linjc16/ctgov huggingface dataset:
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a double blind Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of DN1406131, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and tryptophan 2,3-Dioxygenase 2 (TDO-2) and help the human immune system attack solid tumor cells more effectively.

Official Title
-----------------
A Phase I Study of DN1406131 in Healthy Adults

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: DN1406131
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater of 18 years and less than 45 Weight ≥50 kg,body mass index of 19 26 kg/m2 Signed ICF Exclusion Criteria: active autoimmune disease uncontrolled concurrent illness Smoking Drugs positive serology for HIV, Hepatitis B or C,Syphilis Pregnancy or breastfeeding

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

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

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

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 |
| --- | --- |
| Experimental: DN1406131<br>25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg | Drug: DN1406131<br>* IDO1 and TDO2 inhibitor<br>|
| Placebo Comparator: Placebo<br>25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events - type, incidence, severity | Evaluate the safety and toxicity of DN1406131 in healthy volunteers | 28 day | 
| Maximum Tolerated Dose | To define the Maximum Tolerated Dose (MTD) | 14 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Cmax | 48 hours | 
| Serum for biomarkers of IDO activity (kynurenine and tryptophan) | Evaluation of serum for biomarkers of IDO activity (kynurenine and tryptophan), before and after initiation of therapy. Pharmacodynamics（PD） | 48 hours | 
| Elimination half-life | T1/2 | 48 hours | 
| peak time | Tmax | 48 hours |
Anonymous Survey of Breast Cancer Patients Concerning Their Use of Medical Apps

Study Overview
=================
Brief Summary
-----------------
Breast cancer patients complete questionnaires concerning their use of medical apps.

Detailed Description
-----------------
Breast cancer patients of the department of gynecology at Technical University of Munich and Berlin Charité complete quesionnaires during routine appointments. Intention of the survey is to evaluate the importance of medical apps and the special needs of breast cancer patients. Moreover approaches to improve health care of breast cancer patients are expected to be developed.

Official Title
-----------------
Eine Anonyme Umfrage Bei Brustkrebspatient*Innen Zum Thema Nutzerverhalten Von Gesundheits-Apps

Conditions
-----------------
Health Care Survey

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer patients patients who are legally competent and able to understand and follow instructions of the study staff Exclusion Criteria: none

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Survey<br>Breast cancer patients complete questionnaire concerning their use of medical apps. | Other: Survey<br>* Survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The attitudes of breast cancer patients regarding the use of medical apps: a survey-based study | Evaluation of relative frequency of answers in the questionnaire regarding patient's approach to app-utility | 6 Months |
To Study Safety, Tolerability and Pharmacokinetics of AZD1305 in Healthy Male Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body ( how it is taken up into the body, distributed around the body and disappears from the body) in healthy Japanese males.

Official Title
-----------------
A Single-Centre, Single-Blind, Randomised, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD1305 in Healthy Male Japanese Subjects

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

Intervention / Treatment
-----------------
* Drug: AZD1305
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A body mass index (BMI=weight/height2) of 19 to 27 kg/m2 Japanese males Exclusion Criteria: ECG findings outside normal reference ranges. Potassium outside normal reference ranges.

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD1305<br>* Solution for iv infusion, single dose<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* NaCl solution for iv infusion, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety by assessment of adverse events, ECG variables, BP, pulse rate, physical examination, laboratory variables, body temperature and body weight |  | During the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | During the dosing visits | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, AZD1305, pharmacokinetics, single ascending doses, Japanese, male
Inadequate Emergence After Laparoscopic Surgery in Trendelemburg Position

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determinate if the patients submitted to laparoscopic surgery in trendelemburg position develope more inadequate anaesthesic emergence than patients submitted to laparoscopic surgery in other positions.

Official Title
-----------------
Inadequate Emergence After Anaesthesia in Laparoscopic Surgery in Trendelemburg Position

Conditions
-----------------
Delirium, Cause Unknown, Confusion, Disorientation on Emergence, Delayed Emergence From Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laparoscopic surgery general anaesthesia trendelemburg positioning extubated in the operatory theater Exclusion Criteria: unable of communicate dementia psychiatric history neurosurgery alchohol and drugs addictions

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| trendelemburg positioning<br>Patients undergone laparoscopic surgery in trendelemburg position | |
| Not trendelemburg positioning<br>Patients undergone laparoscopic surgery not in trendelemburg position | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inadequate emergence after anaesthesia | The inadequate emergence after anaesthesia will be evalueted with the Richmond Agitation Sedation Scale, defining as inadequate emergence a punctuation >= +1 (delirium form) and <=-2 (hypoactive form). | 10 minutes after the arrival of the patient in the postsurgical unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedation, delirium, agitation, anaesthesia, laparoscopy, surgery, emergence, steep, trendelemburg, position, delayed, Confusion, Disorientation
Prospective Bladder Cancer Infrastructure (ProBCI)

Study Overview
=================
Brief Summary
-----------------
Prospective nation-wide cohort of high-risk non-muscle-invasive, muscle-invasive and metastatic bladder cancer in the Netherlands

Official Title
-----------------
Prospective Bladder Cancer Infrastructure: an Infrastructure for Observational and Interventional Bladder Cancer Research (ProBCI)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bladder cancer Any stage except Ta 18 years or older Written informed consent Exclusion Criteria: No exclusion criteria Note: participation in ProBCI does not exclude the patient from participation in other studies.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bladder cancer patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Alive/death/emigrated | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression/no progression | 10 yeas | 
| Recurrence-free survival | Recurrence/no recurrence | 10 yeas | 
| Health-related quality of life | EQ-5D (EuroQol-Five Dimensions) | 2 years | 
| Cancer-specific health-related quality of life | QLQ-C30 (Quality of Life Questionnaire-Cancer) | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder cancer, Prospective cohort
Prospective Database for Acute Myeloblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
Prospective Database for Acute Myeloblastic Leukemia

Conditions
-----------------
Leukemia, Myeloblastic, Acute

Intervention / Treatment
-----------------
* Other: Database


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with AML
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Database|database|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and efficacy |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AML
Value of Platelet Indices as Predictive Factor in Thrombocytopenia

Study Overview
=================
Brief Summary
-----------------
Platelets are essential blood component involved in primary hemostasis. A platelet count of less than 150 × 109/L is considered to be thrombocytopenia The causes of thrombocytopenia can be divided into two major groups, a decreased production of platelets or an under proliferative BM and an over-destruction of platelets. Under proliferative BM defects most common cause is aplastic anemia, On the contrary, peripheral destruction of platelets may be as a result of an immune-mediated process namely immune thrombocytopenia (ITP)

Detailed Description
-----------------
ITP is a common auto-immune disease in which platelet count is reduced in peripheral blood leading to petechiae and hemorrhage. The platelet count is decreased because there are auto-antibodies in circulation against platelets that bind to platelets surface and destroy them in the spleen . Aplastic anemia is characterized by suppression of bone marrow function resulting in progressive pancytopenia. The hematology analyzers can now give us certain parameters that can give information about platelets. These parameters are referred to as platelet indices in literature. Platelet indices include mean platelet volume (MPV), platelet distribution width (PDW) and platelet large cell ratio (P-LCR) . They are sensitive, non-invasive, inexpensive biomarkers. MPV is the most commonly investigated platelet parameter, signifies the average size of platelets in the blood. PDW is a marker of platelet anisocytosis, which describes distribution of platelets produced by megakaryocytes and increases upon platelet activation. P-LCR is another marker of platelet activity, is a percentage of all platelets with a volume measuring over 12 fl circulating in the bloodstream .

Official Title
-----------------
Value of the Platelet Indices as a Predictive Factor in Adult Thrombocytopenic Patients

Conditions
-----------------
Main Focus of the Study

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 years old regardless of gender. Platelet count below 100000/cu mm. Confirmed diagnosis aplastic anaemia. Confirmed diagnosis immune thrombocytopenia Exclusion Criteria: Patient who received a platelet or blood transfusion within two weeks prior MPV analysis. Splenectomized patients Patients with chronic infection or inflammations. Diabetics and patients with coronary artery disease. Patients on anti- platelet or anti-inflammatory drugs.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the prognostic predictive value of the platelet indices in thrombocytopenic patients. | • Exploring the validity of platelets indices as prognostic biomarkers in thrombocytopenic patients. | 6months |
Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational study to collect stool and blood from acute myeloid leukemia patients undergoing intensive chemotherapy.

Official Title
-----------------
Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Diagnostic Test: Sample Collection Blood
* Diagnostic Test: Stool Sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (ages 18 - 99 years) undergoing inpatient intensive chemotherapy for newly diagnosed, refractory, or relapsed AML. Patients may or may not have been exposed to any type of therapy before. Any intensive chemotherapy regimen defined as a planned  4 week inpatient stay. Chemotherapy may be delivered for any number of days and on any schedule. Patients may be discharged from the hospital sooner than 4 weeks if the treating physician choose so, but the expectation at the initiation of chemotherapy must be  4 weeks of inpatient stay, as is typical. Able to provide written voluntary consent before performance of any study related procedure.

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 |
| --- |
|Diagnostic Test: Sample Collection Blood|Collected from each patient twice weekly.|
|Diagnostic Test: Stool Sample|Collected from each patient twice weekly.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abundance of Phyla | Abundance in stool and circulating microbiota during intensive chemotherapy in patients with acute myeloid leukemia (AML), measured by16S rRNA gene profiling of biospecimens using the Illumina MiSeq platform | Day 28 | 
| Abundance of Genera | Abundance in stool and circulating microbiota during intensive chemotherapy in patients with acute myeloid leukemia (AML), measured by16S rRNA gene profiling of biospecimens using the Illumina MiSeq platform | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating Microbiota Diversity (Blood) | Describe circulating microbiota diversity over the course of treatment | Day 28 | 
| Microbiota Diversity (Stool) | Describe stool microbiota diversity over the course of treatment | Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AML
A Study to Evaluate the Effect of Far Infrared Radiation for Cancer Treatment

Study Overview
=================
Brief Summary
-----------------
Cancer is the number one killer in Canada and in most countries of the world. The investigators' initial assessment indicates that far infrared radiation has the potential to cure cancer.

Detailed Description
-----------------
The investigators have identified a combination of methods for possible cancer treatment as follows: Energy specific far infrared radiation (5 μm to 20 μm ). No x-rays, gamma rays etc. are used. Oxygenation of the body cells pH balance Lifestyle changes, or A combination of chemotherapy and (1), (2), (3) and (4) above.

Official Title
-----------------
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation for Cancer Treatment

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Radiation: Far Infrared Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cancer patients Exclusion Criteria: non-cancer patients
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Infrared Radiation | Radiation: Far Infrared Radiation<br>* Far Infrared Radiation (5μm to 20μm wavelength)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of far infrared radiation on cancerous tumours |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect on far infrared treatment on different kinds of cancer. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Tumors
The Role of Rheumatological Evaluation in the Management of Patients With Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
We hypothesized that the multi-disciplinary assessment of interstitial lung disease patients would lead to a more accurate diagnosis and consequently alterations in treatment regimens that may lead to improved outcomes.

Official Title
-----------------
The Role of Rheumatological Evaluation in the Management of Patients With Interstitial Lung Disease

Conditions
-----------------
Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Connective Tissue Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years old ILD according to ATS/ERS guidelines Signed inform consent Exclusion Criteria: Previous lung surgery Other significant systemic disease

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 |
| --- | --- | --- |
| The number of patients with collagen related pulmonary fibrosis that are diagnosed by Rheumatologists compared to Pulmonologists. |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interstitial lung disease, Idiopathic pulmonary fibrosis, Connective tissue disease