linjc16/ctgov huggingface dataset:
Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)

Study Overview
=================
Brief Summary
-----------------
This is an expanded access study for cancer treatment with balstilimab alone or in combination with zalifrelimab for an intermediate-size participant population. This study addresses the treatment needs of participants who have been previously and specifically treated with balstilimab alone or in combination with zalifrelimab in a clinical study, who have experienced a benefit from this treatment and/or wish to continue treatment, and who are eligible for treatment under this expanded access study.

Detailed Description
-----------------
This study will not exceed 100 participants. Participants will be reevaluated annually to assess the treatment benefit of zalifrelimab and/or balstilimab and thereby, continued eligibility for treatment. Under this program, treatment will be continued with balstilimab, as either monotherapy or as used in combination therapy with zalifrelimab, for participants that have previously received one or both of these investigational medicinal products in a clinical study.

Official Title
-----------------
Expanded Access for Cancer Treatment With Balstilimab (AGEN2034), Either as Monotherapy, or as Used in Combination With Zalifrelimab (AGEN1884)

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Balstilimab
* Drug: Zalifrelimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must have completed predicate study protocol requirements, including prior treatment duration and follow-up. 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: Balstilimab|An anti-programmed death 1 (PD-1) monoclonal antibody.|
|Drug: Zalifrelimab|An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.|

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
-----------------
Balstilimab, AGEN2034, Zalifrelimab, AGEN1884, Monotherapy
Effectiveness of Intraoperative Cell Salvage in Aseptic Revision Total Hip Arthroplasty.

Study Overview
=================
Brief Summary
-----------------
Intraoperative cell salvage is an important measure of patient blood management but its effectiveness in patients undergoing revision total hip arthroplasty remains unclear. Over the last decade, we have used intraoperative cell salvage systematically in this group of patients. However, since the use of cell salvage has a cost and requires additional resources, we decided to retrospectively investigate its usefulness in this particular indication.

Official Title
-----------------
Effectiveness of Intraoperative Cell Salvage in Aseptic Revision Total Hip Arthroplasty: a Single-center Retrospective Study

Conditions
-----------------
Revision of Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Procedure: Use of Cell Salvage in revision of total hip arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients were adults undergoing elective aseptic revision of hip arthroplasty at the department of orthopedic surgery of the University Hospital of Liege between 01 January 2011 and 31 December 2020. Exclusion Criteria: Patients undergoing revision for infection or with local malignancies were excluded from this study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Use<br>Patients in whom the cell saver was effectively used | Procedure: Use of Cell Salvage in revision of total hip arthroplasty<br>* The effective use of the cell saver was defined as the ability to re-transfuse at least 125 mL of re-suspended red blood cells with a hematocrit of 60 %.<br>|
| Not Use<br>Patients in whom the cell saver wasn't effectively used | Procedure: Use of Cell Salvage in revision of total hip arthroplasty<br>* The effective use of the cell saver was defined as the ability to re-transfuse at least 125 mL of re-suspended red blood cells with a hematocrit of 60 %.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell savage use | The primary outcome was the proportion of patients in whom the cell saver was effectively used (%) | during the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-infused | Total volume of re-suspended blood re-infused (mL) | during the surgical procedure | 
| Hemoglobin | Post-operative hemoglobin level (g/dL) | during the surgical procedure | 
| Allogenic Transfusion | The need for allogenic blood transfusion (unit) | 7 days | 
| Aspirated blood | The total volume of blood aspirated into the reservoir (mL) | during the surgical procedure | 
| Fluid | The total amount of fluid infused (mL) | during the surgical procedure |
Studying Genes to Identify Melanoma in Patients in Iceland and Their Family Members

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying the genes expressed in samples of blood from patients with cancer and their family members may help doctors identify biomarkers related to cancer. PURPOSE: This clinical trial is studying genes to identify melanoma in patients in Iceland and their family members.

Detailed Description
-----------------
OBJECTIVES: Assess the feasibility of Iceland Genomics Corporation (UVS) to identify melanoma in multiple-case families, individuals with multiple tumors, and selected additional family members in Iceland. Assess the feasibility of mutation detection using sequencing and HPLC. Determine UVS' ability to create datasets with demographic, epidemiologic and molecular data. OUTLINE: Participants and patients undergo blood collection and complete lifestyle questionnaires. All patients and population-based controls have DNA samples sequenced for MC1R. Demographic and epidemiologic data on all study participants is collected. Sequencing of the major melanoma susceptibility genes CFDKN2A, CDK4, and MC1R is also performed.

Official Title
-----------------
Genetic Epidemiologic Studies of Melanoma in Iceland

Conditions
-----------------
Melanoma (Skin)

Intervention / Treatment
-----------------
* Genetic: mutation analysis
* Other: high performance liquid chromatography
* Other: laboratory biomarker analysis
* Other: questionnaire administration


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Patients diagnosed with melanoma and selected family members are eligible to participate Must live in Iceland PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: mutation analysis|nan|
|Other: high performance liquid chromatography|nan|
|Other: laboratory biomarker analysis|nan|
|Other: questionnaire administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility to identify melanoma |  |  | 
| Feasibility to detect mutation |  |  | 
| Ability to create datasets |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma, recurrent melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma
Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy

Study Overview
=================
Brief Summary
-----------------
Single usage, open label study in 16 adult healthy males. Eligible subjects will receive a single usage of the investigational device. Retention of the radiolabeled device will be monitored using gamma scintigraphy.

Official Title
-----------------
Retention of an Orally Administered Investigational Device in the Oropharynx of Healthy Human Male Volunteers

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Device: Polymer based lubricating liquid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refrain from nasal, throat, or lung inhalants and exercise for 24 hour prior to the test Are able to tolerate the procedure and Be generally healthy Exclusion Criteria: Have history of allergy or hypersensitivity to the study ingredients Major diseases Taking medication regularly Radiation exposure recently

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Polymer based lubricating liquid<br>* three sprays of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve for the percent of the mucoadhesive liquid retained in the oropharynx |  | one hour |
The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study aims to further validate and extend our previous findings insofar that the effect of the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole on sensorimotor gating processes and its relationship to cognitive performance shall be explored.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-40 Gender: male Exclusion Criteria: Axis I Disorders: lifetime DSM IV diagnosis according to DIA-X of alcohol or illicit drug dependence. No life-time DSM IV diagnosis according to DIA-X of a major affective, psychotic, anxiety disorder, eating-disorder as defined above. Axis II Disorders: lifetime DSM IV diagnosis of personality disorder according to SCID-II. Family history: lifetime history of 1st degree relative (parents and siblings) of a major affective, psychotic, or anxiety disorder as defined above. ECG: QTc-interval >450 msec. Systolic blood pressure <100 mmHg Bradycardia (Hf < 50/Min) und Arrhythmias Hypokalemia or Hypomagnesemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Healthy volunteers with high sensory gating levels. | Drug: Sertindole<br>* oral 3 x 4mg<br>Drug: Placebo<br>* 3 x 4mg Placebo<br>|
| Experimental: 1<br>Healthy volunteers with low sensory gating levels. | Drug: Sertindole<br>* oral 3 x 4mg<br>Drug: Placebo<br>* 3 x 4mg Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI) |  | after placebo and and after medical treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performances |  | after placebo and and after medical treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sertindole, sensory gating, PPI, P50 suppression, CANTAB, Effect of Sertindole on sensory gating (P50 suppression), on sensorimotor gating (PPI), and cognition (CANTAB)
An Observational Study of Avastin (Bevacizumab) in Combination With Carboplatin/Paclitaxel in First Line in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (OTILIA)

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the safety, efficacy, quality of life and predictive/selection factors for Avastin (bevacizumab) in combination with carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be collected during up to 15 months of treatment and 12 months of follow-up. A second recruitment phase has been opened to focus on patients >/= 70 years.

Official Title
-----------------
Non-interventional Surveillance Study (NIS) on First-line (FL) Bevacizumab (Avastin) in Combination With Carboplatin/Paclitaxel in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Conditions
-----------------
Peritoneal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study phase 1: Patients aged >/= 18 years Study phase 2: Patients aged >/= 70 years Newly diagnosed advanced epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer with indication for a first-line carboplatin/paclitaxel chemotherapy in combination with Avastin Exclusion Criteria: Contraindications to Avastin according to Summary of Product Characteristics

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 |
| --- | --- |
| Cohort<br>Overall sample | |
| Subgroup<br>Patients aged >/= 70 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Progression-free survival |  | up to approximately 27 months | 
| Safety: Incidence of adverse events |  | approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires |  | up to approximately 27 months | 
| Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics |  | approximately 5 years | 
| Treatment discontinuations/modifications |  | approximately 5 years | 
| Treatment duration |  | approximately 5 years |
Study in an Ex-vivo Thrombosis Model With Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion

Study Overview
=================
Brief Summary
-----------------
Evaluation of fibrin and platelet deposition on a human umbilical endothelial cell surface in perfusion chamber experiments using human whole blood. Open-label, non interventional study Perfusion chamber experiment will be performed in 30 healthy patients. The Impact of different pH-solutions on thrombus lysis will be evaluated in an in-vitro second step Outcome: D-Dimer content of the thrombus reflecting the size of the thrombus.

Detailed Description
-----------------
All Subjects will have two perfusion chamber experiment as follow with an estimated maximum of blood loss of 165ml: Before blood perfusion, perfuse the system including the chambers with human umbilical vein endothelial cell coated glass slides (HUVEC), with sodium chloride (NaCl) (0.9%), to ensure no leaks and to remove all air bubbles. Blood is drawn from a vein in the arm with a Surflo® Winged Infusion Set, 19G (Terumo Europe, Leuven, Belgium) with a pump (Masterflex® L/S™, Cole-Parmer Instrument Company, Vernon Hills, Illinois, USA). Five mL of blood is discarded before each perfusion. Three in serial placed flow chambers (with HUVEC) heated to 37°C are used. They are made of a Plexiglas block through which a cylindrical hole of 0.2 cm in diameter is machined. The aorta pieces are perfused at 10 mL/min for 5 minutes, followed by a 30 seconds perfusion with NaCl (0.9%). The plasmin degraded thrombus D-Dimer content will be further evaluated under different conditions (different pH solutions).

Official Title
-----------------
Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion

Conditions
-----------------
Thrombosis, Thrombus Formation, Thrombus Stability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Written informed consent Exclusion Criteria: Use of any medication Current diseases Anemia

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 |
| --- | --- | --- |
| D-Dimer content of the plasmin degraded thrombus |  | Assessment will follow after all perfusion chamber experiments (1 week) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perfusion chamber, thrombus D-Dimer, HUVEC
AIM1: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid

Study Overview
=================
Brief Summary
-----------------
There is an epidemic of thyroid cancer that is harmful to patients and the medical system. The study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate when deciding the next step in management for a thyroid nodule. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer.

Official Title
-----------------
Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid

Conditions
-----------------
Thyroid Nodules, Thyroid Cancer

Intervention / Treatment
-----------------
* Behavioral: Counseling using the electronic conversation aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >18 years old presenting for evaluation of a thyroid nodule Exclusion Criteria: Patients with hyperthyroidism Patients with previous biopsy of the nodule of interest Pregnant patients Prisoners

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Counseling using the electronic conversation aid | Behavioral: Counseling using the electronic conversation aid<br>* This conversation aid will help you and your doctor discuss ways to care for your thyroid nodule. We will evaluate the acceptability of the conversation aid and barriers to implementation in clinical practice. Post visit semi structured interviews and recordings of the clinical visits will be qualitatively analyzed. We hypothesize that the conversation aid will be accepted and facilitate the decision making process.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative analysis of the patient and clinician experience using the conversation aid | The clinical visit and post visit semi-structure interviews of patient and clinicians that have used the conversation aid will be analyzed qualitatively to better understand the acceptability of the conversation aid in clinical practice and used to further update the conversation aid. | Up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroid nodules, shared decision making
VEGF In Systemic Circulation Of ROP-infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure systemic levels of vascular endothelial growth factor (VEGF) and other proteins (e.g. IGF-1) in the systemic circulation of infants with retinopathy of prematurity (ROP) following ocular treatment with either intravitreal injections of anti-VEGF agents or retinal laser photocoagulation. The primary aim is to determine if serum VEGF levels change after treatment.

Official Title
-----------------
Study to Measure Systemic VEGF Levels in ROP Infants Following Intravitreal Anti-VEGF Therapy or Retinal Laser Treatment

Conditions
-----------------
Retinopathy of Prematurity (ROP)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of retinopathy of prematurity requiring treatment Exclusion Criteria: Anemia
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ROP infants treated with intravitreal anti-VEGF agents<br> | |
| ROP infants treated with retinal laser photocoagulation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic VEGF levels following treatment | comparing VEGF levels in serum of ROP infants treated with intravitreal anti-VEGF agents vs. retinal laser photocoagulation over 16 weeks post treatment | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic levels of other growth factors (e.g. IGF-1) | comparing systemic levels of other (non-VEGF) factors in serum of ROP infants treated with intravitreal anti-VEGF agents vs. retinal laser photocoagulation | 16 weeks |