louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01412047: Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study
Official title: A Post Marketing, Multi-Center, Trial to Measure Human Anti-Human Antibodies (HAHA) to Soliris (Eculizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paroxysmal Nocturnal Hemoglobinuria
PNH
Keywords: Paroxysmal Nocturnal Hemoglobinuria
PNH
Human Anti-Human Antibody
HAHA
Soliris
eculizumab
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-08
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PNH previously enrolled in study E05-001, who have a eculizumab naive serum sample available for comparison, and who are currently receiving treatment with commerical Soliris.

Brief summary: How does long term treatment with Soliris affect HAHA in PNH patients?

Detailed description: To determine the long term effect of Soliris (eculizumab) treatment on the presence of human anti-human antibodies (HAHA) in Paroxysmal Nocturnal Hemoglobinuria (PNH) patients.

Eligibility criteria: Inclusion Criteria:

* PNH patients who previously participated in study E05-001;
* Patients who have an eculizumab naive serum sample for comparison;
* Patients who currently used commerical Soliris;
* Patients who are willing and able to gie written informed consent.

Exclusion Criteria:

* There are no exclusion criteria for this study.

Primary outcomes:
measure: To summarize the proportion of patients with neutralizing HAHA antibodies.
timeFrame: Six (6) months
Secondary outcomes:
measure: To summarize the proportion of patients with non-neutralizing HAHA antibodies.
timeFrame: Six (6) months
measure: To summarize the proportion of patients with increased hemolysis in setting of neutralizing HAHA antibodies.
timeFrame: Six (6) months
Other outcomes:
Locations:
city: Englewood
country: United States
facility: University Park Hematology Oncology
state: Colorado
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Scarborough
country: United States
facility: Maine Cancer Center of Medicine
state: Maine
city: Melbourne
country: Australia
city: Brussels
country: Belgium
city: Paris
country: France
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Ulm
country: Germany
facility: Institut fur Klinische Transfusionmedizin und Immungenetick
city: Dublin
country: Ireland
city: Firenze
country: Italy
facility: Azienda Ospediliera Universitatia Careggi
city: Napoli
country: Italy
facility: Universita degli Studi di Napoli
city: Nijmegen
country: Netherlands
city: Basel
country: Switzerland
city: London
country: United Kingdom
Study officials:
affiliation: Alexion Pharmaceuticals, Inc.
name: Camille Bedrosian, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02695147: Direct Aortic vs Subclavian Access for TAVI: a Review of the Outcomes in the UK
Official title: Direct Aortic vs Subclavian Access for TAVI: a Review of the Outcomes in the UK
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Stenosis
Lead sponsor: Royal Sussex County Hospital
Sponsor class: OTHER
Collaborators: name: National Institute for Cardiovascular Outcomes Research
First posted: 2016-03-01
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who received TAVI via the subclavian or direct aortic approach in the UK

Brief summary: A retrospective analysis of outcomes of all patients who received TAVI via the subclavian or direct aortic approach between January 2011 and January 2016


Eligibility criteria: Inclusion Criteria:

* Recieve TAVI via subclavian or direct aortic apporach in the UK

Exclusion Criteria:

* Nil

Primary outcomes:
measure: MACE
timeFrame: Up to 5 years (average 3 years)
Secondary outcomes:
measure: Procedural Complications
timeFrame: 30 dyas post procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02773147: Effect of Vitamin B on Plasma Neurofilament Light Protein (NFL) in HIV-infected Individuals With Increased Plasma Homocysteine
Official title: Effect of Vitamin B Substitution on Plasma NFL and Neurocognitive Performance in HIV-infected Individuals With Increased Plasma Homocysteine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HIV
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 60
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 investigate if B vitamin substitution have effect on NFL (neurofilament light protein) plasma levels and neurocognitive performance in HIV-infected individuals with increased plasma homocysteine


Eligibility criteria: Inclusion Criteria:

1. The ability to understand and give informed consent to participate.
2. HIV-1 infected with stable ART \> 12 months
3. Plasma HIV-RNA \< 50 copies/ml
4. Plasma homocysteine ≥ 12 μmol/L (subjects with \< 12 μmol/L will be included in the analysis of secondary endpoint 3 (see 5.4).
5. Male or female, age 18 or older.

Exclusion Criteria:

1. Treatment with trimethoprim-sulfamethoxazole or methotrexate
2. Ongoing B6, B12 or folate substitution
3. Antiepileptic treatment
4. Small bowel or ventricular resection
5. Disturbed absorption in small bowel (Mb Crohn, untreated coeliac disease)
6. Ongoing neurological disease or severe psychiatric disease
7. Any malignant tumor in the history.
8. Severe ongoing infection or opportunistic infection
9. AUDIT \> 7 for men and \> 5 for women
10. MADRS \> 20
11. Significant B12 or folate deficiency that indicate substitution (all subjects will be offered adequate substitution, they will be included in the analysis of secondary endpoint 3 (see 5.4)).
12. Pregnancy at screening visit, or planning pregnancy during study period is an exclusion criteria. (Not due to toxicity of Triobe, but to elevated risk of being prescribed B-vitamins outside of trial. If study object gets pregnant during study, she can continue the study but must be excluded if she starts treatment with other B-vitamin treatment than Triobe.)

Primary outcomes:
measure: Declining NFL or decreased rate of increase of NFL
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Infectious Diseases, Sahlgrenska university hospital
Study officials:
affiliation: Göteborg University
name: Magnus Gisslén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04941547: Association Between Cancer and Anti-synthetase Syndrome
Official title: Association Between Cancer and Anti-synthetase Syndrome : a Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antisynthetase Syndrome
Keywords: cancer
idiopathic inflammatory myopathies
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: CHU Dijon Bourgogne
name: CHU de Reims
name: University Hospital, Strasbourg, France
name: Hopitaux Prives de Metz, Groupe UNEOS
name: Centre Hospitalier Universitaire de Besancon
First posted: 2021-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with antisynthetase syndrome, defined by the positivity of antisynthetase antibodies and the presence of at least one clinical involvment, are included, either with or without cancer, to allow comparison of patients according to the presence of cancer.

Brief summary: Among Idiopathic inflammatory myopathies, antisynthetase syndrome is meant to be rarely associated with cancer. However, clinical evidences of the association of those diseases led to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. The aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in Grand Est and Bourgogne Franche-Comté regions.

Detailed description: Idiopathic inflammatory myopathies area heterogeneous group of disease involving mainly muscles, which paraneoplastic feature has been well characterized, specifically in some subgroups such as dermatomyositis. In contrast, antisynthetase syndrome is thought to be rarely associated with cancer. However, clinical observations of the association of those diseases led us to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. The aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in Grand Est and Bourgogne Franche-Comté regions, describing the type of cancer observed as well as clinical features of patients and diagnostic work-up leading to the diagnosis of cancer.

Eligibility criteria: Inclusion Criteria:

* adult patients
* positive antisynthetase antibodies (JO-1,PL12, PL17, EJ, OJ, KS, RS, YRS)

Exclusion Criteria:

* age under 18
* opposition to data collection
* no positive antisynthetase antibodies
* absence of clinical involvment

Primary outcomes:
measure: cancer prevalence
timeFrame: baseline
Secondary outcomes:
measure: description of cancer type in patients with antisynthetase syndrome
timeFrame: baseline
measure: factors associated with cancer
timeFrame: baseline
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: Thomas Moulinet
state: Lorraine
Study officials:
affiliation: CHRU de Nancy
name: Thomas Moulinet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01094847: Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine
Official title: Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2010-03-29
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare and explore bioavailability of mosapride, the main component of DWJ1252(Test drug) and mosapride medicine(Reference drug).


Eligibility criteria: Inclusion Criteria:

* a healthy adult male within the range of 20 to 50 years old at the time of screening
* with weight of more than 55kg, in the range of IBW 20%: IBW(kg)={height(cm)-100}\*0.9
* who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol.

Exclusion Criteria:

* one with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
* one with gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.
* one with genetic disease like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
* one who is allergic or has clinically significant allergic history to the component of the investigational drug (mosaprisde), and any component from same family, or to other drugs(Aspirin, antibiotics, etc)
* one who shows different rhythm than sinus rhythm in screening, like QTc \>450ms on electrocardiogram, PR interval\>200msec or QRS interval 120\>msec
* one who shows the following result in clinical laboratory test: AST,ALT\>1.25 times of the upper limit of normal range
* one who shows vital signs with the number of systolic blood pressure of 160 mmHg or 100 mmHg, and the number of diastolic blood pressure of 95mmHg or 60mmHg

Primary outcomes:
measure: Pharmacokinetics of Mosapride
timeFrame: 48hr after 1st administration
Secondary outcomes:
measure: Pharmacokinetics of mosapride, M-1
timeFrame: 48hr after 1st administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital IRB
name: Kyung-Sang Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04628247: Effect of Spring Gravity Bar on Gait Pattern in Children With Spastic Diplegia
Official title: Effect of Spring Gravity Bar on Gait Pattern in Children With Spastic Diplegia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spastic Diplegia Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effect of spring gravity bar on gait pattern in children with spastic diplegia

Detailed description: The purpose of this study is to provide insight on investigate the effectiveness of vestibular stimulation on gait pattern by using spring gravity bar , when you bounce up and down it stimulate vestibular system that is considered straight line vestibular stimulation and strength extensor muscle of lower limb by pressure on spring during stance phase all that change gait stability and stride length so can improve gait pattern .

Eligibility criteria: Inclusion Criteria:

1. Their age will be extended from 7 to 10 years.
2. They can walk with limitation or holding on according to GMFCS (level II \& II).
3. They can understand and follow instruction.

Exclusion Criteria:

- 1-children with any visual or auditory abnormalities. 2-children receiving any special medication affecting muscle and /or mental function.

3-children had any recent surgical interference in the lower limb. 4-children with perceptual defects. 5-children with fixed structural deformities lower limb.

Primary outcomes:
measure: Two dimensional gait analysis
timeFrame: 20 minute
measure: Dynamic gait index
timeFrame: 20 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Pediatric Hospital
Study officials:
References:
Clinical trial NCT06647147: Aerobic Training on Lung Function in Fibromyalgia
Official title: Impact of Aerobic Training on Lung Function in Women With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fibromyalgia (FM)
Respiration Disorders
Lead sponsor: Middle East University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 80
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exploring the effect of aerobic exercises on lung function, chest movement, and exercise capacity in women suffering from fibromyalgia.

Detailed description: Eighty women with fibromyalgia will be equally randomly assigned to the experimental (EX) group and the control group (CON). The participants' age will be between 30 and 40 years and they will have mild restrictive lung affection. The Ex group will attend 3 sessions/week of aerobic training at moderate intensity combined with diaphragmatic breathing exercises for 12 weeks, the CON will only attend 3 sessions/week of diaphragmatic breathing exercises for 12 weeks. The lung functions will be assessed by the spirometry testing. The chest expansion will be determined using a tape measurement. Additionally, exercise capacity will be tested using cardiopulmonary exercise testing protocol. All the outcomes will be examined at baseline, and after 12 weeks of the intervention.

Eligibility criteria: Inclusion Criteria:

* Well controlled fibromyalgia.
* Mild restrictive lung affection.
* Body mass index less than 30kg/m2.
* Moderate level of physical activity.

Exclusion Criteria:

* Any chest diseases.
* Musculoskeletal/ neurological limitations to exercise.
* Smokers.
* Pregnant.

Primary outcomes:
measure: Lung function
timeFrame: At baseline and 12 weeks
Secondary outcomes:
measure: Chest expansion
timeFrame: At baseline and 12 weeks
measure: Exercise capacity
timeFrame: At baseline and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: National institute for Gerontology
name: Mohammed Sayed Saif, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06825247: Assessment of the Psychosocial Sexual Health Competencies of Young Adults Born in France (including Those Whose Parents Were Born Abroad), and Proposal of a Sexual Health Promotion Model Adapted to the Needs Identified.
Official title: Assessment of the Psychosocial Sexual Health Competencies of Young Adults Born in France (including Those Whose Parents Were Born Abroad), and Proposal of a Sexual Health Promotion Model Adapted to the Needs Identified.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sexual Health
Keywords: sexual health
psychosocial skills
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adults born in France and living in Pays de Loire

Brief summary: Every year, between 4,000 and 6,000 people discover their seropositivity to the human immunodeficiency virus (HIV). The dynamics of new discoveries vary according to sexual orientation and birthplace. MSM born in France show the sharpest improvement, while heterosexuals born in France show a more moderate decline, and intravenous drug users (IDUs) are still at a low ebb.

There is little fine-grained data available on a national scale to explain these dynamics among people living with HIV (PLHIV).

The acquisition of Psychosocial Competencies in sexual health is a prerequisite for good sexual health. It is important for all young people, and all the more so for young people from immigrant backgrounds, whom we hypothesize, despite the limited existing literature, to be more vulnerable due to the influence of their origins, their parents' culture or language barrier, or even religion.

The primary research question: What psychosocial skills should be included in a sexual health education program for young people born in France (including those born to migrant parents), to enable them to enjoy good sexual health in adulthood?


Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 29 years
* Born in France or its territories,
* Be able to read and write French.

Exclusion Criteria:

* They are under guardianship,
* They refuse to take part in the study.

Primary outcomes:
measure: Health education models
timeFrame: from enrollment of first patient to end of all interviews (3 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
Study officials:
References:
Clinical trial NCT02531347: Comparison of Telemedical and Conventional Treatment of Hypertension
Official title: Treatment of Hypertension Using Telemedical Home Blood Pressure Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2015-08-24
Enrollment: 375
Sex: ALL
Minimum age (years): 55
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare antihypertensive treatment based on either conventional blood pressure measurements or telemedical home blood pressure measurements.

Hypothesis is that telemedical treatment of hypertension is more effective in lowering blood pressure, is more cost-effective and provides better quality of life.


Eligibility criteria: Inclusion Criteria:

* Age 55 to 64 years
* Registered address in the Municipality of Holstebro
* Enrolment at a practice of one of the general practitioners who had agreed to participate in the study
* Telemedical home blood pressure measurement with ≥12 measurements on day 2 and 3.
* Elevated home blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80)
* Hypertension confirmed by daytime ambulatory blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80)
* ECG verified sinus rhythm

Exclusion Criteria:

* Unwillingness to participate
* Normotension
* Withdrawal of consent to participate

Primary outcomes:
measure: Blood pressure reduction
timeFrame: 3 month
Secondary outcomes:
measure: Number of patients reaching target blood pressure
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medical Research and Medicine, Holstebro Regional Hospital, Holstebro, Denmark
name: Nikolai Hoffmann-Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoffmann-Petersen N, Lauritzen T, Bech JN, Pedersen EB. Short-term telemedical home blood pressure monitoring does not improve blood pressure in uncomplicated hypertensive patients. J Hum Hypertens. 2017 Feb;31(2):93-98. doi: 10.1038/jhh.2016.43. Epub 2016 Jun 23.
Clinical trial NCT02189447: Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Keywords: Keratoconus
Ectasia
Corneal Cross-linking
Lead sponsor: The Eye Center and The Eye Foundation for Research in Ophthalmology
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking in patients with keratoconus


Eligibility criteria: Inclusion Criteria:

* contact lens intolerance
* corneal thickness \> 450 micrometers
* Keratometry \< 56 diopters
* Astigmatism \< 6 diopters

Exclusion Criteria:

* corneal thickness \< 450 micrometers
* Keratometry \> 56 diopters
* Astigmatism \> 6 diopters

Primary outcomes:
measure: The change of visual acuity following Photorefractive Keratectomy and Corneal Collagen Cross-linking in patients with Keratoconus
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: