louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03348826: Study of Sodium Bicarbonate in Restoring Blocked Catheters
Official title: Sodium Bicarbonate Injections for Restoration of Flow in a Central Venous Catheter (CVC/Hickman Catheter) or Peripherally Inserted Central Venous Catheter (PICC)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cancer
Central Venous Catheterization
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 0
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: This is a study looking at the use of sodium bicarbonate to restore the flow of blocked central line devices in patients with blood cancers.

Central line devices uses thin tubes that are placed into a vein in the body to give medicines, fluids, nutrients, blood products, etc.

Sometimes, the lines become blocked. The standard procedure to get the line working again is to use alteplase, a protein that dissolves blood clots. While blood clotting is one cause of a blocked line, other reasons included the formation of calcium deposits. Sodium bicarbonate is routinely used in the treatment of patients receiving chemotherapy. Sodium bicarbonate is a liquid drug which is capable of dissolving protein and calcium deposits.

This study will compare whether sodium bicarbonate works just as well as alteplase to recover the function of a blocked line.


Eligibility criteria: Inclusion Criteria:

* Hematology patients with indwelling CVC/PICC line.
* Patients continuing to receive chemotherapy treatment for consolidation, intensification and maintenance regimens in hematological malignancies such as in acute leukemia, lymphoma, myelodysplastic syndrome, supportive care measures using blood products, ongoing anti-infective treatments, and nutrition.
* Patients whose CVC/PICC line becomes obstructed during routine care are being identified and presented to attending physician and pharmacist.
* Mechanical obstruction having been ruled out by visual inspection and manipulation of the patient's posture or extremities or both.

Exclusion Criteria:

* Patients with hemodialysis line occlusions
* Anyone with documentation of prior history of alteplase allergy or hypersensitivity reactions

Primary outcomes:
measure: Successful clearance rate of sodium bicarbonate
timeFrame: 3 hours
measure: Successful clearance rate of alteplase
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Mark Minden, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03240926: Loop Band Validation Study
Official title: Loop Band Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
COPD Exacerbation
COPD Asthma
COPD Bronchitis
COPD, Severe Early-Onset
Lead sponsor: Spry Health
Sponsor class: INDUSTRY
First posted: 2017-08-07
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The main purpose of this study is to assess the accuracy of a non-invasive wearable technology in the form of a wristband.

Detailed description: The main purpose of this study is to assess the accuracy of a non-invasive wearable technology in the form of a wristband. This wristband (Loop Band) uses optical sensors and spectrometry to measure and estimate vitals as well as a full blood gas panel; comparable to the standard method of an invasive arterial line and pressure transducer. The investigators aim to show equivalence of clinical physiologic outcome measurements with the Loop Band relative to current methods (i.e. arterial lines, etc.). In addition, this study aims to validate this wearable technology as a potential alternative to invasive measurements, to reduce complications, and improve accuracy in regards to patient monitoring.

Eligibility criteria: Inclusion Criteria:

* Patient has capacity to consent for the study.
* Anesthetic plan for an arterial line for vital sign monitoring during their surgical procedure.

Exclusion Criteria:

* Active Atrial Fibrillation
* Active C-difficile
* Amputation of the arm at the wrist or above
* The Investigator and/or Clinical Research Nurse will conduct a visual inspection for attributes that may diminish device accuracy. These include but are not limited to: tattoos over the radial artery, burns or heavy scarring over the radial artery, fragile skin, any skin diseases affecting the wrist or arm, Physician discretion-any condition deemed inappropriate that will preclude use of the device.

Primary outcomes:
measure: Device Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate) measured by Arterial Line.
timeFrame: intraoperative
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: intraoperative
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
Study officials:
affiliation: Spry Health
name: Harry Bowles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01536626: Switch From Premixed Human Insulin to Biphasic Insulin Aspart in the Netherlands
Official title: SWITCH Mixtard® 30 NovoLet® to NovoMix® 30 FlexPen®. An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 211
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes treated with BHI 30 who have been by the physician for some reason switched to BIAsp 30

Brief summary: This study is conducted in Europe. The aim of this observational study is to observe and investigate the process of switching from premixed human insulin 30/70 (BHI 30) to biphasic insulin aspart 30/70 (BIAsp 30) in an outpatient setting.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic subjects treated with BHI 30

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin)
Secondary outcomes:
measure: Number of hypoglycaemic events
measure: Treatment satisfaction: ITSQ (Insulin Treatment Satisfaction Questionnaire)
measure: Quality of Life (QoL) using the World Health Organization Wellbeing Index (WHO-5)
Other outcomes:
Locations:
city: Alphen a/d Rijn
country: Netherlands
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06789926: The Impact of Multimedia Psychological Support Platform and Acceptance and Commitment Therapy Workshops of Oncology Nurses
Official title: The Impact of Multimedia Psychological Support Platform and Acceptance and Commitment Therapy Workshops on the Mental and Physical State of Oncology Nurses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oncology Nurse
Psychological Support
Acceptance and Commitment Therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Based on the high levels of emotional distress, burnout, and turnover intentions among clinical oncology nursing staff, this study will provide a multimedia "Mind-Body Support" Line platform and ACT workshop courses as intervention measures for oncology nursing staff. The study aims to explore the effectiveness of these interventions in alleviating their psychological and physical distress, utilizing both qualitative and quantitative research methods to achieve the research objectives.


Eligibility criteria: Inclusion Criteria:

* Currently working as an oncology nurse in a clinical setting

Exclusion Criteria:

* "Unwilling or unable to participate in the full training course"

Primary outcomes:
measure: Psychological flexibility
timeFrame: Measurements will be taken before the workshop intervention, immediately after the workshop intervention, and one month later.
Secondary outcomes:
measure: Physical and Physical State
timeFrame: Measurements will be taken before the workshop intervention, immediately after the workshop intervention, and one month later.
measure: Physical and Physical State
timeFrame: Measurements will be taken before the workshop intervention, immediately after the workshop intervention, and one month later.
measure: Physical and Physical State
timeFrame: Measurements will be taken before the workshop intervention, immediately after the workshop intervention, and one month later.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT04413357: Glycemic Response in Persons with Type 2 Diabetes
Official title: Plasma Glucose and Insulin Response in Persons with Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2020-06-02
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be a randomized crossover design. The subjects will be randomized to one of three interventions on three separate study days, one week apart.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a randomized crossover design with nutrition supplement interventions.

Detailed description: This will be a randomized crossover design with three oral nutrition supplement interventions. The subjects will be randomized to one of three interventions on three separate study days, one week apart.

Eligibility criteria: Inclusion Criteria:

* Age 20-75 years
* Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg
* Hematocrit levels within normal limits
* Having obtained his/her informed consent

Exclusion Criteria:

* Abnormal thyroid function
* Creatinine \>2.0 mg/dl
* Potassium \<3.5 mEq/l
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Unable to give informed consent or follow instructions
* Current insulin therapy or insulin therapy within the past month
* Patient who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the investigators assessment cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial
* Patients with anemia

Primary outcomes:
measure: Area under the blood glucose curve
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary outcomes:
measure: Area under the insulin curves
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
measure: Insulinogenic index
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
Study officials:
affiliation: Nestle Health Science
name: Krysmaru Araujo Torres, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00512057: APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X
Official title: APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Syndrome X
Keywords: cardiac syndrome X
endothelial function
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2007-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Morbidity of patients with cardiac syndrome X (typical anginal-like chest pain and normal coronary arteriograms) is high with continuing episodes of chest pain and frequent hospital readmissions. Management of this syndrome represents a major challenge to the treating physician. Evidence for the important role of endothelial dysfunction and oxidative stress in the pathogenesis of cardiac syndrome X has been recently strengthened by the finding that basal superoxide production predicts future cardiovascular events in this patient group. The investigators have recently shown that high-dose allopurinol abolishes vascular oxidative stress and improves endothelial function in patients with chronic heart failure, which makes allopurinol a prime candidate to reduce oxidative stress in syndrome X. The hypothesis to be tested in this study is whether allopurinol offers dual benefits of improving vascular function and reducing myocardial ischaemia in patients with cardiac syndrome X. This study may discover a novel way to improve endothelial function and anginal symptoms which are often debilitating in these patients.


Eligibility criteria: Inclusion Criteria:

* Typical history of angina
* Positive exercise treadmill test and normal coronary angiogram

Exclusion Criteria:

* Significant valvular heart disease or left ventricular hypertrophy
* Age \<18 years

Primary outcomes:
measure: The primary objective of this study is to investigate the effects of allopurinol on coronary and peripheral microvascular and endothelial function in patients with cardiac syndrome X
timeFrame: 3-5 years
Secondary outcomes:
measure: The secondary objectives of this study are to assess the effects of allopurinol on chest pain incidence, maximal ST-segment depression and Duke's score
timeFrame: 3- 5years
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: University of Dundee
Study officials:
affiliation: University of Dundee
name: Chim Lang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00332657: Anecortave Acetate Risk Reduction Trial (AART)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: AMD
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular degeneration (AMD) in patients who are at-risk for progressing to wet AMD.


Eligibility criteria: Inclusion Criteria:

* Dry AMD in study eye, Wet AMD non-study eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 50.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Proportion of patients with sight-threatening choroidal neovascularization (CNV) in study eye
timeFrame: Month 48
Secondary outcomes:
measure: Time to development of sight-threatening CNV
timeFrame: Timepoint
Other outcomes:
Locations:
city: Bangalore
country: India
facility: India
Study officials:
affiliation: Study Director
name: Terry Wiernas, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00561457: A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
Official title: A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iliac Artery Occlusive Disease
Keywords: Iliac
Artery
Occlusive
Stenosis
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2007-11-21
Enrollment: 134
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: To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease

Detailed description: The study is designed to collect safety and efficacy data on the Bard Luminexx Iliac Stent in a broad patient population having indications for iliac stenting. Effectiveness in this study will be demonstrated by the prevention of Major Adverse Clinical Events (MACE). The composite primary endpoint of this clinical trial is freedom from peri-procedural death and freedom from stented segment revascularization or restenosis (\>50%) at nine months.

Eligibility criteria: Inclusion Criteria:

* Patient or legal guardian understands procedure and provides written informed consent prior to study participation.
* Patient must be able and willing to comply with all study procedures including scheduled follow-up visits and diagnostic tests.
* Lesion(s) distinctly localized in the common and/or external iliac arteries.
* Reference lumen diameter (RLD) 6 mm and 9 mm.
* Stenosis 30% and symptomatic ischemic disease (Category 1-6 Chronic Limb Ischemia or Threatened or Irreversible Acute Limb Ischemia).

Exclusion Criteria:

* Patients diagnosed with preoperative coagulation disorder or with contraindications to antiplatelet or anticoagulant therapy.
* Patients who are pregnant or planning to become pregnant during the clinical investigation.
* Patients with a life expectancy \< 3 years.
* Patients currently or scheduled to be enrolled in another investigation that conflicts with follow-up testing or may confound the study data.
* Patients with absolute contraindication to x-ray contrast media or medications normally administered during an interventional procedure.
* Patients with severe tortuosity or angulation of a vessel that may prevent access in the opinion of the investigator.
* The presence of soft, thrombotic or embolic material within or adjacent to the lesion(s) being treated with the study device, in the opinion of the investigator.

Primary outcomes:
measure: Rate of Major Adverse Clinical Events (MACE)
timeFrame: 9-months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05406557: Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis
Official title: Outcome Comparing Partial and Miniature Pulpotomy in Mature Permanent Molars With Symptomatic Partial Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: Irreversible pulpitis
Partial pulpotomy
Miniature pulpotomy
Vital pulp therapy
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the outcome of partial and miniature pulpotomy in mature permanent molars with symptomatic partial irreversible pulpitis

Detailed description: After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, written informed consent will be obtained from study participants after explaining the procedure and its associated risks and benefits. Clinical diagnosis of symptomatic partial irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing.

Once included, study subjects will be randomly allocated to either Miniature Pulpotomy group or Partial Pulpotomy group. MTA (Mineral Trioxide Aggregate) will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in same appointment.

Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 6 and 12 months from baseline.

Eligibility criteria: Inclusion Criteria:

* The patient with18 -45 years of age.
* Restorable molar teeth.
* Tooth should give positive response to pulp sensibility testing.
* Clinical diagnosis of symptomatic partial irreversible pulpitis.
* Tooth with probing pocket depth and mobility are within normal limits.
* No signs of pulpal necrosis including sinus tract or swelling.
* Non-contributory medical history

Exclusion Criteria:

* Teeth with immature roots.
* No pulp exposure after caries excavation.
* Bleeding could not be controlled in 6 minutes.
* Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic

Primary outcomes:
measure: Clinical and radiographic success
timeFrame: Baseline to 12 Months
Secondary outcomes:
measure: Pain analysis
timeFrame: Baseline to 7 days
measure: Pulp sensibility testing
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Dr. Ankita Ramani
state: Haryana
Study officials:
affiliation: PGIDS, ROHTAK, HARYANA, INDIA-124001
name: DR. ANKITA RAMANI, MDS
role: PRINCIPAL_INVESTIGATOR
References: