louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03209453: Effects of Family Work Shop for Children With Developmental Delays: a Randomized Trial
Official title: Therapeutic Effects of Short-term Family-centered Work Shop for Children With Developmental Delays: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Development Delay
Keywords: family work shop
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To identify the therapeutic effects of short-term family-centered work shop for children with developmental delays

Detailed description: 1. The family work shop has a total of 6 weeks, with 6 families in one course. 2. Two hours per session, one time per week. Aims;

1. Assess the effects of family work shop for children with developmental delays, including functional performance and health-related quality of life.
2. Assess the family strain by work shop for parents of children with developmental delays.

Eligibility criteria: Inclusion Criteria:

* 18 M/O to 36 M/O children with developmental delays, under regular rehabilitation programs

Exclusion Criteria:

* less than 18 M/O and older than 36 M/O failed to obtain written informed consent

Primary outcomes:
measure: change from baseline functional performance (scores) at 6 weeks
timeFrame: baseline and up to 6 weeks
Secondary outcomes:
measure: change from baseline health-related quality of life (scores) at 6 weeks
timeFrame: baseline and up to 6 weeks
measure: change from baseline caregiver health-related quality of life (scores) at 6 weeks
timeFrame: baseline and up to 6 weeks
measure: change from baseline family strain (scores) at 6 weeks
timeFrame: baseline and up to 6 weeks
measure: change from baseline family impact
timeFrame: baseline and up to 6 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
References:
Clinical trial NCT04738253: Correlation Between Ultrasonography Finding and Shoulder Range of Motion in Stroke Patients
Official title: Study on Post-stroke Patients With Limited Range of Motion in the Shoulder Joint Whose Ultrasonographic Findings Show Adhesive Capsulitis and Its Associated Clinical Factors.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Stroke
Frozen Shoulder
Keywords: Cerebral Stroke
Frozen Shoulder
ultrasonography
Lead sponsor: Yeungnam University Hospital
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the cerebral stroke patients with limitation of range of motion on affected shoulder.

Brief summary: Limitation of range of motion in the shoulder joints is common in stroke patients. The causes are stiffness, CRPS, and frozen shoulder. The purpose of this study was to investigate the relationship between frozen shoulder and shoulder LOM in patients with cerebral infarction using ultrasonography.

Detailed description: Ultrasound examination was performed on 50 patients with limited range of motion of the shoulder joint among inpatients or outpatients in the Department of Rehabilitation Medicine of our hospital, who had a stroke of fewer than 2 years, and the findings suitable for adhesive capsulitis, namely the thickness of the joint capsule in the axillary concave Identify those with thickened findings. Their shoulder power rating, passive range of motion, stiffness evaluation (Modified Ashworth Scale, MAS), and the presence or absence of Reflex Sympathetic Dystrophy (RSD) were evaluated, and the relationship with ultrasound findings was investigated.

Eligibility criteria: Inclusion Criteria:

* Those who have been diagnosed with a stroke through CT or MRI within the last 2 years
* Those who are over 19 years old
* Those who have limitations in the range of motion of the shoulder joint

Exclusion Criteria:

* Those diagnosed with adhesive arthritis prior to the onset of stroke
* Patients with a severe shoulder trauma
* Those who performed shoulder surgery

Primary outcomes:
measure: Range of motion of shoulder joint
timeFrame: day 1
Secondary outcomes:
measure: MAS(Modified Ashworth Scale) of elbow Flexor
timeFrame: day 1
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
Study officials:
References:
Clinical trial NCT02716753: Effects of Seminal Plasma on Pregnancy Rate With IVF
Official title: The Effects of Male Factors on the Success Rate of in Vitro Fertilization. Will Deposition of Seminal Plasma Around the External Cervical os Increase Pregnancy Rate?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2016-03-23
Enrollment: 1600
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All couples planned for IVF will be asked to participate. After information and received informed consent they will be randomized into two groups.

At the time for ovum pick up during an IVF procedure either half of the amount of seminal plasma or the same amount of physiological NaCl solution will be installed around the external cervical opening in vagina. The syringe with seminal plasma or physiological NaCl solution will be prepared according to a prearranged randomization list by a technician.

The success rate will be the number of diagnosed pregnancies and live births.

Detailed description: All couples planned for IVF will be asked to participate. After information and received informed consent they will be randomized into two groups.

At the time for ovum pick up during an IVF procedure either half of the amount of seminal plasma or the same amount of physiological NaCl solution will be installed around the external cervical opening in vagina.

Normally we do not use the seminal plasma but now half of it will be installed and the other half analysed regarding a number of cytokines possibly involved in the immunological preparation of the female internal genitalia.

The syringe with seminal plasma or physiological NaCl solution will be prepared according to a prearranged randomization list by a technician.

Eligibility criteria: Inclusion criteria:

* subjects have given informed consent
* infertility for at least 1 year
* the couple wishing IVF
* subjects aged between 20 - 40 years

Exclusion criterion:

* azoospermia

Primary outcomes:
measure: Pregnancy rate
timeFrame: 40 weeks
Secondary outcomes:
measure: Cytokine content
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University Hospital
Study officials:
affiliation: Ostergotland County Council, Sweden
name: Elizabeth Nedstrand, PhD, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04883853: A Newly Modified Technique for Levator Muscle Tucking in Blepharoptosis Surgery: An Egyptian Tertiary Center Study
Official title: A Newly Modified Technique for Levator Muscle Tucking in Blepharoptosis Surgery: An Egyptian Tertiary Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Ptosis
Moderate Ptosis
Keywords: Ptosis, plication, levator muscle, tucking.
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mild to moderate blepharoptosis with good levator function is usually corrected by levator muscle resection or advancement with their modifications with high success rate. Levator plication technique has been strongly suggested in patients with mild to moderate ptosis, advocated by its simple and rapid recovery. Its drawback is a high recurrence rate.

We suggest a modified tucking technique that improves the force of eyelid elevation with preserved normal anatomy of Muller's muscle and conjunctiva with less disturbance to the Levator muscle aponeurosis. It is a short procedure, less complications with good aesthetic results and high patient's satisfaction.

Detailed description: A prospective single-centre study enrolling 180 patients with blepharoptosis at Ain Shams University Hospitals from March 2017 to February 2019. Patients of unilateral or bilateral mild to moderate ptosis with good levator function (more than 8 mm) were included. Those with severe, traumatic, recurrent, mechanical ptosis, Marcus-Gunn jaw winking syndrome, third nerve palsy, absent Bell's phenomenon, or abnormal ocular motility were excluded. The follow-up was at one week, one month, three months, six months, and one year visits. Functional outcome was assessed by analysis of the upper eyelid margin position in relation to the superior limbus and classified as very good (2 mm), good (2-4 mm), poor (5 mm) and preoperative to postoperative difference in marginal reflex distance (MRD). The aesthetic outcome was assessed in the form of symmetry of eyelid height, lid contour, lid crease presence, and degree of patient's postoperative satisfaction.

Eligibility criteria: Inclusion Criteria:

* Mild _moderate blepharoptosis

Exclusion Criteria:

* severe, traumatic, recurrent, or mechanical ptosis, third nerve palsy, Marcus-Gunn jaw winking syndrome, abnormal ocular motility, and absent Bell's phenomenon

Primary outcomes:
measure: post-operative marginal reflex distance
timeFrame: first day postoperative
Secondary outcomes:
measure: upper eyelid margin position
timeFrame: first day postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Marwa Ahmed, M.D,FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00214253: Islet Transplantation in Type 1 Diabetic Patients
Official title: Islet Transplantation in Type 1 Diabetic Patients Using a Steroid-free Immunosuppression Protocol and Thiazolidinedione Insulin Sensitizers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our hypothesis is that a successful clinical islet transplant program can be established at the University of Wisconsin using a steroid -free, sirolimus- and low dose tacrolimus - based immunosuppressive drug regimen (Edmonton protocol). We intend to answer the following research questions: 1) will treatment of islet transplant recipients with thiazolidinediones (i.e. pioglitazone) enhance post-transplant islet function and reduce the number of islets necessary to achieve adequate metabolic control? 2) which type 1 diabetic patients are optimal candidates for islet transplantation (i.e. islet transplant alone or islet after kidney transplantation)? 3) Can cadaver donor pancreases, which are ordinarily discarded and not used for pancreas transplantation be used for islet transplantation?


Eligibility criteria: Inclusion Criteria:

* 16 Type I insulin-dependent diabetic subjects ages 18-60,(8 who have received a prior kidney or liver transplant and have stable renal function, and 8 who have labile glucose regulation and who have failed a trial of intensive exogenous insulin therapy and who have preserved native renal function)

Exclusion Criteria:

* untreated proliferative diabetic retinopathy;
* HgbA1C \>12%; creatinine clearance \< 80 ml/minute or macroalbuminuria \> 0.3 gm/24 hrs;
* presence of panel reactive antibodies \>20%

Primary outcomes:
measure: number of islets necessary to achieve adequate metabolic control
timeFrame: 5 years
measure: post-transplant islet function
timeFrame: 5 years
Secondary outcomes:
measure: Suitability of cadaver donor pancreases for islet transplantation
timeFrame: 5 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Jon Odorico, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03556553: Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities
Official title: Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Diseases
Keywords: composite resin
occlusal caries
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate long-term clinical performance of a self-adhering flowable resin composite in comparison with a conventional flowable resin composite used with an etch\&rinse adhesive system in minimally invasive class I cavities. Twenty-five patients will receive at least one pair of class I restorations. After class I cavities were prepared they were restored either with a self-adhering flowable resin composite (VertiseFlow/Kerr-VR) or with a flowable resin composite (Luxaflow/DMG-LX) in combination with an etch\&rinse adhesive (Teco/DMG) \[according to the manufacturers' instructions. Restorations will be evaluated at baseline and yearly according to FDI criteria by two evaluaters. Statistical analysis will be carried out with Pearson Chi-Square test and Cochran Q-test followed by Mc Nemar's.


Eligibility criteria: Inclusion Criteria:

* having no medical or behavioral problems preventing then from attending review visits, absence of previously placed restorations,having antagonist teeth

Exclusion Criteria:

* poor gingival health,uncontrolled, rampant caries,bruxism,removable partial dentures, xerostomia

Primary outcomes:
measure: Clinical performances of flowable composite resins
timeFrame: Five years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02556853: Ultrasound for Double Lumen Endotracheal Tube
Official title: Comparison Between Ultrasound and Clinical Assessment of the Correct Positioning of Left Double Lumen Endotracheal Tube
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Ultrasound
Keywords: Ultrasound
Double lumen tube
Lead sponsor: 424 General Military Hospital
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The patients will be allocated to 2 groups: the ultrasound group and the clinical group. The correct position of the double lumen tube will be determined by ultrasound (Sonoscape S6®) for the patients of the one group (group U) and by clinical examination for the patients of the other group (group C). The correct placement will be verified by bronchoscopy (Pentax®). The two methods will be compared in terms of sensitivity and specificity. The main purpose of the study is to determine if the ultrasound can be used for determination of the correct placement of the left sided double lumen endotracheal tube


Eligibility criteria: Inclusion Criteria:

* Surgery requiring placement of double-lumen endotracheal tube.
* ASA 1-3

Exclusion Criteria:

* History of difficult or impossible intubation.
* Clinical findings of possible difficult intubation according to the standard preoperative airway assessment.
* Impossible placement of a double lumen tube

Primary outcomes:
measure: Correct position of the tube (yes/no).
timeFrame: Within an average of 5 minutes after the placement of the double lumen tube
measure: Correct position of the tube by bronchoscopy (yes/no).
timeFrame: Within an average of 10 minutes after the placement of the double lumen tube.
Secondary outcomes:
measure: Time needed
timeFrame: Within an average of 10 minutes after the placement of the double lumen tube.
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Anesthesia department; 424 Army General Hospital
Study officials:
References:
citation: Sustic A, Protic A, Cicvaric T, Zupan Z. The addition of a brief ultrasound examination to clinical assessment increases the ability to confirm placement of double-lumen endotracheal tubes. J Clin Anesth. 2010 Jun;22(4):246-9. doi: 10.1016/j.jclinane.2009.07.010.
citation: Sustic A, Miletic D, Protic A, Ivancic A, Cicvaric T. Can ultrasound be useful for predicting the size of a left double-lumen bronchial tube? Tracheal width as measured by ultrasonography versus computed tomography. J Clin Anesth. 2008 Jun;20(4):247-52. doi: 10.1016/j.jclinane.2007.11.002.
citation: Alvarez-Diaz N, Amador-Garcia I, Fuentes-Hernandez M, Dorta-Guerra R. Comparison between transthoracic lung ultrasound and a clinical method in confirming the position of double-lumen tube in thoracic anaesthesia. A pilot study. Rev Esp Anestesiol Reanim. 2015 Jun-Jul;62(6):305-12. doi: 10.1016/j.redar.2014.06.005. Epub 2014 Aug 20. English, Spanish.
Clinical trial NCT01908153: Taste Reward Processing in Pediatric Obesity
Official title: Taste Reward Processing in Pediatric Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Obesity
Keywords: Picture food type
Taste type
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ages 4-8

Brief summary: The study aims to provide a better understanding of the neural influence of eating behavior in the development of childhood obesity. Children ages 4-8 will be recruited to examine fMRI brain response to pictures that signal delivery of a chocolate milkshake and to the taste itself. The brain response will be compared to body mass index percentile scores for each child to help us determine whether brain differences present in adolescents and adults with obesity are present in young children.


Eligibility criteria: Inclusion Criteria:

* ages 4-8
* parent available to complete surveys in English

Exclusion Criteria:

* no presence of metal in body
* no claustrophobia
* no psychiatric or neurological condition that will affect brain function

Primary outcomes:
measure: fMRI brain response to taste of chocolate milkshake
timeFrame: Baseline
measure: fMRI brain response to picture cue
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Department of Psychiatry
state: California
Study officials:
affiliation: Stanford University
name: Cara Bohon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bohon C. Brain response to taste in overweight children: A pilot feasibility study. PLoS One. 2017 Feb 24;12(2):e0172604. doi: 10.1371/journal.pone.0172604. eCollection 2017.
Clinical trial NCT00653653: Medication Optimisation for Reducing Events in a Private Practice Setting
Official title: Observational Study of the Pharmaco-Economic and Medical Effects of Optimising Medication Using Pharmacokinetic Pharmacogenomics and Medication Interaction Analysis in Private Practice.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pharmacogenetic Analysis to Reduce Events.
Keywords: pharmacogenetics
pharmacoeconomics
adverse events
drug metabolism
Lead sponsor: Awenydd GmbH
Sponsor class: INDUSTRY
First posted: 2008-04-07
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: Community sample.

Brief summary: Using a prospective study design of two three month periods (before and after genotyping) in which the patients will self-monitor their health status and possible medical events it is hypothesized that it will be shown that patients having their medication altered to fit their genetic status and/or having their medication altered because of inherent interaction potential will have less recordable events after genotyping and medical analysis than before.

It is well known that ADRs (recordable adverse events to medication) are responsible for a large number of deaths and hospitalizations. Furthermore it is well recorded that genotyping of individual cytochrome P450 enzymes (2D6, 2C9, 2C19, among others) is directly related to a metabolic phenotype - fast metabolisers, slow metabolisers, intermediate and normal metabolisers. These differing phenotypes have altered metabolism of many medications and in a number of retrospective clinical trails it has been shown that ADRs and effect can be reduced/bettered through genotyping and alteration of medication.


Eligibility criteria: Inclusion Criteria:

* older than 18 years
* not demented
* 1 or more documented events in the previous 6 months.
* more than one medication
* multi-morbid

Exclusion Criteria:

* demented
* life expectancy less than 1 year
* heart attack within the last 6 months
* Marcumar® Therapy

Primary outcomes:
measure: Reduction of reported events in the time frame.
timeFrame: 3 months
Secondary outcomes:
measure: Reduction of total costs associated per patient in the time frame.
timeFrame: 3 months
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Awenydd Gmbh
state: NRW
Study officials:
affiliation: Awenydd GmbH
name: Lee S Griffith, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Erlangen-Nürnberg
name: André Gessner, MD Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chialda L, Griffith LS, Heinig A, Pahl A. Prospective use of CYP pharmacogenetics and medication analysis to facilitate improved therapy - a pilot study. Per Med. 2008 Jan;5(1):37-45. doi: 10.2217/17410541.5.1.37.