louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06056219: Rhythmic-Based Training with Immersive Mirror Visual Feedback for Neuro-Rehabilitation
Official title: Effects of Rhythmic-Based Training with Immersive Mirror Visual Feedback on Sensorimotor Function of Upper Extremity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Virtual Reality
Mirror Movement Therapy
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the proposed study, the investigators assumed that rhythmic-based training with immersive mirror visual feedback will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either rhythmic-based training with immersive mirror visual feedback, or mirror therapy on the upper extremity function and brain activity of the stroke patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of stroke with unilateral side involved;
* A score of Mini-mental state examination greater than 24 for proving higher mental function
* Time of onset \> 6 months before treatment begins; and
* Premorbid right-handedness.

Exclusion Criteria:

* Severe vision and hearing impairment;
* Major cognitive-perceptual deficit;
* Other brain disease.

Primary outcomes:
measure: Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test
timeFrame: baseline, 9 weeks and 21 weeks
Secondary outcomes:
measure: Change in the result of Box and block test
timeFrame: baseline, 9 weeks and 21 weeks
measure: Change in the result of Modified Ashworth scale (MAS)
timeFrame: baseline, 9 weeks and 21 weeks
measure: Change in the result of Semmes-Weinstein monofilament (SWM) test
timeFrame: baseline, 9 weeks and 21 weeks
measure: Change in the result of Motor Activity Log
timeFrame: baseline, 9 weeks and 21 weeks
Other outcomes:
measure: functional Magnetic Resonance Imaging
timeFrame: baseline, 9 weeks
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References:
Clinical trial NCT00995319: Acute and Longlasting Side Effects Caused by Radiotherapy in the Head and Neck Area
Official title: Acute and Longlasting Side Effects Caused by Radiotherapy in the Head and Neck Area
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: mouth
Mucositis
Dysphagia
malnutrition
Xerostomia
saliva
tooth injuries
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Helse Midt-Norge
First posted: 2009-10-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All cancer patients with radiation therapy concerning the oral cavity who are in care of the Detal Team at St.Olavs University Hospital

Brief summary: The purpose of this clinical investigation is to evaluate acute and longlasting side effects in patients undergoing radiotherapy for cancer treatment in the head and neck area.

Detailed description: The "Dental Team" at the Department for Oral and Maxillofacial Surgery in Trondheim takes care of patients before, during and also after radiotherapy in the head and neck area. In spite of the use of advanced radiation protocols and prevention measures such as fluoridation splints the team observes significant side effects, both under radiation and also on the long term after concluding treatment. Common problems are for example dermal and mucosal damages, reduced salivation, dysphagia and lesions of the teeth. Aim of the study is the investigation and documentation of side effects and complications in relation to the oral cavity. During the acute and postradiation phase a continuous follow-up over a longer lasting period is proceeded with registration of all relevant parameters. This includes among others dental status and evaluation of quality of life.

Eligibility criteria: Inclusion Criteria:

* radiation concerning the oral cavity
* follow-up at the Dental Team

Exclusion Criteria:

* refused approval
* survival prognosis under one year

Primary outcomes:
measure: salivary flow
timeFrame: 3 months
measure: salivary flow
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department for Oral and Maxillofacial Surgery, St.Olavs Hospital / NTNU
Study officials:
affiliation: St.Olavs Hospital / NTNU
name: Christoph M Ziegler, Prof.Dr.Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05687019: Efficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma
Official title: Efficacy of Hyaluronic Acid and Chondroitin Sulphate in Intravesical Injections on Functional Recovery After Holmium Laser Surgery for Prostate Adenoma (HOLEP-AHCS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostatic Adenoma
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-01-17
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the score on urinary function (International Prostate Score Symptom) at 28 days.

The main objective is to assess the efficacy of treatment with Ialuril® Prefill on functional recovery at 4 weeks, based on the International Prostate Score Symptom.

A paired test will be performed to compare the International Prostate Score Symptom score between 0 and 28 days.

Detailed description: This is an interventional, non-comparative, open-label, monocentric study aimed at evaluating treatment with hyaluronic acid in patients who have undergone surgery (HOLEP procedure) for prostatic adenoma.

Eligibility criteria: Inclusion Criteria:

* Patient eligible for a HOLEP procedure, according to the investigator ;
* Patient able to understand the information related to the clinical investigation, to read the information leaflet and agrees to sign the consent form.

Exclusion Criteria:

* Known intolerance to one of the treatment components: hyaluronic acid, chondroitin sulphate, calcium chloride;
* Prostatic volume greater than 140 cm3;
* Patient under anticoagulant treatment for secondary prevention;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
* Participating patient, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.

Primary outcomes:
measure: International Prostate Score Symptom on Day 28
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Quint-Fonsegrives
country: France
facility: Clinique La Croix du Sud
Study officials:
References:
Clinical trial NCT03743519: The Efficacy of a Tart Cherry Drink for the Treatment of Patellofemoral Pain in Recreational Athletes.
Official title: The Efficacy of a Tart Cherry Drink for Patellofemoral Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 24
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: Patellofemoral pain (PFP) is the most common chronic pathology in sports medicine and physiotherapy clinics. As pain and inflammation are the main symptoms of PFP, non-steroidal anti-inflammatory and analgesic medications are often utilized to decrease pain and inflammation; however alternative treatments are increasingly being sought due to the cardiovascular and gastrointestinal side effects of traditional pain medications. Most researchers advocate conservative treatment, though there is still insufficient clarity regarding the effectiveness of conservative treatment modalities. Dietary interventions for PFP have not received any attention in clinical literature, yet there is a growing body of evidence indicating that cherries have significant anti-inflammatory, antioxidant and pain-mediating effects.

Therefore, the primary purpose of the proposed investigation was to test (using a randomized control investigation) the ability of a tart cherry juice blend to provide symptom relief in recreational athletes with PFP and to understand the biological and mechanical mechanisms behind any changes in PFP symptoms.


Eligibility criteria: Inclusion Criteria:

* Recreationally active
* Suffering from mild to moderate patellofemoral pain with no evidence of any other condition.

Exclusion Criteria:

* Rheumatoid arthritis or other systemic inflammatory condition
* Chronic pain syndrome
* Corticosteroid medication in last 2 months (intra-articular or oral)
* Intra-articular injections of hyaluronic acid in the last 9 months
* Pregnancy
* Diabetes
* Food allergies to cherries.

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - patellofemoral scale
timeFrame: 6-weeks
Secondary outcomes:
measure: COOP-WONCA - psychological wellbeing
timeFrame: 6-weeks
measure: Plasma urate
timeFrame: 6-weeks
measure: Creatinine
timeFrame: 6-weeks
measure: human TNF-alpha
timeFrame: 6-weeks
measure: High sensitivity C-reactive protein
timeFrame: 6-weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 6-weeks
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: University of Central Lancashire
state: Lancs
Study officials:
References:
Clinical trial NCT01983319: tDCS Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery
Official title: Transcranial Direct Current Stimulation Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Hammel Neurocenter
name: Aarhus University Hospital
First posted: 2013-11-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether noninvasive brain stimulation in form of active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more than 3 months after stroke and its importance for effect of tDCS and CIMT combined with tDCS.


Eligibility criteria: Inclusion Criteria:

* stroke onset \>3 months prior to study enrollment
* subject has at least 10 degrees mobility over wrist, thumb and fingers on the affected side
* subject can move, stand up and stand firmly with constrained healthy hand
* subject can perform training 6 hours daily in 2 weeks
* subject is able to understand instructions and be able to cooperate

Exclusion Criteria:

* pregnancy
* contraindications to MRI of brain
* epilepsy, major psychiatric disease
* excessive pain that prevents training
* history of other diseases resulting decreased mobility of affected upper limb

Primary outcomes:
measure: Change in Upper Limb function
timeFrame: Baseline and posttest (an average of 2 weeks from baseline)
Secondary outcomes:
measure: GABA (gamma-aminobutyric acid) activity
timeFrame: Baseline
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Regionhospital Hammel Neurocenter, Research Unit
Study officials:
affiliation: Aarhus University Hospital
name: Henning Andersen, Professor
role: STUDY_DIRECTOR
References:
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
citation: Figlewski K, Blicher JU, Mortensen J, Severinsen KE, Nielsen JF, Andersen H. Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy. Stroke. 2017 Jan;48(1):229-232. doi: 10.1161/STROKEAHA.116.014988. Epub 2016 Nov 29.
Clinical trial NCT01757119: Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia
Official title: Study of the Pharmacokinetics of Serum Iron After Single Oral Administration of Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Iron Deficiency Anemia
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2012-12-28
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetics of serum iron (the amount of iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous sulphate) in women with iron deficiency anaemia.


Eligibility criteria: Inclusion Criteria:

* Women 18-45 years old with iron deficiency anaemia
* haemoglobin level between 85 g/L and 105 g/L
* serum ferritin level \< 15 µg/L
* D14 + 7 days of the menstruation cycle on the day of pharmacokinetic evaluation
* Standard diet

Exclusion Criteria:

* - Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,
* Haemochromatosis or iron overload of secondary origin (blood transfusion),
* Long term treatment known to modify iron absorption,
* Gastro duodenal ulcer,
* Inflammatory bowel disease or any digestive disease which could modify iron absorption,
* Fructose intolerance, syndrome of malabsorption of glucose, galactose, deficit of sucrase-isomaltase,
* Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders),
* Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.

Primary outcomes:
measure: Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Tolerability of single administration (reported adverse events)
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Iasi
country: Romania
city: Timisoara
country: Romania
Study officials:
References:
Clinical trial NCT01055119: Effect of Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder
Official title: Effect of Supplementation With Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2010-01-25
Enrollment: 95
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects behavior and cognition in children with attention deficit hyperactivity disorder.


Eligibility criteria: Inclusion Criteria:

* ADHD diagnosis
* Age 9-12y
* Native German speaker

Exclusion Criteria:

* Allergy against fish and fish products
* IQ below 85
* Objections against pork gelatine

Primary outcomes:
measure: Behavior, Cognition
timeFrame: Before intervention and 16 weeks after start of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Klinik fuer Psychiatrie und Psychotherapie III
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Universitaet Ulm Klinik fuer Psychiatrie und Psychotherapie III
Study officials:
affiliation: Sozialpädiatrisches Zentrum und Kinderneurologie Universitätsklinik für Kinder- und Jugendmedizin, Ulm University
name: Bode Harald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04063319: Nursing Students' Recognition of and Response to Deteriorating Patients
Official title: Nursing Students' Recognition of and Response to Deteriorating Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Keywords: High-fidelity simulation
Self-confidence
Deteriorating patients
Ordinal data
Questionnaire
Lead sponsor: University of Agder
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 183
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall aim of this intervention study is to examine the effects of an high-fidelity simulation intervention in undergraduate nursing education developed to identify recognizing and responding to patient deterioration. Half of the participants will receive an intervention with high-fidelity simulation, while the other half will not receive any instructional intervention.

Detailed description: Simulation-based nursing education is an increasingly used pedagogical approach.

The overall aim of this intervention study is to examine the effects of an high-fidelity simulation intervention developed to identify how recognizing and responding to patient deterioration improves the knowledge and self-confidence of undergraduate nursing students.

Specific aims:

1. To describe and estimate the change in undergraduate nursing students' knowledge and perceived self-confidence after an high-fidelity simulation intervention.
2. To identify the barriers and enablers that may impact on a successful implementation of the high-fidelity simulation intervention.

Half of the participants will receive an intervention with high-fidelity simulation, while the other half will not receive any instructional intervention. All participants will answer a questionnaire developed to measure perceived knowledge and levels of self-confidence pre- and post-intervention or before and after a meeting (control group). Five students and six faculty members will also be interviewed as a part of a process evaluation.

The study is part of a PhD project.

Eligibility criteria: Inclusion Criteria:

* All undergraduate nursing students at two universities enrolling in a specific course that includes high-fidelity simulation

Exclusion Criteria:

- None

Primary outcomes:
measure: Knowledge
timeFrame: Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)
Secondary outcomes:
measure: Levels of self-confidence
timeFrame: Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)
Other outcomes:
Locations:
Study officials:
affiliation: University of Agder
name: Mariann Fossum, Professor
role: STUDY_CHAIR
References:
citation: Haddeland K, Slettebo A, Fossum M. Enablers of the successful implementation of simulation exercises: a qualitative study among nurse teachers in undergraduate nursing education. BMC Nurs. 2021 Nov 22;20(1):234. doi: 10.1186/s12912-021-00756-3.
Clinical trial NCT02993419: Bacillus Particles Prevent Children Antibiotics Associated Diarrhea
Official title: Bacillus Particles Prevent More Children's Antibiotic-associated Diarrhea (AAD), Randomized, Double-blind, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Antibiotic-associated Diarrhea
Lead sponsor: Jiangsu Famous Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 480
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study, into the group of children in the hospital that use clinical antibiotics from one month to three years old，by observing the given antibiotics at the same time with the whole bowel raw or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole bowel prevention clinical efficacy and safety of AAD.

Detailed description: This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study, into the group of children in the hospital that use clinical antibiotics from one month to three years old，by observing the given antibiotics at the same time with the whole bowel raw or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole bowel prevention clinical efficacy and safety of AAD.

Outcome measures

1. MAIN OUTCOME MEASURES: The incidence of diarrhea (stool frequency and character daily rates), the duration of diarrhea, the degree of diarrhea occur.
2. Secondary outcomes: intestinal flora and relevant metabolites, micro-environmental changes.

Eligibility criteria: Inclusion Criteria:

1. Children aged 1-3 years
2. no diarrhea-related symptoms
3. the diagnosis of lower respiratory tract infection (acute bronchitis, pneumonia) in hospitalized children
4. the need for penicillins, cephalosporin antibiotic treatment, treatment for 7-14 days, combined with other antimicrobial agents alone
5. parent or guardian signed informed consent (6）Not used in children with related traditional Chinese medicine injection

Exclusion Criteria:

1. diarrhea in the group, or 2 weeks before admission into children with diarrhea
2. children with ICU wards, digestive tract malformations, children with gastrointestinal surgery, congenital heart disease, artificial heart surgery, children with rheumatic heart disease, infective endocarditis
3. receiving immunosuppressive agents in children
4. Children who received any probiotic preparation 2 weeks before enrollment

Primary outcomes:
measure: Record daily stool frequency, shape observation excrement
timeFrame: every day，A total of seven days
Secondary outcomes:
measure: Strain type
timeFrame: the first day and the seven day
Other outcomes:
Locations:
Study officials:
References: