linjc16/ctgov huggingface dataset:
Natural History Study of Oculopharyngeal Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to test a set of clinical outcome measures longitudinally in a cohort of OPMD patients to identify ones that show quantifiable change over time as the disease progresses. The investigators' goal is to delineate the natural history of OPMD.

Detailed Description
-----------------
OPMD patients will undergo a screening evaluation and testing to confirm the participants carry the OPMD mutation. Subjects fulfilling the inclusion/exclusion criteria will be enrolled and followed prospectively at regular intervals to determine the natural history of this disease. Measures of muscle function and swallowing will be made at baseline and at follow-up visits to measure natural clinical progression.

Official Title
-----------------
Natural History Study of Oculopharyngeal Muscular Dystrophy

Conditions
-----------------
Oculopharyngeal Muscular Dystrophy

Intervention / Treatment
-----------------
* Other: Non-interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OPMD by genetic criteria ≥ 18 years old English-speaking Exclusion Criteria: Another medical condition that precludes safe completion of study tasks (such as severe cardiac or respiratory disease) Another medical condition that causes symptoms similar to OPMD (i.e., ptosis, dysphagia [trouble swallowing] or limb weakness). History of head or neck cancer, or history of radiation to the head or neck A videofluoroscopic swallow study within the 12 months prior to study enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| OPMD Subjects<br>The study cohort consists of individuals with genetically confirmed OPMD who will be followed longitudinally using periodic standardized assessments of clinical status in an observational, non-interventional study. | Other: Non-interventional study<br>* Non-interventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength over time | Change in Manual muscle testing over time | Baseline and every 9 months for 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia severity over time | Videofluoroscopic Swallow Studies | Baseline and every 9 months for 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OPMD
Frontal Bone Window in ICUF (FBW-ICU)

Study Overview
=================
Brief Summary
-----------------
Transcranial doppler (TCD) is an established tool for monitoring flows in intracranial cerebral arteries. Its use is recommanded in the last guidelines on traumatic brain injury. The temporal bone window (TBW) is limited in evaluating flow in the anterior cerebral arteries (ACA) because of an unfavorable insonation angle. Thereby TCD could be unfit to detect a segmental lesion on the anterior cerebral arteries (ACA). The frontal bone window (FBW) is a promising approach in evaluating flows in the ACA. However, the utility of the FBW for patients with acute brain injury (ABI) in ICU has not been yet determined. The goal of the present study is to determine the rate of detection of the ACA by using the FBW in patients with ABI in ICU.

Official Title
-----------------
Assessment of Frontal Bone Window for Transcranial Doppler Among Acute Brain Injured Patients in Intensive Care Units: a Prospective Study.

Conditions
-----------------
Acute Brain Injury

Intervention / Treatment
-----------------
* Other: Transcranial doppler examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Membership in a health insurance scheme Patients with an acute cerebral pathology Hospitalized patients in a supportive care unit of Montpellier University Hospital Be able to benefit from transcranial doppler within 3 days of admission Exclusion Criteria: Clinical suspicion of encephalic death Known allergy to ultrasound gel

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Doppler examination<br>Transcranial Doppler examination | Other: Transcranial doppler examination<br>* Assessment of frontal bone window for transcranial doppler<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measures of ACA flow velocities threw the frontal bone window |  | up to 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adults, Frontal bone window, Transcranial doppler
Vascular Endothelial Growth Factor (VEGF) Levels in Brain Tumor Patients

Study Overview
=================
Brief Summary
-----------------
Objectives: This study is looking at the level of vascular endothelial growth factor (VEGF) circulating in the blood stream of patients diagnosed with either a meningioma or a glioma. The questions that will be addressed include: Can VEGF level alert us to tumor progression or recurrence before MRI changes occur? Is the VEGF level an indicator of the response to treatment? Does the VEGF level correlate with tumor histology and behavior? Is there a relationship between VEGF level and outcome?

Official Title
-----------------
Is VEGF a Useful Serum Biomarker for Patients Diagnosed With Meningioma or Glioma?

Conditions
-----------------
Glioma, Meningioma

Intervention / Treatment
-----------------
* Procedure: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient presenting with glioma or meningioma Exclusion Criteria: a different type of brain tumor
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 |
| --- | --- |
| Glioma<br>patients who are diagnosed with and are being treated for glioma | Procedure: Blood test<br>* an additional vial of blood will be obtained at the time of MRI or at the time of routine blood tests ordered by the medical oncologist. In other words, there will be no extra needle sticks. Just an extra vial of blood will be taken during a routine blood test<br>|
| meningioma<br>patients who are diagnosed with and are being treated for meningioma | Procedure: Blood test<br>* an additional vial of blood will be obtained at the time of MRI or at the time of routine blood tests ordered by the medical oncologist. In other words, there will be no extra needle sticks. Just an extra vial of blood will be taken during a routine blood test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if VEGF levels correlate with tumor progression or recurrence |  | every one to three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if the VEGF level is an indicator of the response to treatment. |  | Every one to three months | 
| Determine if the VEGF level correlates with tumor histology and behavior. |  | Every one to three months | 
| Determine if there is a relationship between VEGF level and outcome. |  | Every one to three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glioma, meningioma, VEGF
Testing the Effect of a Warning About New Drugs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether a new drug warning decreases enthusiasm for new drugs.

Official Title
-----------------
Testing the Effect of a Warning About New Drugs

Conditions
-----------------
Risk Communication

Intervention / Treatment
-----------------
* Other: Presentation of information about drug approval and level of warning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).

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?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Directive new drug warning<br>Survey contains information about when the drug was approved by the FDA (2009)and a directive warning (i.e., stating the issue and why it matters) for new drugs. This directive warning mentions that serious drug side effects may emerge only after the drug is already on the market, and the reader should ask their doctor there is an available drug with a longer track record. | Other: Presentation of information about drug approval and level of warning<br>* Presentation of information about date of drug approval with no new drug warning, a non-directive drug box warning or a directive drug box warning<br>|
| Experimental: Non-directive new drug warning<br>Survey contains information about when the drug was approved by the FDA (2009) and a non-directive warning (i.e., just stating the issue) for new drugs. This non-directive warning mentions only that serious drug side effects may emerge only after the drug is already on the market. | Other: Presentation of information about drug approval and level of warning<br>* Presentation of information about date of drug approval with no new drug warning, a non-directive drug box warning or a directive drug box warning<br>|
| Experimental: No new drug warning<br>Survey contains information about when the drug was approved by the FDA (2009) only. | Other: Presentation of information about drug approval and level of warning<br>* Presentation of information about date of drug approval with no new drug warning, a non-directive drug box warning or a directive drug box warning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypothetical choice of old (vs. newer) drug |  | 0 weeks (assessed during intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehension of the drug warning and drug information |  | 0 weeks (assessed during intervention) |
The Effects of Serum Vitamin D and IVF Outcome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether an association exists between serum vitamin D levels and IVF treatment outcome

Official Title
-----------------
The Effects of Serum Vitamin D and IVF Outcome: a Prospective Cohort Study

Conditions
-----------------
Vitamin D Deficiency, Vitamin D Insufficiency, Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing IVF, ICSI or FET treatment at Birmingham Womens Fertility Centre Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 43 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ART population<br>Patients undergoing IVF/ICSI/FET treatment at the Birmingham Womens Fertility Centre 2013-2014 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rate | USS appearances of intrauterine pregnancy | 7 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical pregnancy rate | Urinary pregnancy test result 2 weeks after embryo transfer | 2 weeks after embryo transfer | 
| Miscarriage rate | Pregnancy outcome of miscarriage | 20 weeks after embryo transfer | 
| Live birth rate | Live birth outcome | 42 weeks after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Infertility, IVF, ART
Observational Study of Type 1 Diabetics Switching From Human Insulins to Modern Insulin Analogues

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoRapid® (insulin aspart) and Levemir® (insulin detemir) after switch from human insulins for treatment of type 1 diabetes under normal clinical practice conditions in Romania.

Official Title
-----------------
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoRapid® (Insulin Aspart) and Levemir® (Insulin Detemir) in a Basal-bolus Regimen for Treatment of Type 1 Diabetes Mellitus in Romania

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin aspart
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subject with type 1 diabetes who is treated with human rapid and intermediate (NPH) insulin in basal-bolus regimen Exclusion Criteria: Subjects currently being treated with insulin aspart and insulin detemir Subjects who were previously enrolled in this study Subjects with a hypersensitivity to insulin aspart or to any of the excipients Subjects with a hypersensitivity to insulin detemir or to any of the excipients Women who are pregnant or have the intention of becoming pregnant within next 6 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: insulin aspart<br>* Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice<br>* Other names: ANA;Drug: insulin detemir<br>* Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | at 24 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5% |  | at 12 weeks and 24 weeks of treatment | 
| Change in FPG (glucose variability) |  | at 12 weeks and 24 weeks of treatment | 
| Change in PPG (postprandial control) |  | at 12 weeks and 24 weeks of treatment | 
| Change in insulin dose and number of injections |  | at 12 weeks and 24 weeks of treatment | 
| Change in body weight |  | at 12 weeks and 24 weeks of treatment | 
| Change in number of hypoglycaemic events |  | at 12 weeks and 24 weeks of treatment | 
| Number of adverse drug reactions (ADR) |  | at 12 weeks and 24 weeks of treatment |
The DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)

Study Overview
=================
Brief Summary
-----------------
Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics

Official Title
-----------------
The DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)

Conditions
-----------------
Bone Marrow Transplant Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Patients who plan on undergoing an allogeneic stem cell transplant and are admitted to UCSF Medical Center. Exclusion Criteria: Inability to provide informed consent and comply with study-related procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics. |  | 7 days |
Sensory Mapping and Thermal Thresholds After Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
The study will investigate topography of sensory changes late after lung cancer surgery

Official Title
-----------------
Sensory Mapping and Thermal Thresholds After Thoracic Surgery

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Understand Danish Age > 18 years old PTPS Exclusion Criteria: Cognitive dysfunction Repeated thoracic surgery Nerve injury from other causes Drug or alcohol abuse

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 |
| --- | --- |
| lung cancer surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermal thresholds (Quantitative Sensory Testing [QST]) | Two QST with 10 days interval | average 18 months after surgery | 
| Sensory mapping | Two QST with 10 days interval | average 18 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
persistent pain, neuropathic pain, Thoracotomy, Chronic Pain
Assessment of Lotrafilcon A Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.

Official Title
-----------------
Assessment of Lotrafilcon A Contact Lenses

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Lotrafilcon A upgrade soft contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have normal ocular findings. Be able to wear the study lenses in the available powers. Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day. Wear Night & Day contact lenses. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Require concurrent ocular medication. Eye injury or surgery within twelve weeks prior to enrollment. Currently enrolled in an ophthalmic clinical trial. Any active corneal infection. Corneal refractive surgery. Wear AIR OPTIX NIGHT & DAY AQUA lenses. Other protocol-defined exclusion criteria may apply.
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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Lotrafilcon A upgrade soft contact lens|Silicone hydrogel contact lens approved for daily wear and extended wear up to 30 consecutive nights.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | 3 months of wear, replacing lenses monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Lens Fit | As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight | 3 months of wear, replacing lenses monthly |