louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01135797: Retrospective Safety Survey In Patients Included In NV1FGF Clinical Trials
Official title: Retrospective Safety Survey In Patients Included In Phase I-II NV1FGF Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Occlusive Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-06-03
Enrollment: 164
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 participating in this observational study previously participated in one of the phase I-II studies for the compound

Brief summary: The objective of this study is to collect retrospectively long term safety data in patients who have participated in the previous phase I-II trials conducted with the compound.


Eligibility criteria: Inclusion criteria:

* Patient randomized, treated and alive at the end of the phase I-II study participation, irrespective of their treatment group,
* Who signed the TALISMAN survey informed consent (or for deceased patients, the informed consent was signed the legal representative/family member as per national regulations - except in countries where Ethics Committee approval only is required for retrospective data collection).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Incidence of Deaths
timeFrame: From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake
measure: Incidence of safety events of interest
timeFrame: From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Diegem
country: Belgium
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Milano
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Geneva
country: Switzerland
facility: Sanofi-Aventis Administrative Office
city: Guildford Surrey
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT02823197: An Intervention to Promote Active Transport for Short Distance Travel in Older Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transport Behaviour Intervention
Keywords: determinants
active transport
intervention
adolescents
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 860
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether a theory- and evidence-based intervention aiming to promote active transport for short distance travel among older adolescents is effective in increasing attitude, subjective norm, self-efficacy, awareness and habit towards active transport, and intention to use active transport after obtaining a driving license.


Eligibility criteria: Inclusion Criteria:

* must understand Dutch
* must participate in the project 'Driving License at School' of the Flemish Foundation for Traffic Knowledge

Exclusion Criteria:

* being younger than 16 years old or older than 19 years old
* already having a driving license

Primary outcomes:
measure: Change in perceived benefits towards active transport
timeFrame: The outcome will be measured at baseline (before start intervention), posttest (1 week after the intervention) and follow-up (8 weeks after the intervention)
measure: Change in perceived barriers towards active transport
timeFrame: The outcome will be measured at baseline (before start intervention), posttest (1 week after the intervention) and follow-up (8 weeks after the intervention)
measure: Change in subjective norm towards active transport
timeFrame: The outcome will be measured at baseline (before start intervention), posttest (1 week after the intervention) and follow-up (8 weeks after the intervention)
measure: Change in self-efficacy towards active transport
timeFrame: The outcome will be measured at baseline (before start intervention), posttest (1 week after the intervention) and follow-up (8 weeks after the intervention)
measure: Change in awareness towards active transport
timeFrame: The outcome will be measured at baseline (before start intervention), posttest (1 week after the intervention) and follow-up (8 weeks after the intervention)
measure: Change in habit towards active transport
timeFrame: The outcome will be measured at baseline (before start intervention), posttest (1 week after the intervention) and follow-up (8 weeks after the intervention)
measure: Change in intention to use active transport after obtaining a driving license
timeFrame: The outcome will be measured at baseline (before start intervention), posttest (1 week after the intervention) and follow-up (8 weeks after the intervention)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00763997: Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation in Analgetic Dosages
Official title: Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet Aggregation
Keywords: dipyrone
platelet aggregation
neuraxial blockage
ibuprofen
platelet aggregation under dipyrone compared to ibuprofen, acetaminophen and parecoxib/valdecoxib
neuraxial blockage in patients receiving ibuprofen is critical in special circumstances, but traditionally not fpr dipyrone
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-10-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Dipyrone is suggested to inhibit the platelet aggregation comparable to th effect of traditional analgetic substances like Ibuprofen. To verify this hypothesis the investigators conducted the study in comparing patients undergoing traumatologic, visceral or plastic surgical procedures. The investigators randomized them to four groups receiving common analgetic doses of either dipyrone, acetaminophen (paracetamol) or valdecoxib/parecoxib. The investigators took blood samples before initiation of the study drug, 1h, 4hs and 24hs after first intake. The investigators compared the aggregation via aggregometry of platelet rich plasma.


Eligibility criteria: Inclusion Criteria:

* Planned traumatologic, orthopedic, visceral or plastic surgical procedures

Exclusion Criteria:

* Prior intake of drugs with effect on the platelet aggregation
* Patients with diseases of the gastrointestinal systems
* Patients with cardiac or circulatory diseases
* Patients receiving corticoids
* Patients with cold or asthma
* ASA-classification \> 3

Primary outcomes:
measure: Percentage of aggregation in platelet rich plasma fter 24 hours of treatment with analgetic doses
timeFrame: 24 hours
Secondary outcomes:
measure: Percentage of aggregation of platelet rich plasma 1hour and 4 hours after initiation of study drug
timeFrame: 4 hours
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: BG University Hospital Bergmannsheil GmbH
Study officials:
affiliation: research associate of the Ruhr University Bochum
name: Matthias Schmauss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leader of the Department for Pain Medicine of the University Hospital Bergmannsheil Bochum
name: Christoph Maier, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01506297: Biologic Assessment of Satiety
Official title: Biologic Assessment of Satiety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: obesity
satiety
body weight management
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2012-01-09
Enrollment: 31
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men and women

Brief summary: Subjective measures of satiety are correlated with biologic mechanisms of appetite control.


Eligibility criteria: Inclusion Criteria:

* medical history (interview) demonstrating good health
* non-smoking
* not taking steroid-based medications
* not planning to or currently attempting to gain or lose weight
* being willing to consent to study conditions
* healthy adults ages 25-45 years
* body mass index between 18-30 kg/m2.
* University of North Dakota students may participate but student status is not required.

Exclusion Criteria:

* diagnosed eating disorders
* current or planned pregnancy
* lactation
* unmanaged hypertension (systolic \>160 mmHg or diastolic \> 100mmHg) and/or other cardiovascular, pulmonary, skeletal and metabolic diseases
* taking medications known to affect appetite, body composition, weight, or food intake

Primary outcomes:
measure: Correlation of subjective and objective satiety responses
timeFrame: measures at -30, -15, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240, 300 minutes
Secondary outcomes:
measure: Repeatability of subjective and objective measures of satiety
timeFrame: measures at -30, -15, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240, 300 minutes
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA GFHNRC
name: Susan K Raatz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04240197: Epidural Waveforms: Pressure Transducer vs CompuFlo
Official title: Reliability of Pressure Waveform Analysis to Determine Correct Epidural Catheter Placement; a Comparison Between Pressure Transducer and the CompuFlo® CathCheck™ System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: European e-Learning School in Obstetric Anesthesia
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this single arm, open label study will be to compare and evaluate the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space when compared to the standard pressure transducer.

Detailed description: 40 patients who had an epidural functioning catheter previously positioned for anesthesia or analgesia will be enrolled. After removing the epidural filter and after having zeroed the instrument, the investigator will connect in a random fashion sequence, a standard pressure transducer attached to a standard invasive blood pressure monitor or to the CompuFlo CathCheck instrument to observe and record the occurrence of epidural pulsatile waveform.

The investigator will also note and evaluate:

The volume of saline priming necessary to obtain the waveform The effects of patient's position on the occurrence and amplitude of epidural pulsatile waveform

Eligibility criteria: Inclusion Criteria:

* patients with an epidural lumbar catheter for anesthesia or analgesia

Exclusion Criteria:

* patients with malfunction or dislodgement of the epidural catheter

Primary outcomes:
measure: Pulse Wave
timeFrame: up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Città di Roma Hospital
Study officials:
affiliation: European e-Learning School in Obstetric Anesthesia
name: Giorgio Capogna, MD
role: STUDY_DIRECTOR
References:
citation: Hilber ND, Rijs K, Klimek M, Saenz G, Aloweidi A, Rossaint R, Heesen M. A systematic review of the diagnostic accuracy of epidural wave form analysis to identify the epidural space in surgical and labor patients. Minerva Anestesiol. 2019 Apr;85(4):393-400. doi: 10.23736/S0375-9393.18.13089-6. Epub 2018 Nov 22.
Clinical trial NCT04445597: ANalyzing Olfactory Dysfunction Mechanisms In COVID-19
Official title: ANalyzing Olfactory Dysfunction Mechanisms In COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV-2
Keywords: Hyposmia
Anosmia
Olfactory Dysfunction
COVID-19
SARS-CoV-2
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Max Planck Research Unit for Neurogenetics
name: AZ Sint-Lucas Brugge
name: Universitair Ziekenhuis Brussel
name: Hospital Clinic of Barcelona
First posted: 2020-06-24
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: We aim to understand the mechanism of olfactory dysfunction in COVID-19.

Detailed description: In December 2019, a new coronavirus causing severe acute respiratory syndrome was described in Wuhan, China. This virus, later named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), spread worldwide and has been designated a pandemic by the World Health Organization.

By the beginning of March 2020, several Ear, Nose, Throat societies raised awareness of a frequent association between coronavirus disease 2019 (COVID-19) and smell disorders.

In the present study, the investigators wish to begin to understand the pathogenesis of olfactory dysfunction in COVID-19.

Eligibility criteria: Inclusion Criteria:

- Deceased hospitalised patients, tested positive or negative for SARS-CoV-2 for patient or control group respectively

Exclusion Criteria:

* none

Primary outcomes:
measure: Prevalence of SARS-CoV-2 in the sampled tissue
timeFrame: Immediately after death
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ/KU Leuven
name: Laura Van Gerven
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05341297: A Transdiagnostic Internet Intervention for Parents of Children With Anxiety and Depressive Symptoms
Official title: Digital Parent-led Transdiagnostic Interventions for Child and Adolescent Anxiety and Depressive Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Problem
Anxiety
Depression
Psychological Distress
Keywords: Internet intervention
transdiagnostic
parent-led intervention
internalizing problems
children
Rational emotive and behavioral therapy
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 111
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
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 efficacy of a transdiagnostic, parent-led, Internet-delivered intervention in reducing child and adolescent internalizing problems.

Detailed description: Anxiety and depressive symptoms are common in children and adolescents. There is substantial research indicating that transdiagnostic Internet interventions are effective for adults and children with anxiety and depressive disorders; however, there is limited research on the efficacy of such programs aimed at parents of children and adolescents with anxiety and depressive symptoms. This study aims to investigate the efficacy of a transdiagnostic Internet intervention for parents of children with elevated anxiety and depressive symptoms.

Eligibility criteria: Inclusion Criteria:

* parent of a child/ adolescent aged 6 to 14 years
* elevated internalizing problems
* have Internet access

Exclusion Criteria:

* undergoing psychotherapy/ pharmacological treatment

Primary outcomes:
measure: Change in the brief Revised Children's Anxiety and Depression Scale - parent version
timeFrame: Baseline, 3 weeks and follow-up at 1 month after treatment termination
Secondary outcomes:
measure: Change in the Patient Health Questionnaire-4
timeFrame: Baseline, 3 weeks and follow-up at 1 month after treatment termination
measure: Change in the Parental Self-Efficacy Scale
timeFrame: Baseline, 3 weeks and follow-up at 1 month after treatment termination
measure: Change in the Family Accommodation Scale
timeFrame: Baseline, 3 weeks and follow-up at 1 month after treatment termination
measure: Satisfaction with the intervention
timeFrame: 3 weeks after treatment initiation
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
affiliation: Babes-Bolyai University
name: Costina R Păsărelu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05459597: Antiepileptic Drugs in Elderly Patients
Official title: Population Pharmacokinetics, Effectiveness and Safety of Antiepileptic Drugs in Elderly Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Seizure, Epileptic
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Qianfoshan Hospital
name: The Second Hospital of Shandong University
name: The Affiliated Hospital of Qingdao University
First posted: 2022-07-15
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with epilepsy (≥65years).

Brief summary: The purpose is to study the population pharmacokinetics, effectiveness and safety of antiepileptic drug (phenytoin, carbamazepine, lamotrigine, levetiracetam, parempanel, etc) in elderly patients and recommend optimized dosage regimens.


Eligibility criteria: Inclusion Criteria:

1. Age ≥65 years old;
2. Diagnosed with epilepsy;
3. Using antiepileptic drugs for treatment;

Exclusion Criteria:

1. Patients who are expected to die within 48 hours;
2. Patients with allergy to antiepileptic drugs;
3. Patients receiving other investigational drugs;
4. Other factors that the researcher considers unsuitable for inclusion.

Primary outcomes:
measure: The peak plasma drug concentration of antiepileptic drugs.
timeFrame: at (0-4) h after oral administration
measure: The random plasma drug concentration of antiepileptic drugs.
timeFrame: at (4-10) h after oral administration
measure: The trough plasma drug concentration of antiepileptic drugs.
timeFrame: at (1-2) h before the next administration
Secondary outcomes:
measure: The incidence of adverse drug reaction
timeFrame: Through study completion, an average of 14 days
measure: The frequency of seizures
timeFrame: Through study completion, an average of 14 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Wei Zhao
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Wei Zhao
role: STUDY_CHAIR
References:
Clinical trial NCT02691897: Melatonin's Effects on Treatment Of Diabetes Mellitus
Official title: The Effects of Melatonin on Serum Glucose Levels of Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
Melatonin
Blood Glucose
Therapeutics
Pineal gland
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the efficacy and safety of melatonin in control of blood sugar in patients with type 2 diabetes mellitus (DM).

Detailed description: Diabetes mellitus (DM) is a major public health problem with increasing worldwide incidence. The main causes for increase in incidence of DM are inactivity, obesity and changes of dietary habits. Investigators think that the changes in the awake-sleep cycle may also contribute to higher incidence of DM in recent years. Melatonin is an important component of the circadian system. Numerous experimental studies have demonstrated that melatonin has many beneficial actions.Melatonin is a potent antioxidant, reduces inflammatory process, lowers blood pressure, improve lipid profiles. Collectively, these data suggest that melatonin may be useful in control of blood sugar in patients with DM.

The aim of this study is to assess the efficacy of melatonin in control of blood sugar in patients with type 2 DM.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus diagnosed by an endocrinologist for more than six months
* FBS=120-160mg/dl
* HbA1C\<8%

Exclusion Criteria:

* Melatonin sensitivity
* Impaired fasting glucose (IFG)
* Impaired glucose tolerance (IGT)
* Under Insulin therapy
* Pregnancy
* Lactation
* Diabetic autonomic neuropathy and orthostatic hypotension
* Renal failure (Creatinin\>1.5mg/dl)
* Diabetic retinopathy
* Diabetic nephropathy
* Malignancy
* Alcohol use
* Liver disease

Primary outcomes:
measure: Fasting blood sugar (FBS)
timeFrame: 3 months
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: Serum Insulin
timeFrame: 3 months
measure: Weight (Body mass index)
timeFrame: 3 months
measure: Waist circumference
timeFrame: 3 months
measure: Serum aminotransferases
timeFrame: 3 months
measure: Number of patients with adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shahid Motahhari Clinic, Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Health Policy Research Center, Shiraz University of Medical Sciences
name: Kamran Bagheri Lankarani, M.D.
role: STUDY_CHAIR
affiliation: Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
name: Mesbah Shams, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Policy Research Center, Shiraz University of Medical Sciences
name: Payam Peymani
role: PRINCIPAL_INVESTIGATOR
References: