linjc16/ctgov huggingface dataset:
Survey of Optical Values of the Breast Using Radiation-Free Pressure-Free Optical Scanning

Study Overview
=================
Brief Summary
-----------------
The purposes of this study is to establish normal optical values of breast tissue in the general population. This will allow for establishing normals for breast composition, and is expected to be useful in the classification of breast lesions into groups such as cysts, benign growths, inflammatory lesions, and possibly early breast cancer.

Official Title
-----------------
Early Screening of Breast Cancer Using Radiation-Free Pressure-Free Optical Scanning

Conditions
-----------------
Breast Lesions, Breast Cyst, Early-Stage Breast Cancer, Benign Growth, Breast

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You must be female You must be 21 to 50 years old You must not have or have had breast cancer. You must not have or have had breast implants or breast surgery You must not have had a breast biopsy or injury, or a breast infection, in 90 days. Exclusion Criteria: Any one or more of the above conditions not met Lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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 |
| --- | --- |
| Women 21-50 years old<br>Women without a diagnosis of cancer or a history of cancer. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical normals for the breast for a variety of conditions |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic compositional standards for (a) diagnosis of a condition such as cyst, benign growth, inflammation, and/or (b) referral for additional evaluation of a region of interest. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening, compositional analysis, metabolism, breast, breast cyst, breast infection, breast inflammation, lipoma, benign growth, Women without a diagnosis for a region of interest in the breast
Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy

Study Overview
=================
Brief Summary
-----------------
AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.

Official Title
-----------------
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Administered Daily for 5 Days Every 3 Weeks to Patients With Metastatic Cancer or Disseminated Malignancy

Conditions
-----------------
Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: imexon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously treated malignant disease of any type. Prior treatment; at least one prior regimen required. Able to perform the activities of daily living. Off prior cancer therapy for at least 4 weeks. If female, neither pregnant nor nursing. Willing to use contraceptives to prevent pregnancy. No other serious illnesses. No other active malignancy. No serious infections. No other current drug therapy for the cancer. Blood counts and blood chemistries in or near normal range. Prior radiation is permitted. Exclusion Criteria: No active brain metastases.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imexon<br>Dose escalation of imexon | Drug: imexon<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the maximally tolerated dose |  |  | 
| determine the pharmacokinetics |  |  | 
| determine the toxicity of the drug on the designated schedule |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic cancer, Disseminated malignant disease
Relationship Between Body Weight and Glycohemoglobin

Study Overview
=================
Brief Summary
-----------------
Control of body weight (BW) is important to prevent and manage type 2 diabetes. Regardless of the close association, little is understood about the precise relationship between BW and glycemic control, which might be of benefit for patients with type 2 diabetes. The researchers investigated the correlation between changes in BW and glycemic control in patients with type 2 diabetes treated with a diet therapy or pioglitazone.

Official Title
-----------------
Relationship Between Changes in Body Weight and Glycohemoglobin Levels in Patients With Type 2 Diabetes Treated With Diet or Pioglitazone.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes under reasonable glycemic control (HbA1c; less than around 7%) type 2 diabetic patients treated with the diet therapy Exclusion Criteria: type 2 diabetic patients with edema, severe liver dysfunction, renal dysfunction, moderate to severe anemia or congestive heart failure type 2 diabetic patients treated with insulin therapy

Ages Eligible for Study
-----------------
Minimum Age: 32 Years
Maximum Age: 76 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 (type 2 diabetes, body weight, HbA1c)<br>The investigators analyzed the recorded data (body weight and glycohemoglobin) of 70 type 2 diabetic patients treated with the diet therapy. Recorded values at 0, 2 and 4 months for body weight (BW) and glycohemoglobin (HbA1c) were used. And changes from baseline (0 month) in BW (ΔBW) were plotted against those of HbA1c (ΔHbA1c). | |
| 2 (type 2 diabetes, pioglitazone, HbA1c)<br>The investigators analyzed the recorded data (body weight and glycohemoglobin) of 23 type 2 diabetic patients treated with pioglitazone. Recorded values at 0, 2 and 4 months for body weight (BW)and glycohemoglobin (HbA1c) were used. And changes from baseline (0 month) in BW (ΔBW) were plotted against those of HbA1c (ΔHbA1c). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
body weight, glycohemoglobin
Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.

Official Title
-----------------
Effect of GLP-1 and GIP on the Maximal Insulin Secretory Capacity in Type-1 Diabetes Mellitus

Conditions
-----------------
Type-1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: glucagon like peptide -1
* Other: NaCl
* Other: glucose dependent insulinotropic polypeptide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-60 years Type-1 diabetes diagnosed between 5-40 years of age Normal weight(BMI 18-27), Insulin treatment from time of diagnosis. Exclusion Criteria: Severe complications to diabetes Abnormal liver or kidney function Haemoglobin below the lower limit Macroalbuminuria Systemic disease Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-1<br>time -30-90 min: Continuous infusion with GLP-1 (1,2pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g). | Other: glucagon like peptide -1<br>* continuous infusion 1,2 pmol pr. kg pr minute at 120 minutes<br>|
| Placebo Comparator: NaCl<br>time -30-90 min: Continuous infusion with NaCl time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g). | Other: NaCl<br>* infusion with NaCl for 120 minutes as placebo-arm<br>|
| Experimental: GIP<br>time -30-90 min: Continuous infusion with GIP-1 (3,6pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g). | Other: glucose dependent insulinotropic polypeptide<br>* continuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal insulin response defined as mean insulin at time 47 and 49 minutes (2 and 4 minutes after infusion of L-Arginine) |  | 2 hours |
A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

Study Overview
=================
Brief Summary
-----------------
To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease

Detailed Description
-----------------
A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

Official Title
-----------------
A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Drug: 4 dose levels of ALV003


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION Health Status Healthy volunteers must be in good health Celiac Disease must be well controlled and in good health Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods. Body Mass Index (BMI) of < 30 kg/m2, EXCLUSION A positive urine test for alcohol or illegal drugs at screening. The subject has received an experimental drug within 30 days of the present study. History of substance abuse, within the last 5 years Clinically significant abnormal lab values, as determined by the PI Alcohol consumption of > 2 standard drinks equivalents per day12. Positive pregnancy test within 7 days prior to study drug administration. history of any medically significant condition considered by the PI to adversely affect participation in the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Placebo | Drug: 4 dose levels of ALV003<br>* 4 dose levels of ALV003 vs placebo<br>* Other names: ALV003 and ALV003 placebo equivalent;|
| Active Comparator: B<br>Active study Drug: ALV003 | Drug: 4 dose levels of ALV003<br>* 4 dose levels of ALV003 vs placebo<br>* Other names: ALV003 and ALV003 placebo equivalent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability |  | Throughout | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celiac Disease
Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis

Study Overview
=================
Brief Summary
-----------------
A trial of combination of two drugs for the treatment of refractory lupus nephritis.

Detailed Description
-----------------
Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis: a 12-month prospective study

Official Title
-----------------
Low-dose Combination of Mycophenolate Mofetil and Tacrolimus for Refractory Lupus Nephritis: a 12-month Prospective Study

Conditions
-----------------
Lupus Nephritis

Intervention / Treatment
-----------------
* Drug: low dose combination of MMF and Tac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active nephritis documented by renal biopsy within 24 months of entry; Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages; Serum creatinine (Scr) less than 200umol/L. Exclusion Criteria: Previous intolerance to either MMF/Tac; Scr >200umol/L; Informed consent unavailable.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Combination treatment<br>treatment arm | Drug: low dose combination of MMF and Tac<br>* mycophenolate mofetil 500mg BID + tacrolimus 2mg BID<br>* Other names: Cellcept and Prograf;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | adverse events experienced by patients as a measure of tolerability | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lupus, nephritis, glomerulonephritis, nephropathy, refractory
Vaccine Therapy in Treating Patients With Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.

Detailed Description
-----------------
OBJECTIVES: Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™). OUTLINE: This is an open-label, multicenter study. Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™). After completion of study treatment, patients are followed at 30 days. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Official Title
-----------------
Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™

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

Intervention / Treatment
-----------------
* Biological: polyvalent melanoma vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma At least 1 in-transit skin lesion measuring 3-10 mm in the longest diameter PATIENT CHARACTERISTICS: Age 18 to 80 Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: polyvalent melanoma vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage III melanoma
Radiographic Changes and Clinical Implications of Implantation of Shortened Uncemented Femoral Stems in THA

Study Overview
=================
Brief Summary
-----------------
The hip prosthesis market is constantly growing with the number of prostheses reaching 949,000 in 2019. Along with this, there is also an increase in interest in short stems also called shortened stems. Thus on Pubmed, in 5 years, 171 publications have been listed. Thus, it seems interesting to study and analyze the performance of the shortened stem used in the Department of Orthopedic Surgery and Traumatology of the University Hospitals of Strasbourg and to compare them with the results of the literature.

Detailed Description
-----------------
The objective of this study is to observe the appearance of shortened stem radiological abnormalities at least 2 years postoperatively.

Official Title
-----------------
Study of Radiographic Changes and Their Clinical Implications at 2 Years of Implantation of Shortened Uncemented Femoral Stems in Total Hip Arthroplasty

Conditions
-----------------
Aseptic; Osteonecrosis, Hip Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female (age ≥18 years old) Subject operated for first-line THA for an indication of centric hip osteoarthritis (including minor dysplasia and coxa profunda) and aseptic osteonecrosis of the femoral head Subject who received a THA between January 2015 and December 2019 Subject who received an uncemented shortened SCC or SCLA femoral stem Radiological data available: pre-operative, immediate post-operative and post-operative at a minimum of 2 years (≥24 months) Subject not objecting to the reuse of their data for scientific research purposes. Exclusion criteria: Subject having expressed its opposition to the reuse of its data for scientific research purposes. Patient operated for inflammatory pathology or major dysplasia, recovery Associated fractures or sequelae of fractures Patient having presented intraoperative or early complications such as infections, intraoperative fracture, dislocation of the hip following the installation of the THA Revision of hip arthroplasty during the study follow-up period for a cause not studied in the study.

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 |
| --- | --- | --- |
| Bone changes around the femoral implant at 2 years on hip radiographs. |  | 2 years postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip Osteoarthritis, Aseptic; Osteonecrosis, Coxarthrosis, Avascular Necrosis of the Femoral Head
Long-Term Specified Drug Use-Results Survey for Xtandi Capsule

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients.

Official Title
-----------------
Xtandi® Capsules 40 mg Protocol for Long-Term Specified Drug Use-Results Survey

Conditions
-----------------
Castration-resistant Prostate Cancer

Intervention / Treatment
-----------------
* Drug: enzalutamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no history of treatment with enzalutamide Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enzalutamide group<br>oral | Drug: enzalutamide<br>* oral<br>* Other names: MDV3100;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of Adverse Events |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Up to 2 years | 
| Change from baseline in PSA value | PSA: prostate-specific antigen | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xtandi, MDV3100, long term use, enzalutamide