linjc16/ctgov huggingface dataset:
A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors

Study Overview
=================
Brief Summary
-----------------
This is a single arm, open-label, dose escalation, PK expansion and efficacy expansion study of phase I. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.

Official Title
-----------------
Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study

Conditions
-----------------
Gastric Cancer, Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: SHR-A1811


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a pathologically or cytologically documented advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma and colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1. Has an ECOG PS 0-1. Has a life expectancy of ≥ 3 months. Has adequate organ function Exclusion Criteria: Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1. Has received HER2 antibody drug conjugates,. Central nervous system metastasis or meningeal metastasis with clinical symptoms Has active infection requiring systemic treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-A1811<br> | Drug: SHR-A1811<br>* There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLT and the recommended Phase 2 dose (RP2D) |  | Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-21). |
A Trial on the Effect of Emotional Disclosure of Traumatic Life Events on Physical Health

Study Overview
=================
Brief Summary
-----------------
This is a randomized, controlled trial on the effect of emotional disclosure of traumatic life events on physical health. The hypothesis is that expression of emotions could possibly improve physical health.

Official Title
-----------------
A Randomised Controlled Trial on the Effect of Emotional Disclosure of Traumatic Life Events on Physical Health

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

Intervention / Treatment
-----------------
* Behavioral: emotional disclosure
* Behavioral: placebo writing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: any mental or physical illnesses in the last three months

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: emotional disclosure<br>writing about emotional events from the past | Behavioral: emotional disclosure<br>* writing about emotional events from the past<br>|
| Placebo Comparator: placebo writing<br>writing about how they spent their time the previous day | Behavioral: placebo writing<br>* writing about how they spent their time the previous day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health centre visits |  | within 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory infections |  | within 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emotional disclosure, expressive writing, students
The Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia

Study Overview
=================
Brief Summary
-----------------
To report the possible role of S.B 8.4% in the treatment of COVID-19pneumonia.

Official Title
-----------------
The Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia: A Preliminary Report of Short Term Follow up

Conditions
-----------------
Pneumonia, Covid19

Intervention / Treatment
-----------------
* Drug: Sodium Bicarbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years. Fever ≥ 38º C with upper respiratory tract manifestations, generalized bone ache with or without gastrointestinal symptoms as diarrhea. Chest CT with signs suggestive of COVID-19. Mild and moderate cases of COVID-19 pneumonia with respiratory and hemodynamic stability. - High C reactive protein (CRP).- With or without history of contact with index case who is isolated in a governmental hospital assigned for treatment of patients proved to have RT-PCR positive test for COVID-19 With or without abnormalities in the total or differential white cell count. Welling to sign a fully informed consent. Exclusion Criteria: Severe and critical illness with respiratory failure and/ or hemodynamic instability. CT with pleural effusion with or without lung cavitation. Other organ failure.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sodium Bicarbonate<br>Inhalation of Sodium Bicarbonate 8.4% via nebulizer | Drug: Sodium Bicarbonate<br>* Inhalation of Sodium Bicarbonate 8.4% via nebulizer<br>|
| Placebo Comparator: Control<br>placebo | Drug: Sodium Bicarbonate<br>* Inhalation of Sodium Bicarbonate 8.4% via nebulizer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical recovery | defined as return of body temperature and relief of cough for more than 72 hours measured in days | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary recovery status | assessed by Chest CT defined as exacerbated, unchanged, moderately improved (with less than 50% pneumonia resolved) and significantly improved (with more than 50% pneumonia resolved). | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19
Central Mammary Duct Excision; How to Improve the Outcome?

Study Overview
=================
Brief Summary
-----------------
the study compares two surgical techniques in excision of the central duct system of the breast. known also as major duct excision

Detailed Description
-----------------
first technique used is the original Hadfield techniques. the other technique is Almasad technique published in 1999. in this technique, de-epithelialization of a supraareolar area of nearly 2cm is done and elevation of the nipple areola complex is done to support the retroareolar area.

Official Title
-----------------
Central Mammary Duct Excision; How to Improve the Outcome?

Conditions
-----------------
Duct Ectasia Breast, Benign Breast Disease

Intervention / Treatment
-----------------
* Procedure: major duct excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females with nipple discharge / recurrent peri-ductal mastitis - Exclusion Criteria: suspicion or evidence of malignancy
Sexes Eligible for Study
-----------------
Female

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

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 |
| --- | --- |
| Active Comparator: Hadfield technique group<br>central/mammary duct excision is done by the ordinary method described by Hadfield | Procedure: major duct excision<br>* 2 methods of major/central mammary duct excision are compared as regard the outcome<br>|
| Active Comparator: Al Masad technique group<br>same procedure with de-epithelization of the upper pararaeolar area | Procedure: major duct excision<br>* 2 methods of major/central mammary duct excision are compared as regard the outcome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction and sensation of nipple areolar complex complications | cosmetic outcome assessed via score between non-satisfied -extremely satisfied sensation is assessed via acotton bad comaring both side or nearby skin | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications | eg nipple areolae complex (NAC) sensation, necrosis...etc | 6 months |
Oculocardiac Reflex Brain Wave Monitor

Study Overview
=================
Brief Summary
-----------------
Oculocardiac reflex during routine strabismus surgery was prospectively observed in association with routine brain wave monitoring. Providence Hospital institutional review board (IRB) approved this observational study without need for consent.

Detailed Description
-----------------
Introduction: The oculocardiac reflex (OCR), bradycardia that occurs during strabismus surgery, is blocked by anticholinergics and enhanced by opioids and dexmedetomidine. Two recent studies suggest that deeper inhalational anesthesia monitored by bispectral index (BIS) protects against OCR; the investigators wondered if our data correlated similarly. Methods: In an ongoing, prospective study of OCR elicited by 10-second, 200 gram square-wave traction on extraocular muscles (EOM) from 2009 to 2013, anesthetic depth was estimated in cohorts using either BIS or Narcotrend monitors. The depth of anesthesia was deliberately varied between first and second EOM tested.

Official Title
-----------------
The Oculocardiac Reflex Influenced at Different Levels of Brain Wave Monitoring

Conditions
-----------------
Bradycardia, Strabismus

Intervention / Treatment
-----------------
* Device: non-invasive monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all Exclusion Criteria: those receiving anticholinergic medications

Ages Eligible for Study
-----------------
Minimum Age: 3 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BIS<br>Monitored with BIS (bispectral index) monitor in addition to other conventional monitors of blood pressure, ECG, oxygen saturation and anesthetic agent concentration. | Device: non-invasive monitor<br>* cutaneous EEG monitor<br>* Other names: brain wave;|
| Narcotrend<br>Monitored with Narcotrend monitor in addition to other conventional monitors of blood pressure, ECG, oxygen saturation and anesthetic agent concentration. | Device: non-invasive monitor<br>* cutaneous EEG monitor<br>* Other names: brain wave;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate change | bradycardia with extra ocular muscle tension | intraoperative 10 seconds |
Group Size in Basic Life Support (BLS) Courses

Study Overview
=================
Brief Summary
-----------------
Basic Life Support (BLS) is important for outcome in cardiac arrest.Therefore, it is crucial to improve the quality of education in resuscitation training. Better training will eventually lead to more effective CPR skills in course participants. BLS courses in both international resuscitation associations (European Resuscitation Council and American Heart Association are typically taught in small groups of 6 participants. In reality group sizes of up to 10 participants are used, because these courses are highly demanded and cost intensive. There is no evidence for the effective group size to be clinical and cost effective. Therefore the investigators perform this prospective study to determine the maximum number of participants an instructor can oversee without missing more than 20% of errors made during an instructional BLS session.

Official Title
-----------------
Determining a Threshold for the Clinical and Cost-effectiveness of Group Size During Basic Life Support Courses

Conditions
-----------------
Educational Problems, Resuscitation

Intervention / Treatment
-----------------
* Other: errors made in one BLS session


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active BLS- Instructors at the Bern Simulation and CPR-Center (BeSiC), at the Bern University Hospital, Bern, Switzerland Exclusion Criteria: Decline to participate

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants<br>Active BLS- Instructors at the Bern Simulation and CPR- Center (BeSiC), at the Bern University Hospital, Bern, Switzerland. Participants have to oversee a BLS instructional session, where standardized errors are performed by trained volunteers. | Other: errors made in one BLS session<br>* BLS instructors have to oversee a standardized BLS training session, where standardized errors are made by trained volunteers.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The threshold of number of course participants in a BLS educational session | How many volunteers can be overseen by one instructor who still is able to correctly identify and correct serious BLS errors of all course participants. | BLS educational session 10 minutes |
Alere i FluA*B Biologic Test Relocated in Emergency Service for Flu Diagnosis

Study Overview
=================
Brief Summary
-----------------
It appears that the heavyness of flu pathology, the diagnosis limits and the validity of it was well studied in the last years.However, the economical impact and the organisation benefit in emergency service is not yet evaluated Our purpose is to study the impact of implementation of fast flu diagnosis by molecular biology available in emergency service in the economic field .

Official Title
-----------------
Alere i FluA*B Biologic Test Relocated in Emergency Service for Flu Diagnosis

Conditions
-----------------
Flu

Intervention / Treatment
-----------------
* Diagnostic Test: Test A i Flu A&B implemented in emergency service


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: respiratory symptoms fever >38°C general symptoms of flu like pathology Exclusion Criteria: cognitive disorders patient with guardianship patient already having a flu diagnosis in the last 7 days without social protection.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Test A i Flu A&B implemented in emergency service|Test A i Flu A&B implemented in emergency service|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to have the result of the biological test |  | 3 hours |
Prognosis of Extremely Premature Birth

Study Overview
=================
Brief Summary
-----------------
Pregnant women at risk of giving birth before 28 weeks' gestational age will be enrolled. Fetal circulation will be studied and blood for inflammatory parameters will be collected. If birth occurs before 28 weeks, detailed information on clinical course of the newborn until discharge from the neonatal intensive care unit will be recorded,and specimens of amniotic fluid, placenta, blood and urine will be collection for inflammatory parameters. After discharge the children will be followed according to a specific protocol until 5 years of age.

Detailed Description
-----------------
The study includes a regional cohort (Western Norway) of approximately 50 extremely preterm infants born per year over a three year period. Detailed information on fetal condition (growth, circulation, infection), neonatal resuscitation and clinical course (details on ventilatory support, circulation, pulmonary function as assessed with a neonatal spirometry technique, cerebral imaging, nutrition, growth) will be recorded. Biobank samples of blood and amniotic fluid from the mother, and from placenta, blood, urine, and tracheal aspirates will be collected form the infant, primarily to examine for inflammatory parameters. After discharge, follow-up at 6, 12, 36 and 56 months will be conducted using standardized tests (Ages & Stages, INFANIB, Denver Developmental Screening test, Bayley scales, WPPSI and ABC movement tests).

Official Title
-----------------
Mortality and Morbidity of Infants Born With Gestational Age Less Than 28 Weeks

Conditions
-----------------
Infant, Premature, Diseases, Perinatal Morbidity, Development, Problem;Growth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born with gestational age less than 28 weeks Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 22 Weeks
Maximum Age: 27 Weeks

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 |
| --- | --- | --- |
| Health | Outcome in terms of growth, lung function, cerebral imaging (MR), cardiac and intestinal morbidity at discharge from the neonatal intensive care unit | 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health | Growth and Developmental outcome at 12 months corrected age | 1 year | 
| Health | Outcome in terms of growth, behavior and psychomotor development (Bayley scales) | 3 years | 
| Health | Growth and motor, cognitive and mental development at 5 years of age (ABC movement test, WPPSI) | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extremely premature infant, outcome, follow-up
Application of Desferal to Treat COVID-19

Study Overview
=================
Brief Summary
-----------------
In this study, defined cases of COVID-19 with mild, moderate or severe pneumonia will be treated with standard treatment regimens in combination with IV injection of Deferoxamine. Improvement in clinical, laboratory and radiological manifestations will be evaluated in treated patient compared to control group.

Official Title
-----------------
Application of Iron Chelator (Desferal) to Reduce the Severity of COVID-19 Manifestations

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: Deferoxamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of COVID-19 Disease, Exclusion Criteria: Previous history of allergy to Deferoxamin, Pregnancy, kidney dysfunction,

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Desferal addition to standard treatment<br> | Drug: Deferoxamine<br>* Intravenous infusion of Deferoxamine<br>|
| Experimental: Experimental: standard treatment<br> | Drug: Deferoxamine<br>* Intravenous infusion of Deferoxamine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | All cause of death | up to 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in patients clinical manifestation | Mild, Moderate or Severe | up to 20 days | 
| change in patients PaO2 |  | up to 20 days | 
| Length of hospitalization | days | up to 20 days | 
| C-reactive protein |  | up to 20 days | 
| lymphocyte count |  | up to 20 days | 
| length of intensive care unit stay |  | 1 to 20 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Deferoxamine