linjc16/ctgov huggingface dataset:
Vascular Risk Progression in Normal and Diabetic Control Subjects.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the progression of cardiovascular disease (CVD) in normal control individuals and in patients with controlled diabetes.

Detailed Description
-----------------
Cardiovascular disease remains the greatest cause of mortality in people with diabetes mellitus. This observation study will evaluate non-traditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over 1 year. This study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intimal medical thickness.

Official Title
-----------------
Vascular Risk Progression in Normal and Diabetes Control Subjects

Conditions
-----------------
Diabetes, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 years old or more and willing to return for annual testing for 2 years. Those with Diabetes need to have the condition for at least 5 years. Normal controls need to have no diabetes, kidney disease, or chronic disease. Exclusion Criteria: Estimated GFR <60 (mL/min/1.73m2) Any condition that would change weight dramatically in the near future such as malabsorption, pregnancy, malignancy For Normal: BMI>30, BP > 140/90 , LDL > 130. For Diabetes: BP> 135/85, A1C> 8%. LDL > 100.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 Cardiovascular disease (CVD) in Participants without diabetes<br>Progression of cardiovascular disease (CVD) in participants without diabetes | |
| 2 Cardiovascular disease (CVD) in participants with type 2 Diabetes<br>Progression of cardiovascular disease (CVD) in participants with type 2 Diabetes with good control | |
| 3 Cardiovascular disease (CVD) in participants with type 1 diabetes<br>Progression of cardiovascular disease (CVD) in participants with type 1 diabetes with good control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid intima media measurement change | To describe carotid intima media measurement change over 2 year period in normal individuals compared to individuals with well controlled diabetes | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Vascular risk, Inflammation
Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Cancer (Study P01499)(TERMINATED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) when given in combination with Gemcitabine and Cisplatin in patients with advanced cancer.

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: Farnesyl Protein Transferase Inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced cancer for which there is no treatment available which would have a reasonable chance of disease palliation or cure Age greater than or equal to 18. SWOG performance Status less than or equal to 2. Meets protocol requirements for specified laboratory values. Written informed consent and cooperation of patient. Exclusion Criteria: Prior treatment with an FPTI Knowledge of intracranial metastases or carcinomatous meningitis. Poor medical risks because of nonmalignant systemic disease or uncontrolled active infection. Medical conditions that would interfere with taking oral medications. Significant uncontrolled diarrhea. Chemotherapy, radiotherapy or major surgery within 4 weeks; full recovery from prior treatment. Concomitant use of CYP3A inhibitors/inducers per protocol. Known HIV positivity or AIDS-related illness. Pregnant or nursing women. Men or women of childbearing potential who are not using an effective method of contraception. Concurrent chemotherapy, hormonal therapy, radiotherapy or immunotherapy. QTc prolongation (>440 msecs) at baseline. Patients with previous high-dose therapy requiring stem cell rescue or bone marrow transplant, or irradiation to >30% of bone marrow-containing areas. Patients that have received Mitomycin-C or nitrosoureas.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Farnesyl Protein Transferase Inhibitor|nan|

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
-----------------
Advanced Cancer
Sexual Dysfunction in Patients With Chronic Liver Disease

Study Overview
=================
Brief Summary
-----------------
This project will determine the incidence of sexual dysfunction in patients with chronic liver disease, through questionnaires. The questionnaires have been designed to assess several facets of sexual health, e.g. libido, physical symptoms, depression, etc. 150 patients in our liver outpatient department, and 150 healthy volunteers will be asked to fill in the questionnaire in paper form. The results of this project will be used to produce patient resources, advice sheets and educational materials for patients with chronic liver disease. There is also scope to consider possible interventions in the future to improve sexual dysfunction in patients with chronic liver disease.

Official Title
-----------------
Sexual Dysfunction in Patients With Chronic Liver Disease

Conditions
-----------------
Liver Diseases, Liver Cirrhosis

Intervention / Treatment
-----------------
* Diagnostic Test: Sexual function questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of a chronic liver disease (including those who have had liver transplantation) Aged 18-75 Able to give informed written consent Exclusion Criteria: Major psychiatric disease Patients who lack capacity Patient with no chronic liver disease Patients not proficient in English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic liver disease<br> | Diagnostic Test: Sexual function questionnaire<br>* Sexual function questionnaire and cognitive screening assessments<br>|
| Healthy volunteers<br> | Diagnostic Test: Sexual function questionnaire<br>* Sexual function questionnaire and cognitive screening assessments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with sexual dysfunction | The number of patients suffering from sexual dysfunction in patients with chronic liver disease | 12 months |
Evaluating the Effect of Inositol Supplementation in Overweight Children on Basal Insulin and Body Weight

Study Overview
=================
Brief Summary
-----------------
Inositol in involved in the insulin pathway. In literature it has been demonstrated to improve insulin sensitivity and ovarian function in women affected by PCOS. In a preliminary study conducted on obese children between 7 and 15 years, the investigators have demonstrated that Inositol administration (Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg) before a Glucose Oral Tolerance Test reduces the increase of insulin levels, particularly in subjects with basal insulin ≥ 15 uU/ml. So the aim of this study is to evaluate the potential therapeutic effect of inositol, as non-pharmacologic agent, in preventing tipe II diabetes in children.

Official Title
-----------------
Effects of Inositol Supplementation in Children With Excessive Body Weight and Insulin Resistance

Conditions
-----------------
Insulin Resistance

Intervention / Treatment
-----------------
* Dietary Supplement: Inofolic Combi
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 8-18 years old overweight or obesity basal insulin ≥ 20 uU/ml Exclusion Criteria: pubertal delay hypogonadism hypothyroidism or hyperthyroidism obesity-related genetic diseases

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inositol<br>Administration of Inofolic Combi (Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg - Lo.Li Pharma S.r.l.) 2 capsules every day for 1 month | Dietary Supplement: Inofolic Combi<br>* Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg. 2 capsules every day for 1 month.<br>|
| Placebo Comparator: Placebo<br>Administration of placebo. 2 capsules every day for 1 month | Other: Placebo<br>* 2 capsules every day for 1 month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal Insulin | Evaluation of the efficacy of inositol in reducing basal insulin | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Evaluation of the efficacy of inositol in reducing body weight | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inositol, insulin resistance, overweight, children
Protective Effects of Oral L-Arginine CI-AKI

Study Overview
=================
Brief Summary
-----------------
This trial was performed to examine the efficacy of oral L-arginine for preventing CI-AKI in chronic kidney disease (CKD) patients.

Detailed Description
-----------------
Contrast-induced acute kidney injury (CI-AKI) is a common complication in hospitalized patients. Nitric oxide-signal transduction plays an important role in prevention of CI-AKI. L-Arginine is an amino acid involved in ammonia detoxification, and is well known as a precursor to nitric oxide, a key component of endothelial-derived relaxing factor. This is a prospective randomized, double blind, placebo controlled trial among CKD stage 3-4 patients undergoing computer tomography. Eligible patients were randomly assigned to two groups: (1) arginine 3 g/day or 6 capsules per day, and (2) placebo 6 capsules per day for 3 days before contrast media injection. Serum cystatin C, serum creatinine and estimated GFR was measured at baseline and 48 hours after procedure.

Official Title
-----------------
Protective Effects of Oral L-Arginine Supplement in Patients With CKD After Intravenous Contrast Media Injection

Conditions
-----------------
Contrast Induced AKI

Intervention / Treatment
-----------------
* Dietary Supplement: L-arginine
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Stable CKD stage 3-4 patients Patients undergoing elective contrast media injection Exclusion Criteria: History of arginine allergy Acute kidney injury diagnosed within 4 weeks Active infection/sepsis Severe liver disease

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arginine<br>Participants need to take arginine 3 g/day orally for 3 days before CT with contrast media injection | Dietary Supplement: L-arginine<br>* Comparison of the efficacy of L-arginine 3 grams for days versus placebo in contrast induced AKI prevention<br>|
| Placebo Comparator: Placebo<br>Participants need to take placebo (corn powder) 3 g/day orally for 3 days before CT with contrast media injection | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Contrast-induced acute kidney injury (CI-AKI) |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse effects |  | 48 hours |
Efficacy of Bimatoprost 0.03% in Patients Who Are Low-Responders to Latanoprost

Study Overview
=================
Brief Summary
-----------------
To evaluate the IOP-lowering efficacy of bimatoprost 0.03% in patients found to be low-responders to latanoprost therapy.

Official Title
-----------------
Efficacy of Bimatoprost 0.03% in Patients Who Are Low-Responders to Latanoprost

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Bimatoprost 0.03%, Latanoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Male or female > 18 years of age Documented low-responder to latanoprost therapy as delineated in the outline above. Diagnosis of open-angle glaucoma or ocular hypertension Ability to provide informed consent and likely to complete all study visits Exclusion Criteria: · Known contraindication to bimatoprost or any component of any study medication Uncontrolled systemic disease Active ocular disease other than glaucoma or ocular hypertension Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear solutions will be permitted) History of intraocular surgery within the last 3 months

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bimatoprost 0.03%, Latanoprost|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prospective and Retrospective Breast Cancer Database

Study Overview
=================
Brief Summary
-----------------
In order to accelerate border crossing between basic research and clinical research in breast cancer, it is necessary to easily use clinical and biological data. That is the reason why it is very important to create a clinical, biological and pathologic beast cancer database, mainly prospective but also retrospective. All data are from patients treated in Toulouse Centre. The scientific community will easily have access to clinical and biological informations through a centralized, structured database , leading to optimize patients with breast cancer treatment.

Official Title
-----------------
Creation of a Prospective and Retrospective Breast Cancer Database

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

Intervention / Treatment
-----------------
* Other: clinical biological database collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patient Histologically confirmed breast cancer of any stage Affiliated to a social security system in france Who signed the informed consent Exclusion Criteria: Any psychiatric or medical condition that would make the patient unable to give a signed informed consent

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 |
| --- |
|Other: clinical biological database collection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Database of patients with breast cancer |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, database
Does Transfer of Poor-quality Embryos With Good-quality Embryos Improve Pregnancy Outcome in Women Undergoing IVF/ICSI?

Study Overview
=================
Brief Summary
-----------------
Women planned to undergo blastocyst-stage embryo transfer after IVF/ICSI were randomized into 2 groups: group I: women who had only good-quality embryo transfer. group II: women who had both good-quality and poor-quality embryo transfer. primary outcome was ongoing clinical pregnancy rate

Official Title
-----------------
Does Transfer of Poor-quality Embryos With Good-quality Embryos Improve Pregnancy Outcome in Women Undergoing IVF/ICSI?

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Embryo transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women undergoing primary IVF/ICSI cycles for tubal factor/unexplained infertility and had blastocyst-stage ET Exclusion Criteria: cleavage-stage ET. women who had no good-quality embryos to transfer women who had known poor endometrial receptivity

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Good-quality embryo transfer<br>Women who had only good-quality embryo transfer | Other: Embryo transfer<br>* Transfer of different qualities of embryos at blastocyst stage<br>|
| Active Comparator: good- and poor-quality embryo transfer<br>Women who had both good- and poor-quality embryo transfer | Other: Embryo transfer<br>* Transfer of different qualities of embryos at blastocyst stage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing clinical pregnancy rate | viable intrauterine pregnancy ongoing beyond 12 weeks of gestation | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical pregnancy rate | positive serum hCG | 2 weeks after ET | 
| Clinical pregnancy rate | sonographic detection of viable intrauterine gestational sac | 4 weeks after ET | 
| Multiple pregnancy rate | No. of intrauterine gestational sacs | 4-6 weeks after ET | 
| Ectopic pregnancy rate | Extrauterine pregnancy | 6 weeks after ET |
A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of the HARMONY study is to assess the safety and efficacy of an investigational drug called HuZAF, in patients with moderate to severe Crohn's disease (CD). HuZAF is a humanized anti-Interferon-gamma (anti-IFN-γ) monoclonal antibody, which binds and blocks IFN-γ, a protein in the immune system that is involved in inflammation. Antibodies are proteins normally produced by our immune system to help fight off foreign substances. Scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the antibodies in our bodies, to target diseases.

Detailed Description
-----------------
Participants will be randomized, assigned by chance, to one of five treatment groups consisting of: four groups differing in the amount of study drug given and one placebo group. The initial dose of study drug will be given intravenously, injected into a vein in the arm. Four weeks later, three subsequent doses of study drug will be given subcutaneously, through the skin, every four weeks for three doses. Patients will be followed for approximately six months after receiving their final dose.

Official Title
-----------------
A Phase II, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) Administered to Patients With Moderate to Severe Crohn's Disease

Conditions
-----------------
Crohn's Disease, Colitis, Intestinal Disease, Gastrointestinal Disease, Digestive System Disease

Intervention / Treatment
-----------------
* Drug: anti-Interferon-gamma monoclonal antibody


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients 18-70 years old Patients with moderate to severe Crohn's disease Patients who have had Crohn's disease for at least 6 months Patients who have previously been treated for Crohn's disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: anti-Interferon-gamma monoclonal antibody|nan|

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
-----------------
Crohn's Disease, Colitis, Monoclonal antibody therapy, anti-interferon gamma