linjc16/ctgov huggingface dataset:
Study Of Use Of Pemetrexed In Patients With Non-Small Lung Cancer Metastatic In Andalusian Public Health System

Study Overview
=================
Brief Summary
-----------------
STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN PUBLIC HEALTH SYSTEM

Official Title
-----------------
STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN PUBLIC HEALTH SYSTEM

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years Confirmed diagnosis of metastatic NSCLC Pemetrexed Starts 1st line (either induction or maintenance) in any of the following periods: January 1, 2010 to March 31, 2010 October 1, 2011 to December 31, 2011 Exclusion Criteria: Patients receiving pemetrexed within a clinical trial protocol because it is an experimental environment that does not reflect clinical practice.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pemetrexed 500 mg/m 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine utilization profile (line treatment and scheme used) of pemetrexed in patients with non-small cell lung cancer metastatic (CPNMm) in Andalusia. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Determine the progression-free survival and overall survival 2) Evaluate the degree of adherence in prescribing pemetrexed patients with CPNMm in Andalusia approved indications, the recommendations of the Pharmacy and Therapeutics Committees and |  | 12 months |
L-carnitine and Metformin in Obese PCOS Women.

Study Overview
=================
Brief Summary
-----------------
L-carnitine and plus metformin in clomiphene-resistant obese PCOS women, reproductive and metabolic effect: a randomized clinical trial

Detailed Description
-----------------
the trial aims to compare L-carnitine and plus metformin in clomiphene-resistant obese PCOS women with placebo to state the reproductive and metabolic effects in form of pregnancy and insulin resistance parameters and lipid metabolism.

Official Title
-----------------
L-carnitine Plus Metformin in Clomiphene-resistant Obese PCOS Women, Reproductive and Metabolic Effects: a Randomized Clinical Trial

Conditions
-----------------
PCOS

Intervention / Treatment
-----------------
* Drug: L-carnitine and Metformin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pco obese ifertile Exclusion Criteria: no medical disorders no hormonal treatment in the previous 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-carnitine and Metformin<br>L-carnitine and Metformin in Obese PCOS Women trying induction of ovulation with clomiphene citrate. | Drug: L-carnitine and Metformin<br>* L-carnitine plus Metformin was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.<br>* Other names: motova plus and glucphage;|
| Active Comparator: placebo<br>placebo was given toObese PCOS Women trying induction of ovulation with clomiphene citrate. | Drug: placebo<br>* placebo was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | number of women with clinical pregnancy | 3 momths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovulation rate | number of women with follicle >18mm. | 3 momths | 
| abortion rate | number of women with abortions | 3 momths | 
| insulin resistance | fasting glucose and insulin | 3 momths | 
| lipid metabolism | Triglyceride, cholesterol | 3 momths |
Medical Telephone Triage of Emergency Calls for Thoracic Pain

Study Overview
=================
Brief Summary
-----------------
Thoracic pain is the main symptom of acute coronary syndrome (ACS), urgent and serious illness. Whereas hospital mortality decreased until reaching 10%, out-of-hospital mortality remains high: half of the deaths occur during the first two hours. The benefit of an early diagnosis of ACS in term of morbidity and mortality is well established. Identification of the coronary origin of a thoracic pain by the telephone triage physician of the pre-hospital emergency service (SAMU) leads to the sending of a physician staffed ambulance (UMH) and is thus a key element of the prognosis. The aim of the study is to build a telephone predictive score of ACS at the triage of calls for non traumatic thoracic pain. The separate analysis of the questionnaires by sex will authorize the validation of a unique score or two distinct scores for men and women.

Detailed Description
-----------------
In France, approximately 30% of the calls for thoracic pain associated with an ACS do not benefit from the sending of an UMH. Our assumption is that this situation could be improved if telephone triage physicians were guided by recommendations or consensual algorithms of decision. The telephone triage doctor will manage a single questionnaire with the patient, with demographic and simple clinical data. The construction of the score will be done by the analysis of these data confronted with the final diagnosis (effective ACS or not). The effective existence of an ACS among patients with thoracic pain will be affirmed by an expert committee after collection of the intra-hospital patient's data and the follow-up at one month.

Official Title
-----------------
Medical Telephone Triage of Emergency Calls for Thoracic Pain: Construction of a Probability Score for Acute Coronary Syndrome.

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient presenting a non-traumatic chest pain. Call to the telephone triage center in first (direct call from the patient) or second intention (call of another person before the patient) Exclusion Criteria: - Inability to speak directly to the patient

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

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

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 |
| --- | --- | --- |
| diagnosis of acute coronary syndrome (ACS) | The criterion selected to build these scores will be the effective existence of an ACS among included patients. | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute coronary syndrome, thoracic pain, prehospital, diagnostic score
Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy

Study Overview
=================
Brief Summary
-----------------
Gene therapy is a promising strategy to treat hearing loss and vestibular disorders, and Associated adenovirus (AAV) is shown as a good viral vector for inner ear therapy in animal models. This study aims to study in vitro viral transduction of AAV in human inner ear cells, collected during non-conservative surgeries for vestibular schwannoma.

Official Title
-----------------
Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy

Conditions
-----------------
Hearing Loss, Sensorineural

Intervention / Treatment
-----------------
* Other: Peroperative collect of inner ear cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient ≥ 18 years old Operative indication for a non-conservative resection of vestibular schwannoma, decided by the surgeon in accordance with the patient Informed consent obtained Patients with a french social protection (AME excluded) Exclusion Criteria: Intravestibular or intra-cochlear extension of the tumor Pregnant woman Patient with administrative control Medical contra-indication

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 |
| --- | --- |
| AAV viral transduction<br>Collection of inner ear cells during a non-conservative surgical approach (translabyrinthine or transotic). | Other: Peroperative collect of inner ear cells<br>* After obtaining an informed consent during the preoperative medical visit, and if a non-conservative approach (translabyrinthine or transotic) is decided, the collect of inner ear cells will be performed during surgical approach. The sample will be collect in a sterile tube, and carried to the laboratory were it will be placed bon cell culture.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AAV transduction in inner ear cells | The transduction will be measured with immunostaining techniques | 10 days |
Imaging of Prostate Cancer Using Two-dimensional MR Spectroscopy and Diffusion Tensor Imaging

Study Overview
=================
Brief Summary
-----------------
The goal is to develop MR imaging techniques to improve delineation of cancer extent, and to improve differential diagnosis between prostate cancer and benign prostate hyperplasia or other benign diseases.

Official Title
-----------------
Imaging of Prostate Cancer Using Two-dimensional MR Spectroscopy and Diffusion Tensor Imaging

Conditions
-----------------
Prostate Lesions

Intervention / Treatment
-----------------
* Device: magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male older than 21 years of age and under age of 80, Either a normal healthy volunteer; a patient who has confirmed prostate cancer and decided to receive prostatectomy; or a patient who has persistent elevated PSA higher than 4.0 ng/ml, and with a prior benign biopsy scheduled to receive the second biopsy. Exclusion Criteria: Unwilling to give informed consent, Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants, Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities, Have received orthodontic work involving ferromagnetic materials, Claustrophobic, Unable to lie down still for 60 minutes.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: magnetic resonance imaging|MR contrast agent (0.1 mmol/kg)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that multi-voxel MR spectroscopy and diffusion tensor imaging can accurately diagnose prostate cancer and benign diseases, also to provide an accurate disease extent. |  | at completion of the study |
Vascular and Metabolic Effects of Vytorin

Study Overview
=================
Brief Summary
-----------------
The investigator hypothesize that vytorin may improve vascular and insulin resistance in hypercholesterolemic patients

Conditions
-----------------
Hypercholesterolemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypercholesterolemia Exclusion Criteria: overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c > 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br> <br> |
| Active Comparator: vytorin 10<br>vytorin 10 mg | Drug: vytorin<br> <br> |
| Active Comparator: vytorin 20<br>vytorin 20 mg | Drug: vytorin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilation |  | 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance |  | 8 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
statins, insulin resistance
An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder

Study Overview
=================
Brief Summary
-----------------
Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has considerable economic impact on our society. Bipolar mania accounts for 1 in 7 psychiatric emergencies and is associated with significant morbidity and mortality. The purpose of the study is to evaluate the safety and efficacy of open-label memantine in the acute management of adults with bipolar I disorder hospitalized for mania.

Official Title
-----------------
A Pilot Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder

Conditions
-----------------
Bipolar Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a documented clinical diagnosis of bipolar I disorder and must be currently experiencing a manic or mixed episode. Patients must be voluntarily hospitalized with a primary diagnosis of mania. Exclusion Criteria: Rapid cycling bipolar disorder. Suicidal risk. First manic episode. ECT, clozapine or a depot neuroleptic in the past 3 months. Substance dependence. Known HIV infection. Co-morbid serious, uncontrolled systemic illness.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- |
|Drug: Memantine HCl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young Mania Rating Scale (YMRS) |  |  | 
| Mania Rating Scale |  |  | 
| Clinical Global Impression |  |  | 
| Montgomery Asberg Depression Rating Scale |  |  | 
| Positive and Negative Syndrome Scale (PANSS) |  |  | 
| PANSS - Excited Component |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar I Disorder, Mania, Memantine HCl
Viennese Registry on Patients With Chronic Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
The rationale of this study is to establish a registry to detect and follow patients with CLI treated in Vienna. The Vienna CLI registry is meant to document the incidence, prevalence, and actual outcome of CLI patients in a real world setting and should serve as a tool for the evaluation of medical, endovascular and surgical interventions. It will help determining the prognosis of individual patients and have impact on economic and political decisions in Vienna concerning this disease and the related costs.

Detailed Description
-----------------
This is a prospective observational cohort study including consecutive patients with CLI. The study will be initiated as a single center evaluation and is intended to be step-wise expanded to a Vienna-wide systematic survey. The study will include patients with chronic critical limb ischemia and ischemic ulcerations as defined by Fontaine stage IV or Rutherford stages 5 & 6. The study will include all patients presenting with CLI to the participating centers including inpatients and outpatients. Patients will be followed up 1 month, 3 months, 6 months, 12 months and then every 6 months. The study will be continued at least until the 5 year data of the last included patient are available.

Official Title
-----------------
Phase IV Hospital Based Registry to Explore the Outcome of Chronic Critical Limb Ischemia

Conditions
-----------------
Chronic (> 2 Weeks) Critical Ischemia With Skin Defect in Lower Limbs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic (> 2 weeks) critical limb ischemia in one or both of the lower extremities with necrosis and/or gangrene in the limb (peripheral artery disease IV according to Fontaine's classification or Rutherford stage 5 & 6) of whatever genesis (atherosclerotic, aneurysmatic, embolic, inflammatory) ankle/brachial index < 0.4 or toe pressure < 30 mmHg Ability to give written informed consent Exclusion Criteria: o Ulceration exclusively due to nonvascular causes like neuropathy (without coexisting hemodynamic impairment as defined above) or venous ulceration (without coexisting arterial impairment as defined above)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| one group only<br>all participants | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | 5 years | 
| ipsilateral amputation rate |  | 5 years | 
| stroke |  | 5 years | 
| myocardial infarction |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peripheral artery disease stage IV (Fontaine's classification) or stage 5 and 6 (Rutherford's classification
Cervical Carcinoma in Shatby University Hospital and Its Relation to Human Papilloma Virus

Study Overview
=================
Brief Summary
-----------------
incidence of detection of carcinogenic types of human papilloma virus in 60 cases of cervical cancer

Official Title
-----------------
Cervical Carcinoma in Shatby University Hospital and Its Relation to Human Papilloma Virus

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: human papilloma virus testing and genotyping in cervical cancer cases


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cervical cancer Exclusion Criteria: none
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cervical cancer group, control group<br> | Diagnostic Test: human papilloma virus testing and genotyping in cervical cancer cases<br>* an observational analytical prospective cross-sectional study was managed from July 2019 to July 2022 on 70 cervical cancer patients collected from gyne-oncology unit in Shatby obstetrics and gynecology university hospital of Alexandria medical school after taking a written consent and following approval by Alexandria medical school institutional ethics committee. All patients were subjected to full history taking as age, gravidity, parity, contraceptive history, medical disease, detailed marital history and smoking. Collection of the sample from all cases of the study for human papilloma virus testing and genotyping was done after diagnostic workup and before treatment of the study cases at any time in post-menopausal women and at mid cycles period in premenopausal women by cervical smear using PAP spatula and endocervical brush.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of human papilloma virus infections and genotyping using real time PCR |  | 10 days |