:

* To have more than 18 YO
* To be female
* To do at least 5 hour of sport training per week in last two years
* To be part of federated club that allows them in their weekly practice to participate in recreational matches or small local championship during weekends.
* To have scapular diskinesis by McClure scale

Exclusion Criteria:

* To have an actual injury
* To have an history of injury in last 12 months
* To take drugs that can affect to control motor.
* To be part or participate in a control motor program or specific prevention program
* To have a recent surgery in last year in upper or back.
* A score below 45 points on the Personal Psychological Apprehension Scale.

Primary outcomes:
measure: Scapular Static Positioning Assessment: Upper distance
timeFrame: Changes from baseline after a month
measure: Scapular Static Positioning Assessment: Lower distance
timeFrame: Changes from baseline after a month
Secondary outcomes:
measure: RI Range of movement
timeFrame: Changes from baseline after a month
measure: External rotation strenght
timeFrame: Changes from baseline after a month
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Universidad de Extremadura
Study officials:
References: