linjc16/ctgov huggingface dataset:
COVID-19 Wellness Survey

Study Overview
=================
Brief Summary
-----------------
This study will collect data on physical activity, food consumption, stress, sleep, and alcohol consumption habits both before and after the national emergency for COVID-19 was put into place. This will help identify the health behavior changes taking place due to the COVID-19 pandemic in the United States. Data on past and current health behaviors will be self-reported by participants via a single online survey. The retrospective health behavior questions will be the same quantitative questions as the current health behavior questions so a direct comparison can be made. There will be a couple qualitative questions to assess what each participant feels are the greatest barriers or impacts to their current health behaviors. Participants will be recruited via convenient sampling. Data collected in this study will show a decline in at least one healthy behavior after the United States national emergency for COVID-19.

Official Title
-----------------
COVID-19 Health and Wellness Self-Assessment Survey

Conditions
-----------------
Health Behavior

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Under the age of 18 and anyone who does not currently reside in the United States

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 Survey Group<br>Group of individuals participating in the survey via self-selection. There is not intervention being administered. The group is simply answering questions on their health behaviors before COVID-19 and their health behaviors in the past 7-30 days, during the COVID-19 outbreak in the United States. | Other: Survey<br>* No intervention is being administered.<br>* Other names: There is no intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Behavior Change Regression Questionnaire | A negative shift in health behaviors when comparing individual health behavior before COVID-19 and the last 7-30 days. This behavior change may be in one or multiple health behaviors measured. A negative shift is indicated by overall decrease in physical activity time or intensity, increase in sitting time, increase in alcohol consumption days or drinks on drinking occasions, a decrease in fruit/vegetable consumption, or indication of consuming more food. | 1-3 months |
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases

Study Overview
=================
Brief Summary
-----------------
The Diagnostic yield and Safety of transbronchial cryobiopsy in the diagnosis of diffuse parenchymal lung diseases are investigated in this multicenter, prospective and real world study.

Official Title
-----------------
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases: a Prospective, Multicenter, Real World Study

Conditions
-----------------
Diffuse Parenchymal Lung Diseases

Intervention / Treatment
-----------------
* Procedure: Transbronchial cryobiopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed. Exclusion Criteria: The radiological data indicates non-DPLD The clinical examinations mentioned above are not completed. The patient cannot endure or does not agree the procedure.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cryobiopsy<br>Transbronchial cryobiopsy is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety. | Procedure: Transbronchial cryobiopsy<br>* Transbronchial cryobiopsy procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnotic yield | Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy (in 12 weeks). | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diffuse parenchymal lung diseases, Diagnosis, Transbrochial cryobiopsy
Ostom-i Alert Sensor Quality of Life Validation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the usability and acceptance of the Ostom-i Alert Sensor. The investigators would like to see if is generally helpful to ostomy patients and whether it has a beneficial impact on living with an ostomy bag. Results from this study will be used to determine if a larger clinical study is feasible.

Detailed Description
-----------------
Evidence from clinical experience shows that patients with ostomies go through a significant life change to learn to live with the ostomy bag. These changes can include an altered body image, changes in daily routines, and for some, changes in life patterns such as work and leisure activities (Burckhardt). Previous studies have also shown that ostomy patients have negative changes in their physical, psychological, social, and spiritual quality of life (Krouse). An ostomy patient developed the Ostom-i Alert Sensor after experiencing these changes - the goal of the sensor is to make life easier for patients with ostomy bags, by allowing for easier output measurements and anticipation of bag changes. In this study, we hope to use this new device and track any improvements for quality of life for ostomy patients.

Official Title
-----------------
Validating the Use of a Novel Wearable Device in Improving Quality of Life of Ostomy Patients

Conditions
-----------------
Ostomy

Intervention / Treatment
-----------------
* Device: Ostom-i Alert Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years of age use of an ostomy bag for at least six months must own an iPhone, iPod Touch, or Android Exclusion Criteria: use of large urostomy bags

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ostom-i Alert Sensor|Sensor on ostomy bag.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved quality of life with any ostomy bag | We would like to see if using the sensor improves the quality of life while living with an ostomy bag. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-management (able to manage using and changing their ostomy bag) | Are users better able to manage using and changing their ostomy bag? | 4 weeks | 
| Sleep quality (report a higher quality of sleep while using the sensor with their ostomy bag?) | Do participants report a higher quality of sleep while using the sensor with their ostomy bag? | 4 weeks | 
| Confidence and self-image (participant report a better self-image and more self-confidence?) | Do participants report a better self-image and more self-confidence with their ostomy bag than before using the sensor? | 4 weeks |
Kinetic Study of CD8+ CMV-specific Cellular Immunity in Renal Transplant Patients After Receiving Thymoglobulin

Study Overview
=================
Brief Summary
-----------------
Renal transplant candidates who have CMV-specific, CD8+ T-cells, are CMV-seropositive and carry HLA-A1 and/ or HLA- A2 alleles have a high probability to maintain this type of immunity during the three first months after the transplant, despite induction immunosuppressive therapy (thymoglobulin).

Official Title
-----------------
Kinetic Study of CD8+ CMV-specific Cellular Immunity in Renal Transplant Patients After Receiving Thymoglobulin

Conditions
-----------------
Renal Transplant Infection

Intervention / Treatment
-----------------
* Drug: Thymoglobulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal transplant recipients with CMV-positive serology. Patients with pre-transplant, CMV-specific CD8+ T cell-mediated immunity, i.e. IFNγ levels ≥0.2 UI/mL (QF-CMV Reactive). Adults over 18 years of age. Patients receiving induction therapy with thymoglobulin (at least a cumulative dosage of 1mg/kg). Patients receiving prophylaxis with valganciclovir (900 mg/day, adjusted to kidney function) until day 90 after transplant. Patients who signed an informed consent Exclusion Criteria: Multivisceral transplantation, including pancreas-kidney transplantation. HIV infected patients. Patients who cannot comply with the monitoring protocol.

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 |
| --- | --- |
| candidates for renal transplant<br> | Drug: Thymoglobulin<br>* This study will use non-probability, convenience sampling from patients kidney transplants who receive induction immunosuppressive therapy with thymoglobulin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV-specific, CD8+ T-cell immunity | Percentage of patients with CMV-specific, CD8+ T-cell immunity at any of the established time points for monitorization. CMV-specific, CD8+ T-cell immunity will be defined as production of IFNγ ≥0.2 UI/mL (QF-CMV Reactive). | 18 months |
Human Breastmilk in Young Children With Norovirus Infection of the Gut

Study Overview
=================
Brief Summary
-----------------
Human Breast milk in young children with Norovirus Infection

Detailed Description
-----------------
The investigators hypothesize that children with clinically significant norovirus infection of the gut who receive enteral human milk will more successfully clear the virus or experience improved symptoms compared to children not receiving human milk.

Official Title
-----------------
A Pilot Study of Enteral Donor Human Milk in Young Children With Norovirus Infection of the Gut

Conditions
-----------------
Norovirus Infections

Intervention / Treatment
-----------------
* Dietary Supplement: Donor Breastmilk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with at least two stool samples taken at least 7 days apart that are positive for norovirus Child has an underlying disease or has received immunosuppressive medication or chemotherapy such that clearance of norovirus is expected to be impaired. Exclusion Criteria: The presence of other pathogens causing diarrhea that have specific treatments does not preclude enrollment. However, specific treatment should be offered in addition to human milk.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Donor Breastmilk<br>Donated human milk is subjected to pasteurization prior to use. Milk consumption is to be overseen by a Registered Dietician. Oral or enteral milk feeding will begin at 180 ml/day and will be advanced as quickly as tolerated to a goal of 360 ml/day for 6 weeks. If symptoms and stool tests for norovirus do not improve after 6 weeks, milk administration may continue for an additional 6 weeks. | Dietary Supplement: Donor Breastmilk<br>* Donor breastmilk will be obtained from the Mother's Milk Bank of New England.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loose/Unformed/Liquid Stools or Abdominal Cramping | Episodes or number of days of loose/unformed/liquid stools or abdominal cramping will be reported. | Up to 12 weeks | 
| Norovirus | Stool samples will be tested for the presence of norovirus. | Up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stem cell transplant, human breastmilk
A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the optimal tolerated regime of PEP005 for the treatment of actinic keratoses of the face or face and scalp.

Detailed Description
-----------------
Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.

Official Title
-----------------
An Open-label, Multi-centre, Dose-escalation, Cohort Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel When Applied to a 25 cm2 Contiguous Actinic Keratoses Treatment Area on the Face or Face and Scalp.

Conditions
-----------------
Actinic Keratoses

Intervention / Treatment
-----------------
* Drug: PEP005


Participation Criteria
=================
Eligibility Criteria
-----------------
Male patients at least 18 years of age. Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus. Four to eight clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or face and scalp. 5. Ability to follow study instructions and likely to complete all study requirements. 6. Written informed consent has been obtained. 7. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PEP005|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal tolerated regime of PEP005 Topical Gel in patients, when administered as either two day or three day application schedules to a 25 cm2 contiguous AK treatment area on the face or face and scalp |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy at 2 or 3day application PEP005 Topical Gel at the MTD of 0.025% in the Expanded Cohort, and at 2 lower concs of 0.0175% and 0.0125% at either a 2 or 3day application, when applied to 25cm2 AK treatment area on face or face/scalp. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Actinic Keratoses (AK), PEP005, Topical, Dermatology
A Real World Study of the Treatment of Gastric Adenocarcinoma With Huachansu

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of huachansu oral preparation in the treatment of inoperable locally advanced or advanced metastatic gastric adenocarcinoma, including gastric esophageal adenocarcinoma.

Detailed Description
-----------------
In this multicenter, controlled, retrospective, real-world study, the original medical records of participants diagnosed with inoperable locally advanced or advanced metastatic gastric adenocarcinoma (including gastric esophageal junction adenocarcinoma) receive treatment in research centers from January 1, 2014 to December 31, 2019 were collected. To evaluate the efficacy and safety of oral huachansu in the systematic treatment of locally advanced or advanced metastatic gastric adenocarcinoma.

Official Title
-----------------
A Real World Study of the Treatment of Locally-inoperable Advanced or Advanced Metastatic Gastric Adenocarcinoma With Huachansu

Conditions
-----------------
Gastric Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients who meet all the following criteria are included in the study: Diagnosed with gastric adenocarcinoma (including gastric esophageal junction adenocarcinoma) by histopathology or cytology at the enrolled centers From January 1, 2014 to December 31, 2019. Stage of disease (clinical or pathological stage) is locally advanced or advanced (stage IIIB-IV) . The doctor judged that the tumor tissue was unresectable. At least two medical records. At least one huachansu oral preparation (tablet, capsule) was used during treatment (observation group only) . Exclusion Criteria: Patients who meet any of the following criteria are not allowed to enter the test: Lack of clinical data related to important research indicators (survival). Refusal to cooperate with follow-up.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observation group<br>huachansu oral preparation (tablet, capsule) was used. | |
| control group<br>huachansu was not used. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | 
| AE;SAE | adverse event;Serious Adverse Event | 1 year, year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADR;SADR | Adverse Drug Reaction;Serious Adverse Drug Reaction | 1 year, year 1 |
Haemodynamic Feasibility Study of Sensors Within a Tilting Table Examination

Study Overview
=================
Brief Summary
-----------------
This study´s aim is to explore physiological associations concerning pulse wave velocity, heart rate and blood pressure in order to make taking the blood pressure more comfortable.

Conditions
-----------------
Syncope

Intervention / Treatment
-----------------
* Device: measurement of blood pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with syncope and planned tilting table investigation male and female patients aged at least 18 years persons being able to understand and to follow the study stuff´s instructions Exclusion Criteria: pregnancy or breast feeding patients not being able to consent cardiac pacemaker / defibrillator illness of skin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| syncope<br> | Device: measurement of blood pressure<br>* measurement of pulse wave velocity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| data about possible correlation | Correlation between pulse wave velocity, pulse rate and blood pressure | 45 minutes |
Repository: Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant

Study Overview
=================
Brief Summary
-----------------
This is a repository to store blood and stem cell samples for future research.

Detailed Description
-----------------
Our Hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of GVHD by determining the qualitative and quantitative changes in T regulatory cells throughout the transplant process. Our understanding of this can lead to new treatment strategies and improved clinical therapeutic implications.

Official Title
-----------------
Repository for Study: Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant (HSCT)

Conditions
-----------------
Hematopoietic Stem Cell Transplantation, Graft vs Host Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions Exclusion Criteria: Patients < 18 or > 70 years old undergoing either autologous transplant or allogeneic transplant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
T-Lymphocyte Subsets