linjc16/ctgov huggingface dataset:
Transcatheter Heart Valve (THV) Sizing and Leakage After Transcatheter Aortic Valve Implantation (TAVI) Before and After Establishing Routine Preprocedure Multi Slice Computerized Tomography (MSCT) Aortic Assessment. A Retrospective Registry Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of annular sizing strategy (MDCT versus TEE) in transcatheter aortic valve implantation on the prevalence and severity of paravalvular regurgitation.

Official Title
-----------------
Transcatheter Heart Valve (THV) Sizing and Leakage After Transcatheter Aortic Valve Implantation (TAVI) Before and After Establishing Routine Preprocedure Multi Slice Computerized Tomography (MSCT) Aortic Assessment. A Retrospective Registry Study

Conditions
-----------------
Aortic Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients implanted with a THV at Aarhus University Hospital Exclusion Criteria: Learning curve patients (the first 40 patients implanted with a THV device at Aarhus University Hospital, Skejby).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MSCT-based prothesis sizing<br> | |
| Echocardiographic-based prothesis sizing<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of no/ mild paravalvular leakage before and after introduction of routing preoperative MSCT |  | 1 week to 3 months post-TAVI | 
| MSCT vs. echocardiographic aortic valve sizing before TAVI |  | time of TAVI | 
| THV size before and after introduction of routing preoperative MSCT |  | time of TAVI |
Behavior and Knowledges of Patients Enrolled Into SIOUX Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to contribute to the evaluation of SIOUX study by adding data about the choices of the observant patients, the mis-observant ones or the protocol deviations.

Detailed Description
-----------------
The adherence to treatment for osteoporosis doesn't exceed 50% after one year. The SIOUX project about the inter-professional collaboration (attending physician with dispensary pharmacist) developed therapeutic patient education (TPE) plans and created follow-up booklets which were dealt to the patients who have to transmit it to their two medical professionals twice a year during three years one after one. The results after 18 months are encouraging about the improvement of adherence to treatment and about the lifestyle changes.

Official Title
-----------------
Understand the Behavior and the Knowledges of Patients Enrolled Into SIOUX Study

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients enrolled into SIOUX study Exclusion Criteria: cognitive troubles which prevent the patient to participate in individual interview

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 |
| --- | --- | --- |
| Medication management | semi-structured interview | year 1 |
An Observational Study to Investigate the Effects of Rapid Transmeridian Travel

Study Overview
=================
Brief Summary
-----------------
Observational study to investigate circadian rhythm patterns

Official Title
-----------------
An Observational Study to Investigate the Effects of Rapid Travel

Conditions
-----------------
Jet Lag Disorder

Intervention / Treatment
-----------------
* Other: Transmeridian travel across multiple time zones


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability and acceptance to provide written consent Men or women between 18-75 years Body Mass Index of ≥ 18 and ≤ 30 kg/m2 Exclusion Criteria: History (within the 12 months prior to screening) of psychiatric disorders Major surgery, trauma, illness or immobile for 3 or more days within the past month Pregnancy or recent pregnancy (within 6 weeks) A positive test for drugs of abuse at the screening visit Any other sound medical reason as determined by the clinical investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Single group<br>No treatment | Other: Transmeridian travel across multiple time zones<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG) |  | 4 days | 
| Karolinska Sleepiness Scale (KSS) in subjects who experienced rapid transmeridian travel. |  | 4 days |
Sief_Twist Sign a Novel View in Fetal Echocardiography

Study Overview
=================
Brief Summary
-----------------
To describe Sief_twist sign as a novel sign in fetal echocardiography as a new ,easy , time effective view in fetal heart examination .

Official Title
-----------------
Sief_Twist Sign a Novel View in Fetal Echocardiography

Conditions
-----------------
Fetal Echocardiography

Intervention / Treatment
-----------------
* Diagnostic Test: Fetal echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton fetus . gestational age 14-37 weeks. no maternal medical disorder . no morbed obisity. Exclusion Criteria: evidence of fetal infection. chorioamnionitis. fetal anomalies. abnormal fetal karyotype patient withdrawal from the study and/or unavailability for follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Extended fetal heart examination | Diagnostic Test: Fetal echocardiography<br>* fetal heart examination by medical ultrasound<br>|
| B<br>Modified extended heart examination | Diagnostic Test: Fetal echocardiography<br>* fetal heart examination by medical ultrasound<br>|
| C<br>Sief_Twist sign only examination | Diagnostic Test: Fetal echocardiography<br>* fetal heart examination by medical ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| obtaining clear images for fetal cardiac structures via standard views which is 4 chamber view[4CH.], left outflow tract view[LVOT.] , right outflow tract view [RVOT.], three vesseles trachea view [3VTV.] | 4 chamber view that describe 4 heart chambers which are 2 atria , 2 ventricles - LVOT. view describes outflow of aorta from left ventricle in normal heart - RVOT describe outflow of pulmonary from rt. ventricle in normal heart - 3VTV describes view of aorta, pulonary and superior viena cava at upper chest | 15 miutes |
Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI

Study Overview
=================
Brief Summary
-----------------
Using Multi-tracer to early diagnosis of therapy-associated cardiotoxicity using multimodality PET/MRI.

Detailed Description
-----------------
In this study investigators evaluated cardiac uptake by different molecular probe such as FDG, FAPI-04 using multimodality PET/MRI. Previous studies have shown that increased cardiac uptake of FDG on PET may be an indicator of myocardial injury after chemotherapy. Cardiac magnetic resonance (CMR) allows for multiparametric evaluation of cardiac morphology, ventricular function, myocardial perfusion, and viability. The combination of PET with MR (PET/MR) is therefore an alternative attractive pairing for diagnostic imaging. The aim of this study is to find noninvasive and effective method for early diagnosis of cardiotoxicity after chemotherapy or immunotherapy

Official Title
-----------------
Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI

Conditions
-----------------
Positron-Emission Tomography, Magnetic Resonance Imaging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: availability of a clinical pre- and post-therapy clinical evaluation encompassing electrocardiogram (ECG) ; normal findings at pre-therapy clinical evaluation; cancer planned chemotherapy or immunotherapy scheme ; available staging FDG-PET/CT scan (PET0); Exclusion Criteria: cannot lie supine for half an hour; refuse to join the clinical researcher; without metal implants.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| therapy group<br>lymphoma patients planned chemotherapy or immunotherapy scheme | |
| healthy control group<br>Inclusion criteria for the controls were no known diseases or syndromes, within the age range from 18 to 35 years. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVR | the ratio of the standardized uptake value(SUVR) of multi-tracer for the heart within each time window to that of the normal tissue such as hepatic blood pool、blood pool and gluteus. | 150 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Of Mapping Value and LVEF From Baseline | The change of mapping value and left ventricular ejection fraction between the value before treatment and the value after treatment was calculated based on cardiac magnetic resonance | 150 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FDG, Positron-Emission Tomography, cardiotoxicity, Magnetic Resonance Imaging, FAPI
Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in insomnia patients.

Official Title
-----------------
Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients (Study LUN01S)

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: Eszopiclone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insomnia participants who did not take eszopiclone before assessment Participants who receive assessment by using sleep questionaries
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with insomnia<br>Participants with insomnia who will receive eszopiclone, per approved label. | Drug: Eszopiclone<br>* The usual dosage of eszopiclone is 2 mg per dose for adults and 1 mg per dose for elderly participants, taken orally before bedtime. The dosage may be adjusted according to the participant's symptoms, but a single dose should not exceed 3 mg in adults and 2 mg in elderly participants.<br>* Other names: EZOP; Lunesta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of overall improvement | Participants will be interviewed regarding sleep improvement at 4 weeks after first dose or discontinuation relative to predose, and select the appropriate answer of: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia
Antibiotics Versus Therapeutic Ultrasound for Sinusitis

Study Overview
=================
Brief Summary
-----------------
Question: Is the effect of therapeutic ultrasound equally effective to antibiotic for treatment of sinusitis? Design: A randomized clinical trial with concealed allocation, self-assessment by the subjects and intention-to-treat analysis.

Detailed Description
-----------------
Subjects (n=48) with clinically diagnosed acute bacterial rhinosinusitis (ABRS)will included. The antibiotic group will receive amoxicillin (500 mg) 3 times per day for 10 days. The ultrasound group will receive therapeutic ultrasound over sinuses at 1.0 W/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days. Improvement of symptoms (pain and congestion; numeric rating scale; 0-10) from day 1 to days 4 and 21 will be recorded. Relapses, side-effects and satisfaction with treatment will be assessed at one-year follow-up.

Official Title
-----------------
Antibiotics Versus Therapeutic Ultrasound for Treatment of Sinusitis: a Randomized Clinical Trial

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Drug: Antibiotic (Amoxicillin)
* Other: Therapeutic ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pain when bending forward, headache, pain in the teeth, purulent nasal secretion, double worsening and white blood cell count (WBC). Patients eligible for the study had to meet one of the first three criteria (pain when bending forward, headache, pain in the teeth) and all of the other indicators (purulent nasal secretion, double worsening, a left handed displacement of lymphocytes and a right handed displacement of granulocytes on the WBC as indication of bacterial infection). Subjects over 15 years of age were included. Exclusion Criteria: Subjects with any kind of antibiotic or allergic treatment within the last three weeks. Antibiotic intolerance. Pregnant women.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Active Comparator: Antibiotic<br> | Drug: Antibiotic (Amoxicillin)<br>* 500 mg, 3 times per day for 10 days<br>|
| Experimental: Therapeutic ultrasound<br> | Other: Therapeutic ultrasound<br>* 1.0 W/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and congestion over in forehead, around nose and pain in the teeth |  | Day 1, 4 and 21, and one-year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic, Ultrasound, Efficacy, Treatment
A Study to Compare Adjuvant Concurrent Chemoradiation (CCRT) to Adjuvant Radiation Therapy (RT) in Grade 2 and 3 Extremity Soft Tissue Sarcomas

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to retrospectively evaluate the outcome of adjuvant concurrent chemoradiation delivered to patients with high grade non-metastatic soft tissue sarcomas of the extremities at the investigators institution paired with patients treated by adjuvant radiation therapy

Official Title
-----------------
A Retrospective Cohort Study to Assess Adjuvant Concurrent Chemoradiation (CCRT) Compared to Adjuvant Radiation Therapy (RT) in the Treatment of Grade 2 and 3 Extremity Soft Tissue Sarcomas

Conditions
-----------------
Sarcoma,Soft Tissue

Intervention / Treatment
-----------------
* Radiation: adjuvant concurrent chemoradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients consecutive enrolled from 1990 to 2004 with soft tissue sarcomas located either in the limbs or girdles, superficial or deep, grade 2 or 3 (FNCLCC), who were first treated with radical conservative surgery and adjuvant RT atto a minimum biologically equivalent dose of 45 Gy, with or without concurrent adjuvant chemotherapy. Exclusion Criteria: A patient record captured outside the time frame from 1990 to 2004 with trunk, retro-peritoneum, and head and neck localisations, grade 1 histology and, PS≥3, were excluded as well as and those plus patients who had received neoadjuvant treatment. Differentiated liposarcomas, dermatofibrosarcomas protuberans, extraskeletal Ewing's sarcomas, primitive neuroectodermal tumors and osteosarcomas were also excluded due to specific treatment strategies.

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 |
| --- |
|Radiation: adjuvant concurrent chemoradiation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 60 months |
Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

Study Overview
=================
Brief Summary
-----------------
Study hypotheses is that Antiparasitic therapy in patients with chronic diarrhea after travel to a developing country, with a negative stool findings, will be significantly effective in eliminating diarrhea and other gastro-intestinal complaints compared to similar patients receiving placebo.

Detailed Description
-----------------
It is common to encounter travelers from developing countries who suffer from persistent diarrhea after returning home. In many cases repeated stool samples are negative for bacteria, parasites and helminthes and the cause of the diarrhea is not found. The main debate is whether this condition is a persistent parasitic infection (unidentified) or post-infectious irritable bowel syndrome.However, clinical experience suggests that some of these travelers respond to antiparasitic therapy. This study aims to answer the question whether antiparasitic treatment in these cases is beneficial.

Conditions
-----------------
Chronic Diarrhea, Abdominal Pain, Bloating

Intervention / Treatment
-----------------
* Drug: Tinidazole and Albendazole
* Drug: Placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diarrhea (3 or more soft stools per day) for at least two weeks after a trip to a developing country in the past year Stool sample negative for bacteria, parasites and helminthes at least once Has not received, until now, antiparasitic or antihelminthic therapy Exclusion Criteria: Bloody diarrhea Fever during enrolment 5. Allergy to the offered medication

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo arm<br>2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days | Drug: Placebo control<br>* 2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days<br>|
| Experimental: Tinidazole and Albendazole treatment<br>Tinidazole 1 gram BID for 2 days followed by Albendazole 400mg BID for 7 days | Drug: Tinidazole and Albendazole<br>* Tinidazole 2 gr/daily for 2 days followed by Albendazole 400mg X2 /day for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in gastrointestinal complaints |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic diarrhea, travelers, Parasites, albendazole, tinidazole
Prognosis Predicting of CRC Patients Based on Morphology and Molecular Biomaker of CTC

Study Overview
=================
Brief Summary
-----------------
Detecting circulating tumor cells from I-IV stage colorectal cancer patients pre-and post-operatively. Analyzing the morphology and biomarkers of CTCs and builting prognosis predicting model based on the morphology and biomarkers of CTCs. Verifying the prognosis model by the survival data.

Official Title
-----------------
Prognosis Predicting of CRC Patients Based on Morphology and Molecular Biomaker of Circulating Tumor Cells

Conditions
-----------------
Colorectal Cancer, Circulating Tumor Cell

Intervention / Treatment
-----------------
* Diagnostic Test: Circulating tumor cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years; Histologically proven colorectal carcinoma (TNM stage I-IV) R0 resection is possible according to preoperative evaluation Written informed consent for participation in the trial. Exclusion Criteria: Primary tumor or metastases not able to be removed radically Receiving any preoperative treatment (Including chemotherapy, radiotherapy and target therapy) Have other malignant tumors meanwhile Other previous malignancy within 5 years

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training Group<br>Training group including about 500 patients that be using to building the prognosis model | Diagnostic Test: Circulating tumor cell<br>* detecting circulating tumor cell pre- and post operatively<br>|
| Validation Group<br>Validation group including about another 500 patients that be using to validating the prognosis model | Diagnostic Test: Circulating tumor cell<br>* detecting circulating tumor cell pre- and post operatively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | The sensitivity of the predictive based on the number and type of circulating tumor cell | 1 year | 
| Specificity | The specificity of predictive model based on the number and type of circulating tumor cell | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | Area under curve of the predictive model | 1 year |