louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00800956: Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion of Esreboxetine
Official title: An Open Label, Single Oral Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Esreboxetine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Radiolabel ADME study Healthy volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-03
Enrollment: 4
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to learn more about how esreboxetine is handled by the body i.e. the absorption, metabolism and excretion of esreboxetine.


Eligibility criteria: Inclusion Criteria:

Healthy male subjects aged 45 to 65 years Body mass index (BMI=weight/height2) 18 to 30 kg/m2

Exclusion Criteria:

Any clinically relevant abnormality identified on the screening medical assessment Any condition possibly affecting drug absorption Subjects with exposure to significant radiation (eg serial Xray or CT scans, barium meal etc)or who have participated in a radiolabelled study in the past 12 months, or who have occupational exposure to radioactivity History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5ounces (150ml) of wine or 12 ounces (360ml) of beer or 1.5 ounces (45ml) of hard liquor) within 6 months of screening 12-lead ECG demonstrating QTc\>450mses at screening Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication

Primary outcomes:
measure: Cumulative excretion of radioactivity in urine and and faeces as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and faeces for the assessment of parent drug and metabolites of esreboxetine where possible
timeFrame: Approx 10 days
measure: Pharmacokinetic parameters of esreboxetine and identification and abundance of metabolites in plasma, urine and faeces if possible
timeFrame: Approx 10 days
Secondary outcomes:
measure: Clinical safety data
timeFrame: Approx 10 days
measure: Pharmacokinetic parameters of plasma esreboxetine metabolites if possible
timeFrame: Approx 10 days
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05562856: Clinical Evaluation of White Spot Lesions Treated by S-PRG Material and Composite Sealants in Comparison With ICON
Official title: Clinical Evaluation of White Spot Lesions Treated by Surface Pre-reacted Glass Filler Coating Material and Composite Sealants in Comparison With Icon Resin Infiltration by Using Laser Fluorescence and Spectrophotometer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesions
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dental caries is the primary cause of tooth loss and oral diseases. Dental decay is a continuous pathological process with loss of tooth minerals, demineralization, which involves the destruction of tooth structure from acids. The first sign of early active demineralization is white spot lesions (WSLs) on the tooth surface, meanwhile, subsurface active mineral decomposition.

Detailed description: Deposition of minerals depends on the equilibrium between demineralization and remineralization which may happen as a natural repair mechanism. The aim of this trial is to comparatively evaluate the efficacy of surface pre-reacted glass filler (S-PRG) Barrier Coat coating material against the Icon resin infiltration in the ability to improve the caries lesion state of the WSLs along 1 year. Laser fluorescence was used to compare the two materials to evaluate the caries progression. PRG Barrier Coat group showed immediate significant improvement in LF scores in demineralization progress and inhibition of caries progression with a significant improved effect. S-PRG Barrier Coat was clinically successful strategy in inhibition of caries and improve remineralization.

Eligibility criteria: Inclusion Criteria:

* Patients within 20-40 years of age.
* Each patient has 4 or more WSLs.
* Mild and moderate WSLs according to Gorelick's scale.
* Good oral hygiene and willing patients who can attend the study visits.
* a Symmetrical number of permanent teeth in each arch (mesial to second molars).

Exclusion Criteria:

* Active carious lesions.
* Facial surface restorations.
* Intrinsic and extrinsic stains.
* Patients who have a significant medical history or if they smoke.
* Criteria for discontinuation; Mortality and acquiring severe debilitating disease

Primary outcomes:
measure: Assessments of caries lesion state of WSLs:
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of color change of WSLs:
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohamed Wakwak
Study officials:
affiliation: Alazhar Univerisity
name: Khalid Noman, PROF
role: STUDY_DIRECTOR
References:
Clinical trial NCT01268956: Circulating Lymphatic Progenitor Cell and Lymph Node Metastasis
Official title: Correlation of Circulating Lymphatic Progenitor Cells With Lymph Node Metastasis in Ovarian Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ovarian cancer patients

Brief summary: Correlation of circulating lymphatic endothelial progenitor cells with lymph node metastasis

Detailed description: Correlation of circulating lymphatic endothelial progenitor cells with lymph node metastasis in ovarian cancer patients

Eligibility criteria: Inclusion Criteria:

* ovarian cancer patients diagnosed by pathologic examination

Exclusion Criteria:

* other malignant disease inflammatory disease untreated diabetic and hypertension chronic renal failure rheumatoid arthritis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Obstetrics & Gynecology, Southwest Hospital
state: Sichuan
Study officials:
affiliation: Southwest Hospital, China
name: Pianyifan pianyifan, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06654856: The Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients with Acquired Lumbar Spinal Stenosis
Official title: A Prospective, Multicenter, Single Group, Open-label and Observational Study to Evaluate the Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients with Acquired Lumbar Spinal Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 243
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who require treatment of Dong-A Opalmon® tab due to acquired Lumbar Spinal Stenosis

Brief summary: This study is to evaluate the Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients With Acquired Lumbar Spinal Stenosis


Eligibility criteria: Inclusion Criteria:

* Men or women aged ≥ 19 years
* Subjects with acquired Lumbar Spinal Stenosis who show normal results in the Straight Leg Raising (SLR) test and exhibit intermittent claudication, requiring treatment with Dong-A Opalmon® tab
* Subjects who voluntarily consent to participate in this observational study

Exclusion Criteria:

* Subject for whom the medicinal products administration is contraindicated according to the approved domestic drug information: Pregnant women or those who may be pregnant, Subject with genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Subjects considered as unsuitable for participation in this observational study by the principal investigator or sub-investigator

Primary outcomes:
measure: Change from baseline in score of 'Symptom severity' and 'Physical function' items in Zurich Claudication Questionnaire at 8 weeks
timeFrame: Change from baseline at 8 weeks
Secondary outcomes:
measure: Mean score for 'Satisfaction' item in Zurich Claudication Questionnaire at 8 weeks
timeFrame: At 8 weeks
measure: Change from baseline in Oswestry Disability Index score at 8 weeks
timeFrame: Change from baseline at 8 weeks
measure: Change from baseline in score for first question (how much can you walk) of Zurich Claudication Questionnaire Part 2 'Physical Function' at 8 weeks
timeFrame: Change from baseline at 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center
Study officials:
References:
Clinical trial NCT02048956: Hydrotherapy Intervention in Elderly With Knee Osteoarthritis
Official title: 8-weeks Hydrotherapy Intervention in Patients With Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
hydrotherapy
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis is a common condition characterized by pain and functional disability in older people. Prevalence increases with age and is more frequent in older women. The aim of this study was to assess the effects of an 8-weeks hydrotherapy training with elastic bands on pain and functional disability in old people with knee osteoarthritis.

Detailed description: The main symptoms of knee osteoarthritis are pain and functional disability. These symptoms are caused by a progressive loss and deterioration of articular cartilage with reactive new bone formation at the joint's surface and margins involving articular cartilage, soft tissues and bone damage. Many treatment programs have been developed, including medication with nonsteroidal anti-inflammatory drugs, physical modalities, and therapeutic exercises. It is hypothesized that a hydrotherapy treatment during 8 weeks would benefit patients with knee osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* confirmed clinical diagnosis of knee osteoarthritis

Exclusion Criteria:

* total knee arthroplasty
* inability to co-operate or follow instructions.
* a major neurological disorder

Primary outcomes:
measure: Changes in pain pressure threshold
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Changes in lower extremity strength
timeFrame: baseline, 8 weeks
measure: Dual task
timeFrame: baseline, 8 weeks
measure: Functional ability
timeFrame: baseline, 8 weeks
measure: Changes in balance
timeFrame: baseline, 8 weeks
Other outcomes:
measure: Quality of sleep
timeFrame: baseline, 8 weeks
Locations:
city: Granada
country: Spain
facility: Faculty of health Sciences. University of Granada
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04790656: Interventional Effects on Myocardial Revascularization Post-surgical Patients
Official title: Effects of Continuous Positive Airway Pressure (CPAP)and Physical Exercise on Cycle Ergometer in Myocardial Revascularization Post-surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Revascularization
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to evaluate the effectiveness of physical exercise on a cycle ergometer combine with CPAP in the postoperative period after myocardial revascularization

Detailed description: Physical exercise on a cycle ergometer combine with CPAP as an adjunct to the rehabilitation of hospitalized subjects who will undergo myocardial revascularization will be safe, decrease the length of stay in the ICU, and help maintain functional capacity

Eligibility criteria: Inclusion Criteria:

* Subjects who have undergone myocardial revascularization surgery
* An ejection fraction of greater than40%
* Post operative mechanical ventilation for \<12hours
* No definite diagnosis of chronic obstructive pulmonary disease and asthma

Exclusion Criteria:

* With complications in post operative period (e.g., Artial fibrillation, prolonged mechanical ventilation)
* Hemodynamically unstable patients
* Intolerance to CPAP(continuous positive airway)mask

Primary outcomes:
measure: Modified Borg scale
timeFrame: 4th day
measure: 6 min walk distance
timeFrame: 4th day
measure: 1 min sit to stand test
timeFrame: 4th day
measure: Digital Monovacumeter
timeFrame: 4th day
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Rawalpindi institute of cardiology
state: Punjab
Study officials:
affiliation: Riphah college of rehabilitation and allied health sciences - Rawalpindi
name: Anam Aftab, Phd*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01652456: Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support
Official title: Alcohol and TObacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Head and Neck Cancer
Lung Cancer
Keywords: addiction support
addiction specialist
lung cancer
head and neck cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-07-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a multicenter, interventional, randomized study for preventive and therapeutic strategies for patients with head and neck or Lung cancer; contribution of an addiction support


Eligibility criteria: Inclusion Criteria:

* first head and neck or lung cancer
* first support
* 18 ≤ age ≤ 60
* lives in Lille Metropolis
* having an addiction to alcohol and tobacco
* covered by health insurance
* signed informed consent

Exclusion Criteria:

* prior cancer
* mesothelioma and oesophageal cancer
* unable to undergo trail medical follow up (geographical, social and psychological reasons)
* pregnant or nursing woman
* patient under guardianship

Primary outcomes:
measure: systematic addiction consultation
timeFrame: 12 months after diagnosis
Secondary outcomes:
measure: progression free survival
timeFrame: 24 months after diagnosis
measure: overall survival
timeFrame: 24 months after survival
measure: alcohol and tobacco consumption
timeFrame: baseline, 3 months, 6 months and 12 months after diagnosis
measure: alcohol + tobacco withdrawal and addiction support
timeFrame: 12 months after diagnosis
measure: addiction follow up
timeFrame: 24 months after diagnosis
Other outcomes:
Locations:
city: Lille
country: France
facility: Oscar Lambret Center
city: Lille
country: France
facility: Centre Hospitalier Régional et Universitaire - Hopital CALMETTE
city: Lille
country: France
facility: Centre Hospitalier Régional et Universitaire - Hopital HURIEZ
Study officials:
affiliation: Centre Hospitalier Régional et Universitaire
name: Corinne VANNIMENUS, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02939456: Comparison Of DIR-MRI And DCE-MRI In Detection Of Prostate Cancer: A Pilot Study
Official title: Comparison Of Double Inversion Recovery Magnetic Resonance Imaging (Dir-Mri) And Dynamic Contrast Enhanced Magnetic Imaging (Dce-Mri) In Detection Of Prostate Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of the Prostate
Keywords: prostate
cancer
MRI
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI).

Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team.

Detailed description: This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI). Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team. The research team will look at the variability of LNR score amongst the two scan typed and the DCE-MRI and DIR-MRI images will be correlated with biopsy results to give an indication of the accuracy.

Eligibility criteria: Inclusion Criteria:

* Patients referred for prostate MRI for possible prostate cancer
* Safe to undergo an MRI scan
* Able to give informed consent

Exclusion Criteria:

* MRI referrals where prostate cancer is not the question
* Patients who are not safe to undergo an MRI scan
* Patients who have undergone prostate biopsy in the previous 10 weeks
* Patients unable to give informed consent

Primary outcomes:
measure: Lesion to Normal tissue Ratio (LNR) recorded for DIR-MRI and DCE-MRI
timeFrame: 3 months
Secondary outcomes:
measure: Correlation of biopsy and DIR-MRI and DCE-MRI findings
timeFrame: 3 months
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
state: Staffordshire
Study officials:
affiliation: University Hospitals of North Midlands NHS Trust
name: Eric Onwuharine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00188656: Computed Tomography (CT) in Head and Neck Patients
Official title: Minimum Dose CT in the Detection of Lung Nodules in Patients With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lung Tumors
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is conducting a comparison of chest x-ray (CXR) and minimum dose thoracic CT (MnDCT) in the detection of lung nodules (metastases) in patients with head and neck carcinoma.

Detailed description: A comparison of chest x-ray (CXR) and minimum dose thoracic CT (MnDCT)in the detection of lung nodules (metastases) in patients with head and neck carcinoma

Eligibility criteria: Inclusion Criteria:

* Patients with squamous cell carcinoma of the head and neck

Exclusion Criteria:

* None

Primary outcomes:
measure: Detection of lung metastases
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Narinder Paul, FRCP C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01138956: Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine
Official title: Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Visceral Leishmaniasis
Immune Response
Treatment
Keywords: Visceral leishmaniasis
N-acetylcysteine
Antimony
Immune response
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to evaluate the immune and therapeutic responses of visceral leishmaniasis patients using N-acetylcysteine (NAC) as an adjuvant therapy to pentavalent antimony.

Detailed description: In this study we intend to evaluate the immune and therapeutic responses of patients with visceral leishmaniasis N-acetylcysteine (NAC) as an adjuvant to standard treatment with pentavalent antimony, compared to treatment with antimonial only through a blind randomized clinical trial. Our hypothesis is that patients treated with NAC associated with pentavalent atimonial have a rapid changing of the immune responses, towards TH1, and clinical improvement when compared to patients who will use only the standard treatment

Eligibility criteria: Inclusion Criteria:

* Age 2 to 50 years
* Diagnosis of visceral leishmaniasis

Exclusion Criteria:

* Other acute or chronic diseases
* Use of immunosuppressive drugs
* AIDS
* History of allergy to NAC and/or pentavalent antimony

Primary outcomes:
measure: Patient recovery from the visceral leishmaniasis after treatment
timeFrame: 6 months
Secondary outcomes:
measure: Immune response of visceral leishmaniasis patients after proposed treatment
timeFrame: one year
Other outcomes:
Locations:
city: Aracaju
country: Brazil
facility: University Hospital
state: Sergipe
Study officials:
affiliation: Hospital Universitário
name: Roque P Almeida, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: