linjc16/ctgov huggingface dataset:
What Happens to First Trimester Nuchal Translucency

Study Overview
=================
Brief Summary
-----------------
First trimester nuchal translucency is a call point for genetic abnormalities and birth defects. Nuchal translucency varies with LCC and therefore with gestational age as described by Chung et al who created a 99th percentile curve of nuchal translucency versus LCC. The majority of centers use the 3.5 mm cutoff as the 99th percentile instead of using nuchal translucency based on LCC. The objective of this study is to compare the fate of nuchal hyperclites> = 99th p but <3.5mm versus 3.5mm. For this the investigators have studied the ultrasound and genetic abnormalities. The investigators were also interested in the pregnancy outcomes and the percentage of pregnancies in the group> = 99th p and <3.5mm that would have been sampled for a high combined risk for trisomy 21, and therefore to determine the benefit of a systematic sample. for HCN as well as the interest of performing an ACPA that would not be performed on a sample with a high risk of trisomy 21.

Official Title
-----------------
What Happens to First Trimester Nuchal Translucency Greater Than or Equal 99ème Percentile and Inferior 3.5 mm

Conditions
-----------------
Nuchal Translucency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: nuchal translucency> = 99th percentile Exclusion criteria: - multiple pregnancies
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nuchal translucency> = 99th percentile and <3.5mm<br>Nuchal translucency> = 99th percentile and <3.5mm | |
| Nuchal translucency> = 3.5 mm<br>Nuchal translucency> = 3.5 mm | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancies without ultrasound or genetic abnormalities | Pregnancies without ultrasound or genetic abnormalities | immediate antenatal and postnatal period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACPA interest | ACPA interest | immediate antenatal and postnatal period | 
| percentage of samples for high risk combined for trisomy 21 | percentage of samples for high risk combined for trisomy 21 | immediate antenatal and postnatal period | 
| Pregnancy outcomes | Pregnancy outcomes | immediate antenatal and postnatal period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Ultrasound abnormalities, Genetic abnormalities
Diaphragmatic Echography in Critically Ill patientS

Study Overview
=================
Brief Summary
-----------------
Acute respiratory failure (ARF) is characterised by a discrepancy between load imposed on respiratory muscles and their capacity. Recently, diaphragmatic ultrasonography has been introduced in the clinical practice to evaluate diaphragmatic function. In particular, the investigators will focus on Diaphragmatic Displacement measured by M-mode ultrasonography. The aim of this study was to compare the diaphragmatic displacement with traditional weaning parameters in potentially ready to be extubated patients undergoing a spontaneous breathing trial (SBT).

Official Title
-----------------
Evaluation of Diaphragmatic Displacement During Spontaneous Breathing Trials in Critically Ill Patients

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Device: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mechanically ventilated since more than 24 hours clinical improvement of the underlying acute cause of the respiratory failure adequate cough reflex absence of excessive and/or purulent tracheobronchial secretion stable cardiovascular status stable metabolic status adequate pulmonary function adequate mentation Exclusion Criteria: age <18 years pregnancy presence of thoracostomy, pneumothorax or pneumomediastinum presence of flail chest or rib fractures neuromuscular disease use of muscle-paralyzing agents within 48 hours before the study history or new detection of paralysis or paradoxical movement of a single hemi-diaphragm on diaphragm ultrasonography

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill patients<br>Ultrasonography in critically ill patients in weaning from mechanical ventilation | Device: Ultrasonography<br>* Ultrasonographic assessment of the diaphragm function<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning success | A successful weaning attempt was registered when patients were extubated and breathed spontaneously for more than 48 hours. The reinstitution of mechanical ventilation at the end of spontaneous breathing trial, reintubation within 48 hours or non-invasive ventilation (NIV) support after extubation defined a failed weaning attempt. | within the first 48 hours after the spontaneous breathing trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diaphragm, Ultrasound, Critically ill patients
Evaluation of Chewing Efficiency of Conventional Complete Denture in Comparison to Reinforced Poly Amide Denture

Study Overview
=================
Brief Summary
-----------------
the trial is done in order to reinforce polyamide to improve its modulus of elasticity to be able to use it as a denture base material in all clinical cases

Official Title
-----------------
Evaluation Of Chewing Efficiency Of Metal-Reinforced PolyAmide Denture Base In Comparison To Conventional Heat Cured Acrylic Resin Denture Base For Mandibular Complete Denture (A Randomized Clinical Trial)

Conditions
-----------------
Mouth, Edentulous

Intervention / Treatment
-----------------
* Other: polyamide
* Other: heat cured acrylic resin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient with age range (45-55) completely edentulous and in good medical condition. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles. Free from any tempro-mandibular joint disorder. The patients have good oral hygiene. The edentulous ridges should be covered by firm healthy mucosa. Healthy and co-operative patients. Exclusion Criteria: Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day). Previous history of radiotherapy or chemotherapy. Any skeletal problem dictates surgical intervention. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included. Patient with xerostomia or excessive salivation. No intraoral soft and hard tissue pathosis. Psychiatric problems.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reinforced polyamide denture base<br>metal reinforced polyamide denture base | Other: polyamide<br>* metal reinforced polyamide denture base material<br>* Other names: nylon;|
| Active Comparator: conventional acrylic resin denture base<br>conventional heat cured acrylic resin denture base | Other: heat cured acrylic resin<br>* conventional heat cured acrylic resin denture base material<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chewing efficiency assessed using sieving method | chewing efficiency of the mandibular complete denture | 6 weeks |
Toe Walker Gait Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the change in ankle plantar flexion while walking, following treatment with the Ankle Dorsiflexion Dynasplint (AFD) for children diagnosed as Toe Walkers. For twelve weeks, patients will either receive the standard treatment or the same standard treatment and the Dynaslint worn at night.

Official Title
-----------------
Dynamic Splinting for Toe Walking: a Randomized, Controlled Study With Gait Analysis

Conditions
-----------------
Gait

Intervention / Treatment
-----------------
* Other: standard of care treatment
* Device: Ankle Flexion Dynasplint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Toe Walking secondary to CP Idiopathic TW Inability to ambulate with initial heel-contact Inability to bear weight and stand flat-footed for over one minute Inability to stand or hop on one foot (symptomatic) for more than one minute Exclusion Criteria: Acid Maltase Deficiency Myopathy Acute Paralytic Poliomyelitis Spinal Muscular Atrophy-all types Stroke, ischemic or hemorrhagic, all types Multiple Sclerosis Traumatic Brain Injury (including Shaken Baby Syndrome) Unilateral ROM deficits in Knee or Hip Previous Achilles Tendon lengthening surgery Hemiplegic Cerebral Palsy Muscular Dystrophy-all types

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>25 Control subjects will only receive SOC (a weekly standardized physical therapy and daily wear of an AFO). | Other: standard of care treatment<br>* weekly standardized physical therapy and daily wear of an AFO<br>|
| Experimental: Dynasplint<br>25 Patients will receive the standard of care as well as an Ankle Flexion Dynasplint | Device: Ankle Flexion Dynasplint<br>* Weekly standardized physical therapy, daily wear of an AFO and nightly wear of the ankle flexion Dynasplint<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plantar flexion while ambulating | The primary endpoint or dependent variable of this study will be the change in excessive plantar flexion while ambulating. A repeated measures analysis of variance (ANOVA) will be performed to measure kinematic change in gait patterns calculated with an ambulation laboratory test. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
toe walker, Pediatric toe walking, ankle flexion
Penile Prosthesis in Patients With Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
Erectile dysfunction (ED) is defined as the persistent inability to attain and or maintain an erection sufficient to permit satisfactory sexual performance

Detailed Description
-----------------
In the literature, well- designed studies evaluating safety and efficacy of inflatable penile prosthesis (IPP) is lacking. So, this series aimed at investigating this prospectively.

Official Title
-----------------
Assessment of Safety and Efficacy of Inflatable Penile Prothesis in Patients With Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Device: inflatable penile prosthesis (IPP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients complaining of ED with contraindication or failure of medical treatment Exclusion Criteria: Patients lacking manual dexterity or mental abilities necessary to operate the pump General contraindications as uncorrectable bleeding tendency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: inflatable penile prosthesis (IPP)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inflatable penile prosthesis (IPP)<br>inflatable penile prosthesis (IPP) | Device: inflatable penile prosthesis (IPP)<br>* inflatable penile prosthesis (IPP)<br>* Other names: penile prosthesis (IPP);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with improved erectile dysfunction | The number of patients with improved erectile dysfunction | 3 years |
Light at Night Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this mechanistic study is to examine light sensitivity (melatonin suppression) in people with bipolar depression I, and compare it to healthy controls. This is not a treatment study.

Detailed Description
-----------------
The bipolar disorder I and healthy control arms are recruited from the existing Heinz C. Prechter Bipolar Research Program at the University of Michigan.

Official Title
-----------------
Light at Night Study

Conditions
-----------------
Bipolar Disorder, Light Sensitivity

Intervention / Treatment
-----------------
* Other: Light intensity,  30 lux
* Other: Baseline light intensity, <1 lux


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18-30 kg/m2 Appropriate sleep schedules according to study staff. Sleep schedule is self-reported and confirmed through a sleep diary Healthy eyes as ascertained by eye exam at University of Michigan Kellogg Eye Center Willing and able to maintain stable sleep schedule during study. Participants will be breathalyzed and undergo urine drugs screens at every lab visit Acknowledge and understand that participants cannot drive themselves home after certain lab visits. Note that the research team will provide a travel stipend of $10 per visit to offset potential rideshare/taxi costs Exclusion Criteria: Color blindness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy controls<br>No co-morbid medical or psychiatry diagnoses No family history of mental illness No current medication use Non-smoking | Other: Light intensity,  30 lux<br>*  30 lux compared to very dim light baseline condition <1 lux<br>Other: Baseline light intensity, <1 lux<br>* Very dim light condition<br>|
| Experimental: Bipolar I disorder<br>Clinical diagnosis of Bipolar I disorder Can be (not required, not exclusionary) taking lithium and/or sodium valproate and/or antidepressants Can be (not required, not exclusionary) light smokers | Other: Light intensity,  30 lux<br>*  30 lux compared to very dim light baseline condition <1 lux<br>Other: Baseline light intensity, <1 lux<br>* Very dim light condition<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melatonin levels | Melatonin will be reported as an average percentage of suppression in the  30 lux condition as compared to <1 lux | Up to approximately 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circadian, Light Intensity
Total Shoulder Arthroplasty Multi-Center Registry

Study Overview
=================
Brief Summary
-----------------
The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.

Detailed Description
-----------------
The study is a non-randomized multi-center prospective registry and subjects will be treated according to standard of care at each center. Subjects will be approached for participation in this study after they have made the decision to undergo a primary or revision shoulder arthroplasty procedure. The treating surgeon will obtain verbal consent from the patient for a research coordinator to screen for eligibility. Patients who meet all criteria will be offered enrollment into the study. The total enrollment goal is a minimum of 500 anatomic shoulder arthroplasty and 500 reverse shoulder arthroplasty subjects enrolled in the multi-center registry.

Official Title
-----------------
Total Shoulder Arthroplasty Multi-Center Registry

Conditions
-----------------
Shoulder Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy. Patient is between the ages of 18 and 100 years. The patient has a planned primary or revision implantation of an anatomic (hemi-arthroplasty or total arthroplasty) or a reverse shoulder prosthesis system manufactured by Arthrex. Patient has a standard of care preoperative CT taken within 6 months that has been submitted for Arthrex VIP (Virtual Implant Positioning) planning. Exclusion Criteria 1. Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | Measure of pain intensity. This is done with the Visual Analog Scare. (VAS) | 10 years |
Claudication, Systematic Evaluation of Limp on Treadmill

Study Overview
=================
Brief Summary
-----------------
Vascular claudication is a common cause of functional limitation. This painful condition is a source overall muscle deconditioning in the peripheral arterial diseased (PAD) patient leading gradually to a state accented inactivity. The characterization of the claudication as it results from a proximal or distal ischemia has never carried out. Investigators will analyze dynamic pedometer parameter throughout walking tests in PAD patients with claudication

Detailed Description
-----------------
Patients referred for exercise tests on treadmill for the quantification of walking ability will gave a recording of their walking parameters through an instrumented treadmill recording biomechanic parameters (surface electromyography, walking pace; force of the foot/treadmill interface, length of the step.. etc.) Analysis will be performed until walking is stopped due to usual claudication during a constant load 2 miles per hour 10% slope treadmill procedure.

Official Title
-----------------
Claudication et Fatigue Musculaire de l'artériopathe

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Device: Biomechanic parameters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred for treadmill testing Age > 18 Claudication Covered by the French Healthcare system Consent to participate Exclusion Criteria: Unstable angina History of lower limb osteo articular rheumatologic disease Lower limb amputation Cardiac or respiratory failure Neurologic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PAD patients<br>Patients with grade 1 claudication Measurement of biomechanic parameters while walking on treadmill | Device: Biomechanic parameters<br>* recording of biomechanic parameters and surface electromyography at the thigh and calf level throughout the walking period, in PAD patients .<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root mean square (RMS) of the electromyogram signal | Calculation for the difference (change) in RMS value at the end vs.beginning of the walking test (RMS is calculated over 15 sec at rest and 15 sec just before the end of the walking period) | Evaluation is complete immediately at the end of each walking test. (The end of the walking period is the end of participation of each patient, no follow up of patients) |