linjc16/ctgov huggingface dataset:
Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

Study Overview
=================
Brief Summary
-----------------
This study evaluated that strict control of perioperative blood glucose following pancreatic resection by using an artificial pancreas would improve postoperative surgical site infection.

Detailed Description
-----------------
This study recruited 50 patients undergoing elective pancreatic resection for pancreatic diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided into two groups: one for whom glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale and another that received programmed infusion of insulin determined by the control algorithm of the artificial pancreas.

Official Title
-----------------
Prevention for Surgical Site Infection After Pancreatic Resection

Conditions
-----------------
Pancreatic Diseases

Intervention / Treatment
-----------------
* Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective pancreatic resection for pancreatic diseases. Exclusion Criteria: weight loss greater than 10% during the previous 6 months sign of distant metastasis respiratory, renal, or heart disease
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>glucose levels were controlled using sliding scale | |
| Experimental: 2<br>received programmed infusions of insulin determined by the control algorithm of the artificial pancreas | Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)<br>* artificial pancreas<br>* Other names: an artificial pancreas system (Nikkiso Inc, Tokyo, Japan);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of surgical site infection |  | 30th postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of hypoglycemia and cost during the hospitalization |  | during the hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery
Pain Screening in Refugee Survivors of Torture

Study Overview
=================
Brief Summary
-----------------
The investigators are evaluating refugee torture survivors who are receiving services at the Weill Cornell Center for Human Rights. There are two research questions in this study: if the current standard of care results in the under or missed diagnosis of pain and pain syndromes, and if a validated pain screening tool can supplement the current standard protocol used in the assessments of survivors of torture.

Detailed Description
-----------------
The research plan consists of three components: The Weill Cornell Center for Human Rights will coordinate with the research team regarding eligible subjects. Researchers will contact potential subjects utilizing interpreter services. Interested participants will be scheduled for an appointment for an examination by a pain physician and to complete the Brief Pain Inventory.

Official Title
-----------------
The Implementation of a Novel Pain-screening Tool in the Diagnoses of Pain Symptoms and Syndromes in Refugee Survivors of Torture

Conditions
-----------------
Pain, Chronic

Intervention / Treatment
-----------------
* Other: Brief Pain Inventory Short Form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women from any country over the age of 18 refugees receiving services from the Weill Cornell Center for Human Rights Exclusion Criteria: Have not experienced torture Subjects whose representative does not believe that they are a good candidate for the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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 |
| --- | --- |
| Other: Brief Pain Inventory Short Form<br>Completes the Brief Pain Inventory Short Form | Other: Brief Pain Inventory Short Form<br>* Brief Pain Inventory Short Form<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with chronic pain or pain syndromes as assessed by a non-invasive pain evaluation conducted by a pain physician | Evaluate whether or not current standard protocols for the assessment of survivors of torture result in under or missed diagnosis of pain and pain syndromes that are identifiable by a pain specialist physician | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with chronic pain or pain syndromes as assessed by the Brief Pain Inventory (BPI) Short Form | Evaluate whether or not a validated pain screening tool can supplement the current standard protocols used in the assessment of survivors of torture. | Day 1 |
Endometrial Scratching for Cryopreserved Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
Endometrial injury performed in a cycle preceding the one for embryo transfer is associated with an increased implantation and pregnancy rate when carried out during the month preceding that of ovulation induction and fresh embryo transfer. However, there is no evidence about the effect of this intervention on the transfer of cryopreserved embryos.

Official Title
-----------------
Endometrial Scratching for Cryopreserved Embryo Transfer: a Randomized Controlled Trial

Conditions
-----------------
Subfertility

Intervention / Treatment
-----------------
* Procedure: Endometrial injury


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 At least one cryopreserved embryo Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Endometrial injury<br>Women allocated to this group will be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer. | Procedure: Endometrial injury<br>* Endometrial biopsy using a pipelle de Cornier<br>* Other names: Endometrial scratching;|
| No Intervention: Control<br>Women allocated to this group will NOT be submitted to endometrial injury before undergoing endometrial preparation for embryo transfer. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth | The complete expulsion or extraction from its mother of a product of fertilization, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Note: Multiple gestational sacs are counted as one clinical pregnancy. | 3 months | 
| Miscarriage | The spontaneous loss of a clinical pregnancy | 5 months |
Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules

Study Overview
=================
Brief Summary
-----------------
The study aimed to determine the best intervention between Core biopsy and Fine needle aspiration in diagnosis of thyroid malignancy.

Official Title
-----------------
Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules, A Prospective Study

Conditions
-----------------
Thyroid Nodule, Thyroid Diseases, Thyroid Gland; Node

Intervention / Treatment
-----------------
* Procedure: FNB
* Procedure: Core biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with nodules larger than 1 cm in diameter and suspicious ultrasound criteria with TIRADS category III or higher. Exclusion Criteria: Patients with a history of hemodynamic instability or inadequate coagulation profile were excluded

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FNB<br> | Procedure: FNB<br>* Fine needle aspiration from the nodules<br>Procedure: Core biopsy<br>* Core biopsy from thyroid nodules<br>|
| Active Comparator: Core biopsy<br> | Procedure: FNB<br>* Fine needle aspiration from the nodules<br>Procedure: Core biopsy<br>* Core biopsy from thyroid nodules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of samples in FNB and CNB matching the final pathology | Comparing number of samples in FNB and CNB that make same diagnosis as the final postoperative pathology | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroid nodule, Core needle biopsy, FNB
EUROpE-RSI (EURopean Online Evaluation RSI Study)

Study Overview
=================
Brief Summary
-----------------
The investigators want to identify and show differences in standards and procedures of in-hospital rapid sequence induction by collecting data with an online survey for anaesthetist in Europe.

Detailed Description
-----------------
The study is designed as a web-based online survey for anaesthetist in Europe. They will be invited via mail, as members of the European Society of Anaesthesiology (ESA), the participation is voluntary. The survey contains 30 items about the standards and procedures of in-hospital rapid sequence induction (RSI). There will be a selection of possible answers, only a few items contains free-text answers. The study collects only personal data to age, country, gender and level of training. The collected data should identify differences in the procedures of RSI.

Official Title
-----------------
EUROpE RSI-Study (EURopean Online Evaluation) - Pan-european Online-survey About Rapid Sequence Induction (RSI) by Anesthetists

Conditions
-----------------
Rapid Sequence Induction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency physician Exclusion Criteria: None Emergency physician

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Differences in the procedure of the RSI (Rapid sequence induction) | The questionnaire date will be collected up to 6 month and processed with Microsoft Excel. | 04.30.2016-10.30.2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rapid Sequence Induction, European, Evaluation, EUROpE RSI, Standards, RSI
The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

Study Overview
=================
Brief Summary
-----------------
The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.

Conditions
-----------------
Hemoglobinuria, Paroxysmal

Intervention / Treatment
-----------------
* Drug: eculizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PNH; At least 18 years old Avoid conception; and Willing and able to give written informed consent Exclusion Criteria: Active bacterial infection Participation in any other drug trial Pregnant breast feeding, or intending to conceive Not vaccinated against N meningitidis

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: eculizumab|600mg IV every week and 900mg IV every 2 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Immunomodulation of E.Coli Nissle 1917 in Patients With Grass Pollen Rhinoconjunctivitis

Study Overview
=================
Brief Summary
-----------------
Due to the worldwide increasing prevalence of the allergic rhinoconjunctivitis, new therapeutical strategies are needed. The symptomatic treatment with topical and systemic antihistamines and corticosteroids are often insufficient. E.coli Nissle 1917 has immunomodulatory capacities and reveals less side effects. E.coli Nissle 1917 has no sedative properties and exhibits no hepatotoxic qualities. Thus, E.coli Nissle 1917 represents a new relevant therapeutical agent.

Official Title
-----------------
Explorative Analysis of the Immunomodulatory Capacities of Apathogenic Escherichia Coli Nissle 1917 in Patients With Rhinoconjunctivitis Due to Grass Pollen Allergy

Conditions
-----------------
Rhinoconjunctivitis

Intervention / Treatment
-----------------
* Drug: Mutaflor
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical relevant grass pollen allergy with required treatment since 2 years positive skin prick test to grass positive sIgE towards grass (CAP 2) written informed consent Exclusion Criteria: perennial rhinoconjunctivitis sinusitis chronic diarrhoea and other existing severe gastrointestinal diseases current specific immunotherapy to grass pollen

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 placebo capsule matching the experimental treatment, according to the experimental arm<br>|
| Experimental: Mutaflor<br> | Drug: Mutaflor<br>* 1 capsule contains 2.5 - 25 billion viable bacteria of the strain E. coli Nissle 1917, 1 capsule daily over the first 4 days, 2 capsules daily until the end of treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom-medication score |  | 45 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
E.coli, Mutaflor, grass pollen, rhinoconjunctivitis, rhinoconjunctivitis caused by grass pollen
Optical Coherence Tomography of Retinal Abnormalities Associated With Choroidal Nevus, Choroidal Melanoma and Choroidal Melanoma Treated With Iodine-125 Brachytherapy

Study Overview
=================
Brief Summary
-----------------
During regularly scheduled appointments, Optical Coherence Tomography (OCT) is performed on consented subjects. The OCT is a new type of camera that takes very detailed pictures inside of the eye and deeper into eye tissues. Optical Coherence Tomography imaging of intraocular tumors may lead to improved diagnosis and monitoring of tumors within the eye.

Conditions
-----------------
Ocular Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18 years or older) with: choroidal nevus greater than or equal to 3.0 mm in longest basal diameter, or greater than or equal to 1.25 mm in apical height or: choroidal melanoma located in the posterior pole (4mm or less from the center of fovea or the border of the optic nerve head) Exclusion Criteria: Ocular media opacity in the tumor eye that prevents adequate functional testing or imaging and prior or concurrent retinal or choroidal disease in the tumor eye that prevents adequate functional testing or imaging

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular Melanoma, Optical Coherence Tomography, Eye Tumor, Choroidal Melanoma, Uveal Melanoma
Effect of Depression, Anxiety and Stress Scores on Embryo Transfer Success

Study Overview
=================
Brief Summary
-----------------
Psychological status of couples attending to IVF programmes is important due to possible effect on final result. Observers aim to invertigate the depression, anxiety and stress scores of couples before and after the procedure.

Detailed Description
-----------------
Studying effect of psychology on IVF is not a new idea. Before and after scores of women attending to IVF programmes had been studies numerous times. However, there is not sufficient data about the contbibution of male compartment upon the process. Investigators aimed to study both male and female participants. Final scores will not be evaluated unless at least goog quality blastocsyt is not transferred.

Official Title
-----------------
Effect of Depression, Anxiety and Stress Scores on Embryo Transfer Success

Conditions
-----------------
Stress, Pregnancy

Intervention / Treatment
-----------------
* Other: questionaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 40 year old women attending to IVF programme Exclusion Criteria: Azospermia and severe male factor for whom sperm freezing will be required History of RIF Known genetik abnormality of couples

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 women attending IVF programme<br>Women attending to IVF programme will be evaluated for pscyhological parameters before and after the precedure | Other: questionaire<br>* two questionaires for each group<br>|
| 2 partners of women attending to IVF programme<br>Men who are partners of women attending to IVF programme will be evaluated for pscyhological parameters before and after the precedure | Other: questionaire<br>* two questionaires for each group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive pregnancy test | blood test will be taken after embryo (blastocyst) transfer | 12 days after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, anxiety, stress, pregnancy, IVF
CD155 in Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
This research is designed to investigate the prognostic and predictive value of CD155 in muscle invasive bladder cancer.

Official Title
-----------------
Predictive Value of CD155 for Survival and Effectiveness of Chemotherapy in Patients With Muscle Invasive Bladder Cancer

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Drug: Adjuvant chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with non-metastatic muscle invasive bladder cancer pathology confirmed urothelial carcinoma underwent cystectomy and pelvic lymph node dissection Exclusion Criteria: not enough tissue for immunohistochemistry patients with a second neoplasm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| FUSCC cystectomy cohort<br>patients underwent cystectomy in Fudan University Shanghai Cancer Center | Drug: Adjuvant chemotherapy<br>* adjuvant chemotherapy using Gemcitabine plus Cisplatin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival | Time to recurrence or metastasis | 2018.1.1-2023.12.31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time to death | 2018.1.1-2028.1.1 | 
| Benefit from neoadjuvant chemotherapy | response to neoadjuvant chemotherapy | 2018.1.1-2028.1.1 | 
| Benefit from adjuvant chemotherapy | Survival analysis grouped by adjuvant chemotherapy | 2018.1.1-2028.1.1 |