linjc16/ctgov huggingface dataset:
Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients

Study Overview
=================
Brief Summary
-----------------
Does prolonged GnRH downregulation prior to ART improve the clinical pregnancy rate in postoperative endometriosis patients? (A single centre randomised controlled trial)

Conditions
-----------------
Endometriosis, Infertility

Intervention / Treatment
-----------------
* Drug: triptorelin
* Drug: ethinylestradiol + dienogest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven endometriosis with complete treatment of all endometriosis lesions during laparoscopy only first three ART cycles normal uterine cavity Eligible for ovarian stimulation with long agonist protocol Exclusion Criteria: FSH>20 IU/L presence of large intramural fibroids (> 3 cm) <4 oocytes obtained in any previous fresh ART cycle ART with sperm derived from testicular biopsy ART with Preimplantation Genetic Diagnosis/Screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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 |
| --- | --- |
| Active Comparator: oral oestroprogestogen pre-treatment<br>preparation with oral oestroprogestogens prior to downregulation in an assisted reproductive technology treatment (ART) cycle | Drug: ethinylestradiol + dienogest<br>* oral oestroprogestogen<br>* Other names: Louise;|
| Experimental: gonadotropin-releasing hormone (GnRH) pre-treatment<br>preparation with gonadotropin-releasing hormone (GnRH) analogues prior to downregulation in an assisted reproductive technology treatment (ART) cycle | Drug: triptorelin<br>* gonadotropin-releasing hormone (GnRH) agonist<br>* Other names: decapeptyl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate per initiated ART cycle |  | participants will be followed for the duration of the ART cycle including the pregnancy test, an expected average of 10 weeks in the active comparator group and an expected average of 18 weeks in the experimental group | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility, endometriosis, assisted reproductive technology
Relationship Between Homocysteine and BMD

Study Overview
=================
Brief Summary
-----------------
The association between Homocysteine (Hcy) levels and bone mineral density (BMD) has been debated. Some studies have found a relationship between increased Hcy plasma levels and BMD in contrast; other studies have not found a relationship. The purpose of our study was to investigate whether or not Hcy plasma levels are related to BMD in a group of postmenopausal women.

Official Title
-----------------
Evaluation of the Relationship Between Homocysteine Levels and Bone Mineral Density in Postmenopausal Women

Conditions
-----------------
Postmenopausal Women

Intervention / Treatment
-----------------
* Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women BMD measured by dual-energy X-ray absorptiometry (DXA) Exclusion Criteria: Primary ovarian failure Early menopause Cardiovascular, liver, or renal diseases Surgical menopause History of cancer Receiving treatment known to influence levels of Hcy or bone mineralization (folates or vitamin B12 supplements, menopausal hormonal treatment, corticosteroids, anticonvulsants, heparin, thiazide diuretics, and antiresorptive agents).

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyperhomocysteinemia<br> | Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)<br>* BMD expressed in absolute values as g/cm2 and T-scores<br>|
| Normal Hcy levels<br> | Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)<br>* BMD expressed in absolute values as g/cm2 and T-scores<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD expressed in absolute values as g/cm2 |  | one year before or after Homocysteine levels | 
| Lumbar spine T-score |  | one year before or after Homocysteine levels | 
| Femoral neck T-score |  | one year before or after Homocysteine levels | 
| Total hip T-score |  | one year before or after Homocysteine levels |
Feasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain preliminary information on the potential of 99m Tc-EC-DG SPECT imaging to distinguish cancer from non cancer.

Official Title
-----------------
A Pilot Feasibility Study of 99mTc EC DG SPECT/CT Imaging in the Treatment Response Evaluation in Patients With Locally Advanced Head and Neck Cancer

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: 99mTc-EC-DG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment naive patients with histologically proven cancer of the head and neck T4 primary tumor (all sites), N2 or N3 locoregional disease (all sites) At least one measurable site of disease At least 18 years of age Karnofsky performance status > or = 70% or ECOG <2 Able to tolerate SPECT/CT imaging Adequate bone marrow function Adequate liver function Adequate renal function Written consent from patients Female patients of childbearing potential must have a negative pregnancy test within 0-7 days prior to the first SPECT study Exclusion Criteria: Diabetics with insulin dependence or blood sugar levels >200 mg/dL prior to imaging Patient weight above the SPECT/CT table weight limit Pregnant and/or lactating female Unequivocal demonstration of metastatic disease Patients unwilling to or unable to comply with protocol

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging<br> | Drug: 99mTc-EC-DG<br>* 99mTc-EC-DG will be used before the SPECT/CT scans throughout the study to determine the its effectiveness. 20 mCi of 99mtc-EC-DG will be administered through a vein through a catheter. This will be done before the SPECT/CT scan at 4 weeks and 10 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent Disease within 6 months of CRT |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent Disease within 2 years of CRT |  | 2 years |
Detection of Ischemia in Asymptomatic Diabetics

Study Overview
=================
Brief Summary
-----------------
Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5 years for the occurrence of cardiac death or non-fatal myocardial infarction. The aims are: To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with Type 2 Diabetes Mellitus. To identify on the basis of clinical and/or biochemical variables in a high-risk cohort in which screening for coronary artery disease is appropriate. To assess progression of (silent) myocardial ischemia after 3 years. To assess the occurence of cardiac death or nonfatal myocardial infarction during 5 years follow-up in screened and not screened subjects.

Official Title
-----------------
Detection of Ischemia in Asymptomatic Diabetics

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 50-75 years Type 2 diabetes mellitus Exclusion Criteria: Angina or anginal equivalent Abnormal rest ECG (Q or ST depression) Known CAD Stress testing within the last 3 years

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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<br>Screening at start study with Adenosine vasodilator stress Tc-99m Sestamibi SPECT imaging | |
| 2<br>No screening | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%. |  | At study entry | 
| At repeat stress imaging three years after recruitment 79% of subjects showed resolution of ischemia, whereas only 10% developed new ischemia. |  | 3 years after start | 
| Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
silent ischemia, type 2 diabetes mellitus, screening, cardiac outcome, Prevalence silent myocardial ischemia, Cardiac outcome in screened and not-screened subjects
Tumour Registry Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The registry aims to collect and analyse information on the antineoplastic treatment of breast cancer in daily routine practice of office-based and clinic-based medical oncologists in Germany.

Detailed Description
-----------------
The TMK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of breast cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. The impact of nutrition (MaNut) and physical activity (MaNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (MaTox) and the multiple patient-reported outcomes (MaLife).

Official Title
-----------------
Clinical Registry to Present Treatment and Sequences of Treatments in Routine Practice in Germany

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer 18 years and older Antineoplastic or antihormonal treatment Exclusion Criteria: No breast cancer Below 18 years No antineoplastic or antihormonal treatment

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of Antineoplastic Treatment |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Advanced Breast Cancer, Epidemiology, Registry, Health Services Research, Germany, Palliative Treatment, Adjuvant Drug Therapy, Nutrition Assessment, Physical Activity
Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects.

Detailed Description
-----------------
Single dose escalation study of 5 dose levels of VBY-376. Eight subjects per group will receive one dose of VBY-376 then have multiple blood draws for pharmacokinetic evaluation and followed for safety with laboratory evaluations, ECG's, vital signs, and adverse events. Safety data will be reviewed before proceeding to the next dose.

Official Title
-----------------
A Randomized, Double-blinded, Placebo-controlled, Sequential, Single Ascending Dose Evaluation of the Safety and Pharmacokinetics of VBY-376 in Healthy Adults

Conditions
-----------------
Chronic Hepatitis C Infection

Intervention / Treatment
-----------------
* Drug: VBY 376


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females between 18 and 45 years of age screening body mass index between 20 and 29 kg/m2 in good health with no clinically significant medical conditions able to comprehend and willing to sign an informed consent Exclusion Criteria: history of renal, hepatic impairment, stomach or intestinal surgery or resection, malabsorption syndrome anemia or blood donation within 8 weeks of check-in plasma donation within 4 weeks of check-in history of alcoholism or drug addiction within 1 year prior to check-in use of drugs of abuse no tobacco-containing products within 6 months of study participation of any clinical trial within 30 days history or presence of abnormal ECG no prescription or over-the-counter medications within 14 days of study and during the study history of Gilbert's syndrome

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VBY 376|Doses of 50mg and higher or placebo will be evaluated.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of VBY-376 in single oral doses in healthy subjects. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of VBY-376 after single oral doses and the effect of food on VBY-376. |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VBY-376 Hepatitis C pharmacokinetics safety
The Effect of Probiotics on Exacerbation of Inflammatory Bowel Disease Exacerbation (Crohn's Disease)

Study Overview
=================
Brief Summary
-----------------
Inflammatory Bowel Disease (IBD) is an immune mediated chronic intestinal condition. It includes ulcerative colitis (UC) and Crohn's disease(CD). probiotics have been shown to be effective in varried clinical conditions ranging fron infantile diarrhea, necrotizing enterocolitis,helicobacter pylori infections, etc.

Detailed Description
-----------------
This is a prospective study that will enroll 50 patients with Crohn's disease.Each patient will get the study medication for 6 weeks and will be evaluated twice- before enrollment and after 6 weeks of treatment.

Official Title
-----------------
The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) and Markers of Inflammation

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Probiotic
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with Crohns' disease who are stable or have mild acute exacerbations that do not necessitate treatment with systemic corticosteroids Exclusion Criteria: pregnant women, under 18 years or over 60 years, patients with known ulcerative colitis, patients with any cancer, patients with heart failure

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>To study the effect of probiotic on the ability to build endothelial progenitor stem cells and to study clinical recovery of patients with Crohn's Disease. | Drug: Probiotic<br>* Clinical evaluation according to the Crohn's activity scale<br>* Other names: powder in HPMC Capsule;|
| Placebo Comparator: placebo<br>This will be the comparison group to the experimantal group that recives Probiotic. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial stem cells | to study the ability to create endothelial progenitor stem cells following probiotic management compared to placebo group | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease, endothelial progenitor cells, probiotic
Experiential Avoidance in Combat Veterans With and Without Posttraumatic Stress Disorder

Study Overview
=================
Brief Summary
-----------------
This study plans to examine if symptoms of PTSD affect how Veterans who have served in combat think and react to certain information, and whether or not this has an influence on suicidal thoughts.

Official Title
-----------------
Experiential Avoidance in Combat Veterans With and Without Posttraumatic Stress Disorder

Conditions
-----------------
PTSD, Suicidal Ideation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of combat service Diagnosis of PTSD confirmed by the CAPS or No current diagnosis of PTSD Age 18-65 Exclusion Criteria: Inability to adequately respond to questions regarding the informed consent procedure. History of significant neurological disease Diagnosis of Schizophrenia or other Psychosis Alcohol abuse/dependence or illicit drug use in the two weeks prior to testing No history of combat service

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| PTSD cohort<br> | |
| No PTSD cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Scale for Suicidal ideation |  | One time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Suicidal ideation, Cognitive processes
Impact of Explanation Given to Parents on Rate of Post-partum Influenza Vaccination

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether an explanation to parents for the need for post-partum influenza vaccination will influence their compliance.

Official Title
-----------------
Impact of Explanation Given to Parents on Rate of Post-partum Influenza Vaccination

Conditions
-----------------
Newborn Morbidity

Intervention / Treatment
-----------------
* Other: Oral and written explanation
* Other: Follow-up questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All parents discharged from well-baby nursery Exclusion Criteria: -
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: Parallel Assignment
Interventional Model Description: Case-control study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Explanation<br>Explanation to parents on importance of post-partum influenza vaccination on health of their newborn infant with a follow-up questionnaire to determine rate of vaccination | Other: Oral and written explanation<br>* Oral and written explanation on importance of post-partum influenza vaccination for the health of their newborn infant<br>Other: Follow-up questionnaire<br>* Follow-up questionnaire to determine whether participants have receive post-partum vaccination<br>|
| Active Comparator: No explanation<br>No explanation will be given to parents but they will be followed-up with a questionnaire to determine rate of vaccination | Other: Follow-up questionnaire<br>* Follow-up questionnaire to determine whether participants have receive post-partum vaccination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of post-partum influenza vaccination | Telephone questionnaire to parents to determine compliance with vaccination | 2 months |