louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07010172: Fibromyalgia, Cognitive Rehabilitation Software
Official title: Effectiveness of Cognitive Rehabilitation Software in Female Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Cognitive Rehabilitation
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-06-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In recent years, especially in developed countries, FMS has emerged as a serious social problem by decreasing labour force and quality of life. Especially clinicians have started to consider cognitive dysfunction in FMS as a separate clinical condition. In the light of the data obtained, can say that cognitive dysfunction increases in the presence of depression, anxiety, sleep disorders, endocrine imbalances and pain.

Neuroscience and technological advances make it possible to meet the demand for care and improve the quality of stimulation by enabling the automation of many cognitive training procedures, improving patient record reliability and optimising performance of disability functions. The recently implemented RehaCom and HeadApp programmes (Schuhfried, Austria). excellent results have been reported in clinical practice with no significant adverse effects.

This study will investigate the effectiveness of a cognitive rehabilitation programme using computer software in female patients with fibromyalgia.


Eligibility criteria: Inclusion Criteria:

* Being a woman
* Diagnosed with fibromyalgia
* 18-65 years old

Exclusion Criteria:

* concomitant neurological disorder, learning disorder or cognitive impairment
* current alcohol or recreational drug dependence or long-term (≥5 years) history of substance abuse
* visual or hearing impairment that would interfere with cognitive testing
* diagnosis of untreated obstructive sleep apnoea,
* atypical sleep/wake patterns (e.g. night shift workers)
* Lack of computer and internet access

Primary outcomes:
measure: Stroop Colour and Word Test
timeFrame: start and first month
measure: Number Range Test
timeFrame: start and first month
Secondary outcomes:
measure: modified Fibromyalgia impact questionnaire
timeFrame: start and first month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01279772: This Trial is a Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas
Official title: A Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas Treated With R-CHOP With or Without Radiotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diffuse Large B-Cell Lymphoma of the Breast
Lead sponsor: International Extranodal Lymphoma Study Group (IELSG)
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 1
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: Previously untreated patients with localized DLBCL of the breast.

Brief summary: In this study, the investigators propose that the addition of rituximab will lower the risk of systemic and local relapses in patients with localized PBL. Patients will be treated with 6 cycles of RCHOP-14 or RCHOP-21. The administration of radiotherapy following chemotherapy is strongly recommended, based on the findings of the retrospective IELSG study, but will be at the discretion of the treating center.


Eligibility criteria: Inclusion Criteria:

* Previously untreated patients with DLBCL of the breast.
* Patients must have CD20 positive tumors.
* Stage IE or IIE.
* Must have at least one objective measurable or evaluable disease. Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.
* Patients must have an ECOG performance status 0-2.
* Patients must have adequate organ function as evidenced by the following laboratory studies ( within 2 weeks prior to registration):

  * Creatinine Clearance \> 50 ml/min
  * Total bilirubin \< 2.0 mg/dl and AST \< 2 x upper limit of normal. If documented hepatic involvement with lymphoma, total bilirubin can be \< 3 x ULN, and AST \< 5 x ULN.
  * Absolute neutrophil count \> 1500/mm3 and platelet count \> 100,000/mm3. If documented bone marrow involvement with lymphoma, absolute neutrophil count \> 500/mm3 and platelet count \> 50,000/mm3.
* Patients must be age \> 18 years.
* Patients must have a normal left ventricular ejection fraction to be eligible.

Exclusion Criteria:

* historical or radiographic evidence of CNS metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
* pregnant or breast feeding patients. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
* active infection requiring parental antibiotics.
* known HIV infection

Primary outcomes:
measure: local and CNS relapse rate
timeFrame: 12-month
Secondary outcomes:
measure: progression free survival
timeFrame: 12-month
measure: overall survival
timeFrame: 5-year
measure: overall, complete and partial response rates following RCHOP
timeFrame: at the end of chemotherapy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05210972: Coronary Artery Disease Severity in Newly Diagnosed Dysglycemia
Official title: Severity of Newly Diagnosed Coronary Artery Disease in Patients With Newly Diagnosed Diabetes and Pre-diabetes: A Cohort Study in a Cardiac Center in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Dysglycemia
Lead sponsor: Saud Al Babtain Cardiac Center
Sponsor class: OTHER_GOV
First posted: 2022-01-27
Enrollment: 150
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: A single center cohort study, where all comers, adult patients without prior diagnosis of DM, who are admitted with a first-time diagnosis of CAD, as confirmed by invasive coronary angiography, either elective or as emergency, will be eligible. The study will prospectively enroll consecutives and contemporary cases for each group of diabetes, pre-diabetes and normal glycemia.

Brief summary: This cohort study will measure how severe is the coronary artery disease (CAD), at time of CAD diagnosis, clinically and angiographically in the different cohorts of newly diagnosed diabetes and prediabetes versus normal glycemia patients in the study center.


Eligibility criteria: Inclusion Criteria:

* All adult patients with consents.
* First time diagnosis of CAD and no prior diagnosis of diabetes milletus (DM), or prediabetes.
* Coronary artery disease confirmed by invasive coronary angiography.

Exclusion Criteria:

1. Patients with known significant anemia, increased hemoglobin turnover, active hemoglobin drops or on erythropoietin therapy.
2. Pregnant and post-partum patients (up to 3 months post-delivery).
3. Patients with severe chronic renal failure (estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.72 m2).
4. Patients on any medications with glucose lowering effects.

Primary outcomes:
measure: Coronary artery disease severity
timeFrame: 1 day (During the hospital admission)
Secondary outcomes:
measure: Correlation of HbA1c to CAD severity
timeFrame: 1 day (During the hospital admission)
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Saud Albatain cardiac Center
Study officials:
References:
Clinical trial NCT00663572: Food Habit Programming: Influence of Genetics and Early Nutrition in a Population of Preterm Infants
Official title: Food Habit Programming: Influence of Genetics and Early Nutrition in a Population of Preterm Infants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Preterm Infants
Keywords: Newborn
nutrition
genetic
feeding behaviour
psychomotor development
long-term effects
nutritional imprinting.
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 234
Sex: ALL
Minimum age (years): 2
Maximum age (years): 25
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants \< 33 SA who stayed at least 2 weeks after birth in Nantes hospital, included in the " Grandir ensemble " network, 2 years old in 2008 and 2009

Brief summary: Influence of neonatal nutrition and growth on psychomotor development of 2 years preterm infants.-Joint influence of environmental factor (early nutrition) and genetics factors on feeding behaviour setting- up in a particular population of infants of whom nutrition and life conditions during first weeks of life were purely controlled.


Eligibility criteria: Inclusion Criteria:

* Preterm infants \< 33 SA who stayed at least 2 weeks after birth in Nantes hospital, included in the " Grandir ensemble " network, 2 years old in 2008 and 2009

Primary outcomes:
measure: Neurodevelopmental evaluation by ASQ (Age and stages Questionnaire) at 2 years of age
timeFrame: 2 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
Study officials:
References:
citation: Migraine A, Nicklaus S, Parnet P, Lange C, Monnery-Patris S, Des Robert C, Darmaun D, Flamant C, Amarger V, Roze JC. Effect of preterm birth and birth weight on eating behavior at 2 y of age. Am J Clin Nutr. 2013 Jun;97(6):1270-7. doi: 10.3945/ajcn.112.051151. Epub 2013 Apr 24.
Clinical trial NCT03193372: A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated With Finacea Foam for Rosacea
Official title: A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated With Finacea Foam for Rosacea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rosacea
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2017-06-20
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with rosacea and currently receiving topical monotherapy with Finacea Foam

Brief summary: To survey rosacea patients about their concerns, treatment satisfaction, and quality of life associated with their Finacea Foam treatment


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Diagnosis of rosacea by a medical professional
* Currently using Finacea Foam as topical monotherapy for rosacea
* Willing and able to provide voluntary, informed consent to participate in this study

Exclusion Criteria:

- Use of any other topical treatment for rosacea at the time of enrollment

Primary outcomes:
measure: Demographics and clinical characteristics
timeFrame: one-time survey in 2 week recruitment window
measure: Rosacea-relevant comorbidities and complications
timeFrame: one-time survey in 2 week recruitment window
measure: Rosacea subtype
timeFrame: one-time survey in 2 week recruitment window
measure: Past use of topical rosacea treatments
timeFrame: one-time survey in 2 week recruitment window
measure: Patient concerns collected by Rosacea Treatment Preference Questionnaire
timeFrame: one-time survey in 2 week recruitment window
measure: Treatment satisfaction assessed by Satisfaction with Medicines Questionnaire (SATMED-Q)
timeFrame: one-time survey in 2 week recruitment window
measure: Quality of life measured by Dermatology Life Quality Index (DLQI)
timeFrame: one-time survey in 2 week recruitment window
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Harbor
country: United States
facility: Xcenda, LLC
state: Florida
Study officials:
References:
Clinical trial NCT02244372: Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity
Official title: A 8-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunity
Keywords: Cordyceps sinensis mycelium culture extract(Paecilomyces hepiali, CBG-CS-2)
immunity
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-4, IL-6, IL-12, IFN-γ, TNF-α), hs-CRP, antibody titer, and upper respiratory tract infection(URI)


Eligibility criteria: Inclusion Criteria:

* Males and females 20-80 years old
* Who had suffered more than twice Upper respiratory infection\* disorder or common cold causing URI
* Able to give informed consent

Exclusion Criteria:

* WBC concentration below 3000 ㎕
* Subjects vaccinated against influenza within the last 6 months prior to the study
* Subjects with Upper respiratory infection at screening visit
* Subjects with BMI \< 18.5 kg/m2 at screening visit
* Allergic or hypersensitive to any of the ingredients in the test products
* Diagnosed of gastrointestinal disease such as Immune-related diseases, severe hepatic, renal failure, and diabetes
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in Cytotoxicity
timeFrame: 4, 8 weeks
Secondary outcomes:
measure: Changes in Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α)
timeFrame: 4, 8 weeks
measure: Changes in hs-CRP
timeFrame: 4, 8 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT02545972: Once-a-day Tacrolimus Conversion Study: The OneTAC Trial
Official title: A Prospective Non-randomized Trial of Conversion From Twice a Day Tacrolimus to Once Daily Modified Release Tacrolimus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure
Keywords: immunosuppression
Lead sponsor: Newark Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 100
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: This study investigates the use of tacrolimus extended release in stable patients who have undergone a heart transplant. All patients will receive the study medication free of charge for the 1 year duration of the study.

Detailed description: Tacrolimus has been extensively studied in solid organ transplantation. It is FDA approved for heart transplant recipients as a twice a day formulation (Prograf brand name, as well as generic formulations). A modified release formulation is available and FDA approved for kidney transplant recipients (Astagraf, Astellas Pharmaceutical), but is not approved for heart transplant patients.

In this study the investigators will study 100 patients who are stable on twice a day Tacrolimus and convert these subjects to once a day modified release Tacrolimus. The investigators will observe these patients for 1 year following the switch and assess safety and efficacy in a heart transplant population.

Eligibility criteria: Inclusion Criteria:

* Adult, age 18 or higher
* Heart transplant recipient at least 365 days post-transplant at time of study screening
* Informed consent available
* Willingness to return for study visits, clinically indicated bloodwork
* On tacrolimus-based chronic immunosuppression.
* Self-identified ethnic group is provided

Exclusion Criteria:

* Prior heart or solid organ transplant
* Less than 365 days post-transplant at study screening
* Receiving cyclosporine based immunosuppression or calcineurin inhibitor free regimen
* Concurrent kidney or other solid organ
* Inability to provide informed consent
* More than 15 years post-transplant

Primary outcomes:
measure: The change in glomerular filtration rate slope between the 6 months prior to study enrollment and 6 months post-study enrollment.
timeFrame: 6 months
Secondary outcomes:
measure: The change in glomerular filtration rate slope between the 6 months prior to study enrollment and 12 months post-study enrollment.
timeFrame: 12 months
Other outcomes:
Locations:
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
Study officials:
affiliation: Newark Beth Israel Medical Center
name: David A Baran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02150772: The Diagnostic Value of Shear Wave Elastography
Official title: Shear Wave Elastography in the Diagnosis and Risk-stratification of Thyroid Nodules - a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodule
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Background: The main goal when diagnosing thyroid nodules, is to differentiate the few malignant from the overwhelming background of benign nodules. Currently available pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic thyroid surgery is necessary. Therefore, there is a need to develope the diagnostic tools for pre-operative diagnostic work-up of thyroid nodules.

The study will investigate a novel ultrasonographic technique called Shear Wave Elastography (SWE) in the pre-operative evaluation of thyroid nodules.

Aim:

To evaluate the diagnostic value of SWE in the pre-operative diagnosis of thyroid nodules in a tertiary surgical center.

Perspectives:

An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the economic and surgical resources.


Eligibility criteria: Inclusion Criteria:

* Nodules in the thyroid size more than 1 cm and patient undergoing thyroid surgery

Exclusion Criteria:

* Not undergoing thyroid surgery

Primary outcomes:
measure: Elasticity Index
timeFrame: same day
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Øre-Næse-Halsafdeling H, Aarhus University Hospital
Study officials:
affiliation: Dep. of otorhinolaryngology, Aarhus University Hoapital
name: Kristine Z Rubeck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dep. of oto-rhinolarymgology and Head and Neck surgery, Aarhus Universtity Hospital
name: Viveque E Nielsen, MD PhD
role: STUDY_DIRECTOR
affiliation: Dep. of Endocrinology, Odense University Hospital
name: Steen J Bonnema, PhD, DMSc
role: STUDY_CHAIR
affiliation: Dep. of Pathology, Aarhus University Hospital
name: Marie Louise Jespersen, MD
role: STUDY_CHAIR
affiliation: Dep. og General Surgery, Aarhus University Hospital
name: Peer Christiansen, DMSc
role: STUDY_CHAIR
References:
citation: Bakkegaard P, Londero SC, Bonnema SJ, Nielsen VE, Jespersen ML, Swan KZ. Risk-stratification of thyroid nodules examined by 18FDG-PET/CT while ensuring congruity between imaging and histopathological localization. Eur Arch Otorhinolaryngol. 2021 Dec;278(12):4979-4985. doi: 10.1007/s00405-021-06733-5. Epub 2021 Mar 13.
Clinical trial NCT02070172: Active and Passive Cervical Flexion-rotation Tests
Official title: A Comparison of Range of Motion During the Active and Passive Flexion-rotation Tests in Subjects Patients With Cervicogenic Headache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervicogenic Headaches
Keywords: headache diagnosis
flexion rotation test
range of motion
upper cervical
Lead sponsor: Des Moines University
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: two groups of subjects were included; those with cervicogenic headaches and an asymptomatic group of healthy volunteers

Brief summary: Motion limitations have been previously reported in people with headaches originating from the neck/cervicogenic headaches. A test involving flexing and rotating the neck has been found useful to diagnose this type of headache. This observational study investigates this neck motion test when performed actively by the patient and passively by the examiner, then compares the results of motion attained.


Eligibility criteria: Inclusion Criteria:

* One-sided headaches
* Headaches caused by neck movement or sustained head positioning
* Neck, shoulder, or arm pain
* Intermittent headaches at least one headache per week for greater than 2 months
* Headaches of moderate intensity

Exclusion Criteria:

* A diagnosis of rheumatoid arthritis
* Current pregnancy
* International Headache Society criteria for other headache forms (such as tension or migraine)
* Cervical radiculopathy
* Treatment for headaches by a physical therapist, chiropractor, massage therapist, or osteopath in the past month
* Positive test for vertebral artery insufficiency or cranial-vertebral ligament instability

Primary outcomes:
measure: Cervical Range of Motion in degrees with the Flexion Rotation Test
timeFrame: Baseline only
Secondary outcomes:
measure: Northwick park neck disability index
timeFrame: Baseline only
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: Des Moines University
state: Iowa
Study officials:
affiliation: Des Moines University
name: Shannon Petersen, PT, DScPT
role: PRINCIPAL_INVESTIGATOR
References: