louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01034436: Fatty Acid Quality and Overweight (FO-study)
Official title: Fatty Acid Quality and Overweight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Reduction and Insulin Sensitivity
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to study the health effects of fatty acid quality in healthy, overweight individuals.


Eligibility criteria: Inclusion Criteria:

* no use of medication, healthy, 27\<BMI\<40

Exclusion Criteria:

* pregnant and lactating women, chronic diseases.

Primary outcomes:
measure: Will intake of fat as diacylglycerols give weight reduction in overweight individuals?
timeFrame: baseline (0 weeks), 12 weeks
Secondary outcomes:
measure: Will a high intake of ALA involve reduced levels of inflammatory markers?
timeFrame: baseline (0 weeks), 12 weeks
measure: Will a high intake of ALA involve changes in insulin sensitivity?
timeFrame: baseline (0 weeks), 12 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Akershus University College
state: Lillestrom
Study officials:
affiliation: Oslo and Akershus University College
name: Stine Marie Ulven, PhD
role: STUDY_CHAIR
References:
citation: Telle-Hansen VH, Christensen JJ, Formo GA, Holven KB, Ulven SM. A comprehensive metabolic profiling of the metabolically healthy obesity phenotype. Lipids Health Dis. 2020 May 9;19(1):90. doi: 10.1186/s12944-020-01273-z.
Clinical trial NCT01043536: Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost (SIB-IMRT) in the Treatment of Glioblastomas in Adults
Official title: Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost in Association With a Temozolomide in the Treatment of Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glioblastoma
Keywords: IMRT
Radiotherapy escalation dose
glioblastoma
escalation radiotherapy dose
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
First posted: 2010-01-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main goal of this study is to evaluate and to determine the dose of a highly accurate irradiation (allowing to increase the dose delivered while restricting the risk of complication) in association with temozolomide.


Eligibility criteria: Inclusion Criteria:

* Histopathologically proven diagnosis of glioblastoma (WHO grade IV astrocytoma)
* Diagnosis must be obtained by a stereotactic or surgical biopsy
* Age between 18 and 70
* Total or partial surgical resection deemed as not possible by a neurosurgeon
* OMS performance status 0 or 1
* Adequate blood function : absolute neutrophil count \> 1.5 x 109/L, platelets count \> 100 x 109/L platelets;
* Adequate liver function: bilirubin \< 1.5 ULN (upper limit of normal), ALT and AST \< 3 ULN,
* Adequate renal function: creatinine \< 1.5 ULN
* Patient must have been informed and must have signed the specific informed consent form.

Exclusion Criteria:

* other malignancy histology
* resection of the brain tumor complete on MRI exploration
* patient unable to give informed consent
* patient presenting counter-indication to MRI exploration
* patient must not have received neither radiotherapy nor chemotherapy for that affection
* concomitant malignancy
* patient already enrolled in another biomedical study with an experimental molecule
* pregnant, nursing woman, or without contraception
* private individuals of freedom or under tutelage (including legal guardianship)
* psychiatric, behavioural disorders or geographical situation precluding the administration or follow-up of the protocol (including claustrophobia)

Primary outcomes:
measure: To determine the OTR (optimal tolerated regimen) of radiotherapy administered in combination with temozolomide as first-line therapy in patients with de novo glioblastoma
timeFrame: 3 months after the start of the radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges François Leclerc
state: Bourgogne
Study officials:
affiliation: Centre Georges François Leclerc
name: Gilles Truc, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01319136: Improved Analysis Methods for Infusion Tests
Official title: Novel Infusion Method for Describing CSF Dynamics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Normal Pressure Hydrocephalus
Keywords: new infusion test method
reference method
cerebrospinal fluid dynamics
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2011-03-21
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that had a preoperative investigation because of communicating hydrocephalus. MRI revealed ventriculomegaly (Evans ratio \> 0.3), no obstruction to CSF flow at visual inspection. Most, but not all, fulfilled the criteria of "probable" or "possible" INPH.

Brief summary: Objective: Patients with Idiopathic Normal Pressure Hydrocephalus are improved with shunt surgery. To increase the accuracy of the diagnosis, supplementary tests that characterize the cerebrospinal fluid (CSF) dynamics are used. The infusion test is one of these, used for shunt surgery selection and postoperative evaluation of shunt function. Forty-eight patients that had a preoperative investigation because of communicating hydrocephalus at the university hospitals in Umeå and Uppsala, Sweden, participated in the study. The purpose of this study was to evaluate a new method, with a new infusion protocol and new analysis methods, and compare it to the current method.


Eligibility criteria: Inclusion Criteria:

* preoperative investigation because of communicating hydrocephalus
* ventriculomegaly (Evans ratio \> 0.3)
* no obstruction to CSF flow at visual inspection

Exclusion Criteria:

* postoperative infusion test investigations
* patients that were unable to understand instructions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
state: Uppland
city: Umeå
country: Sweden
facility: Umeå University Hospital
state: Västerbotten
Study officials:
affiliation: Department of Clinical Neuroscience
name: Jan Malm, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02859636: Pronostic Value of Endothelial Dysfunction in Heart Failure
Official title: Pronostic Value of Endothelial Dysfunction in Heart Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Decompensation
Cardiac Failure
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with more than 18 years and less than 81 years, hospitalized for acute heart failure with left ventricular impairment (LVEF \< 45%)

Brief summary: The main objective is to evaluate the pronostic value of endothelial dysfonction in acute heart failure on a combined criteria associating cardiovascular mortality, nex hospitalisation for decompensated heart failure, cardiac graft or ventricular assistance 2 month and 1 year before acute heart failure.


Eligibility criteria: Inclusion Criteria:

* patients hospitalized for acute heart fialure with Left Ventricular Ejection Fraction (LVEF) \< 45 % on echocardiography

Exclusion Criteria:

* Informed consent form not signed
* Cardiogenic, septic or hemorragic shock
* Acute coronary syndrom with elevated troponin
* valvular surgery or aorto-coronary graft during next 3 months
* Cancer
* Pregnancy
* life expectancy over than 1 year
* chronic renal impairment

Primary outcomes:
measure: MR Proadrenomedulline
timeFrame: 6 months
measure: catecholamins
timeFrame: 6 months
timeFrame: 6 months
measure: late endothelial progenitors
timeFrame: 6 months
measure: Peripheral tissular perfusion
timeFrame: 6 months
measure: mortality
timeFrame: 6 months
measure: hospitalisation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01971736: Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening
Official title: Randomized-controlled Split-face Treatment of Facial Rhytids and Laxity in Asians Using Long-pulse 1064nm Laser
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Tightening
Skin Laxity
Wrinkle Reduction
Keywords: 1064nm YAG laser
laxity
rhytides
asian
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 22
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adults with visble signs of aging

Brief summary: We study the efficacy of 1 pass of stacking pulses of long pulse 1064nm laser on the face for skin tightening immediately post laser and 3 months follow up.

Detailed description: To study the efficacy on facial skin tightening and wrinkle reduction after a single pass of double stacking pulses of long pulse 1064nm laser on the face in skin types III-V immediately post procedure and at 3 months. The study is a split-face placebo-controlled single-blind study.

Eligibility criteria: Inclusion Criteria:

* ages 35-60 years

Exclusion Criteria:

1. History of skin malignancy
2. Patients on immunosuppression
3. Patients with other known internal malignancy
4. Patients with malnutrition, vitamin or mineral insufficiency
5. Patients on colchicine, penicillamine
6. Patients with weight loss 7.5% of usual body weight within 3 months
7. history of botulinum toxin injection within 6 months
8. history of facial filler injection within 1year

Primary outcomes:
measure: visual analog scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Dept. of dermatology, Phramongkutklao hospital
Study officials:
affiliation: Phramongkutklao College of Medicine and Hospital
name: Pinyapat - Kanechorn-Na-Ayuthaya, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02931136: Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging
Official title: Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Mild Cognitive Impairment
Biomarker
Diagnosis
Treatment
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 300
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is based on the Flutemetamol-PET senile plaque imaging to investigate the peripheral blood biochemical and brain MRI imaging biomarkers and to research completely independent intellectual property rights neuropsychological test tool for the MCI due to AD. At the same time, the investigators will study the efficacy and safety of early treatment of MCI due to AD by Huperzine A in 52 weeks.

Detailed description: This is a randmized, double-blind, placebo-controll study.

Eligibility criteria: Inclusion Criteria:

* memory complaint, preferably corroborated by a spouse or relative.
* objective memory impairment.
* normal general cognitive function.
* intact activities of daily living.
* absence of dementia.
* the positive of brain senile plaque.

Exclusion Criteria:

* more than two lacuna ischemia (of diameter \< 1 cm) as revealed by MRI fluid-attenuated inversion recovery (FLAIR) sequence.
* other type of dementia except AD

Primary outcomes:
measure: The average annual conversion rate in patients of MCI due to AD convert to the AD.
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Shifu Xiao, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05993936: The Effect Of E-Mobıle Traınıng Gıven Postnatal Perıod On Postnatal Comfort And Breastfeedıng Self-Effıcıency
Official title: The Effect Of E-Mobıle Traınıng Gıven In The Postnatal Perıod On Postnatal Comfort And Breastfeedıng Self-Effıcıency
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breastfeeding
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The period until the 42nd day after birth is called the postpartum period by the World Health Organization (WHO) Especially the first week of the postpartum period is the transition period both physiologically and psychologically, and the period when postpartum problems are at the highest level.This study was planned as a two-group control and e-mobile application in order to determine the effect of e-mobile training given in the postpartum period on postpartum comfort and breastfeeding self-efficacy.


Eligibility criteria: Inclusion Criteria:

The ages of 18-35, Primiparous and multiparous pregnancy, Not clinical diagnosis of risky pregnancy, Able to understand and speak Turkish, Without communication difficulties and mental disabilities The mother and the baby have not developed any complications during pregnancy, delivery and postpartum period, Having a smart phone in the mobile application group, Those who have not attended childbirth preparation classes,

Exclusion Criteria:

* Preterm birth
* Postterm birth

Primary outcomes:
measure: mobile application aim 1
timeFrame: postpartum 7th week
measure: mobile application aim 2
timeFrame: postpartum 7th week]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05476536: Effectiveness of Technology for Metabolic Diseases Combined Sarcopenia
Official title: The Effectiveness of Technology Combined Self-health Management and Home Care Model Improved the Metabolic Diseases, Sarcopenia, and Serum Inflammation and Metabolic Markers Among Middle-aged and Elderly Individuals in the Community
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Disease
Keywords: self-health management
metabolic diseases
sarcopenia
frailty
intervention
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
name: Ministry of Science and Technology, Taiwan
First posted: 2022-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The lifestyle program intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome, sarcopenia or frailty. Thus, the purpose of this study was to assess the efficacy of intervention program on metabolic syndrome subjects in Taiwan.

Detailed description: The study is a 2-parallel groups' randomized controlled trial. Participants with metabolic syndrome (three or more risk factors - triglycerides (TG) \>150 mg/dL, systolic blood pressure (SBP) ≥130 mm Hg, diastolic blood pressure (DBP) ≥85 mm Hg, or fasting blood glucose≥100 mg/dL; high-density lipoprotein cholesterol\<50 mg/dL, or waist circumference ≥80 cm) are enrolled. The four community units are randomized to receive a lifestyle intervention (intervention arm) or an education leaflet (control arm). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and 4th months. All participants complete a structured questionnaire, including basic information, SOF, physical performance, physical activity, and food-frequency.

Eligibility criteria: Inclusion Criteria:

* older adult with age ≥ 40 years
* community-dwelling
* no hearing and visual acuity difficulties

Exclusion Criteria:

* Unconscious
* Cognitive impairment or dementia

Primary outcomes:
measure: metabolic syndrome
timeFrame: 4 month follow up
measure: body weight
timeFrame: 4 month follow up
measure: BMI
timeFrame: 4 month follow up
measure: Frailty
timeFrame: 4 month follow up
Secondary outcomes:
measure: short physical performance battery
timeFrame: 4 month follow up
measure: upper limb muscle strength
timeFrame: 4 month follow up
measure: static balance ability
timeFrame: 4 month follow up
measure: physical agility and dynamic balance ability
timeFrame: 4 month follow up
Other outcomes:
measure: Physical activity
timeFrame: 4 month follow up
measure: dietary behaviors
timeFrame: 4 month follow up
Locations:
city: Taoyuan
country: Taiwan
facility: Taoyuan
Study officials:
affiliation: Chang Gung University of Science and Technology
name: Shu-Hung Chang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05958836: Quality of Life in Patients Treated With Leadless Pacemakers
Official title: Quality of Life and Clinical Outcomes in Patients Treated With Leadless Micra Transcatheter Pacemakers as Compared With Traditional Transvenous Pacemakers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Leadless Micra Transcatheter Pacemaker
Quality of Life
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are eligible if they meet the indication of a single or dual chamber permanent pacemaker. All subjects should fit the following inclusion criteria and disagree with the exclusion criteria.

Brief summary: The study aims to carry out a domestic multi-center, prospective, non-randomized, non-blinded post-approval study to assess health-related QoL between Micra TPS and conventional PM implantation. Meanwhile, pocket and leads related complications would also be evaluated between these two strategies.


Eligibility criteria: Inclusion Criteria:

* With an age arranged from 18 to 80 years old;
* Conforming to indication of a pacemaker implantation;
* Life expectancy\>1 year;
* Normal cardiac function with preserved LVEF;
* Adequate self-care ability or self-help skills before pacemaker implantation;
* Mentally healthy so as to participate in the quality-of-life assessments;
* Willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.

Exclusion Criteria:

* Subject with indication for ICD/ CRT-P/CRT-D;
* Subject with persistent symptomatic sinus bradycardia;
* Subject has an existing or prior pacemaker, ICD or CRT device implant;
* Subject has unstable angina pectoris or has an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment;
* Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD);
* Subjects with a life expectancy of less than 12-months;
* Subjects with medical condition which precludes patient from participation in the opinion of the investigator, such as arthritis, lung disease or previous stroke, renal dysfunction, recent major surgery within six months, clinically overt congestive heart failure;
* Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence;
* Psychological disorders unable to participate in the quality-of-life assessments.

Primary outcomes:
measure: Health-related quality of life measured by EQ-5D-5L
timeFrame: 6 Months post implant
measure: Health-related quality of life measured by NHP (Nottingham Health Profile)
timeFrame: 6 Months post implant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04359836: A Study to Explore the Role of Gut Flora in COVID-19 Infection
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gut Microbiome
Gastrointestinal Microbiome
COVID
COVID-19
Corona Virus Infection
Coronavirus
Coronaviridae Infections
Coronavirus 19
Coronavirus-19
COVID 19
Keywords: Microbiome
Coronavirus
Corona Virus
19
COVID
COVID-19
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 18 and older

Brief summary: This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.

Detailed description: In this study the stool of patients who are being treated for COVID-19 will be tested during treatment and then again following treatment to determine if the virus is shed in the stool during infection, afterwards, or both.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female of 18 years of age or older
3. Diagnosis of COVID-19 infection by RT- PCR within 1 week of Screening

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Treatment with total parenteral nutrition

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: One year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: One year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Papoutsis A, Borody T, Dolai S, Daniels J, Steinberg S, Barrows B, Hazan S. Detection of SARS-CoV-2 from patient fecal samples by whole genome sequencing. Gut Pathog. 2021 Jan 30;13(1):7. doi: 10.1186/s13099-021-00398-5.