louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02357043: User Performance Evaluation for DARIO™ BGMS
Official title: User Performance Evaluation for DARIO™ Blood Glucose Monitoring System (BGMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: LabStyle Innovations Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-06
Enrollment: 368
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study aims to evaluate the accuracy of the blood glucose level results obtained from fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to Yellow Springs Instrument (YSI) as well as to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons using only device labeling.

Detailed description: Each subject enrolled in the study will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Blood Glucose Monitoring System (BGMS). Immediately after the subject tested him/herself a trained nurse/technician will collect another blood sample from the subject for testing by the Yellow Springs Instrument (YSI). The subject will complete a usability questionnaire on his/her experience using the Dario Blood Glucose Monitoring System (BGMS) and the nurse/technician will complete a questionnaire assessing the subject's performance. A venous blood sample for Complete Blood Count (CBC) will be taken by the nurse/technician and sent for analysis.

Eligibility criteria: Inclusion Criteria:

1. Subject has Type I or Type II diabetes
2. Subject speaks and reads English proficiently
3. Subjects owns and uses Android and iOS based smart mobile device for at least 1 year
4. Subject is able and agrees to sign the informed consent form (minor subjects must be accompanied by a parent or legal guardian to provide consent for their participation in the study).

Exclusion Criteria:

1. Subject has medical training or works in the field of Blood Glucose Monitoring System (BGMS)
2. Subject is critically ill
3. Subject has an impairment that prevents him/her to follow the study procedures
4. Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study

Primary outcomes:
measure: Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Remington-Davis, Inc.
state: Ohio
Study officials:
References:
Clinical trial NCT05573243: Clinical Evaluation of Composite Restorations Using Two-steps Universal Adhesive in Non-carious Cervical Lesion (NCCL)
Official title: Long-term Clinical Evaluation of Composite Restoration Using Two-steps Universal Adhesive in Non-carious Cervical Lesion: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-carious Cervical Lesion
Keywords: clinical trial
universal adhesive
etch-and-rinse
selective enamel etching
self-etch
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical study is to compare the clinical performance of a new 2-steps universal adhesive in patients with non-carious cervical lesions. The main question it aims to answer is: Is there any difference in clinical performance of a new 2-steps universal adhesives bonded with different etching strategies.

Participants will have restorations using a new 2-steps universal adhesives in different etching strategies.

* etch-and-rinse
* selective enamel etching
* self-etch


Eligibility criteria: Inclusion Criteria:

* Available for follow-up visits
* Have at least 28 teeth/ 20 teeth under occlusion
* Have at least 3 non-carious cervical lesions without peri-apical lesion. The lesion is not nearly exposed pulp and no history of previous restoration.

Exclusion Criteria:

* Rampant / uncontrolled caries
* Advanced untreated periodontal disease
* \>2 cigarette packs/day
* Systemic or local disorders that could not undergo dental procedures
* Xerostomia
* Severe bruxism, clenching, TMD
* Pregnancy at the time of screening
* Known history of sensitivity to resin or related materials
* Fixed orthodontic appliance or planning to have orthodontic treatment within 3 years

Primary outcomes:
measure: sensitivity (modified USPHS)
timeFrame: 3 years
measure: retention (modified USPHS)
timeFrame: 3 years
measure: secondary caries (modified USPHS)
timeFrame: 3 years
Secondary outcomes:
measure: marginal adaptation (modified USPHS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Dentistry, Manidol University
Study officials:
affiliation: Faculty of Dentistry, Mahidol University
name: Pipop Saikaew, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Paris Matos T, Perdigao J, de Paula E, Coppla F, Hass V, Scheffer RF, Reis A, Loguercio AD. Five-year clinical evaluation of a universal adhesive: A randomized double-blind trial. Dent Mater. 2020 Nov;36(11):1474-1485. doi: 10.1016/j.dental.2020.08.007. Epub 2020 Sep 12.
Clinical trial NCT00231543: Laparoscopy in Children: Does it Decrease the Metabolic, Endocrine and Inflammatory Stress Response to Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-Oesophageal Reflux
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2005-10-04
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial was to characterise the intra and post operative metabolic, endocrine and inflammatory response to laparoscopic fundoplication in children. We are testing the hypothesis that laparoscopic fundoplication is associated with a lack of hypermetabolism and catabolism and blunting of the endocrine/inflammatory stress response


Eligibility criteria: Inclusion Criteria:

* infants and children with gastro-oesophageal reflux

Exclusion Criteria:

* septic shock, multi-organ dysfunction syndrome, cardiac, renal or congenital metabolic abnormalities

Primary outcomes:
measure: resting energy expenditure
Secondary outcomes:
measure: whole body protein turnover
measure: indices of inflammatory response
measure: pro and anti inflammatory cytokines
measure: free radical production
measure: post operative pain
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital and the Institute of Child health
Study officials:
affiliation: Institute of Child Health
name: Agostino Pierro, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: McHoney M, Wade AM, Eaton S, Howard RF, Kiely EM, Drake DP, Curry JI, Pierro A. Clinical outcome of a randomized controlled blinded trial of open versus laparoscopic Nissen fundoplication in infants and children. Ann Surg. 2011 Aug;254(2):209-16. doi: 10.1097/SLA.0b013e318226727f.
citation: McHoney M, Eaton S, Wade A, Carnielli V, Kiely E, Drake D, Curry J, Pierro A. Effect of laparoscopy and laparotomy on energy and protein metabolism in children: a randomized controlled trial. J Pediatr. 2010 Sep;157(3):439-44, 444.e2. doi: 10.1016/j.jpeds.2010.02.067. Epub 2010 Apr 18.
Clinical trial NCT00456443: Invasive Infections in Children With Hemoglobinopathies
Official title: Invasive Infections in Children With Hemoglobinopathies. A Clinical Descriptive Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia
Sickle Cell Anemia
Keywords: Thalassemia
Sickle cell anemia
Splenectomy
Infections
Streptococcal Pneumonia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-04-05
Enrollment: 200
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Patients diagnosed as having hemoglobinopathies are exposed to serious bacterial infections, principally those patients that underwent splenectomy. Since the introduction of anti pneumococcal vaccine the incidence decreased significantly but other bacteria besides encapsulated bacteria takes place as principal cause of invasive infections. The purpose of this study is to analyse in a retrospective study the incidence of those infections in a group of patients suffering from thalassemia and sickle cell anemia treated in our clinic.


Eligibility criteria: Inclusion Criteria:

* All patients treated in the Pediatric Hematology Unit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Study officials:
affiliation: Pediatric Hematology Unit, Ha'Emek Medical Center
name: Ariel Koren, MD
role: STUDY_DIRECTOR
affiliation: Pediatric Dpt B - Ha'Emek Medical Center
name: Waheeb Sakran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06242743: Type of Needle Bevel on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia
Official title: Effect of Needle Bevel Type on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia (a Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 66
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: fear of the discomfort that comes with anesthetic needle insertion. For dental local anesthesia, needles with a scalpel-designed bevel have been claimed to decrease pain elicited by injection.

Objective of the study: The purpose of this study is to assess the effect of needle bevel on patient's perception of pain during inferior alveolar nerve block anesthesia and the needle tip will be further assessed for deformation.

Materials and Methods: The study will be a double-blind randomized controlled clinical trial, with a parallel design. A total of sixty-six healthy children will be selected from The Pediatric Dentistry and Dental Public Health Clinic, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 Frankel behavioral rating scale. Written consent will be obtained from the legal guardian. Participants will be randomly allocated into two groups according to the type of needle bevel that will be used. Group I (test group) will receive inferior alveolar nerve block (IANB) using a double scalpel blade bevel needle, while group II (control group) will receive IANB using a standard blade bevel needle. All the procedures will be videotaped. Pain reaction will be evaluated subjectively using a face scale modified from the Maunuksela scale and objectively using the Sensory, Eye, and Motor (SEM) scale. After the respective single injection, the needles will be fixed on an object slide and prepared for microscopic examination.


Eligibility criteria: Inclusion Criteria:

* Healthy children with ASA I, II Classification.
* Children with no learning disabilities.
* Positive or definitely positive behavior according to the Frankl Scale.
* Patient requiring local anesthetic injection IANB for dental treatment.
* Written consent of the legal guardian.

Exclusion Criteria:

* Medically compromised patient.
* Children with emergency treatment needs, such as abscess, cellulitis and space infection.
* Hypersensitivity to local anesthetic drugs

Primary outcomes:
measure: Objective Pain assessment
timeFrame: During procedure
measure: Subjective pain assessment
timeFrame: During procedure
Secondary outcomes:
measure: Needle deformation
timeFrame: During procedure
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT02753543: Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma
Official title: A Multi-center, Prospective, Single-arm, Open Label Phase II Study of Chidamide Combined With Chemotherapy in the Treatment of Peripheral T Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral T Cell Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 33
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.


Eligibility criteria: Inclusion Criteria:

* Pathologically verified peripheral T-cell lymphoma, partial response or stable disease after 3 cycles of CEOP (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or CEOP(cyclophosphamide,vincristin,epirubicin and prednisone)/IVE (ifosfamide, epirubicin, etoposide)/GDP(Gemcitabine, Cis-platinum, Dexamethasone)
* Age ≧16 years, ≦75 years
* ECOG (Eastern Cooperative Oncology Group) =0,1,2
* No previous history of malignancy
* Radiologically measurable disease
* Life expectancy\>6 months
* Informed consented

Exclusion Criteria:

* Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
* Lab at enrollment(unless caused by lymphoma)

  * Neutrophile\<1.5\*10\^9/L
  * Platelet\<75\*10\^9/L
  * Hemoglobulin\<90g/L
  * ALT(alanine aminotransferase) or AST (aspartate aminotransferase ) \>2\*ULN,AKP(alkaline phosphatase) or bilirubin \>1.5\*ULN (upper limit of normal )
  * Creatinine\>1.5\*ULN
* Other uncontrollable medical condition that may that may interfere the participation of the study

  * Not able to comply to the protocol for mental or other unknown reasons
* Pregnant or lactation
* HIV infection

Primary outcomes:
measure: complete response
timeFrame: 21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)
Secondary outcomes:
measure: Progression free survival
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Each cycle of treatment and then every 3 months for 1 year（each cycle is 21 days）
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03064243: A Phase II Study of Apatinib in STS Patients
Official title: Effectiveness and Safety of Apatinib for the Patients With Advanced Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Apatinib is a kind of innovative medicines approved by China Food and Drug Administration（CFDA）, which was researched by Jiangsu Hengrui Pharmaceutical Co., Ltd. Apatinib is a kinase inhibitor of receptor tyrosine with VEGFR2. The protocol is to explore Apatinib for the effectiveness of advanced soft tissue sarcoma and safety.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* Histologically proven advanced soft tissue sarcoma, At least one measurable lesion. Including: Synovial sarcoma, leiomyosarcoma, Alveolar soft part sarcoma, Undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, Liposarcoma, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma, Angiosarcoma, Spindle cell sarcoma, rhabdomyosarcoma treated by chemotherapy, Ewing's sarcoma of soft tissue/Primitive neuroectodermal tumor. Excluding: Malignant peripheral nerve sheath tumor, chondrosarcoma, Dermatofibrosarcoma protuberans, Gastrointestinal stromal tumor, Inflammatory myofibroblastic sarcoma, Malignant mesothelioma.
* Must have evidence of unresectable residual disease.
* In the last 6 months, at least one chemotherapy regimen (including anthracyclines) was used in patients who failed or were unable to tolerate treatment.
* ECOG ps≤2.
* Life expectancy: more than 3 months.
* Prior aptinib less than 2 weeks and at least 1 month since prior aptinib；at least 1 month since prior inhibitor of mTOR or EGFR pathway.
* Not pregnant or nursing；Fertile patients must use effective contraception.
* Hematopoietic

  * HB≥90g/L
  * Absolute neutrophil count ≥ 1,500/mm\^3
  * Platelet count ≥ 80,000/mm\^3

Exclusion Criteria:

* Uncontrollable hypertension;
* Has influence of oral drugs;
* Patients with high risk of gastrointestinal blooding;
* INR\>1.5×ULN，APTT\>1.5×ULN;
* Allergic to any ingredient of this product;
* Less than 1 month since last major surgery;
* Brain metastases;
* With the second cancer.

Primary outcomes:
measure: 6 months PFS rate
timeFrame: From baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yu W, Zhang H, Chen J, Zhang X, Chen Y, Qu G, Huang G, Zhou Y, Ye T, Fan Z, Yao Y. Efficacy and safety of apatinib in patients with untreated or chemotherapy-refractory soft tissue sarcoma: a multicenter, phase 2 trial. Ann Transl Med. 2022 Sep;10(18):981. doi: 10.21037/atm-22-4229.
Clinical trial NCT04229043: Gastric Emptying of Water and Sports Drink in Labor
Official title: Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Gastric Emptying
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects in each group will drink one of two drinks: water or sports drink. We will measure the changing volume in the stomach using ultrasound over the next 60 minutes.
Primary purpose: OTHER

Brief summary: To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink.

Detailed description: This is a randomized un-blinded study comparing the gastric emptying halftime of water versus a carbohydrate-based sports drink.

Cohorts Women in early labor who have not received pain medication will be enrolled in the study. This will be called the 'unmedicated' group. A second cohort of women who have received an epidural in early labor will be enrolled and studied using identical methods. This will be the 'epidural' group.

Study Intervention Subjects in each group will drink one of two drinks: water or sports drink. The changing volume in the stomach will be measured using ultrasound over the next 60 minutes. Subjects will be asked their degree of hunger on a 10-centimeter visual analogue scale prior to drinking, and for the next two hours at regular intervals. Subjects will be free to consume as per obstetric protocols. The study will be finished once the patient consumes food or drink, feels hunger ≥4/10, or two hours after the sports drink.

Hypothesis The primary hypothesis is that water will empty faster than the sports drink. A second hypothesis is that women with epidural pain relief will have similar gastric halftimes as women without pain medications.

Eligibility criteria: Inclusion Criteria:

* Gestational age of 36 weeks or greater
* American Society of Anesthesiology Physical Status 2 or 3
* Induction of labor or early labor (cervical dilation \< 6cm)
* Singleton gestation

Exclusion Criteria:

* Recent food ingestion (\<3 hours)
* Preeclampsia
* Receiving magnesium sulfate
* Having received narcotics within 12 hours
* Diabetes mellitus
* Multiple gestations
* Active nausea or reflux symptoms

Primary outcomes:
measure: Gastric emptying half time
timeFrame: 60 minutes
Secondary outcomes:
measure: Hunger
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Isreal Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT02922543: A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use
Official title: Revlimid 5 mg Capsules Special Use-results Surveillance of Long Term Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Teratogenicity
Thrombocytopenia and haemorrhage
Neutropenia and infection
Venous thromboembolism
Allergic reactions
Diarrhoea or constipation
Peripheral neuropathy
Cardiac failure
Arrhythmia
Renal failure
Myocardial infarction
Interstitial lung disease
Tumour lysis syndrome
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-10-04
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Relapsed or refractory multiple myeloma (MM) patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance.

Brief summary: To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have received long-term treatment with it under the actual condition of use.

1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled, 300, is reached (estimated to be approximately 1 year and 3 moths).
2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid (estimated to be approximately 4 years and 3 months).


Eligibility criteria: Inclusion Criteria:

* Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Shinko Hospital
state: Hyogo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: