linjc16/ctgov huggingface dataset:
Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in HER2-positive MBC

Study Overview
=================
Brief Summary
-----------------
To explore the real world situation of trastuzumab and lapatinib combined chemotherapy in China, and to explore the relationship between progression free survival and treatment.

Official Title
-----------------
Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. woman, age > 18 years old 2. Diagnosed with HER2 +Metastatic Breast Cancer 3. Dual anti-HER2 therapy (lapatinib and trastuzumab) plus chemotherapy for at least one cycle, starting from 2013.09.01-2019.07.31 4. Available medical history Exclusion Criteria: 1. Incomplete medical history

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dual anti-HER2 group<br>Dual anti-HER2 therapy (lapatinib and trastuzumab) plus chemotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 6 weeks | 
| OS | Overall survival | 6 weeks | 
| ORR | Objective Response Rate | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Pattern | Choice of Treatment | 6 weeks |
Study in Patients With Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the most safe and effective dose of the investigational drug in comparison with a control drug and placebo.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Formoterol Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with a history of asthma Written guardian approval Exclusion Criteria: Current or recent asthma exacerbation, requiring hospitalization History of smoking Debilitating or systemic and/or life-threatening diseases.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Formoterol Fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of lung function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function, as well as vital signs |  |  | 
| Physical Exam results, AE reporting, etc |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Formoterol, Fumarate
Anaesthesia and Apoptosis

Study Overview
=================
Brief Summary
-----------------
Anesthetics cause widespread apoptosis in the developing brain, resulting in neurocognitive abnormalities. However, it is unknown whether anesthesia-induced neurotoxicity occurs in humans because there is currently no modality to assess for neuronal apoptosis in vivo

Official Title
-----------------
Effect of Anaesthesia on Apoptosis During Congenital Heart

Conditions
-----------------
Apoptosis

Intervention / Treatment
-----------------
* Other: apoptosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: congenital heart corrective surgery Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: apoptosis|study of apoptotic changes due to anaesthesia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apoptotis during anaesthesia | measuring markers of apoptosis pathway | 24 hours |
Human Milk: Understanding the Mechanisms Linked to the Prevention of Obesity and Diabetes in Children Exposed in Utero to Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
Breastfeeding has been associated with decreased obesity. However, this relationship is not as clear in children who have been exposed to GDM and the mechanisms involved are little known. The overall objective of the project is to study the mechanisms of breastfeeding on the growth of children in women who have had a GDM. More specifically, the project want to compare the macronutrient and hormone composition of breast milk of women with and without GDM. Investigators also want to associate the levels of hormones related to satiety and energy metabolism (i.e. endocannabinoids, ghrelin, leptin) in the human milk of women with or without DG and the growth of the child. A total of 60 women (30 with GDM and 30 without GDM) will collect breastmilk at 2 months postpartum.

Detailed Description
-----------------
Other data collected: Waist circumference, DXA, Fasted blood sample, Oral glucose tolerance test, Breastfeeding habits, Food habits, Baby's height et weight.

Official Title
-----------------
Human Milk: Understanding the Mechanisms Linked to the Prevention of Obesity and Diabetes in Children Exposed in Utero to Gestational Diabetes

Conditions
-----------------
Gestational Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breastfeeding women Exclusion Criteria: Type 1 or type 2 diabetes Preterm birth History of bariatric surgery Multiple births

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GDM+<br>Women with history of gestational diabetes | |
| GDM-<br>Women without history of gestational diabetes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the mechanisms linked to the effect of breastfeeding on the growth of children in women who have had GDM. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare macronutrient and hormone composition of breast milk of women with and without GDM. |  | 6 months | 
| Associate level of hormones related to satiety and energy metabolism (i.e. endocannabinoids, ghrelin, leptin) in the human milk of women with or without GDM and the growth of the child. |  | 6 months |
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in patients having undergone a hematopoietic stem cell transplantation.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Parallel Groups, Placebo-controlled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation (HSCT)

Conditions
-----------------
Acquired Bleeding Disorder, Bleeding During/Following Surgery

Intervention / Treatment
-----------------
* Drug: standard therapy
* Drug: placebo
* Drug: activated recombinant human factor VII
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone a hematopoietic stem cell transplantation Exclusion Criteria: Known or suspected allergy to trial product Participation in other trials with unapproved drugs or trials with equal or similar objective

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: standard therapy<br>* Standard treatment of bleeding<br>Drug: placebo<br>* Placebo<br>|
| Experimental: Low dose<br> | Drug: standard therapy<br>* Standard treatment of bleeding<br>Drug: activated recombinant human factor VII<br>* Two days repeated treatment regimen - low dose administered i.v. (into the vein)<br>|
| Experimental: High dose<br> | Drug: standard therapy<br>* Standard treatment of bleeding<br>Drug: activated recombinant human factor VII<br>* Two days repeated treatment regimen - high dose administered i.v. (into the vein)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on bleeding, defined as change in bleeding score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion requirements |  |  | 
| Bleeding evaluation |  |  | 
| Adverse events |  |  | 
| Changes in safety coagulation parameters |  |  |
Effectiveness of Respirators Fit Factor in Healthcare Providers With and Without Beard

Study Overview
=================
Brief Summary
-----------------
The study aim will be to determine the fit factor of surgical masks and filtering respirators in healthcare providers with and without beard. A randomized clinical trial will be carried out recruiting a sample of 52 healthcare providers with and without beard. Fit factor will be measured with both surgical masks and filtering respirators and compared between healthcare providers with and without beard.

Official Title
-----------------
Effectiveness of Respirators Fit Factor in Healthcare Providers With and Without Beard: A Randomized Clinical Trial

Conditions
-----------------
Community Health Workers, Filtration, Masks

Intervention / Treatment
-----------------
* Other: Surgical masks
* Other: Filtering respirators


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthcare providers Exclusion Criteria: Pulmonary diseases Pregnant women Not sign the informed consent form

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Health care providers with beard<br> | Other: Surgical masks<br>* Surgical masks will be applied in health care providers<br>Other: Filtering respirators<br>* Filtering respirators will be applied in health care providers<br>|
| Other: Health care providers without beard<br> | Other: Surgical masks<br>* Surgical masks will be applied in health care providers<br>Other: Filtering respirators<br>* Filtering respirators will be applied in health care providers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fit factor | Particles count into masks compared to particles count outside of the masks | Change from baseline fit factor immediately after intervention |
Evaluation of Questionnaires of Tumor Patients With and Without Additive Homeopathic Therapy

Study Overview
=================
Brief Summary
-----------------
Tumor patients receiving conventional tumor therapies are included into this study. The patients are randomized into two groups receiving either additive homeopathic therapy or not. Two questionnaires referring to subjective feeling and life quality are filled out by the patients with each visit to the outpatients Department. One of them is the QLQC30 questionnaire of the EORTC. The results of the questionnaires of the two groups are compared.

Detailed Description
-----------------
Quality of life is an important issue for cancer patients, especially during the periods of chemotherapy and radiation. Preliminary results have revealed positive effects of add-on homeopathy on quality of life as well as subjective well-being. Patients are receiving classical homeopathy with administration of either globules and/or dilutions. With each appointment, patients complete two questionnaires.

Official Title
-----------------
Evaluation of Quality of Life of Tumor Patients With and Without Additive Homeopathy.

Conditions
-----------------
Tumor

Intervention / Treatment
-----------------
* Other: additive homeopathic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tumor patients between 18 and 100 years old Exclusion criteria: Patients younger than 18 years, patients having completed less than 3 questionnaires.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: additive homeopathic treatment<br>These patients receive additive homeopathic treatment during conventional cancer treatment. | Other: additive homeopathic treatment<br>* These patients receive additive homeopathic treatment<br>* Other names: homeopathic remedies according to the Pharmacopoeia;|
| No Intervention: no additive homeopathic treatment<br>These patients do not receive additive homeopathic treatment during conventional cancer treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference with regard to subjective feeling and life quality with or without homeopathic treatment |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Life quality, questionnaire, tumor patients
Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.

Detailed Description
-----------------
A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome. An interim analysis will be made after 40 included patients in the study.

Official Title
-----------------
A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery

Conditions
-----------------
Low Anterior Resection Syndrome

Intervention / Treatment
-----------------
* Device: Transanal irrigation
* Drug: Medication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that have undergone surgery for rectal cancer (sphincter saving surgery, low anterior resection) Adult ≥ 18 years old Have scoring major LARS (according to the Low anterior resection syndrome score) Exclusion Criteria: stoma recurrent disease Another colorectal surgery Inflammatory bowel disease (IBD)

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transanal irrigation<br>Manual transanal irrigation to control bowel function. | Device: Transanal irrigation<br>* Effect of Transanal irrigation (TAI) using Peristeen® anal irrigation system - Coloplast<br>* Other names: Peristeen® anal irrigation system - Coloplast;|
| Active Comparator: Medication<br>Medication to control bowel function. | Drug: Medication<br>* Medication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum)<br>* Other names: One or a combination of Loperamide, Sorbitol, Sterculia gum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel function | Cleveland incontinence questionnaire | 1 year | 
| Bowel function, Low anterior resection syndrome (LARS) | Assessed using LARS questionnaire (score 0-42, a high score indicates poor bowel function) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QoL) | Assessed using EORTC Quality of life questionnaire (QLQ)-C30 | 1 year |
Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis

Study Overview
=================
Brief Summary
-----------------
To test the ability of palifermin (a recombinant human keratinocyte growth factor) to decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis Overlap, diseases in which there is extensive sloughing of the skin and mucosa, including that of the eyes, gastrointestinal tract, respiratory and genitourinary systems.

Official Title
-----------------
Palifermin Treatment of Toxic Epidermal Necrolysis

Conditions
-----------------
Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome

Intervention / Treatment
-----------------
* Drug: Palifermin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Skin biopsy in early disease showing apoptotic keratinocytes in the epidermis and in more advanced disease necrosis of the entire epidermis Epidermal detachment or erythematous to purpuric macules involving more than 10% of body surface area in addition to involvement of the oropharynx; there may be further involvement of other mucosal surfaces, ie. conjunctivae, gastrointestinal tract, respiratory and genitourinary epithelia Age of 18 years old or older The patient is expected to survive longer than 48 hours Exclusion Criteria: Skin detachment above 90% of the body surface area Skin detachment has not progressed during the previous 48 hours A positive serum pregnancy test Age < 18 years old Known hematologic or solid organ malignancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palifermin<br>Palifermin 60 micrograms/kg/day IV for 3 consecutive days | Drug: Palifermin<br> <br> * Other names: Kepivance;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-cutaneous Re-epithelialization |  | The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-mucosal Re-epithelialization |  | The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days | 
| Time-to-cessation of Epidermal Necrosis |  | The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days |