linjc16/ctgov huggingface dataset:
Linus Health CDS Retrospective Validation Study

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective validation study of deidentified Clinical Decision Support (CDS) recommendations generated by the Linus Health Core Cognitive Evaluation (CCE) for patients who have completed the CCE. Site investigators consist of clinical experts including neurologists and geriatricians in the U.S. After signing the study agreements, the experts will receive batches of anonymized CCE outputs of patients and will rate the appropriateness of each CDS recommendation for each patient based on their review of the CCE results and their clinical judgment and expertise. The experts will also rate the clinical appropriateness of various parts of CDS pathways that form the LH CDS decision tree.

Official Title
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Retrospective Validation Study of Clinical Decision Support (CDS) Recommendations in the Linus Health Core Cognitive Evaluation

Conditions
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Cognitive Impairment, Motor Disorders, Dementia

Intervention / Treatment
-----------------
* Diagnostic Test: Core Cognitive Evaluation (CCE)


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Age 55 and above Has already completed the Linus Health CCE Exclusion Criteria: Incomplete CCEs CCEs that are flagged as Requires clinician review

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Core Cognitive Evaluation (CCE)|The Linus Health Core Cognitive Evaluation (CCE) is an easy-to-use but powerful tool to augment and facilitate cognitive health assessment during a patient's visit to their PCP. As a digital assessment solution, the CCE combines objective insights into cognitive ability with patient-reported insights to detect early signs of cognitive impairment and reveal specific modifiable risk factors earlier than the existing status quo assessments. The CCE is an FDA-listed Class II 510k exempt software as a medical device. The CCE has two components: The Digital Clock and Recall (DCR™) test and the Life and Health Questionnaire (LHQ).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median rating of each CDS recommendation | Rating of clinical appropriateness on the scale of 1 (extremely inappropriate) to 9 (extremely appropriate) for each set of CDS recommendations generated by the Linus Health CCE. | 2-3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraclass correlation coefficient (ICC) of each rating | ICC of each rating of clinical appropriateness to evaluate the inter-rater variability. | 2-3 weeks |
The Effect of Smile Designs on Aesthetic Perception

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to examine the effect of designs using different aesthetic dental proportions made with the digital smile design program on the aesthetic perception of individuals of different ages, gender, and educational status. The main questions it aims to answer are: The golden ratio is the most aesthetic ratio known and accepted in dentofacial structures. There is no significant difference between the aesthetic perception of dental students, dentists, specialist dentists and laypeople. Participants will answer: The first 5 questions related that demographic data such as age, gender, and educational status. The smile designs of a woman and a man, prepared according to 8 different principles, will be evaluated by the participants according to the Likert scale. Researchers will compare the 4th and 5th-grade students of a dentistry faculty, dentists, specialist dentists and laypeople to see the effect of smile design on facial aesthetic perception.

Official Title
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The Effect of Smile Designs Using the Digital Smile Design Program on Aesthetic Perception

Conditions
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Dentistry, Perception

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Anyone who can answer the survey online Exclusion Criteria: individuals under the age of 18

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| 4th-grade students of a dentistry faculty<br> | |
| 5th-grade students of a dentistry faculty<br> | |
| Dentists<br> | |
| Specialist dentists<br> | |
| Laypeople<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert scale | There are 5 rating levels on the Likerts scale: very ugly, ugly, unstable, beautiful, very beautiful. People in 5 different groups will evaluate different smile designs with a Likert scale according to their aesthetic perceptions. | 1 day (single measurement) |
The Influence of Desensitizing Agent on Postoperative Sensitivity in Posterior Composite Restoration

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the influence of desensitizing agents on reducing post-operative sensitivity in posterior composite.

Official Title
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The Influence of Desensitizing Agent on Postoperative Sensitivity in Posterior Composite Restoration: A Randomized Controlled Clinical Trial

Conditions
-----------------
Dentin Hypersensitivity

Intervention / Treatment
-----------------
* Other: Hurriseal desensitizer
* Other: Gluma desensitizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having active primary class I carious lesions on vital molar teeth either in the middle or the inner third of dentin in the three quadrants of each patients. Teeth having a positive reaction to vitality test (cold test), no signs of pulp inflammation, or spontaneous pain before treatment. Preoperative radiographic record of the carious lesions. Buccolingual width is no more than half the inter-cuspal distance Exclusion Criteria: Excessive tooth wear due to clenching or abnormal habits. Patients with direct occlusal contact by antagonist cusp (traumatic occlusion). Patients with periodontal or gingival disease. Patients using analgesics and/or anti-inflammatory medicine.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Composite with Hurriseal desensitizer<br> | Other: Hurriseal desensitizer<br>* Patients will receive Hurriseal desensitizing agent and universal bond and composite. Cavities will be restored with light-cured composite resin following the application of bonding agent.<br>|
| Active Comparator: Composite with Gluma Desensitizer<br> | Other: Gluma desensitizer<br>* Patients will receive Gluma desensitizing agent and universal bond and composite. Cavities will be restored with light-cured composite resin following the application of bonding agent.<br>|
| No Intervention: Composite without desensitizer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypersensitivity assessment | Air spray will be applied from a 2-mm distance on to the occlusal for 3 seconds. The severity of patients' pain/sensitivity will be recorded using (0-10) numerical rating scale. The score will be ranged from 0 (No pain) to 10 (maximum pain) | up to 12 months |
Extension for Menopause Sample Collection

Study Overview
=================
Brief Summary
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This study will provide urine samples from women going through the menopause transition in order to maintain the SPD sample bank. Symptom information and cycle length will also be recorded to observe how these change through the menopause transition.

Detailed Description
-----------------
This is an extension to a previous sample collection (Protocol-1326) where additional samples will be collected from the women who continue to go through the menopausal transition (i.e. are not post-menopausal). Three sets of 10 consecutive daily urine samples will be collected at three timepoints (month 0, month 6 and month 12). Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts and stored at -80˚C until required.

Official Title
-----------------
Extension for Menopause Sample Collection

Conditions
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Menopause

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Pre- and peri-menopausal volunteers(assigned by STRAW+10 criteria) who completed PROTOCOL-1326 Exclusion Criteria: Post-menopausal volunteers (12 months since last menstrual period) Use of hormone replacement therapy (HRT) Use of hormone contraception Hysterectomy and/or oophorectomy Pregnant or breast feeding Other medical reason for amenorrhea (absence of menstruation)

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Urine Samples Collected | Daily Urine Samples | Daily samples for 10 days at 0, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopause Symptom Information | Experience of a range of menopause symptoms | Recorded at 0, 6 and 12 months |
Registry for Mayo Clinic Adult Congenital Heart Disease Control Population

Study Overview
=================
Brief Summary
-----------------
This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.

Official Title
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Control Population for the Mayo Clinic Adult Congenital Heart Disease Registry

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ≤ 30. No current cardiac medications. Systolic BP ≤ 140 mmHg. Diastolic BP ≤ 90 mmHg. Capacity to consent. Exclusion Criteria: To be assessed via EMR screening. Patient confirmation during screening visit. Screening tests as applicable. History of cardiovascular disease. eGFR < 30. Current orthopedic limitations.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Oxygen Uptake | Peak Oxygen Uptake (L/min) : 1.7 ± 0.1 | 6 Months | 
| Peak Right Ventricular - Pulmonary Coupling | Peak Right Ventricular - Pulmonary Coupling: (|%|/mmHg): 0.786 ± 0.065 | 6 Months |
Effectiveness Of DN and STM Combined With Self-Stretching for Management of Calf and Heel Pain

Study Overview
=================
Brief Summary
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To determine the effectiveness of dry needling and soft tissue mobilization with self-stretching for the management of calf and heel pain. In our topic pain and physical dysfunction are our variables

Official Title
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Effectiveness Of Dry Needling and Soft Tissue Mobilization Combined With Self-Stretching for Management of Calf and Heel Pain

Conditions
-----------------
Heel Pain Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Dry Needling
* Diagnostic Test: Self Stretching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be between the ages of 25 to 60 years. Female and males. History of heel and calf pain. Pain level moderate . Trigger point / inactive trigger points. Acute stage patients. Exclusion Criteria: Phobias like injections or needles. Unwilling patients Patients on anticoagulant medicines. Patients with RA Fibromyalgia syndrome. Pateint with recent trauma and surgery.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry needling along stretches and soft tissues therapy<br> | Diagnostic Test: Dry Needling<br>* Dry needling treatment will be consisting of two treatments per week<br>|
| Active Comparator: stretching and soft tissue mobilization<br> | Diagnostic Test: Self Stretching<br>* Self stretching groups both will receive a TrP manual interventions and stretching protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry Needling and Soft Tissue Mobilization with Self-Stretching | Effectiveness Of Dry Needling and Soft Tissue Mobilization Combined with Self-Stretching for Management of Calf and Heel Pain | 6 Months |
Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy

Study Overview
=================
Brief Summary
-----------------
Iron deficiency anemia (IDA) is a very common health problem during pregnancy and intravenous (IV) iron substitution has become part of routine management. Recent studies have raised concerns about association of IV iron infusion and development of secondary transitory hypophosphatemia (HP) in adults including pregnant women. The study aimed to evaluate the impact of IV iron administration during pregnancy on newborn's phosphatemia. The investigators conducted a prospective, single-center, observational study in the Geneva University Hospitals (HUG), from September 2022 to March 2023. Pregnant women treated either with IV iron or with oral iron during pregnancy were included. At delivery, a maternal blood sample to assess hemoglobin, hematocrit, ferritin, phosphate and calcium and an umbilical cord blood sample to assess levels of phosphate and calcium were collected. Difference in demographics and clinical characteristics between the two groups were explored using univariate analyses. Multivariate analyses were performed to test the contribution of IV iron substitution on cord blood phosphatemia and calcemia, considering potential confounding factors. Neonatal HP was defined as a phosphate level lower than 1.3 mmol/L.

Official Title
-----------------
Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy

Conditions
-----------------
Iron Induced Hypophosphatemia

Intervention / Treatment
-----------------
* Drug: IV iron administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single pregnancy Term (>37SA) pregnancy Oral or IV iron substitution from second trimester Exclusion Criteria: Multiple pregnancy Fetal anomalies Preterm birth
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 |
| --- | --- |
| Oral iron<br> | |
| IV iron<br> | Drug: IV iron administration<br>* IV iron administration during pregnancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of cord blood phosphate in neonates |  | Single timepoint at delivery |
An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM

Study Overview
=================
Brief Summary
-----------------
This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state Pharmacokinetics (PK) during chronic dosing with aficamten.

Official Title
-----------------
An Open-Label Study of Aficamten for Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Conditions
-----------------
Obstructive Hypertrophic Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: Aficamten


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of a Cytokinetics trial investigating CK-3773274 LVEF ≥55% at the Screening Visit Exclusion Criteria: Has participated in another investigational device or drug study or received an investigational device or drug <1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted. Since completion of a previous study of aficamten has:Developed new-onset paroxysmal or permanent atrial fibrillation (AF) requiring rhythm restoring treatment (e.g., direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may rescreen for JX01003 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days. Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation). Had a confirmed LVEF <40% with an associated dose interruption during participation in a prior study with aficamten. History of appropriate implantable cardioverter defibrillator (ICD) shock within 30 days prior to screening. Has received treatment with mavacamten.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Aficamten<br>Patients in this arm take daily dose of Aficamten. Each patient will start at the lowest dose (5 mg) in the pre-specified dose range and undergo dose titration up to a maximum of 20 mg. | Drug: Aficamten<br>* 5-20mg<br>* Other names: CK-3773274;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events observed during dosing of Aficamten in patients with symptomatic oHCM. | Patient incidence of reported adverse events (AEs) Patient incidence of reported serious adverse events (SAEs) Patient incidence of left ventricular ejection fraction (LVEF) < 40 % | through study completion, at least 1 year |
Sponsor-Initiated OCS Liver Perfusion (OLP-II) Registry

Study Overview
=================
Brief Summary
-----------------
OLP-II Registry is a sponsor-initiated, multi-center, observational, post-approval registry.

Detailed Description
-----------------
The objective of the sponsor-initiated OLP-II Registry is to collect data on the post-transplant clinical outcomes of donor livers preserved and assessed on OCS Liver System and to document performance of the OCS device in the realworld setting.

Official Title
-----------------
Sponsor-Initiated OCS Liver Perfusion (OLP-II) Registry

Conditions
-----------------
Liver Transplant

Intervention / Treatment
-----------------
* Device: OCS Liver


Participation Criteria
=================
Eligibility Criteria
-----------------
All liver transplant recipients who are transplanted with an OCS-perfused donor liver are eligible for the Registry.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OCS Liver Transplant Recipients<br>All liver transplant recipients who are transplanted with an OCS-perfused donor liver are eligible for the Registry. Up to 10,000 subjects will be enrolled. | Device: OCS Liver<br>* The TransMedics® Organ Care System (OCSTM) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | 1-year patient survival with the originally transplanted liver (patient and graft survival) post-liver transplant. | 1-year |