louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00444808: Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
Official title: Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rib Fractures
Pain
Keywords: Rib fracture
Pain
intranasal calcitonin
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2007-03-08
Enrollment: 19
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: This study, which will be conducted at the emergency room of the Sacré-Cœur hospital, requires the recruitment of 60 subjects and involves some telephone follow-up.

Calcitonin administered as an intranasal spray is already used to relieve pain caused by broken vertebrae and we seek to determine if it can be as efficient in the case of pain caused by broken ribs.This study aims at testing the hypothesis that subjects suffering from the accidental fracture of one or more ribs will get relief through the intranasal spraying of calcitonin and/or will use less opiate medication for pain relief (a combination of oxycodone chlorhydrate and acetaminophen called Percocet®).


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or more.
* Accidental rib fracture (one or more) visible on a lung\\thorax radiography, or on a CT Scan of the thorax, as determined by the emergency physician or the radiologist.
* The rib fracture is the main cause of pain.
* The patient says yes to the question "do you wish something for your pain" (the result of the quantitative assessment of the pain in not taken into consideration) or the patient has already received an analgesic before the initial assessment by the emergency physician.
* The patient is seen no more than 48 hours after the accident.

Exclusion Criteria:

* The patient is already receiving SC.
* Allergy or intolerance to SC, oxycodone chlorhydrate or acetaminophen
* Active neoplasia history for at least 5 years
* Toxicomania history as revealed by case history
* Osteoporosis linked to hyperparathyroidism
* Patient already using opiate analgesics or other analgesics on a regular basis (excluding aspirin at doses of 325 mg or less, as a prophylactic for cardiovascular diseases and under stable posology for at least 15 days)
* Steroid use within the past month
* Pregnancy, breast feeding
* Non-availability of patient for telephone follow-ups or follow-up appointments.

Primary outcomes:
measure: Reduction of the pain level by 30% as measured on the visual analog scale of 0-100 mm on days 1, 3, 7, 14, 21, 28.
measure: and/or reduction the use of back-up medication on days 1, 3, 7, 14, 21, 28.
Secondary outcomes:
measure: Improvement in the quality of life and sleep.
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital du Sacré-Coeur
state: Quebec
Study officials:
affiliation: Centre de recherche hôpital du Sacré-Coeur de Montréal
name: Raoul Daoust, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03068208: Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians
Official title: Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians: Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lichen Amyloidosis
Keywords: Methylene blue
photodynamic therapy
primary cutaneous localized amyloidosis
lichen amyloidosis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of Methylene blue mediated Photodynamic therapy for primary localized cutaneous amyloidosis treatment in Asians, pilot study.


Eligibility criteria: Inclusion Criteria:

* Patients, aged \> 18 years old with lichen amyloidosis diagnosed by using clinical presentation and pathological findings.

Exclusion Criteria:

* Those with systemic disease associated cutaneous amyloidosis
* Pregnancy or lactating woman
* Those who are allergic to urea, olive oil
* Those who are photosensitive to ultraviolet radiation
* Those who had been previously treated with any of which -medications, radiation, laser within 3 months and 1 month for topical therapy

Primary outcomes:
measure: Roughness evaluation by using visioscan
timeFrame: Change from baseline roughness at every 2 weeks up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
affiliation: Chulalongkorn University
name: Einapak Amnarttrakul, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06340308: Clinical Study With Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol
Official title: Clinical Study With Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyslipidemias
Lead sponsor: University of Pavia
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2024-04-01
Enrollment: 36
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: To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol on lipid profile

Detailed description: To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol compared to placebo on lipid profile in patients with LDL cholesterol \> 115 and \< 190 mg/dl.Patients were allocated to receive 1 or 2 tablets of the nutraceutical for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* LDL Cholesterol \> 115 mg/dl and \< 190 mg/dl
* primary prevention

Exclusion Criteria:

* patients with neoplastic and liver diseases, renal failure and diabetes mellitus
* pregnant or breastfeeding women
* hypersensitivity to any of the ingredients
* therapy with lipid-lowering drugs

Primary outcomes:
measure: Variations of lipid profile
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo Foundation
Study officials:
References:
Clinical trial NCT00401908: Factors Contributing To Cardiovascular Morbidity and Mortality in Patients With Gastrointestinal Bleeding
Official title: Factors Contributing To Cardiovascular Morbidity and Mortality in Patients With Gastrointestinal Bleeding
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastrointestinal Bleeding
Acute Coronary Syndrome
Keywords: Acute gastrointestinal bleeding
Acute coronary syndrome
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2006-11-22
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population.

Brief summary: The rate of complication and death of patients with acute digestive tract bleeding is increased in the setting of acute coronary heart disease. The aim of the study is to establish the relative importance of the risk factors contributing to the death rate from acute digestive tract bleeding in patients admitted with acute coronary heart disease.

Detailed description: The rate of complication and death of patients with acute digestive tract bleeding is increased in the setting of acute coronary heart disease. The aim of the study is to establish the relative importance of the risk factors contributing to the death rate from acute digestive tract bleeding in patients admitted with acute coronary heart disease. This study will be conducted at MMC and involve collecting your clinical information from our medical records and computer systems. Approximately 200 adult patients with acute coronary heart disease and acute digestive tract bleeding admitted to MMC will be enrolled and followed up for 1 year after recruitment. We propose to develop criteria and a scoring system that will assist your doctors in caring for patients like you in the future.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with acute CS and acute GI bleeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: Jianjun Li, MD
role: STUDY_DIRECTOR
affiliation: Maimonides Medical Center
name: Scott M Tenner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maimonides Medical Center
name: Jacob Shani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maimonides Medical Center
name: Ting-Hui Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01217008: Safety Study of GRNOPC1 in Spinal Cord Injury
Official title: A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
GRNOPC1
Lead sponsor: Lineage Cell Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI).


Eligibility criteria: Major Inclusion Criteria:

* Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation \< 5 levels
* Last fully preserved neurological level from T-3 through T-11
* From 18 through 65 years of age at time of injury
* Single spinal cord lesion
* Informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 11 days following injury
* Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI

Major Exclusion Criteria:

* SCI due to penetrating trauma
* Traumatic anatomical transection or laceration of the spinal cord
* Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations
* Inability to communicate effectively with neurological examiner
* Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
* History of any malignancy
* Pregnant or nursing women
* Body mass index (BMI) \> 35 or weight \> 300 lbs.
* Active participation in another experimental procedure/intervention

Primary outcomes:
measure: Safety
timeFrame: One year
Secondary outcomes:
measure: Neurological function
timeFrame: One year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Palo Alto/San Jose
country: United States
facility: Stanford University/Santa Clara Valley Medical Center
state: California
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Medical Center/Kernan Orthopaedics and Rehabilitation Hospital
state: Maryland
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT00764608: Study of the Human Skin Microbiome
Official title: Study of the Human Skin Microbiome
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Healthy
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is the goal of the study to survey multiple skin locations of humans at multiple time points

Brief summary: Numerous organisms live on and in healthy human skin. This study seeks to survey the diversity of this complex ecosystem by collecting samples from approximately 1000 individuals in order to determine the type of organisms living on their skin.

Detailed description: Subjects age 18 and above may be included in the study. It is the goal of the study to survey multiple skin locations of humans at multiple time points. The subjects' samples will be analyzed using DNA methods in order to identify the types of microbes present on the swabs. Other substances such as proteins, RNA, and other metabolites may also be analyzed. DNA or other molecular components of the sample will be extracted. Alternately, microbes in the sample can be cultured directly. The samples will be explored using molecular analyses. The backbone of the analyses will be shotgun metagenomic sequencing and 16S rDNA amplicon sequencing. The results of these analyses will be used to identify and describe the microbiome of the skin.

Eligibility criteria: Inclusion Criteria:

* Subjects must be 18 years of age or older.
* Subjects must be able to consent for themselves.
* Must be willing to participate to a swab of the skin.

Exclusion Criteria:

* Subjects cannot be 17 years of age or younger.

Primary outcomes:
measure: Numerous organisms live on and in healthy human skin. This study seeks to survey the diversity of this complex ecosystem by collecting samples from approximately 1000 individuals in order to determine the type of organisms living on their skin.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Southwest Regional Wound Care Center
state: Texas
Study officials:
affiliation: Southwest Regional Wound Care Center
name: Randall Wolcott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02500823: Association Between Mitochondrial DNA Content and Risk of Coronary Heart Disease
Official title: Association Between Mitochondrial DNA Copy Number in Peripheral Blood Cells and Risk of Developing Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: Mitochondrial DNA copy number
Peripheral blood cells
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 200 eligible CHD patients were anticipated to include in this study.Moreover, The 200 healthy controls without previous CHD history were also recruited from individuals who visited investigator's hospital for physical examination during the same time period.

Brief summary: Compelling epidemiological evidence indicates that alterations of mitochondrial DNA, including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with the initiation and development of cardiovascular disease. This study was undertaken to investigate whether mtDNA copy number in peripheral blood cells could be used as a risk predictor for coronary heart disease.


Eligibility criteria: Inclusion Criteria:

1. History of documented myocardial infarction;
2. Prior coronary revascularization intervention (coronary artery bypass graft surgery or percutaneous coronary intervention);
3. The presence of ≥ 50% stenosis in one or more coronary arteries identified during cardiac catheterization;

Exclusion Criteria:

1. History of malignancy or end-stage renal disease;
2. Blood transfusion within one month or prior bone marrow transplantation
3. Patients who reluctant to sign informed consent

Primary outcomes:
measure: Relative copy number of mitochondrial DNA
timeFrame: From date of percutaneous coronary intervention until the date of discharging from hospital, assessed up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: WenYi Guo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu LP, Cheng K, Ning MA, Li HH, Wang HC, Li F, Chen SY, Qu FL, Guo WY. Association between peripheral blood cells mitochondrial DNA content and severity of coronary heart disease. Atherosclerosis. 2017 Jun;261:105-110. doi: 10.1016/j.atherosclerosis.2017.02.013. Epub 2017 Feb 20.
Clinical trial NCT06458023: TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age
Official title: Train-of-four Monitoring Using the Tetragraph Neuromuscular Transmission Monitor and Comparison to Standard (Visual) Train-of-four Assessment With a Peripheral Nerve Stimulator in Patients Less Than 1 Year of Age.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in pediatric patients less than 1 year of age and when feasible to compare it to standard TOF monitoring using a qualitative monitor.


Eligibility criteria: Inclusion Criteria:

* ASA 1-4
* ≤ 1 year of age
* undergoing a surgical procedure with general anesthesia and requiring the administration of an NMBA

Exclusion Criteria:

* Patients less than 28 days old
* Patients with history of a peripheral neurologic or neuropathic disorder
* Patients in whom the upper extremity cannot be used for TOF monitoring
* Patients undergoing a surgical procedure in which neuromuscular blockade is not required
* Edematous patients

Primary outcomes:
measure: EMG changes
timeFrame: During the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT06484023: Posterior Tibial Transcutaneous Neurostimulation in Idiopathic Overactive Bladder
Official title: Place and Efficacy of Treatment With Posterior Tibial Transcutaneous Neurostimulation in Women With Idiopathic Overactive Bladder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: neurostimulation
Lead sponsor: Hopital Nord Franche-Comte
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for overactive bladder and using the TENSI+ for at least 3 months

Brief summary: Overactive bladder is a clinical diagnosis affecting up to 17% of women. The existing medical treatment, anticholinergics, has many side effects and is sometimes ineffective. Neurostimulation of the posterior tibial nerve is a validated 3rd-line therapy, after failure of perineal re-education and medication. Studies on TENS have shown a real impact on patients quality of life and encourage its use in routine clinical practice. TENSI+ medical device is a treatment for overactive bladder. It is non-invasive, placed over the posterior tibial nerve pathway and sends electrical stimulation via electrodes located on the skin. Discreet and without side effects for users, this treatment is indicated as 3rd-line treatment for people suffering from idiopathic overactive bladder with no contraindications. The aim of this study is to assess the quality of life of patients using this device, both before use and after at least 3 months of use.


Eligibility criteria: Inclusion Criteria:

* Patients treated for overactive bladder
* Patients using the TENSI+ for at least 3 months

Exclusion Criteria:

* Neurological disease that may explain overactive bladder
* Patient having received anticholinergic drug treatment during neurostimulation.
* Have one or more contraindications to wearing the device: pacemaker, defibrillator, wearing a mechanical implant near the electrode placement area, ankle joint problems, damaged skin, cognitive impairment.

Primary outcomes:
measure: Assessment of quality of life in patients who received treatment correctly treatment with TENSI +
timeFrame: Comparison before/after 3 month at least of TENS use
Secondary outcomes:
Other outcomes:
Locations:
city: Trevenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References: