linjc16/ctgov huggingface dataset:
Association Between HER2 Status and pCR Rate in ER-positive Breast Cancer Receiving Neoadjuvant Endocrine or Chemotherapy

Study Overview
=================
Brief Summary
-----------------
In estrogen receptor (ER)-positive breast cancer (BC), human epidermal growth factor receptor-2 (HER2)-low ones are reported to have distinct clinical and molecular features from those with HER2-zero or HER2-positive status. However, the association between HER2-low status with response to endocrine therapy is largely unknown. In this study, we included 518 ER-positive BC patients who received either neoadjuvant endocrine therapy (NET) or neoadjuvant chemotherapy (NCT). The pathologic complete response rate (pCR) of HER2-low and HER2-zero tumors re-sponding to neoadjuvant therapies were compared. The difference in disease-free survival (DFS) and overall survival (OS) between the two groups was also analyzed. The pCR (defined as ypT0/isNx) in HER2-low BCs and in HER2-zero BCs for NET cohort and NCT cohort were compared.

Official Title
-----------------
Association Between HER2 Status and pCR Rate in ER-positive Breast Cancer Receiving Neoadjuvant Endocrine or Chemotherapy

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: NET or NCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with invasive breast cancer and who received surgery from 2015 to 2021 Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NET<br> | Drug: NET or NCT<br>* In this study, we included 518 ER-positive BC patients who received either neoadjuvant endo-crine therapy (NET) or neoadjuvant chemotherapy (NCT).<br>|
| NCT<br> | Drug: NET or NCT<br>* In this study, we included 518 ER-positive BC patients who received either neoadjuvant endo-crine therapy (NET) or neoadjuvant chemotherapy (NCT).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathologic complete response rate (pCR) | ypT0/isNx | through study completion, an average of 6 months |
Suitability of 11C-ORM-13070 as a PET Tracer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron emission tomography tracer.

Official Title
-----------------
Suitability of 11C-ORM-13070 as a Positron Emission Tomography Tracer; an Open Study in Healthy Males

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

Intervention / Treatment
-----------------
* Drug: 11C-ORM-13070


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health ascertained by detailed medical history and physical examination Males between 18 and 45 years Body mass index (BMI) between 18-30 kg/m2 Weight 55-95 kg (inclusive) Exclusion Criteria: Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant medication during the study. Regular consumption of more than 21 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol) Current use of nicotine-containing products more than 5 cigarettes or equivalent/day Inability to refrain from using nicotine-containing products during the stay in the study centre Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre e.g. propensity in getting headache when refraining from caffeine-containing beverages Blood donation or loss of significant amount of blood within 3 months prior to the screening visit Abnormal 12-lead electrocardiogram (ECG) finding of clinical relevance Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into the study Anatomical abnormality in MRI which may in the opinion of the investigator interfere with the interpretation of PET results Participation in a drug study within 3 months prior to the entry into this study Participation in a prior PET study

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 11C-ORM-13070<br> | Drug: 11C-ORM-13070<br>* Single dose of i.v. solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suitability of 11C-ORM-13070 as a PET tracer |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteer study
Profiling the Endocannabinoid Response to Hedonic Eating

Study Overview
=================
Brief Summary
-----------------
Study into the endocannabinoid response to consuming a palatable versus a neutral food.

Official Title
-----------------
Profiling the Endocannabinoid Response to Hedonic Eating

Conditions
-----------------
Obesity, Food Preferences

Intervention / Treatment
-----------------
* Other: Food palatability


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy (self-report) Dutch Evaluating one of the used foods as palatable Evaluating one of the used foods as neutral Hb value between 8.1 and 11.0 mmol/L at screening Exclusion Criteria: restraint eating lack of appetite difficulties eating/swallowing endocrine disorders energy restricted diet two months prior to study weight change > 5 kg in two months prior to study stomach or bowel disease taste or smell disorders (self-report) not consuming foods used in the study smoking > 1 cigarette per day drinking > 21 units alcohol per week

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palatable-neutral<br>Participants are exposed to palatable food in the first test session, and to the neutral food in the second test session. | Other: Food palatability<br>* Food palatability is modulated<br>|
| Experimental: Neutral-palatable<br>Participants are exposed to neutral food in the first test session, and to the palatable food in the second test session. | Other: Food palatability<br>* Food palatability is modulated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endocannainoid levels | To assess changes in endocannabinoid plasma levels prior to, during and after eating a palatable versus a neutral food | prior to, during and two hours after eating | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic polypeptide (pg/ml) | To assess changes in pancreatic polypeptide plasma levels prior to, during and after eating a palatable versus a neutral food | prior to, during and two hours after eating | 
| Ghrelin (pg/ml) | To assess changes in ghrelin plasma levels prior to, during and after eating a palatable versus a neutral food | prior to, during and two hours after eating |
Clinical Trial Comparing Continuous Versus Intermittent Hemodialysis in ICU Patients

Study Overview
=================
Brief Summary
-----------------
The mortality of acute renal failure (ARF) remains to be high (around 60-70%) despite manifold improvements in ICU care. At present, it is not clear if the method chosen for renal replacement therapy, i.e. intermittent haemodialysis (IHD) or continuous haemofiltration (CVVH), might impact on the outcome of these patients. For this purpose, a prospective randomised clinical study of the effect of continuous versus intermittent renal replacement therapy on the mortality and outcome of acute renal failure will be performed.

Detailed Description
-----------------
please see above

Official Title
-----------------
Prospective Randomised Clinical Trial of the Effect of Continuous Versus Intermittent Renal Replacement Therapy on the Mortality and Outcome of Acute Renal Failure in ICU Patients

Conditions
-----------------
Acute Renal Failure

Intervention / Treatment
-----------------
* Other: RRT for acute kidney failure using the CVVH method
* Other: RRT for acute kidney failure using the IHD (intermittent HD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all ICU patients requiring renal replacement therapy Exclusion Criteria: patient denies informed consent patient not requiring intensive care therapy kidney transplanted patients chronic renal failure (serum creatinine > 3mg/dl)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CVVH arm<br> | Other: RRT for acute kidney failure using the CVVH method<br>* patients randomized to receive CVVH<br>* Other names: does not apply;|
| Active Comparator: IHD arm<br> | Other: RRT for acute kidney failure using the IHD (intermittent HD)<br>* patients randomized to receive IHD<br>* Other names: does not apply;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at 2 weeks after RRT |  | 2 weeks after RRT in follow-up |
Life After Cancer: Behavioral Treatment Study to Improve Quality of Life

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to find new ways to improve the quality of life of people who have been treated for colon or rectal cancer.

Detailed Description
-----------------
Individuals who take part in the study can expect: Two Interviews: To be interviewed by our research staff over the phone. The interviews will include questions about your current quality of life and health. Brief Writing in a Journal: To write for 15 minutes twice a week for two weeks about aspects of your life.

Official Title
-----------------
Expressive Writing and Adjustment to Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Expressive writing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated for stage I, II or III colon or rectal cancer in the past 5 years Completed surgical treatment Must be able to read and write in English Exclusion Criteria: History of other cancers, with the exception of non-melanoma skin cancer

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Writing in a journal 15 minutes a day | Behavioral: Expressive writing<br>* Behavioral intervention using writing about cancer to improve quality of life outcomes<br>|
| Placebo Comparator: 2<br>Control Writing in a journal 15 minutes a day | Behavioral: Expressive writing<br>* Behavioral intervention using writing about cancer to improve quality of life outcomes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | self-report depressive symptoms | 2-Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer, colon cancer, rectal cancer
An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety of topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198.

Conditions
-----------------
Moderate to Severe Cyclic Mastalgia

Intervention / Treatment
-----------------
* Drug: Danazol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: menstruating females at least 18 years of age BMI less than 30 moderate to severe breast pain associated with the menstrual cycle in good general health Exclusion Criteria: pregnant within the last 6 months has taken in the last 3 months or currently taking hormonal contraception history of malignancy or currently being treated for cancer of the breast or genital organs has had breast implants or breast reduction surgery

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Danazol|High dose FP1198 applied once daily to both breasts for 6 treatment cycles.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in breast pain |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cyclic mastalgia, cyclic breast pain, fibrocystic breast disease
Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of botulinum toxin type A (Dysport®) injections into pericranial muscles compared to placebo to prevent migraine attacks.

Official Title
-----------------
A Phase II, Multicentre, Randomised, Double-blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Biological: Botulinum toxin type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having migraine without aura or with typical aura as defined by International Headache Society criteria Migraine attacks have been persisting for more than 1 year 2 to 6 migraine attacks per month of at least moderate severity over the 3 months preceding the pre-inclusion visit 2 to 6 migraine attacks of at least moderate severity during the screening period Exclusion Criteria: Non-migraine headaches such as tension-type headaches Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migraine aura without headache, migraine with acute onset aura, ophthalmoplegic migraine, retinal migraine, complications of migraine Onset of migraine is after age of 50 Overuse of acute migraine medications (individuals who take medications for acute migraine more than 10 days per month) or have a history of drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Botulinum toxin type A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant decrease of the number of migraine attacks with Dysport® compared to placebo. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the intensity of the migraine attacks. |  | 3 months | 
| Reduction of duration of the migraine attacks. |  | 3 months | 
| Reduction of migraine medication consumption. |  | 3 months | 
| Improvement of quality of life. |  | 3 months |
Effect of Preoperative Music on Anxiety

Study Overview
=================
Brief Summary
-----------------
In this study, we are planning to evaluate whether listening to the music of the patient's choice preoperatively contributes to postoperative anxiety.

Detailed Description
-----------------
Preoperative anxiety can be detected via structured and standardised screening by the State - Trait Anxiety Inventory (STAI) I and II. 117 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70 will be included in our study. preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into two groups as preoperative music played and not played. The list of patients listening to the music will be played through the headphones which are the preference of the patients. The postoperative STAI questionnaire will be applied again. results will be evaluated statistically

Official Title
-----------------
The Effect of Favorite Music on Postoperative Anxiety and Pain

Conditions
-----------------
Music on Postoperative Anxiety

Intervention / Treatment
-----------------
* Other: music
* Other: no music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inguinal hernia surgery speak Turkish language Exclusion Criteria: Patients with dementia and psychiatric disorders anxiolytic and psychiatric drug users patients without written consent poor vision, significant hearing loss, active opioid use, unwillingness to participate in the study unwillingness to listening to music

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: music<br>The preference of the patients will be listened to preoperatively through the headphones. | Other: music<br>* The preference of the patients will be listened to preoperatively through the headphones<br>|
| Other: no music<br>preoperative music will not be listened | Other: no music<br>* the patients will not be listened<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STAI score | preoperative and postoperative STAI I and II score questions will be asked. | 24 hours | 
| 11-point numerical rating scale (NRS) | 11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative anxiety, State - Trait Anxiety Inventory
Study of AFP464 +/- Faslodex in ER + Breast Cancer

Study Overview
=================
Brief Summary
-----------------
AFP464 is an investigational agent which may be effective in the treatment of cancer. The purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer patients.

Detailed Description
-----------------
This is a randomized, open-label study. Patients will be randomized in a 1:1 ratio to single arm AFP464, or AFP464+Faslodex. Patients will be treated until disease progression is noted.

Official Title
-----------------
A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy

Conditions
-----------------
Breast Neoplasm

Intervention / Treatment
-----------------
* Drug: AFP464
* Drug: AFP464 + Faslodex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proven breast cancer, ER+ status; progression on an aromatase inhibitor; measurable disease or evaluable disease with serum CA27.29>=50 U/mL; adequate bone marrow, liver and renal function; DLco grade 0 or 1. Exclusion Criteria: HER2 positive, thoracic radiotherapy or symptomatic pulmonary disease, brain metastases,

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AFP464<br>74 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle. | Drug: AFP464<br>* AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle<br>* Other names: (aminoflavone);|
| Experimental: AFP464 + Faslodex<br>AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycles and Faslodex administered per package label. | Drug: AFP464 + Faslodex<br>* AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycles and faslodex administered per the package label<br>* Other names: (aminoflavone) + (Fulvestrant);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit Response | Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Determination of progression free survival | 6 months | 
| Number of participants with adverse events | Determination of the number of patients who experience adverse events | 6 months |