linjc16/ctgov huggingface dataset:
Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis

Study Overview
=================
Brief Summary
-----------------
This study will compare the accuracy of diagnosing adenomyosis by obtaining hysteroscopic guided endomyometrial biopsy and comparing it to accuracy of diagnosis by transvaginal ultrasound and magnetic resonance imaging.

Detailed Description
-----------------
Preoperative diagnosis of adenomyosis is usually difficult. The use of ultrasound and MRI for preoperative diagnosis is still of low positive predictive values. The majority of cases of adenomyosis are diagnosed postoperatively after justo pathological examination of the hysterectomy specimens. The introduction of the concept of preoperative diagnosis of adenomyosis through a hysteroscopic endomyometrial biopsies may be a very good method for preoperative diagnosis of this condition. Participants patients who are diagnosed as adenomyosis by Ultrasound and MRI and scheduled for hysterectomy will undergo an endomyometrial biopsy. The accuracy of this method, its sensitivity, specificity, positive and negative predictive values of this method will be compared with the conventional methods for preoperative diagnosis of adenomyosis after final diagnosis by final gusto pathological diagnosis of hysterectomy specimens.

Official Title
-----------------
Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis. A Prospective Cross-sectional Study

Conditions
-----------------
Adenomyosis

Intervention / Treatment
-----------------
* Diagnostic Test: hysteroscopic guided endomyometrial biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with abnormal uterine bleeding due to adenomyosis diagnosed by transvaginal ultrasound and mri and scheduled for hysterectomy Exclusion Criteria: hysterectomy not performed incomplete ultrasound and mri information

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: hysteroscopic guided endomyometrial biopsy|we will obtain hysteroscopic guided endomyometrial biopsy in cases of adenomyosis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare endomyometrial biopsy with postoperative pathology to calculate Accuracy and likelihood ratio of endomyometrial biopsy to diagnose adenomyosis . |  | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, positive and negative predictive values of endomyometrial biopsy for diagnosis of adenomyosis compared to US and MRI |  | through study completion, an average of 1 year |
Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to characterize the time profile of the decongestant properties of xylometazoline and to investigate its effect on sleep, general well-being and smell/taste.

Official Title
-----------------
A Double-Blind, Randomized, Parallel Group, Placebo Controlled Study, Evaluating the Decongestant Effect, Time to Onset, Duration of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold

Conditions
-----------------
Common Cold

Intervention / Treatment
-----------------
* Drug: Xylometazoline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years Have had moderate common cold symptoms for less than 36 hours. Exclusion Criteria: Congested/runny nose for more than two continuous weeks in the previous 12 months Deviated septum or nasal polyps Recent use of antibiotics Recent sinusitis Other protocol-defined inclusion/exclusion criteria may apply.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xylometazoline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the decongestant effect of xylometazoline in subjects with |  |  | 
| common cold compared to placebo treatment by means of rhinomanometry over a period of 12 hours. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction |  |  | 
| and duration of relief of nasal obstruction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Common cold, xylometazoline
EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will be measured by a statistically significant greater mean reduction from baseline compared to endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.

Official Title
-----------------
A Randomized Double-Blind, Placebo Controlled, Flexible Dose, Parallel Group Study of Extended-Release Lorazepam (EDG004) for the Treatment of Generalized Anxiety Disorder (GAD)

Conditions
-----------------
Generalized Anxiety Disorder (GAD)

Intervention / Treatment
-----------------
* Drug: Extended-release lorazepam
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between the ages of 18-65 years and Diagnosed with GAD and No other psychiatric conditions, and are otherwise medically healthy. Exclusion Criteria: Women who are pregnant or lactating.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDG004<br>EDG004 - Extended release lorazepam capsules | Drug: Extended-release lorazepam<br>* Extended-release lorazepam capsules<br>* Other names: EDG004;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42) | HAM-A Total Score was rated by the clinician. Scores range from 0 to 56. A lower score is favorable. Baseline was defined as the last non-missing value prior to receiving double-blind study drug. | Day 42 (Visit 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42) | Measured on a 7-point scale 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Baseline was defined as the last non-missing value prior to receiving double-blind study drug. | Day 42 (Visit 7) |
Serum Endocan Levels and Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
In diabetic patients, serum endocan level has been significantly increased in patients and the levels on the long-term complications are correlated. Based on the Iinformation obtained from these studies, it can be said that there is a strong association between diabetes and serum endocan levels.

Detailed Description
-----------------
It has been shown that endocan level of plasental tissue in gestational diabtes patients is significantly increased when looking at the same week compared with plasenta tissue samples of helathy pregnancy. From the information obtained from these studies, it can be said that there is a strong association between diabetes mellitus and serum endocan levels. investigators aimed to determine the relationship between serum endocan levels and gestational diabetes in the study.

Official Title
-----------------
Evaluation of Serum Endocan Levels in Patients With Gestational Diabetes

Conditions
-----------------
Gestational Diabetes, Endocan

Intervention / Treatment
-----------------
* Diagnostic Test: Serum Endocan Levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being pregnant at 24-26 weeks of gestation having oral glucose toleranse screening test age between 18-45 years Exclusion Criteria: having in utero mort fetus having a previous diagnosis of diabetes having a multiple pregnancy having a coronary artery disease having preeclampcia having a pregnancy obtained by assisted reproductive technology using cigarette using alcohol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with Gestational Diabetes<br>pregnant women who are at 24-26 weeks of gestational age with positive oral glucose tolerance screening test. | Diagnostic Test: Serum Endocan Levels<br>* Detection of Serum Endocan Levels and detection of possible diagnostic association with gestational diabetes<br>|
| Other: Healty Pregnants<br>pregnant women who are at 24-26 weeks of gestational age with normal oral glucose tolerance screening test. | Diagnostic Test: Serum Endocan Levels<br>* Detection of Serum Endocan Levels and detection of possible diagnostic association with gestational diabetes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of diagnostic value of serum endocan levels in patient with gestational diabetes | Identifying diagnostic value of serum endocan by comparing serum levels of endocan in groups. | 3 months |
Long-Term Experience and Health Effects of COVID-19

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. Data will be deidentified and consolidated to create a large national longitudinal database.

Detailed Description
-----------------
Ths is a longitudinal, observational, descriptive study to gather data needed to support a better understanding of COVID-19 from the perspective of a diverse national population. This multi-phase study will use an action research approach to identify specific ways that physician groups, federally qualified health centers (FQHCs), public health departments, and other health and social services systems in the United States can address healthcare needs and mitigate the transmission of COVID-19. Email surveys will be used to assess the historical and current status of participants by medical condition, geography, and demographic characteristics, as well as their history of symptoms (e.g. recent cough, fever, loss of sense of taste or smell, etc.) and their current psychosocial needs. The study will provide the structure for an iterative exploration of trends over time (up to 24 months). The opt-in survey will be posted and available to individuals 18 and older who choose to participate. Survey frequency will be every two weeks. To analyze broader trends, all survey responses will be de-identified and aggregated. Overall general findings will not be linked to individuals or physician groups when reporting and publishing study results.

Official Title
-----------------
A Longitudinal, Long-Term, Observational Study of COVID-19 Experience and Health Effects

Conditions
-----------------
Covid19, Corona Virus Infection, Quality of Life, Risk Reduction

Intervention / Treatment
-----------------
* Other: none - observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Any gender specification Has consented to proceed with survey Is able to complete the survey via email on a regular basis Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: none - observational|online survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal survey | To gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
covid-19, corona virus, covid19, coronavirus, SARS-CoV-2, infection, household, transmission, vaccine, clinical trials, online, Altura, outpatient, telemedicine
A Novel Prognostic Model of NPI for Risk-Predicting and Clinical Decision-making in Diffuse Large B-Cell Lymphoma in the Rituximab Era

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the predictive value of a model of Nomogram Prognostic Index (NPI) in patients with Diffuse Large B cell lymphoma.

Official Title
-----------------
A Novel Prognostic Model of NPI for Risk-Predicting and Clinical Decision-making in Diffuse Large B-Cell Lymphoma in the Rituximab Era

Conditions
-----------------
Diffuse Large B Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed diagnosis of CD20+ DLBCL Exclusion Criteria: primary central nervous system lymphoma double-hit lymphoma

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 |
| --- | --- | --- |
| Overall survival |  | 5-year |
Glottic Width and Respiratory Flow in Patients With Various Lung Diseases

Study Overview
=================
Brief Summary
-----------------
In this study the investigators examine the glottic width and the respiratory flow at rest in patients with various lung disease. The investigators postulated that a positive expiratory pressure is created through the narrowing of the glottic width in patients with hyperinflation.

Official Title
-----------------
Glottic Width and Respiratory Flow in Patients With Various Lung Diseases

Conditions
-----------------
Lung Diseases

Intervention / Treatment
-----------------
* Other: Laryngoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical indication for a bronchoscopy Minimum age of 18 years Signed informed consent Exclusion Criteria: Patients requiring mechanical ventilation during bronchoscopy Disease of the larynx Inability to breathe through the mouthpiece

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 with COPD<br> | Other: Laryngoscopy<br>* Observation of glottic width in different arms<br>|
| Patients with interstitial lung disease<br> | Other: Laryngoscopy<br>* Observation of glottic width in different arms<br>|
| Healthy subjects<br> | Other: Laryngoscopy<br>* Observation of glottic width in different arms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angle of the glottic width |  | 18 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glottic movement, emphysema, copd, vocal cord
Liquid Biopsy in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess clinical utility of combined circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) in the diagnosis of primary lung cancer.

Detailed Description
-----------------
The peripheral blood and tumor tissue samples are collected from the participants.CTC and ctDNA are analyzed from the blood samples.

Official Title
-----------------
Clinical Utility of Combined CTC and ctDNA Assay in the Diagnosis of Primary Lung Cancer

Conditions
-----------------
Lung Cancer (Diagnosis), Circulating Tumor Cell

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histology-proven lung cancer or a clinical suspicion of lung cancer Age >=18, < 80 years No previous history of cancer treatment within 5 years Patients who agree to participate Exclusion Criteria: Patients who have been diagnosed with malignancy within 5 years Patients with previous history of lung cancer Patients who have uncontrolled coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Diagnostic sensitivity of combined CTC and ctDNA | To compared the sensitivity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of combined CTC and ctDNA | To compared the accuracy of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer | 1 year | 
| Diagnostic specificity of CTC and ctDNA | To compared the specificity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, Circulating Tumor Cell, Cell-Free Tumor DNA, Liquid Biopsy
Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery

Study Overview
=================
Brief Summary
-----------------
the aim of the SERAPHINE study is to gather data stemming from the French research database BERHLINGO (= Base d'Etude et de Recherche en Hémostase pour Les Investigateurs du Grand-Ouest, i.e. Database for Research on Hemostasis for the Investigators of Western France), in order to get a detailed report about the therapeutic management and use of turoctocog alfa (NovoEight®) in surgery in pwHA (Patient with inherited Hemophilia A).

Official Title
-----------------
Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery

Conditions
-----------------
Hemophilia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Regardless of age No inhibitor (anti-FVIII alloantibodies) at the time of treatment. No objections expressed to participate in the study after having been informed of its purposes and the data involved. No other inherited hemorrhagic disorders than HA Exclusion Criteria: In order to reflect the reality of daily practice, no criteria for non-inclusion are provided for other than the refusal of the patient or his or her legal representative to participate in the study or the existence in the patient of a contraindication to the use of turoctocog alfa (NovoEight®) treatment.

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

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the effectiveness of turoctocog alfa (NovoEight®) to prevent hemorrhagic complications during minor and major surgery procedures in pwHA | Overall evaluation by the investigator of the hemostatic effectiveness of turoctocog alfa (NovoEight®) for the prevention of hemorrhagic complications in a surgical setting (excellent, good, fair, poor/none according to recommendations of the SSC of ISTH) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the safety of turoctocog alfa (NovoEight®) when used during surgery in patients with the occurrence of adverse events (AEs), especially hemorrhagic and thrombotic complications or development of inhibitors. | Nature and incidence of AEs, including serious AEs, AEs related to turoctocog alfa (NovoEight®) | 1 year | 
| Assessing the duration of replacement therapy and factor VIII consumption in clinical practice during surgery in patients treated with turoctocog alfa (NovoEight®) | Number of administrations and total required dose of turoctocog alfa (NovoEight®) in IU/kg | 1 year |