linjc16/ctgov huggingface dataset:
Constipation and Gut Transit in DMD Patients

Study Overview
=================
Brief Summary
-----------------
In this research study the investigators want to screen Duchenne Muscular Dystrophy (DMD) patients for signs and symptoms of constipation in patients over 18. The investigators hypothesized: DMD patients have a high prevalence of constipation than in the general population. Prevalence of constipation will increase with age and with worsening functional status.

Detailed Description
-----------------
The following procedures will take place during the study. Constipation Assessment: The patient will be asked to complete a questionnaire about any symptoms of constipation. A physician from the study team will perform an abdominal physical exam The patient will have routine x-rays that monitor for spine compression fractures. These films will also be used to assess stool content. Clinical Information The following information will also be collected during the clinic visit ; Age at diagnosis and genetic mutation Age at loss of ambulation if applicable Medications Functional status

Official Title
-----------------
Constipation and Gut Transit in Duchenne Muscular Dystrophy Patients

Conditions
-----------------
Constipation, DMD

Intervention / Treatment
-----------------
* Device: SmartPill ingestion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of Duchenne Muscular Dystrophy (based on clinical presentation and verified by compatible muscle biopsy or known dystrophin gene mutation). Age greater than or equal to 18 years old Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Motility<br>This arm will ingest the SmartPill. | Device: SmartPill ingestion<br>* The participant would ingest the SmartPill and wear the data receiver for up to 5 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI transit times | Gi transit times will be computed by an investigator. | up to 5 days |
Dexmedetomidine for Laryngeal Mask Airway Insertion

Study Overview
=================
Brief Summary
-----------------
The investigators attempted to determine the optimal dose of dexmedetomidine required for the successful insertion of LMA during propofol induction without a neuromuscular blocking agent.

Detailed Description
-----------------
After a predetermined bolus dose of dexmedetomidine was injected over 2 min, anesthesia was induced with propofol 2.0 mg/kg. After confirming the loss of eyelash reflex and the bispectral index (BIS) score decreased below 60, the insertion of LMA was attempted.

Official Title
-----------------
Optimal Dose of Dexmedetomidine for Laryngeal Mask Airway Insertion During Propofol Induction

Conditions
-----------------
Drug Usage

Intervention / Treatment
-----------------
* Drug: dexmedetomidine
* Drug: propofol
* Device: laryngeal mask airway (LMA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II patients undergoing general anesthesia for short elective surgery (<1 hr) Exclusion Criteria: G-E reflux obesity (BMI>30) anticipated difficult airway

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine<br>After intravenous infusion of dexmedetomidine for 2 min, propofol 2.0 mg/kg was administrated. And laryngeal mask airway device was inserted(LMA # 3,4). | Drug: dexmedetomidine<br>* The dose of dexmedetomidine was determined by modified Dixon's up-and-down method, starting from 0.5 μg/kg (0.1 μg/kg as a step size).<br>* Other names: precedex;Drug: propofol<br>* Propofol 2.0 mg/kg was administrated<br>* Other names: 2% fresofol;Device: laryngeal mask airway (LMA)<br>* The insertion of laryngeal mask airway (LMA) was attempted, after confirming the loss of eyelash reflex,the bispectral index (BIS) score decreased below 60.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful insertion of LMA | the response of patients to the insertion of LMA (classified as either 'movement' or 'no movement') during infusion of dexmedetomidine and propofol. | from baseline to 2 min after insertion of LMA (participants will be followed for the duration of anesthetic induction, an expected average of 10 min). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LMA insertion, dexmedetomidine, propofol
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).

Official Title
-----------------
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients Implanted With the GORE® Hybrid Vascular Graft Versus Non-heparin Bonded Synthetic Vascular Grafts.

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Device: GORE® Hybrid Vascular Graft
* Device: Non-heparin bonded synthetic graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is not a candidate for a native fistula. The patient requires the creation of an upper arm vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease. The patient has been on hemodialysis for ≥1 month. Exclusion Criteria: The patient is scheduled for a different surgical procedure within 30 days post Index Procedure. The patient has a known hypercoagulable disorder or bleeding disorder. The patient has had a previous instance of Heparin Induced Thrombocytopenia Type II (HIT type II) or has known sensitivity to heparin.

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GORE® Hybrid Vascular Graft<br>GORE® Hybrid Vascular Graft | Device: GORE® Hybrid Vascular Graft<br> <br> |
| Other: Non-heparin bonded synthetic graft<br>Non-heparin bonded synthetic graft | Device: Non-heparin bonded synthetic graft<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points | Antibody screening was performed using a commercial poly-specific EIA that detects antibodies of any of the IgG, IgA, and / or IgM classes against PF4/polyvinyl sulfonate complexes, the EIA-GAM. | 14 days after index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, End Stage Renal Disease, Vascular Graft
Clinical Trials for Comparison of Two Kinds of Moxibustion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy of Shingigu and Charcoal moxibustion scientifically and objectively.

Detailed Description
-----------------
Moxibustion is traditional treatment that regulate circulation of Qi-blood by making the body warm to prevent and treat disease. Recently many kinds of moxibustion and moxibustion apparatus were developed. However evaluating efficacy of moxibustion is insufficient. Thus, there is need for objective evaluating about efficacy of moxibustion.

Official Title
-----------------
Clinical Trials for Comparison Between Shingigu and Charcoal Moxa on CV-12

Conditions
-----------------
Temperature Change

Intervention / Treatment
-----------------
* Device: Moxibustion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 65 years old Exclusion Criteria: Hyperthyroidism Heart disease(Heart failure, angina pectoris, myocardial infarction) Uncontrolled hypertension (SBP>145mmHg or DBP>95mmHg) Severe renal disorder Severe liver disorder Diabetes Mellitus Female are in the duration of pregnancy

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Shingigu<br>Treat with Shingigu | Device: Moxibustion<br>* Comparison of different kinds of moxibustion<br>|
| Active Comparator: Charcoal<br>Treat with Charcoal | Device: Moxibustion<br>* Comparison of different kinds of moxibustion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature Change after moxa treatment |  | 30 minutes after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Temperature Change, Moxibustion, Warming effect
Long-Term IOP Fluctuation and VF Progression After Triple Procedure

Study Overview
=================
Brief Summary
-----------------
Long-term intraocular pressure (IOP) fluctuation may be significantly associated with the progression of glaucomatous visual field loss, even in patients kept always low IOP after triple procedure, an effective approach for patients with coexisting glaucoma and visually significant cataracts.

Detailed Description
-----------------
Previous studies reported that lowering intraocular pressure (IOP) slowed the advancement of visual field damage in glaucoma patients. However, even if the IOP can been substantially lowered, reduction of mean and peak IOP does not always prevent visual field progression.We believe that the long-term IOP fluctuation may play a significant role in visual field deterioration in those patients.

Official Title
-----------------
Long-Term Intraocular Pressure Fluctuation and Visual Field Progression in Glaucoma Patients With Low Intraocular Pressure After Triple Procedure

Conditions
-----------------
Glaucoma, Filtering Surgery, Intraocular Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Underwent triple procedure At leas 3 years of follow-up after surgery IOP <18mmHg at each postoperative visit A minimum of 5 visual field examinations A reference visual field defect score of 16 or less Good reliability indices of visual field Exclusion Criteria: Any other significant ocular diseases or intraocular surgical histories, Diseases that may affect visual field or diabetes
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 |
| --- | --- | --- |
To Assess the Predictive Value of D-dimer Level on the Occurrence of Cardiovascular Events

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study was to assess whether D-Dimer level at entry or an increase of D-Dimer level during the follow-up could predict the occurrence of subsequent cardiovascular events in patients with atrial fibrillation.

Detailed Description
-----------------
Patients will be followed-up every 4 months with clinical assessment and D-dimer blinded measurement.

Official Title
-----------------
Place Des D-dimères Dans la Prise en Charge Des Patients en Fibrillation Auriculaire : Evaluation de la Valeur prédictive Des D-dimères Sur la Survenue d'événements Thromboemboliques

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: atrial fibrillation Exclusion Criteria: follow-up not possible, poor prognosis within 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fribrillation, cardiovascular events, aging, D-dimer
Safety Analysis of Implantation of Stromal Vascular Fraction

Study Overview
=================
Brief Summary
-----------------
Stromal vascular fraction (SVF) can be isolated from fat (adipose) tissue in an outpatient in-clinic procedure. Platelet rich plasma (PRP) can be isolated from peripheral blood. The SVF includes a variety of different cells and growth factors where the adipocyte (fat cell) population has been removed. The use of SVF in the clinic for a variety of indications is analyzed for incidences of safety and tolerability.

Official Title
-----------------
Safety Analysis of Implantation of Stromal Vascular Fraction

Conditions
-----------------
Safety Issues

Intervention / Treatment
-----------------
* Procedure: Stromal Vascular Fraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 15 and 97 Able and willing to give written informed consent Up to date on all age and gender appropriate cancer screening Exclusion Criteria: Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study Life expectancy < 6 months due to concomitant illnesses. Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. Active infectious disease patients known to have tested positive for HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. Will have an expert consulted as to patient eligibility based on the patient's infectious status Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 97 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: Stromal Vascular Fraction<br>Isolation of SVF from fat tissue for re-administration into the same patient | Procedure: Stromal Vascular Fraction<br>* The fat was separated via centrifuge to isolate the SVF and the cells were delivered intraarticularly, intravenously, intrathecally, or intradiscally directly into the same patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Collection of adverse events | 12 months |
Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder

Study Overview
=================
Brief Summary
-----------------
Using implantable loop recorder the investigators wish to detect atrial fibrillation in high risk patients and compare it to the results using conventional Holter monitoring. The hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The investigators want to detect those people so they can receive appropriate anticoagulation treatment. The patients will get a comprehensive workup including ecg, echocardiography and blood tests.

Official Title
-----------------
Detection of Subclinical Atrial Fibrillation in High Risk Patients (> 65 Years, Hypertension, Diabetes Mellitus) Using Implantable Loop Recorder

Conditions
-----------------
Arterial Hypertension, Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Conventional Holter monitoring
* Device: Implantable loop recorder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 65 years arterial hypertension (at least dual treatment) diabetes mellitus (oral antidiabetics or insulin) Exclusion Criteria: known atrial fibrillation ischaemic heart disease Current anticoagulation treatment Ejection fraction <45 % significant valvular heart disease previous stroke/transient ischemic attack peripheral arterial disease end stage renal disease thyreotoxicosis

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Holter monitoring<br>Screening of patients with older age, arterial hypertension and diabetes for paroxysmal atrial fibrillation by using conventional Holter monitoring | Other: Conventional Holter monitoring<br>* Patients undergo 72h Holter monitoring<br>|
| Other: Implantable loop recorder<br>Screening of patients with older age, arterial hypertension and diabetes mellitus for paroxysmal atrial fibrillation by using an implantable loop recorder | Device: Implantable loop recorder<br>* Implantation of loop recorder with follow-up by remote monitoring<br>* Other names: REVEAL XT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First episode of atrial fibrillation |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between echocardiographic parameters and incidence of atrial fibrillation |  | 1 year |
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.

Study Overview
=================
Brief Summary
-----------------
The objective of this trial is to assess the efficacy of reducing plasma low-density lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg and Crestor 10mg F.C. Tablets in hypercholesterolemia population.

Official Title
-----------------
A Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Roty F.C. Tablets 10mg Versus Crestor 10mg F.C. Tablets in Patients With Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Crestor®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 20 to 85; LDL - C between 130 mg/dL and 250 mg/dL; TG < 400 mg/dL; Who without use of any statin within 2 week prior to the trial; Informed consent given. Exclusion Criteria: Known hypersensitivity or history of SAE with another HMG-CoA reductase inhibitor, in particular any history of myopathy; Active liver disease/severe hepatic impairment(Child-Pugh C,ALT2×ULN); Treatment with Cyclosporin or any disallowed drug; Patients with unstable angina pectoris; Pregnant, lactating women; Patients who have severe medical condition(s) that in the view of the Investigator prohibits participation in the trial.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br>One Rosuvastatin tablet 10mg taken once daily. | Drug: Rosuvastatin<br>* 10mg,once daily<br>* Other names: Roty;|
| Active Comparator: Crestor®<br>One Crestor® tablet 10mg taken once daily. | Drug: Crestor®<br>* 10mg,once daily<br>* Other names: Rosuvastatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks. |  | baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1. |  | baseline to week 12 |