louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00092807: Sitosterolemia Extension Study (0653-003)(COMPLETED)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia - 1 Year Open-Label Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lipid Metabolism, Inborn Errors
Heart Disease
Keywords: Homozygous Sitosterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 37
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.

Detailed description: The duration of treatment is 52 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with elevated sitosterol levels while taking current medication

Exclusion Criteria:

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Primary outcomes:
measure: To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.
Secondary outcomes:
measure: Assess the percent change relative to baseline in LDL-C/plasma campesterol concentrations, and safety and tolerability after long-term treatment with MK0653 10 mg/day in patients with homozygous sitosterolemia
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Salen G, von Bergmann K, Lutjohann D, Kwiterovich P, Kane J, Patel SB, Musliner T, Stein P, Musser B; Multicenter Sitosterolemia Study Group. Ezetimibe effectively reduces plasma plant sterols in patients with sitosterolemia. Circulation. 2004 Mar 2;109(8):966-71. doi: 10.1161/01.CIR.0000116766.31036.03. Epub 2004 Feb 9.
Clinical trial NCT00573807: Energy Specific Far Infrared Radiation Treatment for Sciatica
Official title: Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Sciatica.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Sciatica
Keywords: Neuralgia, Sciatic
Sciatic Neuralgia
Sciatica, Bilateral
Lower back pain
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A preliminary study to determine the use of far infrared radiation for the treatment of back pain

Detailed description: Sciatica is created by joint misalignment, muscle spasm and inflammation. Generally, sciatica is a combination of lower back pain, pain radiating into the buttock and possibly down the leg.

Far infrared radiation of the sciatic nerve, coupled with the stretching of the spinal cord, is a promising non-invasive method for treating sciatica.

Eligibility criteria: Inclusion Criteria:

* Persons with lower back pain

Exclusion Criteria:

* None

Primary outcomes:
measure: The primary end point is to determine the therapeutic effects of far infrared radiation on the Sciatic nerve.
timeFrame: 2 years and 6 months
Secondary outcomes:
measure: Far infrared treatment for other pain syndromes
timeFrame: 2 years and 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: STUDY_DIRECTOR
affiliation: GAAD Medical Research Institute Inc.
name: Kwasi Donyina, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01737307: Effect of Fluoride Varnish and CPP-ACP on Oral and Salivary Symptoms During Chemotherapy
Official title: Effect of Fluoride Varnish and CPP-ACP Paste on Oral and Salivary Symptoms of Patients Under Chemotherapy: A Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mucositis
Dry Mouth
Infection
Keywords: Fluoride Varnish
CPP-ACP paste
Dry mouth
Burning sensation
Chemotherapy
Lead sponsor: Azad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to investigate the effect of Fluoride varnish and Casein Phospho-Peptide Amorphous Calcium Phosphate (CPP-ACP) containing paste on oral symptoms and salivary characteristics in patients under chemotherapy.

Detailed description: Chemotherapy as a treatment method of cancers, affects different parts of the oral cavity such as oral mucosa, teeth and salivary glands caused by salivary glands dysfunction during chemotherapy.Oral status of patients under chemotherapy will be affected by consumption of the drugs and their side effects such as reduction of the saliva, dryness of the oral cavity, changes in bacterial balance, oral mucosa damage, bleeding due to irritation of the tissues, xerostomia, dental caries, burning sensation, dysgeusia and dysphagia. No effective preventive protocol has been presented for oral care during chemotherapy.

Patients who were met the inclusion criteria (aged over 12, diagnosed to have cancer by an oncologists and needed chemotherapy drugs, had at least 20 teeth, had no other pathologic lesion in their oral cavity, were not treated by radiotherapy and did not have specific systemic diseases or head and neck cancer) were selected for the study. the participants were evaluated according to oral and salivary symptoms.

Eligibility criteria: Inclusion Criteria:

* to have cancer (in the first stage of their treatments)
* to have at least 20 teeth,
* age over 12

Exclusion Criteria:

* to have pathologic lesion in the oral cavity
* being under radiotherapy
* to have specific systemic diseases
* to have head and neck cancer

Primary outcomes:
measure: oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth.
timeFrame: 6 weeks after first visit
Secondary outcomes:
measure: pH of saliva
timeFrame: 6 weeks after first visit
measure: pH of dental plaque
timeFrame: 6 weeks after first visit
measure: Quantity of saliva ( rest and stimulated)
timeFrame: 6 weeks after first visit
measure: Saliva buffering capacity
timeFrame: 6 weeks after first visit
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Azad University of Medical Sciences, Dental Branch
Study officials:
affiliation: Azad University of Medical Sciences, Dental Branch
name: Sepideh Banava, Assist-Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02204488: Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2-3
Official title: Total Joint Arthroplasty or Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2 and 3: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trapeziometacarpal Osteoarthritis
Thumb Carpometacarpal Osteoarthritis
Keywords: Osteoarthritis
Thumb
Total joint arthroplasty
Trapeziectomy
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 62
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. A relatively new treatment modality, which has been further developed in recent years is the total joint arthroplasty. Randomized prospective trials and long-term results are lacking, but prospective cohorts show a faster recovery and good results after one year, without an increase in complication rate.

We hypothesize that a total joint arthroplasty gives a better objective and subjective result after one year than a trapeziectomy.


Eligibility criteria: Inclusion Criteria:

* Women.
* 40 years of age or more.
* Symptomatic trapeziometacarpal osteoarthritis.
* Eaton \& Glickel stage 2 and 3.

Exclusion Criteria:

* An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
* Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.
* Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
* Symptomatic carpal tunnel syndrome in same hand.
* Symptomatic Quervain's tenosynovitis in same hand.
* Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
* Insufficient knowledge of Dutch language.

Primary outcomes:
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
timeFrame: 5 years after surgery
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
timeFrame: 1 and 5 years after surgery
measure: Disabilities of Arm Shoulder and Hand (DASH)
timeFrame: 1 and 5 years after surgery
measure: Grip strength
timeFrame: 1 and 5 years after surgery
measure: Thumb mobility
timeFrame: 1 and 5 years after surgery
measure: Complications
timeFrame: 1 and 5 years after surgery
measure: Return to work
timeFrame: 1 and 5 years after surgery
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Hospital
state: Overijssel
Study officials:
affiliation: Isala
name: Jeroen H. van Uchelen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01189188: Ultrasound Guidance for Radial Arterial Blood Sampling
Official title: Ultrasound Guidance for Radial Arterial Blood Sampling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radial Artery
Ultrasonography
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-08-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aim to determine if ultrasound guidance results in improved technique when drawing blood via a radial artery puncture.


Eligibility criteria: Inclusion Criteria:

* The subject has signed consent
* The subject is affiliated with a social security system
* Health status necessitates an arterial blood sample for diagnostic, prognostic or therapeutic reasons

Exclusion Criteria:

* The subject is participating in another study
* The subject is in a study exclusion period determined by a previous study
* The subject is under guardianship
* The subject refuses to sign consent
* Impossible to correctly inform the patient
* The patient is pregnant, breastfeeding, or parturient
* Allergies to one or more of the following: methyl, propylbenzoate, propylene glycol, chlorhexidine gluconate
* Contraindication for an arterial puncture (at the radial artery)
* Cardio-respiratory arrest

Primary outcomes:
measure: Is only one puncture attempt necessary to attain the radial artery? yes/no
timeFrame: maximum two hours
Secondary outcomes:
measure: The number of puncture attempts required to attain the radial artery
timeFrame: maximum two hous
measure: Visual Analog Scale score for pain felt by the patient (0.0 to 10.0)
timeFrame: Maximum two hours
measure: Visual Analog Scale score for patient satisfaction (0.0 to 10.0)
timeFrame: Maximum two hours
measure: Visual Analog Scale score for health professional satisfaction (0.0 to 10.)
timeFrame: Maximum two hours
measure: Presence / absence of a hematoma at the site of puncture
timeFrame: two hours
measure: Presence / absence of other complications
timeFrame: Two hours
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Romain Genre-Grandpierre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
Clinical trial NCT04140188: SLNB After Nipple Sparing Mastectomy
Official title: Sentinel Lymph Node Biopsy After Nipple Sparing Mastectomy: Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sentinel Lymph Node Biopsy
Mastectomy, Subcutaneous
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sentinel Lymph Node Biopsy (SLNB) after nipple sparing mastectomy (NSM) is controversial. This study aims to investigate feasibility of SLNB with radioisotope method.

Detailed description: Volunteer patients who has underwent to NSM at least more than 6 months prior will be included to the study. Radioisotope will be injected via intradermal route to the breast underwent to NSM patients and lymphoscintigraphy images will be obtained to detect activity in axilla. If hot nodule is detected then it will be concluded that SLNB can be performed after NSM.

Eligibility criteria: Inclusion Criteria: NSM with/without SLNB at least 6 months prior to this study -

Exclusion Criteria: previous axillary dissection and active breast cancer

-

Primary outcomes:
measure: Enhancement in axilla
timeFrame: 4 hours after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
state: Sariyer
Study officials:
affiliation: Acibadem University
name: Halil KARA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Intra M, Veronesi P, Gentilini OD, Trifiro G, Berrettini A, Cecilio R, Colleoni M, Rietjens M, Luini A, Paganelli G, Veronesi U. Sentinel lymph node biopsy is feasible even after total mastectomy. J Surg Oncol. 2007 Feb 1;95(2):175-9. doi: 10.1002/jso.20670.
citation: Karam A, Stempel M, Cody HS 3rd, Port ER. Reoperative sentinel lymph node biopsy after previous mastectomy. J Am Coll Surg. 2008 Oct;207(4):543-8. doi: 10.1016/j.jamcollsurg.2008.06.139. Epub 2008 Jul 21.
Clinical trial NCT05359588: Functional Prognosis of Post-operative Patients With Cerebral Small Vascular Disease(CSVD)
Official title: Association Between Postoperative Cerebral Vascular Complication and Functional Prognosis and Cerebral Small Vascular Disease (CSVD) After Thoracic Surgery : an Exploratory Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Small Vessel Diseases
Long Term Adverse Effects
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 212
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all postoperative patients between 65 and 85 years old with pre-operative brain MRI results in Renji Hospital Affiliated to Shanghai Jiaotong University from November 2020 to December 2021 after thoracic surgery

Brief summary: The investigators perform a retro-prospective exploratory cohort study among patients 65 to 85 years old with pre-operative head MRI result after thoracic surgery in Renji Hospital Affiliated to Shanghai Jiaotong University from November 2020 to December 2021. Perioperative data were collected, including preoperative general condition, laboratory examination, auxiliary examination (blood routine, blood coagulation, liver and kidney function, etc.), perioperative indicators （use of anesthetics, anesthetic time, blood pressure, etc.）, postoperative cerebral function follow-up and occurrence of cerebral vascular complications (brain infarction, brain bleed, etc.) of patients.


Eligibility criteria: Inclusion Criteria:

* 65≤age\<85
* after thoracic surgery
* finish pre-operative brain MRI

Exclusion Criteria:

* mental illness
* existing dementia and other diseases: Alzheimer disease, dementia, Parkinson's disease, Huntington's disease, systemic lupus erythematosus, etc.
* previous cerebral infarction or hemorrhage

Primary outcomes:
measure: Incidence of postoperative overt stroke
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Physical function after surgery as assessed using Activities of Daily Living (iADL) Scale
timeFrame: 1 year after surgery
measure: Physical function after surgery as assessed using the Modified Rankin Scale
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University, School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT06688188: 68Ga-JH12 PET/CT: Dosimetry and Biodistribution Study
Official title: 68Ga-JH12 PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Malignant Neoplasm
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 68Ga-JH12 is a novel radiotracer targeting C-X-C motif chemokine receptor 4 (CXCR4). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH12 in patients with different types of cancer.

Detailed description: C-X-C motif chemokine receptor 4 (CXCR4) is highly expressed in patients affected with malignant tumors and ex-vivo analyses provided evidence that the expression level on the tumor cell surface is tightly linked to the proliferation index. In recent years, the diagnostic PET agent 68Ga-Pentixafor targeting this chemokine receptor has been extensively validated in haematological malignancies and solid tumors. 68Ga-JH12, a novel radiopharmaceutical targeting CXCR4, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, the safety, biodistribution, and radiation dosimetry of 68Ga-JH12 in patients with Various Cancers were observed to evaluate the dosimetric characteristics of 68Ga-JH12.

Eligibility criteria: Inclusion Criteria:

* Various solid tumors with available histopathological findings
* Signed informed consent

Exclusion Criteria:

* pregnant or lactational women
* who suffered from severe hepatic and renal insufficiency

Primary outcomes:
measure: safety and tolerability
timeFrame: up to 1 week
Secondary outcomes:
measure: Dosimetry of normal organs and tumors
timeFrame: From right after tracer injection to 150 minutes at post-injection
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT00193388: Weekly Topotecan in the Second-Line Treatment of Small Cell Lung Cancer
Official title: Phase II Trial of Weekly Topotecan in the Second-Line Treatment of Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this phase II trial, we will evaluate the weekly schedule of topotecan in the second-line treatment of patients with small cell lung cancer

Detailed description: Upon determination of eligibility, all patients will be receive:

* Topotecan

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Small Cell Lung cancer
* Progression after one previous regimen
* Measurable or evaluable disease
* Able to perform activities of daily living with assistance
* Adequate bone marrow, liver and kidney function
* No more than three previous courses of radiation therapy
* Accessible for treatment and follow up
* Must give written informed consent prior to study entry

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Central nervous system involvement
* Serious or active infection
* Serious underlying medical condition
* Other active neoplasms

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Median survival
measure: 1-year survival
measure: Symptomatic improvement
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Anthony Greco, MD
role: PRINCIPAL_INVESTIGATOR
References: