louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02904447: Plantar Forces Mid-term After Hemiarthroplasty With HemiCap for Hallux Rigidus
Official title: Plantar Forces Mid-term After Hemiarthroplasty With HemiCap for Hallux Rigidus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hallux Rigidus
Keywords: hemicap
hallux rigidus
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who has had an operation with proximal hemiarthroplasty (hemicap) 1st MTP proximal prosthetics 2006-2014 in Hvidovre Hospital, Glostrup Hospital or Hamlet-Aleris Hospital.

Brief summary: The purpose of this study is to examine variabel pressure gradients of the 1st toe, 2-5th toes and the metatarsal distal caput in patients who have had surgery with a partial proximal hemiarthroplasty in the 1st metatarsalphalangeal joint (MTP) between 2006-2014.

Also, to examine these variables and compare them to the totalt range of motion and pain, to find out if the measured pedobar pressure can be used identify the well treated patient and the poorly treated patient.

The pedobar pressure gradients will be compared with a control group with healthy feet.


Eligibility criteria: Inclusion Criteria:

* patients who has hemicap 1. MTP joint.

Exclusion Criteria:

* patients who haad revision surgery, for example removal of hemicap and desis og 1. MTP joint.

Primary outcomes:
measure: Plantar forces under the hallux and the forefoot in patients operated with a hemiCAP in the 1st MTPJ.
timeFrame: One examination for each patient, approximately 30 min.
Secondary outcomes:
measure: Range of motion (degrees)
timeFrame: One examination for each patient, approximately 30 min.
measure: Level of pain
timeFrame: One examination for each patient, approximately 30 min.
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: Copenhagen
Study officials:
References:
Clinical trial NCT01037647: VLDL-triglyceride Kinetics in Type 2 Diabetes
Official title: VLDL-triglyceride Kinetics and -Metabolism in the Post Absorptive State and During Hyperinsulinemia in Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Diabetic dyslipidemia
VLDL-TG kinetics
VLDL-TG metabolism
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
name: The Novo Nordic Foundation
name: The Danish Diabetes Association
First posted: 2009-12-23
Enrollment: 22
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 11 men with type diabetes and 11 healthy men, matched for age and BMI.

Brief summary: Type 2 diabetes is associated with diabetic dyslipidemia, which is a major risk factor for coronary heart disease. Triglycerides (TG) and cholesterol are transported in the system of lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. Evidence suggests that increased concentration of very low-density lipoprotein triglyceride (VLDL-TG) is a central pathophysiological feature of the lipid and lipoprotein abnormalities in diabetic dyslipidemia.

The objective of this study was to investigate VLDL-TG kinetics and aspects of peripheral VLDL-TG metabolism, i.e. to what extent VLDL-TG associated fatty acids (FA) are oxidized or deposited in regional adipose tissue, in subjects with type 2 diabetes and healthy controls in the postabsorptive state and during acute hyperinsulinemia using ex-vivo labeled VLDL-TG tracers.


Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

* Known disease except type 2 diabetes (type 2 diabetic subjects)
* Smoking
* Alcohol abuse
* Prescription medication expect oral antidiabetics (type 2 diabetic subjects)

Primary outcomes:
measure: VLDL-TG production and clearance rates
Secondary outcomes:
measure: VLDL-TG oxidation
measure: VLDL-TG subcutaneous adipose tissue storage
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical department M (Endocrinology and Diabetes), Aarhus University Hospital
state: DK
Study officials:
affiliation: Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark
name: Søren Nielsen, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen IR, Sondergaard E, Sorensen LP, Nellemann B, Gormsen LC, Jensen MD, Nielsen S. Increased VLDL-TG Fatty Acid Storage in Skeletal Muscle in Men With Type 2 Diabetes. J Clin Endocrinol Metab. 2017 Mar 1;102(3):831-839. doi: 10.1210/jc.2016-2979.
citation: Sorensen LP, Andersen IR, Sondergaard E, Gormsen LC, Schmitz O, Christiansen JS, Nielsen S. Basal and insulin mediated VLDL-triglyceride kinetics in type 2 diabetic men. Diabetes. 2011 Jan;60(1):88-96. doi: 10.2337/db10-0564. Epub 2010 Sep 21.
Clinical trial NCT03791047: Evaluation of Muscle Thickness and Balance in Young and Older Adults
Official title: The Relationship Between Muscle Thickness and Dynamic Balance in Young and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Balance; Distorted
Keywords: Balance
Postural control
Muscle
Older adults
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study evaluates muscle thickness of trunk and lower limb and balance in young and older healthy adults. The participants will be evaluated muscle thickness for 14 different muscle and balance which evaluated by computerized force plate system.

Detailed description: Aging had an adverse affect on musculoskeletal system and balance parameters. Decreased muscle strength or thickness negatively affect person's balance control. But there are no information in the literature about the relationships between muscle thickness and balance in healthy subjects. In addition to, it is not known which muscle responsible for balance. Therefore, this study will evaluate muscle thickness via ultrasonography and balance in young and older adults. Balance will be evaluated computerized Balance system. Muscle thickness for different 14 muscle ( diaphragm, transversus abdominis,multifidus, longissimus, quadratus lumborum, rectus abdominis, external and internal obliques, rectus femoris, vastus intermedius, vastus lateralis, tibialis anterior, gastrocnemius, soleus) will be evaluated by ultrasonography at the right side. Only diaphram muscle will be evaluated both right and left side.

Eligibility criteria: Inclusion Criteria For Young Adults:

* To be a volunteer to participate
* to be an aged 18-40 years old.

Inclusion Criteria For Older Adults:

* To be a volunteer to participate
* to be an aged 65-90 years old.

Exclusion Criteria:

* Walking with assist device
* Having a visual deficits
* Having an orthopedic problems that affect balance
* Having a neurological disorders
* Having a musculoskeletal disorders that affect balance
* Having an undergone orthopedic surgery

Primary outcomes:
measure: Limits of Stability
timeFrame: 15 minutes
Secondary outcomes:
measure: Muscle thickness
timeFrame: 30 minutes
measure: Postural Sway
timeFrame: 15 minutes
measure: Fear of falling
timeFrame: 15 minutes
measure: Joint position sense
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ozden Ozkal
Study officials:
affiliation: Hacettepe University
name: Ozden Ozkal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozkal O, Kara M, Topuz S, Kaymak B, Baki A, Ozcakar L. Assessment of core and lower limb muscles for static/dynamic balance in the older people: An ultrasonographic study. Age Ageing. 2019 Nov 1;48(6):881-887. doi: 10.1093/ageing/afz079.
Clinical trial NCT05184647: Total Splenectomy vs Partial Splenectomy in Non-malignant Hemoglobinopathies : Study Comparing the Effectiveness
Official title: Total Splenectomy vs Partial Splenectomy in Non-malignant Hemoglobinopathies : Study Comparing the Effectiveness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Splenectomy; Status
Keywords: Pediatrics
Non-malignant hemoglobinopathies
Comprative effectivness
Partial Splenectomy
Total Splenectomy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 18 years olds with partial or total splenectomy for non malignant hemoglobinopathies

Brief summary: Partial splenectomy or total splenectomy are the two surgical treatment of non-malignant hemoglobinoptahie. The aim of this treatment is to decrease transfusion. The main risk is infectious in total splenectomy, that's why partial splenectomy was suggest. But the efficiency of partial splenectomy decrease over time and a totalisation could be mandatory.


Eligibility criteria: Inclusion criteria:

* Children between 0- 18 years olds
* Total or partial splenectomy
* Non malignant hémoglobinopathies

Exclusion criteria:

- Total or partial splenectomy outside of non malignant hemoglobinopathies

Primary outcomes:
measure: Compared the effectiveness with the number of transfusion
timeFrame: Day 1
Secondary outcomes:
measure: Number of infectious event in total and partial splenectomy
timeFrame: Day 1
measure: number of totalisation in partial
timeFrame: Day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Nicolas KALFA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00222547: Deworming and Enhanced Vitamin A Every 6 Month in Rural Indian Children Aged 1-6
Official title: Deworming and Enhanced Vitamin A Supplementation DEVTA Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Village Children
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2005-09-22
Enrollment: 720000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Randomisation of 72 large rural areas ("blocks") into a 2 x 2 trial of six- monthly treatment of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or neither. The placebo group get no trial treatment at all and do not receive physical placebos.


Eligibility criteria: InclusionCriteria:

* Area of residence

Exclusion Criteria:

* NONE

Primary outcomes:
measure: childhood mortality rate at age 1-6
Secondary outcomes:
measure: fecal egg counts, plasma retinal, growth, sign of Vitamin A deficiency
Other outcomes:
Locations:
city: Lucknow
country: India
facility: Shally Awasthi
state: Uttar Pradesh
Study officials:
affiliation: King George Medical University, Lucknow
name: Shally Awasthi, MD
role: STUDY_CHAIR
References:
citation: Awasthi S, Peto R, Read S, Richards SM, Pande V, Bundy D; DEVTA (Deworming and Enhanced Vitamin A) team. Population deworming every 6 months with albendazole in 1 million pre-school children in North India: DEVTA, a cluster-randomised trial. Lancet. 2013 Apr 27;381(9876):1478-86. doi: 10.1016/S0140-6736(12)62126-6. Epub 2013 Mar 14.
citation: Awasthi S, Peto R, Read S, Clark S, Pande V, Bundy D; DEVTA (Deworming and Enhanced Vitamin A) team. Vitamin A supplementation every 6 months with retinol in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial. Lancet. 2013 Apr 27;381(9876):1469-77. doi: 10.1016/S0140-6736(12)62125-4. Epub 2013 Mar 14.
Clinical trial NCT02738047: Reduction of Adverse Drug Events and Readmissions
Official title: Pharmacogenomic Test Assessment for Medication Management in the Advancement of Medicine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pharmacogenomic Testing for Medication Management
Lead sponsor: ClinLogic LLC
Sponsor class: INDUSTRY
First posted: 2016-04-14
Enrollment: 280000
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are under treatment with several drugs with any of the sequences of biochemical reactions, catalyzed by enzymes, known to be influenced by genetic variation in a patient population.

Brief summary: Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.

Detailed description: Pharmocogenomic. A multicenter, observational study to evaluate the use of a Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known to be influenced by genetic variation.

Eligibility criteria: INCLUSION CRITERIA

Patients may be included in the Study if they meet all of the following inclusion criteria:

1. Male or female patients of 25 years of age or older who are able to give their written Informed Consent to participate in a Clinical Study based on voluntary agreement with a thorough explanation of the patient's participation will be provided to them.
2. Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 120 days ("index PGx test assessment");
3. Patient was receiving at least one medication known to be associated with allelic variation at the time of the ("index PGx test assessment"), including over-the- counter medications;
4. Patient has a history of at least one TDAE over the 24-month period preceding the PGx test assessment, or has experienced inadequate efficacy from a target drug.

EXCLUSION CRITERIA

Patients will be excluded from the Study if any of the following criteria apply:

1. Patient is currently hospitalized;
2. Patient's medical and medication history is unavailable over the 120-day period preceding the PGx test assessment;
3. Patient is unable to provide an accurate history due to mental Incapacity;
4. Patient is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Study.

Primary outcomes:
measure: Radar, Pharmocogenomic
timeFrame: The period of enrollment is anticipated to be 36 months with a 120- day follow-up period, for total study duration of approximately 40 months from first patient enrolled to completion of follow-up on the last patient in.
Secondary outcomes:
Other outcomes:
Locations:
city: York
country: United States
facility: MD@Home
state: Pennsylvania
Study officials:
affiliation: GXL
name: Haleh Farzanmehr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GXL
name: Haleh Farzanmehr, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00569647: Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis
Official title: Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: preoperative anxiety
burn reconstruction
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2007-12-07
Enrollment: 25
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Children with burns often require repeated reconstructive surgeries. These children tend to develop high levels of anxiety before coming to the operating room. Preoperative sedation, while somewhat effective in relieving this anxiety, has a number of side effects. The researchers hypothesized that preoperative anxiety could be effectively reduced by the utilization of a device which induces a relaxing hypnotic state through emmersion in a virtual reality environment.

Detailed description: The virtual reality environment is created by a Virtual Reality Hypnosis (VRH) device. The patient wears a headset which contains video and audio display. A twenty minute program is viewed, which guides the patient into a relaxed state via soothing audio and video input.

Eligibility criteria: Inclusion Criteria:

* Child presenting for reconstructive burn surgery

Exclusion Criteria:

* Visual or auditory difficulties

Primary outcomes:
measure: anxiety reduction
timeFrame: preoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Cincinnati
name: John E McCall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01102647: Cholesterol Metabolism in Heterozygous Phytosterolemia
Official title: Assessment of Cholesterol Metabolism in Heterozygous Phytosterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Disease
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 26
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to examine the effect of plant sterols on cholesterol absorption and synthesis in people with heterozygous phytosterolemia.

Detailed description: A plant sterol supplementation study will be conducted in individuals who are heterozygous for phytosterolemia compared to non-carriers. The study will use a double-blind, randomised, crossover, placebo-controlled design in which participants will consume 2 treatments including 1.6 g of plant sterol pills and a placebo pill, each for 4 weeks. A 4 week washout period will separate the two treatment periods. Plant sterol concentrations will be measured by gas liquid chromatography and absorption will be measured by the ratio of campesterol to lathosterol in plasma. Cholesterol absorption and synthesis will be measured by dual stable isotope technique, involving simultaneous administration of 13C-cholesterol and deuterium oxide, respectively.

Eligibility criteria: Inclusion Criteria:

* heterozygous for phytosterolemia, wild-type.

Exclusion Criteria:

* Pregnant,
* Previous heart attack,
* Kidney disease.

Primary outcomes:
measure: Decrease in plasma LDL-cholesterol
timeFrame: 29 days
Secondary outcomes:
measure: Increase plasma plant sterols
timeFrame: 29 days
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Peter J Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Myrie SB, Mymin D, Triggs-Raine B, Jones PJ. Serum lipids, plant sterols, and cholesterol kinetic responses to plant sterol supplementation in phytosterolemia heterozygotes and control individuals. Am J Clin Nutr. 2012 Apr;95(4):837-44. doi: 10.3945/ajcn.111.028985. Epub 2012 Feb 29.
Clinical trial NCT02862847: Study of the Prevalence of Cosavirus and Salivirus Infections, Two New Genera of Picornaviridae, In Infants
Official title: Study of the Prevalence of Cosavirus and Salivirus Infections, Two New Genera of Picornaviridae, In Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastro entérite
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 615
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children de moins de 5ans présentant ou non un épisode de gasto entérite

Brief summary: Cosavirus and Salivirus are two new genera of Picornaviridae and are responsible for acute diarrhoea. They have been identified in the pathological stools of infants and immuno-compromised subjects on every continent with prevalences ranging from 2.8% to 8.8% depending on the virus, the cohort and the country studied.

To date, no study on these two viruses has been conducted in France to evaluate the circulation and the pathogenicity of these viruses in subjects with diarrhoea.

The aim of this study is thus to:

* show that these viruses are in circulation in France in infants younger than 5 years old and that the proportions are similar to those reported in the literature.
* confirm the relationship between the diarrhoea and the infection with these viruses.


Eligibility criteria: Inclusion Criteria:

* Children younger than 5 years
* Children hospitalized or consulting at Dijon CHU during the 12 months of the study for acute gastroenteritis. Acute gastroenteritis is defined by at least 3 soft or liquid stools or at least 3 bouts of vomiting within 24 hours or signs (diarrhoea or vomiting) accompanied by at least 2 additional symptoms among diarrhoea or vomiting, abdominal pain, fever

for controls

* Children younger than 5 years old
* Children hospitalized or consulting at Dijon CHU during the 12 months of the study for any illness without diarrhoea (other than exclusion criteria).

Exclusion Criteria:

* Persons without national health insurance cover
* Children older than 5 years.
* Children presenting chronic diarrhoea (\> 2 weeks) (e.g. Crohn and UC)
* Children with immune deficiency.
* Children with nosocomial gastroenteritis; the nosocomial aspect will be defined as the onset of acute diarrhoea occurring after the 48th hour after admission

for controls

* Persons without national health insurance cover
* Children older than 5 years.
* Children with chronic diarrhoea (\> 2 weeks) (e.g. Crohn and UC)
* Children with immune deficiency.

Primary outcomes:
measure: Rate of viruses detected
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: