louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05781776: Otago Exercise Program And Gaze Stability Exercise In Older Adults
Official title: Comparison of Effects of Otago Exercise Program vs. Gaze Stability Exercise on Balance and Fear of Fall in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance
Keywords: Berg balance scale
Fall efficacy scale-International
Rehabilitation
Exercises
Older Adults
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms pretest-posttest design.
Primary purpose: OTHER

Brief summary: Fall occurrences and the associated risk of injury are debilitating and major health concerns in the older population. Several interventions have been investigated and implemented to address the needs of balance impairments and to reduce the increased risk of falls. This study aimed to compare the effectiveness of the Otago exercise program (OEP) and gaze stability exercises (GSE) on balance and the risk of falls in older adults residing at an old age home facility. 30 elderly participants were equally and randomly divided into two groups: Group OEP received the OEP and group GSE received GSE for eight weeks (thrice a week). In addition, both groups also performed core muscle-strengthening exercises. The Berg balance scale (BBS) and the Fall efficacy scale-International (FES-I) were the outcome measures.


Eligibility criteria: Inclusion Criteria:

* Participants were independent in ambulation
* They were performing activities of daily living independently
* They had impaired balance having Berg Balance Scale (BBS) score between 35-45
* They had dynamic Gait Index score between 11-19
* They had mini-mental status exam scores \> 22

Exclusion Criteria:

* severe vision or hearing impairment,
* neurological disorders including epilepsy, Alzheimer's disease, vertigo, Parkinson's disease, etc.,
* muscular disorders which limit functional activity (Osteoarthritis, Rheumatoid arthritis, etc.),
* taking medications that affect balance,
* severe cardiovascular conditions,
* recent Lower limb injury or Surgery,
* obesity

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: 8 weeks.
measure: Fall efficacy Scale- International (FES-I)
timeFrame: 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, M.P.Th.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01308476: SMS Reminder to Assess Adherence
Official title: Assessment if a Daily SMS (Short Message System) Reminder Improves the Adherence of COPD Patients to Therapy With Spiriva® 18 Microgram
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-03-04
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients

Brief summary: 6 months open label non-interventional observational study acc to § 4, section 23 and § 67, section 6 German Medicines Act with two parallel groups

1. the SMS group receiving a daily SMS - a reminder to inhale Spiriva® 18 Microgram
2. the control group not receiving a daily SMS reminder

Detailed description: Purpose:

Study Design:

observational

Eligibility criteria: Inclusion criteria:

* Chronic obstructive pulmonary disease (COPD) patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines
* User of mobile phone

Exclusion criteria:

- Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the SPC

Primary outcomes:
measure: Adherence to Spiriva HandiHaler Over Time
timeFrame: Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24
Secondary outcomes:
measure: Change From Baseline in Adherence to Spiriva HandiHaler Over Time
timeFrame: Week 8, Week 12, Week 16, Week 20 and Week 24
measure: Response Rate Regarding Adherence
timeFrame: 24 weeks
measure: Patients Compliance With SMS System
timeFrame: 24 weeks
measure: Patients Assessment of Usefulness of the SMS System
timeFrame: Visit 2 (12 weeks) and visit 3 (24 weeks)
measure: Physicians Assessment of Usefulness of the SMS System
timeFrame: Visit 2 (12 weeks) and visit 3 (24 weeks)
measure: Physicians Recommendation of the SMS System
timeFrame: Visit 2 (12 weeks) and visit 3 (24 weeks)
measure: Patients Satisfaction With SMS System
timeFrame: Visit 2 (12 weeks) and visit 3 (24 weeks)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Cottbus
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Koblenz
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Lübeck
country: Germany
facility: Boehringer Ingelheim Investigational Site 5
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02265276: A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease
Official title: A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease (GLAZED Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fatty Liver
Keywords: NAFLD, Diabetes, Glitazone
Lead sponsor: Command Hospital, India
Sponsor class: OTHER_GOV
First posted: 2014-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic syndrome. The prevalence of the same has been increasing rapidly in India, along with an increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and the therapeutic options are limited. Insulin sensitizing drugs are used in the management of NAFLD.

Detailed description: The therapeutic options for the management of nonalcoholic fatty liver disease (NAFLD) include lifestyle modifications, insulin sensitizers, vitamin E, antioxidants and cytoprotective agents. Glitazones are insulin sensitizing drugs and act by stimulating the PPAR gamma receptors. The drugs like Pioglitazone and Rosiglitazone have shown conflicting results in the NAFLD trials. Dual PPAR stimulators (PPAR gamma and PPAR alfa) are known as the "Glitazars" and are useful in simultaneously controlling the hyperglycemia, dyslipidemia and insulin resistance. Saroglitazar is the first drug approved in the investigators country for the management of diabetic dyslipidemia. The investigators plan to study the efficacy of this drug in comparison to Pioglitazone in patients of NAFLD over a period of 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Drug naive patients with NAFLD diagnosed on ultrasonography, BMI \> 23 kg/m2 and ALT \> 1.5 times the upper limit of normal

Exclusion Criteria:

* Use of any drugs other than lifestyle modification for NAFLD, HbA1c \> 8% FBS\>200, Bilirubin \> 1.5 mg/dL
* Any illness likely to cause transaminitis and positive viral markers

Primary outcomes:
measure: Change in the NAFLD fibrosis score
timeFrame: At baseline and the end of 24 weeks
Secondary outcomes:
measure: Change in body composition
timeFrame: At baseline and the end of 24 weeks
measure: Change in insulin resistance
timeFrame: At baseline and the end of 24 weeks
measure: Change in lipid profile
timeFrame: At baseline and the end of 24 weeks
measure: Change in HbA1c
timeFrame: At baseline and the end of 24 weeks
Other outcomes:
Locations:
city: Panchkula
country: India
facility: Command Hospital
state: Haryana
Study officials:
affiliation: Command Hospital
name: Hari Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03376776: Epiretinal Proliferation in Eyes With Full Thickness Macular Hole
Official title: Epiretinal Proliferation in Eyes With Full Thickness Macular Hole
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Disease
Keywords: idiopathic macular hole
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 390
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The eyes with macular hole

Brief summary: We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.

Detailed description: We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.

Eligibility criteria: Inclusion Criteria:

* Eyes with macular hole

Exclusion Criteria:

* Eyes with retinal detachment, retinal vascular disease, glaucoma, proliferative diabetic retinopathy

Primary outcomes:
measure: Recovery of foveal microstructure
timeFrame: 6 months
Secondary outcomes:
measure: Visual improvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Mitaka-shi
country: Japan
facility: Makoto Inoue
state: Tokyo
Study officials:
affiliation: Kyorin Eye Center
name: Makoto Inoue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615276: Neuromuscular Electrical Stimulation (NMES) and Muscle Protein Accretion (ES-PRO)
Official title: The Effect of Neuromuscular Electrical Stimulation on Post-prandial Muscle Protein Accretion in Healthy Elderly Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: Neuromuscular Electrical Stimulation
Ageing
Protein ingestion
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 10
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES will be studied.


Eligibility criteria: Inclusion Criteria:

* Male
* Age 65 - 85 years
* 18.5 \< BMI \< 30 kg∙m2

Exclusion Criteria:

* Type II diabetes
* All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders, paralysis, hip/knee surgery).
* Use of anticoagulants, blood diseases, allergy for lidocaine
* Use of NSAIDs and acetylsalicylic acid
* Patients suffering from PKU (Phenylketonuria)
* Presence of implantable cardioverter defibrillator and/or pacemaker
* Performed regular resistance type exercise in the past 6 months

Primary outcomes:
measure: Tracer enrichment in the muscle biopsy
timeFrame: 4 hours after protein ingestion
Secondary outcomes:
measure: Fractional synthetic rate (FSR)
timeFrame: 0-4 hours after protein ingestion
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht UMC
name: Luc JC van Loon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
Clinical trial NCT02884076: Validation of Sodergren Score for Haemorrhoids in Malaysia
Official title: Validating the Ability of the Sodergren Score to Guide Management of Symptomatic Haemorrhoids in a Malaysian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhoids
Keywords: Hemorrhoids
Sodergren score
Validation
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 500
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: Consecutive patients at specialist clinics

Brief summary: To validate the ability of the Sodergren score in guiding the management of symptomatic haemorrhoids in a Malaysian population.

Detailed description: All participating, consented subjects will be scored with the Sodergren score prior to receiving a standardized ambulatory treatment regime. The questionnaire will be self-administered by the subjects. Subjects whom are not able to self-administer the questionnaire will be assisted by the investigator or research assistant. The nature and severity of the subject's haemorrhoidal symptoms are considered as the pre-treatment baseline. A follow up period of 12 months will be carried out post treatment for failure or success of treatment. The data collected will be compared to pre-treatment scores and analyzed statistically.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Male and female genders
* Previous ambulatory treatment
* Internal Haemorrhoids

Exclusion Criteria:

* Presence of external haemorrhoids
* Prior haemorrhoidal surgery
* Anti-coagulant therapy
* Anal fissure
* Inflammatory bowel disease
* Underlying colon-rectal malignancy

Primary outcomes:
measure: Method of treatment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ipoh
country: Malaysia
facility: HRPB
state: Perak
Study officials:
affiliation: University of Malaya
name: Hon Leong Sha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pucher PH, Qurashi M, Howell AM, Faiz O, Ziprin P, Darzi A, Sodergren MH. Development and validation of a symptom-based severity score for haemorrhoidal disease: the Sodergren score. Colorectal Dis. 2015 Jul;17(7):612-8. doi: 10.1111/codi.12903.
Clinical trial NCT03862976: Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies
Official title: Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Electronic fetal hear rate monitoring (EFM), or cardiotocography (CTG), records changes in fetal heart rate and their temporal relationship to uterine contraction. It has been developed with the aim of detecting fetal hypoxia during labor and hence to prevent metabolic acidosis. Despite being the standard for intrapartum management, this technique, significantly increase the operative delivery rate, and is associated only with less seizures as neonatal benefit. Another concern is also the variability in the interpretation.

Several techniques have been studied in order to decrease the high false positive rate. Fetal ST waveform analysis (STAN) has been studied combined with CTG. A recent meta-analysis of randomized trials, however, showed that STAN during labor did not improve perinatal outcomes or decrease operative delivery rates, except for a 9% decrease in operative vaginal delivery.Comparisons of visual and computerized interpretation of EFM have also been reported. However, whether or fetal monitoring with computer analysis improve perinatal outcomes is still subject of debate.

Thus, we aim to evaluate whether intrapartum fetal monitoring with computer analysis increase the incidence of obstetric intervention when compared with visual analysis through a single-center randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Women with singleton gestation
* 18 years to 50 years
* High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia

Exclusion Criteria:

- IUGR

Primary outcomes:
measure: cesarean section
timeFrame: at the time of delivery
Secondary outcomes:
measure: gestational age at delivery
timeFrame: at the time of delivery
measure: admission to neonatal intensive care unit
timeFrame: at the time of delivery
measure: birth weight
timeFrame: at the time of delivery
measure: APGAR score at delivery
timeFrame: at the time of delivery
measure: neonatal death
timeFrame: 28 days of live of the neonate
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Gabriele Saccone
Study officials:
References:
Clinical trial NCT05432076: Sleep in Pediatric Intensive Care Patients
Official title: Investigation of the Effect of Sleep Band and White Noise Use on Time to Sleep in Pediatric Intensive Care Patients Aged 3-12 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Keywords: White noise
sleep band
pediatric intensive care
baby/child
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 78
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The sample of the study consists of a total of 78 patients, 39 in the experimental and 39 in the control group. As a result of the power analysis using the G\*Power 3.0.10 program; A total of at least 78 samples were found to be sufficient with 90% power and 5% margin of error (n1: 39, n2: 39).

Brief summary: This research will be carried out experimentally in order to investigate the Effect of Sleep Band and White Noise Use on the Time to Sleep in Pediatric Intensive Care Patients aged 3-12 months. The research will be carried out in Adana Province Seyhan State Hospital Pediatric Intensive Care Unit. The data obtained by creating experimental and control groups will be calculated. "Baby Information Form, Baby Sleep Problems Diagnosis Form, Baby Sleep Observation Form and Vital Findings Follow-up Chart" will be used to collect research data. In the study, sleep bands and white noise will be used for sleep for the babies in the experimental group, while the control group will not be interfered with. Ethics committee, institutional permission and informed consent from the parents of the infants will be obtained for the conduct of the study. SPSS demo package program will be used in data analysis. Examining the Effect Effect of Sleep Band and White Noise Use on Transition Time to Sleep in Pediatric Intensive Care Patients aged 3-12 months

, sleep ecology , sleep diagnostics Patients aged 3-12 months At the end of the research, it will be examined whether there is a difference between the sleep time, waking frequency and total sleep time of the babies in the experimental group using the sleep band and white noise, and the babies in the control group.


Eligibility criteria: Inclusion Criteria:

* Not taking intravenous sedation and anesthetic drugs for the last 12 hours
* Extubated
* Infant patients who do not have respiratory distress
* Absence of pain

Exclusion Criteria:

* Mechanically ventilated and intubated patients
* Patients hospitalized with the diagnosis of respiratory distress
* Patients with vision and hearing problems

Primary outcomes:
measure: sleep
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Ebru Kaltar
state: Çukurova
Study officials:
affiliation: Çukurova University
name: Şenay Çetinkaya
role: STUDY_DIRECTOR
References:
Clinical trial NCT00213876: Research of Molecular and Metabolic Markers in Oligodendrogliomas Comparatively to Other Brain Tumours
Official title: Research of Molecular and Metabolic Diagnostic Markers in Oligodendrogliomas A and B Comparatively.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oligodendrogliomas
Keywords: Brain tumours
oligodendrogliomas
allelotyping
SAGE
Presence of molecular abnormalities statistically linked to survival or response to chemotherapy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 189
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with oligodendroglioma or medulloblastoma or glioma

Brief summary: At present, diagnosis of oligodendroglioma is made on histological and radiographic criteria in the French Mayo-Ste Anne classification. The less frequent grade A oligodendrogliomas are characterized by no vascular contrast on RMN evaluation comparatively to grade B forms. This benign histological subtype relapses in few cases with a more aggressive histology. To determine these relapsed cases at diagnosis, a collection of tumour begun in February 2004. Then, our study was designed to identify diagnostic molecular and metabolic markers that could eventually be used as a signature characterising grade A versus grade B oligodendrogliomas. The molecular analysis will use genomic techniques like allelotyping study, quantitative real-time PCR, gene sequencing , serial analysis of genomic expression and immunohistochemistry, since the metabolic study will be the spectroscopic examination of in vivo tumour. This study will include paediatric and adult patients followed for oligodendrogliomas, medulloblastomas and gliomas to compare the different tumour signatures. All these results will be correlated to survival and clinical features.


Eligibility criteria: Inclusion Criteria:

* Paediatric and adult patients (\> 1 year of age)
* Patient with oligodendroglioma or medulloblastoma or glioma
* Possibility of 3 year follow-up
* Patient consent obtained

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Natacha Entz-Werle
Study officials:
affiliation: Hopitaux Universitaires de Strasbourg
name: Natacha Entz-Werle, MD
role: PRINCIPAL_INVESTIGATOR
References: