louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04487665: Oral Manifestations of Coronavirus Disease 2019(COVID-19) :a Multicentre Study
Official title: Oral Manifestations of COVID-19: a Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patient with no previous serious illness - from different country

Brief summary: online questionnaire will be distributed in different country to detect the oral change in patient diagnosed with COVID-19

Detailed description: an online survey will be performed through google form. Investigators in different country will share the questionnaire with patient diagnosed positive COVID-19.

data collected will be statically analyse to detect the oral picture of the virus.

Eligibility criteria: Inclusion Criteria:

* positive COVID-19

Exclusion Criteria:

* children
* patient not confirmed by swab

Primary outcomes:
measure: oral ulcer
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: hyposalivation
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00362765: Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study
Official title: Assessment of Insulin Sensitivity in Type 2 Diabetics Treated With Metformin, Fenofibrate and Their Combination.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Dyslipidemia
Keywords: Type 2 Diabetes
Dyslipidemia
Hyperinsulinemic
Clamp
Metformin
Fenofibrate
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-08-10
Enrollment: 8
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double-blind, randomized placebo-controlled study in type 2 diabetes and dyslipidemic patients.Patients will be randomized to one of four treatment arms for 16 weeks: placebo, fenofibrate, metformin, or metformin and fenofibrate combination.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria:

* Type 1 diabetes.

Primary outcomes:
measure: Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC)
timeFrame: 16 weeks
Secondary outcomes:
measure: Gluconeogenesis, Glycogenolysis, Skeletal muscle and liver fat content, Abdominal fat content, Body energy expenditure and respiratory quotient, Lipids and glycemic parameters
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Site 2
city: Dublin
country: Ireland
facility: Site 3
city: Pisa
country: Italy
facility: Site 1
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT03931265: Ketohexokinase Isoforms in Endometrial Cancer.
Official title: Prognostic Evaluations of Ketohexokinase Isoforms in Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Gynecologic Oncology Group
First posted: 2019-04-30
Enrollment: 220
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with endometrial cancer who underwent staging surgeries in the Far Eastern Memorial Hospital

Brief summary: Our preliminary analysis with clinical database suggested that, in patients with type I endometrial cancer, high ketohexokinase-expressing group have lower survival probabilities than low ketohexokinase-expressing group. To understand the importance of ketohexokinase expression and isoform switch during the development of type I endometrial cancer, we propose a series of in vitro experiments and clinical examinations in this project.


Eligibility criteria: Inclusion Criteria:

* \>20 years
* Women with endometrial cancer who are about to be admitted to hospital for gynecological staging.
* Women who have undergone gynecological staging surgery for endometrial cancer in the past.

Exclusion Criteria:

* Women with endometrial cancer who receive preoperative chemotherapy or radiation therapy.

Primary outcomes:
measure: The role of ketohexokinase isoforms in the overall survival of endometrial cancer.
timeFrame: 5 years
Secondary outcomes:
measure: Correlation of ketohexokinase isoforms with the other prognostic risk factors
timeFrame: 5 years
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT01179165: Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients
Official title: Application in High Risk Groups of Recently Developed Noninvasive Methods in Diagnosing Coronary Heart Disease.A Community Based Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Volda Hospital
First posted: 2010-08-11
Enrollment: 104
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes without known cardiac disease between 40 and 75 years of age

Brief summary: The purpose of this study is to investigate the prevalence of cardiac disease/coronary artery disease and diagnostic yield of different non-invasive methods in patients with type 2 diabetes 40-75 years of age at examination. Exercise tests, Doppler echocardiographic examination with Tissue Velocity Imaging, stress Echocardiography, transthoracic Doppler of coronary arteries with coronary flow reserve, and cardiac MRI with late enhancement at rest, and perfusion after vasodilatation stress will be used in the study. A subpopulation will in addition measure forearm vasodilation(FMD) and CFR before and after 4 months of exercise training.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Age at diagnosis \> 30 years
* Age at inclusion 40-75 years

Exclusion Criteria:

* Angina pectoris
* Coronary angiography/stress-test diagnostic of coronary artery disease last 3 years
* Previous myocardial infarction, coronary bypass operation/PCI or heart failure
* Clinical indication for stress -testing
* Active bronchospasm excluding use of adenosine
* eGFR \< 30 ml/min/m2
* short estimated life expectancy due to cancer, chronic liver/renal diseases

Primary outcomes:
measure: Prevalence of cardiac abnormalities/disease according to different examination modalities
timeFrame: at primary examination
Secondary outcomes:
measure: Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI.
timeFrame: at baseline
measure: Relationship between CFR in LAD and forearm FMD
timeFrame: 4 months
measure: Doppler echocardiographic findings related to clinical, laboratory and MRI findings
timeFrame: at baseline
measure: Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI
timeFrame: 4 months
Other outcomes:
Locations:
city: Volda
country: Norway
facility: Volda Hospital HF
Study officials:
affiliation: Norwegian University of Science and Technology
name: Torstein L Hole, MD, PhD
role: STUDY_CHAIR
affiliation: Norwegian University of Science and Technology
name: Rune Wiseth, Md, Phd
role: STUDY_CHAIR
affiliation: Norwegian University of Science and Technology
name: Svein Hareide, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05759065: A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
Official title: A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 350
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: The overall objective of this study is to conduct a randomized effectiveness-implementation trial to test the non-inferiority of tele-Brief Behavioral Treatment for Insomnia vs. tele-Cognitive-Behavioral Therapy for Insomnia among socioeconomically disadvantaged adults with insomnia in the primary care setting.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Meet clinical diagnostic criteria for insomnia
* Insomnia severity score \> 10
* Eligible to receive care through publicly supported medical assistance, OR
* Identify as race or ethnic minority
* Has capacity for informed consent

Exclusion Criteria:

* Untreated, current major depressive disorder
* History of bipolar or psychosis
* Active substance abuse or drug abuse
* Excessive daytime sleepiness
* Seizure within the past 1 year
* Main sleep period outside of 8pm - 11am
* Regular nightshift work
* Untreated, previously diagnosed moderate to severe sleep apnea
* Severe medical condition, which may require hospitalizations over the next 6 months
* Active suicidal ideation, if elicited passively during screening
* Pregnant or planning to become pregnant

Primary outcomes:
measure: Insomnia severity index, ISI
timeFrame: 3 months
Secondary outcomes:
measure: Insomnia severity index, ISI
timeFrame: 6- and 12-months
measure: Quality of Life and Symptoms - Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
timeFrame: 3-months
measure: Quality of Life and Symptoms - Generic-quality of life
timeFrame: 3-months
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 3-months
measure: Patient Health Questionnaire for depression (PHQ-8)
timeFrame: 3-months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Impairment, 8a
timeFrame: 3-months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b
timeFrame: 3-months
measure: Diary reported sleep duration
timeFrame: 3-months
measure: Diary-reported sleep efficiency
timeFrame: 3-months
measure: Number of participants with hypnotic use self-reported from the sleep diary
timeFrame: 3-months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT02364765: Assessment of Hematologic Parameters Before and After Bimaxillary Orthognathic Surgery
Official title: Assessment of Changes of Hematological Parameters and Need for Blood Transfusion in Bimaxillary Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Blood Loss
Keywords: Maxillofacial Orthognathic Surgery
Hemoglobin
Red Blood Cells
Hematocrit
Blood Platelets
Body Weight
Operative Time
Age Groups
Gender
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the present study was to compare some hematologic parameters and operation time in patients who underwent esthetic bimaxillary surgery under hypotensive anesthesia.

Detailed description: Patients who underwent bimaxillary surgery were prospectively evaluated. Patients were divided into groups based on the surgical procedure and sex (predictor variables). Hemoglobin, red blood cells, hematocrit, and platelet were the primary outcome variables, operation time was the secondary outcome variable, and the patients' age and weight were the other variables.

Eligibility criteria: Inclusion Criteria:

* All consecutive patients listed for elective bimaxillary osteotomies for orthognathic correction by one surgical team, and admitted from August 2010 until June 2012.

Exclusion Criteria:

* Patients who were having single maxillary osteotomies, Le Fort II and III osteotomies, those with general contraindications for extensive surgical intervention, syndromic patients, those with cleft palate, and those with general diseases or hematological disorders.

Primary outcomes:
measure: Change in hematologic parameters
timeFrame: From immediately before the surgery until 24 h after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Department of Oral and Maxillofacial Surgery - Baleia Hospital
state: Minas Gerais
Study officials:
affiliation: Department of Morphology, Institute of Biological Sciences, Federal University of Minas Gerais
name: Antônio LN Custódio, DDS MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chrcanovic BR, Toledo GL, Amaral MB, Custodio AL. Assessment of hematologic parameters before and after bimaxillary orthognathic surgery. Oral Maxillofac Surg. 2016 Mar;20(1):35-43. doi: 10.1007/s10006-015-0525-2. Epub 2015 Aug 18.
Clinical trial NCT00052065: TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer
Official title: Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ovarian Neoplasms
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2003-01-23
Enrollment: 28
Sex: FEMALE
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: This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in patients with platinum refractory or resistant ovarian cancer.


Eligibility criteria: Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube cancer or primary peritoneal cancer
* Recurrent epithelial ovarian cancer or persistent disease following primary treatment
* At least one, but no more than four, prior platinum-containing chemotherapy regimens
* At least one prior taxane-containing regimen

Exclusion Criteria

* A history of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease-free for 2 years
* Known leptomeningeal metastases or carcinomatous meningitis
* Have received prior Doxil or other liposomal doxorubicin
* Having received whole pelvis radiation therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
References:
citation: Kavanagh JJ, Levenback CF, Ramirez PT, Wolf JL, Moore CL, Jones MR, Meng L, Brown GL, Bast RC Jr. Phase 2 study of canfosfamide in combination with pegylated liposomal doxorubicin in platinum and paclitaxel refractory or resistant epithelial ovarian cancer. J Hematol Oncol. 2010 Mar 11;3:9. doi: 10.1186/1756-8722-3-9.
Clinical trial NCT01458665: Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears
Official title: Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * The purpose of this study is to compare the clinical and anatomical outcomes of rotator cuff repair with Platelet-Rich Plasma (PRP) and conventional rotator cuff repair in treatment of medium to large rotator cuff tears.
* PRP application to arthroscopic rotator cuff repair would accelerate recovery after arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall satisfaction, and enhance structural integrity of repaired tendon.


Eligibility criteria: Inclusion Criteria:

medium to large rotator cuff tear as a determined by clinical examination and MR prior to surgery.

Exclusion Criteria:

* previous history of shoulder surgery
* acute trauma
* chronic dislocation
* pyogenic infection
* rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
* showed abnormal serological test results
* thrombocytopenia (platelets less than 15000 per microliter)
* had been received anti-platelet medication
* psychiatric problems that precludes informed consent or inability to read or write
* other serious problems that preclude participation of the study

Primary outcomes:
measure: Constant-Murley shoulder score
timeFrame: Postoperative 3months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Study officials:
affiliation: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
name: Chris H. Jo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01010165: Determination of New Biomarkers of Septic Arthritis by Surface-Enhanced Laser Desorption/Ionization Time-Of-Flight (SELDI-TOF)
Official title: Caractérisation de Nouveaux Biomarqueurs de l'Arthrite Septique Par Technique SELDI-TOF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Arthritis
Keywords: acute arthritis
bacteria
crystal arthritis
proteomic
SELDI-TOF
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-11-09
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from the Grenoble University Hospital

Brief summary: Septic arthritis is a frequent, potentially disabling and/or life-threatening disease. To diagnose a septic arthritis is a complex procedure, first because of numerous differential diagnoses (such as crystal arthritis), second because of poor sensitivity of initial gram staining (for example after untimely antibiotic therapy).

This protocol will use SELDI-TOF as a tool to analyse joint fluid of patients with various acute, polymorphonuclear-rich arthritis, as to determine specific and sensitive new biomarkers of a septic origin.

Such biomarkers will allow rapid diagnosis of septic arthritis in the first hours of admission.


Eligibility criteria: Inclusion Criteria:

* acute arthritis (onset not more than 7 days ago)
* joint fluid leukocyte count : more than 2000/mm3, more than 50% polymorphonuclear

Exclusion Criteria:

* none (apart from unability to accept inclusion)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: olivier epaulard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01992965: Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients
Official title: Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperglycemia
Keywords: continuous glucose monitoring；
critically ill;
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of real-time continuous glucose monitoring system on glucose control and outcomes of critically ill patients.

Detailed description: Real-time continuous glucose monitoring system has shown great accuracy and feasibility in critically ill patients. However, its impact on glucose control and outcomes has nearly unknown. Thus, Investigators designed this study to evaluate the effect of real-time continuous glucose monitoring system on glucose control and outcomes of critically ill patients.

Eligibility criteria: Inclusion Criteria:

* More than 18 years old male or female;

  * Expected ICU stays longer than 72 hours;

    * Glucose level more than 8 mmol/L when enrolls in the ICU;

      * Patients or their legal surrogates have signed the informed consent.

Exclusion Criteria:

* Pregnant or lactating women;

  * ICU stays less than 72 hours;

    * Usage of real-time continuous glucose monitoring system is considered as a contraindication.

Primary outcomes:
measure: Glycemic Control Measures including: Percentage of target blood glucose levels (defined as between 8mmol/L and 10mmol/L); Time of hyperglycemia (defined as >10mmol/L); Hypoglycemia rate (defined as < 2.2mmol/L); Glucose lability index
timeFrame: Glycemic control measures will be assessed up to five days.
Secondary outcomes:
measure: Prognosis Measures including: Duration of mechanical ventilation；Time of ICU stay; Time of hospital stay; 28 days - mortality rate
timeFrame: All the participants will be followed for the duration of hospital stay or 28 days.
measure: Cost
timeFrame: Cost associated with glucose monitoring
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Intensive care unit of West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Yan Kang, MD
role: STUDY_DIRECTOR
References: