linjc16/ctgov huggingface dataset:
Histologic Diagnoses of Incidentally Detected Lesions on MRI

Study Overview
=================
Brief Summary
-----------------
Patients who received breast MRI will be evaluated for a variety of indications including : # each indication : 1) known cancer staging for local exent, 2)high risk, 3)high suspicion clinical finding, 4)questionable mammo finding, 5)silicone leak The number of incidental lesions not detected by any other method that were subsequently subjected to biopsy with the following BIRADS categories 3-# reasons for bx 4-# 5-# Of the lesions detected % of each BIRADS category were postive histologies-ductal, lobular, DCIS, etc. and negative (fibrosis, hyperplasia, etc.) Criteria for classification: morphology, dynamics, clinical significance will be evaluated and a predictive value established.

Detailed Description
-----------------
Patients who received breast MRI will be evaluated for a variety of indications including ? # each indication : 1) known cancer staging for local exent, 2)high risk, 3)high suspicion clinical finding, 4)questionable mammo finding, 5)silicone leak The number of incidental lesions not detected by any other method that were subsequently subjected to biopsy with the following BIRADS categories 3-# reasons for bx 4-# 5-# Of the lesions detected % of each BIRADS category were postive histologies-ductal, lobular, DCIS, etc. and negative (fibrosis, hyperplasia, etc.) Criteria for classification: morphology, dynamics, clinical significance will be evaluated and a predictive value established. This study is limited to retrospective chart review with the only foreseeable risk being that of disclosure of PHI. To minimize this risk, data collection forms will be identified by subject ID number. A master list of these ID numbers linked to subject medical record number will be maintained in the investigator's file and kept in a secure location accessible only to the study team for purposes of verification of data and validation of results. The medical record number will not be recorded on any other form containing subject PHI. The only foreseeable breach of confidentiality would be for the security of the investigator's files to be compromised

Official Title
-----------------
Histologic Diagnoses of Incidentally Detected Lesions on MRI

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients subjected to biopsy as a result of findings seen only on MRI Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer
Descartes-11 in Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
This Phase I/2 study will test the safety and anti-myeloma activity of ascending doses of Descartes-11 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.

Official Title
-----------------
Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Biological: Descartes-11
* Drug: Fludarabine
* Drug: Cyclophosphamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active multiple myeloma that is refractory after at least 2 prior lines of therapy; measurable disease; adequate vital organ function; and no active infection.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose-Escalation<br> | Biological: Descartes-11<br>* CAR T-Cells<br>Drug: Fludarabine<br>* Pre-conditioning chemotherapy<br>Drug: Cyclophosphamide<br>* Pre-conditioning therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence (number) of Treatment-Emergent Adverse Events | Safety and Tolerability | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Response | IMWG treatment response criteria | Time Frame: 1, 3, 6, 9 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAR-T, CART, CAR T Cell, CAR T-Cell, Multiple Myeloma, BCMA, B cell maturation antigen, B-cell maturation antigen, Descartes-11
Retrospective Chart Review Study of Patients Treated With Votiva Device

Study Overview
=================
Brief Summary
-----------------
retrospective data collection is to gain insight into patients satisfaction post Votiva treatments for the complex of vulvovaginal symptoms.

Official Title
-----------------
Retrospective Chart Review Study of Patients Treated With Votiva Device

Conditions
-----------------
Vulvovaginal Signs and Symptoms

Intervention / Treatment
-----------------
* Device: Votiva device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18years of age at the time of the procedure patients with symptoms of at least one of the following: vaginal relaxation syndrome, vaginal atrophy, vaginal dryness, dyspareunia, SUI, Vaginal laxity, recurrent UTI, recurrent vaginal infections, Linchen Sclerosis, perineal pain, itchiness. At least one Votiva procedure that included FormaV applicator treatment with or without combination with Fractora/Morpheus8 Applicators treatments Exclusion Criteria: active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scarring.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Votiva device|A retrospective chart review of the medical records|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant satisfaction post treatment | • Participant satisfaction post treatment. Number of patients who are satisfied with post treatment results [ Time Frame: Baseline to 4 weeks post-treatment/s] | 4 weeks post treatment |
Characterization and Pathogenesis of ACLF

Study Overview
=================
Brief Summary
-----------------
This single-center prospective observational study aims at characterization of pathogenesis of ACLF. There will be three different cohorts investigated with the main endpoint mortality in these groups. SAPIENT = Sepsis ACLF patients, to investigate the differences between ACLF and sepsis in cirrhosis PROACT = Portal mediators as ACLF Targets, to assess portal venous biomarkers in patients receiving TIPS leading to ACLF and identify potential treatment targets ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts, to assess in ACLF-patients receiving liver transplantation predictors of survival, which may improve selection of ACLF-patients for liver transplantation Secondary endpoints will be different in the three different cohorts and biological material will be collected for separate ancillary studies.

Official Title
-----------------
Beobachtungsstudie für Die Charakterisierung Der Pathogenese Des Akut-auf-chronischen Leberversagens

Conditions
-----------------
Acute-On-Chronic Liver Failure, Liver Cirrhosis, Portal Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cirrhosis Exclusion Criteria: extrahepatic and metastatic malignancy, refusal for participation decision of attending phycisian

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 |
| --- | --- |
| SAPIENT = Sepsis ACLF patients<br> | |
| PROACT = Portal mediators as ACLF Targets<br> | |
| ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | number of patients | 90 days |
Dalacin-T Gel Post Approval Study

Study Overview
=================
Brief Summary
-----------------
To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify the clinical positioning of Dalacin T Gel.

Official Title
-----------------
Phase IV Clinical Study Of Clindamycin Phosphate Topical Gel In The Treatment Of Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: clindamycin
* Drug: nadifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acne vulgaris patients found by a investigator to have at least 10 inflammatory lesions (papules, pustules) on a portion of either a cheeks or the forehead, with an inflammation severity of moderate or worse. Exclusion Criteria: Patients with, for example, acne elastosis, steroidal acne, necrotizing acne, or occupational acne.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 35 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

| Intervention/Treatment |
| --- |
|Drug: clindamycin|nan|
|Drug: nadifloxacin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of investigator) at Treatment Week 4 or EOT (discontinuation) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of the Data Review Committee based on photographs) at Treatment Week 4 or EOT (discontinuation) According |  |  |
Color Perception in Dentistry (CPD)

Study Overview
=================
Brief Summary
-----------------
Visual shade matching (VSM) is the most common procedure to select an adequate shade in dentistry. This clinical procedure requires the use of a shade guide, being Vita Classical (VC) the most popular among the available guides. VSM is a subjective and inconsistent process with many observer related variables (e.g. color deficiency, experience, gender and eye fatigue) that can influence on the final color appearance. The gender influence on the accuracy of VSM is controversial. The purpose of this study is to evaluate the VSM performed by female (F) and male (M) students, using VC shade guide, testing the null hypothesis that VSM is not influenced by gender.

Detailed Description
-----------------
Female and male observers will be analyzed. Human upper central incisors (UCI) will be shade matched to shade tabs from Vita Classical (VC) shade guide. The spectral reflectances from the four UCI and from the 16 VC shade tabs will be measured using a spectroradiometer (SP). Measurements will be performed over a gray background, inside a viewing booth and under D65 illuminant (diffuse/0º geometry). CIELAB coordinates (L*, a* and b*) will be calculated according to CIE D65 illuminant and CIE 2º Standard Observer. Two color difference metrics (CIELAB and CIEDE2000(2:1:1)) will be used to find the best option for each UCI, using VC shade guide. Data will be analyzed using descriptive statistics and McNemar test (α=0.05).

Official Title
-----------------
Influence of Gender on Visual Shade Matching in Dentistry

Conditions
-----------------
Gender

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dental students (DS) from University of Passo Fundo. DS with some knowledge and clinical experience with shade matching. DS from 20 to 35 years old. Exclusion Criteria: DS with abnormal color vision.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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 |
| --- | --- |
| Females observers (F)<br>those with female gender characteristics | |
| Male observers (M)<br>those with male gender characteristics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gender effect on visual shade matching |  | The study last for 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
color, dentistry, gender
Safety and Efficacy of Two Dosages of Inhaled TPI ASM8 Compared to Placebo in Mild to Moderate Asthmatic Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy, safety and tolerability of two dosages of a new drug TPI ASM8 administered by inhalation for 14 days to mild to moderate asthmatic patients, aged between 18-65, non-smokers . The study will also look at the nature and quantity of inflammatory white cells in the lung secretions and in the blood, and some additional inflammation markers.

Detailed Description
-----------------
See above

Official Title
-----------------
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, To Evaluate And Compare The Safety, Tolerability And Efficacy Of Two Dosages Of Inhaled TPI ASM8 Administered For 14 Days In Patients With Mild to Moderate Asthma.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: TPI ASM8
* Drug: ASM8


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 y. old, non or ex-smokers for > 6 months Mild to moderate asthmatic in general good health On either low-dose inhaled corticosteroid or steroid naive No other asthma medication Regular sputum producer EOS more than 3% at randomization, FEV1 > 70% Exclusion Criteria: Respiratory infection within last 4 weeks Any condition that may affect the conduct of the study as per the investigators

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPI ASM8<br>ASM8 0.25mg | Drug: TPI ASM8<br>* 0.25mg, 0.5mg for 14 days, daily dosage<br>|
| Experimental: ASM8 as TPI ASM8<br>TPI ASM8 0.5mg | Drug: ASM8<br>* inhalation 0.25mg daily for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum eosinophils at Day 1 and Day 14 and safety on Day 14 |  | Prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV 1 on Day 1 and Day 14 |  | Prospective | 
| Rescue Medication (albuterol)for 21 days |  | Prospective | 
| Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF |  | Prospective | 
| Blood eosinophils at Day 0 and Day 15 |  | Prospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High eosinophils level in sputum
Evaluation of Hemostasis in Bleeding and Thrombotic Disorders

Study Overview
=================
Brief Summary
-----------------
The objective of this study will be to assess the coagulation system in-vitro in a variety of bleeding and clotting disorders using the ROTEG analyzer and the thrombin generation assay.

Detailed Description
-----------------
This is an exploratory study involving blood coagulation assays in a select group of individuals. The ROTEG is a newly developed coagulation analyzer which allows the continuous assessment of whole blood coagulation from the formation of the first fibrin fibers and activated platelets, to the formation of a three-dimensional whole blood clot until the eventual dissolution of the clot. This device will not be used as a diagnostic or procedure tool. No recommendations regarding interpretation of the results or implications for future treatment will be provided.

Official Title
-----------------
Evaluation of Hemostasis in Bleeding and Thrombotic Disorders Using the Roteg Analyzer and the Thrombin Generation Assay

Conditions
-----------------
Blood Coagulation Disorders, Inherited, Thrombotic Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congenital or Acquired Bleeding Disorder Congenital or Acquired Thrombotic Disorder Exclusion Criteria: Poor venous access

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 98 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 |
| --- | --- | --- |
| Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders | Coagulation will be assessed by continuously recording clot firmness, thrombin generation, and platelet function | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hereditary Bleeding disorder, Thrombotic Disorder
Pain Processing and Pain Reporting in Patients With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The study investigates pain processing and pain reporting in patients with Alzheimers disease compared to healthy participants. Employing a within-subject design, the study includes patients with Alzheimers disease and healthy participants that are exposed to thermal stimuli. During the test session the facial expressions of the participant are video recorded. By repeating this on separate test days, the involvement of pain relief and pain increase is investigated.

Official Title
-----------------
Pain Processing and Pain Reporting in Patients With Alzheimer's Disease

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Behavioral: Thermal stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate patients with Alzheimers disease (group 1) Healthy participants ( group 2) Exclusion Criteria: Chronic pain conditions Other medical, psychiatric or neurological disorders Use of pain-reliving medication 24 hours prior to testing

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Alzheimers diseased patients<br>Behavioral: Different thermal stimulation. Recording of facial expression during thermal stimulation. | Behavioral: Thermal stimulation<br>* Thermal stimulation<br>|
| Healthy participants<br>Behavioral: Different thermal stimulation. Recording of facial expression during thermal stimulation. | Behavioral: Thermal stimulation<br>* Thermal stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale (NRS) | Acute pain assessed on numerical rating scale from 0 (no pain experience) to 10 (worst pain), examining pain intensity. The participant will provide a number on the scale which reflects their pain intensity. | Participants will be tested on three different days. The numerical rating scale will be applied after each thermal stimulus for each test session. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment in persons with Impaired Cognition (PAIC) | Video recordings will be analyzed with the PAIC scale from 0 (not at all) to 3 (great degree). | Participants will be video recorded on each of the three test days during testing. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Alzheimers disease