linjc16/ctgov huggingface dataset:
Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
A study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with T2DM.

Detailed Description
-----------------
A multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CT-996 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes, Overweight or Obesity

Intervention / Treatment
-----------------
* Drug: CT-996
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants 18-65 years old, inclusive BMI of 25 - 40, inclusive Stable body weight for two months Exclusion Criteria: History of significant medical conditions and malignancy Uncontrollable hypertension History of alcoholism or drug addiction within 1 year prior to Screening Current or recent participation in an investigational clinical trial

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-996<br>Capsule of CT-996 intervention | Drug: CT-996<br>* Capsule of CT-996<br>|
| Placebo Comparator: Placebo<br>Capsule of placebo matching CT-996 dose | Drug: Placebo<br>* Capsule of Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events in CT-996 participants | To evaluate the safety and tolerability of CT-996 | Baseline up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observe drug concentration (Cmax) of CT-996 | PK Cmax | Baseline up to 28 days | 
| Effect of a High-Fat Meal on Plasma Concentration of CT-996 | Determine the effect of a high-fat meal on the PK of CT-996 following a single dose | Baseline up to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, Obesity, Overweight
Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration

Official Title
-----------------
Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Other: Sample examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed neovascular age-related macular degeneration. Exclusion Criteria: Chronic gastrointestinal disorders
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<br>Patients | Other: Sample examination<br>* No intervention will be performed<br>|
| Control<br>Control | Other: Sample examination<br>* No intervention will be performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal microbiome profile | Intestinal microbiome profile | 2022-2023 |
OCT and OCTA Deep Learning in Waldenström's Macroglobulinemia Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in Waldenström's Macroglobulinemia patients, using optical coherence tomography angiography.

Detailed Description
-----------------
Waldenstrom macroglobulinemia (mak-roe-glob-u-lih-NEE-me-uh) is a rare type of cancer that begins in the white blood cells. The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features. The study evaluates the changes in optical coherence tomography angiography features in Waldenstrom macroglobulinemia, elaborating these data with artificial intelligence.

Official Title
-----------------
OCT and OCTA Deep Learning in Waldenström's Macroglobulinemia Patients

Conditions
-----------------
Waldenstrom Macroglobulinemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age older than 18 years diagnosis of Waldenstrom Macroglobulinemia absence of previous ocular surgery and congenital eye diseases. absence of errors of refraction absence of lens opacities absence of low-quality OCT and OCTA images Exclusion Criteria: • age younger than 18 years previous ocular surgery and congenital eye diseases errors of refraction lens opacities low-quality OCT and OCTA images

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| waldenstrom macroglobulinemia patients<br> | |
| healthy patients matched age and sex without waldenstrom macroglobulinemia and ocular disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measurements of retinal and choriocapillary vessel density in Waldenstrom Macroglobulinemia patients. | The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density matched with clinical parameters resulted from the artificial pancreas device | up to three months |
Total Body Perfusion in Patients With Chest Pain

Study Overview
=================
Brief Summary
-----------------
The Purpose of this study is to better understand changes in obstructive coronary artery disease in different organs other than the heart such as the brain and the kidneys using a new generation total body PET scanner.

Detailed Description
-----------------
Patients with chest pain and suspected CAD will be studied using total body PET imaging with O15-water perfusion imaging

Official Title
-----------------
Total Body Perfusion in Patients With Chest Pain

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented history of chest pain with CT imaging showing a potential for obstructive coronary artery disease Ability to sustain adenosine injection 0.14 mg/kg/min Exclusion Criteria: Second or third degree AV-block without pacemaker Sick sinus syndrome Consumption of coffee or aminophylline within 12 hours of administration Recent use of dipyridmole or dipyridamole-containing medications Known hypersensitivity to adenosine Unstable acute MI or acute coronary artery syndrome, and prior cardiac transplantation Active wheezing and bronchospasm Sinus bradycardia with HR<40 bmp

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 |
| --- | --- | --- |
| Perfusion in heart, brain and kidneys during rest and adenosine stress, and their associations with psychologic factors and anginal symptoms | Multiorgan perfusion changes in patients with chest pain | The imaging day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association between perfusion in heart, brain and kidneys, and adverse events during five year follow-up | Multiorgan perfusion changes in patients with chest pain as related to outcome | Five year follow-up after the imaging |
MRI in Ovarian Tumors

Study Overview
=================
Brief Summary
-----------------
Role of multi paramrtric MRI and MRI perfusion in indetermint ovarian lesions by using ORADS MRI

Detailed Description
-----------------
Aim of study the purpose of this study is to investigate the capabilities of multi parametric MRI including DCE perfusion and DWI to discriminate between benign and malignant ovarian masses .

Official Title
-----------------
Role of Multi Paramertic MRI and MRI Perfusion in Indetermint Ovarian Lesions by Using ORADS MRI

Conditions
-----------------
Ovarian Neoplasms

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females with ovarian masses - Exclusion Criteria: females with known benign ovarian masses
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: females with ovarian masses
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: female with ovarian masses<br>MRI with contrast according to the kidney function test of the patients | Device: MRI<br>* MRI with contrast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI in ovarian tumors | Role of parametric MRI in determint ovarian lesions by using ORADS MRI | 2 years |
Perioperative Management of Colorectal Cancer Patients Infected With COVID-19: a Multicenter Prospective Cohort Study.

Study Overview
=================
Brief Summary
-----------------
This trial is a multicenter prospective cohort study to explore timing of colorectal cancer surgery after COVID-19 infection so that can assist clinicians and patients. Currently, there is less evidence on perioperative outcomes after COVID-19 vaccination and the omicron variant. Therefore, it is necessary to update previously published consensus which recommends that patients should avoid elective surgery within 7 weeks of COVID-19 infection remain, unless the benefits of doing so exceed the risk of waiting. Aiming at the above problems, we plan to carry out a multicenter prospective cohort study to develop perioperative management according patients' different conditions.

Official Title
-----------------
Perioperative Management of Colorectal Cancer Patients Infected With COVID-19: a Multicenter Prospective Cohort Study.

Conditions
-----------------
Colorectal Cancer, Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Procedure: Timing of colorectal cancer surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing colorectal cancer surgery infected with COVID-19 but nucleic acid test result is negative the patients compliance is good signed the consents voluntarily Exclusion Criteria: undergoing emergency surgery(intestinal obstruction, intestinal perforation, intestinal hemorrhage, et al.) The patients' situations which judged by situations is not suitable to participate in the clinical trial
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 |
| --- | --- |
| More than 7 weeks<br>Timing of colorectal cancer surgery is more than 7 weeks after confirmed COVID-19 infection by COVID-19 nucleic acid test. | Procedure: Timing of colorectal cancer surgery<br>* The timing of colorectal cancer surgery is different according patients' different conditions which is difined as more than 7 weeks or less than 7 weeks.<br>|
| Less than 7 weeks<br>Timing of colorectal cancer surgery is less than 7 weeks after confirmed COVID-19 infection by COVID-19 nucleic acid test. | Procedure: Timing of colorectal cancer surgery<br>* The timing of colorectal cancer surgery is different according patients' different conditions which is difined as more than 7 weeks or less than 7 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical complications | Complications including: intraperitoneal hemorrhage, anastomotic leak, anastomotic bleeding, abdominal infection, pulmonary infection, chylous fistula, intestinal obstruction, et al. | 30 days after surgery |
Outcomes of Perforation After Colorectal Endoscopic Submucosal Dissection

Study Overview
=================
Brief Summary
-----------------
Endoscopic resection of superficial colorectal neoplasms decrease risk of colorectal cancer. En bloc resection is necessary for large superficial lesions with risk of superficial submucosal cancer and is advised if feasible for all lesions. Endoscopic submucosal dissection (ESD) allows en bloc resection of large superficial colorectal neoplasms, increasing curative resection rate and decreasing local recurrence risk. However, the risk of perprocedural or delayed perforation is higher compared to wild field piece meal endoscopic mucosal resection. Endoscoping clipping and closing methods mostly allow conservative treatment, but some case still necessitate surgery. The aim of our study is to describe and ananalyse outcomes after perprocedural or delayed perforation in all patients undergoing ESD and analyse the need for surgical intervention.

Official Title
-----------------
Outcomes of Perforation After Colorectal Endoscopic Submucosal Dissection

Conditions
-----------------
Colorectal Neoplasms, Perforation of Rectum, Perforation Colon

Intervention / Treatment
-----------------
* Procedure: Endoscopic submucosal dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients from the FECCO (NCT04592003) cohort experiencing perprocedural or delayed perforation age over 18 years old Exclusion Criteria: patients refusing exploitations of health datas patient treated with endoscopic mucosal resection

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 |
| --- | --- |
| Perforation<br>all patients with immediate or delayed perforation identified from the FECCO (NCT04592003) | Procedure: Endoscopic submucosal dissection<br>* standard ESD performed and complicated with a perprocedural or delayed perforation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery | Rate of surgery following perforation after ESD | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | length of hospital stay (days) | 60 days | 
| Hospital readmission |  | 30 days | 
| Curative resection rate |  | 60 days | 
| Endoscopically closed perforation rate |  | 30 days | 
| Risk factors for endoscopic closure failure |  | 30 days | 
| 30-days mortality rate |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic submucosal dissection, laterally spreading tumors, perforation
Cystatin D Fibrinogen Like Protein 1

Study Overview
=================
Brief Summary
-----------------
to detect role of cystatin D and fibrinogen like protein 1 in rheumatoid arthritis asses relationship between disease activity and cystatin D and fibrinogen like protein 1

Official Title
-----------------
Role of Cystatin D and Fibrinogen Like Protein 1 in Rheumatoid Arthritis and Their Relation to Disease Activity

Conditions
-----------------
Fibrinogen Like Protein 1

Intervention / Treatment
-----------------
* Diagnostic Test: ELISA TEST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patient diagnosed for rheumatoid arthritis Exclusion Criteria: patient with overlap syndrome indiviuals with other auto immune diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| active disease<br> | Diagnostic Test: ELISA TEST<br>* ELISA TEST for cystatin D and fibrinogen like protein<br>|
| control<br> | Diagnostic Test: ELISA TEST<br>* ELISA TEST for cystatin D and fibrinogen like protein<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detect role of cystatin D and fibrinogen like protein 1 | detect role of the two biomarkers and there relationship to rheumatoid arthriths | one year |
Clinical Evaluation and Assesment of Ginigivitis Patients Treated by Yarrow Natural Extract in Compare to a Contro Group

Study Overview
=================
Brief Summary
-----------------
A double-blind, prospective, randomized, intra-individual comparative, single-center clinical study was conducted. Participants were placed in parallel groups, and the study was performed in the Department of Operative Dentistry and Periodontology, Dental School and Hospital, Minia university to compare the antibacterial activity of yarrow Moringa herbal combinations nanoparticles in compared to Chlorhexidine as a potential treatment for gingivitis.

Official Title
-----------------
Clinical Assessment of Antibacterial Anti-inflammatory Activities of Yarrow Moringa Herbal Combinations in Bucco Adhesive Films

Conditions
-----------------
Gingivitis

Intervention / Treatment
-----------------
* Drug: Yarrow and moringa mixture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a minimum of four natural uncrowned teeth in one quadrant present good general health can follow instructions Exclusion Criteria: were pregnant or breastfeeding evidence of antibiotic use during the 4 weeks prior to the study were allergic to personal care/consumer products or their ingredients

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Bucco-adhesive films with Yarrow and Moringa extract nanoparticles | Drug: Yarrow and moringa mixture<br>* yarrow and moringa mixture nano particles loaded on buccal film<br>|
| Active Comparator: control group<br>Cholorohexiden oral gargles | Drug: Yarrow and moringa mixture<br>* yarrow and moringa mixture nano particles loaded on buccal film<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibacterial and anti inflammatory activities | scoring of erthymia and pain (no pain=0) and the other end (worst pain=10). | two weeks |
Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Several case reports have described the use of rocuronium and sugammadex in patients with myasthenia gravis (MG). However, reports regarding the effects of sugammadex compared with that of acetylcholinesterase inhibitors (AChEIs) on perioperative outcomes of video-assisted thoracoscopic surgery (VATS)-thymectomy in patients with MG are still lacking. Thus, the investigators will investigate the effects of sugammadex compared to AChEIs on the postoperative recovery in patients with MG who underwent VATS-thymectomy. This retrospective study include patients with MG, aged> 18 years who received sugammadex or pyridostigmine-glycopyrrolate or neostigmine-glycopyrrolate after VATS-thymectomy between November 2007 and December 2020. Inverse Probability of Treatment Weighting (IPTW) adjustment will be performed to balance the baseline characteristics between the two groups. The primary outcome is the length of postoperative hospital stay, and the secondary outcomes are the incidence of postoperative mortality and postoperative complications, as well as postoperative extubation and reintubation rates in the operating room after VATS-thymectomy; the outcomes are compared between the two groups. 

Official Title
-----------------
Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study

Conditions
-----------------
Myasthenia Gravis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients underwent VATS-thymectomy between November 2007 and December 2020 Exclusion Criteria: Patients who was not diagnosed with myasthenia gravis Age ≤ 18 Patients for which no reversal agent was used

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| sugammadex group<br>patients who administered sugammadex | |
| AChEI group<br>patients who administered pyridostigmine-glycopyrrolate or neostigmine-glycopyrrolate | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital stay | length of postoperative hospital stay (day) | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative mortality |  | up to 1 year | 
| postoperative complication incidence |  | up to 1 year | 
| postoperative extubation rate in the OR |  | up to 1 year | 
| postoperative reintubation rate in the OR |  | up to 1 year |