louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02115724: Nitric Oxide Bioavailability and Early Life Stress (NO-Stress)
Official title: Effect of Low Childhood Socioeconomic Status (SES) on Adult Endothelial Function and Nitric Oxide Bioavailability in Vivo and ex Vivo
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Low childhood SES
Early Life Stress
Endothelial function
Flow mediated dilation
Cardiovascular disease
Subcutaneous adipose arterioles
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-04-16
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cardiovascular disease is the leading cause of death in the United States. Other studies have shown that stress, early in life, could be a risk factor for cardiovascular disease, later in life. This study will look at the effect of early life stressors on your cardiovascular health.

Detailed description: This study will have two parts involved to investigate the role that childhood SES status has on cardiovascular health.

Part one: Subjects will give a blood sample which will be processed and analyzed. Flow mediated dilation (FMD) and Pulse wave velocity (PWV/PWA) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg of Vitamin C, 600 IU of Vitamin E, and 600 mg of alpha-lipoic acid) or placebo on two days separated by at least 72 hours. Nitroglycerin mediated dilation (NMD, 0.4mg sub-lingual nitroglycerin spray), will be assessed at baseline.

Part two: Subjects, if interested will undergo a subcutaneous gluteal/hip fat biopsy. Micro vessels will be isolated from the adipose tissue and analyzed by pressurized myography for endothelial function and nitric oxide bioavailability.

Eligibility criteria: Inclusion Criteria:

* documented childhood SES
* men and premenopausal women ages 18-40
* lean/overweight/or obese with BMI\< or equal to 39kg/m2

Exclusion Criteria:

* cardiovascular, renal, pulmonary, hepatic, cerebral, or metabolic,disease
* use medications that affect vascular tone
* post menopausal women
* have class 3 obesity or BMI over 40

Primary outcomes:
measure: Acute Change in Flow mediated dilation
timeFrame: Change from baseline (2 hours)
Secondary outcomes:
measure: Acute Change in Biomarkers of oxidative stress
timeFrame: Change from baseline (2 hours)
measure: Acute Change in Arterial Stiffness
timeFrame: Change from baseline (2 hours)
measure: Acute change in Flow mediated dilation
timeFrame: Immediate
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Prevention Institute , Georgia Regents University
state: Georgia
Study officials:
affiliation: Augusta University
name: Ryan Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590524: Feasibility Study on the Effect of Complementary Methods as Supportive Interventions for Parents of Children With Cancer
Official title: Randomized Control Trial for the Effect of Guided Imagery and Progressive Muscle Relaxation in Reducing Anxiety for Parents of Hospitalized Children With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Mood
Coping
Keywords: Parent
childhood cancer
Complementary and Alternative
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether Guided Imagery and Progressive Muscle relaxation are effective as stress reducing techniques in parents of hospitalized children with cancer.

Detailed description: Having a children with cancer can be a source of stress for parents during hospitalization. The stress experienced by the parents can negatively influence their functionality, daily activities, psychological state and also their physical condition. The studies in the literature have mainly focused on the child rather than the parent, and studies specifically for guided imagery are scarce. Since the parents are often neglected by the healthcare professionals during the stress evoking period of hospitalization, this study will test the effectiveness of complementary methods in improving the psychological state of the parents.

Eligibility criteria: Inclusion Criteria:

* willingness to participate
* having a child with childhood cancer been hospitalized for 4 weeks
* have a child (0-18) of age with childhood cancer
* able to speak and write Greek fluently
* no previous experience with CAM techniques

Exclusion Criteria:

* receiving drug therapy for stress
* using another CAM technique during the study

  * parents of children receiving palliative care

Primary outcomes:
measure: Changes in the number of Participants with anxiety
timeFrame: 1 week, 2 week, 3 week , 4 week
Secondary outcomes:
measure: Changes in the number of Participants with mood changes
timeFrame: 1 week, 2 week, 3 week , 4 week
measure: stress level with Biodots
timeFrame: 1 week, 2 week, 3 week, 4 week
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Archbishob Makarios Hospital
Study officials:
affiliation: Cyprus University of Technology
name: Andreas Charalambous, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00720824: Reduction of Immunization Discomfort in Children
Official title: Reduction of Immunization Discomfort in 4-6 Year Old Children: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Immunizations
Children
Injections
aged 4-6 Years
Hypnosis
Lead sponsor: Berberich, F. Ralph, M.D.
Sponsor class: INDIV
First posted: 2008-07-23
Enrollment: 42
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A combination of topical anesthetic, plastic arm gripper, visual focusing task and hypnotic suggestions will reduce the discomfort associated with immunization of pre-kindergarten aged children.

Detailed description: Randomization of 42 children evaluated the method described above against an office routine control group.

Eligibility criteria: Inclusion Criteria:

* All children ages 4-6 years scheduled to receive routine pre-kindergarten immunizations

Exclusion Criteria:

* Inability to follow verbal directions
* Significant concurrent illness
* Prior invasive procedures, excluding neonatal circumcision

Primary outcomes:
measure: Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort.
timeFrame: 10 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Pediatric Medical Group
state: California
Study officials:
affiliation: Pediatric Medial Group
name: f. Ralph berberich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01044524: Study to Investigate ADME of 14C Labeled SLV334 After an i.v. Infusion
Official title: An Open Label Study to Determine ADME of 14C Labeled SLV334 and Its Metabolites After Single Intravenous Dose Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacology, Clinical
Keywords: 14C labeled ADME (Aborption Distribution Metabolism and Elimination) study
Phase I
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-01-08
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the absorption, distribution, metabolism and excretion after giving 2000 mg 14C-SLV334 via a 1-hour infusion. The absolute bioavailability will also be determined.


Eligibility criteria: Inclusion Criteria healthy non-smoking subjects Exclusion Criteria QTc \> 430 ms; positive drug screen

Primary outcomes:
measure: Percentage excreted in urine and feces
timeFrame: 16 days
measure: metabolic profile SLV334
timeFrame: 16 days
measure: AUC, CL, lambda z, Cmax, t1/2, tmax and Vss
timeFrame: 16 Days
Secondary outcomes:
measure: adverse events
timeFrame: 16 days
measure: vital signs
timeFrame: 16 days
measure: ECG
timeFrame: 16 days
measure: Laboratory safety variables
timeFrame: 16 days
measure: Physical examination
timeFrame: 16 days
Other outcomes:
Locations:
city: Zuid-Laren
country: Netherlands
facility: S334.1.004 - Site 1
Study officials:
affiliation: Abbott Products
name: Anita Vanderlaan
role: STUDY_DIRECTOR
References:
Clinical trial NCT03456024: Abdominal Pain and Symptoms Post Gastric Sleeve
Official title: Chronic Abdominal Pain and Discomfort in Morbid Obese Patients Before and After Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Pain
Quality of Life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Voss Sykehus
First posted: 2018-03-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for sleeve gastrectomy for morbid obesity at Oslo University Hospital and Voss sykehus

Brief summary: Exploration of abdominal pain post sleeve gastrectomy in morbid obese patients

Detailed description: The primary aim is to evaluate abdominal pain in morbid obese patients before and after sleeve gastrectomy. The investigators will especially focus on chronic abdominal pain, and its relation to quality of life and weight loss. In a sub-analysis the investigators will compare the findings of the present cohort with patients operated with Roux-en-Y gastric bypass.

Primary endpoints/outcomes:

- Define the prevalence of chronic abdominal pain 2 years after sleeve gastrectomy

Secondary endpoints/outcomes:

- Evaluate and characterise chronic abdominal pain in regard to:

* Weight development
* Obesity-related comorbidities
* Health-related quality of life
* Postoperative complications
* Metabolic effects after surgery
* Nutritional status
* Socioeconomic status

Eligibility criteria: * Inclusion criteria

  * Patients undergoing sleeve gastrectomy at the Center for Morbid Obesity and Bariatric Surgery, Oslo University Hospital and a collaborating center.
  * Signed written and informed consent for study enrollment
* Exclusion criteria

  * Patients who dont understand Norwegian language
  * Previous bariatric surgery
  * Indication for sleeve gastrectomy for other reasons than for morbid obesity

Primary outcomes:
measure: Chronic abdominal pain 2 years after gastric sleeve
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life related to abdominal pain and symptoms
timeFrame: 2 years
Other outcomes:
measure: Comparison to gastric bypass
timeFrame: 2 year
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Tom Mala, MD,Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT05697224: Aschistosoma Haematobiumspecific microRNAas a Tumor Marker for Early Diagnosis and Prognosis of Bilharzial Bladder Cancer in Eygpt
Official title: Role of Aschistosoma Haematobiumspecific microRNAas Atumor Marker for Early Diagnosis and Prognosis of Bilharzial Bladder Cancer in Eygpt
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: miRNAs have been detected in different bodily fluids, which suggests significant potential, such as their use as biomarkers in diagnostics and prognostics. Sha-mir-71a was abundantly found in the urine of patients with bladder cancer as compared to benign bladder cystitis associated with schistosomiasis . Additionally, this miRNA was more highly detected in urine samples from patients with bilharzial bladder cancer than bladder cancer not associated with bilharziasis (schistosomiasis), suggesting its specificity in the identification of bladder cancer associated with infection.


Eligibility criteria: Inclusion Criteria:

* urinary symptoms (hematuria, urinary retention, dysuria... etc.), who were planned to undergo cystoscopy for suspicion of bladder cancer (BC) or benign bilharzial cystitis (Bil), will be selected.

Exclusion Criteria:

* : In bladder cancer group Patients who have received chemotherapy, or with previously diagnosed other malignancy within the past 5 years.

Primary outcomes:
measure: use micro RNAas adiagnostic test for early diagnosis of shistosomal bladder cancer
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
citation: Eissa S, Matboli M, Essawy NO, Kotb YM. Integrative functional genetic-epigenetic approach for selecting genes as urine biomarkers for bladder cancer diagnosis. Tumour Biol. 2015 Dec;36(12):9545-52. doi: 10.1007/s13277-015-3722-6. Epub 2015 Jul 3.
citation: Abd El-Aal AA, Bayoumy IR, Basyoni MM, Abd El-Aal AA, Emran AM, Abd El-Tawab MS, Badawi MA, Zalat RM, Diab TM. Genomic instability in complicated and uncomplicated Egyptian schistosomiasis haematobium patients. Mol Cytogenet. 2015 Jan 22;8(1):1. doi: 10.1186/s13039-014-0104-5. eCollection 2015.
citation: Chen L, Yuan L, Wang G, Cao R, Peng J, Shu B, Qian G, Wang X, Xiao Y. Identification and bioinformatics analysis of miRNAs associated with human muscle invasive bladder cancer. Mol Med Rep. 2017 Dec;16(6):8709-8720. doi: 10.3892/mmr.2017.7726. Epub 2017 Oct 4.
Clinical trial NCT01610024: Northern Board Beet Breathlessness Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Exercise Tolerance (Measured in Minutes)
Lead sponsor: Northern Health and Social Care Trust
Sponsor class: OTHER_GOV
First posted: 2012-06-01
Enrollment: 8
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

Brief summary: Hypothesis: Beetroot juice increases the exercise tolerance of patients with chronic lung disease.

Using the already established pulmonary rehabilitation model, we aim to split the group of 8 into 2 groups, each group taking 500ml of beetroot juice 24 hours before there class on alternate (differing) weeks to see if it improves their overall exercise tolerance.


Eligibility criteria: Inclusion Criteria:

* Already planned to attend the pulmonary rehabilitation class

Exclusion Criteria:

* Angina Prescribed regular nitrates, a resting heart rate \>100bpm, a resting blood pressure \<110 systolic, postural hypotension, prescribed PDE5 inhibitors.

Primary outcomes:
measure: Exercise Tolerance
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Antrim
country: United Kingdom
facility: Antrim Area Hospital
state: County Antrim
Study officials:
References:
Clinical trial NCT05261724: Diffusion-tensor Imaging in Brain Tumors Evaluation
Official title: Contribution of Diffusion Tensor Imaging and Tractography in Primary and Secondary Brain Tumors Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diffusion Tensor Imaging
Tractography
MRI
Lead sponsor: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 100
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: Patients with suspected primary or secondary brain tumors, confirmed by routine MRI evaluation followed by surgical treatment and histopathological exam.

Brief summary: Primary and secondary brain tumors are challenging pathologies regarding diagnosis and treatment. MRI is widely used in the imaging evaluation and surgical planning, due to its spatial resolution and ability of tissular characterization.

In this study patients with suspected brain tumors, confirmed by routine MRI evaluation (T1, T2, T2\*, FLAIR, T1 with contrast sequences) will undergo DWI and DTI evaluation. By analyzing collected data from MRI evaluation and patient records regarding surgical and histopathological data our aim is to investigate derived imaging biomarkers with impact in the surgical planning and rehabilitation of the patients.


Eligibility criteria: Inclusion Criteria:

* brain tumors confirmed by routine MRI evaluation
* surgical treatment with histopathological diagnosis

Exclusion Criteria:

* MRI contraindications
* past or present neurological or neurosurgical condition, beside the tumor
* pregnancy

Primary outcomes:
measure: Tract damage
timeFrame: 3 months
Secondary outcomes:
measure: Craniotomy size
timeFrame: 3 months
Other outcomes:
Locations:
city: Targu Mures
country: Romania
facility: SCJU Mures
state: Mures
Study officials:
affiliation: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
name: Mihail Porutiu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02724124: Acute Effect of Static Stretching and Muscle Warming on the Functional Performance of College Volleyball Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Manifestations
Keywords: exercise muscle stretching
electromyography
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 55
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is analyze the effects of static stretching and active warm up, isolated and associated, in functional performance of the lower limbs in college volleyball athletes.

Study hypothesis:

H0: The stretching and / or warm up, alone or in combination, do not alter the functional performance of volleyball players.

H1: The stretching and / or warm up, alone or in combination, alter the functional performance of volleyball players.

Detailed description: This is a cross-over study containing 11 volleyball athletes randomly divided into 5 groups: control (C), warming-up (gAQ), stretching (gAL), warming-up and stretching (gAQAL), stretching and warming-up (gALAQ). All subjects underwent the evaluation measures of functional performance that were conducted pre and post intervention.

Eligibility criteria: Inclusion Criteria:

1. being male;
2. were aged between 18 and 28 years of age;
3. no previous history of orthopedic disorders, rheumatic disorders, cardiovascular, metabolic and / or vestibular and neurological disorders that prevent them from participating in the study dysfunctions;
4. no history of injury, trauma or disease in the lower limbs in the last six months, without surgery;
5. participate in the University Selection UFRN;
6. training time display mode in the above two years with a frequency of at least three times a week.

Exclusion Criteria:

1. presence of injury during the survey period;
2. not conduct evaluative and intervention procedures;
3. waiver to participate.

Primary outcomes:
measure: Muscle Power
timeFrame: Evaluation of power after fifteen minutes the application of intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00913224: To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets
Official title: A Relative Bioavailability Study of Diclofenac Sodium 50 mg Enteric-Coated Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Keywords: Anti-inflammatory
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 17 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Red River Clinic
name: Paul D. Larsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02790424: Adjustment Exploratory Protocols and Functional Evaluation of New Non Invasive Devices in Patient Volunteers
Official title: Adjustment Exploratory Protocols (MagnetoEncephaloGraphy Study : MEG, ElectroEncephaloGram : EEG, Magnetic Resonance Imaging : MRI, Functional MRI : MRIf, Motor Platform) and Functional Evaluation of New Non Invasive Devices (REX BIONICS Exoskeleton) in Patient Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Diseases
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 35
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: Parameters, sequences or paradigms optimisation in view of data quality and relevancy improvement.

Detailed description: Various tests are needed for methodological optimization of the several devices (per-operative MRI, MEG, EEG, SPECT-CT, motor platform) of the technological platform.

Eligibility criteria: Inclusion Criteria:

* Volunteers patient
* Male or female aged over 18 years
* Registered in the French social security scheme
* Signed informed consent

Exclusion Criteria:

* Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)
* Contraindication to Magnetic resonance imaging (MRI)
* All categories of protected persons

Primary outcomes:
measure: Magnetic brain activity
timeFrame: 2 hours
measure: Brain imaging
timeFrame: 2 hours
measure: Electrical brain activity
timeFrame: 2 hours
measure: Motor activity parameters
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CLINATEC
Study officials:
References: