louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02681354: Dual Task Training in Elderly Using the BioRescue
Official title: What is the Influence of Dualtask-training With the BioRescue (Analyses and Rehabilitation of Mobility) on Static Balance, Dynamic Balance During Gait and Cognitive-motor Dual Tasks During Gait: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: elderly
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Mild cognitive impairment (MCI) is accompanied by gait and balance problems while dual tasking. During a 6 to 8 weeks training with the BioRescue (virtual reality), institutionalized elderly people with MCI will relearn dual tasks in combination with balance. Afterwards, the transferring effect on gait in general, balance and cognition will be examined.


Eligibility criteria: Inclusion Criteria:

* minimum age: 65
* Participants with increased fall-risk (i.e. Timed Up-and-Go Test (TUG) \> 20 sec)
* Participants with Mild Cognitive Impairment (MCI) measured by the Montreal Cognitive Assessment (MoCa \< 25). MCI: A state of altered cognition, characterized by a decline in one or more cognitive domains, typically including memory while the independence for daily activities remains intact.
* Participants have a positive result on the 'Stops Walking While Talking' test

Exclusion Criteria:

* Diagnosis of Dementia, based on a specialized diagnostic bilan of a doctor-specialist.
* In rehabilitation for a recent injury or recent prothesis of the upper or lower extremities.
* Serious limitations of the lower and or upper limb.
* Not able to walk more than 10 meters independently (walking-aid allowed).

Primary outcomes:
measure: Static balance
timeFrame: day 1
measure: Static balance
timeFrame: week 8
measure: Dynamic Balance
timeFrame: day 1
measure: Dynamic Balance
timeFrame: week 8
measure: instrumented timed Up-and-Go test while dual-tasking
timeFrame: day 1
measure: instrumented timed Up-and-Go test while dual-tasking
timeFrame: week 8
measure: "stops walking while talking" test
timeFrame: day 1
measure: "stops walking while talking" test
timeFrame: week 8
Secondary outcomes:
measure: fall incidence
timeFrame: up to 8 weeks
measure: cognitive function
timeFrame: day 1
measure: cognitive function
timeFrame: week 8
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
city: Hasselt
country: Belgium
facility: Woon- en zorgcentrum Sint Elisabeth
Study officials:
affiliation: Hasselt University
name: Peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03861754: Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study
Official title: Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Physical Activity
Healthy Obesity, Metabolically
Keywords: Obesity
Weight loss
Weight maintenance
Physical activity
Fitness
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu Deaconess Institute Foundation sr
name: Oulu University Hospital
First posted: 2019-03-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective To study if exercise added to weight loss treatment at the beginning of the weight loss intervention or at 6 months could sustain the weight loss achieved or give extra boost for weight reduction.

Design 36-month, 4-group parallel, randomized trial.

Setting Oulu, Finland.

Participants 120 obese adults (body mass index ≥ 30).

Intervention Participants were randomly assigned to behavioural modification (iBM) (n = 30), behavioural modification + exercise from 0 to 3 months (CWT1) (n = 30), behavioural modification + exercise from 6 to 9 months (CWT2) (n = 30), and a control group (CON) (n = 30). Questionnaires and measurements were performed at baseline, 3,9,4 and 36 months. The intervention consisted of an intensified weight loss period (1-12 months) followed by a weight maintenance period (13-36 months). Intensified behavioural modification included 14 individual face to face meetings, eleven times with a personal therapist (qualified nurse) and three times with a nutritionist. Weight maintenance period included six individual meetings with personal therapist. Twelve weeks supervised exercise was offered three times a week, 40 minutes at a time. In the CWT1 group supervised exercise was offered at months 1-3 and in the CWT2 group at months 4-6.

Measurements Body weight (primary outcome) and waist circumference (secondary outcome)


Eligibility criteria: Inclusion Criteria:

* Body mass Index \> 30
* Age 18-64

Exclusion Criteria:

* Pregnancy
* Health reasons preventing exercise and exercise test
* Medication preventing exercise and exercise test
* Previously diagnosed diabetes

Primary outcomes:
measure: Weight change
timeFrame: Change from baseline weight at 36 months
Secondary outcomes:
measure: Waist circumference change
timeFrame: Change from baseline waist circumference at 36 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu Deaconess Institute Foundation sr
Study officials:
References:
Clinical trial NCT04778254: PEEK Versus Metallic Attachment-retained Obturators
Official title: PEEK Versus Metallic Attachment-retained Obturators Regarding Patient Satisfaction: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Neoplasms
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients' satisfaction evaluation and radiographic evaluation of the terminal abutments of attachment- retained maxillary obturators with metal framework versus milled PEEK framework in the management of maxillectomy cases.

Detailed description: Eighteen participants were randomly divided into three parallel groups (n=6). Participants of PEEK group received attachment-retained obturators with milled PEEK framework, metal group received an attachment-retained obturator with metallic framework and conventional group received conventional clasp-retained obturators with metallic framework (Control group). Evaluation included radiographic evaluation and patients' satisfaction where two scales were followed in this study, including "The Obturator Functioning Scale" and "The European Organization for Research and Treatment of Cancer Head and Neck 35" using one way ANOVA test.

Eligibility criteria: Inclusion Criteria:

* patient underwent surgical removal of half of maxilla
* participants with a sufficient number of natural teeth(class I and \\or class IV Aramany classification) not less than 5 teeth, mouth opening is not less than 25 mm, intact soft palate,

Exclusion Criteria:

* participants are exposed to radiotherapy or chemotherapy during last year.
* participant with congenital defect

Primary outcomes:
measure: patient satisfaction 1(change" is being assessed)
timeFrame: 1 week to 6 months
measure: patient satisfaction 2 (change" is being assessed)
timeFrame: 1 week to 6 months
Secondary outcomes:
measure: Radiographic evaluation (change" is being assessed)
timeFrame: base line,6 months, 9 months,12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohamed Sharaf
Study officials:
affiliation: Beni-Suef University
name: Mohamed Sharaf, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02453854: Small Changes a One Year Protocol for Weight Management
Official title: Study Protocol: Small Changes, a One-year Weight Management Intervention for Adults Who Are Overweight or Obese
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Small Changes
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A trial comparing Treatment as usual with Motivational Interviewing focussed treatment in the 'Small Changes' programme.

Detailed description: A quasi-experimental design. With one arm focussed on 'treatment as usual' and the other on Motivational Interviewing. Subjects were not randomly assigned but treated as two separate cohorts one Running October 2011-October 2012 using the Treatment as usual and a separate cohort running from October 2012 to October -2013 using motivational interviewing as the approach for treatment.

Eligibility criteria: Inclusion Criteria:

* Body Mass index equal to or greater than 30 kgm2

Primary outcomes:
measure: weight
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00615654: Aquatic Physical Therapy in Fibromyalgia
Official title: A Randomized Clinical Trial of Aquatic Physiotherapy Program on Functional Capacity in Patients With Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: Hydrotherapy,
RCT,
Lead sponsor: Sao Camilo University Center
Sponsor class: OTHER
First posted: 2008-02-14
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To investigate whether patients undergoing aquatic physiotherapy in groups improve their functional capacity, by means of the distance covered in the six-minute walk test (6WT), and to compare this with a control group. Methods: Forty women that had not been practicing regular physical activity for one year were randomly allocated either to the Study Group (SG) to undergo an aquatic physiotherapy program in groups applied twice a week, including aerobic exercises, muscle strengthening and relaxation for 12 weeks, or to the Control Group (CG), which did not do any physical activity. Both groups maintained their treatment with medications. All patients underwent two evaluations: one at the start and the other after 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients of both genders with a medical diagnosis of FS, without age restrictions and without impaired cognition, who had not been practicing regular physical activity for one year

Exclusion Criteria:

* Presence of other rheumatic diseases and cardiovascular problems
* Smoking
* Absence of medical permission for swimming pool activities
* Starting other therapies, or changes to and/or discontinuation of medical treatment

Primary outcomes:
measure: functional capacity
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: São Camilo University Center
state: SP
Study officials:
affiliation: São Camilo University Center
name: Rafaela O Gimenes, Ms
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02059954: Vaginal vs. Laparoscopic Hysterectomy
Official title: Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroids
Uterine Leiomyoma
Abnormal Uterine Bleeding, Unspecified
Keywords: Hysterectomy
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Austrian Urogynecology Working Group (AUWG)
First posted: 2014-02-11
Enrollment: 100
Sex: FEMALE
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: Hysterectomy for benign indication is one of the most common surgical procedures in women. Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but the proportion of laparoscopic (and robotic) hysterectomies is increasing.

This study will compare a range of clinical and subjective outcomes of vaginal vs. total laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return to work as well as cosmesis, quality of life and sexual health.


Eligibility criteria: Inclusion Criteria:

* benign indication for vaginal hysterectomy (e.g., abnormal uterine bleeding, fibroids, atypical endometrial hyperplasia)
* clinical exam indicates vaginal hysterectomy is feasible
* no major concomitant surgery
* able to complete questionnaires in German

Exclusion Criteria:

* uterine malignancy
* major concomitant surgery (e.g., for incontinence or prolapse)
* clinical exam indicating vaginal hysterectomy not feasible
* contraindication for surgery or laparoscopy

Primary outcomes:
measure: Operating time (min.)
timeFrame: Surgery
Secondary outcomes:
measure: Complications
timeFrame: 6 weeks
measure: Anesthesia time (min.)
timeFrame: surgery
measure: Quality of life
timeFrame: 12 months
measure: Sexual health
timeFrame: 12 months
measure: Return to work
timeFrame: 3 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie
city: Graz
country: Austria
facility: Medical University of Graz/Dept. OB/GYN
city: Leoben
country: Austria
facility: LKH Leoben/Abteilung Gynäkologie
Study officials:
affiliation: Medical University of Graz
name: Karl F Tamussino, MD
role: STUDY_CHAIR
affiliation: Medical University of Graz
name: Rene W Laky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03395054: The Effects of Cervical Stabilization Exercises on Pulmonary Functions and Respiratory Muscle Strength
Official title: The Effects of Cervical Stabilization Exercises on Pulmonary Functions and Respiratory Muscle Strength in Patients With Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: neck pain
pulmonary function test
respiratory muscle strength
cervical stabilization exercises
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the effects of stabilization exercises on pulmonary functions and respiratory muscle strength. 42 participants with neck pain enrolled the study.

Detailed description: This study aims to assess the effects of stabilization exercises on pulmonary functions and respiratory muscle strength. 42 participants with neck pain enrolled the study. Participants were divided into two groups, stabilization group (n=21) and the control group (n=21). The participants underwent a total of 24 sessions of treatment thrice a week for eight weeks under the supervision of a physiotherapist.

Eligibility criteria: Inclusion Criteria:

* neck pain longer than 3 months
* patients between ages of 18 and 55

Exclusion Criteria:

* patients with neurologic symptoms
* patients with chronic pulmonary disease
* previous surgery on cervical region

Primary outcomes:
measure: pulmonary functions
timeFrame: 8 weeks
measure: respiratory muscle strength
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Institute of Health Sciences
state: Altındağ
Study officials:
affiliation: Hacettepe University
name: Birgül Morkoç, phd student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06140654: Oral Health-related Patterns of Food Selectivity in Dental Populations
Official title: Oral Quality of Life and Food Intake Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Disease
Food Selection
Keywords: eating behavior
food preferences
Lead sponsor: Hôpital Rothschild
Sponsor class: OTHER
First posted: 2023-11-20
Enrollment: 125
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: French adults, aged from 30 to 65 years old.

Brief summary: The present study was undertaken in order to describe the clinical profiles of food selective behavior in 35-65 years dental and non-dental populations.

Detailed description: The study population included 125 participants, recruited within the general population and in a dental clinic: -Non-dental group included 62 non-seeking dental treatment subjects, aged 30-65 years, previously recruited during the OralPom survey. -Dental group included 63 patients recruited from September 2019 to December 2020 among patients seeking/pending dental treatment within the university dental clinic of the Rothschild hospital (AP-HP Sorbonne University, Paris, France).

Both groups took part in an individual session with a dental practitioner during which food selectivity, medical history, and oral health status were assessed.

Eligibility criteria: Inclusion Criteria:

* Non-dental group : non-seeking dental treatment subjects, aged 30-65 years.
* Dental group: patients seeking/pending dental treatment within the university dental clinic of the Rothschild hospital (AP-HP Sorbonne University, Paris, France), aged between 35 and 65 years, literate French speakers, willing and able to complete the survey in a single setting.

Exclusion Criteria:

* For non dental group :Declared painful conditions including temporo-mandibular disorder, cephalalgia, oral or dental pain, diagnosis of acute orofacial disease (i.e. rhinitis) or sensory trouble (i.e. anosmia, dysgeusia) neither at the time of the experiment nor in the recent past, pregnancy, head and neck irradiation, eating disorders, enteral or parenteral feeding, and cognitive impairment or impaired communication.
* Patients suffering from cognitive impairment or impaired communication are excluded.

Primary outcomes:
measure: Food selectivity score
timeFrame: During clinical examination session (1 hour) at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Université de Paris
Study officials:
affiliation: Unievrsité Paris Cité
name: Adeline Braud, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06394154: Validation of a Mental Health Scale for Young People With Chronic Stomach Symptoms
Official title: Validation of the Youth Version of the Alimetry Gut-Brain Wellbeing Survey: A Mental Health Scale for Patients With Chronic Gastroduodenal Symptoms
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Functional Gastrointestinal Disorders
Gastroparesis
Vomiting; Cyclical
Nausea
Vomiting
Rumination Syndrome
Aerophagy
Dyspepsia
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
Collaborators: name: University of Auckland, New Zealand
First posted: 2024-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic gastroduodenal symptoms aged 12-17 years

Brief summary: This study aims to validate the Alimetry® Gut-Brain Wellbeing Survey- Youth Version (AGBW-Y), a mental health scale developed for patients aged 12-17 years with chronic stomach symptoms.

Detailed description: There is currently a lack of validated questionnaires developed to assess mental health within patients with chronic stomach symptoms. Our team has therefore developed and validated a new mental health scale for patients with gastroduodenal symptoms, the Alimetry® Gut-Brain Wellbeing (AGBW) Survey.

However, the AGBW Survey was developed and validated for patients aged 18 years and over. Therefore, the Alimetry® Gut-Brain Wellbeing Survey- Youth Version (AGBW- Y) was developed for use in patients with chronic gastroduodenal symptoms aged 12-17 years. This scale is adapted from the adult AGBW Survey, with more appropriate wording for this age group.

This study will distribute an anonymous, online survey to adolescent patients with chronic gastroduodenal symptoms aged 12-17 years. This survey will ask questions about a patient's general demographics, gastrointestinal symptoms, and mental health in order to assess the validity and reliability of the AGBW-Y.

Eligibility criteria: Inclusion Criteria:

* Aged 12-17 years
* Able to read and write fluently in English
* Meet the Rome IV criteria and/or have a self-reported previous clinical diagnosis for at least one of the following childhood gastroduodenal DGBIs: gastroparesis, cyclic vomiting syndrome, functional nausea, functional vomiting, rumination syndrome, aerophagia, or functional dyspepsia

Exclusion Criteria:

* Patients with self-induced vomiting
* Patients with an eating disorder

Primary outcomes:
measure: Internal Consistency Reliability of the AGBW-Y total score and subscales
timeFrame: Baseline
measure: Convergent Validity of the AGBW-Y total score and subscales
timeFrame: Baseline
measure: Divergent Validity of the AGBW-Y total score and subscales
timeFrame: Baseline
measure: Concurrent Validity of the AGBW-Y total score and subscales
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03072654: Tracheal Anatomy After Thyroidectomy
Official title: Thyroidectomy Improves Tracheal Anatomy and Airflow in Patients With Nodular Goiter: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Goiter, Nodular
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for thyroidectomy for symptomatic benign nodular goiter

Brief summary: The investigators aimed at investigating the effects of thyroidectomy on tracheal anatomy and airflow in patients with benign nodular goiter, employing a prospective observational study.

Magnetic resonance images of the neck and respiratory flow-volume curves were performed prior to and six months following surgery. Tracheal and thyroid volumes, smallest cross-sectional area of the trachea (SCAT), tracheal narrowing, tracheal deviation and tracheal encirclement by the thyroid were evaluated. Through flow-volume curves respiratory function, including both in- and expiration, was evaluated.


Eligibility criteria: Inclusion Criteria:

* Reads and write Danish

Exclusion Criteria:

* Suspected or present malignancy
* Neuromuscular disease
* Prior surgery to the neck

Primary outcomes:
measure: Changes in tracheal anatomy
timeFrame: 6 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Brinch FA, Dossing H, Nguyen N, Bonnema SJ, Hegedus L, Godballe C, Sorensen JR. The Impact of Esophageal Compression on Goiter Symptoms before and after Thyroid Surgery. Eur Thyroid J. 2019 Jan;8(1):16-23. doi: 10.1159/000493542. Epub 2018 Oct 17.