linjc16/ctgov huggingface dataset:
Study of Efficacy of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small-cell Lung Cancer Before Surgery

Study Overview
=================
Brief Summary
-----------------
To study the activity of chemotherapy with Gemzar-carboplatin in the preoperative setting for operable stages of non-small-cell lung cancer and to identify novel molecular markers correlated with chemosensitivity and prognosis

Official Title
-----------------
Phase II Study of the Response Rate of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small Cell Lung Cancer Before Surgery

Conditions
-----------------
Lung Neoplasms

Intervention / Treatment
-----------------
* Drug: gemcitabine, carboplatin
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically proven, newly diagnosed primary bronchogenic non-small cell lung cancer Measurable or evaluable tumour on chest X-ray or CT scan. No multiple ipsilateral or contralateral parenchymal tumours Stage I(exceptT1N0),II,IIIa disease as shown by PET-CT

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine, carboplatin|nan|
|Procedure: surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological response rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 18 months | 
| overall survival |  | 18 months | 
| quality of life measurements |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer
Longterm Outcome of Inpatient Cognitive and Behavioral Therapies for Agoraphobia

Study Overview
=================
Brief Summary
-----------------
While cognitive therapy and exposure therapy are both proven to be effective for panic disorder and/or agoraphobia when outcome is assenssed up to one year after treatment (Gould et al., 1995) the scientific knowledge about long-term course of these disorders is still scanty. Although several long-term outcome studies have been conducted, the quality of these studies has been questioned. The aim is to conduct a follow-up study of patients with either panic disorder with history of agoraphobia or agoraphobia without history of panic disorder. the patients were treated in a group format at Modum Bad during the years 1989 to 1997. Four subsamples will be included in the study. Subsample 1 (76 patients treated in 1989 and 1990) received combined cognitive and psychodynamic treatment. Subsample 2 and 3 (46 patients treated in 1992 - 1993) were allocated to either cognitive therapy or guided mastery treatment. Subsample 4 (45 patients treated in 1994 - 1996) received cognitive and schema focused therapy. In the follow-up study the participants will be requested to complete the same self report measures as they completed at intake, discharge and at previous follow-up times. the participants will also be interviewed using the SCID-I and II as they were at the previous assessments. The present sample is relatively unique in having received pure psychosocial experimental treatments. The very long term efficacy of cognitive therapy relative to behavioural treatmetns for agoraphobia can be evaluated, and the potential moderating effects of personality disorders can be assessed.

Official Title
-----------------
Longterm Outcome of Inpatient Cognitive and Behavioral Therapies for Panic Disroder and Agoraphobia

Conditions
-----------------
Agoraphobia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the DSM-IV kriteria for either panic disorder, panic disorder with agoraphobia or agoraphobia Exclusion Criteria: psychosis dementia substance abuse

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cognitive, schema focused, guided mastery, exposure<br> | |

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
-----------------
Long term outcome
Factors Associated With Residual Disease In The Central Cone

Study Overview
=================
Brief Summary
-----------------
Cervical conization using the loop electrosurgical excision procedure (LEEP) is the standard treatment for patients with high-grade cervical intraepithelial neoplasia. Several studies have shown that excising a central cone reduces the rate of positive endocervical margins. The purpose of this study is to identify clinicopathological factors associated with residual disease in the central cone and to develop a predictive model to better determine which patients may require this additional procedure.

Detailed Description
-----------------
This study pretends to create a retrospective database including all patient who underwent a loop electrosurgical excision procedure by treatment for high-grade cervical intraepithelial neoplasia and create a a predictive model for top-hat resection in patients with high grade CIN

Official Title
-----------------
Factors Associated With Residual Disease In The Central Cone: A Disease Prediction Model

Conditions
-----------------
Cervical Intraepithelial Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent a loop electrosurgical excision procedure (LEEP) Exclusion Criteria: a diagnosis of micro-invasion or nonsquamous histology less than six months of follow-up incomplete information in their clinical charts.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Identify the clinical and pathologic factors associated with residual disease | Whit the variables identified as factors associated with the residual disease develop a predictive model to determine which individuals may require additional procedures in the uterine cervix to ensure negative margins. | 1month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
residual disease, central cone, predictive model
Heart Failure and Anemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether increasing hemoglobin concentration in patients with heart failure and anemia will improve the patients' functional status, including exercise tolerance and New York Heart Association (NYHA) classification.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Impact of Subcutaneous (SC) Darbepoetin Alfa Treatment on Exercise Tolerance in Subjects With Symptomatic Heart Failure (CHF) and Anemia.

Conditions
-----------------
Heart Failure, Anemia

Intervention / Treatment
-----------------
* Drug: Darbepoetin Alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - At least 21 years of age - Symptomatic CHF for at least 3 months - Limited exercise tolerance on a treadmill - Reduced left ventricular ejection fraction - Stable heart failure medication - Hemoglobin concentration between 9.0 and 12.5 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Unable to do cardiopulmonary exercise testing - Major organ transplant (e.g., lung, liver, heart) or in renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent epogen or darbepoetin alfa therapy - Recent blood transfusion

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Darbepoetin Alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise tolerance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA classification; patient-reported outcomes |  |  |
Capnography During Percutaneous Endoscopic Gastrostomy (PEG)

Study Overview
=================
Brief Summary
-----------------
In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.

Official Title
-----------------
Clinical Value of Advanced Patient Monitoring Using Capnography With Analysis of the Integrated Pulmonary Index During Percutaneous Endoscopic Gastrostomy.

Conditions
-----------------
In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated.

Intervention / Treatment
-----------------
* Device: Capnography
* Device: Standard monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 Years and older Scheduled for PEG with propofol sedation Exclusion Criteria: No informed consent ASA V Emergency endoscopy Preexisting hypotension, bradycardia or hypoxemia

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capnography<br>Arm with capnographic monitoring | Device: Capnography<br>* Capnographic monitoring<br>|
| Placebo Comparator: Standard monitoring<br>Standard monitoring | Device: Standard monitoring<br>* Standard monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia |  | From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further complications |  | From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypoxaemia - capnography - integrated pulmonary index - PEG
Prevalence of Wild Type ATTR

Study Overview
=================
Brief Summary
-----------------
Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with lumbar spinal stenosis (LSS).

Detailed Description
-----------------
The study will include patients that receive surgical management and treatment for LSS, and will consist in the prospective, longitudinal collection of peripheral blood, urine samples, tissue biopsies and clinical data. The results of the project could provide a future benefit for patients with the same condition by: i) identifying accessible and sensitive biomarkers for the identification of patients at risk for having an underlying ATTRwt; ii) optimizing the therapeutic strategies in an era of innovative but cost-intensive treatments; iii) provide the proof of principle for a regular follow-up of patients who eventually will become symptomatic for overt organ ATTRwt involvement; and iv) providing the rationale for future studies based on early access disease-modifying approaches.

Official Title
-----------------
Prevalence of Amyloidosis in Patients With Lumbar Spinal Stenosis

Conditions
-----------------
Wild-type Transthyretin Amyloidosis

Intervention / Treatment
-----------------
* Diagnostic Test: HE and Congo red staining


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female ≥ 50 years-old with indication of surgery treatment according to local standards for Lumbar spinal stenosis (LSS) confirmed by MRI Availability of the baseline and follow-up annotations Informed consent will be obtained from the patient before any study related procedures Exclusion Criteria: Previous diagnosis of amyloidosis

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Patients with LSS surgery indication<br> | Diagnostic Test: HE and Congo red staining<br>* Biopsies will be formalin fixed, processed routinely, and sent to the Department of Pathology for evaluation by hematoxylin and eosin and Congo red staining by pathologists. Biopsy specimens with confirmed amyloid deposits via Congo red staining will be further analyzed using immunohistochemistry for subtyping.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report the prevalence of ATTRwt in patients with CTS and/or LSS. | Prevalence of ATTRwt in a prospective population. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wild-type TTR amyloidosis, lumbar spinal stenosis, prevalence
Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study

Study Overview
=================
Brief Summary
-----------------
One of the major roles of interventional EUS is biliary drainage (EUS-BD) as an alternative to ERCP-based biliary decompression. In fact, even when performed by expert endoscopists, ERCP-based stenting fails in 5% of cases. In these cases, standard alternative approaches include surgical bypass and percutaneous transhepatic cholangiography and biliary drainage (PTBD). However, these procedures are associated with higher patient discomfort and prolonged hospital stay. The most diffuse approach for EUS-BD are choledochoduodenostomy (CDS) or hepaticogastrostomy (HGS). As a matter of fact, since dedicate devices as lumen apposing metal stents (LAMS), have been adopted for CDS, we have been witnessing the escalation of such procedure. On the other hand, the diffusion of EUS-HGS is still limited due to the complexity of the procedure and the lack of dedicated devices. However, recently a dedicated stent was conceived as asymmetrically covered and shaped in order to have its uncovered, tubular end into the intrahepatic ducts and the covered, flanged end into the gastric cavity, to reduce the risk of migration. The developement of such stent could further increase both the technical feasibility and the clinical outcomes of HGS in order to explore the whole potential of this procedure and to definitively find its role in biliary drainage algorithm.

Official Title
-----------------
Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study

Conditions
-----------------
Malignant Bilio-pancreatic Diseases

Intervention / Treatment
-----------------
* Other: HANARO biliary stent placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • subjects with malignant bilio-pancreatic diseases with an indication to undergo biliary stent positioning for biliary drainage after ERCP failure. Exclusion Criteria: Age < 18 y Contra-indication for endoscopy or interventional radiology Unsigned informing consent form, ICF Pregnancy

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

| Intervention/Treatment |
| --- |
|Other: HANARO biliary stent placement|HANARO biliary stent placement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE and SAE events | To assess the technical safety for EUS-guided hepaticogastrostomy. | 12 Months |
The Thai Red Cross Society Prevention of Mother-To-Child Transmission of HIV (TRCS PMTCT) Program

Study Overview
=================
Brief Summary
-----------------
To assess the safety and the efficacy of Highly Active Anti-Retroviral Treatment (HAART) for the Prevention of Mother-To-Child Transmission of HIV (PMTCT)

Detailed Description
-----------------
To describe characteristics of HIV-infected pregnant women who request HAART from the Thai Red Cross Society PMTCT (TRCS PMTCT) program To study adverse pregnancy outcomes among HIV-infected pregnant women who receive HAART To study adverse events in infants born to women who receive HAART during pregnancy To evaluate risk factors for HAART-related toxicities and for perinatal HIV transmission To establish the pilot model of care for HIV-infected pregnant women in middle income country

Official Title
-----------------
The Thai Red Cross AIDS Research Centre

Conditions
-----------------
HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCT

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers meeting all of the following criteria will be considered eligible for enrollment in the study: HIV-infected pregnant women (as defined by the hospital) Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using thumb print. Availability for follow-up for the planned study duration Exclusion Criteria: Volunteers meeting any of the following criteria will be excluded from the study: 1.Persons who have a history of a medical or psychiatric disorder by interview and physical examination according to standard practices, that in the judgment of the treating physician, would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-infected pregnant women | Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-infected pregnant women who request HAART from the TRCSPMTCT
Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine whether an investigational drug can help patients suffering from major depression with pain symptoms, and gather data on the safety of the investigational drug including any side effects that might be associated with it.

Official Title
-----------------
Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain

Conditions
-----------------
Depression, Pain

Intervention / Treatment
-----------------
* Drug: Duloxetine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You must be suffering from symptoms of depression for at least the past 2 weeks (sadness, loss of interest in daily activities, feelings of hopelessness or guilt, sleeplessness or lack of energy) You must have pain symptoms with no known cause, such as unexplainable, head, chest, or back pain, overall aches and pains, or other unexplainable pains. You need to be available to visit a doctor's office about once a week for 10 weeks. Exclusion Criteria: You are a woman and are pregnant or breastfeeding. You have a current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder. You have had a primary diagnosis of an anxiety disorder within the past 6 months. You have a history of alcohol or drug dependence or abuse within the past 6 months. You have a serious medical illness.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine Hydrochloride|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
-----------------
depression, pain, blues, sadness, aches