louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04289727: Skeletal Fragility in Type 1 Diabetes: Glycemic Control and Bone Strength
Official title: Skeletal Fragility in Type 1 Diabetes: Glycemic Control and Bone Strength
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type1diabetes
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 children and adolescents between the age of 8 to 14 years with type 1 diabetes and 40 children and adolescents between the age of 8 to 14 years without type 1 diabetes.

Brief summary: The purpose of this research study is to find out how bones are affected in children and adolescents with type 1 diabetes (T1D) as compared to children and adolescents without type 1 diabetes.

Detailed description: T1D is primarily associated with decrements in bone strength due to disrupted microarchitecture occurring during peak bone mass accrual, and this disruption arises from hyperglycemia and glycemic variability. Impaired bone development during this period likely predisposes to an increased fracture risk across the lifespan.

The investigators will compare baseline, 12 month and 24 month changes in High-resolution peripheral quantitative computed tomography/micro-finite element analysis (HR-pQCT/μFEA)-based estimates of bone strength and bone turnover by biochemical measurements in 40 T1D children at the onset of peak bone mineral accretion (n=40) versus sex and puberty-matched healthy controls (n=40). The investigators will determine relationships between changes in bone strength (including trabecular and cortical components) and measures of glycemic control and variability by continuous glucose monitoring (CGM).

Eligibility criteria: Inclusion Criteria (T1D and Controls):

- Children within 2 years preceding the onset of the pubertal growth spurt

Inclusion Criteria (T1D participants):

- documentation of β-cell autoimmunity and need for insulin replacement

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR)\< 60 ml/mim
* 25(OH)D level \< 20 ng/ml.
* Celiac disease
* Autoimmune thyroid disease
* Addison's disease
* History of pathological fractures

  -- Disorders associated with altered skeletal structure or function
* Bone active drugs in past year
* Diabetes of other or unclear etiology

Primary outcomes:
measure: Change in microarchitecture by HR-pQCT
timeFrame: Two Years
measure: Change in bone mineral density by Dual X-ray Absorptometry (DXA)
timeFrame: Two Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center-Harkness Pavillion
state: New York
Study officials:
affiliation: Columbia University
name: Mishaela Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01277627: Influence of Nevirapine on HCV Viral Load
Official title: Influence of Nevirapine on HCV Viral Load Among HIV/HCV-coinfected Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HCV Infection.
HCV Viral Load.
Keywords: HCV
HIV
Nevirapine
HCV viral load
Efavirenz
Protease inhibitors
Lead sponsor: Valme University Hospital
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2011-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Nevirapine-based antiretroviral therapy is associated with lower plasma HCV viral load in HIV/HCV-coinfected individuals.


Eligibility criteria: Inclusion Criteria:

* HIV infection.
* Older than 18 years.
* Chronic hepatitis C.
* Undetectable HIV viral load during one year before starting study.
* To have not received HCV therapy during one year before starting study.
* To have not started efavirenz or protease inhibitors o nucleoside analogs during 6 months before starting study.
* Non contraindications for drugs included in this study.
* To change an antiretroviral regimen including efavirenz or protease inhibitors by nevirapine due to side effects, interactions or pregnancy (NVP group)
* To continue with a antiretroviral regimen including efavirenz or protease inhibitors (non-NVP group)

Both groups will be matched according to these variables:

* Liver stiffness.
* HCV genotype.
* Hospital.
* Time from starting antiretroviral therapy.
* Previous third drug (EFV or PI) to introduction of NVP.

Exclusion Criteria:

* HCV therapy during follow-up

Primary outcomes:
measure: Changes in HCV viral load
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Valme University Hospital
Study officials:
References:
Clinical trial NCT01463527: Using Capnography to Reduce Hypoxia During Pediatric Sedation
Official title: Using Capnography to Reduce the Incidence of Hypoxia in Children During Moderate Sedation in the Pediatric Emergency Department: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoventilation
Hypoxia
Keywords: Hypoventilation during sedation
Hypoxia associated with hypoventilation
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2011-11-02
Enrollment: 167
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that the addition of capnography during moderate sedation will improve recognition of hypoventilation and apnea. This will lead to an increased frequency of staff interventions such as verbal or physical stimulation for these events in order to improve ventilation which will in turn lead to a reduction in the frequency of oxygen desaturations. If capnography proves to be effective in creating earlier detection and intervention for hypoventilation and apnea during moderate sedation provided by non-anesthesiologists, this device can be used in a variety of clinical settings to enhance patient safety.


Eligibility criteria: Inclusion Criteria:

* Children 1-20 years old who require IV sedation in the Pediatric Emergency Department at Yale-New Haven Children's Hospital

Exclusion Criteria:

* Unable to tolerate nasal-oral cannula
* Conditions that effect end-tidal carbon dioxide measurement (active asthma, diabetic ketoacidosis, severe dehydration or trauma)
* Intubation

Primary outcomes:
measure: Frequency of Staff Interventions for Hypoventilation.
timeFrame: Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)
Secondary outcomes:
measure: Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%.
timeFrame: Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Children's Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Melissa Langhan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langhan ML, Shabanova V, Li FY, Bernstein SL, Shapiro ED. A randomized controlled trial of capnography during sedation in a pediatric emergency setting. Am J Emerg Med. 2015 Jan;33(1):25-30. doi: 10.1016/j.ajem.2014.09.050. Epub 2014 Oct 5.
Clinical trial NCT06495827: Predicting Response to Chemotherapy in Colorectal Cancer Via Multi-dimensional Analyses of the Tumor Associated Neutrophils
Official title: Zhongshan Hospital，Fudan University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tumor Associated Neutrophils
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 653
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study enrolled multiple cohorts, consisting of 653 tumor microarray specimens of CRC patients from Zhongshan Hospital

Brief summary: A single biomarker is not adequate to identify patients with colorectal cancer (CRC) who have the potential to benefit from adjuvant therapy, presumably owing to the complexity of tumor-infiltrating immune cells (TIICs). The density and spatial organization of TIICs has not been definitely established to explore their predictive value. This study aimed to investigate the prognostic significance of TIICs and its biological predictive value in CRC.


Eligibility criteria: Inclusion Criteria:

1. Voluntarily sign a written ICF.
2. The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
3. The expected survival period is ≥ 3 months.

5. Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology.

6. Colorectal cancer patients who have not received systematic anti-tumor therapy in the past.

Exclusion Criteria:

1. Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).
2. Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.
3. Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration

Primary outcomes:
measure: PFS
timeFrame: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04610827: Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder
Official title: Optimum Frequency and Timing of Oral Iron Administration for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sleep Disorder
Restless Legs Syndrome
Periodic Limb Movement Sleep Disorder
Iron-deficiency
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 6
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder.


Eligibility criteria: Inclusion Criteria:

* Ferritin equal to or lower than 24 mcg/L drawn within the last 30 days.
* Age 2 to 10 years.
* Diagnosis of restless leg syndrome, periodic limb movement disorder, or sleep disturbance.

Exclusion Criteria:

* Currently taking oral formulation of iron other than a multivitamin.
* Untreated obstructive sleep apnea.
* Gastrointestinal disorder, including gastroesophageal reflux disease and celiac disease.
* Prior gastrointestinal surgery; e.g., gastrectomy, duodenal bypass, and presence of G-tube.
* Use of H2 blocker, antacid, or proton pump inhibitor.
* Inflammatory disorders, including juvenile idiopathic arthritis or inflammatory bowel disease.
* Elevated CRP at time of initial ferritin or report of illness in past 4 weeks.

Primary outcomes:
measure: Ferritin Level
timeFrame: 2 months
measure: Side Effects
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Julie Baughn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00977327: Comparison of Neuro-navigational Systems for Resection-Control of Brain Tumors
Official title: Comparison of Two Neuro-navigational Systems for Resection-control of Intra-axial Brain Tumors. The PoleStarN-20 Intra-operative Magnet Resonance Imager and the Mison SonoWand Intra-operative Ultrasound System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glioma
Keywords: Glioma
Intraoperative MR
Intraoperative Ultrasound
resection
Intraoperative navigation
Extent of resection
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-09-15
Enrollment: 120
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: Purpose:

* Improvement of extent of resection by the use of intraoperatively acquired image data sets to navigate.
* Better define the role of different intra-operative imaging modalities, used to update the navigational data set, in aiding the surgeon during resection of intra-axial brain lesions.
* To examine the cost-effectiveness of different intraoperative navigational systems as a function of operative time and Operative time (Surgery including imaging)

There is increasing neuro-oncological evidence that extent of resection might have an impact in particular in low-grade lesions.


Eligibility criteria: Inclusion Criteria:

* Patients must have neuro-radiological evidence of a brain lesion. Eligible are all histological types of brain lesions.
* \> 18 years of age.
* Male and female.
* Patient must be a surgical candidate, according to general anesthetic and neurosurgical criteria.
* Patient should be able to undergo MRI.
* Informed consent as per protocol.

Exclusion Criteria:

* Patient unwilling to undergo surgery for resection of brain tumor.
* Patient medically not eligible to undergo craniotomy. (Medical contraindication).
* Patient has a medical contraindication or is unwilling to undergo MRI scanning (pacemaker, other metal device ot parts in head or body,).
* Kidney function compromise (Creatinine values \> 1.4 mg/dL).

Primary outcomes:
measure: The primary end point of the study is assessment and comparison of intra-operative Magnet Resonance Imaging and ultrasound to better define its impact on the extent of resection.
timeFrame: 72 hours
Secondary outcomes:
measure: Secondary end points should identify criteria for selecting the right system for a specific patient (Patient selection), and cost-effectiveness.
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sorasky MC
Study officials:
affiliation: Tel-Aviv Sorasky Medical Center
name: Andrew Kanner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06151327: Alternating Pressure Air Mattress and Pressure Injury Prevalence
Official title: Explore the Relationship Between Implementation of Alternating Pressure Air Mattress and Pressure Injury Prevalence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Injury
Alternating Pressure Air Mattress
Implementation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 50419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in hospital with pressure injury

Brief summary: explore the correlation of accurate implementation of APAM and pressure injury prevalence


Eligibility criteria: Inclusion Criteria:

patients with pressure injury

Exclusion Criteria:

-

Primary outcomes:
measure: proportion of full thickness pressure injury
timeFrame: 2020/1 ~2023/8
Secondary outcomes:
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: National Taiwan Universiyt Hospital Yunlin Branch
state: Yunlin
Study officials:
affiliation: National Taiwan University Hospital Yunlin brach
name: Hui-Hsiu Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01081327: Warfarin - How Good Are we at Maintaining Target Range ?
Official title: Observational Record Linkage Study Investigating Incidence of Adverse Events in Patients Anti-coagulated for Lone Atrial Fibrillation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Warfarin
Safety
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: NHS Tayside
First posted: 2010-03-05
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving Warfarin for lone atrial fibrillation

Brief summary: Patients with atrial fibrillation are often anticoagulated with Warfarin. Warfarin has a narrow therapeutic window requiring frequent monitoring. This study aims to investigate the incidence of adverse events in the "real world" for patients receiving Warfarin for lone atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Prescription for Warfarin
* Atrial Fibrillation

Exclusion Criteria:

* Other conditions associated with increased risk of embolisation e.g. rheumatic valve disease, atrial mixoma.
* Conditions with increased risk of bleeding.

Primary outcomes:
measure: Bleeding Complication
timeFrame: 10 years
measure: Cardiovascular outcome
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Centre for Cardiovascular and Lung Biology, Univeristy of Dundee
Study officials:
References:
Clinical trial NCT01449227: Natural Course of Adhesive Capsulitis of Hip
Official title: Natural Course of Adhesive Capsulitis of Hip
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adhesive Capsulitis
Keywords: adhesive capsulitis
hip
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample painful hip with limited ranage of motion

Brief summary: The purpose of this prospective study is to see the natural course of adhesive capsulitis of hip. The study is based on the hypothesis that the natural course of adhesive capsulitis of hip is similar to that of adhesive capsulitis of shoulder. This study is also based on a hypothesis that hip joint capsule stretching exercise will result in pain relief, recovery of hip range of motion in months.


Eligibility criteria: Inclusion Criteria:

* Painful hip with Limited range of motion (especially external rotation and abduction)

Exclusion Criteria:

* Acute trauma history
* hematologic abnormality (Rheumatologic disease, Autoimmune disease)
* Radiologic abnormality (joint degenerative change, calcification, loosebody, evidence of Femoroacetabular impingement, osteonecrosis of femoral head, etc)
* MRI: Extra-articular pathology

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06922227: HIPEC Surgery and Hemodynamics
Official title: Perioperative Hemodynamic and Respiratory Changes During Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Cytoreductive Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemodynamics
Cytoreductive Surgery
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Keywords: HİPEC
cytoreductive surgery
Hemodynamics
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years and older who are scheduled for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy

Brief summary: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) involves the intraoperative administration of heated chemotherapeutic agents into the abdominal cavity following cytoreductive surgery (CRS). The increasing use of CRS combined with HIPEC has introduced certain procedural and physiological considerations that distinguish it from other surgical interventions, posing unique challenges for researchers and clinicians alike.

Despite advancements in surgical and anesthetic techniques, this combined approach is frequently associated with significant hemodynamic instability, coagulation abnormalities, respiratory complications, and nutritional imbalances.

The study aims to contribute to the existing body of knowledge by examining the physiological alterations induced by HIPEC, thereby offering practical insights and guidance for investigators involved in the management and study of this complex therapeutic modality.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old Patients planned to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy
* ASA II-III-IV physical class

Exclusion Criteria:

* \<18 years
* Emergency cases

Primary outcomes:
measure: physiological parameter ; heart rate
timeFrame: Intraoperatively
measure: physiological parameter; systolic/diastolic blood pressure
timeFrame: Intraoperatively
measure: physiological parameter; SpO2
timeFrame: Intraoperatively
measure: anesthesia device measurement parameter; EtCo2
timeFrame: Intraoperatively
measure: anesthesia device measurement parameter; Pmax
timeFrame: Intraoperatively
Secondary outcomes:
measure: Preoperative data
timeFrame: 24 hours before surgery
measure: Postoperative data
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: Ankara Etlik City Hospital
name: Miray G Özdemir
role: PRINCIPAL_INVESTIGATOR
References: