linjc16/ctgov huggingface dataset:
Study of Talabostat in Advanced Melanoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the antitumor activity and safety of talabostat in patients with metastatic melanoma.

Conditions
-----------------
Melanoma, Skin Cancer

Intervention / Treatment
-----------------
* Drug: talabostat (PT-100) tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed melanoma that is metastatic (unresectable Stage IV per AJCC 2002) Patients with measurable disease defined as at least one measurable index lesion with clearly defined margins ECOG Performance Status of 0, 1, or 2 Expected survival ≥12 weeks Written informed consent Exclusion Criteria: More than 1 prior chemotherapy or biotherapy regimen for Stage IV melanoma Radiation therapy to >50% of the bone marrow. Patients must not have had prior radiotherapy to index lesions unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation. Clinically significant laboratory abnormalities CNS metastases Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for melanoma. Patients must have recovered from all of the side effects of treatment in order to be enrolled. Pregnant or lactating women.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: talabostat (PT-100) tablets|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Remnants of Conception After Suction Evacuation of Missed Abortion

Study Overview
=================
Brief Summary
-----------------
All women admitted for surgical evacuation of missed abortion after failure of medical treatment from June 2016 underwent transvaginal sonography immediately after completion of the procedure as judged by the operator to ensure absence of remnants.

Detailed Description
-----------------
Women indicated for surgical evacuation of missed abortion up to 12 weeks were included. Standard surgical evacuation of uterus by suction followed by sharp curettage under general anaesthesia were done for all cases. When the operator judged the procedure as complete, transvaginal sonography was done by dedicated sonographer using portable ultrasound machine in theatre. If remnants were detected the procedure was repeated till the cavity seen empty.

Official Title
-----------------
Sonographic Detection of Remnants After Surgical Evacuation of Missed Abortion

Conditions
-----------------
Miscarriage

Intervention / Treatment
-----------------
* Diagnostic Test: Sonographic examination of uterus after surgical evacuation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: multiparous. have missed abortion up to 12 weeks gestational age by dating. failed medical evacuation. consented for the procedure. Exclusion Criteria: suspicion of sepsis. Suspected molar pregnancy. previous evacuation trial. abnormal uterus like fibroids. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Sonographic examination of uterus after surgical evacuation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence remnants of conception | transvaginal sonographic detection | immediately after the end of the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remnants of conception
Risk Factors for Diabetes After Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
This study is proposed to investigate the incidence of Post Transplant Diabetes Mellitus (PTDM) as well as associated risk factors for the development of PTDM in patients undergoing allogenic stem cell transplantation.

Detailed Description
-----------------
Allogenic stem cell transplantation from related or unrelated donors has been used successfully to cure patients with a variety of hematological malignancies. Graft-versus-host disease (GVHD) is an alloreactive immune phenomenon, where the activated donor T cells recognizes the recipient as being foreign and effects a cytotoxic response. GVHD occurring in the first 100 days after transplantation is termed acute GVHD and is characterized by hepatitis, dermatitis, and enteritis. High dose corticosteroids remain one of the cornerstone therapies to treat acute GVHD. However, an association between corticosteroid therapy and the development of diabetes mellitus after solid organ transplantation has become widely recognized. Similarly, post transplant diabetes mellitus (PTDM) has been increasingly noted in the allogenic stem cell transplant population, however, to date, no systematic study has been completed to identify the incidence of PTDM and associated risk factors. We propose to investigate the incidence of PTDM as well as associated risk factors for the development of PTDM in patients undergoing allogenic stem cell transplantation.

Official Title
-----------------
Risk Factors for Developing Diabetes Mellitus After Allogenic Stem Cell Transplantation

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 65 years or age Fulfills institutional criteria for and is scheduled to undergo an allogenic stem cell transplantation at VUMC Exclusion Criteria: Younger than 18 years or older than 65 years Pre-existing diabetes mellitus Positive pregnancy test Unable to complete the conditioning regimen prior to stem cell transplantation Unable to give informed consent

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?
-----------------
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
-----------------
Allogenic Stem Cell Transplantation, Diabetes Mellitus
A Retrospective Study About Treatment Strategy After First/Second Line EGFR-TKI Failure

Study Overview
=================
Brief Summary
-----------------
This is a multi-center retrospective study, designing to access the best treatment strategy in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2). PD1 is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist 1.1 criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter what second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.

Official Title
-----------------
Which Treatment Strategy is Best in Non-small Cell Lung Cancer Patients Harboring EGFR Mutant Type After First/Second Line EGFR-TKI Failure, a Retrospective Study

Conditions
-----------------
Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who was confirmed stage IV (according to International Association for the Study of Lung Cancer（IASLC） TNM staging, 2009) non-small cell lung cancer (NSCLC) by histology or cytology between year 2009 to 2013, harboring EGFR mutant type (19 and/or 21 exon mutation). Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm according to Recist 1.1 criterion (by contrast CT). Patients who take EGFR-TKI as first/second line therapy. Exclusion Criteria: Patients who has taken EGFR-TKI before. Patients who take EGFR-TKI as third or more line. Patients who take EGFR-TKI concurrent with chemotherapy or other anti-tumor drug. The evaluated lesions has treated with radiotherapy before or concurrent with EGFR-TKI. Patients whose EGFR expression is positive by immunochemical and/or EGFR amplification is positive by Fluorescence In Situ Hybridization(FISH), without mutation detection evidence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Progression Free Survival 2 (PFS2) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) |  | 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-small cell lung cancer, EGFR mutant type, first/second line EGFR-TKI
NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine and placebo in patients with peripheral chronic neuropathic pain.

Official Title
-----------------
NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain: a Randomized, Double-Blind, Placebo-Controlled, Crossover Study

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: NS1209
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Neuropathic pain and allodynia after a peripheral nerve injury (VAS >= 4) Exclusion Criteria: Patients who cannot cooperate and do no understand Danish Fertile women Clinically significant abnormality or disease Drug and alcohol abuse Clinically abnormal ECG Hypersensitivity to any of the treatments Patients in treatment with cimetedin, antidepressants, antipsychotics, antiepileptics except gabapentin, anticoagulants, Na channel blockers and beta blockers Patients who have previously been treated in a NS1209 study Patients treated with an investigational drug

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NS1209|nan|
|Drug: Lidocaine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Spontaneous ongoing pain intensity (VAS 0-100) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of responders (at least 33% pain reduction) |  |  | 
| Effect on evoked allodynia (VAS 0-100) |  |  | 
| Pain relief for overall spontaneous pain (complete, good, moderate, slight, none or worse) |  |  | 
| Feeling of unpleasantness (VAS 0-100) |  |  | 
| Pain on movements (VAS 0-100) |  |  | 
| Daily pain (NSP 0-10) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral neuropathic pain, Neuropathic pain, Chronic pain
Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
A total intravenous anesthesia (TIVA) is a useful anesthetic technique that reduces the incidence of postoperative nausea and vomiting (PONV). Investigator hypothesized the incidence of PONV can be further reduced when palonosetron is added to TIVA.

Official Title
-----------------
Comparative Study of TIVA(Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing PONV(Postoperative Nausea and Vomiting)

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Total intravenous anesthesia
* Drug: Total intravenous anesthesia plus palonosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA Physical Status 1 or 2 Elective gynaecological laparoscopic surgery of ≥ 1h duration Exclusion Criteria: Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation Vomiting or retching in the 24 h preceding surgery Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry Ongoing vomiting from gastrointestinal disease

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Tiva group (Group T)<br> | Drug: Total intravenous anesthesia<br>* Total intravenous anesthesia plus normal saline 1.5 ml immediately before induction of anesthesia<br>|
| Active Comparator: TIVA plus palonosetron group (Group T+P)<br> | Drug: Total intravenous anesthesia plus palonosetron<br>* Total intravenous anesthesia plus palonosetron 0.075 mg(1.5 ml)immediately before induction of anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting |  | For 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of nausea |  | For 24 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palonosetron, PONV(postoperative nausea and vomiting), TIVA(Total intravenous anesthesia)
High-field Brain Magnetic Resonance Spectroscopy

Study Overview
=================
Brief Summary
-----------------
Magnetic resonance spectroscopy (MRS) allows non-invasive measurement of the concentration of up to 18 metabolites in the brain (neurochemical profile). The objective of this proposal is to develop new methods for high-field brain MRS (3 to 7 Tesla). Our main hypothesis is that higher magnetic fields lead to improved spatial and temporal resolution and improved quantification precision. Aims To obtain improved neurochemical profiles in the brain using single voxel proton MRS at very high field (3 Tesla to 7 Tesla). To develop new methods for proton magnetic resonance spectroscopic imaging (MRSI) to obtain metabolic maps at very high field (3 Tesla to 7 Tesla). Since this project is focused on technical development, only healthy volunteers will be recruited (no patients).

Official Title
-----------------
Technical Developments for High-field Brain Magnetic Resonance Spectroscopy

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years old Exclusion Criteria: no metallic implant or other MRI-incompatible device

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision of quantification of brain metabolites concentrations | This protocol is devoted exclusively to technical development and testing of MRS methods on our MR scanners. As such, there is no well-defined outcome measure or time frame. It is a continuous effort. We recruit subjects on an ongoing basis to test, optimize, and assess the performance of newly developed techniques. | One time only | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
magnetic resonance spectroscopy, quantification precision, brain, brain metabolites
Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy

Study Overview
=================
Brief Summary
-----------------
Compare changes in bowel function before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy. Compare objective anatomic outcomes before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy.

Official Title
-----------------
Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy

Conditions
-----------------
Pelvic Organ Prolapse, Constipation, Bowel Dysfunction, Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Procedure: Robotic sacral colpopexy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who underwent robotic assisted laparoscopic sacral colpopexy Exclusion Criteria: Any other procedure for the treatment of pelvic organ prolapse
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robotic-assisted sacrocolpopexy patients<br>Patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 and August 2011. | Procedure: Robotic sacral colpopexy<br>* Patients who underwent robotic assisted sacral colpopexy for the treatment of pelvic organ prolapse<br>* Other names: robotic-assisted laparoscopic sacral colpopexy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bowel function | -Patients completed a validated colo-rectal-anal distress inventory (CARDI-8) at all 3 intervals. Specific complaints of splinting with defecation, excessive straining/pain with bowel movements, incomplete bowel emptying/obstructive symptoms and fecal incontinence were addressed. In addition, patients completed a validated colorectal-anal impact questionnaire (CRAIQ-7) at all 3 intervals. The CRAIQ-7 addresses bowel symptoms and the extend of quality of life impingement | preoperatively, 6 months, and one year post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective anatomic outcomes | The pelvic organ prolapse quantification system (POP-Q)- an objective, validated, standardized method of quantifying the degree of pelvic organ prolapse present was used at all visits. | preoperatively, 6 months, and one year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pelvic organ prolapse, constipation, bowel dysfunction, irritable bowel syndrome (IBS), CRADI-8, CRAIQ-7, splinting with defecation, excessive straining, bowel movements, fecal incontinence, bowel symptoms
Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

Study Overview
=================
Brief Summary
-----------------
Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.

Detailed Description
-----------------
This study aims to evaluate the repeatability and reproducibility of Masimo's pulse CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.

Official Title
-----------------
Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

Conditions
-----------------
Anemia, Healthy

Intervention / Treatment
-----------------
* Device: Rad-67 and DCI Mini Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age one month and older Weight greater than or equal to 3 kg The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study Exclusion Criteria: Decision-impaired adult and pediatric patients who are unable to give informed consent/assent Decision-impaired adult on behalf of a pediatric patient who is unable to assent Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc. Subjects deemed not suitable for the study at the discretion of the investigator Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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

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

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: Test subjects<br>Each subject receives the Rad-67 and DCI Mini sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference. | Device: Rad-67 and DCI Mini Sensor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability and reproducibility of CO-oximeter and sensor | The Repeatability and Reproducibility of the sensor will be assessed by varying the testing conditions (operator/device, finger, subject, and repetition) to determine the device and sensor's precision in SpHb measurements. | 120 minutes |