louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04572386: Clinical Performance of Low Technique Sensitive Self Cured Universal Adhesive Vrs Light Cured Universal Adhesive in Patients With (NCCLs): 18 m RCT
Official title: Clinical Performance of Low Technique Sensitive Self-cured Universal Adhesive Versus Light Cured Universal Adhesive in Patients With Non-carious Cervical Lesions (NCCLs): 18 Month Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Carious Cervical Lesion
Keywords: universal bond
NCCls
3m single bond universal
Palfique, Tokuyama, Japan
self cure
non carious cervical lesions
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to evaluate the clinical performance of self-cured adhesive versus light cured universal adhesive in non-carious cervical lesions (NCCL) resin composite restorations after 18 month


Eligibility criteria: Inclusion Criteria:

* particepant with age rang 18-55
* particepant with non carious cervical lesion

Exclusion Criteria:

* particepant outside age rang
* particepant with periodontal problem that might affect the teeth to be treated

Primary outcomes:
measure: Number of fracture restoration
timeFrame: 18 month
measure: number of restoration with retention loss
timeFrame: 18-month
Secondary outcomes:
measure: Number of restoration with change in colour or texture
timeFrame: 18 month
measure: Number of restoration caused biological harm
timeFrame: 18 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04226586: Nutritional Stimulation of Growth in Children With Short Stature
Official title: Nutritional Stimulation of Growth in Children With Short Stature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Stunting
Growth Failure
Keywords: essential amino acids
short stature
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Short stature is a frequent reason for referral to a pediatric endocrinology clinic. Short stature is especially prevalent among those with failure to thrive (whose weight is significantly below the average weight of his/her peers). The growth hormone has limited efficacy for medical treatment of short stature when the cause of short stature is not growth hormone deficiency. This study will investigate the effect of 6 months of nutritional supplement (essential amino acids) compared to placebo in the linear growth of short children who have not yet reached puberty.


Eligibility criteria: Inclusion Criteria:

* Ages 3 to 11 years (inclusive).
* Pre-pubertal status (i.e. Tanner stage 1 for breast development for girls and testicular enlargement for boys and pubic hair for both sexes).

Exclusion criteria:

* Ages younger than 3 years or older than 11 years.
* Medical history of a neurologic, endocrinologic, genetic, or metabolic problem known to have a direct effect on height growth. This includes, but is not limited to, children with a Growth hormone deficiency, Down syndrome, Turner syndrome, Russel-Silver syndrome, Prader-Willi syndrome, Pseudohypoparathyroidism, chronic kidney disease, malabsorptive syndromes, cancer survivors, etc.
* Currently being treated or previously treated with Growth hormone, or history of oral steroid treatment within the last 3 months.
* Being in puberty.

Primary outcomes:
measure: Linear Growth
timeFrame: 6 months
Secondary outcomes:
measure: Body Composition
timeFrame: 6 months
measure: Body Composition
timeFrame: 6 months
measure: Body Composition
timeFrame: 6 months
Other outcomes:
measure: Serum growth factor concentrations
timeFrame: 6 months
measure: Serum growth factor concentrations
timeFrame: 6 months
measure: Serum amino acid concentrations
timeFrame: 6 months
Locations:
city: Little Rock
country: United States
facility: Emir Tas
state: Arkansas
Study officials:
affiliation: Arkansas Children's Research Insitute
name: Emir Tas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03061786: Prognosis of Acute Kidney Injury:China Collaborative Study on AKI（CCS-AKI）Study
Official title: Prognosis of Acute Kidney Injury:China Collaborative Study on AKI（CCS-AKI）Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 1000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients

Brief summary: Acute kidney injury (AKI) is a common clinical syndrome, especially in the hospital patients. AKI is recognized as an important risk factor for incident chronic kidney disease, accelerated progression to end-stage renal disease,and increased risk of short-term and long-term mortality.This study is to observe the prognosis of hospitalized patients with AKI in China.


Eligibility criteria: Inclusion Criteria:

* clinically diagnosed with acute kidney injury, according to KDIGO criteria

Exclusion Criteria:

* Nephrectomy
* Kidney transplantation
* Peak serum creatinine of less than 53µ mol/L
* Serum creatinine decrease after amputation
* Patients died during hospitalization
* End-stage kidney disease(chronic kidney disease stage 5)
* malnutrition

Primary outcomes:
measure: estimated glomerular filtration rate decline
timeFrame: 2 years
measure: Chronic kidney disease classification upgrade
timeFrame: 5 years
measure: New cardiovascular events
timeFrame: 5 years
measure: All-cause mortality
timeFrame: 5 years
Secondary outcomes:
measure: AKI recovery
timeFrame: 5 years
measure: Rehospitalization
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT05074186: Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke
Official title: Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: Jacobs institute
First posted: 2021-10-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The Jacobs Institute is participating in a Sponsor Investigator study designed to collect prospective clinical evidence to evaluate the use of a neurological thrombectomy device for clot retrieval in acute ischemic patients

Detailed description: The neurological thrombectomy device is an investigational device

Eligibility criteria: Inclusion Criteria:

at least 18 years of age at time of consent Has baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 8; Able to be treated within 8 hours of stroke symptom onset or Last Known Normal (LKN);

Exclusion Criteria:

Cannot provide consent or legally authorized representative not available to provide consent

Primary outcomes:
measure: Evaluate technical efficacy outcomes with radiographical measurements
timeFrame: Day 1
measure: outcomes with radiographical measurements
timeFrame: day 1
Secondary outcomes:
measure: Evaluate technical efficacy outcomes with radiographical measurements
timeFrame: Day 3
measure: Evaluate technical efficacy outcomes with radiographical measurements
timeFrame: 90 days
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: kaledia Health/Buffalo General Medical Center/GVI
state: New York
Study officials:
References:
Clinical trial NCT05782686: Impact of Systematic Shaving on Margins
Official title: Reduction of Affected Margins in Conservative Surgery for Breast Cancer: Impact of Systematic Shaving in the Operating Room
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Margin, Tumor-Free
Breast Cancer
Surgery
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 234
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to demonstrate the reduction of positive margins in the definitive pathology of patients undergoing breast-conserving surgery with the systematic shaving technique compared to conventional surgery, and the reduction of second interventions for margin enlargement.

Detailed description: Patients with breast cancer who undergo breast-conserving surgery are randomized in the operating room after lumpectomy into 2 groups of 117 patients each: shaving/no-shaving (standard surgery).

Eligibility criteria: Inclusion Criteria:

1. Breast-conserving surgery.
2. Imaging diagnosis as the only breast tumor focus according to mammography, breast ultrasound and/or nuclear magnetic resonance;
3. Pathological diagnosis of carcinoma in situ or infiltrating
4. Oncoplastic without associated flaps;

Exclusion Criteria:

1. Male patients;
2. Patients with a history of ipsilateral breast cancer.
3. Oncoplastic that includes flaps
4. Multifocality or multicentricity;
5. Pregnant or lactating patient;
6. Stage IV patients;
7. Patients eligible for mastectomy;

Primary outcomes:
measure: Margin involvement
timeFrame: 3 weeks after each surgery
measure: Re-interventions
timeFrame: 3 weeks after each surgery
Secondary outcomes:
measure: Shaving versus intraoperative pathological study
timeFrame: 3 weeks after each surgery
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital de Bellvitge. Instituto de Investigación Biomédica de Bellvitge (IDIBELL)
name: Amparo Garcia Tejedor, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02835586: STREAMER : STent Restenosis And MEdicaments Release
Official title: STREAMER : Stent Restenosis and Medicaments Release : Does Local Delivery of Paclitaxel be Safe and Efficient in Stenting of TransAtlantic InterSociety Consensus (TASC) Class C and D Femoropopliteal Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Critical Ischemia
Keywords: paclitaxel
critical ischemia
restenosis
femoropopliteal artery lesions TASC C and D
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a pilot study to evaluate the feasibility and the efficiency of local delivery of paclitaxel after stenting of long femoropopliteal arterial lesions TASC C and D before the realization of a large randomized multicentric study. Patients concerned are in critical ischemia.


Eligibility criteria: Inclusion Criteria:

* patients with critical ischemia of a lower limb with ankle pressure \< 50 mmHg
* lesions TASC C and D of the superficial femoral or popliteal artery

Exclusion Criteria:

* patient allergic to paclitaxel
* patient with a cancer, a neutropenia, with immunosuppressor medicament or chemotherapy
* patient with contraindication to take 2 anti-aggregants platelets

Primary outcomes:
measure: Percentage of patients with femoropopliteal artery restenosis
timeFrame: 12 months
Secondary outcomes:
measure: Occurence of adverse events due to paclitaxel
timeFrame: From1 day to 12 months
measure: Number of patients with target lesion revascularization
timeFrame: 12 months
measure: Occurence of amputation free-survival
timeFrame: 12 months
measure: cumulated rate of morbi-mortality (TCMM)
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval
Study officials:
affiliation: department of vascular surgery, Edouard Herriot Hospital, LYON
name: Nellie DELLA SCHIAVA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06544486: Contemporary Restorative Materials in Primary Molars
Official title: Clinical Evaluation of Contemporary Ion Releasing Restorative Materials in Primary Molars Subjected to Selective Caries Removal: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Cention N
Resin-modified glass-ionomer cement
Hybrid glass-ionomer cement
Zinc reinforced glass-ionomer cement
Primary Molar Teeth
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 86
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to compare the clinical effectiveness of four ion-releasing restorative materials in the proximal cavities of primary molars that underwent selective caries removal. The main questions to answer are:

* Will there be any difference among the restorative materials clinical succes in the means of modified United States Public Health Services (USPHS) criteria for dental restorations?
* Will there be any difference among the restorative materials in the means of preservation of pulpal vitality? Eighty six children (262 teeth), between 5 and 9 years old (7.15±1.14) enrolled for the study. Researchers will compare the clinical performance of restorative materials, (1:Equia Forte HT; 2: Fuji II LC; 3: Cention N; 4: ChemFil Rock), applied to the proximal cavities of primary molars following selective caries removal, according to the modified USPHS criteria.

Participants will:

- visit the clinic 1st,3rd,6th,12th,18th,24th,30th and 36th months after the restoration.


Eligibility criteria: Inclusion Criteria:

For participants:

* no known or suspected history of allergy to medications or restorative materials
* no habits of teeth grinding or clenching
* presence of at least one interproximal carious lesion

For teeth:

* carious lesion reaching at least 1/2 dentin
* in contact with adjacent teeth and in occlusion with antagonist teeth
* have no pathological mobility
* periodontally healthy
* no symptoms of pulpal pathology
* physiological root resorption should not exceed one-third of the root length if seen
* permanent tooth germ present below the tooth

Exclusion Criteria:

* did not attend their follow-up appointments

Primary outcomes:
measure: Clinical evaluation of the filling materials according to the modified USPHS criteria
timeFrame: Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.
Secondary outcomes:
measure: Preservation of pulpal vitality
timeFrame: Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Zulfikar Zahit Ciftci, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02514486: Assessment of Cancer Concerns at the End of Treatment (ACE)
Official title: Assessment of Cancer Concerns at the End of Treatment (ACE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer(BC) Survivors
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 332
Sex: FEMALE
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: Breast cancer survivors

Brief summary: This study will describe patient-reported symptom burden and concerns, quality of life (QOL), and health behaviors of breast cancer(BC) survivors who have completed initial treatments (e.g., surgery, chemotherapy, and/or radiotherapy), assess the feasibility of using a web-based platform to collect patient-reported outcome (PRO) data, and evaluate provider satisfaction following delivery of an electronic health record (HER)/EPIC summary of these PROs. Secondary aims will estimate differences in referral to available services between those providers exposed to the PRO summary and historical controls. BC survivors who have completed initial treatment and present within the first year following treatment for an end of treatment (EOT)/survivorship focused visit will be the focus of this study.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with invasive, non-metastatic BC (Stage I, II, or III) without hematogenous or distant metastases
2. Have completed initial treatment (chemotherapy, radiotherapy, and/or surgery). May still be receiving hormonal or targeted therapy (e.g., tamoxifen, aromatase inhibitors).
3. Within 1 year of completing primary treatment
4. Scheduled for an EOT visit
5. Age 18 years or older
6. Can understand written English
7. Have internet access and a working email address

Exclusion Criteria:

1. Diagnosed with non-invasive (Stage 0/DCIS) or metastatic (Stage IV) cancer or hematogenous or distant metastatic disease
2. No working email address -

Primary outcomes:
measure: Completion of Questionnaire
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Linda Jacobs, CRNP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05445986: Immediate Implant Placement With or Without Buccal Bone Dehiscence
Official title: Clinical, Radiographic and Aesthetic Evaluation of Immediate Implant Placement With or Without Buccal Bone Dehiscence in the Anterior Maxilla
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implant Failed
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 29
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 in need of single implant replacement

Brief summary: Immediate implant placement has been advantageous in terms of reduced treatment time and fewer surgical interventions. Given the fact that the level of buccal bone acts as a major prognostic factor for IIP, the indications for immediate implant placement were suggested to be limited to intact alveolar sockets.In recent years, many attempts have been performed to compensate for the alveolar ridge resorption in immediate implant placement in compromised sockets. The clinical outcomes of IIP with guided tissue regeneration and connective tissue grafting using papilla preservation technique in compromised extraction sockets has not been previously reported.


Eligibility criteria: Inclusion Criteria:

* patients with anterior failing teeth (from cainine to cainine) with the presence of neighbouring teeth
* sufficient bone volume to achieve primary stability at implant insertion

Exclusion Criteria:

* with uncontrolled periodontitis
* heavy smoker (\>10 cigarettes/day)
* unwilling to sign the informed consent

Primary outcomes:
measure: mucosa recession
timeFrame: baseline to 1-year
Secondary outcomes:
measure: probing depth
timeFrame: baseline to 1-year
measure: bleeding on probing
timeFrame: baseline to 1-year
measure: Pink Esthetic Score (0-14)
timeFrame: baseline to 1-year
measure: thickness of buccal bone plate
timeFrame: baseline to 1-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hositpal
state: Shanghai
Study officials:
References:
Clinical trial NCT00543686: Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma
Official title: A Randomised Controlled Open-Label Phase IV Mono Centre Study to Compare the Response Profiles of Montelukast Versus Fluticasone in Children With Pre-School Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Pre-School Asthma
Responder Profiles
Fluticasone
Montelukast
Leukotriene
Children with Pre-School Asthma
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2007-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Explorative comparison of montelukast with inhaled steroids (fluticasone) to estimate responder profiles, in terms of symptom scores, rescue medication, increase of FEV1, in correlation to presence of allergy, bronchial hyperreactivity (PD20), exhaled NO, excretion of leukotrienes, response to RABA and laboratory parameters in patients with pre-school asthma i.e. asthma phenotypes.


Eligibility criteria: Inclusion Criteria:

* Male or female patients age 4 -6 years
* Diagnosis of mild intermittent bronchial asthma (Step I-II) in the past 6 - 12 months as stated by the investigator:
* Use of inhaled beta-2-agonists \< 1/week (max 3 puff /d)
* Exacerbation-free interval \> 4 weeks prior to visit 1
* The written informed consent of parents after received written and oral information about the aim, purpose and risks of the study must be present

Exclusion Criteria:

* Asthma severity ≥ Step 2
* Severe concomitant diseases
* Suspected non-compliance
* age below 4 and age above 7 years
* last study participation \< 30 days

Primary outcomes:
measure: The primary efficacy variable is the number of responders with a very good asthma symptom control defined as requiring no rapid acting beta agonist (RABA) between the 2. and 6th week of intervention (end of trial)
Secondary outcomes:
measure: the number of patients requiring at least five times RABA between the 2. and 6th week, the number of patients with an increase of FEV1 7.5%, the symptom score, symptom free days, rescue medication, presence of allergy RAST > 2, concentration of eNO, PD20
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe University, Department of Pulmonology
state: Hessen
Study officials:
affiliation: Johann Wolfgang Goethe-University Frankfurt, Zentrum für Kinderheilkunde I, Haus 32, Abt. Pneumologie
name: Stefan Zielen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zielen S, Christmann M, Kloska M, Dogan-Yildiz G, Lieb A, Rosewich M, Schubert R, Rose MA, Schulze J. Predicting short term response to anti-inflammatory therapy in young children with asthma. Curr Med Res Opin. 2010 Feb;26(2):483-92. doi: 10.1185/03007990903485148.