louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03605173: Study on the Correlation of Free Vitamin d With BMD and Fracture
Official title: Free Vitamin D Correlate Better With BMD and Fracture Than Total Serum Vitamin D?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 125
Sex: ALL
Minimum age (years): 48
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: According to the free hormone hypothesis, the biological activity of a hormone is carried by the portion that is not bound to protein or its carrier in circulation. Based on this, we believe that the free vitamin d, which is the proportion of Vitamin D unbound to vitamin D binding protein and albumin, performs the calcium-regulating functions of the vitamin. Hence, our objective is to study whether free vitamin correlated better with BMD and fracture than the total vitamin D.

Detailed description: Osteoporosis is a major health issue worldwide as it increases the risk of fragility fracture and chronic disability. The studies on the association between vitamin d and osteoporosis have yielded conflicting results. While some have shown a positive correlation, others have concluded that there is no association at all. Recent reports have shown vitamin D supplementation do not prevent fragile fractures. This might be because the actual vitamin D status, which should be the free vitamin D, has not been measured.

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of osteoporosis and with or without fracture
* post- menopausal women
* age \> 48 years

Exclusion Criteria:

* vitamin D supplementation in recent 6 months
* patients on steroid
* age \< 48 years
* patients with chronic diseases such as liver cirrhosis, renal failure, hypertension, hyperparathyroidism

Primary outcomes:
measure: Free vitamin D
timeFrame: ! day
measure: Total vitamin D
timeFrame: ! day
Secondary outcomes:
measure: BMD
timeFrame: ! day
measure: Vertebral fracture
timeFrame: ! day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third affiliated hospital of sun yat sen university
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Kishor Chhantyal, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chhantyal K, He L, Mo J, Yin M, He T, Chen Y, Yang Y, Zhang L, Rong L. Free vitamin D correlate better with bone mineral density and thoracolumbar junction osteoporotic vertebral fractures than serum vitamin D. BMC Musculoskelet Disord. 2020 Mar 12;21(1):164. doi: 10.1186/s12891-020-3179-7.
Clinical trial NCT03823573: Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty
Official title: Prospective Clinical Trial Regarding the Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty in Rio Hortega University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fast Track
Tranexamic Acid Adverse Reaction
Knee Osteoarthritis
Keywords: fast track
total knee arthroplasty
tranexamic acid
drain
Lead sponsor: Hospital del Rio Hortega
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 175
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients undergoing total knee arthroplasty will follow two different rehabilitation protocols. In one of them, they will start walking the day of surgery and discharged on a 48 hours basis. On the other one, start walking 3 days after surgery and discharged on a 96 hours basis. Outcomes will be satisfaction, pain, range of movement, incidence of DVT and overall complications.

Detailed description: Randomization will be performed concealed the day before surgery. Tranexamic acid will be used in both groups. Rapid recovery group will not be using a drain, whereas the standard protocol group will have one.

Eligibility criteria: Inclusion Criteria:

* Knee osteoarthritis willing to undergo total knee arthroplasty
* Age 55-79
* Consent

Exclusion Criteria:

* Hipersensibility to any of the components used
* Epilepsy
* Pulmonary embolism

Primary outcomes:
measure: Pain: Morphine clorhydrate shots requested by the patient
timeFrame: 24 hours
measure: Range of Motion
timeFrame: 6 months
measure: Ultrasonography incidence of deep vein thrombosis
timeFrame: 4 weeks-8 weeks
measure: Overall score given by the patient to the knee replacement process
timeFrame: 6 months
measure: Infection
timeFrame: 1 year
measure: Blood loss
timeFrame: 48 hours
measure: Oxford Knee Score pre op and post op
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Universitario del Río Hortega
Study officials:
References:
Clinical trial NCT00643773: The Effect of Leucine on Body Composition and Muscle Characteristics in Elderly, Type 2 Diabetes Patients
Official title: The Influence of Leucine Supplementation on Body Composition and Muscle Characteristics in Elderly, Type 2 Diabetes Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Keywords: Elderly
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2008-03-26
Enrollment: 60
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The purpose of this study is to determine whether long term leucine supplementation has a positive effect on body composition and muscle characteristics in elderly, type 2 diabetes patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes

Exclusion Criteria:

* Impaired renal or liver function
* Cardiac disease
* Subjects with metal implants
* Hypertension
* Diabetes complications
* Exogenous insulin therapy

Primary outcomes:
measure: Body Composition
timeFrame: 1, 3, and 6 months
Secondary outcomes:
measure: Muscle characteristics
timeFrame: 1, 3, and 6 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Marika Leenders, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leenders M, Verdijk LB, van der Hoeven L, van Kranenburg J, Hartgens F, Wodzig WK, Saris WH, van Loon LJ. Prolonged leucine supplementation does not augment muscle mass or affect glycemic control in elderly type 2 diabetic men. J Nutr. 2011 Jun;141(6):1070-6. doi: 10.3945/jn.111.138495. Epub 2011 Apr 27.
Clinical trial NCT05724173: Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
Official title: Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anarthria
Dysarthria
Tetraplegia
Spinal Cord Injuries
Amyotrophic Lateral Sclerosis
Brain Stem Infarctions
Locked in Syndrome
Muscular Dystrophies
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2023-02-13
Enrollment: 2
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: OTHER

Brief summary: The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

Detailed description: The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 80 years of age.
* Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
* Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
* Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.

Exclusion Criteria:

* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
* Chronic oral or intravenous steroids or immunosuppressive therapy
* Other serious disease or disorder that could seriously affect ability to participate in the study

(There are additional exclusion criteria)

Primary outcomes:
measure: Device Safety
timeFrame: 1 year
Secondary outcomes:
measure: Device Feasibility
timeFrame: At participant exit from study, or up to 5 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Stanford University
name: Jaimie Henderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03252873: THE FACTORS AFFECTING THE ADHERENCE TO THE PULMONARY REHABILITATION PROGRAM IN COPD
Official title: INVESTIGATION THE FACTORS AFFECTING THE ADHERENCE TO THE OUTPATIENT PULMONARY REHABILITATION PROGRAM IN COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: adherence
pulmonary rehabilitation
copd
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All COPD patients refered to the pulmonary rehabilitation unit.

Brief summary: Investigators will compare the factors affecting the adherence to the outpatient pulmonary rehabilitation program in COPD patients

Detailed description: Patients were referred to the Pulmonary Rehabilitation Unit and were recommended to participate in the exercise program by a team of experts included in this study.

Demographic and clinical characteristics of patients were recorded before the pulmonary rehabilitation program. All cases were evaluated by pulmonary function test, arterial blood gas analysis, six minute walking test, MMRC Dyspnea Scale. Causes that prevented program adaptation of those who did not participate in the program or who left the program were questioned. Patients completing the eight-week PR program will compare with those who did not complete the program or who did not start the program at the recommended time.

Eligibility criteria: Inclusion Criteria: COPD Patients referred to the outpatient pulmonary rehabilitation unit -

Exclusion Criteria: To be unvolunteer

-

Primary outcomes:
measure: Respiratory Function Test
timeFrame: 15 minutes
Secondary outcomes:
measure: Blood Gase Analysis
timeFrame: 5 minutes
measure: Six minute walk test
timeFrame: 10 minutes
measure: MMRC Dyspnea Scale
timeFrame: 5 minutes
measure: SGRQ Questionnaire
timeFrame: 20 minutes
measure: HAD Questionnaire
timeFrame: 15 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01912573: Nasal Naloxone for Narcotic Overdose
Official title: Nasal Naloxone for Narcotic Overdose
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Drug Overdose
Keywords: heroin
prescription pain killers
narcotics
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 236
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine if nasal naloxone is inferior to standard care for naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to provide either standard care or nasal (IN) naloxone as the initial response to a suspected opioid overdose. Standard care includes administration of naloxone by intravenous (IV), intramuscular (IM) or intraosseus (IO) methods.

Detailed description: This is a randomized, prospective trial that will compare clinical outcomes for parenteral naloxone according to the standard of care (TAU; administration via intravenous \[IV\], intramuscular \[IM\] or intraosseus \[IO\] delivery) versus intranasal \[IN\] for the prehospital emergency treatment of suspected opioid overdose. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to administer either standard care or IN naloxone as the initial response to a suspected opioid overdose.

Eligibility criteria: Inclusion Criteria:

* Presence of hyperventilation or respiratory arrest OR
* EMS assessment that the person needs naloxone for possible opioid or unknown drug overdose

Exclusion Criteria:

* EMS assessment that the participant is less than 12 years old

Primary outcomes:
measure: Proportion of patients with adequate respiration within 10 minutes
timeFrame: 10 minutes after intervention administration
Secondary outcomes:
measure: Number of patients requiring second dose of naloxone
timeFrame: within 10 minutes of initial dose
measure: Time to first naloxone administration
timeFrame: at baseline
measure: Opioid Withdrawal Symptoms
timeFrame: baseline
measure: Naloxone Adverse Events
timeFrame: 3 hours
measure: Proportion of Patients breathing unassisted upon arrival to the hospital
timeFrame: within 1 hour
measure: Days of hospitalization following naloxone administration
timeFrame: 7 days
measure: Mortality rate
timeFrame: 7 days
Other outcomes:
Locations:
city: Batavia
country: United States
facility: Clermont County
state: Ohio
city: Portsmouth
country: United States
facility: Scioto County
state: Ohio
city: West Union
country: United States
facility: Adams County
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Judith Feinberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03260673: Corneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes Mellitus
Official title: 白内障超声乳化术对2型糖尿病患者角膜内皮细胞的影响 Corneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Diabetes Mellitus
Keywords: cataract
phacoemulsification
type 2 diabetes mellitus
corneal endothelial cells
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 58
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Among the 60 patients enrolled in this study, the experimental group was 77.5 ±9.2 years old, and the control age was 76.3±8.7 years, with no statistical difference (P = 0.87). All patients were treated for 3 months.

Brief summary: This study investigate the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.

Detailed description: The investigators do the clinical prospective study including 30 patients with type 2 diabetes and 30 control patients without diabetes scheduled to undergo cataract surgery. The corneal endothelial cell density, variation in endothelial cell size (CV), percentage of hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months postoperatively.Then, the investigators compared the two sets of data. At last observing the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.

Eligibility criteria: Inclusion Criteria:

the experimental group:

1. Clinical diagnosis of cataract
2. Type 2 diabetes mellitus
3. The recent blood glucose control was stable
4. The glycosylated hemoglobin \< 8%

The control group:

1. Clinical diagnosis of cataract
2. No history of type 2 diabetes

Exclusion Criteria:

1. Corneal lesions
2. Anterior inflammation
3. Ocular trauma or surgical history
4. Glaucoma
5. Corneal endothelial cell density \< 1500 / mm squared

Primary outcomes:
measure: Comparison of the corneal endothelial cell density before-after cataract surgery
timeFrame: half year
Secondary outcomes:
measure: Comparison of the endothelial cell size before-after cataract surgery
timeFrame: half year
measure: Comparison of the percentage of hexagonal cells before-after cataract surgery
timeFrame: half year
measure: Comparison of the central corneal thickness(CCT) before-after cataract surgery
timeFrame: half year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00279773: Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
Official title: A Phase I Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: Acute
Myeloid
Leukemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-01-20
Enrollment: 34
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: The primary objective is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of TKI258 when administered to subjects with acute myeloid leukemia (AML).


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Acute Myeloid Leukemia
* Eighteen years of age or older
* Life expectancy of at least 2 months

Exclusion Criteria:

* Intracranial disease or epidural disease
* Clinically significant cardiac disease
* Diabetes mellitus uncontrolled with medication
* Pregnant or breast feeding women
* Dementia or altered mental status
* Known pre-existing clinically significant or uncontrolled disorder of the hypothalamic-pituitary axis, adrenal or thyroid glands
* Previous pericarditis
* Malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea,diarrhea,vomiting

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: 28 days - dose-escalation; 4 months - dose-expansion
measure: Dose limiting toxicity
timeFrame: 28 days - dose-escalation; 4 months - dose-expansion
measure: Safety profile
timeFrame: 28 days - dose-escalation; 4 months - dose-expansion
Secondary outcomes:
measure: Evaluation of plasma pharmacokinetics and pharmacodynamics
timeFrame: 28 days - dose-escalation; 4 months - dose-expansion
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas, M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Wang X, Kay A, Anak O, Angevin E, Escudier B, Zhou W, Feng Y, Dugan M, Schran H. Population pharmacokinetic/pharmacodynamic modeling to assist dosing schedule selection for dovitinib. J Clin Pharmacol. 2013 Jan;53(1):14-20. doi: 10.1177/0091270011433330. Epub 2013 Jan 24.
Clinical trial NCT06809673: PA.RI.GE. Study. The Prognostic Role of Inflammatory Circulating Biomarkers in HNSCC: a Prospective Multicentric Trial
Official title: PA.RI.GE. Study. The Prognostic Role of Inflammatory Circulating Biomarkers in HNSCC: a Prospective Multicentric Trial
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Head and Neck Cancer
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by HNSCC (larynx, oral cavity, hypopharynx) treated with primary surgery +/- adjuvant treatment.

Not included patient with prior tumors or other immunosuppressive/immunostimalnt treatment or disease.

Brief summary: This is a clinical, observational, non-pharmacological, multicenter, prospective case-control no-profit study to assess the prognostic role of several circulating inflammatory biomarkers


Eligibility criteria: Inclusion Criteria:

1. Age \&gt; 18 years;
2. Written informed consent;
3. Squamous carcinoma of the hypopharynx, larynx and oral cavity;
4. Clinical stage I-IVa according to the VIII edition of AJCC staging system
5. Primary surgery as first line curative intent treatment, followed by ± adjuvant radiotherapy± chemotherapy based on the pathological findings following the NCCN guidelines

Exclusion Criteria:

1. Relapsing or metastatic disease
2. Locally advanced disease not amenable to curative intent treatment
3. Previous local or systemic treatment for head and neck cancer
4. Previous malignancies (exluding non-melanoma skin cancers) unless complete remission has been achieved at least 5 years before entering the study
5. Psychiatric disorder or known substance abuse
6. Concomitant immunosuppressive treatment
7. Concomitant immunostimulant treatment
8. Chronic inflammatory disease
9. Autoimmune disease
10. Major surgery in the previous year
11. History of recent onset of any condition which, in the investigator's opinion, could interfere with patient adherence for the entire duration of the protocol.
12. Positive serum pregnancy test for women of childbearing age. Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal.

Primary outcomes:
measure: To identify a profile of circulating biomarkers in patients affected by HNSCC
timeFrame: 72 months
measure: To identify a subset of patients in which biomarkers modifications might anticipate disease recurrence
timeFrame: 72 months
Secondary outcomes:
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS Policlinico San Martino
Study officials:
References:
citation: Zahorec R. Neutrophil-to-lymphocyte ratio, past, present and future perspectives. Bratisl Lek Listy. 2021;122(7):474-488. doi: 10.4149/BLL_2021_078.