louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04452110: Investigation of the Reliability of Ultrasonography Usage in the Diagnosis of Temporomandibular Joint Diseases
Official title: Investigation of the Reliability of Ultrasonography Usage in the Diagnosis of Temporomandibular Joint Diseases: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Device Reliability
Keywords: Ultrasonography
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Applying to Our University

Brief summary: In the literature, temporomandibular joint diseases on the diagnostic value of the use of ultrasonography in diagnosis studies are lacking. In this study in the diagnosis of temporomandibular joint diseases revealing the reliability of the use of ultrasonography. It is aimed to contribute to the literature in terms of.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 who apply with TMJ problems
* Patients with pain in the joint and chewing muscle area

Exclusion Criteria:

* Syndromic patients
* Patients under the age of 18
* Patients with a history of orthognathic surgery
* Pregnants
* Antidepressant Users
* Patients Using Removable Dentures
* Patients who have had joint treatment in the past six months

Primary outcomes:
measure: Joint Pain Scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Dentistry Faculty
state: Fatih
Study officials:
References:
citation: Erturk AF, Yelken Kendirci M, Ozcan I, Gokcen Rohlig B. Use of ultrasonography in the diagnosis of temporomandibular disorders: a prospective clinical study. Oral Radiol. 2023 Apr;39(2):282-291. doi: 10.1007/s11282-022-00635-w. Epub 2022 Aug 3.
Clinical trial NCT00005410: Epidemiology of Coronary Heart Disease in Blacks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Coronary Disease
Myocardial Infarction
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To conduct an analysis of the epidemiology of coronary heart disease (CHD) in Blacks using data collected from the 'Survival and Ventricular Enlargement (SAVE) Following Myocardial Infarction' study.

Detailed description: BACKGROUND:

Ample data now exist to dispel the prevailing clinical impression that coronary heart disease (CHD) occurs infrequently in United States Blacks. It is well known that CHD is the leading cause of death among United States Blacks. Among patients with acute myocardial infarction who often present with typical ischemic chest pain, it has been shown that Blacks present more often without chest pain when compared to whites and Hispanics. In addition, more than 25 percent of the myocardial infarction patients have unrecognized infarctions. Morbidity and mortality associated with angina pectoris, cardiovascular disease, and myocardial infarction occurs in United States Blacks at rates which are at least comparable to their white counterparts. Yet, there are limited epidemiological studies designed to identify the determinants of CHD in the Black population.

The patients were originally screened to participate in a multicenter clinical trial on 'Survival and Ventricular Enlargement (SAVE) Following Myocardial Infarction.' Only 28 patients out of 599 screened subjects were eligible for the SAVE study. The baseline data obtained from the 599 screened subjects comprised the database.

DESIGN NARRATIVE:

Data analysis was performed to: determine the prevalence of coronary heart disease in Blacks presenting with chest pain; identify the correlates of CHD in Blacks; determine the sensitivity and specificity of a Rose questionnaire angina in Blacks; determine the association between the Rose questionnaire angina and CHD manifestations in Blacks, and identify predictive and causal models of CHD.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Peniston RL, Adams-Campbell L, Fletcher JW, Williams EC, Murigande C, Mensah E, Crittenden MD, Diggs JA. Coronary arteriographic findings in black patients and risk markers for coronary artery disease. Am Heart J. 1994 Mar;127(3):552-9. doi: 10.1016/0002-8703(94)90662-9.
citation: Adams-Campbell LL, Peniston RL, Kim KS, Mensah E. Body mass index and coronary artery disease in African-Americans. Obes Res. 1995 May;3(3):215-9. doi: 10.1002/j.1550-8528.1995.tb00141.x.
Clinical trial NCT05160610: Improving Thrombolysis Implementation Based on Electronic Monitoring in Acute Ischemic Stroke (ITEM)
Official title: Improving Thrombolysis Implementation Based on Electronic Monitoring in Acute Ischemic Stroke (ITEM): a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thrombolysis Rate
Keywords: Acute ischemic stroke
Electronic monitoring
Intravenous thrombolysis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 2720
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: A cluster randomized controlled trial will be conducted. Hospitals in Zhejiang Province, China, will be randomized into two arms (1:1): an intervention arm and a control arm.

Hospitals in the intervention arm will receive a multilevel intervention based on the AACTT theory, whereas hospitals in the control arm will receive no intervention and maintain routine care. All the hospitals will receive electronic monitoring. Hospitals with no stroke center or with \<20 cases received thrombolysis per year will be excluded from the study.


Eligibility criteria: Inclusion Criteria:

1. Patients presented with clinical signs of acute ischemic stroke within 4.5 hours of stroke onset
2. Patient's age is \>18 years

Exclusion Criteria:

Contraindication for intravenous thrombolysis

Primary outcomes:
measure: Thrombolysis rate within 4.5 hours
timeFrame: Up to 4.5 hours
Secondary outcomes:
measure: Thrombolysis rate within 3 hours
timeFrame: Up to 3 hours
measure: Excellent neurological outcomes
timeFrame: At 90 days
measure: Favorable neurological outcomes
timeFrame: At 90 days
measure: modified Rankin Scale score
timeFrame: At 90 days
measure: All-cause death rate
timeFrame: At 90 days
measure: Hemorrhagic transformation
timeFrame: At 7 days
measure: Symptomatic intracranial hemorrhage
timeFrame: At 7 days
measure: Door-to-image time
timeFrame: Up to 4.5 hours
Other outcomes:
measure: the proportion of acute ischemic stroke patients with Door-to-Needle Time≤60min
timeFrame: Up to 4.5 hours
measure: Door-to-needle time
timeFrame: Up to 4.5 hours
measure: Onset-to-needle time
timeFrame: Up to 24 hours
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Ethics committee the second affiliated hospital, school of medicine, Zhejiang University, China
name: Zexin Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00210210: Administration of Ketamine to Prevent the Post-operative Pain
Official title: Effect of Ketamine, at the Induction and Its Maintenance to Prevent the Post-operative Pain: Clinical Trial in Cancerology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Breast Cancer
Keywords: Post-operative-pain
Breast cancer
Morphine
Analgesia
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The surgery of breast cancer is responsible for post-operative pain, needing in about 30% some morphine consumption; like that, the association of ketamine with general anaesthesia may decrease morphine's use and so its adverse effects. The purpose is to evaluate the analgesic effect of a receptor NMDA's antagonist ( ketamine)


Eligibility criteria: Inclusion criteria:

* Patients 18 years older
* ASA class 1 or 2
* with surgery of breast cancer (mastectomy or tumorectomy)

Exclusion criteria:

.Kétamine hypersensitivity

* Major psychiatric disorders
* Major cardio-vascular disorders
* Major neurologic disorders
* Major ocular disorders
* Morphine in pre-operative period

Primary outcomes:
measure: Morphine consumption (first 48 post-operative hours)
Secondary outcomes:
measure: Visual analog rating scale during the first 48 post-operative hours: at 15mn,1H,2H,12H, 24H,36H,48H
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Study officials:
affiliation: Institut Bergonié
name: Sylvie COLOMBANI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04868110: Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion
Official title: Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion by Increasing Fiber Intake and Changing the Maternal Microbiome During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Weight Gain
Maternal Fat Accretion
Infant Fat Accretion
Keywords: Fat mass
Gestational weight gain
Infant fat mass
High fiber
Microbiome
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women in the control group will participate in weekly lessons for 18 weeks on eating a high fiber diet and will received daily snacks.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to learn if consuming a high fiber diet will reduce gestational weight gain and maternal and infant fat accretion.


Eligibility criteria: Inclusion Criteria:

* Pre-pregnancy BMI 18.5 - 45.0 kg/m2

Exclusion Criteria:

* Comsuming more than 20 g/day of fiber
* No phone and internet access
* Pre-gestational diabetes
* Diagnosed with diabetes
* Pre-eclampsia
* Hypertension
* Other metabolic abnormalities
* Asthma
* Heart disease
* Smoking
* Drug abuse
* Recent antibiotic use
* Pregnancies of multiples

Primary outcomes:
measure: Maternal Weight Changes
timeFrame: Baseline through 2-mounths postpartum
measure: Maternal Fat Accretion Changes
timeFrame: Baseline through 2-mounths postpartum
measure: Identify Changes in Fiber Intake
timeFrame: Baseline through 2-months postpartum
measure: Identify Changes in Dietary Quality
timeFrame: Baseline through 2-months postpartum
Secondary outcomes:
measure: Infant Fat Accrual
timeFrame: Birth to 12-month old
measure: Maternal Weight
timeFrame: 2-months through 12-months postpartum
measure: Maternal Fat Accretion
timeFrame: 2-months through 12-months postpartum
measure: Dietary Fiber Intake
timeFrame: 2-months through 12-months postpartum
measure: Dietary Quality
timeFrame: 2-months through 12-months postpartum
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Holly Hull, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956410: To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
Official title: An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Active immunization
Alzheimer disease
Antibody
Central Nervous System Diseases
Neurodegenerative diseases
Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-08-11
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Patients who have completed the Core study with no significant safety concerns

Exclusion Criteria:

* Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression).
* Diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease.
* diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation.

Primary outcomes:
measure: Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66.
timeFrame: 66 weeks
Secondary outcomes:
measure: Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through to the end of the study to week 66.
timeFrame: 66 weeks
measure: Evaluate the antibody response after 4 additional injections in the Extension study in patients initially treated with CAD106 in the Core study.
timeFrame: 66 weeks
measure: Collect long-term safety information through SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1.
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Southampton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Abeta immunotherapy with CAD106 in mild Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 27;7(1):23. doi: 10.1186/s13195-015-0108-3. eCollection 2015.
Clinical trial NCT00093210: Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B
Official title: A Double-Blind, Randomized, Crossover Evaluation of the Pharmacokinetics of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R); and an Open-Label Safety and Efficacy Evaluation of rFIX-R in Previously Treated Patients With Moderate to Severe (FIX:C≤2%) Hemophilia B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemophilia B
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-10-07
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this clinical research study is to establish the bioequivalence of 2 treatments, rFIX and rFIX-R, when given as a 10-minute intravenous bolus infusion.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe hemophilia B (FIX: C ≤2%)
* Previously treated patients (PTPs) with ≥150 documented exposure days
* Age ≥ 12 years (US sites only)

Exclusion Criteria:

* Detectable factor IX inhibitor defined as ≥0.6 Bethesda Units for pooled plasma reported by the local laboratory (family history of inhibitors will not exclude the patient)
* Patient history of factor IX inhibitor replacement therapy
* Patient unable to be off factor IX replacement therapy for at least 5 days without bleeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
citation: Rendo P, Smith L, Lee HY, Shafer F. Nonacog alfa: an analysis of safety data from six prospective clinical studies in different patient populations with haemophilia B treated with different therapeutic modalities. Blood Coagul Fibrinolysis. 2015 Dec;26(8):912-8. doi: 10.1097/MBC.0000000000000359.
Clinical trial NCT01557010: Evaluate the Efficacy and Safety of DWP05195 in Subjects With Post-Herpetic Neuralgia
Official title: The Clinical Trial for Evaluation of Efficacy and Safety of DWP05195 in Postherpetic Neuralgia: Double-blind, Placebo-controlled, Randomized, Multi-center, Exploratory Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy, safety of administered DWP05195 in Postherpetic Neuralgia.


Eligibility criteria: Inclusion Criteria:

* Male or Female subjects aged 20 to 80 years
* Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia(PHN).
* Subjects must have pain present for \> 3 months after healing of the acute herpes zoster skin rash.

Exclusion Criteria:

* Other severe pain that may potentially confound pain assessment.
* Subjects with symptoms of neuropathic pain applied Medical Equipment
* Within 2 years: Subjects were diagnosed with cancer

Primary outcomes:
measure: Endpoint change from the baseline after administered 8 weeks mean pain score based on the Numerical pain Rating Scale(NPRS) from the subject's daily pain diary
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00324610: Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen
Official title: Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Breast Neoplasms
Chemotherapy
Keywords: fluoropyrimidines
metastases
pharmacokinetics
phase 1-2 study
Lead sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Sponsor class: OTHER
First posted: 2006-05-11
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity.

Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen.

Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen


Eligibility criteria: Inclusion Criteria:

* Histologically proven breast adenocarcinoma
* Evaluable or measurable metastases
* HER-2 status 0 or 1 in immnohistochimy or negative in FISH/CISH
* Previously treated with anthracyclines and taxanes
* Age \> = 18 y
* No more than two previous chemotherapy regimens for metastases
* No nervous central system involvement
* Hormonal therapy must have been stopped two weeks before enrollment
* Adequate biologic function
* Performance status OMS \< = 2
* Signed informed consent

Exclusion Criteria:

* History of other malignancies, except basocellular cancer, in situ cervix carcinoma
* Gastro intestinal disease that might affect absorption of capecitabine
* Cardiac failure or angina pectoris uncontrolled
* Hypersensitivity for capecitabine, fluorouracil, or one of their excipient
* Known dihydropyrimidine dehydrogenase (DPD) deficiency
* Concomitant anticancer therapy (included hormonotherapy)
* Concomitant radiotherapy
* Treatment with sorivudine and analogs
* Pregnant or breast feeding patients. Contraception methods excluding hormonal treatment is required.
* Inclusion in an experimental protocol within 30 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Ho¨Pital Europeen Georges Pompidou
Study officials:
affiliation: HEGP , PARIS
name: eric levy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL TENON, PARIS
name: joseph Gligorov, MD
role: STUDY_CHAIR
affiliation: CENTRE RENE HUGUENIN, SAINT CLOUD, FRANCE
name: Michèle TUBIANA HULIN, MD
role: STUDY_CHAIR
affiliation: INSTITUT CURIE, PARIS france
name: VERONIQUE DIERAS, MD
role: STUDY_CHAIR
affiliation: centre antoine lacassagne, NICE, France
name: Rémi LARGILLIER, MD
role: STUDY_CHAIR
References: