louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04266210: Clinical Evaluation of a Restorative Glass Ionomer and a Composite Resin for the Restoration
Official title: Clinical Evaluation Two Restorative Systems in Non-carious Cervical Lesions at Patients With Different Systemic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Disease
Keywords: non-caries cervical lesions
glass ionomer
composite resin
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical performances of a restorative glass ionomer and a composite resin will be compared in the restoration of non-carious cervical lesions (NCCLs) at patients with systemic diseases.

After recruiting participants with at least 2 NCCLs and at least one systemic disease, all restorations will be placed by a single clinician. All lesions will be cleaned before restoring.

NCCLs will be divided into two groups: a conventional restorative glass ionomer cement \[Fuji Bulk (GC, Tokyo Japan) (FB)\] and a posterior composite resin \[G-ænial Posterior (GC, Tokyo Japan) (GP)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.


Eligibility criteria: Inclusion Criteria:

Patients with at least one systemic disease such as hypertension, cancer in remission after chemotherapy or radiotherapy, diabetes mellitus, hemophilia, heart disease, coronary artery disease, rheumatoid arthritis, chronic obstructive pulmonary disease, lupus eritematozus.

Patients using medications for hypertension, diabetes mellitus, hemophilia, heart disease, coronary artery disease, rheumatoid arthritis, chronic obstructive pulmonary disease, lupus eritematozus.

Patients who are able to attend recall appointments.

Age greater than 18 years who had at least one systemic disease At least two NCCLs needed to be restored.

At least 20 teeth in occlusion.

Exclusion Criteria:

Non-vital teeth

Mobility of teeth

Severe periodontal disease

Heavy bruxism habit

Primary outcomes:
measure: Clinical performances of different restoratiove systems
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT01437410: Endoscopic Ultrasound-guided Fine Needle Aspiration of Solid Masses: Histological and Immunohistochemical Evaluation
Official title: Endoscopic Ultrasound-guided Fine Needle Aspiration of Solid Masses: Histological and Immunohistochemical Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Mass
Peripancreatic Mass
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 116
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent EUS-FNA to evaluate solid pancreatic or peripancreatic lesions from January 2009 to July 2010 in Samsung Medical Center,

Brief summary: The aim of this retrospective single center study was to evaluate the clinical utility of histological and immunohistochemical analyses of specimens obtained by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA).


Eligibility criteria: Inclusion Criteria:

* We retrospectively reviewed medical records of patients who underwent EUS-FNA to evaluate solid pancreatic or peripancreatic lesions from January 2009 to July 2010

Exclusion Criteria:

* Patients with unavailable data

Primary outcomes:
measure: the diagnostic accuracy of cytology, histology, and combined analysis of specimens obtained by EUS-FNA for pancreatic or peripancreatic solid masses
timeFrame: at least 6 months after surgery or clinical follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT04565210: Effects of Oriental Music on Preterm Infants
Official title: Effects of Oriental Music oN Preterm InfAnts: A Randomized Controlled Trial. (OMNIA Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature
Behavior, Child
Keywords: Music therapy
Premature infant
Heart rate variability
Behavior state
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 102
Sex: ALL
Minimum age (years): 14
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to explore the effect of oriental music on premature infants' physiological and behavioral parameters during their hospital stay in the NICU.

Detailed description: Music exposure during care of preterm infants is the subject of increasing research. Many studies have shown positive impact of music exposure such as classical western music, lullabies or Quran on pain and physiological parameters of preterm infants in a neonatal intensive care unit (NICU) setting. No such study have explored the effect of oriental music which is the main popular music listened to in the Levant and Middle East and North Afrika (MENA) region.

We aim in this study to find out if the oriental music exposure in preterm infants improves babies' heart rate variability, physiological parameters and behavior state during their NICU stay.

Eligibility criteria: Inclusion Criteria:

* Clinically stable infants born between 28 and 366/7 weeks of gestation and ≥31 weeks Post Menstrual Age (PMA).
* Infants planned to stay in the NICU for at least 2 weeks at the time of enrollment.

Exclusion Criteria:

* Congenital anomaly affecting heart rate and hearing, significant brain insult (such as severe or moderate hypoxic ischemic encephalopathy, intraventricular hemorrhage (IVH) grade 3 or 4 or periventricular leukomalacia) that might affect the neurodevelopmental outcome.
* Receiving medications that might interfere with heart rate and reaction to music exposure such as midazolam or morphine.

Primary outcomes:
measure: Heart rate variability
timeFrame: 3 years
Secondary outcomes:
measure: Mean Respiratory rate
timeFrame: 3 years
measure: Oxygen Saturation
timeFrame: 3 years
measure: Behavioral state
timeFrame: 3 years
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
affiliation: American University of Beirut Medical Center
name: Lama Charafeddine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02940210: Clinical Trial to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy
Official title: A Randomized, Single-blind, Multi-center, Phase III Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Patients With Thyroidectomy (Scheduled)
Lead sponsor: CGBio Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-20
Enrollment: 172
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy and safety of adhesion barrier Mediclore versus no treatment in patients with total thyroidectomy


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Male or female at least 20 years of age
* Patients without clinically significant lab
* Patients scheduled for thyroidectomy

Exclusion Criteria:

* Another clinical trials within 1 month
* History of previous surgery on same position
* Anticoagulant, general steroids within a week from surgery
* Immunosuppression or autoimmune disease
* General or local infection
* Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
* Incompatible medications
* History of drug or alcohol abuse, mental disorder
* Pregnant or lactating women and fertile women who is not using proper contraceptive method
* History of esophagus diseases
* Keloid symptoms

Primary outcomes:
measure: Adhesion incidence rate following 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Su won
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT02594410: Zainidip in Renal Artery Stenosis
Official title: The Efficacy of Renal Artery Stent Combined With Standardized Medical Therapy in Patients With Atherosclerotic Renal Artery Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 149
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of renal artery stent combined with standardized medical therapy as treatment for renal artery stenosis.


Eligibility criteria: Inclusion Criteria:

* Age between 40 - 75
* Diameter of stenosis of renal artery or main branch of renal artery ≥60％. If diameter of stenosis is 60% - 75%, pressure difference between proximal and distal end ≥20 mm Hg (1mmHg=0.133kPa) or Captopril renography positive;
* Systolic blood pressure before taking antihypertensive ≥180mmHg and/or diastolic blood pressure ≥110 mmHg; taking three antihypertensive including one diuretics with systolic blood pressure ≥140mmHg and/or ≥90 mmHg;
* length of ipsilateral kidney is greater than 7.0cm.

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) \<30 ml/ (min﹒1.73 m 2) \[eGFR (mL/min/1.73 m2) = 186.3 \* serum creatinine (mg/dl) -1.154 \* Age-0.203 \* 0.742 (female)\[11\];
* unstable condition and unable to tolerate interventional therapy;
* anatomy of renal artery pathology not suitable for interventional therapy;
* allergic to dihydropyridines;
* III degree atrioventricular block
* contrast allergy ;
* any known malignant tumor;
* non-compliant, history of alcoholism or drug abuse.

Primary outcomes:
measure: Glomerular filtration rate
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
Study officials:
References:
Clinical trial NCT05184010: Arthroscopic Treatment With Ulnar Nerve Release for Elbow Osteoarthritis
Official title: Arthroscopic Treatment With and Without Ulnar Nerve Release for Elbow Osteoarthritis --a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Osteoarthritis, Elbow
Ulnar Nerve Release
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 24
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 is a prospective randomized controlled study of arthroscopic release for primary osteoarthritis of the elbow with stiffness with or without ulnar nerve release. The patients with primary osteoarthritis of the elbow with stiffness, which ulnar neuropathy proven by electromyography without clinical symptoms, were randomly divided into groups before the operation. Before the arthroscopic operation was began, the procedure of ulnar nerve release was performed according to the group(release group or unrelease group). In different time periods postoperatively, the quantitative and qualitative indicators including pain, functional score, muscle strength, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with ulnar nerve release.


Eligibility criteria: Inclusion Criteria:

1. Age \>18 years
2. Primary osteoarthritis of the elbow with stiffness. Osteoarthritis was confirmed on CT-arthrography, by cartilage damage, osteophytes or local or global joint impingement.
3. Ulnar neuropathy proven by electromyography without clinical symptoms
4. Failure at least 6 months of conservative treatment
5. Availability of medical information for \>2 years of follow-up

Exclusion Criteria:

1. Severe skin contracture or wound problem that could affect the neurovascular structures or require flap surgery.
2. Revision surgery
3. Ulnar nerve pathology results in clinical symptom such as motion and feeling deficiency
4. Other indication for elbow arthroscopy: synovial or inflammatory rheumatoid pathology, osteochondritis dissecan, acute infection, tumor or pure capsular stiffness.
5. Inadequate or loss of follow-up
6. elbow instability

Primary outcomes:
measure: DASH
timeFrame: baseline-2 years postoperatively
Secondary outcomes:
measure: ROM(F-E and rotation)
timeFrame: baseline-2 years postoperatively
measure: Strength
timeFrame: baseline-2 years postoperatively
measure: MEPS
timeFrame: baseline-2 years postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan hospital
state: Beijing
Study officials:
affiliation: Sports Medicine Service, Beijing Jishuitan hospital
name: Yi Lu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01931410: The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ıntrapartum Haemorrhage
Postpartum Haemorrhage
Lead sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital
Sponsor class: OTHER_GOV
First posted: 2013-08-29
Enrollment: 618
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage.


Eligibility criteria: Inclusion Criteria:

1. live and singleton pregnancy
2. Elective caesarean
3. Gestational week greater than 37 weeks
4. patient between 18-44 year old

Exclusion Criteria:

1. -multiple pregnancy
2. Preeclampsia
3. Gestational diabetes
4. Macrosomia
5. Oligohidraamnıos
6. Polihidraamnıos
7. Myoma
8. Morbid obesity
9. Coagulatıon defect (such as HELLP syndrome)

Primary outcomes:
measure: Postpartum Haemorrhage
timeFrame: postpartum 24 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: T.C.S.B. Kanuni Sultan Süleyman Research Hospital
name: Berhan AŞICIOĞLU, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05355610: Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease
Official title: Objective Vestibular Evaluation & Rehabilitation With Intratympanic Dexamethasone and Gentamicin in Meniere's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibular Disorder Preservation
Keywords: dexamethasone, gentamicin
Lead sponsor: Combined Military Hospital Quetta
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 93
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with unilateral Meniere's disease with intractable vertigo will be administered two doses of intratympanic gentamicin plus dexamethasone 1 week apart
Primary purpose: TREATMENT

Brief summary: Intractable symptoms of Meniere's disease will be treated with intratympanic steroids.

At the same time intratympanic dexamethasone will be used to rescue hearing

Detailed description: For Alleviation of Intractable symptoms of Meniere's disease will be treated with intratympanic steroids. Measured with pre and post therapy vestibular severity index.

At the same time intratympanic dexamethasone will be used to rescue hearing measured with speech reception threshold and speech discrimination threshold

Eligibility criteria: Inclusion Criteria:

* All patients of unilateral Meniere's disease with severe vestibular symptoms

Exclusion Criteria:

* Bilateral disease, operated cases

Primary outcomes:
measure: Vestibular Rehabilitation
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Quetta
country: Pakistan
facility: CMH Quetta
state: Balochistan
Study officials:
affiliation: CMH Quetta
name: Zeeshan Ayub, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: CMH Quetta
name: Zeeshan Ayub, FCPS
role: STUDY_CHAIR
References:
Clinical trial NCT05223010: Melatonin for Pediatric Emergence Agitation
Official title: Evaluation of Preoperative Melatonin on Emergence Agitation After Herniorrhaphy Surgeries in Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Emergence Agitation
Keywords: melatonin
emergence agitation
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 117
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: efficacy of melatonin premedication on emergence agitation in children undergoing herniorrhaphy surgeries

Detailed description: Before administration of the oral premedication, each patient's baseline heart rate, mean systemic arterial pressure, pulse oximetry, and sedation score (yale preoperative score) will be recorded All the anesthetic and surgical techniques will be standardized. On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Baseline readings of all the parameters will be recorded.

Sevoflurane 3-8 MAC will be used for induction of anaesthesia. While intravenous line is inserted, atropine 0.01 mg/kg, atracurium 0.0.05 mg/kg is given. Anaesthesia maintainance done by 1.5-2 MAC sevoflurane. At the end of operation discontinuation of inhalational anesthesia will be done and muscle relaxant will be reversed by neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Then children were transferred to recovery till complete recovery Parameters assessed are induction time (IT) time from the start of sevoflurane inhalation to the start of endtracheal tube insertion, duration of anesthesia (DA) time from the start of sevoflurane inhalation to discontinuation of sevoflurane inhalation, time up to spontaneous eye opening (time from removal of endotracheal tube till spontaneous eye opening), duration of stay in recovery and any side effects

Eligibility criteria: Inclusion Criteria:

* ASA I
* scheduled for unilateral inguinal herniorrhaphy
* parents conscent

Exclusion Criteria:

* allergy to this study drug
* Patients with a history of cardiovascular, psychiatric, neurological, endocrine, chest disease, and/or severe renal or hepatic dysfunction

Primary outcomes:
measure: emergence behaviour
timeFrame: 5 min, 15 min and 30 min after arrival to recovery
Secondary outcomes:
measure: yale preoperative anxiety scale
timeFrame: before administration of oral premedication and before anaesthesia induction
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine, University Hospitals
state: Menoufia
Study officials:
References:
Clinical trial NCT03228810: Genetic Biomarker Discovery for Metastatic Prostate Cancer
Official title: ROR1751: Genetic Biomarker Discovery for Metastatic Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 4
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with metastatic prostate cancer

Brief summary: Biomarkers from circulating cell-free tumor DNA in peripheral blood will identify patients with metastatic prostate cancer diagnosed with C11 choline PET/CT who will benefit from metastasis-directed radiation, ablative therapies, and/or surgery. Tissue and blood will be collected before treatment. If patients receive androgen deprivation, then blood will be collected after neoadjuvant androgen deprivation but before radiation, ablative therapies, or surgery. Subsequent samples will be obtained at 3 months and 6 months following treatment, after which no further patient contact will occur.


Eligibility criteria: Inclusion Criteria:

* Men age 18 years old and older.
* Histologically proven diagnosis of prostate cancer.
* Radiographic evidence of non-regional lymph node involvement, pelvic lymph node recurrence, and/or bone metastases.
* Requiring a clinically directed biopsy or resection of tumor at Mayo Clinic Rochester.
* Receiving local therapy for metastatic disease with radiation, ablative therapies, and/or surgery at Mayo Clinic Rochester.
* Willingness to provide blood sample prior to receipt of treatment, as well as after neoadjuvant androgen deprivation therapy and at 3 months and 6 months after radiation, ablation, or surgery.
* Absence of a second active malignancy.
* An understanding of the protocol and its requirements, risks, and discomforts.
* The ability and willingness to sign an informed consent.

Exclusion Criteria:

* Inability on the part of the patient to understand the informed consent or be compliant with the protocol.
* History of a serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine).

Primary outcomes:
measure: Detect cell-free tumor DNA in patients with metastatic prostate cancer
timeFrame: prior to treatment
measure: Calculate cell-free tumor DNA in relation to metastasis-directed radiation and androgen deprivation therapy (ADT)
timeFrame: before and immediately after ADT and at 3 months and 6 months after radiation
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
References:
citation: Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.