linjc16/ctgov huggingface dataset:
A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta)

Study Overview
=================
Brief Summary
-----------------
This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).

Official Title
-----------------
Non-interventional Study of Six-month Retrospective Reporting of Hemoglobin Levels in Patients With Renal Anaemia Who Are Treated With MIRCERA® (Methoxy-polyethylene-glycol-epoetin Beta)

Conditions
-----------------
Anemia, Kidney Disease, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Renal anemia treated with Mircera for at least 6 months before entering study Exclusion Criteria: Patients who refuse or are incapable of giving their written informed consent to retrospective data collection

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL) | Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL | Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment. | Up to 6 months |
Open-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.

Study Overview
=================
Brief Summary
-----------------
Current treatment for gastroesophageal reflux disease(GERD)confirms an unmet need in patients, based on slow onset of action and an inability to provide 24-hour gastric acid suppression. Clinical data on lavoltidine demonstrates a rapid onset of action, high potency, and prolonged duration of effect after single dose. Since tolerance to the class of compounds to which lavoltidine belongs may be dose dependent, the current study is designed to determine if 40mg lavoltdine given for 7days develops tolerance.

Official Title
-----------------
An Open-Label Study of the Development of Pharmacodynamic Tolerance to 7-days Administration of Lavoltidine 40mg

Conditions
-----------------
Gastroesophageal Reflux Disease, Reflux, Gastroesophageal

Intervention / Treatment
-----------------
* Drug: Lavoltidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male, from 18-55 years Have BMI from 19-30 kg/m2 do not present with abnormal clinical lab findings are able to tolerate a nasogastric pH electrode. Exclusion Criteria: Helicobacter-positive on a C13 urea breath test have a baseline median 24-hour gastric pH>3

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lavoltidine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the degree of pharmacodynamic tolerance following seven days administration of lavoltidine 40mg on gastric pH as assessed by percentage of 24hrs pH>4. |  | seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether or not significant pharmacodynamic tolerance occurs as early as the second dose of 40mg lavoltidine. Safety and tolerance of seven days administration of lavoltidine 40 mg, in healthy male volunteers. |  | seven days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacodynamics,, tolerance, H2 antagonist,, AH23844,, lavoltidine,, gastroesophageal reflux disease (GERD), pharmacokinetics,
Management of Non Convulsive Status Epilepticus

Study Overview
=================
Brief Summary
-----------------
Non convulsive status epilepticus is a persistent change in behavioural and or mental process from baseline associated with continuous epileptiform activity in electroencephalograph,it occur in about 50 percent in patients with coma and convulsions and in 8-13 percent in intensive care unit patients

Detailed Description
-----------------
Early recognition and treatment of non convulsive status epilepticus are essential to optimize response to treatment and to prevent neurological sequelae, over diagnosis and aggressive use of anticonvulsants can contribute to morbidity and mortality.It displays great diversity in response to anticonvulsants,therefore treatment in intensive care units is required for selected cases .The aetiology and clinical forms are strong predictors for the overall prognosis.Treatment is poorly understood and follows the standard regimen for convulsive status epilepticus

Official Title
-----------------
Management of Non Convulsive Status Epilepticus

Conditions
-----------------
Status Epilepticus

Intervention / Treatment
-----------------
* Other: cross sectional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have generalized tonic colonic convulsions and prolonged post ictal state more than 30 minutes patients presented with un explained psychic or speech disorder patients presented with stupor or confusion Patients presented with un explained coma Exclusion Criteria: patients with progressive neurological disease Patients with severe cerebral anoxia Patients with liver or hepatic impairment

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: cross sectional|Electroencephalograph will be done to all patients who fulfill the inclusion criteria to detect presence of electrical discharge with in the brain.Complete blood count ,liver function test ,kidney function test ,blood glucose level and serum electrolytes will be done to selected cases according to the clinical presentation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cured patients | Number of cured patients | An average of 1 year |
Observational Study of Safety and Efficacy of Levemir® in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India.

Official Title
-----------------
An Observational, Safety and Efficacy Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus.

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

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subject with type 2 diabetes Exclusion Criteria: Subjects with a hypersensitivity to insulin detemir or any of its excipient Children below 6 years Subjects who are pregnant, lactating or planning to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Start dose and frequency of insulin detemir is to be decided by physician. The choice of patient is also at the discretion of Physician<br>* Other names: Levemir®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change from baseline |  | after 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events |  | after 26 weeks | 
| Number of all adverse events |  | after 26 weeks | 
| Number of all hypoglycemic episodes (24 hr, daytime and nocturnal) |  | after 26 weeks | 
| HbA1c change from baseline |  | after 26 weeks | 
| FBG (Fasting Blood Glucose) change from baseline |  | after 26 weeks | 
| Percentage of patients achieving targets of HbA1c less than 7 % and less than 6.5 % |  | after 26 weeks | 
| Insulin dose and frequency at the end of the study |  | after 26 weeks |
Echocardiographic Changes During Adjuvant Therapy in Hispanic Women With Her-2 Neu Expressing Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study retrospectively looks at changes in Echocardiographic parameters while using transtuzumab

Detailed Description
-----------------
Transtuzumab based chemo-immunotherapy is commonly administered to patients diagnosed with early stage HER-2 expressing breast cancer, because it decreases the risk of relapse. Transtuzumab affects cardiac function and potential benefits in decreasing cancer recurrence have to be balanced against short and long term toxicity. We have previously identified a high prevalence of metabolic syndrome and type II diabetes mellitus in our patients with breast cancer. These patients may be particularly susceptible to cardiotoxic effects of transtuzumab based therapy. Aim of this study is to assess the changes in the cardiac function of women who are undergoing transtuzumab based therapy for early stage breast cancer.

Official Title
-----------------
Echocardiographic Changes During Adjuvant Therapy in Hispanic Women With Her-2 Neu Expressing Breast Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage 1,2,3 breast cancer Her2+ Exclusion Criteria: Stage 4 cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVEF | LV ejection fraction | Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Hospitalized for Cardiac Issues. | any hospitalization for cardiac issues | 1 year |
Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells)

Study Overview
=================
Brief Summary
-----------------
Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies and in the number of circulating functional replicative competent endothelial progenitor cells (EPC's) after bariatric surgery.

Detailed Description
-----------------
Same as above

Official Title
-----------------
Vascular Endothelium Changes After Bariatric Surgery

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

Intervention / Treatment
-----------------
* Behavioral: pre-bariatric weight loss program
* Procedure: bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes, Glucose > 200mg/dl, currently be ing treated with oral medications and HGA1c . 6.5, and BMI .35. Exclusion Criteria: Type 1 Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: baratric surgery<br>surgery vs.weight loss program 6 months prior to bariatric surgery | Procedure: bariatric surgery<br>* bariatric surgery for weight loss<br>|
| Other: pre-bariatric weight loss program<br>weight loss program prior to bariatric surgery | Behavioral: pre-bariatric weight loss program<br>* standard 6 month physician directed pre-bariatric weight loss program<br>* Other names: weight loss program;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Late Outgrowth Endothelial Progenitor Cells | Primary outcome is the change in Late outgrowth endothelial progenitor cells 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT). | 24 months |
Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and DBT.

Official Title
-----------------
Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis

Conditions
-----------------
Breast Screening

Intervention / Treatment
-----------------
* Procedure: breast ultrasound
* Procedure: DBT (Full field digital mammography + tomosynthesis)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other. Exclusion Criteria: Age < 30 years old Male patients Patients with any clinical symptoms (palpable mass, nipple discharge, etc) Patients with known cancer Patients with any breast surgery or biopsy within 90 days prior to the study Patients with breast implants Patients pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| women scheduled for breast screening<br>Each patient will have the following: Screening whole breast ultrasound DBT (Full field digital mammography + tomosynthesis views in the CC and MLO projections). The only change in patient management will be the addition of digital breast tomosynthesis views in patients scheduled for FFDM alone. DBT is currently clinically approved and being offered on a voluntary basis to patients scheduled for FFDM. | Procedure: breast ultrasound<br> <br> Procedure: DBT (Full field digital mammography + tomosynthesis)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimate the cancer detection rates | The detection rate of each imaging test is defined as the proportion of patients who are positive on that imaging test who truly have the disease compared to the total number of women screened. A positive imaging test is defined as a test with a recommendation for biopsy (BI-RADS 4 or 5). | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound, Digital Breast Tomosynthesis, 14-119
The Performance / Safety of the Celsite® Venous Access Ports

Study Overview
=================
Brief Summary
-----------------
The Celsite® Venous Access Ports System are intended to be used for repeated intravenous administration of, for example, chemotherapy, antibiotic and antiviral drugs, total parenteral nutrition, blood sampling or transfusion. The objective is to assess the device's safety to deliver medication over the time in regard to the rate of adverse events related to the Celsite® access ports written in the IFU.

Official Title
-----------------
Post Market Clinical Follow-up Study on the Performance /Safety of Celsite® Venous Access Ports in Patients Who Need Repeated Venous Access

Conditions
-----------------
The Performance / Safety of the Celsite® Venous Access Ports

Intervention / Treatment
-----------------
* Device: Venous access port implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years old Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) prior to all evaluations. Patient for whom the access port placement has already been determined as the best treatment option within the regular planning of the patient's treatment in accordance with the IFU. Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol Exclusion Criteria: Patient for whom the technical and/ or clinical characteristics of the access port placement or use is outside the scope of the IFU. Patient not followed-up in the center where the access port is implanted. Pregnancy Patient < 18 years of age

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Venous access port implantation|Venous access port implantation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the device's safety | The primary variable is the incidence/frequency of all adverse reactions/complications (intraoperative, postoperative, late etc.) which occurred during the study. Focus will be done on all adverse reactions/complications (intraoperative, postoperative, late etc.) related to the Celsite® access ports written in the IFU in comparison with the published data. | 2 years |
Berlin Deep Brain Stimulation Depression Study

Study Overview
=================
Brief Summary
-----------------
In this study efficacy and safety of deep brain stimulation of the cingulate cortex in 20 patients with treatment resistant major depression will be investigated. In addition, the stress axis, the cortical GABAergic system, neurotrophins and event-related potentials will be assessed.

Official Title
-----------------
Investigation of Efficacy and Safety of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression in a Multicenter, Double-blind, Prospectivly-designed Delayed-onset Study (Tiefe Hirnstimulation Zur Behandlung Therapieresistenter Depressionen-eine Multizentrische, Doppelblinde, Prospektive Studie Mit Einem Delayed-onset Design)

Conditions
-----------------
Treatment Resistant Depression

Intervention / Treatment
-----------------
* Device: DBS of Cg25


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient is diagnosed with a severe major depressive episode patient is in a chronic current MDE and/or has had a history of recurrent MDEs patient has not had an acceptable clinical response due to failure with at least three antidepressant treatments during the current episode. patient has a score > 20 on the HAMD24 patient is stable on current psychotropic medication for at least 6 weeks patient is >25 and <80 years Global Assessment of Function (GAF) score of < 45 Exclusion Criteria: Atypical Depression (according to DSM IV) Other relevant psychiatric axis I or axis II diseases Relevant neurological diseases Relevant cardiac or pulmonary diseases with enhances anaesthesiological risk (ASA Score > 3) Patient is currently enrolled in another investigational study not associated with the current study Patient has a history of, or evidence of, significant brain malformation or significant head injury Patient is likely to require a whole body MRI after implantation

Ages Eligible for Study
-----------------
Minimum Age: 25 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: B<br> | Device: DBS of Cg25<br> <br> |
| Experimental: A<br> | Device: DBS of Cg25<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD/MARS score reduction |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures |  | 4 weeks |