louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05129137: Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg)
Official title: Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg) and Individual Nefopam Hydrochloride and Paracetamol Taken Alone or Concomitantly After Oral Single Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Unither Pharmaceuticals, France
Sponsor class: INDUSTRY
Collaborators: name: Accutest Research Laboratories (I) Pvt. Ltd.
First posted: 2021-11-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: An open-label, randomized, four-period, four treatments, cross-over trial in healthy volunteers
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to assess the pharmacokinetic profile of a Fixed Dose Combination nefopam hydrochloride (30 mg) / paracetamol (500 mg) and individual components taken alone or concomitantly after oral single dose.


Eligibility criteria: Inclusion Criteria:

* Male and non-pregnant female human subjects, age 18 - 45 years.
* Body Mass Index between 18.5-30 Kg / m2 .
* Subjects with normal findings .
* Willingness to follow the protocol requirements

Exclusion Criteria:

* Known history of hypersensitivity to Nefopam, Paracetamol or related drugs.
* Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
* Subjects with a history of convulsive disorders.
* Subject with a moderate or severe renal impairment
* History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
* Female subjects not confirming to using birth control measures,

Primary outcomes:
measure: Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose
timeFrame: up to 48 hours post dose
measure: Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose
timeFrame: up to 48 hours post dose
Secondary outcomes:
measure: Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose
timeFrame: up to 48 hours post dose
measure: Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose
timeFrame: up to 48 hours post dose
measure: N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose
timeFrame: up to 48 hours post dose
measure: N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose
timeFrame: up to 48 hours post dose
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 48 hours
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Accutest Research Laboratories
Study officials:
affiliation: Accutest Research Laboratories
name: Pramila Yadav, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03344237: hsTnT in Patients Admitted to the ED With Atrial Fibrillation in the Era of NOACs - Heidelberg Registry of Atrial Fibrillation
Official title: High-Sensitivity Cardiac Troponin T in Patients Admitted to the Emergency Department With Atrial Fibrillation in the Era of Novel Oral Anticoagulants - Heidelberg Registry of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of approximately 5000 consecutive patients with atrial fibrillation presenting to the emergency department of the Heidelberg University Hospital between March 2013 and June 2017

Brief summary: The purpose of the Heidelberg Registry of Atrial Fibrillation (HERA-FIB) is to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department in the era of novel oral anticoagulants (NOACs).


Eligibility criteria: Inclusion Criteria:

* documented atrial fibrillation
* availability of at least one hsTnT measurement

Exclusion Criteria:

* none

Primary outcomes:
measure: Vascular and non-vascular death
timeFrame: Follow up after at least 6 months
measure: Nonfatal myocardial infarction
timeFrame: Follow up after at least 6 months
measure: Stroke/systemic embolism
timeFrame: Follow up after at least 6 months
Secondary outcomes:
measure: Stroke, systemic embolism, myocardial infarction, vascular death, non-vascular death, composite endpoint of vascular and non-vascular death, nonfatal MI, stroke/systemic embolism
timeFrame: Follow up after at least 6 months
Other outcomes:
measure: Major bleeding by definition of International Society on Thrombosis and Haemostasis (ISTH)
timeFrame: Follow up after at least 6 months
Locations:
city: Heidelberg
country: Germany
facility: Department of Cardiology, Angiology and Pneumology, Heidelberg University Hospital
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Heidelberg
name: Mehrshad Vafaie, Dr.med.Dr.med.univ.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03066037: Regional-anaesthesiological Infiltration Techniques for the Management of Chronic Pain: a Retrospective Study
Official title: Regional-anaesthesiological Infiltration Techniques for the Management of Chronic Pain: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Trigeminal Neuralgia
Cluster Headache
Post-Zoster Neuralgia
Post Zoster Pain
Neuropathic Pain
Keywords: regional-anaesthesiological infiltration
block series
invasive pain treatment
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are included with any refractory neuropathy, refractory headache or chronic disease with any invasive pain infiltration technique applied. All infiltration series are embedded in multi-modal therapy concepts.

Brief summary: There is a significant debate whether local infiltration techniques may be a method to treat complicated chronic pain syndromes, e.g. refractory headache. Until now there is a lack of evidence regarding efficacy of this treatment especially in long term follow up. Similarly, indication and management are under debate. Aim of this trial is to analyse pain scores during first treatment with anaesthesiological infiltration series.


Eligibility criteria: Inclusion Criteria:

* patients with chronic pain disease undergoing regional-anaesthesiological infiltration series

Exclusion Criteria:

* pregnancy
* patients in legal custody
* age \<18 years

Primary outcomes:
measure: NRS reduction during therapy
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of blocks in a series
timeFrame: 4 weeks
measure: Time till recurrent pain
timeFrame: 24 weeks
measure: clinical course of pain
timeFrame: 2 weeks
measure: type of infiltration
timeFrame: 2 weeks
measure: co-parameters of pain chronification
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité hospital
Study officials:
affiliation: Charité University Berlin
name: Michael Schäfer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dworkin RH, O'Connor AB, Kent J, Mackey SC, Raja SN, Stacey BR, Levy RM, Backonja M, Baron R, Harke H, Loeser JD, Treede RD, Turk DC, Wells CD. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain. 2013 Nov;154(11):2249-2261. doi: 10.1016/j.pain.2013.06.004. Epub 2013 Jun 6.
citation: Tafelski S, Beutlhauser T, Gouliou-Mayerhauser E, Fritzsche T, Denke C, Schafer M. [Practice of regional anesthesia for chronic pain patients in specialized pain services : A nationwide survey in Germany]. Schmerz. 2015 Apr;29(2):186-94. doi: 10.1007/s00482-014-1503-6. German.
Clinical trial NCT02231437: Post-marketing Surveillance of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease
Official title: Post-marketing Surveillance (in Accordance With § 67,6 AMG) of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 3488
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: general practitioners, pneumologists and internists

Brief summary: The aim of this post-marketing surveillance is to obtain further information about the tolerability of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of Chronic obstructive respiratory tract disease
* Patients of either sex, including children over 6 years

Exclusion Criteria:

- Contraindications listed in the Instructions of Use/Summary of Product Characteristics of Berodual® metered-dose inhaler

Primary outcomes:
measure: Overall severity of the clinical picture rated on a 4-point scale
timeFrame: after 3 and 6 weeks
Secondary outcomes:
measure: Changes in dyspnea and/or asthma attacks rated on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Number of dyspnea episodes rated on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Number of awakenings due to night-time dyspnea rated on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Assessment of morning coughing with expectoration on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Assessment of tolerability on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Number of patients with adverse drug reactions
timeFrame: up to 6 weeks
measure: Changes in pathological auscultation findings rated on a 3-point scale
timeFrame: after 3 and 6 weeks
measure: Changes in concomitant medication
timeFrame: up to 6 weeks
measure: Assessment of efficacy on a 4-point scale
timeFrame: after 3 and 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06395337: Multimodal Imaging in Rectal Cancer & Pancreatic Cancer
Official title: A Phase I/II Study to Evaluate the Safety and Feasibility of Multimodal Imaging Using a Dual-labeled Anti-CEA Antibody in Patients With Rectal or Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Rectal Cancer
Pancreatic Cancer
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
First posted: 2024-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Most digestive cancers show (over)expression of the tumour marker carcinoembryonic antigen (CEA). Therefore, interest in CEA-targeting tracers has increased over the past years. CEA-targeting tracers can be used for preoperative, intra-operative and postoperative imaging purposes. This study focusses on both preoperative and intraoperative multimodal imaging and image-guided surgery in patients with rectal cancer or pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of rectal cancer where a (beyond) TME resection is planned for OR Clinical suspicion of PDAC
* Scheduled for surgical resection
* Age over 18 years
* Signed informed consent

Exclusion Criteria:

* Any medical condition present that in the opinion of the investigator will affect patients' clinical status
* Administration of a radionuclide within 10 physical half-lives prior to study enrollment
* Pregnancy or lactation
* Known CEA negative tumor: If a patient had a primary tumor which did not express CEA determined immunohistochemically on the resection specimen of a prior operation or biopsy.

Primary outcomes:
measure: Safety of dual-labeled antibody as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0
timeFrame: 30 days
Secondary outcomes:
measure: Intensity of fluorescence
timeFrame: 7 days
measure: Intensity of radiosignal
timeFrame: 7 days
measure: Concordance between CEA and tracer
timeFrame: 7 days
measure: Blood levels of the dual-labeled antibody
timeFrame: 30, 60, 120, 180 minutes
measure: Biodistribution
timeFrame: 7 days
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
References:
Clinical trial NCT02172937: Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease, a Phase 1-2 Study
Official title: Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Graft vs Host Disease
Keywords: Stem Cell Transplantation
Decidual Stromal Cells
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2014-06-24
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.

Detailed description: Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1-2x10\^6 cells/kg at one or more occasions dependent on clinical response.

Eligibility criteria: Inclusion Criteria:

* Acute graft versus host disease grade 2-4.
* Are on calcineurin inhibitor and high dose corticosteroids.

Exclusion Criteria:

None.

Primary outcomes:
measure: Actuarial survival at six months after first DSC infusion
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Response at 28 days after onset of graft versus host disease
timeFrame: 28 days after inclusion
measure: Response at 84 days after onset of graft versus host disease
timeFrame: Up to 84 days after inclusion
measure: Response at 168 days after onset of graft versus host disease
timeFrame: Up to 168 days after inclusion
measure: Side effects
timeFrame: Up to 6 months after inclusion
measure: Incidence of severe infections
timeFrame: Up to one year after inclusion
measure: Disease free survival
timeFrame: Up to one year after inclusion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Olle Ringdén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erkers T, Nava S, Yosef J, Ringden O, Kaipe H. Decidual stromal cells promote regulatory T cells and suppress alloreactivity in a cell contact-dependent manner. Stem Cells Dev. 2013 Oct 1;22(19):2596-605. doi: 10.1089/scd.2013.0079. Epub 2013 Jul 2.
citation: Ringden O, Erkers T, Nava S, Uzunel M, Iwarsson E, Conrad R, Westgren M, Mattsson J, Kaipe H. Fetal membrane cells for treatment of steroid-refractory acute graft-versus-host disease. Stem Cells. 2013 Mar;31(3):592-601. doi: 10.1002/stem.1314.
citation: Sadeghi B, Remberger M, Gustafsson B, Winiarski J, Moretti G, Khoein B, Klingspor L, Westgren M, Mattsson J, Ringden O. Long-Term Follow-Up of a Pilot Study Using Placenta-Derived Decidua Stromal Cells for Severe Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2019 Oct;25(10):1965-1969. doi: 10.1016/j.bbmt.2019.05.034. Epub 2019 Jun 4.
Clinical trial NCT05810337: Splenda: Effects on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake
Official title: The Effects of Splenda (Sucralose) on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake in Humans: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Glucose Metabolism Disorders
Keywords: Blood glucose
Appetite
Energy intake
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the effects of Splenda, an artificial sweetener powder containing sucralose, on post-prandial blood glucose levels, appetite scores and subsequent energy intake.

Detailed description: Participants are randomly assigned to receive either the placebo drink (4.5g maltodextrin dissolved in 250ml water) or the Splenda drink (4.5g Splenda dissolved in 250ml water) taken alongside a high calorie breakfast.

Blood glucose measurements will be obtained through finger-pricking and appetite will be measured using self-reported visual analogue scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after breakfast. Energy intake will be measured using a 24 hour food diary.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female adults (18-64 years)

Exclusion Criteria:

-

Primary outcomes:
measure: Change in blood glucose
timeFrame: -5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)
measure: Change in appetite
timeFrame: -5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)
Secondary outcomes:
measure: 24 hour energy intake
timeFrame: 0 - 24 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Christopher Corpe, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06629337: Effect of Aerobic Exercise with Blood Flow Restriction on Post-exercise Hypotension in Young Adults: the Role of Histamine Receptors
Official title: Effect of Aerobic Exercise with Blood Flow Restriction on Post-exercise Hypotension in Young Adults: the Role of Histamine Receptors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehypertension (elevated Blood Pressure) or Hypertension
Lead sponsor: California Baptist University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: It was hypothesized that aerobic exercise with blood flow restriction (BFR) induced post exercise hypotension (PEH), and the reduction in blood pressure (BP) was due to peripheral vasodilation via the histamine receptors. Ten male participants participated in this study. The participants were randomly assigned to walk for 10 minutes at 6.4 k/m, 0% grade with or without BFR after taking histamine receptor blockade. Following exercise, BP was measured at 10 min interval for 60 minutes. Heart rate (HR), stroke volume (SV), cardiac output (CO), mean arterial pressure (MAP), and total peripheral resistance (TPR) were evaluated.


Eligibility criteria: Inclusion Criteria:

* good health,
* nonsmokers
* those not taking medications that could affect cardiovascular function

Exclusion Criteria:

* hypertension
* muscular skeletal disorder

Primary outcomes:
measure: Post-exercise hypotension before and after the histamine blockade
timeFrame: 10 min, 20 min, 30 min, 40 min, 50 min, and 60 min post exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Riverside
country: United States
facility: California Baptist University
state: California
Study officials:
References:
Clinical trial NCT03528837: Acute Kidney Injury in Neonates at NICU in Assiut University Children Hospital Descriptive Study
Official title: Acute Kidney Injury in Neonates at NICU in Assiut University Children Hospital Descriptive Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Acute Kidney Injury
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study of cases of acute kidney injury in neonates and its causes and it's outcome

Brief summary: Acute kidney injury (AKI) is a complex disorder with clinical manifestations ranging from mild dysfunction to complete anuric kidney failure. Its leads to sudden and rapid decline in renal excretory function within hours to days,accompanied by accumulation of nitrogenous waste products such creatinine,urea and other clinically un measured products

Detailed description: Acute kidney injury (AKI) is an under-recognized morbidity of neonates; the incidence remains unclear due to the absence of a unified definition of AKI in this population and because previous studies have varied greatly in screening for AKI with serum creatinine and urine output assessments. Premature infants may be born with less than half of the nephrons compared with term neonates, predisposing them to chronic kidney disease (CKD) early on in life and as they age. AKI can also lead to CKD, and premature infants with AKI may be at very high risk for long-term kidney problems. AKI in neonates is often multifactorial and may result from prenatal, perinatal, or postnatal insults as well as any combination thereof.

Eligibility criteria: Inclusion Criteria:

* All cases of acute kidney injury in neonates who will be admitted to NICU Assiut University Children Hospital during the duration of the study.

Exclusion Criteria:

* Cases with chronic renal affection Any case with congenital anomalies

Primary outcomes:
measure: Diagnosed as acute kidney injury
timeFrame: 10-21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university children hospital
Study officials:
References: