louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01140165: Cheese and Human Health
Official title: Effects of Hard Cheese and Butter on Markers of Cardiovascular Disease -A Randomized Controlled Dietary Human Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Danish Dairy Research Foundation, Denmark
name: National Dairy Council
First posted: 2010-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to examine if a diet rich in cheese will have a beneficial effect on risk markers of cardiovascular disease compared to a diet rich in butter.

The primary parameters are total cholesterol as well as LDL-, HDL cholesterol and triacylglycerol (TAG). The secondary parameters are hsCRP, markers of insulin resistance, fasting insulin and glucose (HOMA). Furthermore bloodpressure is measured.


Eligibility criteria: Inclusion Criteria:

* Sign written consent
* Age: 20-70
* BMI: 20-32
* Refrain from dietary supplements and blood donations prior to, and during the study

Exclusion Criteria:

* Known or suspected abuse of alcohol, drugs or medication
* Poor compliance
* Current or previously cardiovascular disease
* Diabetes Mellitus or other severe chronic disease, including severe allergies

Primary outcomes:
measure: Total cholesterol
timeFrame: 6 weeks
measure: LDL cholesterol
timeFrame: 6 weeks
measure: HDL cholesterol
timeFrame: 6 weeks
measure: Triglyceride
timeFrame: 6 weeks
Secondary outcomes:
measure: Insulin
timeFrame: 6 weeks
measure: Glucose
timeFrame: 6 weeks
measure: fasting hsCRP
timeFrame: 6 weeks
measure: Blood pressure
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition
Study officials:
affiliation: Department of Human Nutrition, University of Copenhagen
name: Tine Tholstrup, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hjerpsted J, Leedo E, Tholstrup T. Cheese intake in large amounts lowers LDL-cholesterol concentrations compared with butter intake of equal fat content. Am J Clin Nutr. 2011 Dec;94(6):1479-84. doi: 10.3945/ajcn.111.022426. Epub 2011 Oct 26.
Clinical trial NCT01089465: Cimex Lectularius or Bed Bugs : Vector of Infectious Agents and Pathogenic Role
Official title: Cimex Lectularius or Bed Bugs : Vector of Infectious Agents and Pathogenic Role
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sting
Keywords: Bed bugs
Cimex
insects
bites
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-03-18
Enrollment: 135
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: During the last years, the investigators were the witness to the increase of a old emerging pest due to bed bugs (Cimex lectularius) in the world. Insecticides resistances apparitions and internationals transports increases seem to be the reasons of the pest. Cimex lectularius as vector of parasites, bacteria or virus was often suggested although not much observation are recently investigated in France. This study intends to examine the vectorial ability and the direct pathogenicity of Cimex lectularius.


Eligibility criteria: Inclusion Criteria:

* On the site of takings presence of insects and eggs evoking bedbugs of beds. The identification of certainty will be made in the laboratory. All the insects not apartment to the family of Cimicidae (Criterion of exclusion) are thrown(cast) in trash cans of laboratories for organic products.
* voluntary Patients after reading of the information sheet and the signature of the consent
* Membership of the patient in the national insurance scheme

Exclusion Criteria

* On the site of takings absence of insects and eggs evoking bedbugs of beds
* During the identification of certainty in the laboratory, the captured insects do not make parties of the family of Cimicidae
* The subjects deprived of freedom.
* Patients cancelling their consent.
* Patients violating the protocol of search(research)

Primary outcomes:
measure: Morphological identification of every bedbug Porterage of bacterial agents Porterage of viral agents Biomolecular identification of the insect A breeding of bedbugs Tests of sensibility in insecticides
timeFrame: day 1
Secondary outcomes:
measure: Study of the direct pathogenicity of lectularius C.
timeFrame: day 1, 7, 15 and 30
Other outcomes:
Locations:
city: Nice
country: France
facility: Collection of the bedbugs and dermatological follow-up of the stings
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Pascal Delaunay, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02035865: Mood and Cognitive Outcome After Heart Transplantation (the MOODHEART Study)
Official title: Nevropsykiatri og Hjertetransplantasjon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Diagnosis
Cognition Disorders
Keywords: Psychiatric morbidity
Cognitive function
Heart transplantation
Mortality
Cardiac allograft vasculopathy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surviving participants from two former studies

Brief summary: The investigators aim at characterizing neuropsychiatric consequences of heart transplantation (HTX) and at assessing the impact of depressive symptoms after HTX on mortality and cardiac allograft vasculopathy (CAV).


Eligibility criteria: Inclusion Criteria:

* Participant in one of two former studies and heart transplanted at the time of inclusion into this former study

Exclusion Criteria:

* Cognitively not capable to consent to participation and/or
* Insufficient fluent in the Norwegian language to complete both psychiatric and neuropsychological assessment

Primary outcomes:
measure: Psychiatric morbidity
timeFrame: At time of enrollment
measure: Cognitive function
timeFrame: At time of enrollment
Secondary outcomes:
measure: All cause mortality
timeFrame: 14 and 3 years respectively
measure: Cardiac allograft vasculopathy
timeFrame: 14 and 3 years respectively
Other outcomes:
measure: Cerebral pathology
timeFrame: At time of enrollment
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Ira R. Hebold Haraldsen, MD/dr philos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00504465: Combined Agent Randomized Trial of Induction of Labor
Official title: Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Induction
Cervical Ripening
Keywords: Labor
Labor induction
Cervical ripening
Dinoprostone
Fetal safety
Oxytocin
Cesarean delivery
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2007-07-20
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety.

Detailed description: This study is a non-blinded, three arm randomized trial at 3 sites. Entry criteria were: \>36 weeks' singleton, cephalic gestation with intact membranes and an unripe cervix (Bishop's score \<6). Study arms were: 1) dinoprostone vaginal insert (Cervidil) for 12 hours followed by oxytocin, 2) dinoprostone vaginal insert (Cervidil) for 12 hours with simultaneous oxytocin, and 3) intracervical dinoprostone gel (Prepidil)(one dose) followed by immediate oxytocin. Primary outcome measure was the rate of vaginal delivery \<24 hours. Secondary outcomes were randomization to delivery interval, rate of cesarean delivery (CD) for non reassuring fetal status (NRFS) and rate of uterine hyperstimulation.

Eligibility criteria: Inclusion Criteria:

* \> or = to 36 weeks of gestation
* Singleton fetus
* Cephalic presentation
* Intact membranes and an unripe cervix (Bishop score \<6)

Exclusion Criteria:

* Multifetal gestation
* Rupture of membranes
* Ripe cervix (Bishop score \>6)
* Active labor
* Contraindication to vaginal delivery
* Previous uterine surgery
* Non-cephalic presentation
* Fetal macrosomia

Primary outcomes:
measure: Rate of vaginal delivery <24 hours
Secondary outcomes:
measure: Randomization to delivery interval
measure: Rate of cesarean delivery for non reassuring fetal status
measure: Rate of uterine hyperstimulation
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: The Brooklyn Hospital Center
state: New York
city: Flushing
country: United States
facility: New York Hospital Medical Center of Queens
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Daniel W Skupski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Brooklyn Hospital Center
name: Michael Cabbad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05428865: Correlation Between Body Mass Index, Selective Motor Control and Functional Ability in Children With CP
Official title: Correlation Between Body Mass Index, Selective Motor Control, Spasticity and Functional Ability in Children With Diplegic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diplegic Cerebral Palsy
Keywords: isolated motor control
functional ability
body mass index
cerebral palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 84
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: spastic diplegic cerebral palsy children

Brief summary: PURPOSE:

To investigate the correlations between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.

BACKGROUND:

Cerebral palsy is primarily a disorder of movement and posture

HYPOTHESES:

There is no correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.

RESEARCH QUESTION:

Is there a correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia?

Detailed description: This is an observational correlational study. SCALE will be used to assess selective motor control of lower extremity. GMFM-88 and WEE FIM will be used to assess functional ability. MAS will be used to assess degree of spasticity

Eligibility criteria: Inclusion Criteria:

* spastic diplegic CP, age from 6 to 9 years, able to follow verbal commands or instructions during testing procedures, 1+ and 2 according to Modified Ashworth scale (MAS), (GMFCS E\&R) selected Level II , III.

Exclusion Criteria:

* patients who had contractures or fixed deformities related to the joints of the lower limbs, injection with Botulinium toxin or any orthopaedic surgery in lower limbs within one year before study,

Primary outcomes:
measure: The selective control assessment of lower extremity (SCALE)
timeFrame: through study completion, an average of 1 year
measure: Anthropometric measurements
timeFrame: through study completion, an average of 1 year
measure: Wee Functional Independence Measure (Wee-FIM)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: through study completion, an average of 1 year
measure: Gross Motor Function Classification System Expanded and Revised for CP children between 6th and 12th birthday:
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty Of Physical Therapy
Study officials:
affiliation: Cairo University
name: Faculty OP Therapy, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03770065: Exploratory Study on Two Different Doses of VML-0001 on the Effects on Vaginal pH in Healthy Post-Menopausal Women
Official title: A Phase II, Open-label, Single-Centre, Randomized, Cross-over, Exploratory Study on Two Different Doses of VML-0001, the Base Formulation of Viramal's pH Regulating and Vaginal Moisturizing Cream, on the Effects on Vaginal pH in Healthy Post-Menopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Atrophy
Lead sponsor: Viramal Limited
Sponsor class: INDUSTRY
First posted: 2018-12-10
Enrollment: 14
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Post-Menopausal women

Brief summary: The study is designed to determine the effect on vaginal pH and the duration of action measured on the ability of the base formulation to reduce the vaginal pH


Eligibility criteria: Inclusion Criteria:

* be greater than 45 years
* no positive findings on screening gynaecological examination
* negative smear test within the last 5 years

Exclusion Criteria:

* has signs of vaginal infection
* has evidence of alcohol abuse
* has used hormonal replacement therapy in three months prior to study entry

Primary outcomes:
measure: To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH.
timeFrame: 7-14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc. (MARC)
state: Alabama
Study officials:
affiliation: Doctor
name: James Murray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01180465: A Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity
Official title: A Multi-center, Randomized, Double-masked, Placebo-controlled, Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Weight
Keywords: Treatment of abdominal adiposity
Lead sponsor: Neothetics, Inc
Sponsor class: INDUSTRY
First posted: 2010-08-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: LIPO-102 is under evaluation for treatment of abdominal adiposity


Eligibility criteria: Inclusion Criteria:

* 18 - 50 years old inclusive
* Localized area of abdominal subcutaneous adiposity of Grade 3 or above on the P-PNS or C-PNS
* BMI \< 25kg/m sq
* Stable diet and exercise and body weight

Exclusion Criteria:

* Prior treatment of abdominal subcutaneous adipose tissue
* Females within 12 months postpardum
* Known hypersensitivity to the drugs or components

Primary outcomes:
measure: Safety
timeFrame: 8 weeks treatment and 1 week follow up
measure: Change in abdominal circumference
timeFrame: 8 weeks
Secondary outcomes:
measure: photographic assessment
timeFrame: 8 weeks
measure: Abdominal subcutaneous adiposity questionnaire
timeFrame: 8 weeks
measure: Patient and clinician photo numeric scale
timeFrame: 8 weeks
measure: Patient global assessment of severity scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: New York
country: United States
state: New York
Study officials:
References:
Clinical trial NCT02567565: Evaluation of Tear Film Lipid Layer Thickness Change After Cataract Surgery
Official title: Evaluation of Tear Film Lipid Layer Thickness Change After Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Patients
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cataract patients with lens opacities classification higher than grade III

Brief summary: This study will compare cataract patients before and after phacoemulsification. Evaluations will be performed before and 1 and 3 months following cataract surgery, including measurement of tear film lipid layer thickness, tear film break up time, Schirmer test, corneal and conjunctival fluorescein staining, examination of lid margins and meibomian glands, and the Ocular Surface Disease Index.


Eligibility criteria: Inclusion Criteria:

* cataract patients with lens opacities classification higher than grade III and desire to be spectacle independence for distance and near vision

Exclusion Criteria:

* previous ocular surgery or trauma and the presence of corneal opacities, fundus abnormalities, glaucoma, uveitis, amblyopia, systemic disease, and posterior capsule rupture during cataract surgery

Primary outcomes:
measure: tear film lipid layer thickness
timeFrame: 3-month after phacoemulsification
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Tae-im Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03894865: Screening and Prevalence of Adolescent Idiopathic Scoliosis in Selected Urban and Countryside Schools in Egypt
Official title: Screening and Prevalence of Adolescent Idiopathic Scoliosis in Selected Urban and Countryside Schools in Egypt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Keywords: scoliosis, prevalence
screening, Egypt
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 840
Sex: MALE
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Early detection of scoliosis and determination of which areas are more affected urban or countryside will help in early management. Also, this will guide the government and the community for early intervention to decrease the factors that leads to this postural abnormality. This also will guide another clinician to search for the cause of these posture deformities and to concentrate screening for special areas with special cultures.

Detailed description: Scoliosis may have an impact on the Egyptian society as children between 10-15 years old represent 9.5 % of the population which is the third large category appendix (3). So without the early detection of adolescent idiopathic scoliosis for that age group, bad impacts will be implemented for Egyptian society by causing disabilities and psychological problems for these children.

The early detection of scoliosis is of a great importance as curve detection before skeletal maturation gives a good opportunity for early treatment or prevention of curve progression. Scoliosis has a bad effect on cosmetic appearance, quality of life, Psychological well-being, disability, back Pain, breathing function. It may also progress in adulthood and need further treatment. So a multidimensional and comprehensive evaluation of scoliosis patients is necessary to design a complete therapeutic approach.

Eligibility criteria: Inclusion criteria:

1. Age range from 10 to 15 years.
2. Males students.
3. Students who have structural scoliosis.

Exclusion criteria:

1. Congenital deformities.
2. Recent fracture and there is a fixation in the upper or the lower extremities
3. Neuromuscular disorder (Cerebral palsy and spinal muscle atrophy).
4. Syndromic disorders (Muscular dystrophy, Osteogenesis imperfect, and Spina-bifida).

Primary outcomes:
measure: Positive Adam's forward bending test
timeFrame: 10 minutes
measure: degree of trunk rotation
timeFrame: 15 minutes
Secondary outcomes:
measure: screening
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical therapy, Cairo University
Study officials:
affiliation: Cairo University
name: karima A Hassan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06470165: Priority-Matching Correction Technique in Degenerative Lumbar Scoliosis
Official title: Global Coronal Malalignment in Degenerative Lumbar Scoliosis and Priority-Matching Correction Technique to Prevent Postoperative Coronal Decompensation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Degenerative Lumbar Disease
Scoliosis
Degenerative Scoliosis
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with degenerative lumbar scoliosis (DLS) who underwent correction surgery with reference to our priority-matching correction technique and the standard reported by Obeid and colleagues. Our findings may provide tangible guidance for surgical decision-making in DLS.


Eligibility criteria: Inclusion Criteria:

1. A diagnosis of DLS based on radiography and previous medical record,
2. Age \&gt; 50 years

Exclusion Criteria:

1. Leg length discrepancy,
2. A history of spinal or pelvic surgery,
3. A history of neuromuscular diseases, arthritis or tumor.

Primary outcomes:
measure: Scoliosis Research Society-22
timeFrame: One month, 3 months, 6 months, 1 year, and 2 years after surgery
measure: Oswestry disability index
timeFrame: One month, 3 months, 6 months, 1 year, and 2 years after surgery
measure: Achievement of minimal clinically important difference
timeFrame: Two years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
Study officials:
References: