louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05856136: A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle
Official title: Investigation of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle to Generate Higher Force Behaviors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Respiratory Function Loss
Respiratory Complication
Keywords: elastography
ultrasound
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.


Eligibility criteria: Inclusion Criteria:

- Adult male and female patients undergoing lower extremity orthopedic surgery at the study institutions (St. Mary Hospital and Rochester Methodist Hospital within the Mayo Clinic Rochester hospital system).

Exclusion Criteria:

* Patients who refuse research participation.
* Patients who are pregnant.
* Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).

Primary outcomes:
measure: Change in shear wave speed
timeFrame: Baseline, 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Carlos Mantilla, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05405036: The Psychometric Properties of the Turkish Version of Interpersonal Communication Questionnaire
Official title: The Psychometric Properties of the Turkish Version of Interpersonal Communication Questionnaire in Physiotherapy Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Educational Problems
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 second year students aged 18-23 studying at the physiotherapy and rehabilitation department of Acibadem mehmet ali aydınlar university are planned to participate in the research.

Brief summary: In a study conducted by Lewis et al. in 2008, an "interpersonal communication" questionnaire was developed to measure the perceived interpersonal skills of physiotherapy and rehabilitation students regarding patient interaction. It was determined that the questionnaire used especially after the simulated patient training increased the communication of physiotherapy and rehabilitation students after the simulated patient training. However, the questionnaire was not translated into Turkish and its validity and reliability were not investigated. Therefore, in this study, the authors aim to investigate the Turkish validity and reliability of the Interpersonal Communication Questionnaire as the primary purpose. Secondly, to investigate the effect of simulated patient experience on the perceived interpersonal skills of physiotherapy and rehabilitation students regarding patient interaction at the time of the clinical trial.


Eligibility criteria: Inclusion Criteria:

* Students taking the Measurement and Evaluation II course in Physiotherapy and Rehabilitation

Exclusion Criteria:

* Not volunteering
* Those who are being treated with any psychiatric diagnosis
* Students who fail the course or fail to pass it successfully

Primary outcomes:
measure: Interpersonal Communication Questionnaire
timeFrame: Change from Baseline Scores at 2 week and 6. week
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: Change from Baseline Scores at 6. week
measure: Interpersonal Communication Competence Inventory
timeFrame: Change from Baseline Scores at 6. week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem University
Study officials:
affiliation: Acibadem University
name: Nuray ALACA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00468936: Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms
Official title: Open-Label, Randomized Study Comparing the Patient Reported Severity of GI Side Effects of MMF Versus EC-MPS in Maintenance Heart Transplant Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Heart Transplant Patients
Keywords: anti-rejection
GI side effects
heart transplant patients
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2007-05-03
Enrollment: 100
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: Stable heart transplant patients on Mycophenolate Mofetil (MMF) will sign a screening consent form in order to be evaluated with the gastrointestinal symptom rating scale (GSRS) questionnaire. Those who score three or more on at least two questions are eligible for the study. Once they sign a study consent they are randomized to one of two arms. It is thought that the severity of GI side effects will be reduced over time in patients who are in the Myfortic arm versus the severity of GI side effects over time in patients who remain on MMF treatment. Patients are evaluated by GSRS, The Psychological Well-Being Schedule, and the IT01/02 Checklist for the evaluation of GI symptoms and followed for one year (visits 1 month, 3 months, 6 months, 12 months).


Eligibility criteria: Inclusion Criteria:

* Stable dose MMF for at least 4 weeks
* Over 18 years of age
* Heart transplant at least three months prior to study

Exclusion Criteria:

* GI symptoms known not to be caused by MPA therapy
* Acute rejection episode in past 4 weeks
* History of malignancy since transplant
* Pregnancy

Primary outcomes:
measure: reduction in GSRS score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Dr Nadia S Giannetti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03486236: A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects
Official title: A Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With VX-661/Ivacaftor in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2018-04-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and pharmacokinetics of multiple ascending doses of VX-440 in combination with tezacaftor/ivacaftor (TEZ/IVA) (triple combination \[TC\]) administered for 13 days to healthy male and female subjects


Eligibility criteria: Inclusion Criteria:

* Female subjects of non-childbearing potential only.
* Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight \>50 kg.
* Normal pulmonary function measurements, defined as forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) both ≥80% of their predicted value at screening.

Exclusion Criteria:

* For female subjects: Pregnant or nursing subjects.
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* History of hemolysis.
* Total bilirubin level \>2 × ULN at Screening.

Other protocol defined Inclusion/Exclusion criteria applied.

Primary outcomes:
measure: Safety and tolerability were based on the number and assessment of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: from baseline through safety follow-up visit (up to 29 days)
Secondary outcomes:
measure: Maximum observed concentration (Cmax) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA)
timeFrame: from Day 1 through Day 18
measure: Area under the concentration versus time curve during a dosing interval (AUCtau) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA)
timeFrame: from Day 1 through Day 18
measure: Observed pre-dose concentration (Ctrough) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA)
timeFrame: from Day 1 through Day 18
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Medicines Evaluation Unit
Study officials:
References:
Clinical trial NCT06276036: Autoimmune Cytopenias as a Sign of Primary Immunodeficiency.
Official title: Autoimmune Cytopenias as a Sign of Primary Immunodeficiency: Immunological and Molecular Approach to Optimize the Diagnostic-therapeutic Pathway
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cytopenia
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 53
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Autoimmune cytopenias resistant to treatment are among the most common clinical manifestations observed in patients with congenital alterations of the immune system, such as primary immunodeficiencies (PI). The exact contribution of immune system alterations to the pathogenesis of autoimmune cytopenias has not yet been fully elucidated. Moreover, conventionally employed therapeutic strategies often fail, leading to increased healthcare costs, high morbidity, and even mortality. Therefore, there is a need to establish clinical guidelines for diagnosis and to identify early biomarkers capable of identifying individuals responsive to therapy. Thus, a systematic approach to the study of such pathologies will allow for the identification of early biomarkers and facilitate the development of targeted therapeutic strategies


Eligibility criteria: Inclusion Criteria:

* Clinical and hematological diagnosis of autoimmune cytopenia

Additional inclusion criteria for classification into responder vs. non-responder:

* For immune thrombocytopenic purpura: platelet count increase \>30,000 with at least a twofold increase from pre-treatment value
* For autoimmune hemolytic anemia: Hb ≥10 g/dL with an increase of at least 2 g/dL compared to baseline

Exclusion Criteria:

* Transient cytopenia without confirmation of autoimmunity where frontline treatment is not necessary

Primary outcomes:
measure: Identification of specific markers
timeFrame: Every three to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Catania
country: Italy
facility: Clinica Pediatrica - Università di Catania
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Genova
country: Italy
facility: IRCCS Istituto Giannina Gaslini
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
Study officials:
References:
Clinical trial NCT04509336: Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients
Official title: Comparison of the Efficacy and Safety of Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.


Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years
2. Cirrhotic patients complaining of frequent muscle cramps (\>3 per week) for at least a month

Exclusion Criteria:

1. Patients with allergy to study drugs
2. Renal impairment
3. Peripheral vascular disease
4. Peripheral neuropathy
5. Glaucoma
6. Prostatic enlargement
7. Pregnancy and lactation
8. Patients taking calcium channel blockers, and conjugated estrogens
9. Patients taking vitamin E, taurine, carnitine, narcotic pain medications, muscle relaxants, nonsteroidal anti-inflammatory drugs, or antispastic agents during and for 2 weeks following the study
10. Patients with alcoholic cirrhosis

Primary outcomes:
measure: the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: The difference in severity of cramps between orphenadrine and baclofen groups at the end of treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
Study officials:
affiliation: Tanta University
name: Assem Elfert
role: STUDY_CHAIR
affiliation: Tanta University
name: Sherif Abd-Elsalam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02833636: Prognostic Value of The Age, Creatinine, and Ejection Fraction Score for Non-infarct-related Chronic Total Occlusion Revascularization After Primary Percutaneous Intervention in Acute ST-elevation Myocardial Infarction Patients: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cto, Acef Score
Lead sponsor: Xibei Hospital
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 2952
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between January 2006 to December 2013, a total of 2952 consecutive and unselected acute STEMI patients were admitted to our hospital and treated with successful primary PCI.

Brief summary: The age, creatinine, and ejection fraction (ACEF) score has been used to evaluate the clinical prognostic to patients who underwent PCI. However, it is not known if ACEF score could evaluate the prognostic of recanalization of non-infarct-related coronary arteries (non-IRA) chronic total occlusions (CTO) in patients who successful underwent primary PCI. The objectivity of current study was to assess the prognostic value of ACEF score in acute ST-segment elevation myocardial infarction (STEMI) patients with non-IRA CTO after successful primary PCI.


Eligibility criteria: Among the 2952 patients with STEMI successful treatment by PCI, 395 patients (13.4%) had a non-IRA CTO lesion. 18 patients were excluded from current study as they death within 7 days (n=6) or were not to follow-up (n=7). Due to unavailability of ejection fraction or renal function before CTO-PCI, ACEF score could not be calculated in 5 patients. The remaining 377 patients (95.4%) were finally analyzed in the study. 279 patients performed a staged CTO-PCI attempt(ranging 7-28 days) and was successful in 221 of them. Due to low possibility of PCI success or patients refused to perform PCI, 98 patients did not undergo the PCI attempt. The patients were then divided into successful CTO-PCI group (221 patients) and failed/ non-attempted CTO-PCI group (156 patients).

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Primary outcomes:
measure: Primary end point
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06554236: The Influence of an Orthopaedic Manual Physical Therapy and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain
Official title: The Influence of an Orthopaedic Manual Physical Therapy Approach and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: two-point discrimination
physical therapy
somatoperception
tactile acuity
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2024-08-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: quasi-experimental, one-group repeated measures design
Primary purpose: TREATMENT

Brief summary: Individuals with chronic low back pain and other chronic pain conditions have been shown to have altered somatosensory, the ability to sense input to the tissue, which is processed in the primary somatosensory cortex or S1. Two-point discrimination is currently the best clinical tool utilized to assess an individual's ability to sense touch. This study will assess TPD changes after a course of standard physical therapy care with the addition of sensory training.


Eligibility criteria: Inclusion Criteria:

* DEERS eligible
* 18 to 64 years old
* Low back pain \&gt; 3 months
* Numeric Pain Rating Scale minimal pain rating of 3/10 in the last seven days
* Must be able to commit to 6-10 treatment sessions over a period of at least 6-we

Exclusion Criteria:

* History of spinal surgery
* History of spinal injections or nerve ablations in the past year
* History of traumatic brain injury (TBI)
* History of cerebral vascular accident (CVA)
* Currently pregnant
* Active cancer
* Symptoms below the knee
* Non-MSK condition contributing to low back pain
* Chronic Pain Conditions to include Chronic Regional Pain Syndrome and Fibromyalgia
* Autoimmune Diseases (to include Ankylosing Spondylitis, Lupus, Rheumatoid Arthritis)
* Currently under litigation related to low back pain
* Currently going through Medical Evaluation Board (MEB)
* Retiring or separating from the military within a year
* Currently receiving physical therapy for low back pain

Primary outcomes:
measure: Tactile acuity as measured by two-point discrimation
timeFrame: Performed at baseline visit, 4th week of treatment, and at final visit (8 +/- 2 weeks).
Secondary outcomes:
measure: Pain as measured by numeric pain rating scale
timeFrame: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
measure: Low back perception
timeFrame: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
measure: Tactile Localization Accuracy
timeFrame: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
measure: Function
timeFrame: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).
Other outcomes:
Locations:
Study officials:
affiliation: Brooke AMC
name: Brooke Barletta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04240236: Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy
Official title: Effect of Scalp Blocks on Postoperative Nausea & Vomiting & Recovery Profiles After Craniotomy: A Randomized, Double-Blind, and Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, the investigators hypothesize that preemptive scalp block in neurosurgical patients may decrease incidence of PONV after craniotomy through decreasing intraoperative inhalational agents' concentration and decreasing intraoperative opioids requirements, with better intraoperative hemodynamics and lesser recovery time

Detailed description: Patients will be recruited after admission to the hospital for surgery. Randomization will be performed using computer-generated random number tables in opaque sealed envelopes prepared by an anesthesiologist who will be not part of the study

Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C received scalp block using 20 mL normal saline and will be considered as control group.

Eligibility criteria: Inclusion Criteria:

* ASA I and II patients,
* aged 18 to 50 years,
* 70-80 kg,
* undergoing elective supratentorial craniotomy

Exclusion Criteria:

* patients under 18 years of age,
* pregnancy,
* emergency surgery,
* patients with a Glasgow Coma Score (GCS) less than 15,
* those with documented allergy to bupivacaine,
* regular communication not possible,
* Patients requiring prolonged mechanical ventilation (\> 2 hours after end of surgery) will be also excluded

Primary outcomes:
measure: PONV incidence & severity during the 1st 24 hours in ICU.
timeFrame: 24 hours
Secondary outcomes:
measure: Intraoperative Mean blood pressure in mmHg
timeFrame: 6 hours
measure: Total intraoperative fentanyl consumption in microgram
timeFrame: 6 hours
measure: Recovery time in minutes
timeFrame: 10 minutes
measure: Intraoperative Heart rate as number of beats per minute
timeFrame: 6 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Raham Hasan
Study officials:
affiliation: Assistant Lecturer of Anesthesia, Ain Shams University
name: Raham Hasan Mostafa, MD
role: PRINCIPAL_INVESTIGATOR
References: