linjc16/ctgov huggingface dataset:
One Week Aligner Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.

Detailed Description
-----------------
The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. The aligners are designed to optimally move each tooth at a speed that follows physiologic principles. The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.

Official Title
-----------------
One Week Aligner Evaluation

Conditions
-----------------
Malocclusion

Intervention / Treatment
-----------------
* Device: Invisalign


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have fully erupted dentition except for 2nd and 3rd molars For Teen treatment group, subjects ages <17 years of age For Adult treatment group, subjects ≥17 years of age Exclusion Criteria: Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study Subject with active caries Subject with periodontal disease Subject with TMD symptoms Subject has known allergy to latex or plastic Subjects who are pregnant or will become pregnant during treatment
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 |
| --- | --- |
| Teen<br>< 17 years of age | Device: Invisalign<br> <br> |
| Adult<br>17 years of age or older | Device: Invisalign<br> <br> |
| Adult with Primer Aligners<br>17 years of age or older This group will get Primer Aligners | Device: Invisalign<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Planned to Final Tooth Position | Test vs Historical Control Group | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment time | Length of treatment | Through study completion, an average of 2 years | 
| Subject Quality of Life | Assessment of QoL | Through study completion, an average of 2 years |
Lung Recruitment Improves Right Ventricle Performance

Study Overview
=================
Brief Summary
-----------------
This study test whether a lung recruitment maneuver improves the right ventricle performance after cardiopulmonary bypass. Half of the patients received an standard protective ventilation and the other half the same ventilatory pattern after a lung recruitment maneuver.

Detailed Description
-----------------
Atelectasis is developed in 90% of anesthetized patients after surgery. Protective ventilation with low tidal volumes and positive-end expiratory pressure (PEEP) promotes atelectasis with the potential right ventricle dysfunction induced by the increment in afterload (activation of the pulmonary hypoxic vasocontriction reflex). Lung recruitment can improve the right ventricle performance caused by atelectasis because the pulmonary hypoxic vasocontriction reflex desapear in a normal aerated lungs.

Official Title
-----------------
Lung Recruitment Improves Right Ventricle Performance After Cardio-Pulmonary Bypass

Conditions
-----------------
Atelectasis

Intervention / Treatment
-----------------
* Procedure: Lung recruitment maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiovascular surgery with cardiopulmonary bypass. Patients with a New York Heart Association (NYHA) class I-II, Pre-operative left ventricular ejection fraction ≥ 50 %. Euroscore ≤ 6. Exclusion Criteria: TEE contraindications. Hemodynamically unstable Needi for inotropic support

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- |
| No Intervention: Control group<br>Patients received standard protective ventilation along the protocol. | |
| Experimental: Recruitment maneuver group<br>Patient received a lung recruitment maneuver after cardiopulmonary bypass. The recruitment maneuver consists in 10 breaths at 40/20 cmH2O of plateau pressure and PEEP, respectively. Then, the .ventilatory settings back to protective ventilation but adding 10 cmH2O of PEEP to keep the lungs open. | Procedure: Lung recruitment maneuver<br>* The lung recruitment maneuver consists in a brief and controlled increment in airways pressure (20 cmH2O of PEEP + 20 cmH2O of driving pressure) for 10 breaths.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricle assessment by transesophageal echocardiography |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atelectasis assessment by transesophageal echocardiography |  | intraoperative | 
| PaO2 and respiratory compliance |  | intraoperative |
Correlation of Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome

Study Overview
=================
Brief Summary
-----------------
We designed a study to determine if ovarian volume (OV) and/or follicle number (FN) are independently associated with abnormal metabolic findings in women diagnosed with PCOS. We hypothesized that ovarian morphology but not follicle number would be associated with a significantly higher odds of hyperinsulinemia among women with PCOS.

Official Title
-----------------
Correlation of Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome

Conditions
-----------------
Study the Relationship Between Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A-patients met the Rotterdam criteria of PCO with two out of three of the following: oligo-or-anovulation clinical and/or biochemical hyperandrogenism the presence of 10 or more antral follicles in one ovary and/or a maximum ovarian volume > 10cc B-reproductive age group (16:45 years) C-BMI <40 Exclusion Criteria: A-age >40 years B-BMI>40 C-previous ovarian surgery D-chronic medical disorders [DM , HTN , ...]

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|We try to find an association between insulin resistance with ovarian hormonal and morphological characteristics in patients with polycystic ovarian syndrome|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the ovarian volume and Insulin resistance |  | January 2023- June 2023 | 
| Correlation between the antral follicular count and insulin resistance |  | January 2023- June 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between anti-mullerian hormone values and insulin resistance |  | January 2023- June 2023 | 
| Correlation between FSH values and insulin resistance |  | January 2023- June 2023 | 
| Correlation between LH values and insulin resistance |  | January 2023- June 2023 | 
| Correlation between body mass index and insulin resistance |  | January 2023- June 2023 | 
| Correlation between hirsutism and insulin resistance |  | January 2023- June 2023 |
Tissue Culture Versus Swab Culture in Prosthetic Joint Infections

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to compare the effectiveness and accuracy of tissue cultures and swab cultures to diagnose prosthetic joint infection.

Conditions
-----------------
Revision Total Hip Arthroplasty, Revision Total Knee Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are scheduled for revision TJA surgery. Subjects are willing to sign the informed consent document. Exclusion Criteria: 1. Subject not willing to sign the informed consent document.

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 |
| --- | --- |
| Revision Total Hip Arthroplasty<br> | |
| Revision Total Knee Arthroplasty<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of the Hem-Avert® Perianal Stabilizer Into Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This is a retrospective data-only study following the phased introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice. The investigators aim to capitalize on the introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice in labor and delivery settings in the hospital of Dignity Health - St. Rose, Siena Campus and to determine whether the HEM-AVERT® Perianal Stabilizer reduces the frequency of Cesarean Section during labor and delivery.

Detailed Description
-----------------
The on label device in this study is the HEM-AVERT® Perianal Stabilizer manufactured by Stetrix, Inc. This study is being sponsored by Dignity Health and falls within the guidelines set forth by the Food and Drug Administration in 21 CFR Section 812.2 as a non-significant risk study. The HEM-AVERT® Perianal Stabilizer is a Class II device in accordance with FDA regulation 21 CFR 801.109. Retrospective data will be collected in this study on the reduction of c-section rates and duration of second stage of labor. These data may be used to support an application to the FDA for a new indication of reducing c-sections. It is also possible the second stage labor data may also be used in support of expanded labeling.

Official Title
-----------------
Evaluation of the Hem-Avert® Perianal Stabilizer Into Routine Clinical Practice

Conditions
-----------------
Cesarean Section Rate

Intervention / Treatment
-----------------
* Device: Hem-Avert Perianal Stabilizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vaginal Births Exclusion Criteria: Anticipated non-vaginal 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 |
| --- | --- |
| All Vaginal Births<br>The application of the Hem-Avert Perianal Stabilizer | Device: Hem-Avert Perianal Stabilizer<br>* The HEM-AVERT® Perianal Stabilizer is an FDA approved Class II device in accordance with FDA regulations 21 CFR 801.109. The HEM-AVERT® Perianal Stabilizer is a non-invasive device used to help provide continuous pressure to the perianal region as a means to help provide support during the labor process.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean Conversion Rate | Cesarean Conversion Rate | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Second stage labor times | Comparing second stage labor times | 90 Days | 
| Lacerations | Comparing lacerations | 90 Days |
A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1, open-label non-randomized, single dose study in healthy male subjects.

Detailed Description
-----------------
This is a Phase 1, open-label nonrandomized, single dose study in healthy male subjects to determine the absorption, metabolism, and excretion (AME) of [14C]-PBI-200

Official Title
-----------------
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200 Following a Single Oral Dose in Healthy Male Subjects

Conditions
-----------------
Absorption, Metabolism and Excretion in Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: [14C]-PBI-200


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Males, of any race, 18 to 65 years of age as of the dosing day. Body mass index between 18.0 and 32.0 kg/m2, inclusive. Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness. Key Exclusion Criteria: Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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: [14C]-PBI-200 Treated<br>[14C]-labeled PBI-200 will be administered as a single dose | Drug: [14C]-PBI-200<br>* [14C]-radio-labeled-PBI-200<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Radioactivity in Urine and Feces |  | 28 days | 
| Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to infinity [AUC(0-inf)] |  | 28 days | 
| Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last quantifiable concentration [AUC(0-tlast) |  | 28 days | 
| Maximum Observed Concentration [C(max)] |  | 28 days | 
| Time to Maximum Concentration [T(max)] |  | 28 days | 
| Apparent Terminal Elimination Half-life [t(1/2)] |  | 28 days | 
| Total Radioactivity in Plasma and Whole Blood |  | 28 days | 
| Ratio for AUC(0-inf) Blood / Plasma |  | 28 days | 
| Ratio for AUC(0-inf) Plasma PBI-200 / Total Radioactivity |  | 28 days |
Impact of Conservative Treatment by Custom-made Orthoses in Patients With Haemophilic Ankle Arthropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study intend to evaluate the effectiveness of functional orthoses (including custom-made insoles and shoes) for preventing and controlling repetitive haemarthrosis in patients suffering of haemophilic ankle arthropathy, as well as the orthoses' impact on foot health-related quality of life.

Conditions
-----------------
Haemophilia A, Haemophilia B

Intervention / Treatment
-----------------
* Device: custom-molded insoles and custom-molded shoes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: haemophilia A or B, aged more than 13 years Exclusion Criteria: impossibility to walk on a treadmill recent joint haemarthrosis or muscle haematoma

Ages Eligible for Study
-----------------
Minimum Age: 13 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: custom-molded insoles and custom-molded shoes|custom-made insoles in PELITE foam (hypoallergenic prosthesis grade foam) or leather top cover cork insoles for patients suffering of mild to moderate ankle arthropathy custom-molded shoes in leather for patients suffering of end-stage ankle arthropathy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait analysis, foot pressure measurement, specific joint score |  | To, T1 (3months) and T2 (6months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients with haemophilia A moderate or severe, patients with haemophilia B moderate or severe
Evaluation of Hepatic Fibrosis on Multiparametric MRI

Study Overview
=================
Brief Summary
-----------------
As cirrhosis progresses, alteration of hemodynamics develops and decreased portal flow is often observed. Since direct measurement of portal pressure (HVPG) is invasive, non-invasive methods have drawn a lot of attention. MRI is one of the non-invasive methods and it is able to provide multiparametric data in one examination. Herein, we evaluate hepatic fibrosis with different stage using multiparametric MRI with emphasis on portal flow measurement.

Official Title
-----------------
Evaluation of Hepatic Fibrosis on Multiparametric MRI Including Portal Flow Measurement Using Dual-input Software: Preliminary Study

Conditions
-----------------
Cirrhosis, Hepatitis

Intervention / Treatment
-----------------
* Diagnostic Test: Liver MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...) Or transplant recipient for viral hepatitis and on anti-viral agent medication AND scheduled for liver resection, biopsy or transient elastography AND signed informed consent Exclusion Criteria: younger than 18 years any contra-indication for contrast-enhanced MRI pregnant or nursing women biliary obstruction unable or unwilling to give informed consent

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver MRI<br>Liver MRI including noncontrast (precontrast) flow measurement, DCE, DWI using multiple b-values, MRE and MR fat quantification. | Diagnostic Test: Liver MRI<br>* Multiparametric Liver MRI including following sequences: DCE, DWI, MRE, precontrast flow measurement, fat quantification.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hepatic fibrosis stage | F0-1 vs. F2-4 using multiparametric MRI | 1 month after MRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of varix | presence of esophageal or gastric varices using multiparametric MRI | 1 month after MRI | 
| comparison of portal flow measurement | comparison of portal flow measurement using DCE and precontrast flow measurement | 1 month after MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver, fibrosis, MRI
Changing Diabetes in Children

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The primary objective of the CDiC programme is to improve access to comprehensive diabetes care among the children with diabetes from the economically underprivileged section of the population and to establish a registry for this group of children with type 1 diabetes in India.

Official Title
-----------------
Changing Diabetes in Children (CDiC): Type 1 Diabetes in Economically Underprivileged Children in India

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

Intervention / Treatment
-----------------
* Drug: insulin human


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children diagnosed with type 1 diabetes Parents/caretakers agree to participate in the study Child belongs to the below poverty line economic strata (Centre Director certifies economic status for inclusion in to the study) Exclusion Criteria: Children with type 2 diabetes Children from higher economic status Those getting coverage under other government / private schemes

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Children<br> | Drug: insulin human<br>* Children will receive conventional treatment with human insulin according to standard medical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient assessments: Number of days on insulin |  | After 40 months | 
| Number of days with home blood glucose monitoring |  | After 40 months | 
| HbA1c (glycosylated haemoglobin) |  | After 40 months | 
| Number of episodes of ketoacidosis |  | After 40 months | 
| Number of episodes of severe hypoglycaemia |  | After 40 months | 
| Long-term complications |  | After 40 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of children with HbA1c equal to or below 8.0 |  | After 40 months | 
| Percentage of children who died during the study |  | After 40 months | 
| Percentage of children lost to follow-up |  | After 40 months |