louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06253728: A Study of Biochemical Response to Alternative Proteins
Official title: Comprehensive Study of Biochemical Response to Alternative Protein Sources in Different Food Matrices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postprandial Hyperglycemia
Overweight and Obesity
Type2diabetes
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The overall objective of this research is to determine the digestive faith and health impact of protein and fiber rich foods in different food matrices in type 2 diabetes risk population. This is achieved by controlled postprandial intervention where plasma amino acids, lipids, glucose metabolism, bile acids and microbial metabolites are evaluated as well as fecal microbiota and metabolites.

Detailed description: Detailed research aim of this controlled, randomized crossover postprandial clinical study are:

1. To study the impact of complex plant- and animal-based foods on glucose metabolism, acute inflammation, and markers of microbial fermentation of fiber and proteins.
2. To investigate the difference in the gut mediated metabolism induced by naturally occurring fiber fraction bound plant protein or by plant protein with added fiber when compared to animal protein.
3. To conduct in vitro experiments using fecal samples from participants in the meal study to investigate the distinctions between different animal and plant proteins on both host and microbial metabolites, as well as the function of the gut barrier.

Eligibility criteria: Inclusion Criteria:

* 30-65 years of age
* BMI \>25 kg/m2 and \<35 kg/m2
* Waist circumference with females \>85 cm and with males \>100 cm

Exclusion Criteria:

* Certain chronic diseases requiring regular medication (e.g., type 2 diabetes, chronic liver, kidney, thyroid, or gastrointestinal diseases)
* Pregnancy or breastfeeding
* Gluten-free or vegan diet
* Use of antibiotics within the last 12 months
* Gastrointestinal surgery within the last two years
* High alcohol consumption

Primary outcomes:
measure: Plasma amino acids
timeFrame: 0-4 hours
measure: Gut derived metabolites
timeFrame: 0-24 hours
Secondary outcomes:
measure: Plasma glucose
timeFrame: 0-4 hours
measure: Inflammation marker
timeFrame: 0-4 hours
measure: Plasma triglycerides
timeFrame: 0-4 hours
measure: Urine para-cresol
timeFrame: 24 hours
measure: Plasma insulin
timeFrame: 0-4 hours
measure: Plasma free fatty acids
timeFrame: 0-4 hours
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
Study officials:
affiliation: University of Eastern Finland
name: Marjukka Kolehmainen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05198128: Ovarian Hyperstimulation Syndrome Using Calcium Infusion
Official title: Ovarian Hyper Stimulation Syndrome Using Calcium Infusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: OHSS
calcium infusion
IVF
ICSI
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Calcium for Prevention of Ovarian Hyperstimulation Syndrome (OHSS)
Primary purpose: TREATMENT

Brief summary: the incidence of OHSS and clinical outcomes after calcium IV infusion in high-risk women undergoing ART

Detailed description: Among assisted reproductive technologies (ART), ovarian hyperstimulation syndrome (OHSS) is a serious iatrogenic complication affects up to 30% of women undergoing ART and caries high risks of morbidity and mortality. Women with age younger than 35 years, those with history of polycystic ovary syndrome (PCOS), or having a history of previous OHSS are more susceptible to develop OHSS

Eligibility criteria: Inclusion Criteria:

- infertile women aged 20 to 38 years. BMI ranged from 18 to 40. serum FSH within normal limits( 1-12IU /l) presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration.

Exclusion Criteria:

* endocrinopathies. a systemic disease. and Insulin-dependent diabetes Thyroid disease using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists. patients need coasting for high risk of OHSS. patients need cycle cancellation. severe male infertility requiring testicular sperm extraction.

Primary outcomes:
measure: OHSS rate
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01829828: The Effectiveness of a Patient Self-reported Pain Scoring Tool and a Satisfaction Survey on Cancer Pain Management
Official title: To Evaluate the Effectiveness of a Patient Self-reported Pain Scoring Tool and a Satisfaction Survey on Cancer Pain Management; Multicenter, Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Pain
Cancer pain
Self-reported pain scoring tool
Opioid analgesics
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2013-04-11
Enrollment: 587
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: Inpatients admitted for cancer pain management

Brief summary: The purpose of this survey is to investigate the usefulness of a patient self-reported scoring tool on patient satisfaction improvement.


Eligibility criteria: Inclusion Criteria:

* Patients who have no experience with the study self-reported pain scoring tool
* Patients who are able to understand and answer the pain scoring tool questions
* Patients admitted to a hospital for more than 5 days due to cancer pain
* Patients for whom their pain managing physicians completed the medical staff's survey

Exclusion Criteria:

* Patients who cannot answer the questions due to cognitive impairments

Primary outcomes:
measure: Patient satisfaction with the control of cancer-related pain
timeFrame: At baseline
Secondary outcomes:
measure: Patient perception of pain
timeFrame: At baseline
measure: Patient pain assessment by medical staff
timeFrame: At baseline
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT02885428: Detection no Invasive of a Silent Myocardial Ischemia
Official title: Silent Myocardial Ischemia in Patients With Diabetes Type 2: Diagnostic Value of Myocardial Strains Left Ventricular Resting Echocardiography 2D and 3D, Compared to Stress Echocardiography
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Silent Myocardial Ischemia
Type 2 Diabetes
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with type 2 diabetes, men or women, asymptomatic on the heart level, high risk

Brief summary: The pathophysiological features of myocardial diabetic subject combined with cardiac autonomic neuropathy were behind the quietness of myocardial ischemia, known as silent myocardial ischemia (IMS). These patients have the risk to remain asymptomatic until the sudden onset of a myocardial infarction, or even sudden death.

That is why the investigators want to evaluate the contribution of non-invasive tools to stand in the diagnosis of IMS patients with diabetes type 2, asymptomatic heart on map: Technical myocardial speckle tracking in studying strains overall average left ventricular (longitudinal, circumferential and radial) measured in 2D and 3D at rest, compared to stress echocardiography with dobutamine (ESD)


Eligibility criteria: Inclusion Criteria:

* With at least two cardiovascular risk factors including: hypertension, dyslipidemia, smoking active or interrupted for less than 3 years, family history (relatives of the 1st degree) Accident major CV before 60.
* Or whatever the level of risk factors: peripheral artery disease and / or carotid atherosclerosis, or proteinuria

Exclusion Criteria:

* Valvular heart disease (severe to moderate valvular ) , hypertrophic , dilated , chronic lung
* History of cardiotoxic chemotherapy
* Atrioventricular blocks of degree
* Asthma
* Recent stroke within a month
* Bilateral carotid stenosis tight
* Glaucoma untreated narrow angle
* Subject to exclusion period (determined by a previous study or in progress)
* Inability to give informed about information
* patient under judicial protection
* patient guardianship or curatorship
* Current pregnancy (women of childbearing age )
* Breastfeeding

Primary outcomes:
measure: diagnostic of the silent myocardial ischemia
timeFrame: 80 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Samy TALHA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02577328: Pain Management in Internal Medicine Department
Official title: Pain Management in Internal Medicine Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-10-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in the ward with mild pain and above

Brief summary: The assessment of pain management in Internal medicine department.

Detailed description: The experimental procedure - A Literature review of the management of pain in internal departmnet and after that defining and identifying gaps between the pain management practice recommendations in the literatureareas to that of the departmnet.

Determining the educational processes for the medical team, in initiation treatment for pain and pain assessment. As well, obtain quality indicators to monitor pain management.

Assessment of attitudes, knowledge and tools for pain management team before the educational process and afterwards.

In patients with mild pain or above, a combination of quantitative and qualitative tools will assess the pain and its treatment along the hospitalization in the Internal medicine ward.

Eligibility criteria: Inclusion Criteria:

* All patient with mild pain and above

Exclusion Criteria:

* None

Primary outcomes:
measure: pain reduction
timeFrame: during hospitalization (days)-up to7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05160428: Post Covid-19 Vaccination Development or Flare of ARD
Official title: New or Flare of Musculoskeletal Rheumatic Diseases After Different COVID-19 Vaccines: Multicentre Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Vaccination; Infection
Rheumatic Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Eligibility Criteria:

Patients above 18 years old having MRD manifestations vaccinated against covid-19.

Brief summary: Many patients develop autoimmune diseases after covid-19 vaccination, whether related to the vaccination or not, is still under study. This study will describe potential flare of ARD after COVID-19 vaccination, whether it leads to activity or new MSK manifestations development.

Detailed description: -In this study: patients with known diagnosed rheumatic diseases who are vaccinated (one or full doses) of any type of COVID-19 vaccines will be enrolled. new ARD and prevalence of different MSK manifestations after covid-19 vaccinations also will be reported. The prevalence of flare of ARD after covid-19 vaccinations will be dteremined. Also we will compare between different types and doses of covid-19 vaccinations in inducing ARD or flares.

Study Design: Cross sectional study Target population: any patient with pre-existing received any vaccination against covid-19 visiting rheumatology outpatient clinic.

-any patient develops MSK manifestations after covid-19 vaccination. The disease activity sataus will be measured according to the type of rheumatic disease. For RA , disease activity score28 will be used, in lupus: SLEDAI, in Behcet : BDCAF, in SpA: BASDAI.

Eligibility criteria: Inclusion Criteria:

Age above 18 years Vaccinated against covid-19 (one dose or fully vaccinated)

Exclusion Criteria:

Receiving other vaccine e.g influenza Less than 18 years old

Primary outcomes:
measure: -Prevalence of new ARD after covid-19 vaccinations
timeFrame: 3 moths
measure: prevalence of flare of ARD after covid-19 vaccinations
timeFrame: 3 months
Secondary outcomes:
measure: Prevalence of non-specific MSK symptoms after Covid-19 vaccine.
timeFrame: 3 months
measure: Correlation of the MSK to the 1st and 2nd Covid vaccine dose
timeFrame: 3 months
measure: comparison between different type of covid-19 vaccine in inducing ARD or flare up.
timeFrame: 3 months
measure: disease activity status in the patients who developed the ARD symptoms before and after the vaccine.
timeFrame: 3 months
measure: Any correlation between the appearance of MSK symptoms and the patient's medications
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy Hospital
Study officials:
affiliation: Tanta University
name: Mohamed Abuzaid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02538328: Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery
Official title: Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: laparoscopy
obesity
harmonic scalpel
ligasure
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery especially in gastric bypass surgery patients.

Detailed description: The investigators' department performs 150 gastric bypass surgeries annually. Surgeons use both harmonic scalpel and ligasure sealing device in cases. Aim is to compare both of these devices over coming each other. Benefits ease of these devices are compared.

Eligibility criteria: Inclusion Criteria:

* obesity
* BMI over 40 kg/m\^2

Exclusion Criteria:

* Normal BMI cases

Primary outcomes:
measure: Safety and efficacy of sealing
timeFrame: 1 year
Secondary outcomes:
measure: Bleeding
timeFrame: During the operation
Other outcomes:
Locations:
Study officials:
affiliation: GENERAL SURGERY CHİEF OF GASTROİNTESTİNAL SURGERY
name: cüneyt kayaalp, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02427828: VRES Study in Two Phases to Monitor Cardiac Surgical Patients Following Discharge From ICU
Official title: Continuous, Ambulatory, Non Invasive, Vital Sign Monitoring Using VRES of Cardiac Surgical Patients Following Discharge From Intensive Care. Impact on Detection of Physiological Deterioration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedure, Unspecified
Lead sponsor: OBS Medical Ltd
Sponsor class: INDUSTRY
First posted: 2015-04-28
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Failure to recognise deterioration early is a major cause of preventable deaths amongst hospital patients. The investigators wish to study whether continuous monitoring of 'vital signs' (pulse rate, breathing rate, and blood oxygen saturations) with computer modeled alerting to detect patient deteriorations can reduce cardiac arrest rate and critical care readmissions from the wards by alerting staff to clinical deteriorations more effectively than current paperbased systems.

Continuous monitoring of 'vital signs' can be achieved in two ways. Continuous monitoring of 'vital signs' has traditionally been restricted to the bedside because of the need for the patient to be connected by wires to the monitor.

More recently, advances in telemetry (wireless technology) have allowed the development of wearable devices which allow patients to mobilise freely, whilst constantly monitoring these 'vital signs'.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the Papworth Hospital NHS Foundation Trust for routine cardiovascular surgery and who are discharged from ICU into the study ward (Mallard).

Exclusion Criteria:

* transplant surgery patients,
* VAD patients,
* children (less than 18 years old),
* prisoners (due to constant observation/security may bias normal level of care),
* patients who are subject to additional protections: this includes pregnant women, and persons with mental illness and learning disabilities,
* patients whose anatomy precludes the use of the required monitoring,
* patients who cannot understand written English (and where no translator is available),
* patients who are unable to give consent themselves,
* patients with learning difficulties who cannot understand the information to consent for themselves.

Primary outcomes:
measure: Incidence of ward cardiac arrests
timeFrame: Up to 72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital
state: Cambridgeshire
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: John Mackay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02959528: The Effects of Working Memory Training in Children With Attention-Deficit/Hyperactivity Disorder
Official title: The Effects of Working Memory Training in Children With Attention-Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Psychophysiology
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous studies indicated that children with attention-deficit/hyperactivity disorder (ADHD) often suffer from deficits in executive function, such as attentional control, inhibition, and working memory. One of these executive functions, working memory, plays a critical role in academic performance and classroom behavior. Working memory is essential for performing complex cognitive tasks such as comprehension, learning, and reasoning. Several studies have shown that training of working memory has positive effects for ADHD and other cognitive disorder in children. However, transfer effects across studies appear to be variable and inconsistent. Event-related potentials can be a useful tool to gain insights into such mechanism. Therefore, the aim of the present study is to investigate both near and far transfer effects of N-back training in children with ADHD. In addition, the recording and analysis of event-related potentials will be adopted while children with ADHD perform the complex visuo-spatial and phonological working memory tasks.


Eligibility criteria: Inclusion Criteria:

* ADHD diagnosed according to criteria specified in Diagnostic and statistical manual of mental disorders (DSM-5)
* aged between 8 and 10 years
* intelligence quotient \> 80 (based on Test of Nonverbal Intelligence-Third Edition)
* had normal or corrected-to-normal vision
* right-handed

Exclusion Criteria:

* diagnosis of clinically significant oppositional defiant disorder, Autistic Spectrum Disorders, Asperger's syndrome or depression
* history of seizures

Primary outcomes:
measure: Automated Working Memory Assessment
timeFrame: 6 weeks
Secondary outcomes:
measure: Working memory index in Wechsler Intelligence Scale for Children-IV
timeFrame: 6 weeks
measure: Event-related potentials
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung University
Study officials:
affiliation: Chang Gung University
name: I-Hsuan Shen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00610428: Staccato Prochlorperazine in Migraine (in Clinic)
Official title: A Multi-center, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine Headache, With or Without Aura
Keywords: Migraine, Staccato Prochlorperazine
Migraine headache with or without aura.
Lead sponsor: Alexza Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Development of Staccato Prochlorperazine for the treatment of migraine headache.


Eligibility criteria: Inclusion Criteria:

* Subjects who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months, who have been pain free for at least 48 hours since the end of their last migraine attack, who have a pain rating of Moderate or Severe prior to dosing.

Exclusion Criteria:

* Subjects who have taken any other migraine or pain medication within 48 hours of randomization, with a history of allergy or intolerance to phenothiazines and related drugs, or are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, or unable to use the inhalation device, must be excluded.

Primary outcomes:
measure: Headache Pain Relief at 2 hr Post-dose by 2-point Definition
timeFrame: 2 hours after treatment
Secondary outcomes:
measure: Survival Analysis for Time to Pain Relief
timeFrame: from treatment (time = 0) to 2 hours post treatment
Other outcomes:
Locations:
city: Mount Vernon
country: United States
facility: Arthur H. Elkind, MD
state: New York
Study officials:
name: Sheena Auroa, MD
role: PRINCIPAL_INVESTIGATOR
name: Roger K Cady, MD
role: PRINCIPAL_INVESTIGATOR
name: Arthur Elkind, MD
role: PRINCIPAL_INVESTIGATOR
name: Fred Freitag, DO
role: PRINCIPAL_INVESTIGATOR
name: Lisa Mannix, MD
role: PRINCIPAL_INVESTIGATOR
name: Niana T Mathew, MD
role: PRINCIPAL_INVESTIGATOR
name: Egilius LH Spierings, MD
role: PRINCIPAL_INVESTIGATOR
name: Stewart Tepper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Avram MJ, Spyker DA, Henthorn TK, Cassella JV. The pharmacokinetics and bioavailability of prochlorperazine delivered as a thermally generated aerosol in a single breath to volunteers. Clin Pharmacol Ther. 2009 Jan;85(1):71-7. doi: 10.1038/clpt.2008.184. Epub 2008 Oct 1.