linjc16/ctgov huggingface dataset:
Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy

Study Overview
=================
Brief Summary
-----------------
Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.

Detailed Description
-----------------
The Researcher developed a diagnostic device called Diffuse Optical Spectroscopy Imaging is a non-invasive optical technique that utilizes intensity-modulated, near-infrared light to quantitatively measure optical properties in thick tissues. Diffuse Optical Spectroscopy Imaging can images tissue hemoglobin , oxygen saturation, blood volume fraction, water content, fat content and cellular structure. The measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development. There is no therapeutic benefit to the subject, especially none that might influence the indication for the diagnostic procedure as indicated. However, information obtained may lead to a new form of non-invasive imaging for the early detection of breast cancer.

Official Title
-----------------
Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy

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

Intervention / Treatment
-----------------
* Device: Diffuse Optical Spectroscopy Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy Exclusion Criteria: Female pregnant and age less than 21 years old and have no diagnosis of breast cancer

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diagnostic Tool<br>Diffuse Optical Spectroscopy Imaging | Device: Diffuse Optical Spectroscopy Imaging<br>* Diffuse Optical Spectroscopy Imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic tool | Diffuse Optical Spectroscopy Imaging Breast Cancer Tumor in the response of Chemotherapy | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer receiving chemotherapy
Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood from patients treated with sargramostim in the laboratory may help doctors learn more about the effects of sargramostim on cells. It may also help doctors understand how patients respond to treatment. PURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV melanoma previously treated with sargramostim.

Detailed Description
-----------------
OBJECTIVES: Primary To correlate circulating myeloid-derived suppressor cells (MDSC) and Treg frequencies with clinical outcome. Secondary To correlate circulating anti-sargramostim (GM-CSF) antibody levels with clinical outcome. OUTLINE: Archived peripheral blood mononuclear cells and serum samples are analyzed for circulating myeloid-derived suppressor cells, Treg (CD3+/CD4+/CD25hi/FOXP3+) frequency, and anti-sargramostim (anti-GM-CSF) antibody levels by flow cytometry and anti-GM-CSF neutralizing antibody assay.

Official Title
-----------------
Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF

Conditions
-----------------
Melanoma (Skin)

Intervention / Treatment
-----------------
* Other: flow cytometry
* Other: immunologic technique
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosed with melanoma Stage IV disease HLA-A2^+ and A2^+ Received sargramostim on clinical trial ECOG-4697 Specimens collected at baseline and either day 43 or day 85 (based on most consistent availability) from long-term survivors and patients with poor survival PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: flow cytometry|nan|
|Other: immunologic technique|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall and disease-free survival |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV melanoma
A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder

Study Overview
=================
Brief Summary
-----------------
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).

Official Title
-----------------
A 24-Week, Flexible-Dose, Open-label Extension Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Protocol No. D1050290)

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: Lurasidone HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077). Exclusion Criteria: Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property. Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see Appendix 3 for BMI determination).

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: Open Label<br>Subjects will continue on treatment with the same dose of lurasidone flexible dosing - 40 mg to 12 mg once daily taken orallay at endpoint of the D1050289 ( NCT01143077) core study. | Drug: Lurasidone HCl<br>* 40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Proportions of subjects with AEs, SAEs, and discontinuations due to AEs. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Lurasidone, Latuda
Real-Time Feedback (RTFB) to Improve Colonoscopy

Study Overview
=================
Brief Summary
-----------------
To test whether real-time feedback will improve quality of endoscopic examination.

Official Title
-----------------
Real-Time Feedback (RTFB) to Improve Colonoscopy

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

Intervention / Treatment
-----------------
* Device: AI program for colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Any endoscopist willing to parcipate and performing routine colonscopy Exclusion Criteria: - No exclusion criteria

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: Sequential Assignment
Interventional Model Description: Multiple successive arms testing new feedback options
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testing of degree of mucosal inspection<br>AI provides real-time feedback related to circumferential views during endoscope removal | Device: AI program for colonoscopy<br>* Provides real-time feedback on the endoscopist moniter during colonoscopy.<br>|
| Experimental: Testing of clearing of fecal debris<br>AI provides real-time feedback related to removal of remaining fecal debris | Device: AI program for colonoscopy<br>* Provides real-time feedback on the endoscopist moniter during colonoscopy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate | Percent change in ADR | 5 months post procedure |
The Alouette Test in Parkinson Disease

Study Overview
=================
Brief Summary
-----------------
Reading disorders in Parkinson's Disease (PD) are poorly evaluated due to the lack of validated tests to screen for them. They are often attributed to hand tremors associated with the disease. In this study, the investigating team evaluated the alouette test validated for dyslexia screening, in PD by comparing the results to healthy patients.

Official Title
-----------------
Screening for Reading Difficulties in Parkinson's Disease: An Evaluation of the Alouette Test

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Alouette test (reading test)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Parkinson's Disease Montreal Cognitive Assessment (MoCA) test > 20 Exclusion Criteria: Patient's with supranuclear Palsy Other neurologic disease Any ophthalmologic disease Presence of a nystagmus Visual acuity < 0.6
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Parkinson's Disease<br>Patients with Parkinson's Disease (PD) were evaluated for reading disorders using a screening method validated for dyslexia. | Other: Alouette test (reading test)<br>* The alouette test was assessed at a fixed distance of 40 centimeters on a fixed surface to avoid errors related to hand tremors.<br>|
| Patients without Parkinson's Disease = control group<br>Patients without Parkinson's Disease (PD) were evaluated for reading disorders using a screening method validated for dyslexia. | Other: Alouette test (reading test)<br>* The alouette test was assessed at a fixed distance of 40 centimeters on a fixed surface to avoid errors related to hand tremors.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Alouette test | The Alouette test is based on the precision and speed in reading a short text (279 words). The score corresponds to the total number of words correctly read. | 1 day |
HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles

Study Overview
=================
Brief Summary
-----------------
We recently reported the superiority of the natural cycle to a natural cycle controlled by the administration of human chorionic gonadotropin (hCG) for planning the frozen-thawed embryo transfer cycles, demonstrating a probable negative impact of exogenous hCG on endometrial receptivity.Based on the above findings we conducted the first prospective study that assesses whether there is a difference in pregnancy rate after intrauterine insemination (IUI) in a natural cycle with spontaneous luteinizing hormone (LH) rise compared to natural cycles controlled by hCG for final ovulation.

Official Title
-----------------
Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing Intrauterine Insemination: a Prospective Randomized Study.

Conditions
-----------------
Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing IUI

Intervention / Treatment
-----------------
* Drug: HCG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≤ 36 years, regular menstrual cycles, body mass index (BMI) between 18 and 29 kg/m², basal levels of FSH (≤ 12 IU/l), estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle, normal hysterosalpingography (maximum 3 months prior starting the cycle). The use of donor sperm was also accepted as inclusion criteria. Exclusion Criteria: PCOS endometriosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 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: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: spontaneous LH<br> | Drug: HCG<br>* 5000 IU<br>|
| Experimental: HCG<br> | Drug: HCG<br>* 5000 IU<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rate |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IUI, HCG, Spontaneous LH, pregnancy
Evaluation of Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone

Study Overview
=================
Brief Summary
-----------------
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone.

Official Title
-----------------
A 24-week National Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Trial in India to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone.

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Dapagliflozin
* Drug: Dapagliflozin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent before participating in the study Diagnosed with type 2 diabetes (high blood sugar); HbA1c ≥ 7.2% and ≤10.0% Subjects should be drug naïve Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study & who have a negative serum or urine pregnancy test Exclusion Criteria: Subjects received Insulin therapy within one year of enrollment Subjects who have severe uncontrolled hypertension Subjects who have history of unstable or rapidly progressing renal disease Subjects who have severe liver disease Subjects who receiving treatment for Human immunodeficiency virus (HIV)

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Experimental: 1<br> | Drug: Dapagliflozin<br>* 5mg Oral dose od<br>|
| Experimental: 2<br> | Drug: Dapagliflozin<br>* 10 mg Oral dose od<br>|
| Placebo Comparator: 3<br> | Drug: placebo<br>* 5/10 mg Oral dose od<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in glycosylated haemoglobin A1c (HbA1c). |  | From baseline to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change in fasting plasma glucose (FPG) |  | From baseline to week 24 | 
| mean change in 2- hour postprandial glucose by Mixed Meal Test |  | From baseline to week 24 | 
| mean change from baseline in fasting plasma glucose (FPG) |  | From baseline to week 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase III, Type 2 Diabetes Mellitus, inadequate glycaemic control
Study of Healthy Cohort for Early Detection of Cancer

Study Overview
=================
Brief Summary
-----------------
Cancer produces a significant burden on society with a majority diagnosed at late stages when the chance of cure is low. Early diagnosis improves patient outcomes. Data consisting of lifestyle factors, medications, physical activity, years before conventional cancer diagnosis is also worthwhile for to determine early detection. This is only achievable with longitudinal tracking of a large number of healthy individuals and identifying those who do develop cancer over time.

Detailed Description
-----------------
To conduct a longitudinal cohort study of patients who do not have a malignancy at the time of enrollment and are followed over a 20 year period to see if patients develop a malignancy and associate clinical and lifestyle factors as well as collection of blood. All adults 18 years of age and older undergoing upper or lower endoscopy for routine medical care will be eligible for this study.

Official Title
-----------------
Study of Healthy Cohort for Early Detection of Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults 18 years of age of older undergoing upper or lower endoscopy for routine medical care. Exclusion Criteria: Persons with current malignancy Persons with history of malignancy and treatment within last 5 years of enrollment, excluding non-melanoma skin cancer or cervical in-situ. Persons who are unable or unwilling to provide repeat blood samples and complete follow-up questionnaires Persons who lack the capacity to provide consent Persons who do not speak English Persons who are visually or hearing impaired.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of malignancy | Assessment of participants for the development of malignancy during a 20-year follow-up period. | Up to 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of biomarkers | To identify proteins, RNA and DNA that have changes in expression in those who develop cancer. | Up to 20 years |
Perforator Mapping and Optimizing Design of the Lateral Arm Flap

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to optimize the design of lateral arm flap. Colored duplex will be done for all Participants and compared to intra operative findings. flap modification (Supra facial) dissection to lateral arm flap will be done and the results will compared to the ordinary method of dissection.

Official Title
-----------------
Perforator Mapping and Optimizing Design of the Lateral Arm Flap: Clinical Trial

Conditions
-----------------
Coverage of Soft Tissue Defects

Intervention / Treatment
-----------------
* Diagnostic Test: coloured duplex
* Procedure: supra facial dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients Exclusion Criteria: children injury to pedicle

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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: patients candidate for lateral arm flap<br> | Diagnostic Test: coloured duplex<br>* colored duplex to locate numbers sites and size of perforators.<br>Procedure: supra facial dissection<br>* flap raising in supra facial plane<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numbers of perforators | numbers of perforators in the flap | two years | 
| site of perforators | distance from lateral humeral epicondyle in CM | two years | 
| Size of perforators | size in millimeter | two years |