louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01806012: Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy
Official title: Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy: a Randomized, Single-Blinded Study Comparing the Efficacy to the Routine Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Indications for Laparoscopic Supracervical Hysterectomy
Keywords: Supracervical Hysterectomy
Leiomyomas
Adenomyosis
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery (Europe) GmbH
First posted: 2013-03-06
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of the EnSeal® instrument for laparoscopic supracervical hysterectomy in a randomized, single-blinded comparison to the conventional procedure. The objective of the study is to investigate if the use of the Enseal sealing instrument for supracervical hysterectomy leads to a shortening of the operation time.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Indication for supracervical hysterectomy without additional surgical procedures (i. e. oophorectomy)
* Willingness and capability to comply with all study tests, procedures, and assessment tools
* Capability of providing informed consent.

Exclusion Criteria:

* History of, or evidence of, gynecologic malignancy within the past five years
* Pace maker, internal defibrilator/cardioconverter
* Impaired coagulation parameters
* Unwillingness to be randomized to treatment
* History of median laparotomy
* Intraabdominal adhesions
* Requirement for open laparoscopy

Primary outcomes:
measure: Operation time
timeFrame: Day 1
Secondary outcomes:
measure: Blood loss
timeFrame: Day 2
measure: Post-operative pain
timeFrame: Day 2
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Women' Clinic Tübingen
Study officials:
References:
citation: Rothmund R, Kraemer B, Brucker S, Taran FA, Wallwiener M, Zubke A, Wallwiener D, Zubke W. Laparoscopic supracervical hysterectomy using EnSeal vs standard bipolar coagulation technique: randomized controlled trial. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):661-6. doi: 10.1016/j.jmig.2013.04.014. Epub 2013 Jun 20.
citation: Rothmund R, Szyrach M, Reda A, Enderle MD, Neugebauer A, Taran FA, Brucker S, Hausch A, Wallwiener C, Kraemer B. A prospective, randomized clinical comparison between UltraCision and the novel sealing and cutting device BiCision in patients with laparoscopic supracervical hysterectomy. Surg Endosc. 2013 Oct;27(10):3852-9. doi: 10.1007/s00464-013-2994-4. Epub 2013 May 14.
Clinical trial NCT02301312: Clinical Study of POSS-PCU Vascular Grafts for Vascular Access
Official title: A Clinical Investigation to Assess the Safety and Performance of POSS-PCU Small Diameter Grafts as Conduits in Arteriovenous (AV) Access
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and performance of a new vascular graft made of POSS-PCU as a vascular access conduit for haemodialysis. 30 patients requiring access for dialysis will be enrolled and monitored at regular intervals for 18 months.


Eligibility criteria: Inclusion Criteria:

* Subjects requiring vascular access for haemodialysis
* Subjects with no suitable vein.
* Subjects aged 18 - 80 years old
* Subjects are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
* Patients of child bearing potential, who are sexually active, must agree to the use of 2 highly effective forms of contraception throughout their participation in the study and for 6 months after completion of treatment:

  * Condom with spermicide.

AND 1 of the following:

* Oral contraceptive or hormonal therapy (e.g. hormone implants).
* Placement of an intra-uterine device.

Exclusion Criteria:

* Subjects with predicted short-term survival (less than 18 months) or poor prognosis (this will be on the discretion of the clinician in charge)
* Subjects with left ventricle ejection fraction (LVEF) \<20% diagnosed on ECHO either pre-procedure or documented within the previous 3 months prior to consent.
* Pregnant or lactating
* Allergies to any constituents of the graft material
* Patients who are infected or colonized with Methicillin Resistant Staphylococcus Aureus (MRSA).

Primary outcomes:
measure: Patency rate
timeFrame: 18 months
measure: Safety endpoint of this study is defined as any Serious Adverse Event related to the implantation procedure or device implantation within 30 days of implantation procedure
timeFrame: 30 days
Secondary outcomes:
measure: Patency rate
timeFrame: 12 months
measure: Secondary patency rate
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References:
citation: Askari F, Shafieian M, Solouk A, Hashemi A. A comparison of the material properties of natural and synthetic vascular walls. J Mech Behav Biomed Mater. 2017 Jul;71:209-215. doi: 10.1016/j.jmbbm.2017.03.016. Epub 2017 Mar 23.
Clinical trial NCT00507312: Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools
Official title: Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cardiovascular Diseases
Keywords: To assess two new diagnostic devices for detecting early Heart Failure.
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: HD Medical Group Ltd
First posted: 2007-07-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will be testing two devices which are designed to detect cardiovascular disease in patients as early as possible. As there are now many therapies to prevent and treat this condition it is believed that detecting it early will help reduce the burden of the disease and permit more effective treatment.

The two devices the investigators are testing are the ViScope developed by HD Medical and a device developed by CSIRO. Both of these devices are simple, non-invasive and may provide useful information on how well the heart contracts and relaxes as well as valve function of the heart.

The investigators are planning to enroll 100 healthy subjects, 100 participants with risk factors for heart failure and 300 patients with varying types of heart failure.

The data collected from the experimental devices will be compared to the results from standard tests.

Patients will not have any of their therapies altered as part of this study.


Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Have provided consent

Risk factor patients also require:

* Hypertension \> 2 years
* Diabetes \> 2 years
* Known ischemia, TIA, or stroke
* Arrhythmia; or reduced renal function (eGFR\<50 ml/min)

Heart Failure patients also require:

* LVEF \<40%
* Receiving standard medication for the treatment of symptomatic systolic heart failure with an NYHA Class of II-IV.

Exclusion Criteria:

Health patients (must not have any of the following):

1. Cardiovascular disease
2. Receiving cardiovascular medication
3. Not in normal sinus rhythm (also required for HF patients)

Primary outcomes:
measure: To validate the diagnostic ability of the two devices against echo and clinical data as the "gold standard".
timeFrame: Day 1 (study day)
Secondary outcomes:
measure: Correlation of the devices with standard tests such as BP, HR and BNP.
timeFrame: Day 1 (study day)
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Monash University / Alfred Hospital
name: Henry Krum, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04473612: Physical Status and Upper Airway Function in Neuromuscular Patients
Official title: Degree Physical Status and Upper Airway Function in Neuromuscular Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Diseases
Physical Disability
Airway Disease
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 41
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed of neuromuscular disease aged 6-65 years with an impairment of the upper airway, whether in ventilatory, deglutory or communication capacity.

Brief summary: Inside of studies that report an upper airway function impaired, the upper limb strength has been demonstrated to be determinant in breath, speech and swallow performance. Nevertheless, no previous studies in neuromuscular disease have explored the relation between general disability and upper airway function.

There is a suspicion of upper airway which is associated with physical deterioration, however the extent to which if feeds back has not been explored.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Neuromuscular disease
* Between 6 and 65 years
* Impairment of the upper airway
* Accepted to sign the informed consent

Exclusion Criteria:

* Cognitive impairment.
* Diagnose of autism spectrum disorder or severe intellectual disability
* Physical or functional impairment that limits the performance of evaluation

Primary outcomes:
measure: Hand grip strength
timeFrame: Baseline
measure: Respiratory function
timeFrame: Baseline
measure: Peak expiratory flow
timeFrame: Baseline
Secondary outcomes:
measure: European Quality of Life-5 Dimensions (EQ-5D)
timeFrame: Baseline
measure: Fatigue Severity Scale
timeFrame: Baseline
measure: World Health Organization Disability Assessment Scale (WHODAS) 2.0 (WD2)
timeFrame: Baseline
measure: Activity Limitations in Children and Adults With Neuromuscular Disorders (ACTIVLIM)
timeFrame: Baseline
measure: Brief pain inventory
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Muscle strength of the neck
timeFrame: Baseline
measure: Eating Assessment Tool-10 (EAT-10)
timeFrame: Baseline
measure: Swallowing quality of life questionnaire (SWAL-QOL)
timeFrame: Baseline
measure: Functional Oral Intake Scale (FOIS) questionnaire
timeFrame: Baseline
measure: Karaduman Chewing Performance Scale (KCPS)
timeFrame: Baseline
measure: Orofacial Myofunctional Evaluation with Scores (OMES)
timeFrame: Baseline
measure: Volume Viscosity Clinical Exploration Method (MECV-V)
timeFrame: Baseline
measure: Voice handicap index (VHI-30)
timeFrame: Baseline
measure: Grade, Roughness, Breathing, Asthenia, Effort (GRBAS)
timeFrame: Baseline
measure: Functional evaluation of the voice
timeFrame: Baseline
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
References:
Clinical trial NCT04491812: Triceps Taping on Elbow Flexion Tightness in Extended Erb's Palsy
Official title: Role of Triceps Kinesiology Taping on Elbow Flexion Tightness in Extended Erb's Palsy Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deformity Flexion
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 32
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: physical therapy program Group B: physical therapy program inaddition to kinesiotaping
Primary purpose: PREVENTION

Brief summary: To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy.

Detailed description: PURPOSE:

To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy.

BACKGROUND:

BACKGROUND Neglecting or even delay in Brachial plexus birth palsy management, may result in substantial and chronic impairment. Physiotherapy, microsurgical nerve reconstruction, secondary joint corrections, and muscle transpositions are employed to help the child maximize function in the affected upper extremity. Kinesiology taping can have an effect on muscle performance and support joint by improving proprioception, normalizing muscle tone, correct the inappropriate positions and stimulate skin receptors. The possible effect of kinesiotaping on muscle strength has been investigated by numerous researchers that have theorized that kinesiotaping facilitates an immediate increase in muscle strength by generating a concentric pull on the fascia.

HYPOTHESES:

There will be no role of Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy.

RESEARCH QUESTION:

Is there a role of using Kinesiology tape in preventing elbow flexion tightness in infants with extended Erb's palsy?

Eligibility criteria: Inclusion Criteria:

* 3-6 months of age
* had unilateral extended BPBP involving cervical 5, 6, and 7 roots lesion
* based on an EMG referral by a physiatrist
* had positive grasp reflex on both sides
* had asymmetrical Moro reflex on the affected side.

Exclusion Criteria:

- surgical interferences arm fracture or dislocations hypersensitivity to latex and adhesive tapes

Primary outcomes:
measure: Elbow extension ROM
timeFrame: 3 months
Secondary outcomes:
measure: muscle strength
timeFrame: 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty pf physical therapy, Cairo University
Study officials:
References:
Clinical trial NCT01345812: Time-lapse Evaluation of Embryo Development After Stimulation With One of Two Different Gonadotrophins.
Official title: Time-lapse Assessed Evaluation of Embryo Development After Stimulation With Either Recombinant Follicle Stimulating Hormone (FSH) or Urine-derived Follicle Stimulating Hormone (FSH).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Patients for In Vitro Fertilization(IVF)Treatment
Keywords: ART
IVF
Timelapse
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Fertility Clinic Braedstrup Hospital
name: Herlev Hospital
name: Odense University Hospital
name: Trianglen Fertility Clinic
name: Aagaard Fertility Clinic
name: Ferring Pharmaceuticals
First posted: 2011-05-02
Enrollment: 291
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the investigation is to identify differences in embryo development after follicle stimulation with two different gonadotrophins.

Detailed description: So far the assessment of the development potential of the single embryo has been limited by the vulnerability of the embryos when exposed to fluctuations in temperature and CO2 levels.

Thus embryos can only be allowed to leave incubators for a very limited time period.

However, with the development of time-lapse systems for clinical use it is possible to make continuous time-lapse recordings of embryos while they are in a safe incubator environment.

The embryos are not compromised, but the entire embryonic development can still be seen, and will subsequently provide new and essential information on the competence of the single embryo.

Based on the above it is expected that the probability of selecting the most viable and competent embryo is increased, which, in turn, will increase the success rate for couples seeking infertility treatment.

Eligibility criteria: Inclusion Criteria:

Participants(heterosexuals, lesbian couples and single women) must sign a document of informed consent

* Female age 21-45 years(both inclusive)
* Patients for IVF treatment
* Regular menstrual cycle 21-35 days(both inclusive)
* Normal FSH levels(1-15 IU/L)
* BMI between 18-32(both inclusive)
* Patients must be able to read and understand patient information in national language

Exclusion Criteria:

PCO

- Endometriosis as primary diagnosis

Primary outcomes:
measure: Number of Top Quality Embryos day 2
timeFrame: 44 h after insemination
Secondary outcomes:
measure: Implantation rate
timeFrame: 5 weeks after embryo transfer
Other outcomes:
Locations:
city: Braedstrup
country: Denmark
facility: The fertility clinic
Study officials:
affiliation: IVF clinic Braedstrup
name: Inge Agerholm, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03589612: Regression of Hamstring Flexibility and Performance in Children With Duchenne Muscular Dystrophy
Official title: Regression of Hamstring Flexibility and Performance in Children With Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Performance
Flexibility
Keywords: Duchenne Muscular Dystrophy
performance
hamstring flexibility
regression
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 60
Sex: MALE
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Sixty children will participated this study. Fourty-two children was assessed, and eighteen children will assess in a few months.

Brief summary: Investigator investigated that regression of hamstring flexibility and performance in children with Duchenne Muscular Dystrophy.

Detailed description: Flexibility of hamstrings was evaluated by Popliteal Angle test. Performance was evaluated 6 Minute Walk Test (6 MWT). Regression of hamstring flexibility and performance was examined regression tests. Correlation was examined between popliteal angle test and parameter of North Star Ambulation Assessment.

Eligibility criteria: Inclusion Criteria:

* To be a Duchenne Muscular Dystrophy diagnosis,
* Being in the ambulatory period and climbing four steps independently,
* to be Level 1 and Level 2 according to Brooke Lower Functional Classification Test
* To be able to cooperate
* No any severe contracture in the lower limbs which may prevent assessments,

Exclusion Criteria:

* Children who fail to meet these criteria study.

Primary outcomes:
measure: Popliteal Angle Test
timeFrame: 5 minute
Secondary outcomes:
measure: 6 Minute Walk Test
timeFrame: 6 minute
measure: North Star Ambulation Assessment
timeFrame: 20 minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
affiliation: Hacettepe University
name: Güllü Aydın, Msc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Numan Bulut, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: İpek Gürbüz, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ayşe Karaduman, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Oznur Yılmaz
role: STUDY_DIRECTOR
References:
Clinical trial NCT04233112: Melatonin and Osteogenic Loading on Osteopenia
Official title: Assessing the Efficacy of Melatonin and Osteogenic Loading on Bone Health in an Osteopenic Population: MelaOstrong Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Osteopenia
Lead sponsor: Duquesne University
Sponsor class: OTHER
Collaborators: name: OsteoStrong
First posted: 2020-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population.


Eligibility criteria: Inclusion criteria: To be included in the study, the participant must be a male or female with osteopenia (T-score between -1.0 and -2.5) who is at least 18 years of age. The participant must be willing to undergo an osteogenic loading protocol once per week and/or take a pill (placebo or melatonin) for one year. The participant must also be willing to come to the study location to receive their monthly capsules and to provide urine, have their blood pressure taken and complete questionnaires on 3 occasions (baseline/month 0, month 3 and month 12). The study participants must also be willing to get a DXA scan at months 0 and 12 at one of the three Weinstein Imaging locations.

Exclusion criteria: Women or men with osteoporosis; women or men with osteopenia due to hyperparathyroidism, multiple myeloma, metastatic bone disease, chronic steroid use including corticosteroids; women or men who are on any bone therapies (i.e. bisphosphonates, selective estrogen receptor modulators (SERMs), hormone therapy, teriparatide, and denosumab); men and women with chronic obstructive pulmonary disease (COPD); women or men who smoke; pregnant women; and men or women with muscular dystrophy, unmedicated hypertension, or unrepaired hernia, restrictions to movement and exercise, and parathyroid dysfunctions.

Primary outcomes:
measure: Bone mineral density
timeFrame: O-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: OsteoStrong® in Scott Towne Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Duquesne University
state: Pennsylvania
Study officials:
affiliation: Duquesne University
name: Paula Witt-Enderby, PhD
role: PRINCIPAL_INVESTIGATOR
References: