louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00946738: The Effect of Physical Therapy on Raynaud's Phenomenon Secondary to Systemic Sclerosis
Official title: A Prospective Randomized Controlled Study Analyzing the Effect of Biofeedback and Deep Oscillation on Raynaud´s Phenomenon Secondary to Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Raynaud's Phenomenon
Systemic Sclerosis
Keywords: Raynaud's phenomenon
biofeedback
deep oscillation
systemic sclerosis
physiotherapy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Physiomed Elektromedizin AG Germany
First posted: 2009-07-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of deep oscillation and biofeedback on Raynaud's phenomenon secondary to systemic sclerosis (SSc) remains to be determined. A prospective randomized controlled pilot study was performed in SSc patients receiving either deep oscillation, biofeedback thrice a week for four weeks or were randomized to the control group.


Eligibility criteria: Inclusion Criteria:

* ACR criteria for SSc

Exclusion Criteria:

* acute inflammatory disease, Valentini Score\>3

Primary outcomes:
measure: RP score , measured by a visual analogue scale (VAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: ulceration of the skin and general disease symptoms using analogous VAS-scores
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin
state: 10117
Study officials:
References:
citation: Sporbeck B, Mathiske-Schmidt K, Jahr S, Huscher D, Becker M, Riemekasten G, Taufmann I, Burmester GR, Pogel S, Reisshauer A. Effect of biofeedback and deep oscillation on Raynaud's phenomenon secondary to systemic sclerosis: results of a controlled prospective randomized clinical trial. Rheumatol Int. 2012 May;32(5):1469-73. doi: 10.1007/s00296-011-1882-2. Epub 2011 Apr 8.
Clinical trial NCT05785338: Trial Observationnal
Official title: Diagnosis of Fetal Isolated Cleft Palate Using Assessment of the Posterior Hard Palate Angle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Anomaly
Ultrasound
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included all patients suspected for a cleft palate without cleft lip (18 pregnant women with 24 assessments at different time points), referred to the Multidisciplinary Center for Prenatal Diagnosis in Poitiers (France) between January 2019 and January 2023. We compared the suspected group with 65 unaffected consecutive singleton pregnancies between 17 and 37 weeks, identified from our ultrasound database from June 2022 to Auguste 2022.

Brief summary: The aim of this retrospective longitudinal study was to describe a key factor in the prenatal diagnosis of isolated cleft palate on the axial transverse view, in order to provide better understanding, detection and diagnosis of this anomaly.

Detailed description: Objective: The study aims to evaluate the role of the posterior hard palate angle in the prenatal diagnosis of cleft palate.

Methods: Stored images of the axial transverse view of the fetal secondary palate, obtained at three-level ultrasounds, were used to evaluate the posterior border of the hard palate. The investigators studied the visualization of the posterior nasal spine and the presence of a gap within the hard palate. The investigators also assessed the posterior angle of the hard palate, formed by the posterior borders of the palatine bones next to the most posterior middle point of the palatine bone. The study population comprised 65 consecutive pregnancies of unaffected cases and 17 pregnancies with 24 assessments at different time points, suspected for a cleft palate without cleft lip, including 7 cases of cleft palate, 4 cases of high arched palate and 6 false positive cases.

Eligibility criteria: Inclusion Criteria:

- all patients suspected for a cleft palate without cleft lip referred to the Multidisciplinary Center for Prenatal Diagnosis in Poitiers (France) between January 2019 and January 2023.

Exclusion Criteria for the control group:

* major congenital anomalies or chromosomal aberration,
* premature rupture of the membranes,
* fetal demise,
* patients aged under 18 years.
* If the available images did not allow the evaluation of the hard palate, the case was excluded from further consideration.

Primary outcomes:
measure: Rate of cleft palate without cleft lip
timeFrame: derivery
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
affiliation: CHU Poitiers
name: Iglika Simeonova-Brachot, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06362538: The Cardiovascular Prevention Program
Official title: Cardiovascular Prevention Program at Maria Cecilia Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Prevention
Lead sponsor: Maria Cecilia Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Cardiovascular diseases represent one of the main public health problems being the leading cause of morbidity, disability and mortality. In recent decades, the global prevalence and cardiovascular disease mortality has increased, with 23.6 million annual deaths expected by 2030. In Europe, mortality per year is equal to 2.2 million women and 1.9 million men, representing 47% and 37% of all deaths respectively. In Italy, the situation in terms of deaths due to cardiovascular diseases it is in line with the world ranking and European, being responsible for 44% of all deaths. The only interventional or pharmacological approach is neither effective nor sustainable. The most deaths from cardiovascular diseases are due to atherothrombotic events, which are attributable to a series of risk factors, most of which are modifiable. Turns out itself as a targeted action on these factors with the aim of safeguarding the state of health cardiovascular, may represent the best applicable strategy. It is therefore necessary structure and activate prevention programs aimed at the general population and groups of subjects at higher risk.


Eligibility criteria: Inclusion Criteria:

* primary prevention: age ≥ 30 years with a negative history of cardiovascular events
* secondary prevention: age ≥ 30 years with a negative history of cardiovascular events

Exclusion Criteria:

* severe obesity
* high-grade renal failure
* severe and/or dialysis
* oncological disease in active phase
* pregnancy

Primary outcomes:
measure: measure of body mass index
timeFrame: 12 months
measure: Adherence to the Mediterranean diet
timeFrame: 12 months
measure: blood test to check cholesterol levels
timeFrame: 12 months
measure: blood pressure measurement
timeFrame: 12 months
measure: blood glucose test
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: MCH
state: Ravenna
Study officials:
affiliation: Maria Cecilia Hospital
name: Anna Maria Malagoni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03441438: Mechanisms of Alcohol Sensitivity in AERD
Official title: Mechanisms of Alcohol Sensitivity in Aspirin Exacerbated Respiratory Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aspirin-Sensitive Asthma With Nasal Polyps
Samter's Syndrome
Keywords: alcohol sensitivity
red wine
aerd
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine what type of reactions in the body may be responsible for the respiratory symptoms that occur when patients with Aspirin Exacerbated Respiratory Disease (AERD) drink alcoholic beverages. These reactions are most often seen with red wine.

Detailed description: This is a prospective trial of approximately 60 subjects with AERD to explore the mechanisms behind the physiologic reactions that occur when drinking alcoholic beverages. At various time points patients will be asked to ingest a variety of substances found in red wine after which blood and urine markers of the reaction will be measured.

Eligibility criteria: Inclusion Criteria:

* Healthy Controls - must be 21 years or older
* Aspirin Tolerant Asthma and AERD arms must note a sensitivity to alcoholic beverages

Exclusion Criteria:

* Enzymopathies
* Mastocytosis
* Alcoholism
* Prior severe respiratory reaction to alcohol consumption
* Current pregnancy
* Monoamine Oxidase Inhibitor (MAOI) use
* Age under 21
* Use of leukotriene modifier 1 week before study intervention
* Having undergone and maintained aspirin desensitization

Primary outcomes:
measure: 24 Hour Urinary Leukotriene-E4 (LTE4)
timeFrame: 24 hour
Secondary outcomes:
measure: 24 Hour Urinary Prostaglandin-D2 (PGD2) metabolite
timeFrame: 24 hour collection
measure: Whole blood Activated Basophil Level
timeFrame: 2 hours after ingestion
measure: Whole Blood Activated Eosinophil Level
timeFrame: 2 hours after ingestion
measure: Whole Blood tryptase
timeFrame: 2 hours after ingestion
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Spencer C Payne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cardet JC, White AA, Barrett NA, Feldweg AM, Wickner PG, Savage J, Bhattacharyya N, Laidlaw TM. Alcohol-induced respiratory symptoms are common in patients with aspirin exacerbated respiratory disease. J Allergy Clin Immunol Pract. 2014 Mar-Apr;2(2):208-13.. doi: 10.1016/j.jaip.2013.12.003.
citation: Payne SC. Re: Alcohol-induced respiratory symptoms are common in patients with aspirin exacerbated respiratory disease. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):644. doi: 10.1016/j.jaip.2014.05.003. No abstract available.
Clinical trial NCT06201338: Pre-operative Screening of Functional Fragilities Before Open Aortic Surgery: a New Area
Official title: Pre-operative Screening of Functional Fragilities Before Open Aortic Surgery : a New Area
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Aneurysm
Aortic Occlusion
Lead sponsor: University Paul Sabatier of Toulouse
Sponsor class: OTHER
Collaborators: name: Sarah BADICHE
First posted: 2024-01-11
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Aortic aneurysm \>55mm
* Aortic occlusion responsible for severe claudication of the lower limbs or critical ischemia

Brief summary: Aneurysmal or occlusive abdominal aortic pathology has seen its prevalence increase over the years despite the various cardiovascular risk factor management campaigns deployed.

Currently, a large proportion of these aortic pathologies require effective and definitive treatment by open surgery. In fact, minimally invasive endovascular treatment, which can provide good results in certain cases, cannot be generalized simply and can even lead to sometimes incomplete treatments requiring even more complex secondary open surgery.

The preoperative assessment before open aortic surgery is relatively well coded with cardiological and respiratory assessments in particular. However, the literature has so far never focused on the overall vision of the patient with a complete functional assessment which would make it possible to consider a specific preoperative fragility scale and would thus give practitioners corrective targets before such an intervention. in order to simplify the patient's post-operative journey by limiting complications.

The investigators therefore propose to collect a certain number of elements already collected in standard care in a systematic and prospective manner in order to create a risk scale. All of these elements being modifiable, they should ultimately make patients more robust for such an intervention.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing open aortic surgery in the vascular surgery department

Exclusion Criteria:

* patient refusal

Primary outcomes:
measure: Post operative mortality
timeFrame: day 30 post operative
measure: Major adverse cardiovascular events (MACE)
timeFrame: day 30 post operative
measure: Length of stay
timeFrame: day 30 post operative
measure: Home discharged
timeFrame: day 30 post operative
Secondary outcomes:
measure: Respiratory complications
timeFrame: day 30 post operative
measure: Quality of life : 36-item Short-Form Health Survey
timeFrame: day 30, 3 months, 6 months, 1 year
measure: Quality of life : Quality of Recovery-15
timeFrame: day 30, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse university hospital, vascular surgery department
Study officials:
References:
Clinical trial NCT01651338: Quality of Life and Acupuncture on Chronic Pain: A Randomized Study Before and After Performing
Official title: Islamic Azad University and Dr Sadre Nabavi Clinic
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Chronic Pain
Keywords: Acupuncture
quality of life
Lead sponsor: Islamic Azad University, Sanandaj
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 150
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic pains can affect the life quality. This study has performed in the first time in Mashhad.The purpose of the present study was to examine the effect of acupuncture on the life quality of 150 patients who suffered from chronic pain. Some people like performing acupuncture because they believed it's free of risks and beneficial.

In order to achieve this purpose, we had examined the life quality of the patients before and after acupuncture. This study was randomly performed on 150 patients aged between 17-75. They were suffering from chronic pain.

The questionnaire is based on WHO QOL. The questionnaires were filled out once before acupuncture and once 12 weeks after it.

Detailed description: This study was completed on time.

Eligibility criteria: Inclusion Criteria:

* aged between 17 - 75 years old,
* suffering from arthritis pains,
* migraine backaches,
* muscular spasms,
* pains in the neck, and in the knee
* duration of disease over 1 year

Exclusion Criteria:

* tacking pain relief
* pregnant women

Primary outcomes:
measure: quality of life improvement
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Dr sadre Nabavi clinic
state: Khorasane Razavi
Study officials:
affiliation: IAUM
name: Shahinfar medical university Fathi Najafi, phD student
role: STUDY_DIRECTOR
References:
Clinical trial NCT03672838: A Single Center Pilot Study to Assess the Intra-observer Reliability of Measuring Muscle Strength Using a Hand Held Dynamometer in Children and Adults With Neurofibromatosis Type 1 (NF1) and Type 2 (NF2)
Official title: A Single Center Pilot Study to Assess the Intra-observer Reliability of Measuring Muscle Strength Using a Hand Held Dynamometer in Children and Adults With Neurofibromatosis Type 1 (NF1) and Type 2 (NF2).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurofibromatosis 1 and 2 (NF1 and NF2)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 33
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Patients with clinically confirmed neurofibromatosis type 1 (NF1) or neurofibromatosis type 2 (NF2) or a known neurofibromatosis (NF) mutation aged 5 years and above will be eligible to participate and will be recruited from the neurofibromatosis clinic. Given the need for identifying measures that can reliably and sensitively measure focal muscle weakness and allow for measuring muscle strength as a functional outcome in therapeutic clinical trials in NF, this pilot study will assess the reliability of measuring muscle strength in NF1 and NF2 using a hand-held dynamometer.


Eligibility criteria: Inclusion Criteria:

* For cohort 1:

  * Patients must have clinically confirmed NF1 using the NIH consensus criteria or a known NF1 mutation
  * Ages 5 years and above
  * \< 5/5 strength on Manual Muscle Testing (MMT) testing in at least one muscle group tested on the day of enrollment
  * Able to follow instructions and cooperate with exam to assess strength
* For Cohort 2

  * Patients must have clinically (NIH or Manchester criteria) or genetically confirmed diagnosis of NF2
  * Ages 5 years and above
  * \< 5/5 strength on MMT testing in at least one muscle group tested on the day of enrollment
  * Able to follow instructions and cooperate with exam to assess strength

Exclusion Criteria:

* No orthopedic procedure or other major surgery that could influence extremity strength in past 6 months
* No tibial dysplasia

Primary outcomes:
measure: Intra-class correlation coefficient of strength measurement in the clinically identified weak muscle
timeFrame: 1 day
Secondary outcomes:
measure: Intra-class correlation coefficient of strength measurement in the dominant biceps
timeFrame: 1 day
measure: standard error of measurement of measuring strength in the weak muscles
timeFrame: 1 day
measure: standard error of measurement of measuring strength in the dominant biceps muscle
timeFrame: 1 day
Other outcomes:
Locations:
city: New York
country: United States
facility: New York School of Medicine
state: New York
Study officials:
affiliation: New York School of Medicine
name: Kaleb H Yohay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06037538: User Evaluation of BGM JS200B
Official title: Evaluierung Des Blutglukose Monitoring Systems JS200B Der Firma TysonBio gemäß DIN EN ISO 15197:2015
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Institut fur Diabetes Karlsburg GmbH
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Performance Evaluation by the User of the Blood Glucose Monitoring System JS200B in accordance with DIN EN ISO 15197:2015


Eligibility criteria: Inclusion criteria:

* Male or female patients with hypo-, eu- or hyperglycaemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

* Pregnancy or lactation
* Acute or chronic diseases with the risk of aggravation by the measure
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015

Primary outcomes:
measure: Analysis of system accuracy based on DIN EN ISO 15197
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Institut für Diabetes Karlsburg GmbH
state: Mecklenburg Vorpommern
Study officials:
affiliation: Institut fur Diabetes Karlsburg GmbH
name: Eckhard Salzsieder, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02017938: Establishing the Central and Peripheral Fatigue Indexes and VR Based Anti-fatigue Training Paradigm for Individuals With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease (PD)
Keywords: Fatigue
electromyography (EMG)
central fatigue
cycling training
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past researches indicated that more than half of the individuals with PD demonstrated fatigue symptom. The severity of fatigue was also correlated to the quality of life in individuals with PD. Finding the contributions of the central and the peripheral factors to fatigue, building reliable fatigue indexes, and developing an effective training program for individuals with PD are very important.

The purpose of this project is to develop non-invasive method to monitor central and peripheral fatigue, to establish Virtual Reality(VR) anti-fatigue ergo cycling training paradigm, and to evaluate the long term training effect in individuals with PD.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson disease
* Hoehn and Yahr ≦3

Exclusion Criteria:

* Musculoskeletal injuries
* Osteoporosis
* Diabetes
* Any peripheral or central nervous system injury or disease patients

Primary outcomes:
measure: Muscle twitch force
timeFrame: baseline, 1 week
measure: Muscle voluntary activity level
timeFrame: Baseline,1 week
measure: Heart rate/Heart rate variability
timeFrame: Baseline,1 week
measure: Borg's rate of perceived exertion
timeFrame: Baseline,1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References: