louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04343079: Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.
Official title: Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Breast Neoplasms
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-excision.


Eligibility criteria: Inclusion Criteria:

* • female and 18 years of age or older

  * diagnosed with an early-stage (T1 or T2, and N0 or N1; according to the TNM-classification) invasive breast cancer
  * eligible for breast conserving surgery

Exclusion Criteria:

* • Pregnancy or lactation

  * Diabetes
  * Multifocal tumor disease
  * Diagnosis of inflammatory breast cancer
  * Appointment at the nuclear medicine department for 18F-FDG administration would result in a unacceptable delay of surgery
  * Subject has had exposure to ionizing radiation of more than 1 mSv in other research studies within the last 12 months
  * Subject has recently (\<60 days) or is simultaneously participating in another clinical trial.

Primary outcomes:
measure: investigate the ability of (micro)PET/CT to evaluate the excision margins and determine negativity of these margins, as compared to the gold standard of sectional histopathological evaluation.
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: Oost Vlaanderen
Study officials:
References:
Clinical trial NCT06767579: Comparison of the Incidence of Delirium Caused by Different Anesthetic Agents in Patients Undergoing Liver Transplantation
Official title: Comparison of the Incidence of Delirium Caused by Different Anesthetic Agents in Patients Undergoing Liver Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Liver Cirrhosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 350
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Adults aged 19 years or older
* Recipients of liver transplants who are scheduled to undergo anesthesia using the inhalation anesthetic sevoflurane or the intravenous anesthetic propofol

Brief summary: This study is a prospective observational study that analyzes the incidence of postoperative delirium in patients undergoing liver transplantation, based on the use of the inhalational anesthetic sevoflurane and the intravenous anesthetic propofol.


Eligibility criteria: Inclusion Criteria:

* Adults aged 19 years and older
* Patients undergoing liver transplantation who are scheduled to receive anesthesia with the inhaled anesthetic sevoflurane or the intravenous anesthetic propofol.

Exclusion Criteria:

* Individuals with hearing loss, cognitive impairment or obvious dementia, hepatic encephalopathy, or difficulty in communication.
* Diagnosed with neurological disorders (e.g., brain hemorrhage, stroke, dementia, Parkinson's disease, cognitive impairment, etc.).

Primary outcomes:
measure: incidence of postoperative delirium
timeFrame: from postoperative day 0 to postoperative day 7
Secondary outcomes:
measure: comprehensive geriatric assessment(CGA)
timeFrame: Participants will be followed for the duration of their hospital stay and until their visit within one month after discharge, with an expected average of 4 weeks
measure: duration of delirium
timeFrame: Participants will be followed for the duration of their hospital stay and until their visit within one month after discharge, with an expected average of 4 weeks
measure: total score of QOR-40
timeFrame: Participants will be followed for the duration of their hospital stay and until their visit within one month after discharge, with an expected average of 4 weeks
measure: type of delirium
timeFrame: Participants will be followed for the duration of their hospital stay and until their visit within one month after discharge, with an expected average of 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04905979: Trial of AD113 and Atomoxetine in OSA Patients With Hypertension
Official title: Randomized Double-Blind 2-Period Multiple Dose Crossover Study to Evaluate the Efficacy and Safety of AD113 vs Atomoxetine in OSA Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Hypertension
Lead sponsor: Apnimed
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 21
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, double blind, 2-period, non placebo-controlled crossover study in patients with moderate to severe OSA and controlled hypertension, comparing atomoxetine with AD113

Detailed description: The study is designed to examine the efficacy and safety of AD113 to treat obstructive sleep apnea with hypertension. The study is a two-period multi-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 2 treatments: AD113 for 10 days or Atomoxetine for 10 days. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.

Eligibility criteria: Inclusion Criteria:

* Between 25 to 65 years of age, inclusive, at the Screening Visit.
* AHI 10 to 50 (hypopneas defined by 4% oxygen desaturation)
* History of hypertension or blood pressure at Visit 1 ≥130/80 mmHg

Exclusion Criteria:

* History of narcolepsy.
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
* CPAP should not be used for at least 2 weeks prior to first study PSG
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.

Primary outcomes:
measure: Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve)
timeFrame: 10 days of treatment per crossover arm
Secondary outcomes:
measure: Change in Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
timeFrame: 10 days of treatment per crossover arm
Other outcomes:
Locations:
city: Towson
country: United States
facility: PCCAB
state: Maryland
city: Cincinnati
country: United States
facility: Intrepid Research
state: Ohio
city: Columbia
country: United States
facility: Bogan Sleep Consultants
state: South Carolina
Study officials:
References:
Clinical trial NCT06397079: Oral Care Program for Residients in Long-term Care Facility
Official title: Investigation of Effect on Oral Care Program for Residents in Long-term Care Facility
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elder
Oral Hygiene
Keywords: elder
oral hygiene
long-term care facility
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effectiveness of an oral care program on the oral hygiene for residents in long-term care facility.

Detailed description: The study adopts a randomized clinical trial design and utilizes a cross-over design. The main outcomes include assessments of oral health (Oral Health Assessment Tool, Oral Health Impact Profile, Geriatric Oral Health Assessment Index), tongue coating cleanliness (Tongue Coating Index), dental plaque and gum cleanliness (Plaque Index, Gingival Index, Gingival Bleeding Index), and swallowing ability (Eating Assessment Tool, Function Oral Intake Scale, International Dysphagia Diet Standardisation Initiative).

Eligibility criteria: Inclusion Criteria:

1. Eating by mouth
2. Able to express fluently in Chinese after correcting vision and hearing
3. Normal hand functions
4. Able to follow instructions
5. Willing to participate in the study and sign the informed consent

Exclusion Criteria:

1. Unconsicous
2. Diagnosis of dementia and inability to communicate
3. Having a tracheostomy tube and nasogastric tube
4. Unable to move both upper limbs
5. Bedridden
6. Vulnerable populations (e.g., political, economic, or socially disadvantaged groups)

Primary outcomes:
measure: Oral Health Assessment Tool
timeFrame: Baseline to 4 weeks
measure: Oral Health Impact Profile
timeFrame: Baseline to 4 weeks
measure: Geriatric Oral Health Assessment Index
timeFrame: Baseline to 4 weeks
measure: Tongue Coating Index
timeFrame: Baseline to 4 weeks
measure: Plaque Index
timeFrame: Baseline to 4 weeks
measure: Gingival Index
timeFrame: Baseline to 4 weeks
measure: Gingival Bleeding Index
timeFrame: Baseline to 4 weeks
measure: Eating Assessment Tool
timeFrame: Baseline to 4 weeks
measure: Function Oral lntake Scale
timeFrame: Baseline to 4 weeks
measure: International Dysphagia Diet Standardisation Initiative
timeFrame: Baseline to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Cardinal Tien Hospital
state: Xindian Dist
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: En-Chi Chiu, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04278079: Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy
Official title: Evaluation of Pars Plana Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopic Traction Maculopathy
Pars Plana Vitrectomy
Internal Limiting Membrane Peeling
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigate the effectiveness and safety of pars plans vitrectomy, with internal limiting membrane peeling for cases of myopic traction maculopathy

Detailed description: Performing pars plana vitrectomy for highly myopic patients with decreased visual acuity is the standard of care for patients with myopic traction. A variety of findings are seen by Optical Coherence Tomography. Epiretinal membranes, retinoschisis, lamellar macular holes, and full thickness macular holes are seen. Undergoing vitrectomy, with or without tamponade, in our center, is retrospectively evaluated. Visual acuity change, as well as improvement of the retinal structure by OCT will be examined.

Eligibility criteria: Inclusion Criteria:

* Highly myopic patients, having a refractive errors (spherical equivalent) of more than - 8 Diopter, or an axial length more than 26.5 mm.
* Best Corrected Visual Acuity less than 0.1
* Spectral Domain Optical Coherence Tomography showed; staphylomatous changes, with either: Macular retinoschisis, foveal retinal detachment, full thickness macular hole (with or without macualr hole retinal detachment), or lamellar macular hole, with epiretinal membrane

At least 6 months follow-up

Exclusion Criteria:

* Eyes with diffuse chorioretinal macular atrophy
* Concomitant presence of a choroidal neovascular membrane
* Young patients less than 21 years old.
* History of trauma
* Dense media opacity (corneal/ lenticular)

Primary outcomes:
measure: Improvement of best corrected visual acuity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01574079: Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke
Official title: Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 33
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: Mirror therapy may be an effective intervention in increasing motor control and gait performance in patients with stroke.

Detailed description: Using a mirrored image of the uninvolved extremity superimposed upon the involved extremity during exercise may facilitate improved motor control in patients after stroke.

Eligibility criteria: Inclusion Criteria:

* lower extremity Brunnstrom stage 2,
* lower extremity modified ashworth \< 3,
* has the ability to follow 3-step command in English,
* has only unilateral involvement.

Exclusion Criteria:

* lower extremity Brunnstrom stage 1,
* lower extremity modified ashworth 3 or higher,
* history of prior stroke,
* Passive Range of Motion limitation of hip and or knee flexion \< 90,
* has visual deficits which prevent participation.

Primary outcomes:
measure: Functional Independence Measure - Locomotor Score
timeFrame: measured at admission and discharge from rehab estimated length of stay 14 days
Secondary outcomes:
measure: Timed Up and Go
timeFrame: Measured at admission and discharge with estimated length of stay 14 days
measure: Stroke Rehabilitation Assessment of Movement
timeFrame: measured at admission and discharge with estimated length of stay 14 days
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center - University Rehabilitation
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Lisa J Barnes, PT DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mississippi Medical Center - University Rehabilitation
name: Keri H McCullough, DPT
role: STUDY_DIRECTOR
affiliation: University of Mississippi Medical Center - Director of Neurologic Residency Program
name: Kim C Wilcox, PT MsPT PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00225979: Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
Official title: Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acromegaly
Keywords: Acromegaly
Untreated
Newly diagnosed
Octreotide LAR
Pituitary surgery
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. The objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had any previous treatment for acromegaly.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed or previously untreated acromegalic patients
* Lack of suppression of GH nadir to \<1.0 µg/L, after oral administration of 75 g of glucose (OGTT)
* IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)

Exclusion Criteria:

* Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass
* No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI)
* Symptomatic cholelithiasis

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean GH and IGF-I at baseline, week 12, 24 and 48
Secondary outcomes:
measure: Tumor volume at baseline, week 24 and 48
measure: Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
measure: Quality of life and sleep apnea at baseline, week 12, 24 and 48
measure: Safety and tolerability at any time on treatment
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01193179: A Phase 3 Study of OPC-262 in Patients With Type 2 Diabetes
Official title: Long-term Co-administration Study of OPC-262 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes, Type 2
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 450
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent


Eligibility criteria: Inclusion Criteria:

* 1) Patients who are capable of giving informed consent
* 2) Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner

Exclusion Criteria:

* Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus

Primary outcomes:
measure: Adverse events, clinical laboratory tests
timeFrame: 52 weeks
Secondary outcomes:
measure: Secondary Outcome HbA1c
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Kanto Rigeon
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
city: Tohoku Region
country: Japan
Study officials:
References:
Clinical trial NCT05970679: Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A
Official title: A Randomized, Double Blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient With Primary Hypercholesterolemia or Mixed Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia, Dyslipidemia
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 252
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient with primary Hypercholesterolemia or Mixed Dyslipidemia


Eligibility criteria: Inclusion Criteria:

* Both gender, the person aged 19 or older
* Patients who are diagnosed with primary Hypercholesterolemia or Mixed Dyslipidemia
* LDL- C ≤ 250 mg/dL and TG \< 500 mg/dL on fasting status

Exclusion Criteria:

* Patients with Myopathy, Rhabdomyolysis, Fibromyalgia, hereditary neuromuscular disorders or family history, or Creatine kinase(CK) ≥ 2 x Upper Limit of Normal(ULN) on Visit 1
* Patients with severe renal disorders, Estimated Flomerular Filtration Rate (eGFR) \< 30 mL/min/1.73m\^2 on Visit 1
* Patients with hepatic failure or active or chronic hepatobiliary diseases or aspartate transaminase (AST) or alanine aminotransferase (ALT) ≥ 2.0 x ULN on visit 1

Primary outcomes:
measure: % Change of LDL-C
timeFrame: 8 weeks
Secondary outcomes:
measure: % Change of LDL-C
timeFrame: 4 weeks
measure: % Change of Lipid parameters
timeFrame: 4 weeks and 8 weeks
measure: LDL-C goal achievement rates
timeFrame: 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06276179: Epidural Oxycodone for Pain Management for Lower Limb Amputation
Official title: Epidural Oxycodone for Pain Management for Lower Limb Amputation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epidural
Oxycodone
Pain
Lower Limb Amputation
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of epidural oxycodone for pain management after lower limb amputation.

Detailed description: Phantom limb pain (PLP) is often described as tingling, throbbing, sharp, pins/needles in the limb that is no longer there. It occurs more commonly in upper extremity amputations than lower extremities and tends to be intermittent in frequency. Pain severity varies, and onset can be immediate or years afterward.

The preventive strategies for the PLP pain are difficult to manage and if not addressed adequately may lead to chronic pain. The perioperative role of the anesthesiologist and the acute pain physician is important in the management of somatic and sometimes neuropathic postoperative pain.

Oxycodone is a semi-synthetic narcotic analgesic and historically has been a popular drug of abuse among the narcotic abusing population. Oxycodone is used orally or intravenously.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 65 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status II or III.
* Undergoing lower limb amputation.
* Under epidural anesthesia.

Exclusion Criteria:

* Hypersensitivity to opioids.
* Cardiac arrhythmias.
* Acute asthma or other obstructive airways disease.
* Severe renal impairment.
* Pregnancy.

Primary outcomes:
measure: Acute postoperative pain scores
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Time to the first request for the rescue analgesia
timeFrame: 48 hours postoperatively
measure: Postoperative morphine consumption
timeFrame: 48 hours postoperatively
measure: Incidence of phantom limb pain
timeFrame: 3 months postoperatively
measure: Adverse effects
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
References: