louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00828724: Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State
Official title: An Open Label, Single Dose, Cross-over Study to Assess the Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the PK properties in fed and fasted men and women.


Eligibility criteria: Inclusion Criteria:

1. Males or females aged between 18 and 65 years (inclusive)
2. Able to give signed informed consent
3. BMI 27-45 kg/m2, inclusive
4. Eligible male and female subjects must agree not to participate in a conception process.
5. Considered to be in stable health in the opinion of the Investigator.

Exclusion Criteria:

1. Prior participation in any study of lorcaserin.
2. Clinically significant new illness in the 1 month before screening
3. Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
4. History of any of the following cardiovascular conditions:

   * Myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ECG), CVA, TIA or RIND within 6 months of screening;
   * Cardiac arrhythmia requiring medical or surgical treatment within 6 months of screening
   * Unstable angina
   * History of pulmonary artery hypertension
5. Positive result of HIV, hepatitis B or hepatitis C screens
6. Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
7. Initiation of a new prescription medication within 1 month prior to screening.
8. Recent history (within 2 years prior to the screening visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening.
9. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
10. Use of SSRIs,SNRIs, and other medications must meet the washout period.

Primary outcomes:
measure: To evaluate the pharmacokinetic properties of a single oral dose of lorcaserin in the fed versus fasted state
Secondary outcomes:
Other outcomes:
Locations:
city: Willingboro
country: United States
facility: CRI Worldwide
state: New Jersey
Study officials:
References:
Clinical trial NCT05083624: Feasibility and Prognosis of Early Rehabilitation in Patients With ECMO
Official title: Feasibility and Prognosis of Early Rehabilitation in Patients With Extracorporeal Membrane Oxygenation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation
Keywords: Extracorporeal Membrane Oxygenation
early rehabilation
muscle ultrasound
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: ECMO is increasingly used in critically ill patients with severe circulatory and/or respiratory failure. Because of the catheterization of the femoral artery and femoral vein, usage of sedatives, and occasionally with neuromuscular blockers, ECMO patients are generally considered unsuitable for early activity. However, some recent retrospective studies and a small number of single-center, small-scale prospective studies have shown that early activity of ECMO patients is feasible, and early active activity is associated with recovery of independent function and reduction of delirium incidence.


Eligibility criteria: Inclusion Criteria:

* ECMO time ≥1 day
* Aged older than16 years old and less than 70 years old

Exclusion Criteria:

* coma deep
* sedation muscle relaxation (RAAS-3-5)
* Active bleeding deep vein thrombosis
* High dose of vasoactive drugs
* unstable vital signs
* Acute stage of myocardial infarction (within 2d)
* Malignant arrhythmia
* pregnancy

Primary outcomes:
measure: muscle ultrasound
timeFrame: 7 days
Secondary outcomes:
measure: ECMO duration time
timeFrame: 30 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References:
Clinical trial NCT03734224: Inguinal Hernia Operation and Postoperative Pain
Official title: Inguinal Hernia Operation and Postoperative Pain - a Prospective and Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Inguinal Hernia
Quality of Life
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 270
Sex: MALE
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: Inguinal hernia is a common disease, which is treated surgically when symptomatic. Pain after open inguinal hernia surgery can affect the patient significantly and weaken their quality of life. The aim of this study is to find out if the choice of mesh affects postoperative pain and therefore causes more contacts to the health care center. Our goal is also to find out how the pain affects the patients´ quality of life.


Eligibility criteria: Inclusion Criteria:

* 18-80 years old male patients, with a symptomatic inguinal hernia that can be diagnosed by clinical examination. Primary and unilateral hernia. The operation performed at a day surgery unit.

Exclusion Criteria:

* female
* bilateral hernia
* Incarcerated hernia
* Scrotal hernia
* ASA-classification \>3
* BMI \>35 or \<18
* No hernia found in clinical examination
* Liver cirrhosis
* Other contraindication for inguinal hernia operation
* Anticoagulant therapy, that needs bridge therapy when paused

Primary outcomes:
measure: Number of contacts due to postoperative pain
timeFrame: 3 months
Secondary outcomes:
measure: The use of pain medication
timeFrame: 1 year
measure: Pain intensity
timeFrame: 1 year
measure: Number of contacts
timeFrame: 1 year
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Helsinki University hospital, Jorvi hospital
Study officials:
References:
Clinical trial NCT02091024: Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava
Official title: Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava Extract in Hypercholesterolemic Korean Subjects: a Randomized Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia.

Detailed description: The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia. The investigators measured improvement of lipid profile, including total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol.

Eligibility criteria: Inclusion Criteria:

* Mild hypercholesterolemic subjects(≥200mg/dL of total cholesterol or ≥110mg/dL of LDL-cholesterol)

Exclusion Criteria:

* Self-reported pregnancy, lactation
* Prevalent heart disease, cancer, renal disorder, or diabetes mellitus, and use of lipid-lowering drugs

Primary outcomes:
measure: Changes in total cholesterol
timeFrame: 12 weeks
measure: Changes in LDL-cholesterol
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in triglyceride
timeFrame: 12 weeks
measure: Changes in HDL-cholesterol
timeFrame: 12 weeks
measure: Changes in waist to hip ratio
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT01723124: Low-dose Molecular Breast Imaging: Comparison of Breast Cancer Detection Rate at Initial Screening and Two-year Follow-up
Official title: Comparison of Breast Cancer Detection Rate for Prevalent Screen Low-dose Molecular Breast Imaging and Incident Biennial Screen Low-dose Molecular Breast Imaging in Women With Mammographically Dense Breasts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Dense breast tissue
breast cancer screening
molecular breast imaging
breast cancer
breast
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 228
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research is to evaluate whether repeating a screening Molecular Breast Imaging (MBI) study two years after an initial screening MBI study further improves breast cancer detection in women with dense breast tissue.


Eligibility criteria: Inclusion Criteria:

- Past prior screening mammogram within the previous 11-24 months interpreted as heterogeneously dense or extremely dense and negative or benign \[Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2\]

Exclusion Criteria:

Subjects will be excluded if they:

* Are unable to understand and sign the consent form
* Are pregnant or lactating
* Are physically unable to sit upright and still for 40 minutes
* Have self-reported signs or symptoms that may suggest breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)
* Have had needle biopsy within 3 months, or breast surgery or radiation within 1 year prior to the study
* Are currently receiving chemotherapy or tamoxifen, raloxifene, or an aromatase inhibitor for adjuvant therapy or chemoprevention
* Have undergone bilateral mastectomy
* Have had a prior MBI within 20 months of scheduled study MBI.

Primary outcomes:
measure: Molecular Breast Imaging (MBI) scan
timeFrame: Performed at Year 0 of study
Secondary outcomes:
measure: Molecular Breast Imaging (MBI) scan
timeFrame: Performed at Year 2 of study
Other outcomes:
measure: Comparison of breast cancer detection rate for Year 0 and Year 2.
timeFrame: Year 2 of study
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Deborah Rhodes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rhodes DJ, Hruska CB, Phillips SW, Whaley DH, O'Connor MK. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106-18. doi: 10.1148/radiol.10100625. Epub 2010 Nov 2.
Clinical trial NCT01105624: A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contact Lens Dry Eye
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-04-16
Enrollment: 50
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: The primary objective of this study is to compare the duration of subject reported comfortable contact lens daily wear time in subjects with a history and current complaint of CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to rewetting drops


Eligibility criteria: Inclusion Criteria:

* Have a history of and current complaint of CLDE.
* Use properly fitted daily-wear soft contact lenses.
* Able to wear contact lenses for at least 8 hours a day.
* If female, are non-pregnant or non-lactating.

Exclusion Criteria:

* Have changed brand of contact lens or care solutions within one month prior to Visit 1.
* Use extended (overnight) wear contact lenses.
* Have a clinically significant ophthalmic abnormality.
* Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening.
* Have any active ongoing ocular infection or ocular disease.
* Have a serious medical condition which could confound study assessments.

Primary outcomes:
measure: Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint
timeFrame: 4 weeks
Secondary outcomes:
measure: Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint
timeFrame: 2 weeks
measure: Subject-reported duration of total contact lens daily wear
timeFrame: 4 weeks
measure: Subject-reported rating of overall eye dryness
timeFrame: 4 weeks
measure: Contact Lens-Related Dry Eye Questionnaire
timeFrame: 4 weeks
measure: Tear hyperosmolarity (mOsm)
timeFrame: 4 weeks
measure: Habitual low-contrast visual acuity (LCVA)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University, College of Optometry
state: Ohio
Study officials:
affiliation: Medical Monitor
name: Reza Haque, MD, PhD
role: STUDY_CHAIR
References:
citation: Nichols JJ, Bickle KM, Zink RC, Schiewe MD, Haque RM, Nichols KK. Safety and efficacy of topical azithromycin ophthalmic solution 1.0% in the treatment of contact lens-related dry eye. Eye Contact Lens. 2012 Mar;38(2):73-9. doi: 10.1097/ICL.0b013e31823ff229.
Clinical trial NCT04029324: Clinical Outcomes of Immediate Implant Placement and Early Implant Placement
Official title: Clinical Outcomes of Immediate Implant Placement and Early Implant Placement: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Fractures
Tooth Diseases
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Immediate implant placement (IIP) has been an attractive treatment concept for both patients and clinicians due to reduced surgical interventions and total treatment span. Although soft-tissue alterations or midfacial recession have been demonstrated in previous studies, recent studies have reported positive result following IIP with the modification of surgical interventions. However, high-quality evidence (≥Ib: evidence from at least one randomized controlled trial) on comparing the clinical outcome of IIP with early implant placement (type 2) is limited.


Eligibility criteria: Inclusion Criteria:

* age ≧18 years
* single hopeless teeth in anterior maxilla
* enough apical bone volume to achieve primary stability (\>4mm)

Exclusion Criteria:

* active periodontoal infection
* incomplete buccal bone plate
* unwilling to participate

Primary outcomes:
measure: Midfacial recession
timeFrame: 1-year follow-up
Secondary outcomes:
measure: Papillae recession
timeFrame: 1-year follow-up
measure: marginal bone loss
timeFrame: 1-year follow-up
measure: Probing depth
timeFrame: T2:crown delivery, T3: 1-year follow-up
measure: Bleeding on probing %
timeFrame: T2:crown delivery, T3: 1-year follow-up
measure: Pink esthetic score
timeFrame: T2:crown delivery, T3: 1-year follow-up
measure: Visual Analogue Scale assessement
timeFrame: T1: immediately after surgery,T2:crown delivery, T3: 1-year follow-up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai NinthPeoples' Hospital
Study officials:
References:
Clinical trial NCT06943924: A Comparative Study of CCI, EmSFI, and FTRST Scoring Systems
Official title: COMPARISON OF CCI, EmSFI AND fTRST SCORING SYSTEMS IN PREDICTION OF MORTALITY IN EMERGENCY GENERAL SURGERY CASES OVER 65 YEARS OF AGE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: One Hundred Patients Aged 65 and Older Who Underwent Emergency General Surgical Interventions
Clinical Utility of These Scoring Systems
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 65 years and older who underwent emergency abdominal surgery .

Brief summary: Frailty assessment tools and comorbidity indices play a crucial role, particularly in predicting outcomes for elderly patients undergoing emergency surgery. The Emergency Surgery Frailty Index (EmSFI), Charlson Comorbidity Index (CCI), and the Flemish version of the Triage Risk Screening Tool (fTRST) are considered valuable tools that help understand patients perioperative risk profiles. This study aims to investigate the accuracy and clinical utility of these scoring systems in predicting mortality in individuals aged 65 and older undergoing emergency surgery


Eligibility criteria: Inclusion Criteria Patients aged 65 years and older who underwent emergency abdominal surgery

Exclusion Criteria:

* Multiple hospitalizations for the same pathology,
* Initial admission at another facility,
* History of emergency abdominal surgery before the study period,
* Terminal-stage cancer
* Emergency reoperations following elective surgery,
* Surgery while in the intensive care unit.

Primary outcomes:
measure: Predicting 30-Day Mortality in Elderly Emergency Surgery Patients: A Comparative Study of CCI, EmSFI, and fTRST Scoring Systems
timeFrame: From enrollment to the postoperative at 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dr Lutfi Kirdar City Hospital
Study officials:
References:
Clinical trial NCT03116724: Direct Measurement of Ideal Depth of Central Line
Official title: Direct Measurement of Ideal Depth of Central Line for Right Internal Jugular Venous Catheterization in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Safety During Central Venous Catheterization
Keywords: catheterization, central venous
jugular veins
echocardiography, transesophageal
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Total of 89 patients undergoing elective cardiac surgery will be enrolled.

Right CVC insertion begins at their intersection of the cricoid cartilage level and the triangular point where the sternal head of the SCM muscle meets the clavicular head. After insertion the central venous catheter through the right internal jugular vein and positioning it, the location of the tip of the central venous catheter will be confirmed by TEE.

Detailed description: Investigator confirms the location of the 2 cm from the junction between right atrium and superior vena cava to the end of the tip of the catheter using TEE, and measures the insertion depth of the catheter at insertion point. It is possible to find the ideal central venous catheter insertion depth in actual clinical practice in adult patient.

The ideal central venous catheter insertion depth can be measured accurately when the end of the central venous catheter is monitored with transesophageal ultrasonography, and it can be derived a meaningful formula for predicting the ideal central venous insertion depth from the patient's height .

Eligibility criteria: Inclusion Criteria:

* adult patient over 18 years of age undergoing cardiac surgery under general anesthesia, requiring central venous catheter insertion through the right internal jugular vein and insertion of a TEE probe

Exclusion Criteria:

* Patients who disagree with the study.
* Patients who had difficulty in inserting the central line through the right internal jugular vein.

Primary outcomes:
measure: depth of the central venous catheter in right internal jugular vein
timeFrame: at time of insertion of the central venous catheter
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Dongsan medical center
Study officials:
affiliation: Dongsan Medical Center
name: Jiwon Lee, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06985524: To Observe the Clinical Efficacy of Traditional Chinese Medicine Compound(Weipi Formula ) in the Treatment of Epigastric Stuffiness Syndrome
Official title: Clinical and Preparation Studies of Traditional Chinese Medicine Compound(Weipi Formula) in the Treatment of Epigastric Stuffiness Syndrome
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Functional Dyspepsia(FD) Was Studied
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 256
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: The purpose of this clinical trial is to evaluate the efficacy of the herbal drug Weipi formula in treating functional dyspepsia (FD) in adults. It will also assess the safety of Weipi formula. The main questions the study aims to answer are:

Does Weipi formula reduce participants' TCM syndrome scores? What medical issues might participants experience while taking Weipi formula?

Researchers will compare Weipi formula with a placebo (an identical-looking substance without active drugs) to determine whether Weipi formula is effective in treating functional dyspepsia.

Participant Procedures

Participants will:

Take Weipi formula or the placebo daily for 2 weeks.

Visit the clinic once every week for examinations and tests. Record their symptoms and undergo measurements (e.g., pepsin levels).


Eligibility criteria: Inclusion Criteria:

* ① Meet the diagnostic criteria for epigastric fullness (Pi-Man) in Traditional Chinese Medicine (TCM);

  * Meet the Western diagnostic criteria for functional dyspepsia (FD), specifically postprandial distress syndrome (PDS) subtype, or meet both PDS and epigastric pain syndrome (EPS) subtypes but with PDS as the dominant presentation;

    * Age 18-80 years;

      * Willing to sign the informed consent form.

Exclusion Criteria:

* ① Gastroscopy findings: Benign or malignant digestive diseases (e.g., peptic ulcer, gastric cancer);

  * Severe organic diseases of the liver, gallbladder, spleen, or pancreas;

    * Severe organic diseases in other organ systems;

      * Pregnant or lactating women; ⑤ Patients with psychiatric disorders causing similar symptoms (e.g., schizophrenia, anxiety disorder, major depressive disorder); ⑥ Regular use (≥3 months) of NSAIDs and/or selective COX-2 inhibitors; ⑦ Potassium supplements taken within 2 weeks prior to enrollment.

Primary outcomes:
measure: TCM syndrome scores
timeFrame: From enrollment to the end of treatment at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: he Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Donghu District, Nanchang City, Jiangxi Province, China
state: Jiangxi
Study officials:
References: