louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04524481: Osteoporosis and Haemophilia
Official title: Osteoporosis Screening in Adult Patients With Haemophilia and Influence of Physical Activity on the Prevalence of Osteoporosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Haemophilia
Bone Mass
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2020-08-24
Enrollment: 250
Sex: MALE
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: Adult patients (≥ 18 years of age) suffering from mild (FVIII or IX \>5 %), moderate (FVIII or IX 1-5 %) or severe (FVIII or IX \<1 %) haemophilia A or B

Brief summary: The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia.

Detailed description: The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia. Subsequently, the ascertained prevalence of osteoporosis in patients with haemophilia will be compared to the latest published data of osteoporosis in Germany. Furthermore, the impact of severity of haemophilia, comorbidities as well as the role of both physical activity and individual joint condition as influencing factors on the presence of osteoporosis will be analysed by this study.

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years of age) suffering from mild (FVIII or IX \>5 %), moderate (FVIII or IX 1-5 %) or severe (FVIII or IX \<1 %) haemophilia A or B
* Submitted written consent to participate in the study

Exclusion Criteria:

* Patients suffering from other bleeding diseases
* PWH without written consent
* PWH \< 18 years of age
* Secondary osteoporosis

Primary outcomes:
measure: bone mass/bone density maesurement
timeFrame: 15 minutes
measure: blood sample (Vit. D/Calcium)
timeFrame: 10 minutes
Secondary outcomes:
measure: haemophilia related clinical data
timeFrame: 10 minutes
measure: level of physical activity
timeFrame: non determinable
measure: orthopaedic joint status
timeFrame: 45 minutes
measure: pain condition
timeFrame: 15 minutes
measure: subjective quality of life and subjective physical performance
timeFrame: 10 minutes
Other outcomes:
measure: blood samples
timeFrame: non determinable
measure: Medical history
timeFrame: 10 minutes
Locations:
city: Bonn
country: Germany
facility: University Hospital of Bonn
state: Northrhine Westfalia
Study officials:
affiliation: Medicine of the University of Bonn
name: Andreas Strauß, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02886481: Electrophysiologic Study of Perioperative Monitoring of the Recurrent Laryngeal Nerve: Impaired Vocal Cord Movement After Thyroidectomy
Official title: Electrophysiologic Study of Perioperative Monitoring of the Recurrent Laryngeal Nerve: Impaired Vocal Cord Movement After Thyroidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Laryngeal Nerve
Keywords: thyroidectomy
Electrophysiologic
vocal cord movement
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 133
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 undergoing a total thyroidectomy or a thyroid lobectomy

Brief summary: Paralysis of the recurrent (or inferior) laryngeal nerve (RLN or ILN) is one of the most common and most serious complications of thyroid surgery. Neuromonitoring of the inferior laryngeal nerve (ILN or recurrent) is a technique currently used during thyroidectomy to locate ILN during dissection. Detector electrodes are placed in contact with vocal muscle which is stimulated electrically at the location of ILN, producing an acoustic and visual signal. This is a basic electromyographic technique whose diagnostic and prognostic potential for the entire neuromuscular system has not yet been fully explored. The study of action potentials generated by the stimulation-detection of nerves ILN and vagal nerves at the beginning and end of dissection, notably the decrease in amplitude, could allow a diagnosis during the course of surgery making it possible to diagnose lesions of the nerve and guide the surgeon in his surgical decisions, thus avoiding the risk of bilateral recurrent paralysis. It could also enable the surgeon to give a prognosis for functional recovery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing a total thyroidectomy or a thyroid lobectomy

Exclusion Criteria:

* History of mobility disorder of the vocal cords

Primary outcomes:
measure: electrophysiologic state of the inferior laryngeal nerve
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Nimes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Amiens
name: Vladimir STRUNSKI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04105881: Correlation Between Vitamin D and B Regulatory Cell in Pregnancy
Official title: Correlation Between B Regulatory Cell and Vitamin D Status in Term and Preterm Labor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Labor, Premature
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy term delivery women and preterm labor women

Brief summary: During pregnancy , the maternal immune system is always confronted with fetal alloantigens. the immunological mechanisms that prevent the rejection of the fetus are still not under understood.

Detailed description: During pregnancy , the maternal immune system is always confronted with fetal alloantigens. the immunological mechanisms that prevent the rejection of the fetus are still not under understood.the fetus is normally accepted by the maternal immune system despite despite the expression of paternal alloantigens. Normally, the fetus grows and develops very well with ongoing pregnancy.

B regulatory cells are increased in pregnant women compared to non-pregnant women.

Eligibility criteria: Inclusion Criteria:

* healthy female according to the required groups

Exclusion Criteria:

* patient with infectious disease , tuberculosis ,tumor ,hematologic disease,metabolic bone disease or any other connective tissue diseases were excluded.
* Patient with viral hepatitis.
* serological evidence of HIV infection.

Primary outcomes:
measure: Changes in number of B regulatory cell in pregnant woman
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Assiut university
state: Assiut
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Microbiology and immunology department
name: khalid Hassanein
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zahran AM, Zharan KM, Hetta HF. Significant correlation between regulatory T cells and vitamin D status in term and preterm labor. J Reprod Immunol. 2018 Sep;129:15-22. doi: 10.1016/j.jri.2018.07.004. Epub 2018 Jul 18.
citation: Lima J, Martins C, Leandro MJ, Nunes G, Sousa MJ, Branco JC, Borrego LM. Characterization of B cells in healthy pregnant women from late pregnancy to post-partum: a prospective observational study. BMC Pregnancy Childbirth. 2016 Jun 6;16(1):139. doi: 10.1186/s12884-016-0927-7.
Clinical trial NCT02593981: Addressing Sleep Problems in Older Adults
Official title: To Sleep, Perchance to Dream: A Randomized, Placebo-Controlled Study to Test a Fruit/Honey-Based Foodstuff for Sleep Problems in Older Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep
Keywords: sleep
fruit
honey
geriatric
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall asleep and 19% complain of early-morning awakening. The implications of this sleep deprivation are sobering, particularly among older individuals.

The primary goal of this study is to determine whether a palatable foodstuff which contains a fruit/honey drink and which is taken every evening before bedtime leads to improved sleep in community-living individuals with sleep problems.

Detailed description: This is a randomized, placebo-controlled double-blinded pilot study to explore the use of a fruit/honey drink product for improving sleep in older adults. The purpose of this study is to estimate the effects of a fruit/honey drink using various assessment tools when used as short-term intervention.

This trial proposes to enroll a total of 60 community based older adults. All study patients will be instructed to take the study product every day for 28 days. During which time, study subjects will return weekly to complete study visits for a total of 4 visits.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 60 years old at the time of study registration.
2. Individual describes trouble either falling asleep or staying asleep at study entry.
3. Willing to participate in all aspects of the study.
4. Willing to avoid kiwifruit, cherry, and honey for 4 weeks while on this study.
5. Willing to avoid changes to current sleep medications (may use a stable dose of a currently prescribe sleep medication during the first 4 weeks after stating the intervention).

Exclusion Criteria:

1. Allergic to kiwifruit, cherries, honey, apples, or bananas.
2. Hospitalized or living in a care facility at the time of enrollment.
3. Clinical evidence of active malignant disease (cancer), as per healthcare provider's clinical judgment.
4. Any cancer therapy (for example, chemotherapy, hormonal therapy, radiation, surgery, immunotherapy) in the preceding 3 months.
5. Healthcare provider does not think that study candidate has a specific health problem that precludes participation.
6. Allergy or intolerance of milk products.
7. Women of child bearing potential.

Primary outcomes:
measure: PSQI score
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brent Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01823081: Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eligible eyes are randomized to two groups. Group A will receive three intravitreal injections of bevacizumab at 4 week intervals. In group B, three intravitreal injections of combined bevacizumab and fasudil will be performed with the same frequency.

Best corrected visual acuity (BCVA) and central macular thickness (CMT) will be evaluated prior to injections and then every 4 weeks for 6 months. Fluorescein angiography will be performed at baseline and at weeks 12 and 24. The two groups will be compared in terms of BCVA and CMT changes.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients with diabetic macular edema (DME) and:
* Central macula thickness\> 250μm
* Visual acuity \< 20/40
* No active proliferative diabetic retinopathy
* No history of intravitreal anti-VEGF drug injection or macular laser photocoagulation (MPC) within the past 3 months

Exclusion Criteria:

* History of vitrectomy
* History of cataract surgery within the past 6 months
* History of glaucoma or uveitis
* Presence of any macular disorder other than DME
* Presence of traction on the macula
* Significant media opacity
* Serum creatinine\>3mg/ml

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: 6 months
measure: central macular thickness
timeFrame: 6 months
Secondary outcomes:
measure: Status of macular perfusion
timeFrame: 6 months
measure: intraocular inflammation
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
Study officials:
References:
Clinical trial NCT01364181: The Impact of Udenafil on Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: The Impact of Udenafil on Exercise Capacity in Severe COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspnea
Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
Keywords: Udenafil
Chronic obstructive pulmonary disease
pulmonary hypertension
Phosphodiesterase 5 inhibitors
Exercise
Dyspnea
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Dong-A PharmTech Co., Ltd.
First posted: 2011-06-02
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pulmonary hypertension (PH) is a serious complication of COPD which is associated with shorter survival, more frequent exacerbation, and increased use of health resources. There is no effective pharmacological treatment for COPD-associated PH. Therefore, the investigators wanted to evaluate the effect of udenafil, a phosphodiesterase- 5 (PDE-5) inhibitor, on exercise capacity of severe COPD patients.

Detailed description: Study design

* prospective, single arm, open-label study
* Udenafil 50mg qd po for 8 weeks

Eligibility criteria: Inclusion Criteria:

* Severe COPD who showed post-bronchodilator forced expiratory volume in 1 second (FEV1) less than 50% of predicted value

Exclusion Criteria:

* Acute exacerbation within 4 weeks of the study entry
* Coronary heart disease
* History of adverse event on PDE-5 inhibitors

Primary outcomes:
measure: change of 6-minute walk distance
timeFrame: 8 weeks
Secondary outcomes:
measure: change of mean pulmonary artery pressure
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Ho Il Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park JS, Lim HJ, Cho YJ, Lee JH, Yoon HI, Lee CT. Udenafil improves exercise capacity in patients with chronic obstructive pulmonary disease: a prospective study. COPD. 2012 Aug;9(5):499-504. doi: 10.3109/15412555.2012.694922. Epub 2012 Sep 4.
Clinical trial NCT05580081: Optimizing CBT Implementation Among Community Providers Through Internet-based Consultation and Networking (i-CAN)
Official title: Optimizing CBT Implementation Among Community Providers Through Internet-based Consultation and Networking (i-CAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
CBT
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The RCT is a parallel group design, in which those in Control will be offered i-CAN after the 18 week waiting period.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Although anxiety is one of the most common and debilitating mental health conditions affecting children and adolescents, the vast majority of sufferers do not receive effective treatment. Cognitive-behavioral therapy (CBT) is an evidence-based, frontline treatment for pediatric anxiety, yet many community-based practitioners do not implement CBT with high fidelity, which can detrimentally affect its clinical impact. The goal of this study is to develop and test an online platform to support community providers' effective use of CBT for pediatric anxiety.

Detailed description: Stemming from implementation science and, specifically, the Theory of Planned Behavior, investigators are working alongside community stakeholders to develop a novel, online consultation platform. This platform, termed Internet-based Consultation or Networking (or i-CAN) will utilize a professional navigator (i.e., a provider with CBT expertise), online support and resources, and parallel peer consultation to create a user-friendly and supportive community for providers to get support as they implement CBT. Once finalized, the platform will be tested in the context of a preliminary randomized controlled trial (RCT) with approximately 100 mental healthcare providers who work with anxious children and adolescents. Providers who enroll will be randomly assigned to either the experimental condition (i-CAN) or the control condition (wait-list for i-CAN). The primary outcome of interest is change in intentions to use CBT.

Eligibility criteria: Inclusion Criteria:

* provide direct mental healthcare to anxious youth
* practice in general community within state of Alabama
* agree to try i-CAN

Exclusion Criteria:

* None

Primary outcomes:
measure: Reasoned Action Questionnaire
timeFrame: 18 weeks
Secondary outcomes:
measure: Evidence-based practice attitude scale
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Center for Youth Development and Intervention
state: Alabama
Study officials:
affiliation: UA
name: Susan W White, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04656210: Myotonic Dystrophy - Vascular and Cognition
Official title: Links Between Diabetes and Cognitive Impairment in Myotonic Dystrophy Type 1 : a Non-conventional MRI Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myotonic Dystrophy 1
Diabetes
Carbohydrate Intolerance
Keywords: Cerebral atrophy
MRI
cognition
metabolic syndrome
tauopathy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with DM type 1 monitored annually by the Neuromuscular Disease Reference Centre

Brief summary: The cognitive disorders of adult forms of myotonic dystrophies type 1 are heterogeneous (impairment of executive functions, visio construction and theory of the mind, which can progress to the stage of dementia). Nevertheless, patients have very different degrees of cognitive impairment. Expansion of CTG triplets disrupts the alternative splicing of mRNAs of various proteins, including the insulin receptor and Tau protein. Type 2 diabetes, associated with peripheral insulin resistance, is therefore common in this pathology.

Type 2 diabetes,could to explain the cognitive impairment of patients, through the accelerated development of brain lesions (especially tauopathy and cerebral atrophy).


Eligibility criteria: Inclusion Criteria:

* Molecularly proven type 1 myotonic dystrophy
* Voluntary, having given informed consent
* Socially insured patient
* Patient willing to comply with all study procedures and duration (3 hours + MRI 35 minutes)
* Patient insured under the French social security system
* Signed consent form

Exclusion Criteria:

* Neurological history other than neuropathy: epilepsy, stroke, dementia
* Pregnancy or breastfeeding or woman of childbearing age without effective contraception (a pregnancy test will be done)
* Contra indication to MRI
* Person under guardianship or curators
* Persons of full age deprived of their liberties by a judicial or administrative decision
* Major comorbidity considered as a contraindication by the investigator (cancer, unstable angina, etc.).

Primary outcomes:
measure: Atrophy difference based on two cerebral MRI volumetries
timeFrame: at 4 years
Secondary outcomes:
measure: changes in scores at 4-year neuropsychological assessment of inclusion
timeFrame: At baseline at 4 years
measure: changes in tau biomarkers in blood at 4 years of inclusion
timeFrame: At baseline at 4 years
measure: changes in amyloid biomarkers in blood at 4 years of inclusion
timeFrame: At baseline at 4 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Céline TARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00985010: Manganese in Women With Encephalopathy
Official title: Manganese, Possible Factor of Higher Mortality in Women With Encephalopathy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatic Encephalopathy
Keywords: hepatic encephalopathy
hepatitis C
manganese
mortality
prognosis.
Lead sponsor: Materno-Perinatal Hospital of the State of Mexico
Sponsor class: OTHER
Collaborators: name: Hospital General "Dr. Darío Fernández Fierro"
name: National Institute of Neurology and Neurosurgery
First posted: 2009-09-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients aged \> 18 years, with hepatic encephalopathy and informed consent signed by their families.

Brief summary: Objective:

Report manganese serum levels and mortality in encephalopathic patients.

Patients and participants:

Consecutive patients aged \> 18 years, with hepatic encephalopathy and informed consent signed by their families.

Interventions:

Patients' clinical characteristics as well as biochemical tests of renal function, hemoglobin, glucose and albumin levels were obtained as well as a blood sample to analyze manganese levels with a graphite furnace atomic absorption spectrometer.

Hypothesis:

There is a difference in the manganese levels between male and female patients.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients aged \> 18 years
* With hepatic encephalopathy
* Informed consent signed by their families

Exclusion Criteria:

* Portal bypass surgery
* Cancer of any localization
* Known malignancy and other severe diseases which shorten life expectancy \< 6 months
* Psychiatric illness

Primary outcomes:
measure: Clinical Evolution
timeFrame: six months
Secondary outcomes:
measure: Manganese Levels
timeFrame: Up to six months we followed the recruited patients to determine who were still alive
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: General Hospital "Dr. Darío Fernández Fierro"
state: D.f.
Study officials:
affiliation: Materno-Perinatal Hospital of the State of Mexico
name: Hugo Mendieta Zerón, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Neurology and Neurosurgery
name: Camilo Rios Castañeda, PhD
role: STUDY_DIRECTOR
affiliation: General Hospital "Dr. Darío Fernández Fierro"
name: Mónica Rodríguez Rodríguez, MD
role: STUDY_CHAIR
References:
citation: Zeron HM, Rodriguez MR, Montes S, Castaneda CR. Blood manganese levels in patients with hepatic encephalopathy. J Trace Elem Med Biol. 2011 Dec;25(4):225-9. doi: 10.1016/j.jtemb.2011.07.003. Epub 2011 Oct 4.