louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05596344: Long-term Follow-up of Anxiety and Depression in Patients With Malignant Tumors
Official title: A Single-center, Real-world Prospective Observational Study of the Incidence and Development of Anxiety and Depression in Patients With Malignant Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Tumor
Anxiety
Depression
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-10-27
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with malignant tumors diagnosed by pathology receiving inpatient treatment in Henan Cancer Hospital.

Brief summary: This study was a single-center prospective, real-world observational study with plans to enroll all eligible patients. The basic information, anxiety and depression, treatment and prognosis of these patients were collected.

Detailed description: A total of 200 patients with malignant tumors will be enrolled in Henan Cancer Hospital. This study is a single-center prospective real-world observational study, and all eligible patients are planned to be enrolled. The basic information, anxiety and depression, treatment and prognosis of these patients were collected.

Eligibility criteria: Inclusion Criteria:

1. Men and women of all ages are welcome.
2. Pathological diagnosis of malignant tumor in our hospital.
3. Received at least one hospitalization at this hospital.
4. The expected survival time is greater than 1 year.

Exclusion Criteria:

1.There was no pathological report of malignancy.

Primary outcomes:
measure: Hospital Anxiety Depression Scale
timeFrame: Confirmed in 1 day
measure: Hospital Anxiety Depression Scale
timeFrame: End of the treatment
measure: Hospital Anxiety Depression Scale
timeFrame: The treatment ended 3 months later
measure: Hospital Anxiety Depression Scale
timeFrame: The treatment ended 6 months later
measure: Hospital Anxiety Depression Scale
timeFrame: The treatment ended one year later
measure: Hospital Anxiety Depression Scale
timeFrame: The treatment ended 2 years ago
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Bone and Soft Tissue ,Henan Cancer Hospital
state: Henan
Study officials:
References:
Clinical trial NCT06620744: Magnetocardiography (MCG) Device Use in Patients With Elevated Troponin
Official title: Magnetocardiography (MCG) Device Use in Patients With Elevated Troponin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACS - Acute Coronary Syndrome
Keywords: magnetocardiography
MCG
Lead sponsor: SB Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This prospective device study will examine the feasibility of MCG data collection in a hospital setting using the SandboxAQ MCG device as a potential method to more accurately and quickly quantify cardiac disease of patients with elevated Troponin.


Eligibility criteria: Inclusion Criteria:

* Received a positive hs-cTnI based on the institutions laboratory normal value ranges (e.g. female ≥14 and male ≥35)

Exclusion Criteria:

* Present STEMI
* Having an active atrial fibrillation episode as seen on 12-lead ECG
* Clear non-ischemic cause for symptoms (e.g. trauma)
* Active thoracic metal implants

Primary outcomes:
measure: Proportion (%) of all collected MCG data that meets the necessary data quality. requirements and are deemed suitable for analysis.
timeFrame: Per-scan, on average 5 minutes, day of enrollment
Secondary outcomes:
measure: Sandbox MCG safety
timeFrame: 30-days
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: SB Technology, Inc.
name: Kit Yee Au-Yeung, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06042244: Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis
Official title: Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Frailty
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Significance: This proposed investigation is designed to examine the feasibility of an exercise-based intervention to reduce frailty in people living with MS. The proposed research will be the first to establish the feasibility of targeting frailty in pwMS and will begin to examine the dynamic nature of frailty in MS. These advances will pave the way for planned prospective studies toward effective targets for diagnostics, and rehabilitation of frailty in MS.


Eligibility criteria: Inclusion Criteria:

* Subjects must be aged 40-65 years old to be enrolled in this study.
* Subjects must meet 3 of 5 frailty criteria (weight loss; exhaustion; weakness; slowness; inactivity) to be considered.
* Subjects must have a confirmed diagnosis of MS by the treating neurologist
* be free from MS relapses in the last 30 days
* have an Expanded Disability Status Scale (EDSS) score ≤ 6.0
* be fluent in spoken and written English.

Exclusion Criteria:

* unable to walk unassisted for at least ten meters
* are diagnosed with other clinically important neurological conditions (such as Parkinson's Disease, epilepsy, etc.)
* exhibit severe cognitive impairment (as determined by a Mini-Cog score \<3)
* are diagnosed with active psychiatric problems.
* unstable cardiovascular conditions (e.g., malignant arrhythmias, critical mitral stenosis, clinically severe left ventricular outflow obstruction, critical proximal coronary artery stenosis)
* arthritis of the lower limbs
* acute lower back or lower limbs pain
* rheumatic and/or severe orthopedic problems that may interfere with resistance training.

Primary outcomes:
measure: Primary Outcome
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Landon Center On Aging
state: Kansas
Study officials:
References:
Clinical trial NCT01240044: Respiratory Therapy and Newborn Pain: Comparison Between Techniques
Official title: Study of Respiratory Therapy and Newborn Pain That Made a Comparison Between Physiotherapeutical Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Pain
Respiratory Therapy Techniques
Keywords: Newborn Pain
Respiratory Physiotherapy
Neonatal intensive care unit
Lead sponsor: University of the State of Santa Catarina
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intend to assess the pain intensity of newborns in neonatal intensive care unit (NICU) undergoing different techniques of respiratory therapy and compare these procedures. A randomized controlled clinical trial and blind trial with newborns admitted to NICU. The babies were categorized according to gestational age , age, weight, diagnosis, support and signs of respiratory distress. Then, they were allocated by lot to come from one of 3 groups: G1 - control, G2 - undergoing physical therapy; G3 - received the thoracoabdominal rebalancing. Each newborn received just one physical therapy session in that they were assessed before one of the three procedures (T1), immediately after (T2) and after 15 minutes (T3). This evaluation found cardiorespiratory parameters (oxygen saturation, heart and respiratory rate) and three specific scales for pain assessment (NIPS, NFCS and PIPP). The hypothesis is that newborns hospitalized in intensive care unit did not show pain when undergoing respiratory therapy.


Eligibility criteria: Inclusion Criteria:

* Newborns up to 28 days with any weight and gestational age in ventilatory support or oxygen therapy and clinical indication for Physical Therapy.

Exclusion Criteria:

* Newborns with contraindication of respiratory therapy, those that had problems during any of the study procedures and changes in those suffering from respiratory support or oxygen therapy during data collection.
* If there was failure to collect any of the parameters for evaluating the newborn also was no longer part of the sample.

Primary outcomes:
measure: Changes in cardiorespiratory parameters
timeFrame: Immediately after intervention and 15 minutes after the end of the intervention
measure: Pain Scales (NIPS, PIPP, NFCS)
timeFrame: Immediately after intervention and 15 minutes after the end of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Maternidade Carmela Dutra Hospital
state: Santa Catarina
Study officials:
References:
Clinical trial NCT00545844: Singulair(R) In Asthma And Allergic Rhinitis (0476-383)
Official title: An 8 Week Study to Evaluate the Effectiveness of Adding Montelukast to Inhaled Corticosteroid (ICS) to the ICS/Long-Acting Beta 2-Agonist Therapy in Adult Subjects With Asthma and Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 313
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Patient is a user of Inhaled Corticosteroid (ICS) or ICS/Long-Acting Beta 2-Agonist (ICS/LABA) at any dosage
* Peak expiratory flow is \> or = 80% of predicted value on the day of visit 1
* Uncontrolled as per Canadian asthma consensus guidelines

Exclusion Criteria:

* Unwilling to stop regular use of histamine H1 antagonists for allergic rhinitis symptoms
* Unwilling to stop use of antihistamine eye drops or cromoglycate eye drops or ophthalmic corticosteroid

Primary outcomes:
measure: Asthma Control
timeFrame: 8 weeks (from Week 0 to Week 8)
Secondary outcomes:
measure: The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score
timeFrame: 8 weeks (from Week 0 to Week 8)
measure: Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)
timeFrame: 8 weeks (from Week 0 to Week 8)
Other outcomes:
measure: Patient Global Satisfaction
timeFrame: 8 weeks (from Week 0 to Week 8)
measure: Physician Global Satisfaction
timeFrame: 8 weeks (from Week 0 to Week 8)
measure: Patient Global Allergic Rhinitis Symptoms Assessment
timeFrame: 8 weeks (from Week 0 to Week 8)
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Keith PK, Koch C, Djandji M, Bouchard J, Psaradellis E, Sampalis JS, Schellenberg RR, McIvor RA. Montelukast as add-on therapy with inhaled corticosteroids alone or inhaled corticosteroids and long-acting beta-2-agonists in the management of patients diagnosed with asthma and concurrent allergic rhinitis (the RADAR trial). Can Respir J. 2009 May-Jun;16 Suppl A(Suppl A):17A-31A. doi: 10.1155/2009/145071.
Clinical trial NCT01058044: Adherence to Oral Anticancer Treatment Using Electronic Monitoring System
Official title: A Pilot Study of Adherence to Oral Anticancer Treatment Using Electronic Monitoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer, Sunitinib, capecitabine, anastrozole, letrozole
adherence, anticancer treatment
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to describe adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor. Moreover, this study is aimed at evaluating the feasibility to use a " Medication Event Monitoring System " (MEMS®) in order to assess adherence of an oral anticancer treatment delivered by dispensary pharmacy.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* histologically proven malignant tumor
* documented decision of treatment with i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor
* ambulatory treated subject
* Subject who accept to use MEMS monitors to automatically compile their drug dosing histories
* Written informed consent

Exclusion Criteria:

* any severe concomitant wich makes it undesirable for the patient to participate in the study or which would jeopardize adherence with trial protocol
* patient who does not agreed to participate the program

Primary outcomes:
measure: evaluation of adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor.
timeFrame: everey visit during 6 months
Secondary outcomes:
measure: evaluation of liberal nurse satisfaction
timeFrame: inclusion
measure: resort to healthcare system (oncologist, doctor, nurse, hospital pharmacy, dispensary pharmacy)
timeFrame: during 6 months
measure: Patient satisfaction
timeFrame: 6 months
measure: drug interaction
timeFrame: during 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
Study officials:
References:
Clinical trial NCT05312944: Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome
Official title: Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome : A French Multicentric Retrospective Study (PASS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polymyalgia Rheumatica
Sjogren's Syndrome
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 15
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 fulfilling the ACR/EULAR 2012 criteria for PMR and the ACR/EULAR 2016 criteria for pSS

Brief summary: To determine the phenotype of patients having PMR symptoms and primary Sjogren syndrome (pSS), we used a French national call to identify patients combining both diseases and collected retrospective clinical and biological data.

Detailed description: A national call to identify patients combining pSS and PMR was disseminated in France. Patients with Sjögren's syndrome associated with rheumatoid arthritis were excluded. We described the global population having both diseases and compared them to two historic prospective cohorts of isolated pSS (the prospective cohort of primary Sjögren DiapSS), or isolated PMR (TENOR, a cohort of recent PMR), regarding clinical, imaging and treatments characteristics.

Eligibility criteria: Inclusion Criteria:

* fulfilling the ACR/EULAR 2012 criteria for PMR and the ACR/EULAR 2016 criteria for pSS

Exclusion Criteria:

-

Primary outcomes:
measure: clinical data
timeFrame: at diagnosis
measure: biological data
timeFrame: at diagnosis
measure: biological data
timeFrame: at diagnosis
measure: histological data
timeFrame: at diagnosis
measure: imaging data
timeFrame: at diagnosis
measure: treatments data
timeFrame: at inclusion ( day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
References:
Clinical trial NCT01290744: Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy
Official title: Effect of Additional Clofazimine on ENL Reactions in Leprosy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Borderline Lepromatous Leprosy
Lepromatous Leprosy
Keywords: leprosy
ENL
clofazimine
Lead sponsor: Leonard Wood Memorial
Sponsor class: OTHER
First posted: 2011-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a double-blind, randomized controlled trial examining the effect on ENL reactions of giving an additional year of clofazimine after completion of MDT in leprosy.

Detailed description: Clofazimine is an anti-bacterial agent used to treat leprosy; it is a normal component of WHO-recommended multi-drug therapy (MDT). It is also known to have a beneficial effect in one of the common immunological reactions that occur in leprosy, known as erythema nodosum leprosum, or ENL. When MDT was reduced in length from 24 to 12 months, evidence suggests that ENL became worse. This study is a double-blind, randomized controlled trial examining the effect of giving an additional year of clofazimine after completion of MDT. The endpoints are the incidence and severity of ENL over a period of 3 years in the 2 groups.

Eligibility criteria: Inclusion Criteria:

* 15 to 70 years of age
* MB leprosy
* Pretreatment BI of 4 or more at any site
* Consent

Exclusion Criteria:

* Presence of another serious illness
* Refusal of informed consent

Primary outcomes:
measure: Incidence of ENL reactions
timeFrame: 2 years of follow-up
Secondary outcomes:
measure: Severity of ENL reactions
timeFrame: 2 years of follow-up
Other outcomes:
Locations:
city: Cebu
country: Philippines
facility: Cebu Skin Clinic
state: Vesayas
Study officials:
affiliation: LWM
name: Marivic Balagon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06748144: IO Vancomycin Spine
Official title: Intraosseous Vs. Intravenous Vancomycin Administration in Spine Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Lumbar Fusion Surgery
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this research is to learn if injecting the antibiotic vancomycin directly into the bone marrow (intraosseous) or IO) during a lumbar (spinal) fusion surgery, is as effective or better than the standard method of giving it vancomycin through a vein (intravenous) or IV) during lumbar fusion surgery.


Eligibility criteria: Inclusion Criteria:

* Patient is undergoing open posterior instrumented spinal fusion (PSIF) or transforaminal lumbar interbody fusion (TLIF)
* Patient is able to give informed consent to participate on the study. LAR consents will not be utilized for this study
* Age Range \>18

Exclusion Criteria:

* Previous spine surgery if surgeon deems it will affect the study
* BMI \> 40
* Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
* Inability to administer the IO infusion
* Refusal to participate
* Diabetes as defined as uncontrolled A1C \> 7.5 and eGFR \<59
* Immunocompromised or immunosuppressed patients (HIV, Hep C, ESRD, dialysis, transplant, chemo/radiation treatment in last 6 months, medications)
* No vulnerable populations

Primary outcomes:
measure: Change in Level of Systemic Vancomycin Concentration
timeFrame: Start of skin incision during surgery, Start of closure of skin incision during surgery
measure: Level of Vancomycin Concentration in Bone
timeFrame: During surgery
measure: Level of Vancomycin Concentration in Soft Tissue
timeFrame: During surgery
Secondary outcomes:
measure: Post-Operative Complication Rates
timeFrame: 30 Days Post Surgery, 90 Days Post Surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
References:
Clinical trial NCT01151592: Safety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)
Official title: Assessment of Safety of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Iron Deficiency Anemia
Keywords: Iron deficiency anemia in Chronic Kidney Disease Patients
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-28
Enrollment: 0
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 objective of this study is to assess the safety and tolerability of Venofer in patients with chronic kidney disease who cannot tolerate Ferumoxytol (Feraheme) or intravenous iron containing a dextran (INFed or Dexferrum).

Detailed description: This is a Phase IV, multi-center, open label study that assesses the safety and tolerability of Iron Sucrose (Venofer) in subjects with CKD who require intravenous iron for the treatment of iron deficiency anemia (IDA) but cannot tolerate Ferumoxytol or Iron Dextran.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects \> or = to 18 years of age
* Determined by treating physician to have chronic kidney disease and require a course of intravenous iron
* Subject did not tolerate an intravenous iron containing a dextran or Ferumoxytol within the last year
* Subjects with hemodialysis-dependent or peritoneal dialysis chronic kidney disease should be receiving an erythropoiesis stimulating agent (ESA) as per the iron sucrose package insert

Exclusion Criteria:

* Known history of hypersensitivity or significant intolerance to iron sucrose
* Evidence of iron overload
* Hemochromatosis or other iron storage disorders
* Received an investigational drug within 30 days of screening
* Any other laboratory abnormality, medical condition or psychiatric disorder which would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
* Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception

Primary outcomes:
measure: Incidence and severity of adverse events, overall and related from Day of first iron sucrose administration through the end of the study.
timeFrame: Day 0 through 30 days after the final administration of iron sucrose
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals, Inc.
state: Pennsylvania
Study officials:
References: