louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06843980: MOTION Clinical Trial
Official title: Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis Versus the Use of Non-surgical Treatment: Randomized Clinical Trial and Comparison of Therapies for Medial Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Moximed
Sponsor class: INDUSTRY
First posted: 2025-02-25
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 randomized controlled trial (RCT)
Primary purpose: TREATMENT

Brief summary: Prospective, multicenter, two-arm, 2:1 randomized controlled trial (RCT) comparing the benefits in subjects with medial knee osteoarthritis who are treated with either the MISHA Knee System or with non-surgical treatment.

This is the first randomized head-to-head study comparing outcomes from subjects treated with the MISHA Knee System.


Eligibility criteria: Key Inclusion Criteria:

1. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
2. WOMAC pain ≥ 40
3. Failed to find relief in non-surgical treatment modalities

Key Exclusion Criteria:

1. Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
2. Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
3. Ligamentous instability
4. Active or recent knee infection
5. Inflammatory joint disease, including sequelae of viral infections
6. Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
7. History of keloid, hypertrophic or contracture scaring
8. Propensity for restrictive scar formation or adhesions with prior procedures

Primary outcomes:
measure: WOMAC Pain at 6 Months
timeFrame: 6 Months
Secondary outcomes:
measure: WOMAC Function at 6 Months
timeFrame: 6 Months
Other outcomes:
Locations:
city: Davis
country: United States
facility: UC Davis Department of Orthopaedic Surgery
state: California
city: Oceanside
country: United States
facility: Scripps Clinic Jefferson
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Columbus
country: United States
facility: Ohio State Jameson Crane Sports Medicine Institute
state: Ohio
Study officials:
affiliation: Moximed
name: Rose S Weinstein
role: STUDY_DIRECTOR
References:
Clinical trial NCT01376180: Drug Use Investigation for LAMICTAL
Official title: Drug Use Investigation for LAMICTAL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with epilepsy having the following seizure types.

* partial seizures (including secondary generalized seizures)
* tonic-clonic seizures
* generalized seizures of Lennox-Gastaut syndrome

Brief summary: The purpose of this study is to grasp actual status of usage of lamotrigine tablet and to collect information for using lamotrigine tablet effectively and safely as well as to grasp onset status of adverse events in pediatric subjects, geriatric subjects, pregnant women, subjects with poor renal and hepatic functions.


Eligibility criteria: Inclusion Criteria:

* Subjects with epilepsy having the following seizure types.
* Partial seizures (including secondary generalized seizures)
* Tonic-clonic seizures
* Generalized seizures of Lennox-Gastaut syndrome

Exclusion Criteria:

- None

Primary outcomes:
measure: The number of adverse events in Japanese subjects with epilepsy treated with lamotrigine tablet
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Sunao Kaneko, Yushi Inoue, Masafumi Iijima, Atsuko Ishida, Shogo Inoshiri. Drug Use Investigation of Lamotrigine Tablets in Patients with Epilepsy - Results of Interim Analysis -. 2011;60(3):9-35.
Clinical trial NCT04100980: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Chronic Urinary Tract Infections (UTI)
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Chronic Urinary Tract Infections (UTI)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic UTI
Chronic Urinary Tract Infection
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18 years of age or older who have been diagnosed with chronic urinary tract infections (UTI)

Brief summary: Correlation of Microbiome to Chronic Urinary Tract Infections (UTI) via Relative Abundance Found in Microbiome Sequencing

Detailed description: Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific Chronic UTI types.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent by patient
2. Male or female patients age 18 and older.
3. Diagnosis of chronic UTIs by a physician based upon urinalysis and/or urine culture.

Exclusion Criteria:

1. Refusal by patient to sign informed consent form
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 6 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study.

Primary outcomes:
measure: Correlation of Microbiome to chronic Urinary Tract Infection (UTI) via Relative Abundance Found in Microbiome Sequencing
timeFrame: 1 year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: 1 year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05564780: Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension
Official title: Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Stage 1 Hypertension
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 20000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: STEP-Pre is to investigate the benefits of using anti-hypertensive drugs in the population with a blood pressure of 130-139/80-89 mmHg and evaluate the health economics.

STEP-Pre is a multi-center randomized clinical trial. The cohort will be randomized into the treatment group or control group with a 1:1 ratio. The treatment group will take anti-hypertensive medicine to control blood pressure under 130/80 mmHg. Both groups will take health care education.

STEP-Pre will last 4 years.


Eligibility criteria: Inclusion Criteria:

* Stage 1 hypertension (blood pressure is in 130-139/80-89 mmHg);
* 35 - 64 years old
* Without taking antihypertensive medicine during screening
* Signed the written informed consent

Exclusion Criteria:

* took antihypertensive medicine within the last 1 month;
* History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not lacunar infarction and transient ischemic attack \[TIA\]);
* History of myocardial infarction or unstable angina or history of coronary revascularization (PCI or CABG);
* Lab tests indicating abnormal liver or kidney function (ALT ≥ 3 times the upper limit of normal value, or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2);
* History of sustained atrial fibrillation or Ventricular arrhythmias at entry influencing the measurement of electronic blood pressure；
* Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial;
* Dilated or hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease;
* Severe somatic disease such as cancer;
* Severe cognitive impairment or mental disorders;
* pregnant or breastfeeding, or planning to be pregnant;
* having organ transplantation;
* Participating in other clinical trials.

Primary outcomes:
measure: Cardiovascular Disease
timeFrame: 4 years
Secondary outcomes:
measure: Stroke ( ischemic or hemorrhagic)
timeFrame: 4 years
measure: Acute coronary syndrome
timeFrame: 4 Years
measure: CVD Death
timeFrame: 4 Years
measure: Advanced to Stage 2 Hypertension
timeFrame: 4 Years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00758680: A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED)
Official title: A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1006.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 112
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: This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Participant has a BMI less than or equal to 42 kg/m\^2 at the screening visit
* Participant has been diagnosed with Type 2 Diabetes that is being treated either by diet and exercise alone or by single or combination oral anti-hyperglycemic medications
* Participant is willing to follow a diet containing approximately 50% carbohydrates, 20% protein, and 30% fat during the study
* Participant is a nonsmoker and has not used nicotine containing products for \~ 6 months before start of study

Exclusion Criteria:

* Participant must not be treated with three or more oral anti-hyperglycemic medications, insulin, or PPAR-gamma agonists
* Participant has a history of stroke, chronic seizures, or a major neurological disorder
* Participant has had an eye infection or other inflammatory eye condition within 2 weeks of first dose of study drug
* Participant has glaucoma or is blind
* Participant has a condition known to be related to cataract development
* Participant has had or will have incisional eye surgery within 6 months before screening or has had laser surgery (other than Lasik) within 3 months of screening
* Participant has a history of type 1 diabetes or ketoacidosis
* Participant cannot stop taking certain current medications during the study
* Participant consumes greater than 3 alcoholic beverages per day
* Participant consumes more than 6 servings of caffeinated beverages per day (1 serving is \~ 120 mg caffeine)
* Participant has a history of significant multiple or severe allergies or has had a reaction to or is intolerant of prescription/non-prescription drugs or food
* Participant uses recreational drugs or has had a history of drug abuse within 6 months of start of study

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs) On Study
timeFrame: From Day 1 through the end of poststudy period (up to Day 25)
measure: Number of Participants Who Discontinued Treatment Due to an AE
timeFrame: From Day 1 through the end of poststudy period (up to Day 25)
Secondary outcomes:
measure: Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)
timeFrame: Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01992380: A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects
Official title: Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers

  * Male or female subjects ≥ 50 years of age
  * Mini-mental state examination (MMSE) ≥ 29
* MCI Subjects

  * Male or female subjects ≥ 50 years of age
  * MMSE ≥ 24
  * Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD
  * Have a study partner that can report on subject's activities of daily living
* Probable AD Subjects

  * Male or female subjects ≥ 50 years of age
  * MMSE \> 10
  * Meet clinical criteria for probable AD based on the NIA-AA working group's diagnostic guidelines for AD
  * Have a study partner that can report on subject's activities of daily living

Exclusion Criteria:

* Current clinically significant psychiatric disease
* Evidence of structural brain abnormalities
* Evidence of dementing illness other than AD
* Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* History of alcohol or substance abuse or dependence
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
* Have received or participated in a trial with investigational medications in the past 30 days
* have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.

Primary outcomes:
measure: Test-Retest Reproducibility
timeFrame: 80-100 minutes postdose
measure: Test-Retest Reproducibility
timeFrame: 110-130 minutes postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Research Site
state: California
city: New Haven
country: United States
facility: Research Site
state: Connecticut
Study officials:
affiliation: Avid Radiopharmaceuticals, Inc.
name: Chief Medical Officer
role: STUDY_CHAIR
References:
citation: Devous MD Sr, Joshi AD, Navitsky M, Southekal S, Pontecorvo MJ, Shen H, Lu M, Shankle WR, Seibyl JP, Marek K, Mintun MA. Test-Retest Reproducibility for the Tau PET Imaging Agent Flortaucipir F 18. J Nucl Med. 2018 Jun;59(6):937-943. doi: 10.2967/jnumed.117.200691. Epub 2017 Dec 28.
Clinical trial NCT05956080: Penicillin Allergy Delabeling Among Surgical Patients
Official title: Penicillin Allergy Delabeling Among Surgical Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Penicillin Allergy
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Penicillin allergy testing among surgical patients


Eligibility criteria: Inclusion Criteria:

* surgical patients with reported penicillin allergy

Exclusion Criteria:

* missing consent

Primary outcomes:
measure: Confirmed penicillin allergy
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Medicine Greifswald
name: Sebastian Gibb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medicine Greifswald
name: Christian S. Scheer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04314180: Artificial Intelligence System for Assessing Image Quality of Slit-Lamp Images and Its Effects on Diagnosis
Official title: Artificial Intelligence System for Assessing Image Quality of Slit-Lamp Images and Its Effects on Diagnosis: A Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Segment Disorders
Artificial Intelligence
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria: - Patients should be aware of the contents and signed for the informed consent. Exclusion Criteria: - 1. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths. - 2. Patients who do not agree to sign informed consent

Brief summary: Slit-lamp images are widely used in ophthalmology for the detection of cataract, keratopathy and other anterior segment disorders. In real-world practice, the quality of slit-lamp images can be unacceptable, which can undermine diagnostic accuracy and efficiency. Here, the researchers established and validated an artificial intelligence system to achieve automatic quality assessment of slit-lamp images upon capture. This system can also provide guidance to photographers according to the reasons for low quality.


Eligibility criteria: Inclusion Criteria:

* Patients should be aware of the contents and signed for the informed consent.

Exclusion Criteria:

* 1. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths.
* 2. Patients who do not agree to sign informed consent.

Primary outcomes:
measure: Performance of artificial intelligence system for distinguish between good image quality and poor image quality
timeFrame: 3 months
Secondary outcomes:
measure: The comparison of the performance for previous artificial intelligence diagnostic system with slit-lamp images of different image quality
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03877380: Identification of Difficulties During a First Request for a Personal Autonomy Allowance
Official title: Identification of Difficulties During a First Request for a Personal Autonomy Allowance by Beneficiaries and Identification of the Role of the Attending Physician During This Request.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Persons Requesting a Resource Allocation (APA)
Beneficiairies Requesting a Resource Allocation (APA)
Keywords: personalised autonomy allowance
difficulties
physician's role
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The population studied includes all the people who apply for a first Resource Allocation (APA) in all 6 territories of the department of Ille et Vilaine

Brief summary: The objective of this study is to identify the difficulties when first applying for a first Resource Allocation (Personal autonomy allowance - APA) by beneficiaries and their relatives through a qualitative study and secondarily identification of the role of the attending physician during this request.

Detailed description: The APA, introduced since the French law of 2001 aims to improve the care of people with loss of autonomy.

A regular assessment of autonomy in the elderly should be carried out in order to implement ABS as early as possible. The aim is to set up the necessary home help to avoid or delay institutionalisation.

It therefore seems essential to place oneself on the side of the beneficiaries and their relatives in order to identify the difficulties encountered during a first ABS application and their expectations as to the role of the general practitioner during this application?

Eligibility criteria: Inclusion Criteria:

* Beneficiaries living in Ille et Vilaine
* requesting for the first time a Resource Allocation (APA)

Or

* Persons requesting for the first time a Resource Allocation (APA)
* Allocation of resources for the benefit of a person residing in Ille et Vilaine

Exclusion Criteria:

* Refusal of Resource Allocation
* opposition to participation in the survey.

Primary outcomes:
measure: Semi-structured interview
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Conseil Départemental -Pôle Solidarité Humaine
Study officials:
affiliation: Rennes University Hospital
name: Emilie MENAND, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00796380: Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases
Official title: Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Convulsive Diseases
Lead sponsor: Shenzhen Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2008-11-24
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the efficacy of Xingnaojing for the treatment of convulsive diseases; to investigate whether convulsion episodes can be induced or aggravated by Xingnaojing and the role inflammation plays in the process.


Eligibility criteria: Inclusion Criteria:

1. Febrile convulsion: positive family history of febrile convulsion; aged between 6 months and 6 years old; in accordance with the diagnosis criteria of simple type of febrile convulsion
2. Frequent episodes of epilepsy: epilepsy episodes of all types; \> 3 times / week
3. Refractory epilepsy: no satisfactory efficacy after treatment by 2\~3 antiepileptic drugs; ≥ 1 time / month
4. Cerebral palsy: all types of cerebral palsy in children less than 3 years old. -

Exclusion Criteria:

1. Febrile convulsion: family history of epilepsy, complex type of febrile convulsion, epileptic episodes, febrile convulsion plus
2. Frequent episodes of epilepsy: combined with advanced diseases
3. Refractory epilepsy: epilepsy combined with advanced diseases
4. Cerebral palsy: advanced diseases combined with backwardness or retardation of brain function development.

Primary outcomes:
measure: Antipyretic rate , Frequency of convulsive episodes ,
timeFrame: one year
measure: Frequency of convulsive episodes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: