louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01666392: Omega-3 Fatty Acid Supplementation in Older Adults
Official title: The Impact of Omega-3 Fatty Acid Supplementation on Markers of Inflammation and Lean Body Mass in Older Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Inflammation
Keywords: Omega-3 fatty acid
Fish oil
Muscle mass
Muscle strength
Older adults
Circulating inflammatory cytokines
Skeletal muscle mass
Upper body strength
Lower body strength
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: Nordic Naturals
First posted: 2012-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 60
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 to determine whether Fish oil (Omega-3 Fatty Acid) supplementation has an impact on inflammation and lean body mass in older adults. The investigators expect that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass compared to placebo.


Eligibility criteria: Inclusion Criteria:

* 60 years of age or over

Exclusion Criteria:

* Fish, seafood allergies, nut allergies, soy allergies
* Habitual (\>1/week) fish or seafood consumption
* Current Omega-3 supplement use
* Gastrointestinal problems
* Current anti-inflammatory medication use
* Current anticoagulant medication use

Primary outcomes:
measure: C-Reactive protein
timeFrame: At baseline testing and at 3 month endpoint
measure: IL6
timeFrame: At baseline and at 3 month endpoint
measure: TNFα
timeFrame: At baseline and at 3 month endpoint
Secondary outcomes:
measure: Skeletal muscle mass/body composition
timeFrame: At baseline testing and at 3 month endpoint
measure: Lower body muscular strength
timeFrame: At baseline and at 3 month endpoint
measure: Upper body muscular strength
timeFrame: At baseline and at 3 month endpoint
Other outcomes:
measure: EPA and DHA
timeFrame: At baseline and at 3 month endpoint
Locations:
city: Memphis
country: United States
facility: Department of Health and Sport Sciences, The University of Memphis
state: Tennessee
Study officials:
affiliation: The University of Memphis
name: Zsolt Murlasits, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01941992: Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients
Official title: Role of SAMITAL® in Prevention and Treatment of Oral Mucositis in Patients Treated With Chemo-radiation (CT/RT)for Head-and-neck Squamous Cell Carcinomas. A Double-blind, Phase 2 Placebo Controlled, Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head-and-neck Squamous Cell Carcinoma
Oral Mucositis
Keywords: head and neck
Squamous Cell Carcinoma
oral mucositis
Chemo-radiotherapy
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
Collaborators: name: Indena S.p.A
First posted: 2013-09-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to:

* evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy.
* assess tolerability of SAMITAL and the impact on patients reported outcomes.


Eligibility criteria: Inclusion Criteria:

* Histologically proven squamous cell carcinomas of the head-and-neck
* Eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx
* Stage III or IV disease without evidence of distant metastases
* Patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy
* Age ≥ 18 years
* Karnofsky Performance Status ≥70
* Life expectancy ≥6 months
* Able to swallow and retain oral medication
* Good state of dentition
* Patients must be available for treatment and follow-up
* Confirmation of adequate contraception use by the patient and/or partner
* Signed informed consent

Exclusion Criteria:

* Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx
* Serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities.
* Chronic administration of steroids or immunosuppressants
* Pregnancy.

Primary outcomes:
measure: Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developing at any time during the whole study period.
timeFrame: Within 19 weeks after starting Radiotherapy
Secondary outcomes:
measure: Incidence of adverse events assessed by NCI-Common Terminology Criteria for Adverse Effects (CTCAE version 4.0)
timeFrame: Within 19 weeks after starting Radiotherapy
Other outcomes:
measure: Quality of life assessed by European Organization for Research and Treatment of Cancer quality of life core questionnaire (EORTC QLQ-C30) and specific head and neck module (QLQ-H&N35)
timeFrame: Within 19 weeks after starting Radiotherapy
Locations:
city: Padova
country: Italy
facility: Radiotherapy Department, Istituto Oncologico Veneto
Study officials:
affiliation: Radiotherapy Department, Istituto Oncologico Veneto
name: Lucio Loreggian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05146492: Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)
Official title: Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Pericardial Effusion
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to clarify, in patients with more or less abundant pericardial effusion in the acute phase of a myocardial infarction, the correlation between the existence of this effusion during the acute phase with clinical parameters, biological, angiographic, therapeutic and with transmurality, extent, microvascular obstruction and intra myocardial hemorrhage found on MRI made beyond one week and before the 3rd month of the constitution of the necrosis.


Eligibility criteria: Inclusion Criteria:

* Patient between 18 and 90 years old
* Patient admitted to the acute or semi-recent phase (within the next fifteen days) of a myocardial infarction (primary or recurrent myocardial infarction) documented by a significant enzymatic release of troponin (threshold value at 100) in the course of: chest pain or shock, or flare-up of heart failure (left or global) or successfully resuscitated cardiac arrest, or paroxysmal ventricular arrhythmia with or without sus shift of the ST segment on the input trace, with or without Q wave of necrosis formed. This IDM may or may not be complicated by a more or less abundant pericardial effusion of more than 10 mm in the left parasternal, which may in the extreme be the cause of tamponade;
* Subject affiliated or beneficiary of a social security scheme;
* Patient having signed the free and informed consent.

Exclusion Criteria:

* Patient with a pericardial detachment of less than 10 mm, or only systolic;
* Patient who had a break-in during the primary angioplasty guide or complicated coronary dissection extravasation with secondary pericardial effusion;
* Patient with advanced chronic renal failure
* Patient unable to perform an MRI (with a defibrillator or pacemaker).
* Known allergy to contrast agents, in particular gadolinium
* claustrophobic patient;
* Protected patient: adult under guardianship or other legal protection, deprived of liberty by judicial or administrative decision;
* Pregnant or breastfeeding woman;
* Patient hospitalized without consent.

Primary outcomes:
measure: One-year mortality rate of patients with pericardial effusion
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Private Hospital of Parly II-Le Chesnay
Study officials:
References:
Clinical trial NCT03187392: Pain Relief for Birth Control Implants Insertion
Official title: Topical Lidocaine-prilocaine Cream Versus Lidocaine Infiltration for Pain Relief During Insertion of Subcutaneous Birth Control Implants : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Contraception
Lidocaine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during insertion of birth control implants


Eligibility criteria: Inclusion Criteria:

* female want use subcutaneous birth control

Exclusion Criteria:

* previous scar at side of insertion

Primary outcomes:
measure: Mean pain score during insertion of implant
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Medicine
Study officials:
References:
Clinical trial NCT02493192: Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Parturition
Humanizing Deliver
Labor Pain
Natural Childbirth
Labor Onset
First Labor Stage
Keywords: Parturition
Humanizing Deliver
Labor Pain
Natural Childbirth
Labor Onset
First Labor Stage
Birth ball
meperidine
pethidine
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was performed at Gregorio Marañón Hospital birth centre. A Randomised Clinical Trial comparing the two methods of pain relief in the first time of labour was carried out. In this study, 110 women in the first stage of labour were allocated in two study groups by a randomised block design. One of them used the birth ball as a pain relief method,and the other one used pethidine and haloperidol injection.


Eligibility criteria: Inclusion Criteria:

* healthy pregnant women
* women in the first stage of labour or women at induction of labour
* fetal head in pelvis or whole amniotic membranes
* must be able to understand spanish

Exclusion Criteria:

* intrapartum meconium
* needed of continuous fetal monitoring
* suspecte/compromise fetal wellbeing
* morbidly obese women
* unaccompanied women

Primary outcomes:
measure: pain
timeFrame: 24 months
Secondary outcomes:
measure: Baby´s apgar
timeFrame: 24 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
Study officials:
References:
citation: Leung RW, Li JF, Leung MK, Fung BK, Fung LC, Tai SM, Sing C, Leung WC. Efficacy of birth ball exercises on labour pain management. Hong Kong Med J. 2013 Oct;19(5):393-9. doi: 10.12809/hkmj133921. Epub 2013 Jul 22.
citation: Schult TM, Awosika ER, Schmunk SK, Hodgson MJ, Heymach BL, Parker CD. Sitting on stability balls: biomechanics evaluation in a workplace setting. J Occup Environ Hyg. 2013;10(2):55-63. doi: 10.1080/15459624.2012.748324.
citation: Delgado-Garcia BE, Orts-Cortes MI, Poveda-Bernabeu A, Caballero-Perez P. [Randomised controlled clinical trial to determine the effects of the use of birth balls during labour]. Enferm Clin. 2012 Jan-Feb;22(1):35-40. doi: 10.1016/j.enfcli.2011.07.001. Epub 2011 Aug 31. Spanish.
citation: Gau ML, Chang CY, Tian SH, Lin KC. Effects of birth ball exercise on pain and self-efficacy during childbirth: a randomised controlled trial in Taiwan. Midwifery. 2011 Dec;27(6):e293-300. doi: 10.1016/j.midw.2011.02.004. Epub 2011 Apr 3.
citation: Taavoni S, Abdolahian S, Haghani H, Neysani L. Effect of birth ball usage on pain in the active phase of labor: a randomized controlled trial. J Midwifery Womens Health. 2011 Mar-Apr;56(2):137-40. doi: 10.1111/j.1542-2011.2010.00013.x. Epub 2011 Feb 28.
Clinical trial NCT04759092: A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.
Official title: A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2021-02-18
Enrollment: 8
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Treatment study, open label
Primary purpose: TREATMENT

Brief summary: The study is an open label study on patients with Alzheimer's dementia using home based transcranial direct current (tDCS) stimulation. Aims of the study is to investigate applicability and effect of treatment.

Detailed description: Active tDCS of 2mA is applied via surface based electrodes daily for 30 minutes over a 4 month period. Anodal electrode is placed over the left temporal lobe. Participants is followed up by home visit and phone calls.

Cognitive tests are performed prior to the treatment period, right after finishing 4 months of treatment and 4 months after treatment is terminated.

Eligibility criteria: Inclusion Criteria:

* Age 60-85.
* Fulfil diagnostic criteria of probable Alzheimer's dementia.
* Participants has to live with a caregiver.
* If medicated with cholinesterase inhibitors or memantine, a stable dose the last three months before inclusion is required.

Exclusion Criteria:

* Implant in head
* Seizure history
* Severe illness,
* Psychosis or depression measured with a cornell score over 11.
* Mini mental status (MMSE) score\<17.

Primary outcomes:
measure: To investigate adverse effects of the treatment
timeFrame: 4 months
measure: To investigate effect of the treatment
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms
Study officials:
affiliation: University Hospital of North Norway
name: Ole K Grønli Grønli, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gronli OK, Daae Rasmussen I, Aslaksen PM, Bystad M. A four-month home-based tDCS study on patients with Alzheimer's disease. Neurocase. 2022 Jun;28(3):276-282. doi: 10.1080/13554794.2022.2100710. Epub 2022 Jul 19.
Clinical trial NCT05510492: Evoluation of Nurses' Skill Training on the Intramuscular Injection With Z Technique in Ventrogluteal Region
Official title: Evoluation of Nurses' Skill Training on the Intramuscular Injection With Z Technique in Ventrogluteal Region
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Injections
Keywords: ventrogluteal
intramuscular
injection
nursing
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 95
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluation of the skill training given to nurses on intramuscular injection with the z technique from the ventrogluteal region
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research was planned as a randomized controlled experimental study in order to evaluate the effectiveness of the skill training given to nurses on intramuscular injection with the Z technique from the VG region.

Research Hypotheses H-0: The skill training given to nurses in applying intramuscular injection with the Z technique from the VG region does not affect the nurses' ability to inject with the Z technique from the VG region.

H-1: The skill training given to nurses on intramuscular injection with the Z technique from the VG region affects the nurses' ability to inject with the Z technique from the VG region.

Detailed description: This research was planned as a randomized controlled experimental study in order to evaluate the effectiveness of the skill training given to nurses on intramuscular injection with the Z technique from the VG region.

Eligibility criteria: Inclusion criteria:

• Nurses working in inpatient services other than emergency, outpatient clinic, operating room and pediatrics of a Health Practice and Research Hospital

Exclusion Criteria:

• Nurses who do not agree to participate in the research and/or want to leave the research while it is continuing

Primary outcomes:
measure: In the study, the effectiveness of the skill training given to nurses was measured.
timeFrame: Since the research was in the pre-test post-test design and the post-test was applied at least two weeks later, the data were collected in a period of up to four months.
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi Üniversitesi Sağlik, Uygulama Ve Araştirma Hastanesi
state: Eski̇şehi̇r
Study officials:
References:
Clinical trial NCT04989192: Dose Efficiency of Modern CT Scanners in Oncologic Scans
Official title: On Dose Efficiency of Modern CT-Scanners in the Staging of Malignancies - a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Neoplasm Metastasis
Metastatic Cancer
Keywords: Spectral CT
CT
Computed Tomography
Radiation Dose
Dose Efficiency
Lead sponsor: University Hospital Augsburg
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization of patients referred for a staging CT scan one of three CT scanners routinely used for this purpose in our department
Primary purpose: DIAGNOSTIC

Brief summary: CT-Staging is crucial for therapy planning of patients with malignancies. Dose efficiency and image quality are important parameters for these examinations. Up to now, scientific evidence of dose efficiency of modern CT scanners is mostly derived from retrospective analyses. This prospective study systematically analyzes dose efficiency and image quality of three modern CT scanners by randomization of patients who are scheduled for a CT scan to examine the status of malignancies. After giving informed consent and randomization (1:1:1), the CT scan will be performed at one of the modern CT scanners available at our department. This will allow a systematic allocation to the different scanners.


Eligibility criteria: Inclusion Criteria:

* clinical suspicion of a malignancy or known / confirmed malignancy AND
* indication for contrast-enhanced CT of the body confirmed by board-certified radiologist ('justifying indication' according to German/European radiation protection law) AND
* patient (is able to give informed consent and) has given informed consent.

Exclusion Criteria:

* age \< 18 years
* known or suspected pregnancy
* contraindications for contrast agent (renal failure, allergy, hyperthyroidism)

Primary outcomes:
measure: Objective Image Quality
timeFrame: 1 year
measure: Radiation Dose
timeFrame: 1 year
Secondary outcomes:
measure: Subjective Image Quality (entire cohort and for individual disease groups)
timeFrame: 1 year
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg
state: Bavaria
Study officials:
affiliation: Universitätsklinikum Augsburg
name: Florian Schwarz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01050192: Nutritional Content of Breast Milk From Mothers of Premies
Official title: The Nutritional Content of Breast Milk From Mothers of Premature Neonates During the First 28 Days of Life
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prematurity
Nutrition
Keywords: Prematurity
Nutrition
Breast Feeding
Lead sponsor: Pediatrix
Sponsor class: OTHER
Collaborators: name: Prolacta Bioscience
First posted: 2010-01-15
Enrollment: 0
Sex: ALL
Minimum age (years): 23
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonatal Intensive Care Unit

Brief summary: The purpose of this study is to determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of very low birth weight (VLBW) infants in the neonatal intensive care unit (NICU) and the nutritional value they are actually receiving in a 24 hour period, since as a practical matter, these may not be the same.


Eligibility criteria: Inclusion Criteria:

* Mothers of infants with a gestational age \<=30 weeks in the NICU who are supplying their own breast milk for use by their baby
* Reasonable likelihood of survival of infant to 28 days
* Infant on/ready for oral feeding by DOL 7 days
* Willing to provide breast milk for their baby
* Able to produce at least 7mL breast milk per feeding
* Willing to abide by requirements of the study protocol
* Documentation of informed consent

Exclusion Criteria:

* Unable to provide at least 7mL breast milk per feeding
* Medically unsuitable to provide breast milk to her baby
* Maternal age \<18 years of age

Primary outcomes:
measure: To determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of VLBW infants in the NICU and the nutritional value they are actually receiving in a 24 hour period.
timeFrame: 28 days of life
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
Study officials:
affiliation: Greenville Memorial Hospital
name: Reese Clark, MD
role: PRINCIPAL_INVESTIGATOR
References: