linjc16/ctgov huggingface dataset:
Safety and Performance Study of the NeoChord Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.

Official Title
-----------------
Safety and Performance Study of the NeoChord Suturing Device in Subjects With Degenerative Mitral Valve Disease; Diagnosed With Severe Mitral Regurgitation

Conditions
-----------------
Mitral Valve Regurgitation

Intervention / Treatment
-----------------
* Device: NeoChord DS1000 Artificial Chordae Delivery System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 and < 80 years Candidate for surgical mitral valve repair or replacement Isolated posterior leaflet prolapse Moderate to severe or severe mitral valve regurgitation that is degenerative in nature Exclusion Criteria: Anterior or bi-leaflet prolapse Functional or ischemic MR NYHA Class IV Complex mechanism of MR (leaflet perforation, etc) Significant tethering of leaflets toward LV apex Severely calcified mitral valve annulus Inflammatory valve disease Severe LV dilation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implanting ePTFE sutures<br>Implanting ePTFE sutures as artificial neochordae using the NeoChord DS1000 Artificial Chordae Delivery System | Device: NeoChord DS1000 Artificial Chordae Delivery System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | The placement of at least one neochord using the DS1000 System AND a reduction in mitral regurgitation <= 2+ at the time of the procedure AND maintained MR reduction of <= 2+ at 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Safety | the rate of Major Adverse Events (MAE) defined as a combined endpoint of: death, MI, reoperation for failed surgical repair, non-elective cardiovascular surgery to treat an adverse event, procedural ventilation > 48 hours, procedure-related transfusion of > 2 units blood product, stroke, renal failure, deep wound infection, new onset of permanent AF, and septicemia, through 30 days. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MR, NeoChord, DS1000, Mitral Valve, Mitral Valve Regurgitation, Mitral Valve Repair, Mitral Valve Prolapse, Artificial Chordae
Preterm Infant Growth

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.

Official Title
-----------------
Growth of Preterm Infants Consuming Formula

Conditions
-----------------
Growth, Development, Infant

Intervention / Treatment
-----------------
* Other: infant formula
* Other: control infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born AGA Exclusively formula-fed 28-34 weeks GA at birth Intact GI tract, tolerating full oral feeds Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days Exclusion Criteria: Severe respiratory disease defined as needing mechanical ventilation at discharge Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions. Major congenital malformation, history of GI surgery, severe postnatal complications Daily or routine diuretic use at time of discharge Receiving more than 10% of daily kcals from food additives such as thickeners Currently participating or having participated in another conflicting clinical trial.

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>commercially available formula | Other: control infant formula<br>* commercially available infant formula<br>* Other names: commercially available infant formula fed to infants until 6 months corrected gestational age;|
| Experimental: Test<br>test formula | Other: infant formula<br>* test infant formula fed to infants until 6 months corrected gestational age<br>* Other names: test infant formula;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | weight gain assessed monthly | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth, tolerance, morbidity | gains in length and head circumference assessed monthly, tolerance and morbidity throughout study | 6 months | 
| Total body bone mineral content and density and body composition, protein status, and metabolic markers |  | corrected term and 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant formula, premature infants, Growth and Development
Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro fertilisation/intracytoplasmic sperm injection). Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary hMG (human menopausal gonadotropin)should be more effective than monotherapy.

Official Title
-----------------
Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation Protocols Which Are the Most Common in Clinical Practice Using High Purified Gonadotrophins (u-FSH-HP y u-hMG-HP) in IVF/ICSI

Conditions
-----------------
STERILITY

Intervention / Treatment
-----------------
* Drug: hMG-HP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) between 18 and 30 Prolactin within the laboratory normal range Couples affected by sterility able to treat by IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) Patients undergoing Menopur® and/or Bravelle® treatment Normal thyroid function Women not receiving clomifen citrate or gonadotrophins within one month prior study start Couples willing to participate in the study that have signed the informed consent form Exclusion Criteria: Failure in 3 previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) Policystic ovarian syndrome Seminal samples not apt for IVF-ICSI (according to the criteria of each center) Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months Antecedents of severe ovarian hyperstimulation syndrome (OHSS) Important systemic disease Pregnancy or contraindication to pregnancy
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FSH:LH 1:1 - Treatment Group A<br>Patients with a condition LH (luteinizing hormone) | Drug: hMG-HP<br> <br> |
| FSH:LH 3:2 - Treatment Group B<br>Patients with a condition | Drug: hMG-HP<br> <br> |
| FSH:LH 3:1 - Treatment Group C<br>Patients with a condition | Drug: hMG-HP<br> <br> |
| FSH:LH 3:0 - Treatment Group D<br>Patients with a condition | Drug: hMG-HP<br> <br> |
| Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E<br>Patients with a condition | Drug: hMG-HP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | 0-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical pregnancy rate |  | 0-16 days |
Translation, Cross Cultural Adaptation and Validation of the Italian Version of the Forgotten Joint Score in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This is an observational, prospective study that has the primary goal of validating the Forgotten Joint Score (FJS)

Detailed Description
-----------------
This is an observational, prospective study that has the primary goal of validating the Forgotten Joint Score (FJS) as described by Behrend and Giesinger in 2012. Patients will be given two self-assessment questionnaires (WOMAC and FJS) to perform internal consistency analysis, reliability and comparability of results in a population of people undergoing total knee replacement prosthetic surgery. Comparison of data will be done for each patient by evaluating the evolution of the postoperative period, comparing the results obtained with a well known validated score (WOMAC). Questionnaires will be given pre-operatively, at 6 month ± 2 weeks, and 12 month ± 1 weeks after surgery.

Official Title
-----------------
Italian Validation of the Forgotten Joint Score(Fjs 2015)

Conditions
-----------------
Arthroplasty, Surveys and Questionnaires

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Age range between 55 and 85 years Italian mother-tongue Patients with unilateral gonarthrosis who need total knee prosthesis Exclusion Criteria: Patients with orthopedic pathologies of other origin Patients with history of previous articular prosthetic replacement surgery on joints of the lower limb. Patients with history of previous major cardiovascular events Patients who need aids for walking Patients claiming that they can not submit to follow-up and therefore can not complete the study

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Validating the Forgotten Joint Score. | Patients will be given self-assessment questionnaires Forgotten Joint Score (FJS) to perform internal consistency analysis, reliability and comparability of results in a population of people undergoing total knee replacement prosthetic surgery. FJS: minimum score 0 (worse outcome); maximum 100 (better outcome) | 18 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | weight and height will be combined to calculate the BMI in kg/m^2 | 18 months |
Inter-Device Reliability of the NPi-300 Pupillometer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.

Detailed Description
-----------------
Paired assessments will be made on patients who are consented; and on healthy controls who have verbally assented to participate. We plan to enroll 20 patients and 50 healthy controls. Assessments will be made at the convenience of the patient and healthy controls. Each assessment will include bilateral PLR reading within a 5 minute interval. The first assessment will be completed with the NPi-200 and the second assessment will use the NPi-300. The data will be entered into a CRF. If there is a significant difference between readings from the NPi-200 and the NPi-300, we will repeat the bilateral assessment in the following hour and the regularly scheduled time.

Official Title
-----------------
Inter-Device Reliability of the NPi-300 Pupillometer

Conditions
-----------------
Critical Illness, Neuropathy

Intervention / Treatment
-----------------
* Device: NPi-200 and NPi-300 pupillometers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (Patient Cohort): Subjects will be included if they are adults (>18 years of age) and have a neurological or neurosurgical diagnosis that place them at risk for cerebral edema. Subjects also have to be admitted to the enrolling site. Persons consenting for the study (whether patient or LAR) will need to be able to consent for the study in English. Exclusion Criteria (Patient Cohort): Patients that will be excluded from the study are those that are prisoners, under 18 years of age, or pregnant women. Inclusion Criteria (Healthy Control Cohort): Staff in the enrolling site Exclusion Criteria (Healthy Control Cohort): None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with risk of cerebral edema. | Device: NPi-200 and NPi-300 pupillometers<br>* Device which measures PLR.<br>|
| Healthy Control<br>Staff/Faculty who interact with patients at the enrolling site. | Device: NPi-200 and NPi-300 pupillometers<br>* Device which measures PLR.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupil's reaction to light as measured by Neurological Pupil Index (NPI) | Pupil's reaction to light as measured by Neurological Pupil Index (NPI) algorithm using pupillometer device that grades the pupil's reaction to light on a scale between 0 and 5. The Inter-device reliability is assessed using Cohen's Kappa method: values ≤ 0 as indicating no agreement. | 1 year |
Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)

Study Overview
=================
Brief Summary
-----------------
Aim of the BETAPATH study is to evaluate whether the use of a personal digital assistant (PDA) can improve the adherence of Multiple Sclerosis patients to a therapy with Betaseron. The Personal digital assistant PDA functions as an electronic diary and as an injection reminder.

Official Title
-----------------
Betaferon® Injection Management: Non-interventional Study on Personal Digital Assistant (PDA)Supported Effects on Adherence to a Long-term Injection Therapy (BETAPATH)

Conditions
-----------------
Relapsing-Remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b (Betaseron, BAY86-5046)
* Drug: Interferon beta-1b (Betaseron, BAY86-5046)
* Drug: Interferon beta-1b (Betaseron, BAY86-5046)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients with the diagnosis of Multiple Sclerosis and decision by the investigator to prescribe Betaferon.The decision for treatment type and duration is taken before offering the patient the possibility to participate in the study. Exclusion Criteria: Patients, who do not meet the Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS) criteria, should not be included. Exclusion criteria must be read in conjunction with the German product information.

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 |
| --- | --- |
| Group 1<br> | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* Interferon beta-1b (Betaferon) and Personal Digital Assistant together with a reminder<br>|
| Group 2<br> | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* Interferon beta-1b (Betaferon) and Personal Digital Assistant without a reminder<br>|
| Group 3<br> | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* Interferon beta-1b (Betaferon)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop out rate over 2 years |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability status |  | After 3, 6, 12 and 24 months | 
| Grade of depressiveness |  | After 3, 6, 12 and 24 months | 
| Grade of fatigue |  | After 3, 6, 12 and 24 months | 
| Quality of life |  | After 3, 6, 12 and 24 months | 
| Cognitive status |  | After 12 and 24 months | 
| Injection regularity |  | After 3, 6, 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Interferon beta-1b
Turkish Acquired Haemophilia Registry

Study Overview
=================
Brief Summary
-----------------
Turkish Acquired Haemophilia Registry is a database in which information about clinical features and therapeutic management of acquired haemophilia is collected in Turkey.This is a multicentre, retrospective and prospective registry of subjects diagnosed and/or treated for acquired haemophilia. Patients will be registered and the response to different therapies, details of each bleeding episode and the outcome of haemostatic and immunosuppressive therapy (IST) will be recorded. Any male or female subject diagnosed with inhibitors to FVIII or other factors and treated for acquired haemophilia can be entered on the registry. Patients will be treated according to local practice. No additional tests or procedures are required by the registry. The retrospective period will not be time-limited and data will be collected from those recorded in the hospital notes. The prospective period will begin in September 1.2011, and will last for two years.

Official Title
-----------------
Observational Acquired Haemophilia Registry

Conditions
-----------------
Acquired Haemophilia

Intervention / Treatment
-----------------
* Drug: rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acquired haemophilia diagnosis, written consent Exclusion Criteria: Being unable to give written consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acquired haemophilia patients<br> | Drug: rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin<br>* According to local clinical standards<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acquired haemophilia, factor VIII
23andMe IPF Research Study

Study Overview
=================
Brief Summary
-----------------
The long term goal of this study is to increase genetic understanding of IPF to enable the development of an effective drug for IPF that can improve the lives of those living with the condition.

Detailed Description
-----------------
This study will recruit 1,000 people who have been diagnosed with IPF or Hermansky-Pudlak syndrome (HPS). Eligible participants who consent to participate in 23andMe Research and the IPF Research Study will receive a 23andMe Health + Ancestry kit at no cost. Participants will provide a saliva sample and take a baseline survey online answering questions about their disease diagnosis, testing, treatment, and symptoms. Participants will also be asked to take the same survey 3, 6, and 9 months after completing the baseline survey. The data collected from this study will be incorporated into the 23andMe Database and used to better understand the underlying genetic and environmental factors that contribute to IPF.

Official Title
-----------------
23andMe Idiopathic Pulmonary Fibrosis Research Study

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been diagnosed with IPF or Hermansky-Pudlak syndrome (HPS) Are 18+ years old Live in the US Exclusion Criteria: - Have been diagnosed with sarcoidosis or hypersensitivity pneumonitis

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 |
| --- | --- |
| IPF<br>Participants diagnosed with idiopathic pulmonary fibrosis | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPF Symptom Progression Baseline | Survey asking about disease diagnosis, testing, treatments, and symptom progression | Baseline | 
| IPF Symptom Progression 3 month follow-up | IPF Symptom Progression 3 month follow-up | 3 months post baseline | 
| IPF Symptom Progression 6 month follow-up | Survey asking about disease diagnosis, testing, treatments, and symptom progression | 6 months post baseline | 
| IPF Symptom Progression 9 month follow-up | Survey asking about disease diagnosis, testing, treatments, and symptom progression | 9 months post baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPS, idiopathic pulmonary fibrosis, IPF, pulmonary fibrosis, lung diseases, lung, respiratory tract diseases, rare, rare diseases, Hermansky-Pudlak syndrome