louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02454218: Effect of Transcranial Direct-current Stimulation in Attentional Performance and Pain in Patients With Fibromyalgia
Official title: Effect of Transcranial Direct-current Stimulation in Attentional Performance and Pain in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Transcranial direct current stimulation
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: tDCS can modify the attentional response of patients with fibromyalgia. Methods: This study deals with a randomized, blind, crossover, controlled tDCS-sham. The sample will consist of 40 patients, divided into two groups with sham interventions and active crossover.

Detailed description: Check that the tDCS can modify the attentional response of patients with fibromyalgia. Methods: This study deals with a randomized, blind, crossover, controlled tDCS-sham. The sample will consist of 40 patients, divided into two groups with sham interventions and active crossover. Patients answer the questionnaires in order to verify the Psychological Factors and Clinical. Will use the Impact of Fibromyalgia (QIF), Pittsburgh Sleep Questionnaire, Conditioned Pain Modulation (CPM), Beck Depression Scale II, Catastrophic Scale , Go noGo Test, Attention Network Task (ANT) to verify the ability attentional as well as to verify the Near-infrared spectroscopy (NIRS) brain oxygenation. They will be used before, during and after the intervention with tDCS. Intervention with tDCS or sham will be held in a single session. Expected results: It is expected that fibromyalgia patients undergoing tDCS present, after the intervention, improved attention capacity .

Eligibility criteria: Inclusion Criteria:

* Female patients, literate, right-handed, 18 to 65 years of age, who meet the criteria of the American College of Rheumatology (ACR) for fibromyalgia.

Exclusion Criteria:

* Pregnant women
* Contraindications to tDCS
* Metal implant in the brain
* History of alcohol or drug abuse in the last six months
* Suffer from severe depression (score\> 30 on the Beck Depression Inventory)
* History of neurological disorders
* Unexplained fainting
* Self-reports of head injury or momentary loss of awareness
* Neurosurgery.
* Will also be excluded patients who have decompensated systemic diseases and / or chronic inflammatory diseases (ex .: lupus, rheumatoid arthritis).

Primary outcomes:
measure: Attention capacity after the intervention, assessed by the Attention Network Task
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Porto Alegre Clinical Hospital
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Wolnei M Caumo, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06668818: Clinical Nursing Practice Supported by Results of Research: Mixed-method Study
Official title: Clinical Nursing Practice Supported by Results of Research: Mixed-method Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oncology
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nurses employed at IRCCS-CRO Aviano and patients admitted to the institution as in-patients

Brief summary: The purpose of the study is to assess the attitudes and the use of research by nurses at the IRCCS-CRO Aviano. Furthermore, it will make it possible to identify attitudes towards the use/non-use of research results, specific training needs and targeted interventions to ensure adequate care for cancer patients along the disease course, derived from a constant updating of nursing skills. The study will involve nurses working in different care settings of the Institute and some patients who will be able to express their care needs and research priorities, making a direct contribution towards development of care centred on the health needs, preferences and values of the cancer patients.


Eligibility criteria: Inclusion criteria for nurses:

* All nurses employed at IRCCS-CRO Aviano under fixed-term and permanent contract on 15 September 2023;
* Nursing activities in the departments of medical and surgical oncology and high technologies;
* Full-time and part-time employment contract;
* Signature of consent for participation in the study and processing of personal data (Privacy).

Patient inclusion criteria:

* Patients admitted to the institution as in-patients;
* Age ≥ 18 years;
* Signature of consent for participation in the study and processing of personal data (Privacy);
* Good understanding of the Italian language.

Exclusion criteria for nurses:

- Lack of willingness/interest in participating in the study and signing the consent.

Patient exclusion criteria:

* Day-Hospital patients;
* Age \< 18 years;
* Diagnosis of cognitive dysfunction or psychiatric disorders;
* Difficulties in understanding the Italian language.

Primary outcomes:
measure: To assess the attitudes and use of research by nurses IRCCS of Aviano
timeFrame: 1 year
Secondary outcomes:
measure: To identify nursing issues, research priorities, and educational needs of nurses at IRCCS Aviano.
timeFrame: 1 year
measure: To explore care needs and research priorities of patients at IRCCS Aviano
timeFrame: 1 year
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
state: Pordenone
Study officials:
affiliation: Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
name: Lucia Cadorin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03658018: Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain
Official title: A Prospective, Open-Label, Single-Arm, Single-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Relievant Medsystems, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-05
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting

Detailed description: This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.

Eligibility criteria: Inclusion Criteria:

* Skeletally mature subjects age 25-70 years, inclusive
* Chronic lower back pain for at least six months
* Failure to respond to at least six months of non-operative conservative management
* Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
* Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1

Exclusion Criteria:

* Radicular pain by history or evidence of pain neurological deficit within the past one year.
* Previous surgery performed on the lumbar spine
* Current or history of symptomatic spinal stenosis
* Current or history of osteoporotic or tumor-related vertebral body compression fracture
* Current or history of vertebral cancer or spinal metastasis
* Current or history of spinal infection
* Metabolic bone disease
* BMI greater or equal to 40
* Any radiographic evidence of other important back pathology
* MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1
* Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
* Subjects who are bed bound
* Demonstrates 3 or more Waddell's signs of Inorganic Behavior
* Any evidence of current systemic infection

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 3 months
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 3, 6, 9, and 12 months
measure: Oswestry Disability Index (ODI)
timeFrame: 6, 9, and 12 months
Other outcomes:
Locations:
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
Study officials:
affiliation: Texas Back Institute
name: Isador Lieberman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05665218: Comparison of Different Cardiac Output Measurement Methods in Patients Undergoing Right Heart Catheterization
Official title: Cardiac Output Assessment in Pulmonary Hypertension Patients Undergoing Right Heart Catheterization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Hypertension
Lead sponsor: UOSD Emodinamica Diagnostica e Interventistica
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 1
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: All consecutive patients aged ≥18 years, referred for RHC for suspected PH, were included.

Brief summary: The objective of this observational study is to compare cardiac output evaluation by the Direct Fick method, Indirect Fick method and Thermodiluition in pulmonary hypertension (PH) patients undergoing right heart catheterization (RHC).

The main questions it aims to answer are:

* Are these methods interchangeable?
* Can possible discrepancies influence risk stratification and therapeutic management of PH patients? All consecutive patients aged ≥18 years, referred for RHC for suspected PH, will be included. Exclusion criteria will be contraindications to RHC, cardiac shunts and failure to obtain informed consent. Patients will undergo RHC by a Swan-Ganz catheter through the right internal jugular vein ultrasound-guided cannulation and cardiac output will be calculated using the three above-mentioned methods.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Suspected pulmonary hypertension at clinical and echocardiographic evaluation

Exclusion Criteria:

* contraindication to Right Heart Catheterization (RHC)
* cardiac shunt
* inability to provide informed consent

Primary outcomes:
measure: differences in cardiac output values measured using three different methods (Direct Fick, Indirect Fick and Thermodiluition)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata
Study officials:
affiliation: Interventional Cardiology Unit, SS Annunziata Hospital, Chieti
name: Livio Giuliani, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05328518: Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.
Official title: Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia
Schizophrenia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: schizophrenic womens

Brief summary: Numerous studies reported on comorbidity of fibromyalgia and psychiatric disorders. Approximately 30% of patients with fibromyalgia have major depression at the time of diagnosis; the lifetime prevalence of depression is 74% and that of an anxiety disorder is 60%. In some fibromyalgia patients, mood and cognitive problems are much more prominent than tenderness. From the psychiatric point of view, 49% of PTSD patients and 5% of major depression patients fulfill criteria for diagnosing fibromyalgia.

The association between schizophrenia and fibromyalgia is still unknown.

Study hypothesis Schizophrenia patients, who have an aberrant sensation of pain, have lower prevalence of FM compared to the general population.

Primary objectives

1. Demonstrate that schizophrenia patients have lower prevalence of FM, compared to the general population.
2. To compare the self-reported extent and intensity of pain with selected tender points examination.


Eligibility criteria: Inclusion Criteria:

* Women above 18 years of age.
* Patients must meet DSM-5 criteria for a diagnosis of schizophrenia.
* A stabled mental state.
* If hospitalized, patients are scheduled for discharge on the basis of clinical assessment of psychiatric symptoms.

Exclusion Criteria:

* Mental co-morbidity.
* Diagnosis of myofascial pain syndrome or chronic fatigue syndrome.
* Alcohol or drug use.
* Usage of any pain reliever medications during the week before recruitment.

Primary outcomes:
measure: To compare the self-reported extent by questionnarie and intensity of pain with selected tender points examination.
timeFrame: 1 day
measure: To compare between the degrees in pain recognition in schizophrenia patients who suffer from fibromyalgia to pain recognition in schizophrenia patients who do not suffer from fibromyalgia.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek medical center
Study officials:
References:
Clinical trial NCT05071118: The Efficacy of Pregabalin on the Duration of the Spinal Anesthesia and the Early Postoperative Pain After Total Knee Arthroplasty
Official title: the Effect of Adding Pregabalin on the Onset and the Duration of Spinal Anesthesia and on the Postoperative Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the purpose of this study is to evaluate the effectiveness of administration of pregabalin 2 hours preoperatively on the onset and the duration of the spinal anesthesia in total knee arthroplasty and the role of pregabalin in postoperative analgesia.


Eligibility criteria: Inclusion Criteria:

* the ages of 40 and 70 years
* height 155-170 cm
* American Society of Anesthesiologists grade I or II .
* patients underwent total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

* patients known to be allergic to any medicines.
* patients had a history of drug or alcohol abuse.
* patients were taking opioids or sedative medications,
* patients Inability to communicate with investigators to evaluate the postoperative pain
* patients were in need for postoperative ICU hospitalization .
* patients had a history of psychiatric conditions.
* Patients with a history of taking pregabalin or gabapentin .

Primary outcomes:
measure: onset of spinal anaesthesia
timeFrame: three months
Secondary outcomes:
measure: recovery time
timeFrame: three months
measure: motor block duration
timeFrame: three months
measure: postoperative analgesia
timeFrame: three months.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT04070118: Lower Uterine Segment Thickness and Term Pain,Previous Cesarean Section
Official title: Evaluation of Lower Uterine Segment Thickness in Pregnant Women Presenting With Term Pain and Previous Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section; Dehiscence
Cesarean Section Complications
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In Pregnant Women with Term Pain and Previous Cesarean Section; Patients with visual evaluation of the lower uterine segment thickness and ultrasound

Brief summary: the purpose of the researchers; The aim of this study is to evaluate the consistency of niche dimensions measured by ultrasonography with visual measurement of the surgeon during the operation of the patient when presenting with pain in her current pregnancy.

If patients who have had previous cesarean section present to the emergency department with pain or NST pain, a panic occurs immediately for operation. Purpose of researchers; The aim of this study is to investigate whether a really fine determination of the thickness of the old incision line is associated with full-thickness rupture or incomplete rupture, which appears to be an operation, and if a relationship is found, there is a limit for this thickness.


Eligibility criteria: Inclusion Criteria:

* Patients with a previous cesarean section
* Those in term gestational week (37-42 weeks)
* Those who apply to the emergency with pain

Exclusion Criteria:

* Birden fazla sezaryen geçirilmiş öyküsü olan hastalar
* Önceden geçirilmiş uterin cerrahisi olan hastalar
* Miad olmayan gebeler
* Plesantal yerleşim patolojısı olan gebeler

Primary outcomes:
measure: Measure niche thickness with ultrasound
timeFrame: 1 day
measure: Measure niche thickness with visual evaluation of the surgeon
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT01789918: TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)
Official title: TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistant Hypertension
Keywords: Hypertension
Blood pressure
Renal denervation
Lead sponsor: ReCor Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to include up to one hundred (100) eligible patients as defined within the clinical investigational plan, with a twelve month follow-up period. The ACHIEVE study was originally designed in accordance with the 2007 ESH ESC guidelines for resistant hypertension.


Eligibility criteria: Inclusion Criteria:

* Resistant hypertension, as defined in the 2007 ESH-ESC guidelines
* 18 years of age or older
* Negative pregnancy test for female patients of childbearing potential
* Willing and able to comply with follow-up requirements
* Signed informed consent

Exclusion Criteria:

* Secondary hypertension
* Main renal arteries length \< 20 mm
* Main renal arteries diameter \< 4 mm
* Renal artery stenosis
* Iliac/femoral artery stenosis precluding insertion of the catheter
* Untreated allergy to contrast media
* Currently participating in the study of an investigational drug or device
* Moderate to severe renal insufficiency

Primary outcomes:
measure: Percentage of patients with device- or procedure-related adverse events
timeFrame: 12 months
measure: Change from baseline in systolic blood pressure
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in diastolic blood pressure
timeFrame: 12 months
measure: Change from baseline in anti-hypertensive medication intake
timeFrame: 12 months
measure: Changes from baseline in pulse pressure and nocturnal dipping
timeFrame: 12 months
Other outcomes:
measure: Change from baseline in EQ-5D Quality of Life score
timeFrame: 12 months
measure: Change from baseline in cardiac function
timeFrame: 12 months
Locations:
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg • Bad Krozingen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: CardioVasculäres Centrum
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Lübeck
country: Germany
facility: Universitätsklinikum Lübeck
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Thoraxcenter
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
Study officials:
affiliation: Universitäts-Herzzentrum Freiburg • Bad Krozingen
name: Thomas Zeller, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01992718: What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
Official title: What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Uterine Bleeding
Uterine Fibroids
Adenomyosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Association of University Radiologists
name: GE Radiology Research Academic Fellowship
First posted: 2013-11-25
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging), ultrasound and ultrasound with elastography).

Detailed description: Currently benign conditions of the uterus are frequently underdiagnosed or misdiagnosed. This project will help determine which diagnostic radiology exams are most helpful to the clinician in providing accurate diagnosis. In addition, this study will evaluate which exam (MRI vs. Ultrasound) patients prefer over another exam.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Pelvic pain and/or abnormal uterine bleeding. (this is specific for Arm. 1 of this study)
3. If you have had or are scheduled to have both a pelvic MRI (magnetic resonance imaging) and a pelvic ultrasound with 6 months of the time of enrollment. (this is specific to Arm 2 of this study).

   -

Exclusion Criteria:

1. If you are post-menopausal(have not had a period in at least one year's time).
2. If you have been diagnosed with gynecological malignancy such as uterine, endometrial, cervical or ovarian cancer.
3. If you are unable or unwilling to sign the informed consents
4. If you are unable to undergo the research study exams -

Primary outcomes:
measure: Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids
timeFrame: 1-2 months per patient
Secondary outcomes:
measure: Patient preference between ultrasound and MRI
timeFrame: 6 months per patient
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Katherine Maturen, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: