louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01156740: Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings
Official title: Treatment of Pharyngitis Study (TOPS): A Randomized Equivalence Trial of Intramuscular Penicillin G vs. Oral Amoxicillin Antibiotics for the Treatment of Streptococcal Pharyngitis in Children in Developing Countries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Streptococcal Infections
Pharyngitis
Keywords: streptococcal pharyngitis
randomized clinical trial
amoxicillin
intramuscular benzathine penicillin G.
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: World Health Organization
name: Cairo University
name: University Hospital for Infectious Diseases, Croatia
name: Universidade Federal do Rio de Janeiro
First posted: 2010-07-05
Enrollment: 558
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.


Eligibility criteria: Inclusion Criteria:

* Age: 2-12 years old,
* Presenting with complaint of sore throat
* Parental consent given and child assent if 5 years or older

Exclusion Criteria:

* The parent/guardian reported oral antibiotic use in the past 3 days or injectable penicillin in past 28 days prior to screening
* Had a history of rheumatic fever or rheumatic heart disease
* Required hospitalization for any reason at the time of enrollment
* Had previously been enrolled in the study

Primary outcomes:
measure: Eradication of Group A Streptococcus (GAS)
timeFrame: 21-28 days after 1st visit
Secondary outcomes:
measure: Compliance to treatment
timeFrame: 21-28 days after 1st visit
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
city: Zagreb
country: Croatia
facility: University Hospital for Infectious Diseases
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Mark C. Steinhoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02808572: New Biomarkers of Bone Mineral Metabolism as Cardiovascular Risk Factors in Chronic Kidney Disease Patients
Official title: New Biomarkers of Bone and Mineral Metabolism as Risk Factors for Morbidity/Mortality in Chronic Kidney Disease Patients Not Requiring Dialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
vascular calcifications
cardiovascular risk
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin, fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a 7 year follow-up.


Eligibility criteria: Inclusion Criteria:

* Patient who has signed the written consent form
* Patient with chronic renal failure defined by glomerular filtration rate (GFR) but without dialysis therapy

Exclusion Criteria:

* Pregnancy
* Patient with chronic renal failure requiring dialysis therapy

Primary outcomes:
measure: Occurence of at least one cardiovascular event during the 7 year follow-up according to osteoprotegerin level at inclusion
timeFrame: 7 years after inclusion
Secondary outcomes:
measure: Occurence of at least one cardiovascular event during the 7 year follow-up according to fibroblast growth factor 23 level at inclusion
timeFrame: 7 years after inclusion
measure: Occurence of at least one cardiovascular event during the 7 year follow-up according to vascular calcification score at inclusion
timeFrame: 7 years after inclusion
measure: Mortality
timeFrame: 7 years after inclusion
measure: Kidney functions
timeFrame: during the 7 year follow-up
Other outcomes:
Locations:
city: Montpellier
country: France
facility: AIDER
city: Montpellier
country: France
facility: CHU Montpellier, Cardiology department
city: Montpellier
country: France
facility: CHU Montpellier, Endocrinology department
city: Montpellier
country: France
facility: CHU Montpellier, Intensive care unit
city: Montpellier
country: France
facility: CHU Montpellier, Internal medicine department
city: Montpellier
country: France
facility: CHU Montpellier, Nephrology department
city: Saint-Jean-de-Védas
country: France
facility: AIDER
Study officials:
affiliation: CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
name: Jean-Paul CRISTOL, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05754372: Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia
Official title: Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyperammonemic Encephalopathy
Keywords: hemodialysis
neonate
Hyperammonemic Encephalopathy
inborn error of metbolism
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 10
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants presenting with acute neonatale hyperammonaemia

Brief summary: Acute neonatal hyperammonemia is associated with poor neurological outcomes and high mortality. A user-friendly and widely applicable algorithm - based on kinetics - to tailor the treatment of acute neonatal hyperammonemia. A single compartmental model was calibrated assuming a distribution volume equal to the patient's total body water (V), as calculated using Wells' formula, and dialyzer clearance as derived from the measured ammonia time-concentration curves during 11 dialysis sessions in four patients (3.2 +/- 0.4 kg). Based on these kinetic simulations, dialysis protocols could be derived for clinical use with different body weights, start concentrations, dialysis machines/dialyzers and dialysis settings (e.g., blood flow QB). By a single measurement of ammonia concentration at the dialyzer inlet and outlet, dialyzer clearance (K) can be calculated as K = QB\[(Cinlet - Coutlet)/Cinlet\]. The time (T) needed to decrease the ammonia concentration from a predialysis start concentration Cstart to a desired target concentration Ctarget is then equal to T = (-V/K)LN(Ctarget/Cstart). By implementing these formulae in a simple spreadsheet, medical staff can draw an institution-specific flowchart for patient-tailored treatment of hyperammonemia.

The aim of this study is to validate these formula with a prospective study.


Eligibility criteria: Inclusion Criteria:

* severe acute neonatal hyperammonaemia for which acute hemodialysis is indicated
* inborn error of metabolism
* below 1 year of age

Exclusion Criteria:

* older than 1 year

Primary outcomes:
measure: serum ammonium levels
timeFrame: 1 year
Secondary outcomes:
measure: Removal of treatment sodium benzoate, L-arginine
timeFrame: 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital - Department of Paediatric Nephrology
Study officials:
References:
Clinical trial NCT03142672: Postoperative Pain and Recovery Time After Pulpotomy
Official title: Immediate Postoperative Pain and Recovery Time After Pulpotomy Performed Under General Anaesthesia in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative pain
child
pulpotomy
general anesthesia
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this retrospective study was to compare immediate postoperative pain scores and the need for rescue analgesia in children who underwent pulpotomies and general restorative treatment and those who underwent general restorative treatment only, all under general anaesthesia.

Detailed description: Ninety patients aged between 3 and 7 years who underwent full mouth dental rehabilitation under general anaesthesia were enrolled in the study and reviewed. The experimental group included patients who were treated with at least one pulpotomy, and the control group was treated with dental fillings only. The Wong-Baker FACES scale was used to evaluate self-reported pain and the need for rescue analgesia. The data were analysed using the Kruskal-Wallis test, two sample t- tests, chi-square tests and Pearson's correlation analysis.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent full mouth dental rehabilitation under GA because of their lack of chairside cooperation
* Patients with at least 1 pulpotomy were included in the experimental group (n=45), and patients treated with dental fillings only were included in the control group (n=45); a total of 90 patients were eligible for the study.

Exclusion Criteria:

* Children with special needs and those with any systematic problem (cardiac disease, diabetes, or intellectual disability) were excluded from the study.

Primary outcomes:
measure: Pain scores evaluation
timeFrame: An average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pediatric dentistry
name: Sultan Keles, Dr.
role: STUDY_DIRECTOR
References:
citation: Jensen B. Post-operative pain and pain management in children after dental extractions under general anaesthesia. Eur Arch Paediatr Dent. 2012 Jun;13(3):119-25. doi: 10.1007/BF03262857.
Clinical trial NCT01949272: Optimization of PEEP for Alveolar Recruitment in ARDS
Official title: Optimization of PEEP for Alveolar Recruitment in ARDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
Keywords: ARDS
Lead sponsor: Hopital of Melun
Sponsor class: OTHER
Collaborators: name: Melun Hospital Intensive Care Unit
First posted: 2013-09-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All ICU patients achievinf definition of ARDS stades II and III of Berlin Classification

Brief summary: Actual setting of PEEP in ARDS is based on tables linked to FiO2, or respiratory system plateau pressure (e.g EXPRESS Study) or set regarding esophageal pressure mesurement and transpulmonary pressure calculation. Opera study should confirm if a setting approach based on esophageal pressure is helpfull for any ARDS patient in ICU without deleterious side-effect.


Eligibility criteria: Inclusion Criteria:

* ARDS Stades 2 and 3 with invasive ventilation (EXPRESS settings) within 3 to 12 hours

Exclusion Criteria:

* less 18 years, pregnancy, intracardiac shunt, esophageal catheter cons-indicated

Primary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: 24 hours
Secondary outcomes:
measure: Vd/Vt ratio
timeFrame: 24 hours
Other outcomes:
Locations:
city: Melun
country: France
facility: Melun Hospital ICU
Study officials:
affiliation: Melun Hospital ICU
name: Mehran Monchi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00176072: BlueCQ Bioavailability
Official title: B l u e C Q - P r o j e c t: Bioavailability of Methylene Blue (MB) - Comparison of an Intravenous and Two Oral Formulations - and Influence of Sustained Release MB on Chloroquine (CQ) Concentrations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Methylene Blue
Chloroquine
Pharmacokinetics
Bioavailability
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Bioavailability of methylene blue (MB) - comparison of an i.v. and two oral MB formulations - and influence of sustained release MB on chloroquine (CQ) concentrations in whole blood, plasma and urine.

Intraindividual cross over open comparison in healthy male and female individuals (6:6) with different MB formulations in randomised order for the determination of the absolute bioavailability of MB (part 1), followed by an explorative randomised parallel group comparison of CQ disposition when CQ is given alone (3 males and 3 females) or in combination with 1000 mg sustained release MB (3 males and 3 females) in the participants of study part 1 (part 2).

Detailed description: Maximum whole blood methylene blue (MB) concentrations after i.v. and oral administration may differ in the magnitude of 100:1. For achieving MB concentrations possibly effective against malaria when using different pharmaceutical formulations, determination of oral bioavailability of MB is necessary. To investigate this 12 healthy subjects (6 females, 6 males) will receive in a randomised cross over design MB 50 mg i.v. and MB 500 mg as a oral solution.

For generating this information for a planned phase II/III study in Africa, an intravenous and an oral MB preparation will be investigated.

A second part of the study will explorative investigate the influence of MB on chloroquine (CQ) plasma concentrations. During this part 6 healthy subjects (3 females, 6 males) will receive either CQ alone or in combination with MB 500 mg, the design of this part will be a parallel design.

Eligibility criteria: Inclusion Criteria:

Good state of health physically and mentally

Exclusion Criteria:

Any regular drug treatment currently or past (within the last 2 months) except for oral contraceptives in females Treatment with a known inhibitor or inducer of drug metabolising enzymes or transport proteins within a period of less than 10 times the respective elimination half-life

Any acute or chronic illness, especially:

Glucose-6-phosphate dehydrogenase deficiency Allergic disposition or history of hypersensitivity reactions Smoking Alcohol or drug abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department Internal Medicine VI
name: Gerd Mikus, MD Bsc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02361372: Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients
Official title: Short-term Effect of Kefir-fermented Milk Consumption on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Ministry of Science and Technology, Taiwan
Sponsor class: OTHER_GOV
First posted: 2015-02-11
Enrollment: 69
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a controlled, parallel, double-blind intervention study over 6 months, the investigators investigated the effects of kefir-fermented milk (1,600 mg/kg) supplemented with calcium bicarbonate (CaCO3, 1,500 mg/kg) and bone metabolism in 40 osteoporosis patients, and compared them with CaCO3 alone without kefir supplements. Bone turnover markers were measured in fasting blood samples collected before therapy and at 1, 3, and 6 months. BMD values at the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray absorptiometry (DXA) at baseline and at 6 months.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of osteoporosis patients

Exclusion Criteria:

* Any previous use of parathyroid hormone or sodium fluoride, use of anabolic steroids or growth hormone within 6 months before trial entry or oral or intravenous systemic corticosteroids within 12 months, and any previous use of strontium.

Primary outcomes:
measure: bone mineral density and bone regeneration
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tu MY, Chen HL, Tung YT, Kao CC, Hu FC, Chen CM. Short-Term Effects of Kefir-Fermented Milk Consumption on Bone Mineral Density and Bone Metabolism in a Randomized Clinical Trial of Osteoporotic Patients. PLoS One. 2015 Dec 10;10(12):e0144231. doi: 10.1371/journal.pone.0144231. eCollection 2015.
Clinical trial NCT04815772: Evaluation of the 1999 and 2018 Periodontal Disease Classifications: a Retrospective Study
Official title: Evaluation of Diabetes Mellitus and Smoking on Periodontitis Classifications Using the 1999 and 2018 Periodontal Disease Classifications: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Smoking
Periodontal Diseases
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The individuals with periodontitis who participated in the study were evaluated in three categories:

* individuals who do not smoke and do not have any illnesses
* non-smoking individuals with diabetes
* individuals who smoke and have no systemic disease

Brief summary: The aim of present study was to evaluate how the 2018 classification reflects the severity, extent and progression of the disease, taking into account the risk factors for periodontal disease, smoking and diabetes, when compared with the 1999 classification.


Eligibility criteria: Inclusion Criteria:

* Patients with a complete periodontal chart and full mouth radiographic series at baseline
* Diabetes Mellitus:Patients who consulted by an internist/endocrinologist and underwent HbA1c measurements in the last three months.
* Smoking status:All current smokers who had smoked more than 100 cigarettes in their lifetimes and used cigarettes for more than five years
* Patients meeting the case definition of periodontitis
* Relative radiographic bone loss(in %) was assessed on peri-apical radiograph films

Exclusion Criteria:

* individuals with a systemic disease other than diabetes
* Smokers not reporting the number of cigarette/days or patient(s) with diabetes that do not report Hemoglobin A1c (HbA1c) test results for diabetes.
* individuals who do not suffer from periodontitis
* Patients with inaccessible files because of bad debt, destroyed record, or deceased.

Primary outcomes:
measure: The advantages of including the effect of diabetes and smoking on periodontal disease in the 2018 classification compared to the 1999 classification
timeFrame: The present retrospective study included individuals who were examined and had periodontal measurements made and recorded at the Istanbul Okan University Periodontology Department between 09/01/2018 and 12/01/2019.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Okan University
Study officials:
affiliation: Okan University
name: ekin Beşiroğlu, 1
role: STUDY_DIRECTOR
References:
Clinical trial NCT04033172: Pyrotinib Plus Fulvestrant in Patients With HR+/HER2+ Metastatic Breast Cancer (Pyrotinib+Fulvestrant )
Official title: Pyrotinib Plus Fulvestrant in Patients HR+/HER2+ Metastatic Breast Cancer : a Prospective, Single-arm, Single-center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
HER2-positive Breast Cancer
Keywords: Metastatic Breast Cancer, Pyrotinib, Fulvestrant
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2019-07-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, single-center clinical study of pyrotinib plus fulvestrant as the therapy HR+/HER2+ metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Women aged 18-75 years old; HR positive and HER2 positive (immunohistochemistry or FISH test confirmed).
2. ECOG score ≤ 2, expected survival ≥ 3 months.
3. Histology or cytology confirmed as breast cancer.
4. Prior to trastuzumab and endocrine therapy and progression/recurrence.
5. At least one RECIST 1.1 defined measurable lesions.
6. Normal function of major organs.

Exclusion Criteria:

1. pregnant or lactating women
2. Patients who have relapsed or progressed within 12 months of end of adjuvant or neoadjuvant therapy, including chemotherapy, target therapy (eg lapatinib， trastuzumab), or other anti-tumor therapy. Except for endocrine therapy.
3. Severe chronic gastrointestinal diseases with diarrhea as the main symptom (such as Crohn's disease, malabsorption, or ≥2 grade diarrhea caused by any cause at baseline).
4. Rapid progress of organ invasion (such as liver and lung disease greater than 1/2 organ area or liver dysfunction, etc.)
5. Patients with central nervous system disorders or mental disorders
6. Bone metastasis lesions only, no other measurable lesions.
7. Hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg) without ideal control.
8. Uncontrolled heart disease.
9. Have congenital long or short QT syndrome or have a family history or personal history of Brugada syndrome.
10. Uncontrolled rain metastasis.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Estimated up to 1 year
Secondary outcomes:
measure: OS (overall survival)
timeFrame: Estimated up to 1 year
measure: Objective Response Rate (ORR)
timeFrame: Estimated up to 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Peng Yuan
role: STUDY_CHAIR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jian Yue
role: PRINCIPAL_INVESTIGATOR
References: