linjc16/ctgov huggingface dataset:
Pre-biopsy With Dynamic Acquisitions

Study Overview
=================
Brief Summary
-----------------
This study is being done to test the ability of an investigational mammography camera to find small tumors in patients' breasts.

Detailed Description
-----------------
If you agree to take part in this study, you will be asked to remove your clothes from the waist up and put on a gown. A female technologist will give you an injection of Tc-99m sestamibi in a vein in your arm. This is a drug routinely used for breast imaging. About 10 minutes after your injection, you will be asked to sit in a chair for about 40 minutes. The technologist will position your breast between two small cameras. The cameras will apply a very light compression to your breast to make sure there is no movement during the picture. We will take two pictures of each breast. Each picture takes 10 minutes. You will also be asked to fill out a short questionnaire. If you are found to have additional breast lesions, your doctor and radiologist will be notified so that additional imaging or biopsies can be performed.

Official Title
-----------------
Determination of Sensitivity of a Dual-Headed Small Field of View Gamma Camera for the Detection of Small Breast Lesions

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

Intervention / Treatment
-----------------
* Device: Molecular Breast Imaging (MBI)
* Device: CZT semiconductor detectors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a lesion on Mammogram, Ultrasound or MRI that measured < 2 cm and considered suspicious or suggestive of malignancy Scheduled for biopsy of lesion > 18 years of age Negative pregnancy test, postmenopausal, or surgically sterilized Exclusion Criteria: Prior needle biopsy

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Molecular Breast Imaging (MBI)|To determine the sensitivity of MBI|
|Device: CZT semiconductor detectors|Dual headed CZT semiconductor detectors|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the sensitivity of the dual-head system relative to single-head for detection of sub 10 mm breast lesions, and to determine the number of images that need to be acquired. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MBI, Breast, Breast Cancer
Mirtazapine Versus Placebo in Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo, followed by 8 weeks of open-label mirtazapine 15 mg daily

Detailed Description
-----------------
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg or placebo, followed by 8 weeks of open-label mirtazapine Two weeks run-in, 8 weeks randomized, 8 weeks open label Assessments include dyspepsia questionnaire Nepean dyspepsia index Daily diary Vital signs

Official Title
-----------------
Phase 4 Study of Mirtazapine in Functional Dyspepsia Patients With Weight Loss

Conditions
-----------------
Functional Dyspepsia

Intervention / Treatment
-----------------
* Drug: Mirtazapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Functional dyspepsia according to Rome II criteria Weight loss of > 5% body weights Exclusion Criteria: Organic GI pathology History of upper gi tract surgery Major depression or anxiety Use of antidepressants in the last 2 months Prokinetic drugs or spasmolytic drugs Analgesic use (except paracetamol) Pregnancy or lactation

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mirtazapine<br>mirtazapine 15 mg daily | Drug: Mirtazapine<br>* Mirtazapine 15 mg daily<br>* Other names: mirtazapine is Remergon;|
| Placebo Comparator: Placebo<br>Placebo once daily | Drug: Mirtazapine<br>* Mirtazapine 15 mg daily<br>* Other names: mirtazapine is Remergon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in dyspepsia symptom scores week 8 versus week 0 | The Dyspepsia Symptom Score is calculated from the dyspepsia symptom severity questionnaire at weeks 0, 4 and 8. The symptom score has been used in previous studies (Tack et al., Gastroenterology 1998). | Week 8 compared to week 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual symptom severities | Individual symptom scores from the dyspepsia symptom score (DSS) which is used as primary endpoint | Week 8 compared to week 0 | 
| Nepean dyspepsia index for quality of life in functional dyspepsia | Use of the validated NDI. | Week 8 compared to week 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional dyspepsia, Weight loss, Mirtazapine
Comparison of a Powered Bone Marrow Biopsy Device With a Manual System

Study Overview
=================
Brief Summary
-----------------
Bone marrow biopsy quality as quantified by biopsy cylinder length and diagnostic usefulness is improved with a powered bone marrow biopsy device in comparison with a manual device.

Official Title
-----------------
a Prospective Randomized Controlled Trial Comparing a Powered Bone Marrow Biopsy Device With a Manual System

Conditions
-----------------
Bone Marrow Biopsy

Intervention / Treatment
-----------------
* Device: OnControl BM-Biopsy system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 >= one previous bone marrow procedure INR > 1.4 tThrombocyte count > 10 x109/l informed consent signed Exclusion Criteria: cognitive impairment excessive tissue at anatomical landmarks BMI > 35 kg/m2 allergy to premedication unable to lay flat in prone position

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: Manual (Hospital Systems TRAP Needle)<br>Bone marrow biopsy with a standard manual system | Device: OnControl BM-Biopsy system<br>* Bone marrow biopsy at posterior iliac crest<br>* Other names: http://www.hsmedicalinc.com/;|
| Experimental: Powered<br> | Device: OnControl BM-Biopsy system<br>* Bone marrow biopsy at posterior iliac crest<br>* Other names: http://www.hsmedicalinc.com/;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic usefulness (yes/no) of biopsy cylinder | The bone marrow biopsy cylinder is assessed by a pathologist who rates either diagnostic or non diagnostic | within 1 week of biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient pain during procedure | patients underdoing biopsy rate the pain during, 15 min after and 3-5 days after the proceedure | day 1 (two time points) and day 3-5 |
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.

Detailed Description
-----------------
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Official Title
-----------------
Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Drug: Sargramostim (Leukine)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable but active Crohn's disease at the time of screening Must be able to self-inject or have another person who can help with the injection Exclusion Criteria: Not have a colostomy or ileostomy Not be taking prohibited medications as defined in the protocol Not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery for the next months Not have ever taken this drug or drugs of similar type in the past

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Sargramostim (Leukine)<br>* 6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks<br>* Other names: BAY86-5326;|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction of clinical response and/or remission as defined by decrease in CDAI score |  | After 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time and duration to response/remission |  | During the 8 weeks of treatment | 
| QoL (different methods) |  | During the whole study | 
| Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.) |  | About 20 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morbus Crohn, Sargramostim, Phase III, Placebo Controlled
Investigative Headgear With CPAP Mask

Study Overview
=================
Brief Summary
-----------------
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.

Detailed Description
-----------------
Up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level PAP for the treatment of their OSA. These include current CPAP mask users.

Official Title
-----------------
Investigative Headgear With CPAP Mask

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Headgear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AHI≥5 from the diagnostic night ≥18 years of age Prescribed CPAP or Bilevel therapy for OSA Existing CPAP mask users Exclusion Criteria: Inability to give informed consent Patient intolerant to PAP Anatomical or physiological conditions making PAP therapy inappropriate History of respiratory disease or CO2 retention. Pregnant or think they may be pregnant Investigated by Land Transport Safety Authority

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Headgear<br>Investigative Headgear with CPAP Mask. | Device: Headgear<br>* Investigative Headgear with CPAP Mask.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants perception of the headgear on mask performance | Assess if the headgear with mask changes the perception of the performance of the mask. | 2-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that choose this Headgear over their usual. | Assess the acceptability of the headgear with mask. | 2-4 weeks |
Antihypertensive Response to Losartan and Genetic Polymorphisms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the antihypertensive response of treatment with losartan with reference to genetic polymorphisms.

Official Title
-----------------
Pharmacogenetic of the Antihypertensive Response to the Angiotensin II Blockers in Monotherapy or Associated to Hydrochlorothiazide

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: losartan potassium
* Drug: Comparator: Hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both gender less than 60 years old, with mild-moderate hypertension (SBP greater than and DBP equal or greater than 90 mmhg, BP < 180/110) Never treated for hypertension or who have taken antihypertensive agents sporadically (not more than 15 days total therapy) but not in the 30 days prior to the first visit Patient in therapeutic wash out for 6 months Patient is asymptomatic, absence of significant concomitant diseases, except for non-familial hypercholesterolemia, absence of systemic diseases Women with menopause not treated with hormone replacement therapy or women of reproductive age who do not make use of estro-progestagen agents but who use another safe contraceptive method BMI < 30 for men and < 28 for women Exclusion Criteria: Secondary or malignant hypertension, Na <130 mmol/l, K >5,5 mmol/l, or < 3,0 mmol/l Cardiac disease such as ischemic, HF, arrhythmia, cardiac surgery Pregnant, breast feeding History of nephropathy, metabolic disease, liver disease Alcohol or drug abuse History of angioedema Has a known hypersensibility to study drug(s)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Losartan 50 mg/day for 4 weeks, then doubled to losartan 100 mg/day in case of BP more than 140/90 mm Hg. HCTZ 25 mg will be added at week 8 if BP is more than 140/90 mm Hg. This last regimen will be continued until the end of the study (visit 9-week 48). | Drug: losartan potassium<br>* Losartan 50 mg/day for 4 weeks, then doubled to losartan 100 mg/day (in case of BP more than 140/90 mm Hg.) Continued until the end of the study (visit 9-week 48).<br>Drug: Comparator: Hydrochlorothiazide<br>* Hydrochlorothiazide 25 mg will be added at week 8 if BP is more than 140/90 mm Hg. This last regimen will be continued until the end of the study (visit 9-week 48).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure reduction with reference to genetic polymorphisms. |  | Over 1 Year |
Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer

Study Overview
=================
Brief Summary
-----------------
This expanded access protocol was designed to provide TJ004309 in combination with atezolizumab to the remaining three patients with advanced or metastatic cancer who plan to continue with treatment.

Official Title
-----------------
Expanded Access Protocol for an Intermediate Size Population-use of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: TJ004309
* Drug: Atezolizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the Tracon sponsored 4309ST101 or I-Mab sponsored TJ004309STM103 study and thought to have potential to derive clinical benefit from continued treatment in the opinion of the parent study investigator from dosing of TJ004309 in combination with atezolizumab. Willing or able to comply with study treatment and standard of care testing and procedures. Exclusion Criteria: Any unresolved ongoing toxicity or clinical event that would make continued treatment with TJ004309 inappropriate. Current treatment in another clinical study or treatment with other standard of care therapy. Currently pregnant. Current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might interfere with the patient's participation or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TJ004309|Antibody to CD73|
|Drug: Atezolizumab|Humanized monoclonal antibody to PD-L1|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)

Study Overview
=================
Brief Summary
-----------------
Goal of the study is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable CREDO® heal Stent.

Official Title
-----------------
REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)

Conditions
-----------------
Rescue Stenting

Intervention / Treatment
-----------------
* Device: Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, treated with CREDO® heal according to IFU and: With symptoms onset less than 24 hours before start of the procedure Treated with study device following at least one futile mechanical recanalization attempt with a stent retriever, direct aspiration or combination of both With pre-stroke disability mRS 0-2 Exclusion Criteria: Any contraindication according to IFU and patients: With atherosclerotic (probable according to clinical, anamnestic or laboratory chemical testing) vessel constrictions (high-grade intracranial stenoses > 70 %) with significant circulatory disturbance (haemodynamic infarct pattern and signs of restricted collaterals) and recurrent symptoms in spite of medical therapy With contraindication against treatment with anti-platelet medication With current effective use of oral anticoagulants (e.g. INR >1.7 for Vitamin K antagonists) or direct oral anticoagulants Participating in another trial

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter|Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 at the end of the treatment procedure. | • Technical success defined as successful recanalization of the occluded vessel (expanded treatment in cerebral ischemia score (eTICI) of 2b-3) at the end of the procedure. | Assessed at the end of the treatment procedure. | 
| Primary Clinical Efficacy Endpoint- proportion of patients with mRS 0-2 at 90 (± 20) days after procedure. | • Good clinical outcome 90 (± 20) days after stroke defined as a score of 0-2 on the modified Ranking Scale (mRS 0-2). | 90 (± 20) days. |