linjc16/ctgov huggingface dataset:
Safety of a Diagnostic Strategy With D-Dimer Testing for PE

Study Overview
=================
Brief Summary
-----------------
To determine whether D-Dimer testing, using the MDA D-Dimer assay, can be used to simplify the diagnostic process for pulmonary embolism (PE). This will be assessed by performing a cohort study in 1000 patients with suspected PE. To ascertain if an MDA D-Dimer result of less than 0.75 ug/mL FEU obviates the need for further testing and therapy in patients with suspected PE.

Detailed Description
-----------------
Prospective cohort study of 1000 patients in which those with a negative D-Dimer result undergo no further testing and are followed for 3 months for venous thromboembolism. Patients with a positive D-Dimer undergo standardized testing.

Official Title
-----------------
A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer Testing in Patients With Suspected Pulmonary Embolism

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Procedure: MDA D-Dimer Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Suspected PE Exclusion Criteria: Treatment with full-dose anticoagulants for 24 hours or more OR an ongoing requirement for anticoagulants Other tests for PE performed prior to eligibility assessment (e.g.other D-Dimer, V/Q scan, pulmonary angiogram, spiral CT, compression ultrasound, venogram). Cardiorespiratory instability requiring immediate performance of other tests to diagnose or exclude PE (i.e. inability to wait 30-60 minutes for MDA D-Dimer result) Comorbid condition limiting survival to less than three months Patient has been asymptomatic for seven days prior to presentation Current pregnancy Contraindication to contrast (e.g., allergy, renal failure). Geographic in accessibility which precludes follow-up Presence of central venous catheter (permanent or temporary, including PICC line) at the time of eligibility assessment

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MDA D-Dimer Testing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venousthromboembolism |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Embolism, Deep Vein Thrombosis, MDA D-Dimer Testing, Diagnostic Algorithm
Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy

Official Title
-----------------
Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy

Conditions
-----------------
Gut Microbiota, NSCLC, Pembrolizumab, Chemotherapy

Intervention / Treatment
-----------------
* Drug: Pembrolizumab Combined With Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - non-small cell lung cancer patients with less than brain metastases Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment Patients who have not received intracranial local treatment before Exclusion Criteria: - Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds Patients with hemorrhage in intracranial metastasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Pembrolizumab Combined With Chemotherapy<br> | Drug: Pembrolizumab Combined With Chemotherapy<br>* Pembrolizumab and chemotherapy are carried out at the same time for every 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diversity of gut microbiota | Species and abundance of gut microbiota | 1 year |
Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir

Study Overview
=================
Brief Summary
-----------------
Little is known about efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic ehpatitis B patients who achieved a complete virological response to entecavir and tenofovir. This study aimed to investigate the efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic hepatitis B patients with undetectable heaptitis B virus DNA while on tenofovir plus entecavir combination therapy.

Official Title
-----------------
Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir Combination Therapy-Multicenter Randomized Open-label Controlled Trial

Conditions
-----------------
Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48

Intervention / Treatment
-----------------
* Drug: tenofovir monotherapy
* Drug: tenofovir plus entecavir combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM(rtL180M and/or M204V/I) & ADV (rtA181V/T and/or rtN236T) or ETV (rtT184A/C/F/G/I/L/S, rtS202G, or rtM250L/V, in addition to rtM204V/I) HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval currently receiving TDF+ETV for more than 12 months Exclusion Criteria: Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV

Ages Eligible for Study
-----------------
Minimum Age: 19 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: tenofovir<br> | Drug: tenofovir monotherapy<br>* switching to tenofovir monotherapy<br>|
| Active Comparator: tenofovir plus entecavir<br> | Drug: tenofovir plus entecavir combination<br>* continuing tenofovir plus entecavir<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVR at week 48 | Proportion of patients with a sustained virological response (serum HBV DNA <20 IU/mL) at week 48 | 48 week |
Study Evaluating RGH-188 in the Treatment of Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This is a study designed to evalute the safety and efficacy of RGH-188 in the treatment of acute schizophrenia. This study will be 10 weeks in duration; 6 weeks double-blind treatment, and 4 weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of the three treatment groups--one of two doses of RGH-188 or placebo

Official Title
-----------------
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: RGH-188


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female inpatients, 18-65 years of age, meeting DSM-IV-TR criteria for schizophrenia and having a Total Positive and Negative Syndrome Scale (PANSS) Score >=80 and <=120. A score >=4 on item P1 (delusions) or P3 (hallucinatory behavior) and a score of >=4 on item P2 (conceptual disorganization) or P6 (suspiciousness/persecution) of the PNASS Exclusion Criteria: Patients with documented disease of the central nervous system that can interfere with the trial assessments, including but not limited to stroke, tumor, Parkinson's, organic brain disease, seizure disorder (except for febrile convulsions during infancy), chronic infection, or neurosyphilis; or patients who have suffered a traumatic brain injury resulting in significant impairment

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: RGH-188|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS Total Score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-S |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia
Conserving Breast Surgery - Comparison of Conventional With Sonography

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to test whether surgical removal of a tumor under sonographic control as compared to conventional method reduces the rate of resections and local relapse

Official Title
-----------------
Comparison of Sonographically Assisted With Conventionally Breast Surgery - Prospective, Randomised, Multicenter, Parallel Group Study With Two Study Arms

Conditions
-----------------
Breast Surgery

Intervention / Treatment
-----------------
* Procedure: Sonography assisted breast surgery
* Procedure: Conventional breast surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 70 years Female Presurgical validated breast cancer Exclusion Criteria: Sonographically not defined report Lobular breast cancer Extensive ductal carcinoma in situ

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sonographically assisted breast surgery<br>Sonographically assisted breast surgery | Procedure: Sonography assisted breast surgery<br> <br> |
| Active Comparator: Conventional breast surgery<br>Conventional breast surgery | Procedure: Conventional breast surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of second tumor resections |  | Five years |
Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is therefore to study the actual doses of X-rays delivered to the patient's skin during recanalization of a coronary artery in a context of Chronic Total Occlusion

Official Title
-----------------
Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)

Conditions
-----------------
X-rays; Effects, Chronic Total Occlusion

Intervention / Treatment
-----------------
* Radiation: Gafchromic film


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years-old Patient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization Patient benefiting from a social protection insurance Patient having been informed and not objecting to this research Exclusion Criteria: Patient refusal to participate in the study Patient with known radiosensitivity factors (eg: Lupus) Patient having had radiotherapy treatment of the thoracic region. Patient whose sum of radiation doses to the skin> 0.5 Gy in the thoracic region in the 3 months preceding inclusion. Patient participating in another clinical study Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision Pregnant or breastfeeding woman Patient hospitalized without consent.

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 |
| --- | --- |
| Patient requiring intervention (complex coronary dilation or coronary recanalization)<br>Patient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization | Radiation: Gafchromic film<br>* Before the X-ray radiation, a Gafchromic film will be placed on the patient's back at the start of the operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose measured to the patient's skin at the entrance to the X-ray beam | Dose expressed in Gy (Peak skin dose). | 1 month |
Evaluation of Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8 weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with coronary artery disease.

Official Title
-----------------
An 8-Week Randomized Double Blind Placebo Controlled Multicenter Trial to Evaluate the Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease.

Conditions
-----------------
Myocardial Ischaemia, Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Behavioral: Cholesterol lowering diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of Coronary arterial disease Suffering ischaemic episodes/exercise induced ischaemia Not taking any cholesterol lowering medication Exclusion Criteria: Unstable angina or heart attack less than one month before trial entry Coronary arterial surgery as defined by protocol Uncontrolled hypertension, diabetes, hypothyroidism or laboratory values as defined by the protocol.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rosuvastatin | Drug: Rosuvastatin<br> <br> * Other names: Crestor;|
| No Intervention: 2<br>Diet | Behavioral: Cholesterol lowering diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring. |  | 8 weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in duration of ischemic episodes |  | 8 weekly | 
| Safety |  | 8 weekly | 
| Several laboratory parameters as detailed in the protocol |  | 8 weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crestor, Rosuvastatin, Cholesterol, Coronary artery disease, Myocardial ischaemia.
Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study

Study Overview
=================
Brief Summary
-----------------
This study aims to compare scar outcomes between rapidly absorbable and non-absorbable sutures (stitches) for the closure of wounds after skin cancer removal on the face.

Official Title
-----------------
Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study (RAVNAS)

Conditions
-----------------
Scars

Intervention / Treatment
-----------------
* Other: rapidly absorbable suture (Vicryl Rapide)
* Other: non-absorbable suture (Ethilon)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mohs surgical wound on the face Wound greater than or equal to 4 cm in length Subject is willing and capable of cooperating to the extent and degree required by the protocol and will be able to come for follow-up assessments Subject has read and signed Subject Information and Informed Consent Form Exclusion Criteria: Surgical wound less than 4 cm in length Surgical site outside of face Subject to be be treated with radiation therapy after surgery Subject is not willing or able to attend for follow-up assessments

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rapidly absorbable suture (Vicryl Rapide)<br> | Other: rapidly absorbable suture (Vicryl Rapide)<br> <br> |
| Active Comparator: non-absorbable suture (Ethilon)<br> | Other: non-absorbable suture (Ethilon)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stony Brook Scar Evaluation Scale (SBSES) score |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scar outcome, Mohs surgery, face
I2-CoRT WTP9: Upper Extremity Motor Intervention, Use of Hand Orthosis in People Post-stroke

Study Overview
=================
Brief Summary
-----------------
The upper extremity kinematics of people post-stroke will be monitored with/without an inactive hand orthosis (intervention: added weight to hand) during ARAT, Fugl-Meyer, and Box and Blocks tests. Measurements will occur right after inclusion and repeated once after 7-8 weeks. Upper extremity kinematics and test scores will indicate the influence of additional weight to hand as a possible confounder when, in the future, the hand orthosis would be used as a therapy tool.

Official Title
-----------------
I2-CoRT WTP9 Bovenste Extremiteit Motoriek Interventie Met Hand Orthese Bij Mensen na Een Beroerte

Conditions
-----------------
Stroke, Upper Extremity Dysfunction

Intervention / Treatment
-----------------
* Other: Additional weight at hand


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-stroke Receive regular therapy at Jessa hospital Able to willingly sign informed consent Exclusion Criteria: Relapse during study Secundary complications limiting upper extremity performance

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Added weight to hand<br> | Other: Additional weight at hand<br>* Added weight of an inactive hand orthosis (300 gram)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test | Score | 0 weeks | 
| Action Research Arm Test | Score | 8 weeks | 
| Fugl-Meyer | Score | 0 weeks | 
| Fugl-Meyer | Score | 8 weeks | 
| Box and Blocks | Score | 0 weeks | 
| Box and Blocks | Score | 8 weeks | 
| Upper extremity kinematics | Joint angles | 0 weeks | 
| Upper extremity kinematics | Joint angles | 8 weeks |