linjc16/ctgov huggingface dataset:
A Pilot Study to Explore the Role of Gut Flora in Myasthenia Gravis

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed Description
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The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Myasthenia Gravis.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Myasthenia Gravis

Conditions
-----------------
Myasthenia Gravis, Myasthenia Gravis, Generalized

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent Male or female of all ages. Diagnosis of Myasthenia Gravis by a physician Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myasthenia Gravis<br>Patients who have been diagnosed with Myasthenia Gravis. | Other: No intervention<br>* There is no intervention for this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with Myasthenia Gravis. | Three years |
REpetitive Assessement of SCOREs in Patients on Dual Antiplatelet Therapy

Study Overview
=================
Brief Summary
-----------------
Patients treated with percutaneous coronary intervention (PCI) require dual antiplatelet therapy (DAPT). Preliminary assessment of the PRECISE-DAPT score is mandatory in order to assess the risk of bleeding while on DAPT. The score takes into consideration age, creatinine clearance, haemoglobin, white-blood-cell count and previous spontaneous bleeding. One should consider, however, that some of the variables included in the PRECISE-DAPT score might change with time. As a consequence, the PRECISE-DAPT score should not be considered a static score as it might vary after the initial computation. It remains unknown, however, if the delta PRECISE-SCORE, reflecting the change in score between baseline and follow-up, might predict more reliably the long-term bleeding risk of PCI patients.

Detailed Description
-----------------
The RE-SCORE registry is a multicenter study aimed at comparing the predictive value of the PRECISE-DAPT score assessed at time of discharge vs. the Delta PRECISE-DAPT score, as assessed every 3 months in PCI patients receiving DAPT. The primary end-point of the study is the occurrence of bleeding, as defined according to the criteria of the Bleeding Academic Research Consortium (BARC), either in the whole study population or in men vs women.

Official Title
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REpetitive Assessement of Thromboembolic and Bleeding SCOREs in Patients Treated With Dual Antiplatelet Therapy

Conditions
-----------------
Dual Anti-platelet Therapy

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: All patients undergoing percutaneous coronary intervention and treated with dual antiplatelet therapy for at least 3 months Exclusion Criteria: Contraindications to dual antiplatelet therapy lasting more than 3 months

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 |
| --- | --- | --- |
| Bleeding in the overall population | Bleeding episodes | Up to 12 months | 
| Bleeding in men and women | Bleeding episodes | Up to 12 months |
Is Carotid Intima-media Thickness Affected by A1C Variability?

Study Overview
=================
Brief Summary
-----------------
This study was conducted to evaluate the effect of A1C variability on the progression of carotid artery intima-media thickness in type 2 diabetic patients.

Conditions
-----------------
Type 2 Diabetes, A1C Variability

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: type II fluoroscopy in carotid once a year during 2 years Exclusion Criteria: type 1 diabetes history or clinical evidence of coronary artery disease or cerebral or peripheral vascular disease the presence of albuminuria (defined as 24 hour urine albumin excretion ≥ 30 mg) renal dysfunction (defined as creatinine blood level ≥ 2.0 mg/dL) hepatic dysfunction (defined as alanine aminotransferase and/or aspartate aminotransferase blood level ≥ 3 × upper normal limit) smoking within the past 3 months prior to commencement of the study use of any medication likely to alter IMT such as calcium channel blocker, thiazolidinedione, antiplatelet agent (clopidogrel, cilostazol) use of glucocorticoid pregnancy severe concomitant disease such as cancer infection Cushing's syndrome acromegaly, or any other disorder likely to alter glycemia primary hypercholesterolemia hypothyroidism or hyperthyroidism use of any hormonal drugs alcoholism or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 34 Years
Maximum Age: 79 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 |
| --- | --- | --- |
Study of Nutritional Factors in Porphyria

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether differences in dietary habits are associated with disease activity in patients with acute intermittent porphyria. II. Determine whether premenstrual porphyria attacks are associated with increased luteal phase energy requirements. III. Determine whether energy requirements are higher than intakes in men with unexplained frequent porphyria attacks. IV. Assess the nutritional status of women with acute intermittent porphyria using a comprehensive series of laboratory methods, including zinc and pyridoxine status. V. Determine whether the frequency of disease exacerbations decreases when dietary and nutritional abnormalities are corrected in these patients. VI. Evaluate the safety and efficacy of a parenteral nutrition regimen for patients with acute porphyria attacks.

Detailed Description
-----------------
PROTOCOL OUTLINE: Women record diet intake for at least 1 cycle (28 days), then undergo a comprehensive nutritional assessment at least once during the follicular and luteal phases of the cycle. Men also record diet intake for at least 1 month and undergo indirect calorimetry and other studies. All patients receive a comprehensive analysis of diet and energy metabolism. Energy expenditure, resting metabolic rates, and basal metabolic rates are determined with indirect calorimetry, including measurements taken during the follicular and luteal phases of the cycle. Other testing includes hormone assays, serology for nutritional studies, and a urinary metabolite profile. Zinc, lead, and other metals are measured by atomic absorption spectroscopy. The diagnosis of acute intermittent porphyria is confirmed by erythrocyte porphobilinogen deaminase; urinary aminolevulinic acid, porphobilinogen, and porphyrins; and total fecal porphyrins. Patients hospitalized for acute attacks of porphyria during the study will receive standard treatment, including intravenous hematin and parenteral support.

Conditions
-----------------
Porphyria

Participation Criteria
=================
Eligibility Criteria
-----------------
Acute intermittent porphyria Variegate porphyria and hereditary coproporphyria eligible but analyzed separately

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inborn errors of metabolism, porphyria, rare disease
Caris Molecular Intelligence Registry

Study Overview
=================
Brief Summary
-----------------
This data collection Registry is a multi-center, observational outcomes Database designed to collect data on the demographics, presentation, diagnosis, treatment, resource use, quality of life and outcomes of subjects utilizing Caris Molecular Intelligence™ Services for treatment of solid tumor cancer.

Official Title
-----------------
A Registry of Caris Life Sciences® Molecular Intelligence™ Service (Biomarker Assessment Results) Intended for Correlation With Cancer Clinical Outcomes

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Other: No intervention required, purely observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years, and Solid Tumor analyzed by Caris Molecular Intelligence™ Service Profile(s) and/or Caris Next-Generation Sequencing Exclusion Criteria: Individual test orders; defined as single biomarker assessment Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoner-patients shall not be approached for participation in the Registry.

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 required, purely observational|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided. |  | 5 years per patient |
Relationship Between Mid-luteal Serum Progesterone Levels to Pregnancy Rates in Assisted Reproductive Techniques (ART)

Study Overview
=================
Brief Summary
-----------------
In Assisted Reproductive Techniques (ART) there is a need for luteal support using progesterone, estrogen and probably human chorionic gonadotropin (HCG). The optimal route of administration and dose has not yet been determined. The aim of the study is to investigate whether high levels of mid-luteal serum progesterone are related to higher pregnancy rates in ART cycles. We also plan to investigate whether using higher doses of vaginal progesterone results in higher pregnancy rates.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Additional vaginal progesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mid-luteal serum progesterone levels below 15 ng/dl Exclusion Criteria: Does not sign consent form

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

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

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

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 |
| --- | --- |
| Active Comparator: Supplementary progesterone<br>Women with mid-luteal progesterone levels that are less than 15 ng/dl will receive higher doses of supplementary progesterone | Drug: Additional vaginal progesterone<br>* The progesterone dose will be raised from 200 mg daily to 300 mg daily<br>|
| No Intervention: No additional progesterone<br>No additional progesterone given to women with mid-luteal progesterone levels below 15 ng/dl | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rates |  | One week |
Chronic Periodontitis and Tooth Loss in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Periodontitis is a highly prevalent chronic inflammatory disease that is characterized by loss of the periodontal ligament and alveolar bone, and is a major cause of tooth loss. Results from clinical and epidemiological studies have suggested that periodontitis and tooth loss are more prevalent in individuals with rheumatoid arthritis (RA). There is evidence to suggest that periodontitis could indeed be a causal factor in the initiation and maintenance of the autoimmune inflammatory response that occurs in RA. If so, chronic periodontitis might represent an important modifiable risk factor for RA. However, to date longitudinal studies on the effect of periodontitis on disease progression in RA are lacking. The aim of the present study is to assess the periodontal status of patients enrolled in an established longitudinal cohort of RA patients. These data will then be analysed to evaluate whether or not periodontal inflammation is related to parameters of rheumatoid arthritis.

Official Title
-----------------
Chronic Periodontitis and Tooth Loss in Patients With Rheumatoid Arthritis

Conditions
-----------------
Periodontitis, Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfilling the 1987 revised criteria for the classification of Rheumatoid arthritis Under active follow-up by a rheumatologist at the Dudley Group of Hospitals Participation in study 04/Q2702/18 Establishment of an inception cohort for the prospective evaluation of predictors of cardiovascular morbidity and mortality in patients with rheumatoid arthritis. Participation in study 04/Q2702/18 A prospective study of micro and macro vascular disease in a cohort of patients with Rheumatoid arthritis). Written informed consent Exclusion Criteria: No absolute exclusion criteria

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 |
| --- | --- |
| Patients with rheumatoid arthritis<br>The inception cohort of 400 patients will be followed up for 20 years following recruitment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associations between periodontal parameters and RA related factors including disease activity, severity, progression, and comorbidities |  | 1 year |
Nipple Areola Complex Conservation

Study Overview
=================
Brief Summary
-----------------
96 patients were offered a nipple sparing mastectomy.

Detailed Description
-----------------
96 patients were operated on 109 breasts between Jul 2003 and May 2006 because of breast cancer, recurrence was observed.

Official Title
-----------------
Subcutaneous Mastectomy With Conservation of the Nipple Areola Complex: Broadening the Indications

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

Intervention / Treatment
-----------------
* Procedure: mastectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer Exclusion Criteria: inflammatory breast cancer clinical skin or nipple involvement
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Procedure: mastectomy<br> <br> * Other names: breast surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumour recurrence |  | 07/2003 - 02/2008 | 
| % of nipple areola complex conservation |  | 07/2003 - 02/2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cosmetics |  |  | 
| patient's satisfaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nipple sparing mastectomy, NAC conservation
An Observational Study to Evaluate Lymph Metastases and Prognoses of the Patients With Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
The real-world observational study was designed to explore lymph metastases and prognoses of the Chinese patients with thoracic T1-T3 esophageal cancer

Detailed Description
-----------------
This trial is a real-world non-interventional observational study. The Chinese patients with thoracic T1-T3 esophageal cancer enrolled from Jan.1999 to Jun.2017 were included and the study data on pathologically diagnosed patient demographic/tumor biological characteristics were collected to evaluate the relevance of lymph metastases and prognoses of the subjects.

Official Title
-----------------
A Real-world Observational Study to Evaluate Lymph Metastases and Prognoses of the Chinese Patients With Thoracic T1-T3 Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Procedure: Surgeries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >= 18 years old; Patients who received radical resection of esophageal cancer; Pathologically diagnosed patients with thoracic T1-T3 esophageal cancer after surgeries; Exclusion Criteria: Patients who received upper gastrointestinal surgeries; Patients with second primary tumors;

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 |
| --- | --- |
| T1-T3 esophageal cancer<br>Pathologically diagnosed patients with T1-T3 esophageal cancer who received surgeries | Procedure: Surgeries<br>* Radical resection of esophageal cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of lymph nodes and percentages of patients with surgeries | Numbers of lymph nodes and percentages of patients with surgeries in the patients with thoracic T1-T3 esophageal cancer | 1999 - 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact factors of lymph metastases | Impact factors of lymph metastases | 1999 - 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chinese, real-world evidences, T1-T3 esophageal cancer
Clinical Profiles and Outcomes of Acute Aortic Dissection in the Chinese Patients

Study Overview
=================
Brief Summary
-----------------
Clinical profiles and outcomes of patients with acute aortic dissection have not yet been evaluated in China. The aim of this study is to establish clinical registry of acute aortic dissection in China and to analyze clinical features, managements and outcomes of Chinese patients with acute aortic dissection.

Detailed Description
-----------------
In 1996, the Internation Registry of Acute Aortic Dissection(IRAD) was established to improve clinical diagnosis and treatment of acute aortic dissection. However, most patients from the IRAD are Caucasian. These data were not sufficient to reflect clinical profiles and outcomes of Chinese patients with acute aortic dissection. In China, little is known about clinical features, managements and outcomes of acute aortic dissection involving a large number of patients. The investigators established clinical multicenter registry of acute aortic dissection. Between January 2009 and February 2012, about 2000 were enrolled in the Chinese registry of acute aortic dissection(CRAD) database. The aim of this study is to analyze clinical profiles and outcomes of Chinese patients with acute aortic dissection.

Official Title
-----------------
The Study of The Chinese Registry of Acute Aortic Dissection and Clinical Study of Acute Aortic Dissection in Chinese Patients

Conditions
-----------------
Aorta Thoracic Ascending Dissection, Dissection of Descending Aorta

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stanford type A dissection Stanford type B dissection Retrograde Stanford Type B dissection Unclassified dissection with primary tear located in the aortic dissection Exclusion Criteria: Aortic aneurysm Active infection or active vasculitides Myocardial infarction or Cerebral accident within 2 months Unwillingness to cooperate wiht study procedures or follow-up visits

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic dissection, Risk factor, Feature, Management, Outcome