louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02405429: Temporal Artery Temperature Measurement in Neonates
Official title: Comparing Temporal Artery and Axillary Temperatures With Rectal Temperature in Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newborn Infant
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 49
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital nursery patients

Brief summary: The aim of this study was to evaluate the temporal artery thermometer by comparing temporal artery and axillary thermometer temperature measurements with rectal thermometer temperature measurements in neonatal patients. The investigators measured temporal artery, axillary, and rectal temperatures of 49 infants. Temporal artery temperature was measured using an infrared temporal artery thermometer, and the results with this device were compared with axillary temperature (clinical standard) and rectal temperature (gold standard). The difference between rectal and temporal artery temperatures was compared with the difference between rectal and axillary temperatures for each infant, and the data were analyzed based on weight, postmenstrual age and bed type - open crib or incubator.


Eligibility criteria: Inclusion Criteria:

* Patients in hospital well-baby nursery or neonatal intensive care unit

Exclusion Criteria:

* Birth weight \<500 grams
* Anal atresia
* Central nervous system malformation
* Hypoxic-ischemic encephalopathy
* Clinical concerns for necrotizing enterocolitis or other bowel injury or discontinuity

Primary outcomes:
measure: Temporal Artery Temperature
timeFrame: Mean of 2 measurements within 2 minutes of each other and within 2 minutes of axillary and rectal temperature measurements
measure: Axillary Temperature
timeFrame: Single measurement within 2 minutes of temporal artery and rectal temperature measurements
measure: Rectal Temperature
timeFrame: Single measurement within 2 minutes of temporal artery and axillary temperature measurements
measure: Difference Between Temporal Artery and Rectal Temperatures
timeFrame: Within 2 minutes of each other
measure: Difference Between Rectal and Axillary Temperatures
timeFrame: Within 2 minutes of each other
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Edward F Bell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Syrkin-Nikolau ME, Johnson KJ, Colaizy TT, Schrock R, Bell EF. Temporal Artery Temperature Measurement in the Neonate. Am J Perinatol. 2017 Aug;34(10):1026-1031. doi: 10.1055/s-0037-1601440. Epub 2017 Apr 10.
Clinical trial NCT05229029: RSYR for Fatigue Reduction in Cancer Fatigue Caused by Chemotherapy
Official title: A Multicenter, Randomized, Double-blind Clinical Trial of TCM in Reducing CRF Caused by Chemotherapy in Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cancer-related Problem/Condition
Keywords: Chemotherapy
Fatigue
Cancer
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of Chinese herbal compound in improving fatigue symptoms and quality of life in patients with chemotherapy.

Detailed description: In this study, symptomatic indicators and quality of life were used as the main evaluation indicators. Patients with moderate to severe CRF who received dual drug chemotherapy were given traditional Chinese medicine compound and placebo intervention respectively. The data of fatigue symptoms, quality of life, sleep quality, blood routine test, liver and kidney function were observed and compared, so as to verify the traditional Chinese medicine compound prescription in improving the CRF symptoms and quality of life of chemotherapy patients validity.

Eligibility criteria: Inclusion Criteria:

* Malignant tumor patients with pathological diagnosis
* Men and women aged 18-75
* KPS score ≥ 70, expected survival time more than 6 months
* The function of heart, lung, liver and kidney was normal
* Hemoglobin ≥ 8g
* Neuroendocrine function is normal
* BMI ≥ 18.5.
* Cancer pain, VAS score \< 3
* Fatigue score ≥ 4
* syndrome differentiation is deficiency of Qi and blood

Exclusion Criteria:

* Brain metastases with Symptomatic
* Mental disease
* Severe infection
* Insomniacs
* Pregnant or lactating women

Primary outcomes:
measure: Fatigue score
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Hong Sun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01529229: Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Persistent Allergic Rhinitis Treatment
Official title: A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Moderate - Severe Persistent Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 210
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of Moderate - Severe Persistent Allergic Rhinitis.

Detailed description: * double-blind, non-inferiority, prospective, parallel group trial.
* Experiment duration: 07 days.
* 02 visits (days 0 and 7).
* Efficacy will be evaluated for persistent allergic rhinitis based on nasal symptoms score
* Adverse events evaluation.

Eligibility criteria: Inclusion Criteria:

* Consent of the patient or legal guardian;
* Clinical diagnosis of moderate - severe persistent allergic rhinitis according to the classification of ARIA (Allergic Rhinitis and Its Impact on Asthma);
* Children aged between 2 and 11 years and 11 months (up to 30 kg);
* Presence of nasal symptoms score greater than or equal to 5 (scale 0 to 12)in the last week;
* Evidence of sensitization to aeroallergens in examination (immediate skin tests or serum specific IgE) in the 12 months prior to inclusion.

Exclusion Criteria:

* Participation in clinical trial in 30 days prior to study entry;
* Patients receiving immunotherapy;
* Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ;
* Patients with any clinically significant disease other than allergic rhinitis, including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders;
* Patients on treatment with monoamine oxidase inhibitors (MAOIs);
* Patients who were in use of oral antihistamines or decongestants in the past 15 days;
* Patients who were treated with systemic corticosteroids in the last month;
* Patients who have uncontrolled asthma, chronic sinusitis, drug related rhinitis and nasal anatomic abnormalities.

Primary outcomes:
measure: Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score
timeFrame: 7 days
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Dirceu Solé, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05781529: Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation
Official title: Injectable Platelets Rich Fibrin Versus Hyaluronic Acid With Bovine Derived Xenograft for Alveolar Ridge Preservation (A Randomized Controlled Clinical Trial With Histomorphometric Analysis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Ridge Enlargement
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate.

Detailed description: The aim of this study was to compare injectable platelets rich fibrin (I-PRF) versus hyaluronic acid (HA) in combination with xenografts for ARP. Methods: Thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate. The assessment was done by cone beam CT preoperative and 4 months postoperative to assess radiographic bone gain and crestal bone loss. Clinical parameters were soft tissue thickness, keratinized gingiva and clinical bone width that were assessed preoperative, 4 months and 1 year postoperative. Histological assessment of core bone biopsies 4 months postoperatively was performed by histomorphometric analysis of newly formed bone %, mature bone% and residual graft%

Eligibility criteria: Inclusion Criteria:

* non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar)
* socket type I according to Elian et al., 2007 classification
* tooth to be extracted was free from acute periapical infection or sinus tracts
* thick gingival biotype
* Systemically free according to modified Cornell medical index

Exclusion Criteria:

* smokers patients
* bruxism habits
* patients with poor oral hygiene or not willing to perform oral hygiene measures

Primary outcomes:
measure: Radiographic bone width
timeFrame: 4 months postoperative
Secondary outcomes:
measure: histological and histomorphometric assessment
timeFrame: 4 months postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Doaa Adel Salah Khattab
state: Abbassia
city: Cairo
country: Egypt
facility: Doaa Khattab
state: Abbassia
Study officials:
References:
Clinical trial NCT05632029: Laser Acupuncture in Egyptian Systemic Lupus Females With Insulin Resistance
Official title: Laser Acupuncture in Systemic Lupus Women With Prediabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
PreDiabetes
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: glucose hemosatasis, oxidative stress, abnormalities of blood pressures, and high inflammatory status is high presented in lupus patients.

Detailed description: 64 lupus prediabetic women will equally distributed to group A (n =32 that will receive laser acupuncture (active) for one month (3 days week) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian, laser will be applied for 1 min on every acupiont) or group B (n =32 this group will receive the same protocol of group A but the points will be sham points)

Eligibility criteria: Inclusion Criteria:

* prediabetic lupus females (n =64)

Exclusion Criteria:

* obesity diabetes heart or respiratory problems

Primary outcomes:
measure: Malondialdehyde
timeFrame: It will be measured after 4 weeks of laser application
Secondary outcomes:
measure: systolic blood pressure
timeFrame: It will be measured after 4 weeks of laser application
measure: diastolic blood pressure
timeFrame: It will be measured after 4 weeks of laser application
measure: blood glucose
timeFrame: It will be measured after 4 weeks of laser application
measure: erythrocyte sedimentation rate (at first hour)
timeFrame: It will be measured after 4 weeks of laser application
measure: erythrocyte sedimentation rate (at second hour)
timeFrame: It will be measured after 4 weeks of laser application
measure: C reactive protein
timeFrame: It will be measured after 4 weeks of laser application
measure: adenosine triphosphate
timeFrame: It will be measured after 4 weeks of laser application
measure: Nitrate
timeFrame: It will be measured after 4 weeks of laser application
measure: Glutathione
timeFrame: It will be measured after 4 weeks of laser application
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01271829: Incorporating Avocados in Meals
Official title: Incorporating Avocados in Meals: Effect on Glycemic Index, Insulin Response, Satiety and Satiety-related Gastrointestinal Peptides in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satiety
Glycemic Index
Insulin
Gastrointestinal Peptides and Hormones
Keywords: Avocados
Satiety
Feeding study
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Hass Avocado Board
First posted: 2011-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 23
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to examine the effect of incorporating avocados in meals on post-ingestion glycemic index, insulin response, sensations of satiety and on appetite-related gastrointestinal peptide and hormone release. Also the effect of consuming avocado containing meals on the caloric intake of participants in subsequent eating episodes will be explored.

Each subject will participate in one intervention for one day, wait one or two weeks, come for another intervention, wait one or two weeks and come for a final intervention- three in total. Participants will be randomly assigned to one of six treatment sequences. Postprandial response to the control and two avocado-containing test meals will be assessed and compared using a 3 x 3 single blind cross-over design. The Subjects will be between 25 and 60 years old, female or male, with a BMI of 23 to 32, stable weight, no sports involvement, non-smoking and not dependent on caffeine. Thirty subjects will be recruited.


Eligibility criteria: Inclusion Criteria:

* 23-60 years old
* BMI 23-32
* Stable weight for 6 months
* Live or work near Loma Linda University

Exclusion Criteria:

* Smoker
* Heavy involvement in sports
* Dependent on caffeine

Primary outcomes:
measure: Satiety
timeFrame: 12 hours
Secondary outcomes:
measure: post-ingestion glycemic index
timeFrame: 3 hours
measure: insulin response
timeFrame: 3 hours
measure: appetite-related gastrointestinal peptide and hormone release
timeFrame: 3 hours
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University, Department of Nutrition
state: California
Study officials:
affiliation: Loma Linda University
name: Joan Sabaté, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wien M, Haddad E, Oda K, Sabate J. A randomized 3x3 crossover study to evaluate the effect of Hass avocado intake on post-ingestive satiety, glucose and insulin levels, and subsequent energy intake in overweight adults. Nutr J. 2013 Nov 27;12:155. doi: 10.1186/1475-2891-12-155.
Clinical trial NCT04436029: Descartes-11 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Official title: Descartes-11 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Cartesian Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-06-17
Enrollment: 5
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: To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-11 in patients with high-risk myeloma who have residual disease following induction therapy.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age or older at the time of enrollment
* High-risk multiple myeloma patients who complete pre-transplant induction treatment anti- myeloma drug combination (minimum 2 drugs).

Exclusion Criteria:

* Patients who are pregnant or lactating.
* Patients who have any active and uncontrolled infection. No blood cultures are necessary unless clinically indicated.

Primary outcomes:
measure: Rate of Stringent Complete Response
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center Oklahoma University Health Science Centers
state: Oklahoma
city: Madison
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Mohan M, Gundarlapalli S, Szabo A, Yarlagadda N, Kakadia S, Konda M, Jillella A, Fnu A, Ogunsesan Y, Yarlagadda L, Thalambedu N, Munawar H, Graziutti M, Al Hadidi S, Alapat D, Thanendrarajan S, Zangari M, van Rhee F, Schinke C. Tandem autologous stem cell transplantation in patients with persistent bone marrow minimal residual disease after first transplantation in multiple myeloma. Am J Hematol. 2022 Jun 1;97(6):E195-E198. doi: 10.1002/ajh.26530. Epub 2022 Mar 21. No abstract available.
citation: Mohan M, Hari P, Szabo A, Dhakal B, Chhabra S, D'Souza A. Long term follow up of newly diagnosed multiple myeloma patients treated with pembrolizumab consolidation post-autologous stem cell transplantation. Leuk Res. 2021 Oct;109:106648. doi: 10.1016/j.leukres.2021.106648. Epub 2021 Jun 23. No abstract available.
Clinical trial NCT04872829: Multifocal vs Monofocal IOL in Congenital Cataract Surgery
Official title: Comparative Analysis of Visual Outcomes of Multifocal and Monofocal Intraocular Lenses in Congenital Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Congenital
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 43
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We reviewed the records of 56 eyes of 43 pediatric patients who underwent congenital cataract surgery with phacoaspiration and simultaneous implantation of IOL under one year of age. All patients were directed to our hospital from primary care ophthalmologists or pediatricians

Brief summary: The aim of this study is to evaluate long-term outcome after congenital cataract surgery comparing results achieved with multifocal and monofocal IOLs.

Detailed description: PURPOSE: To assess the impact on visual development of multifocal versus monofocal intraocular lenses (IOLs) implantation in children following congenital cataract surgery.

DESIGN: Retrospective interventional consecutive case series. METHODS: We reviewed the records of 56 eyes of 43 pediatric patients who underwent congenital cataract surgery with phacoaspiration and simultaneous implantation of IOL under one year of age. Corrected distance visual acuity (CDVA), refractive error and ocular motility disorders were evaluated after a follow-up greater than 4 years.

Eligibility criteria: Inclusion Criteria:

* unilateral congenital cataract
* bilateral congenital cataract

Exclusion Criteria:

* other ocular pathologies (such as glaucoma, microphthalmia, micro - or megalocornea, persistent fetal vasculature, retinal congenital disease, corneal scar, traumatic cataracts)
* systemic diseases (such as chromosomal abnormalities, prematurity or mental retardation)

Primary outcomes:
measure: Mean CDVA
timeFrame: CDVA was evaluated after 4 years of age.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bambino Gesù Children's Hospital, Rome, Italy
name: Luca Buzzonetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buzzonetti L, Petroni S, De Sanctis CM, Valente P, Federici M, Benassi C, Iarossi G. Comparative analysis of visual outcomes of multifocal and monofocal intraocular lenses in congenital cataract surgery. J Cataract Refract Surg. 2022 Jan 1;48(1):56-60. doi: 10.1097/j.jcrs.0000000000000705.
Clinical trial NCT00500929: A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP
Official title: Mini-Metrxics: A Single-Centre, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Clinical Trial of CMI X-11S in Higher Risk Geriatric Patients Undergoing Open-Heart Surgical Procedures (OHSP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Disease
Keywords: OHSP
High risk
Geriatrics
Lead sponsor: Cardiometabolics
Sponsor class: INDUSTRY
First posted: 2007-07-13
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To provide information on parameters needed to design a subsequent Phase III confirmatory trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk geriatric patients undergoing open-heart surgical procedures (OHSP) requiring cardio-pulmonary bypass.


Eligibility criteria: Inclusion Criteria:

* Requirement for open-heart (including emergency) surgical procedures requiring cardio-pulmonary bypass:

  * Either:

    * Age ≥ 70 to \<80 with a Parsonnet Mortality Risk Score of ≥13 (poor risk); OR
    * Age ≥ 80

Primary outcomes:
measure: ICU Time
timeFrame: 30 to 45 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Shaohua Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: