louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04381039: The Effect of Customized Insoles on Biomechanics and Pain in Patients With Functional Flatfoot
Official title: The Effect of Customized Insoles on Biomechanics and Pain in Patients With Functional Flatfoot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flexible Flatfoot
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of present study is to compare the effects of 3D printing customized insoles using different thermoplastic materials on functional flatfoot patients' foot function and biomechanics

Detailed description: Functional flatfoot is a common foot disease which induces pain and functional decline. Insoles can be used for intervention and correction, especially customized insoles which are made according to different foot types. There have been few studies using 3D printing for customized insoles for functional flatfoot. Besides, compared to traditional method and subtractive manufacturing, the effect of 3D printing customized insoles is still controversial and depends on technology, materials and design.The purpose of present study is to compare the effects of 3D printing customized insoles using different thermoplastic materials on functional flatfoot patients' foot function and biomechanics. Twelve patients with functional flatfoot (foot function index\> 6) aged 20-65 years old will be recruited in this study. Participants plan to wear three kinds of customized insoles fabricated by 3D printing with Nylon and TPU or computer numerical control machine with EVA. F-Scan system and questionnaires will be used to record foot biomechanics and pain after wearing insoles immediately, and foot condition after three weeks. Statistical analysis will be adopted for repeated-measures analysis of variance （ANOVA） for all outcome measures and post-hoc test will be used to test the difference between groups.

Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 65 years old
* Appearance of decreased medial arch
* Foot posture index score between 6 to 12

Exclusion Criteria:

* History of injuries of the lower extremity within the past 6 months
* Experience of use of orthopedic insole within the past 6 months
* Acute disorders in the lower extremities and spine
* History of surgery on the lower extremities and lumbar spine within the past 6 months

Primary outcomes:
measure: F-scan system
timeFrame: after wearing insole (immediate effect)
Secondary outcomes:
measure: Visual analogue scale
timeFrame: after wearing insole (immediate effect)
measure: Foot function index
timeFrame: after wearing each insole for a week (at least 6 hours per day)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Physical therapy center, national Taiwan university hosipital
Study officials:
References:
Clinical trial NCT03352739: Fornix and NbM as Targets of Stimulation In Alzheimer's Disease
Official title: A Randomized Controlled Study of 12 Months to Evaluate the Safety and Efficacy of Deep Brain Stimulation(DBS) to the Fornix & Meynert Nucleus(NbM) in Patients With Mild to Moderate Alzheimer's Disease(AD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Pins Medical Co., Ltd
First posted: 2017-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to evaluate the efficacy and safety of the DBS to the fornix/NbM among patients who are diagnosed as AD according to a series of evaluations including cerebrospinal fluid (CSF) biomarkers and molecular imaging examinations; The secondary goal is to compare the efficacy among the two treatment groups of different targets.


Eligibility criteria: Inclusion Criteria:

1. Subjects with informed consent;
2. 45-75 years of age;
3. At least 6 years of education;
4. AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines (McKhann et al., 2011);
5. Clinical Dementia Rating Scale (CDR): 1.0-2.0;
6. Positive findings with amyloid PET imaging;
7. Stable prescription of donepezil (5mg, qd) for at least 3 months, and without any intentions to modify the dosage during the observation period.

Exclusion Criteria:

1. Fazekas scale\>2;
2. Neuropsychiatric inventory (NPI) total score ≥10, or any subdomain≥4；
3. Modified Hachinski ischemic score\>4；
4. Young Mania Rating Scale\>11(Young, Biggs, Ziegler, \& Meyer, 1978);
5. Any suicidal tendencies in recent 2 years;
6. Cornell Scale for Depression and Dementia\>10;
7. Familial AD;
8. Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome;
9. Surgical history of the central nervous system;
10. Severe cardiovascular/pulmonary disorders.

Primary outcomes:
measure: Cognitive outcome
timeFrame: 12 months (from 1 month to 13 month after implantation)
Secondary outcomes:
measure: Neuroplasticity outcome
timeFrame: 12 months (from 1 month to 13 month after implantation)
measure: Neuroplasticity outcome
timeFrame: 12 months (from 1 month to 13 month after implantation)
measure: Cognitive outcome
timeFrame: 12 months (from 1 month to 13 month after implantation)
measure: Functional outcome
timeFrame: 12 months (from 1 month to 13 month after implantation)
measure: Safety outcome
timeFrame: 12 months (from 1 month to 13 month after implantation)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University.
Study officials:
References:
Clinical trial NCT04734639: Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity
Official title: Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: appetite control
obesity
Adolescents
exercise
Energy Deficit
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Tza Nou - Maison médicale pour enfants et adolescentes
name: Laboratoire AME2P
First posted: 2021-02-02
Enrollment: 17
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the effect of iso-energetic energy deficits induced by energy restriction alone or exercise + dietary restriction (Mixed deficit) on energy intake and appetite feelings in adolescents with obesity.

Detailed description: The present study will compare the nutritional response to an energy deficit of 500 kcal induced once by dietary restriction alone and once by a mixed deficit (50% by exercise and 50% by dietary restriction) (compared with a control condition). 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (CON); ii) one session with a dietary-induced energy deficit (Def-EI); iii) one session with a mixed deficit (50% by exercise and 50% by dietary restriction) (Def-Mixed).

Their ad libitum energy intake will be assessed at dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility criteria: Inclusion Criteria:

* BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

* Previous surgical interventions that is considered as non-compatible with the study.
* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks

Primary outcomes:
measure: Change from different intervention of energy intake measured during an ad libitum buffet meal (in kcal).
timeFrame: day 1, day 8, day 15
Secondary outcomes:
measure: Hunger feelings
timeFrame: day 1, day 8, day 15
measure: Food reward
timeFrame: day 1, day 8, day 15
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Valérie JULIAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00456339: Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children
Official title: The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Obstructive sleep apnea syndrome (OSAS) in children
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2007-04-04
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of treatment with a steroid and antibiotic on the size of the tonsils and symptoms of children with OSAS.

Detailed description: We will enroll children between 18 months and 12 years of age with mild sleep apnea and treat them with 5 days of prednisolone and 10 days of amoxicillin/clavulanate. We will obtain a questionnaire pre and post treatment and ask the parents to tell us if they think the child has improved enough after treatment to forego surgery. If not, they will undergo an adenotonsillectomy to relieve their sleep apnea and if yes, we will repeat the sleep study to make sure that the apnea has resolved.

Eligibility criteria: Inclusion Criteria:

* Polysomnogram results showing mild obstructive sleep apnea.

Exclusion Criteria:

* Significant medical problems
* Chronic medication intake (except bronchodilators and inhaled steroids)
* Allergy to penicillin or its derivatives.

Primary outcomes:
measure: Sleep apnea questionnaire
timeFrame: 1-2 weeks post treatment
measure: Size of tonsils
timeFrame: before and after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Fuad M Baroody, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06059339: Comparing Pericapsular Nerve Group Block with Lumbar Erector Spinae Plain Block in Total Hip Arthroplasty Surgery
Official title: Comparing Postoperative Opioid Consumption of Pericapsular Nerve Group (PENG) Block with Lumbar Erector Spinae Plain Block in Total Hip Arthroplasty Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Total Hip Arthroplasty
Keywords: Total Hip Arthroplasty
PENG Block
Lumbar Erector Spinae Plain Block
Postoperative Opioid Consumption
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Total hip arthroplasty is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Despite being a frequently performed procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty.

Beyond the immediate postoperative period, regional anesthesia and analgesia can have potentially beneficial effects on long-term outcomes, especially on postoperative pain, functional rehabilitation and morbidity .

The primary implication of this study is to compare postoperative opioid consumption of patients' after total hip arthroplasty using pericapsular nerve group (PENG) block with lumbar erector spinae plain block.

Detailed description: Total hip arthroplasty is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Despite being a frequently performed procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty.

Beyond the immediate postoperative period, regional anesthesia and analgesia can have potentially beneficial effects on long-term outcomes, especially on postoperative pain, functional rehabilitation and morbidity .

The primary implication of this study is to compare postoperative opioid consumption of patients' after total hip arthroplasty using pericapsular nerve group (PENG) block with lumbar erector spinae plain block.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old, undergoing total hip arthroplasty surgery

Exclusion Criteria:

* Patients with solid organ dysfunction, chronic opioid or corticosteroid use, bleeding diathesis, patients receiving inpatient medication, patients with psychiatric disorders and patients who cannot be contacted after surgery.

Primary outcomes:
measure: Opioid Consumption
timeFrame: 24 Hours
Secondary outcomes:
measure: Pain Scores
timeFrame: 48 Hours
measure: rescue analgesia
timeFrame: 48 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References:
Clinical trial NCT01653639: Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222
Official title: Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A to Compare the Bioavailability of 2 Different Strengths of Kogenate FS (BAY14-2222)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemophilia A
Keywords: BAY14-2222
Pharmacokinetics
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-07-31
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY 14-2222).


Eligibility criteria: Inclusion Criteria:

* Males, age 18 to 65 years
* Subjects with Severe hemophilia A with a documented plasma FVIII level of \<1%
* \>/= 150 ED (exposure days) with FVIII concentrates(s) as supported by medical records

Exclusion Criteria:

* Evidence of current or past inhibitor antibody
* History of any congenital or acquired coagulation disorders other than hemophilia A
* Platelet count \<75,000/mm3
* Abnormal renal function (serum creatinine \>2 times the upper limit of the normal range)
* Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5x the upper limit of normal or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) \>1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of BAY14-2222
timeFrame: Up to 48 hours
measure: Area under the plasma concentration vs time curve from time 0 to time of last measurable concentration AUC(0-tlast) of BAY14-2222
timeFrame: Up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03686839: Feasibility Study of Neurofeedback Training for Older Adults With Mild Cognitive Impairment
Official title: Importance of Exploring Feasibility and Acceptability in Application of EEG Neurofeedback in Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment, So Stated
Keywords: Neurofeedback
Acceptance technology
Electroencephalography
MCI
Lead sponsor: Broca Hospital
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 22
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: no randomized, no controlled.
Primary purpose: PREVENTION

Brief summary: This is a non-pharmacological study evaluating the feasibility of a neurofeedback training program in elderly with mild cognitive impairment (MCI) according to recruitment, retention, attendance, acceptability data.

Detailed description: Neurofeedback (NF) can be counted amongst promising techniques to improve cognitive functioning if the principles of application are seriously respected, whilst recognizing the necessary adaptation to the conditions of patients with Mild Cognitive Impairment (MCI). This study examined the feasibility and acceptability of an electroencephalography neurofeedback training protocol in a sample group of older adults with MCI in order to identify the necessary conditions for an improved neurofeedback application. Participants performed an electroencephalography recording, a battery of neuropsychological tests before the neurofeedback training program (T0), following the neurofeedback training program (T2) and 1-month follow-up (T3). A questionnaire about motivation, opinions of technical aspects of NF and feeling of cognitive improvement was administered at T0 and T2.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Mild Cognitive Impairment
* Absence of history of alcohol or other substance consumption

Exclusion Criteria:

* Psychiatric and neurological disorders
* sensory and/or motor deficit.
* involving in another cognitive intervention

Primary outcomes:
measure: Neurofeedback Technology Acceptation Questionnaire
timeFrame: Assessment was at 2 months immediately after the Neurofeedback intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Anne-Sophie Rigaud
Study officials:
affiliation: Broca University Hospital
name: Anne-Sophie AR Rigaud, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03667339: Direct Anterior Total Hip Arthroplasty (THA), in Versus Outpatients : A Prospective Monocentric Study in Rennes University Hospital.
Official title: Direct Anterior Total Hip Arthroplasty (THA), in Versus Outpatients : A Prospective Monocentric Study in Rennes University Hospital.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Direct Anterior Total Hip Arthroplasty
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Direct Anterior Total Hip Arthroplasty

Brief summary: The main objective is to show that cumulative length of stay over the first 45 post operative days (i.e. : primary length of stay and readmission) is significantly lower in the outpatients group than in the inpatients group


Eligibility criteria: Inclusion Criteria:

* Unilateral primary total hip arthroplasty for hip osteoarthritis, primary or secondary osteoarthritis (dysplasia or post-traumatic) or osteonecrosis
* Good enough understanding of outpatient management and patient adherence to post-operative instructions
* Sufficient patient complicance to medical orders
* Living and hygiene conditions, at least, equivalent to the ones the hospital provides
* To be of age
* Non opposition to the protocole participation

Outpatients group :

- Patient schedulded to undergo outpatient THA

Inpatients group :

- Patient schedulded to undergo inpatient THA because of not fiting the following items :

* Less than an hour distance of a Health Center that provides appropriate care with regard to the surgery
* Rapid access to a phone
* Designated driver and caretaker available (at least the first night after discharge from the hospital) after the procedure Or turning down outpatient THA

Exclusion Criteria:

* Anaesthetic point of view :

  * ASA physical status ≥ 3 and : unstabilize disease with appropriate treatment or lack of preoperative mutual agreement between anesthesiologist and surgeon or not inconsiderable interaction between the operation and the disease or its treatment
  * Pre-operative Hb \< 12 (♀) \< 13 (♂) g/L (NB : no Hb control before discharge except if excessive blood loss ; Hb \< 10g/L contraindicates outpatient surgery)
  * Opioid chronic pre-operative therapy or opioid addiction
* Surgical point of view :

  * Ambulatory pre-operative status requiring use of two crutches or walking frame / distance walked \< 30 m
  * THA procedure for femoral neck fracture requiring
  * Additional operative technic needed
* Adult safeguarding.

Exclusion criteria applies to all in and outpatients.

Primary outcomes:
measure: Cumulative lenght of stay
timeFrame: 45 days before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Jean Louis POLARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00291239: Effect of Partial Sleep Deprivation on Cognition and Cytokines in Individuals With Major Depression
Official title: Phase 4 Study on the Effect of Partial Sleep Deprivation on Cognition and the IL-6-gp130-System in Individuals With Major Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depression
Lead sponsor: Zentrum für Integrative Psychiatrie
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2006-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 40 patients with the diagnosis of major depression are included. There are two interventions: partial sleep deprivation (PSD) and normal night sleep (CTRL). Patients are randomly assigned to PSD-(2 undisturbed nights)-CTRL or CTRL-(2 undisturbed nights)-PSD. Cytokine-status, neuropsychological and psychopathometric status are assessed pre and post each interventional and control condition.


Eligibility criteria: Inclusion Criteria:

* Major depression
* Informed consent

Exclusion Criteria:

* Known epilepsy or previous unexplained loss of consciousness after sleep deprivation
* Bipolar disorder
* Acute or chronic inflammatory diseases
* Psychosis
* Suicidal tendency
* Pregnancy or nursing

Primary outcomes:
measure: cognition
measure: cytokine concentration
Secondary outcomes:
measure: clinical improvement
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Zentrum für Integrative Psychiatrie
Study officials:
affiliation: Zentrum für Integrative Psychiatrie
name: Dunja Hinze-Selch, MD
role: PRINCIPAL_INVESTIGATOR
References: