louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04382157: Magnesium Replacement and Hyperglycemia After Kidney Transplantation
Official title: Magnesium Replacement and Hyperglycemia After Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hypomagnesemia
Kidney Transplantation
Keywords: Oral glucose tolerance test
Magnesium hydroxide
hyperglycemia
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The insulin receptor is dependent on magnesium and hypomagnesemia is associated with increased insulin resistance and decreased insulin secretion and action. Recent data suggest that hypomagnesemia may play a role in development of type 2 diabetes. Kidney transplantation patients have low plasma magnesium levels, partly due to treatment with calcineurin inhibitors. However, the role of magnesium in the development of post-transplant diabetes mellitus (PTDM) is unclear.

The present study addresses, whether hypomagnesemia is feasible to reverse by oral administration of magnesium.

The investigators wish to investigate whether oral magnesium supplementation is sufficient to increase magnesium levels in kidney transplant recipients, and if supplementation improves glycemic parameters as measured by an oral glucose tolerance test (OGTT).


Eligibility criteria: Inclusion Criteria:

* Kidney transplant recipients more than one year after transplantation
* Hypomagnesemia (\< 0.7 mmol/L)
* Age ≥ 18 years and able to give written informed consent

Exclusion Criteria:

* Current treatment with magnesium containing medication or supplements
* Current medical treatment for diabetes
* Conditions impairing magnesium absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis)
* Subjects with primary non-graft function and subjects with need of dialysis therapy \>2 months or graftectomy at any time point after transplantation

Primary outcomes:
measure: Magnesium retension at loading test
timeFrame: 24 weeks
Secondary outcomes:
measure: Plasma glucose (mmol/L)
timeFrame: Baseline (Before magnesium loading tests)
measure: Insulin (mg/kg/min)
timeFrame: 2 hours oral glucose tolerance test
measure: C-peptide (nmol/L)
timeFrame: 2 hours oral glucose tolerance test
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT02317757: Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients
Official title: Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients: A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: elderly cancer patients, chemotherapy toxicity
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-12-16
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cancer patients who are older than 70 years old and receiving chemotherapy

Brief summary: These days, there is higher proportion of elderly cancer patients. Most of them have comorbidities, borderline performance status and nutritional status. The discontinuation of chemotherapy due to unbearable toxicities was not uncommon. Comprehensive geriatric assessment might be beneficial in selection of suitable elderly patients for chemotherapy administration.

Detailed description: The patients with the age more than 70 years old who scheduled for chemotherapy were enrolled. Geriatric assessment was performed before starting chemotherapy. The toxicity will be recorded prospectively. Predisposing factors of grade 3 and 4 toxicity will be reported.

Eligibility criteria: Inclusion Criteria:

* more than 70 years of age
* plan to receive first cycle of chemotherapy
* histologically or cytologically proved of cancer

Exclusion Criteria:

* patients who have concurrent chemoradiotherapy
* patients who received local chemotherapy

Primary outcomes:
measure: predisposing factors of patients developed grade 3 or 4 chemotherapy toxicity
timeFrame: from starting chemotherapy to 1 month after last dose of chemotherapy
Secondary outcomes:
measure: incidence of grade 3 or 4 chemotherapy toxicity in elderly
timeFrame: from starting chemotherapy to 1 month after last dose of chemotherapy
measure: Factors associated with good quality of life during receiving chemotherapy
timeFrame: from starting chemotherapy to 1 month after last dose of chemotherapy
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of medical oncology, department of medicine Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Suthinee Ithimakin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02447757: Efficacy and Satisfaction With Remifentanil Analgesia in Parturients During the Childbirth
Official title: Efficacy and Satisfaction With Remifentanil Analgesia in Parturients During the Childbirth: Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Labor and/or Delivery
Keywords: Remifentanil, delivery, childbirth, analgesia, parturition, confinement
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Hospital Sokolov
First posted: 2015-05-19
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients during the delivery

Brief summary: Retrospective observational study to determine the efficacy of remifentanil during the delivery. Authors will search the data in period between 2010 and 2014 in cohort of 100 parturients and obtain data of analgesic efficacy (VAS score after remifentanil analgesia induction) and parturients satisfaction with the method.

Detailed description: In retrospective observational study will authors search the documentation of parturients. The cohort size is estimated to 100 subjects, in period between 2010-2014. Excluded will be all patients who did not signed the informed consent for processing with their medical data.The main aim is to evaluate the efficacy of the remifentanil analgesia in parturients in the first phase of delivery.

The analgesic efficacy will be evaluated by the change in VAS (visual analogue scale) score after induction of remifentanil analgesia Satisfaction will be evaluated by the questionary.

Eligibility criteria: Inclusion Criteria:

* parturients during the delivery
* administered remifentanil analgesia
* signed informed consent

Exclusion Criteria:

* informed consent not signed
* missing data about the analgetic method a analgetic efficacy

Primary outcomes:
measure: Efficacy of remifentanyl analgesia during the delivery
timeFrame: VAS score before the induction of remifentanyl infusion and 1hour after initiation of remifentanil analgesia during the first phase of delivery
Secondary outcomes:
measure: Patient satisfaction with analgetic method
timeFrame: Before initiation of anagetic method (first phase of delivery) and 1hour after childbirth
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: KDAR - department of pediatrics anesthesia and resuscitation
city: Sokolov
country: Czech Republic
facility: Sokolov Hospital
Study officials:
References:
Clinical trial NCT00197457: Pepsinogens as the Early Marker of H. Pylori Eradication
Official title: Serum Pepsinogens as an Early Diagnostic Marker of H. Pylori Eradication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: H. Pylori Infection
Gastric Ulcer
Duodnal Ulcer
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Helicobacter pylori (H. pylori) eradication increases the serum pepsinogen (PG) I/PG II ratio and the percentage change in PG I/PG II ratios was found to be a useful marker of H. pylori eradication (e.g., the PG method). We studied whether the PG method could be an early diagnostic marker of H. pylori eradication even in patients persistently treated with a proton pump inhibitor. Sixty-two H. pylori-positive patients underwent H. pylori-eradication therapy, followed by treatment with a PPI to cure ulcers. Serum levels of PG I and PG II were measured before, at the end of, and at 4 weeks after the eradication therapy. At more than one month after the end of treatments, 13C-urea breath test (UBT) was performed. The cut-off values of percentage changes in PG I/PG II ratios for the diagnosis of eradication of H. pylori were set in proportion to PG I/PG II ratios before eradication in accordance with our previous report. Using the results of UBT as the standard, the percentage change in serum PG I/PG II ratios is useful as an early diagnostic marker for judgment of H. pylori eradication irrespective of PPI treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with H. pylori infection

Exclusion Criteria:

* Patients without H. pylori infection

Primary outcomes:
measure: Whether the serum pepsinogen could be an early diagnostic marker of H. pylori eradication even in patients persistently treated with a proton pump inhibitor compared with 13C-urea breath test.
Secondary outcomes:
measure: Cost-effectiveness for diagnosis of H. pylori eradication by the serum pepsinogen.
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
Study officials:
affiliation: Hamamatsu University
name: Naohito Shirai, MD., PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT06118957: Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery
Official title: A Pilot Randomized Controlled Trial of Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thromboembolism
Keywords: Thromboembolism
Enoxaparin
Cesarean delivery
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the feasibility of randomizing individuals to low molecular weight heparin (enoxaparin) or no treatment following cesarean delivery. The investigators hypothesize that among eligible individuals, at least 35% will enroll, undergo randomization, and complete the allocated treatment group.

Detailed description: Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The first two weeks postpartum are the highest risk period for VTE during pregnancy and the postpartum period. Cesarean delivery is a known risk factor for VTE. In the United States, postpartum prophylaxis with low molecular weight heparin (e.g., enoxaparin) is commonly used during the first 10-14 days after delivery. Enoxaparin has not been demonstrated as an effective intervention to prevent postpartum VTE after cesarean delivery. Before larger scale studies may be completed, a better understanding of ability to randomize individuals to this intervention is needed. This study aims to evaluate the feasibility of randomizing individuals after cesarean delivery to the receipt of enoxaparin prophylaxis or no treatment.

Eligibility criteria: Inclusion Criteria:

* Cesarean delivery at the University of Utah Health

Exclusion Criteria:

* Contraindication to anticoagulation
* Plan for therapeutic anticoagulation
* Known renal dysfunction (creatinine clearance \<30mL/minute)
* History of venous thromboembolism
* High risk thrombophilia
* Receipt of antepartum anticoagulation for \>2 weeks

Primary outcomes:
measure: Rate of eligible individuals enrolled and retained through full study procedures
timeFrame: 6 Weeks
Secondary outcomes:
measure: Rate of venous thromboembolism
timeFrame: 6 Weeks
measure: Rate of wound hematoma or infection
timeFrame: 6 Weeks
measure: Rate of bleeding complications
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Ann Bruno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00395057: A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Choroid Neovascularization
Age-Related Macular Degeneration
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2006-11-02
Enrollment: 138
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration


Eligibility criteria: Inclusion Criteria:

* 50 years or older with "wet" AMD as determined by an ophthalmologist
* decrease in visual acuity (20/40 to 20/640) in at least one eye

Exclusion Criteria:

* Uncontrolled systemic disease
* History of heart attack or stroke within one year of study entry
* Symptomatic coronary artery disease
* Cataracts that interfere with vision

Primary outcomes:
measure: Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3
timeFrame: Month 3
Secondary outcomes:
measure: Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3
timeFrame: Month 3
measure: Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3
timeFrame: Month 3
measure: Visual Functioning Questionnaire (VFQ) at Month 3
timeFrame: Month 3
measure: Time to Treatment With Standard of Care at Month 6
timeFrame: Month 6
Other outcomes:
Locations:
city: Houston
country: United States
state: Texas
city: Sydney
country: Australia
state: New South Wales
city: Makati
country: Philippines
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03037957: A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
Official title: A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharyngitis Bacterial
Lead sponsor: Luminex Molecular Diagnostics
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 704
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with signs and symptoms of pharyngitis for which their doctors ordered a Group A Strep test.

Brief summary: A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period.


Eligibility criteria: Inclusion Criteria:

* Patient and/or patient's legal guardian is willing and able to give informed consent and/or assent for extra research sample.
* The subject's specimen is a throat swab in Liquid Amies based transport medium.
* The specimen is from an adult or pediatric, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinical or resident of a long term care facility.
* The specimen is from a patient for whom a requisition has been made for Group A Strep testing
* The specimen is from a patient exhibiting clinical signs and symptoms of pharyngitis consistent with Group A Strep infection.
* The specimen was received in good condition (no leakage or drying of the specimen).
* The specimen volume is ≥ 850 µL.

Exclusion Criteria:

* The specimen is from a patient who did not provide informed consent/assent.
* The specimen is not a throat swab collected in Liquid Amies based transport medium.
* The specimen is from a patient who is undergoing antibiotic treatment.
* The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 9 below.
* The specimen volume is \< 850 µL.

Primary outcomes:
measure: Clinical performance (sensitivity/specificity) for Group A Strep Assay
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Vienna
country: United States
facility: Advanced Pediatrics Research
state: Virginia
city: Marshfield
country: United States
facility: Marshfield Labs
state: Wisconsin
Study officials:
affiliation: Luminex Corporation
name: Ronald Dunn
role: STUDY_DIRECTOR
References:
Clinical trial NCT01047657: Effects of Weight Loss in Obese Difficult-to-treat Asthmatics
Official title: Effects of Weight Loss in Obese Difficult-to-treat Asthmatics: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Obesity
Weight Loss
Keywords: Asthma
Obesity
weight loss
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2010-01-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty percent of patients with difficult to control asthma seen in our outpatient clinic are obese. The impact of weight reduction in this subpopulation of asthmatics has not been studied. Our aim is to evaluate the impact of weight reduction on asthma control of these patients.

Detailed description: Study design: interventional, open label, randomized

Patients selection

Thirty-three difficult to control obese asthmatic patients, aged between 18 to 65 years old will be recruited from the outpatient clinics of the Pulmonary Division of the University of Sao Paulo Hospital.

Difficult to control asthma will be defined as patients who do not achieve asthma control (according to GINA) despite best treatment regimen and checked adherence after at least three months of treatment.

Intervention: Patients will be divided in two groups: asthma treatment plus weight loss program or asthma treatment alone for 6 months without drug dose changing.

Procedures (baseline and after 6 months) - quality of life questionnaire, asthma control questionnaire, lung function tests, serum and sputum inflammatory markers.

Eligibility criteria: Inclusion Criteria:

* Difficult-to-treat asthma
* Body mass index \> 30kg/m2

Exclusion Criteria:

* Subjets older than 65 years
* Current smoking
* Past smoking history (\> 10 pack-year)
* Pregnancy
* Contraindication for Orlistat or Sibutramine

Primary outcomes:
measure: Asthma control questionnaire (ACQ)
timeFrame: Baseline and six months
Secondary outcomes:
measure: Inflammatory parameters
timeFrame: Baseline and after 6 months
measure: Pulmonary mechanics
timeFrame: Baseline and after 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo - Heart Institute and Hospital das Clínicas
Study officials:
affiliation: Heart Institute, University of São Paulo
name: Sérvulo A. Dias-Júnior, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute, University of São Paulo
name: Alberto Cukier, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01604057: Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass
Official title: A Parallel Group Study to Evaluate the Effect of Six Weeks of Treatment With Nasal Spray (NS) ZT-034, Compared to Subcutaneous (SC) Forteo and Placebo, on Bone Formation, as Assessed by Stimulation of Serum P1NP Levels in Postmenopausal Women With Low Bone Mass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoporosis
Osteopenia
Lead sponsor: Azelon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-05-23
Enrollment: 130
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal Females Age ≥ 45 years.
* Weight \> 45 kg and \< 90 kg
* Normal nasal examination at baseline.
* Low bone mass at lumbar spine, total hip or femoral neck (BMD T-score of ≤ - 1.5 or lower) or a recent (within 5 years of baseline) history of fragility fracture (excluding fractures of hands, feet, face and/or skull) and a T-score of -1.0 or lower at lumbar spine, total hip or femoral neck

Exclusion Criteria:

* Serious Medical Condition
* History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism
* Have a history of cancer within the past 5 years, except for basal cell carcinoma
* Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;
* Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product

Primary outcomes:
measure: Change in Serum P1NP from baseline to end of treatment.
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)
timeFrame: baseline and 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Azelon Pharmaceuticals
name: Brian MacDonald
role: STUDY_DIRECTOR
References: