linjc16/ctgov huggingface dataset:
A Retrospective Chart Review of Deceased Patients With Mucopolysaccharidosis Type IIIB

Study Overview
=================
Brief Summary
-----------------
The objective is to perform a retrospective chart review to generate data to evaluate the clinical characteristics and course of disease progression of MPS IIIB.

Official Title
-----------------
A Retrospective Chart Review of Deceased Patients With Mucopolysaccharidosis Type IIIB

Conditions
-----------------
MPS IIIB (Sanfilippo Syndrome)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The deceased patient was diagnosed with MPS IIIB as determined by either of the following: Documented deficiency of NAGLU enzyme activity. Documented functionally-relevant mutations in both alleles of the NAGLU gene. Patient's parent or legal guardian provides informed consent (unless the requirement for informed consent is waived by local regulations). The availability of pre-defined information in the patient's clinical chart: Exclusion Criteria: There are no exclusion criteria for this study.
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 |
| --- | --- | --- |
| Evaluation of disease presentation and the course of disease progression including the end stage of the disease in patients with MPS IIIB, assessed from medical history data obtained by retrospective chart review of deceased patients. | Data obtained by retrospective chart review will include medical history data including patient demographics, disease manifestation onset, clinical history, diagnostic tests and treatments for MPS IIIB, supportive interventions/medications, clinical chemistry and haematology results, anthropometric data, radiology results, and autopsy findings. | N/A as this is a retrospective chart review of deceased patients | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MPS IIIB, Mucopolysaccharodosis III, Mucopolysaccharidosis type IIIB, Sanfilippo Syndrome
Embryo Transfer With Self-spent Culture Medium

Study Overview
=================
Brief Summary
-----------------
Embryo Transfer With Self-spent Culture Medium or new Culture Medium in Vitro Fertilization - Embryo Transfer Process, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two?

Detailed Description
-----------------
Although some metabolites are present in self-spent culture medium, there are some embryonic exocrine factors secreted by embryo.These factors may have a positive impact on embryo implantation and subsequent development. So it is necessary to compare the two ways of embryo transfer with Self-spent Culture Medium or New Culture Medium in vitro fertilization - embryo transfer process. The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two?

Official Title
-----------------
Can Embryo Transfer With Self-spent Culture Medium Improve Clinical Pregnancy Outcomes in Vitro Fertilization - Embryo Transfer Process?

Conditions
-----------------
in Vitro Fertilization

Intervention / Treatment
-----------------
* Procedure: Self-spent Culture Medium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertility female patients with tubal factors, Infertile female patients with spouse factors Exclusion Criteria: Intrauterine adhesions, Endometriosis, Primary ovarian insufficiency， Infectious disease

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-spent Culture Medium<br>Changing embryo transfer solution with self-spent culture medium | Procedure: Self-spent Culture Medium<br>* Replace embryo transfer solution with Self-spent culture medium in IVF-ET.<br>|
| No Intervention: New Culture Medium<br>embryo transfer with new culture medium in IVF-ET | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Pregnant After 4 Weeks | Observe the clinical pregnancy rate under different embryo transfer methods | 4 weeks | 
| Live Birth | Observe the live birth rate under different embryo transfer methods | 40 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embryo Transfer
Magnetic Resonance Imaging of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.

Official Title
-----------------
Magnetic Resonance Imaging of Breast Cancer

Conditions
-----------------
Breast Cancer, Breast Cancer Non-invasive Breast Cancer

Intervention / Treatment
-----------------
* Procedure: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Female Documented breast physical examination, Documented mammography within 3 months of the MR studies Palpable or mammographically-detected suspect breast lesions Women who have already undergone lumpectomy for breast cancer and have post-biopsy/post-radiation changes will be eligible if they have mammographically-detected or palpable breast abnormalities which are sufficiently suspicious to merit core needle or surgical biopsy. EXCLUSION CRITERIA: Male by birth Able to complete the MR examination. Subjects will be interviewed by one of the investigators for the usual contraindications to MR contraindications including Pacemakers Metallic implants Severe claustrophobia Aneurysm clips Pregnancy Current lactation Other conditions precluding proximity to a strong magnetic field. Received an enhanced MR procedure within 48 hours, Iodinated contrast within six hours, Known sensitivity to MR contrast agents, Not likely to complete the study in full or Other clinical reason which would preclude participation in the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic Resonance Imaging (MRI) of Breast Cancer<br>Contrast-enhanced magnetic resonance imaging (MRI) using the standard department of Radiology MRI screening procedures. The duration of scanning may be variable, but will not exceed 90 minutes. | Procedure: MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer. |  | Length of one MRI scan |
BIO.MASTER.BioMonitor 2 Study

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region.

Official Title
-----------------
Master Study of the Insertable Cardiac Monitor BioMonitor 2.

Conditions
-----------------
Tachyarrhythmia, Atrial Fibrillation, Syncope

Intervention / Treatment
-----------------
* Device: BioMonitor 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients without history of atrial fibrillation and with an indication for BioMonitor 2 device or paients planned for loop recorded guided AF-therapy management, with either current known and documented paroxysmal atrial fibrillation or with current known and documented persistent atrial fibrillation indicated for an ablation or was ablated within the last four weeks. Patient is able to understand the nature of the study and provides written informed consent. Patient is able and willing to complete the planned follow-up visits at the investigational site. Patient accepts the Home Monitoring® concept. Age is ≥ 18 years. Exclusion Criteria: Patients implanted with ICD or pacemaker. Patient who is pregnant and/or breast-feeding or who intends to become pregnant during the time of the study will be excluded. Life expectancy of less than 6 months. Participation in another interventional clinical investigation. Participation in a non-interventional study is permitted.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BioMonitor 2|Implantation of BioMonitor 2|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2 |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R-Wave amplitude ≥ 0.3 mV |  | 1 week |
Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Laparoscopic cholecystectomy (LC) is an easy procedure characterized by its minimal invasiveness, less post-operative pain and early recovery when compared to the open conventional cholecystectomy. However, patients who have undergone LC still complain of postoperative pain. It has been reported that ondansetron produces numbness when injected under the skin and has local anesthetic effect that is 15 times more potent than lidocaine the most widely used local anesthetic and probably explains its antiemetic action. It possesses anti-inflammatory, anesthetic, and analgesic properties by its multifaceted actions as a 5-HT3 receptor antagonist, a Na channel blocker, and a mu-opioid agonist which may have a potential role in decreasing pain. The study aimed to demonstrate the effectiveness of IP administration of ondansetron on pain management post LC.

Official Title
-----------------
Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy

Conditions
-----------------
Cholecystitis

Intervention / Treatment
-----------------
* Drug: Ondansetron
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled to undergo elective LC Exclusion Criteria: Patients undergoing chronic pain treatment Previous allergic response to local anesthetics or 5-HT3 receptor antagonists Patients who received analgesics or sedatives 24 h before scheduled surgery

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ondansetron<br>Ondansetron intraperitoneal in the gall bladder bed | Drug: Ondansetron<br>* Interperitoneal administration in the gall bladder bed<br>|
| Placebo Comparator: Saline<br>Normal saline intraperitoneal in the gall bladder bed | Drug: Normal saline<br>* Interperitoneal administration in the gall bladder bed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in postoperative pain between the two groups using visual analogue score (VAS) |  | 24 hours |
Safety and Efficacy Study of CUBICIN (Daptomycin) Under Conditions of Actual Use

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the safety and efficacy of CUBICIN under conditions of actual use in patients who are diagnosed with complicated Skin and Skin Structure infection (cSSI) or Staphylococcus aureus bacteria including right-sided endocarditis and are prescribed CUBICIN by their physician.

Official Title
-----------------
A Descriptive Study of the Efficacy and Safety of CUBICIN (Daptomycin) Under Conditions of Actual Use in the Philippines

Conditions
-----------------
Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cSSSI known or suspected to be due to gram-positive bacteria Diagnosis of right-sided endocarditis with one or more positive culture for S. aureus within two days prior to initiation of medication Prescribed daptomycin by patient's attending physician Exclusion Criteria: Known allergic or serious adverse reaction to daptomycin Patients with pneumonia Patients with baseline CPK values >1000 U/L or 5x ULN

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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events observed during the treatment duration |  | Ranges from during treatment and up to 14 days after last administration of daptomycin (follow up) | 
| Clinical Response determined by cure rate |  | Ranges from during treatment and up to 14 days after last administration of daptomycin | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Daptomycin, endocarditis, complicated skin and skin structure infection
Tailored Internet Information Supply for Patients - Part 2

Study Overview
=================
Brief Summary
-----------------
Medical expert systems in combination with portal searching meta-search engines are exploited to provide reliable patient-tailored information. A prototype of a web-based information system has been developed and is to be evaluated. Its aim is to answer the decisive question whether expert system guided internet meta-search provides a better information supply for patients seeking health information online then this is possible by using ordinary search engines or health portals. The research does neither investigate the influence of ethical nor legal aspects of internet health information supply.

Detailed Description
-----------------
The study is a follow-up of NCT00746408. It has been conducted because for the first study still not enough participants have been recruited. The study took part at Bamberg University in Germany with 140 participants.

Official Title
-----------------
Quality of Self-Diagnosis by Headache Patients Getting Tailored Internet Information - Part 2

Conditions
-----------------
Headaches

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: can use a computer can surf the internet Exclusion Criteria: is a medical expert

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Intervention 1<br>Participants using the prototype to receive expert system guided tailored internet information about the type of headache of a family member who provided anamnesis data for a common kind of headache. | |
| Control 1<br>Participants using search engines and portals to gather internet information about the type of headache of a family member who provided anamnesis data for a common kind of headache. | |
| Intervention 2<br>Participants using the prototype to receive expert system guided tailored internet information about the type of headache of a family member who provided anamnesis data for a less common kind of headache. | |
| Control 2<br>Participants using search engines and portals to gather internet information about the type of headache of a family member who provided anamnesis data for a less common kind of headache. | |

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
-----------------
Internet, Information supply, Tailoring, Patient empowerment, Headaches, Meta-search, Consumer Health Information, Information Services, Information Storage and Retrieval, Information Systems
The Study of EIT-guided Ventilation Strategy on ARDS Patients

Study Overview
=================
Brief Summary
-----------------
This study is a clinical randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between eit-v / q-oriented individualized ventilation strategy and traditional lung protection ventilation strategy, and to establish the demonstration application of eit-v / q-oriented ventilation strategy in ARDS

Official Title
-----------------
The Study of EIT-guided Ventilation Strategy on ARDS Patients

Conditions
-----------------
ARDS, Pulmonary Perfusion

Intervention / Treatment
-----------------
* Procedure: EIT-guided PEEP setting
* Procedure: ARDS-net PEEP setting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to ARDS Berlin standard, ARDS, PaO2 / FiO2 < 200mmhg, peep > 5cmh2o; According to clinical judgment, lung recruitment therapy is needed due to hypoxemia; The subjects or their families signed informed consent. Admission to ICU was less than 72 hours; The estimated duration of mechanical ventilation was more than or equal to 48 hours; Age ≥ 18 years old and ≤ 80 years old; Exclusion Criteria: The patients with heart implants could not be monitored by EIT; Patients or their families refused to participate in the study; Hypernatremia

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EIT-guided group<br>Treatment based on EIT | Procedure: EIT-guided PEEP setting<br>* Ventilator parameter setting by EIT<br>|
| Placebo Comparator: Control group<br>Treatment based on ARDS-net Peep setting | Procedure: ARDS-net PEEP setting<br>* Ventilator parameter setting according to ARDS-net table<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilation free days |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EIT, ARDS, pulmonary perfusion
Expanded Access for ACE-011

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants designed to provide access to ACE-011.

Official Title
-----------------
Expanded Access for ACE-011

Conditions
-----------------
Myelodysplastic Syndrome

Intervention / Treatment
-----------------
* Drug: ACE-011


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ACE-011|ACE-011 will be administered subcutaneous injection|

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
-----------------
Expanded Access, Compassionate Use
Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound

Study Overview
=================
Brief Summary
-----------------
This study will evaluate thyroid nodules using specialized ultrasound imaging methods.

Official Title
-----------------
Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound

Conditions
-----------------
Thyroid Nodules

Intervention / Treatment
-----------------
* Drug: Definity contrast agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients diagnosed with a thyroid nodule 2. Age greater than or equal to 19 years of age 3. Patients must sign informed consent Exclusion Criteria: 1. Women who are pregnant or nursing 2. Patients with pulmonary hypertension, unstable cardiopulmonary condition,or right to left shunt 3. Hypersensitivity to perfluten 4. Psychological condition that renders the patient unable to understand the informed consent

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Definity contrast agent|Thyroid ultrasound using contrast agent|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the accuracy (sensitivity and specificity) of the contrast enhanced ultrasound for characterization of thyroid nodules. |  | 30 days |