linjc16/ctgov huggingface dataset:
OASIS: Osteoarthritis Sensitivity Integration Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the relative efficacy of a centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical diclofenac) for pain and associated symptom management in knee osteoarthritis. Secondary objectives include the determination of which self-report and experimental pain measures best differentiate those who respond better to duloxetine than diclofenac.

Detailed Description
-----------------
This is a randomized, blinded, crossover, controlled study design comparing duloxetine and topical diclofenac for osteoarthritis pain. The study cohort will be individuals who have a confirmed diagnosis of knee osteoarthritis. Subjects will be randomized only after all entry criteria have been met. These individuals will be evaluated at baseline, and then followed longitudinally following enrollment.

Official Title
-----------------
Central Pain Mechanisms in Osteoarthritis: A Longitudinal Cohort

Conditions
-----------------
Osteoarthritis, Chronic Pain

Intervention / Treatment
-----------------
* Other: Phenotype assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with knee osteoarthritis as defined by American College of Rheumatology (ACR) criteria Males and females age greater than 50 years at time of screening Exclusion Criteria: History of chronic kidney disease or moderate to severe hepatic impairment History of anemia Allergy or intolerance of drug intervention Inability to participate in outcome measures

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Active Comparator: Duloxetine<br>Phenotype assessment prior to and after treatement with duloxetine 20-30 mg oral daily for eight weeks. | Other: Phenotype assessment<br>* Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype<br>|
| Active Comparator: Diclofenac<br>Phenotype assessment prior to and after treatment with topical diclofenac four times daily | Other: Phenotype assessment<br>* Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | One month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Chronic pain, Central pain
Phase III PEG-Intron in HIV-infected Patients (Study P00738)

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron, 1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients compared to placebo. The study will evaluate the efficacy and safety of PEG-Intron when added to stable optimized background antiretroviral therapy in this patient population.

Detailed Description
-----------------
This study will randomize 675 patients (225 in each of the 3 arms) to either: PEG-Intron 1mcg; 3mcg or Placebo, at 90 centers worldwide. Each center will enroll approximately 10 patients. Study drug will be added to optimized background anti-retroviral therapy of patients whose HIV RNA is incompletely suppressed by their therapy (HIV RNA 400-50,000 copies/ML) after 2-6 months. A single dose reduction of 50% will be allowed for toxicity. An Interim Analysis will be conducted when 50% of patients have completed 24 weeks of therapy. The study treatment phase will be 48 weeks with monthly visits for virologic virologic and safety monitoring. The primary endpoint is change in HIV RNA from baseline to week to assess efficacy. Durability of response will be assessed at 48 weeks.

Official Title
-----------------
Phase 3 Study of PEG-Intron in Heavily Treatment-experienced, HIV-infected Patients

Conditions
-----------------
HIV Infections, AIDS

Intervention / Treatment
-----------------
* Drug: PEG-Intron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV positive History of virologic failure on at least 2 antiretroviral regimens including exposure to at least one NRTI, one NNRTI and one PI HIV RNA >400-<50,000 copies/mL Laboratory parameters: platelet count (75,000u/L, hemoglobin >9gm/dl, absolute neutrophil count >1,000/uL, SGOT/SGPT<5xULN. Exclusion Criteria: Current ribavirin therapy Subjects with a recent diagnosis or history of moderate or severe depression requiring ongoing psychiatric intervention Females of childbearing potential who are breastfeeding, who are pregnant, or not using adequate birth control measures Concomitant use of immunosuppressants or cytotoxic agents History of seizure disorder requiring use of anticonvulsants

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: PEG-Intron|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
-----------------
PEG-Intron, treatment experienced
INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
The study is particularly innovative as it will accurately analyze the microscopic characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the pancreas, using a comparative approach of long-survivor/short-survival patients.

Official Title
-----------------
INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors

Conditions
-----------------
Pancreas Cancer, Pancreatic Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years of age at diagnosis Primary pancreatic cancer patients operated on in one of the 4 centres between 2001 and 2016 Histopathological diagnosis of excreto-pancreatic adenocarcinoma of the pancreas, ductal adenocarcinoma or classical adenocarcinoma Tissue blocks (FFPE) available (tumour/healthy tissue) Affiliated to a social security scheme Exclusion Criteria: Absence of Primary Cancer Tissue Blocks (PCTBs) Paraffin block fixed in Bouin or AFA Patient Refusal Pancreatic cancer not corresponding to a conventional excretopancreatic adenocarcinoma such as: carcinoma on intraductal papillary mucinous neoplasm, endocrine tumor/carcinoma, acinar cell carcinoma, ...). Patient died due to post-surgical complications (death within 30 days post-surgery). Surgical resection of macroscopic R2 type.

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 |
| --- | --- | --- |
| Relationship between known prognostic histological markers of pancreatic adenocarcinoma and patient survival. | Tissue analysis will be performed by conventional microscopy and will evaluate histological markers known in the literature to have a prognostic impact. | at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between newly described histological markers for pancreatic adenocarcinoma and patient survival. | Immunohistochemistry tissue analysis. It will allow the evaluation of newly described histological markers for pancreatic adenocarcinoma, which could have a prognostic impact such as the immunophenotype of the inflammatory infiltrate, the expression of the mucins MUC1, MUC5AC, MUC4, MUC16, mesothelin, p53, Ki67 (MIB1) and markers of aggressive subtypes identified by transcriptome studies, in particular the basal-like molecular subtype. | at 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
survival, prognosis, tissue, pancreas cancer
Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy

Study Overview
=================
Brief Summary
-----------------
The development of Immune Checkpoint Blockade (ICB) is a revolution in medical oncology as ICB have changed the standard treatments of several metastatic tumor types. However, the response rate to ICB is low, and the biological bases for this response heterogeneity are poorly understood. In the frame of Immunosup study, we will collect blood (at baseline, post infusion of ICB n°2/4/8 and at progression) and tumor samples (optional: at baseline and progression) from patients with locally advanced or metastatic cancer, treated with ICB, in order to determine if the dynamics of immunosuppressive actors (MDSC, TReg, Immunosuppressive cytokines) predicts response to these immunotherapies.

Official Title
-----------------
Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy-IMMUNO-SUP-IPC 2017-002

Conditions
-----------------
Lung Cancer Metastatic, Locally Advanced Malignant Neoplasm, Non Hodgkin Lymphoma, Urologic Neoplasms

Intervention / Treatment
-----------------
* Procedure: Blood sample collection
* Procedure: Biopsy collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Diagnosis of locally advanced or metastatic solid tumor or lymphoma treated with Immune check blockade Signed informed consent Affiliated to(or beneficiary of) the French Social Security Exclusion Criteria: Pregnant or breastfeeding woman or woman who does not apply effective contraception Emergency Vulnerable person or unable to provide informed consent Emergency Person unable to comply with required study follow up Contraindication to the study procedure

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients treated with Immune Checkpoint Blockade<br> | Procedure: Blood sample collection<br>* Blood samples collection (5EDTA vials) at baseline, post infusion of ICB n°2/4/8 and at progression<br>Procedure: Biopsy collection<br>* Optional biopsy collection at baseline and progression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Plasma immunosuppressive actors in patients treated with a Checkpoint inhibitor | Measure (by flux cytometry) and comparison of plasma immunosuppressive actors, between baseline and the 4th injection of an Immune Checkpoint inhibitor | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarkers, Immune check point blockade, immunomonitoring
Improving the Diagnosis of Pneumonia in Emergency Rooms

Study Overview
=================
Brief Summary
-----------------
A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of pneumonia caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC tests Pneumonia. This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribo Nucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribo Nucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of pneumonia after POC tests.

Official Title
-----------------
Improving the Diagnosis of Pneumonia in Emergency Rooms

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Other: Nasopharyngeal Swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted at hospital for pneumonia requiring, for the emergency physician, a microbiological examination with a POC pneumonia kit. Patient who has freely signed the informed written consent Patient affiliated to a social security scheme Exclusion Criteria: Pregnant woman, parturient or nursing Adult major under guardianship Patient deprived of liberty under court order Patient refusing or unable to sign the informed consent form.
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: Pneumonia Patients<br>Patient admitted at hospital with pneumonia, who need a microbiological diagnosis | Other: Nasopharyngeal Swab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients in percentage with a confirmed etiological diagnosis of pneumonia |  | 1 day |
Chemotherapy Plus Reduced Radiotherapy in Intracranial Germinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the outcome of intracranial germinoma treated with chemotherapy plus reduced radiotherapy.

Detailed Description
-----------------
Treatment outcome of intracranial germinoma is excellent with radiotherapy/chemotherapy. However, late sequelae are unavoidable especially with craniospinal irradiation, and various efforts have been done to reduce the dose and extent of radiotherapy. In this study, chemotherapy and further reduced dose of radiotherapy will be used to minimize the late sequelae in the patients with intracranial germinoma.

Official Title
-----------------
Treatment of Intracranial Germinoma With Chemotherapy Prior to Reduced Dose and Volume of Radiotherapy

Conditions
-----------------
Intracranial Germinoma

Intervention / Treatment
-----------------
* Drug: Carboplatin
* Drug: Etoposide
* Drug: Cyclophosphamide
* Drug: Bleomycin
* Radiation: Reduced dose of radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pathologically proven intracranial germinoma Exclusion Criteria: Elevated serum/cerebrospinal fluid alpha-feto protein Patients with organ dysfunction as follows (creatinine elevation, ejection fraction, liver function test > CTCAE grade 2)

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracranial germinoma<br>Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen Reduced dose of radiotherapy Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site | Drug: Carboplatin<br> <br> Drug: Etoposide<br> <br> Drug: Cyclophosphamide<br> <br> Drug: Bleomycin<br> <br> Radiation: Reduced dose of radiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of late sequelae |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of event free survival |  | Up to 5 years |
Outcome of Idiopathic Pulmonary Fibrosis With Pregnancy

Study Overview
=================
Brief Summary
-----------------
case-control study was conducted between December 2018 to April 2020. To document outcome of IPF with pregnancy.

Official Title
-----------------
Outcome of Idiopathic Pulmonary Fibrosis With Pregnancy

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pulmonary diseases during pregnancy Exclusion Criteria: Patients with pulmonary diseases other than IPF and bronchial asthma were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cases<br>pregnant female with idiopathic pulmonary fibrosis | |
| control group<br>pregnant female with bronchial asthma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any adverse events including gestational complication or disease specific complication | e.g (development of respiratory failure, need for ICU admission). maternal outcome | from the start of inclusion to the study till termination of pregnancy, average 9 months period | 
| neonatal outcome | any unfavorable neonatal outcome as low birth weight | December 2018 to April 2020 | 
| neonatal outcome | any unfavorable neonatal outcome as prematurity or neonatal death. | December 2018 to April 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IPF, pregnancy
Buprenorphine Maintenance for Opiate Dependence - 6

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of buprenorphine as a substitution pharmacotherapy for opiate dependence.

Official Title
-----------------
Buprenorphine Maintenance for Opiate Dependence

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|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
-----------------
opiate dependence
Simplified Medical Abortion Screening: A Pilot Demonstration Project

Study Overview
=================
Brief Summary
-----------------
This study aims to collection additional data on the safety and acceptability of medical abortion without pretreatment pelvic ultrasound or exam in woman who meet certain criteria.

Official Title
-----------------
Simplified Medical Abortion Screening: A Pilot Demonstration Project

Conditions
-----------------
Medical; Abortion, Fetus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Women having medical abortion
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 |
| --- | --- | --- |
| Incidence of serious adverse events |  | 7 days |
Pulmonary Embolism Registry

Study Overview
=================
Brief Summary
-----------------
Acute Pulmonary Embolism (PE) is the most serious clinical presentation of venous thromboembolism (VTE), a leading cause of cardiovascular mortality, exceeded only by stroke and myocardial infarction. Chronic thromboembolic pulmonary hypertension (CTEPH) is the most severe chronic form of CTED and it occurs in 2-4% of patients after acute PE. In Portugal little is known about PE epidemiology and its outcomes, including complications like CTED. The main goal of this study is, therefore, to understand PE epidemiology and complications in the northern region of Portugal. This information can enable the organization of a structured health care network that can potentially benefit all PE patients.

Official Title
-----------------
Pulmonary Embolism Registry

Conditions
-----------------
Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute symptomatic or asymptomatic PE, Age >18 years, Availability of a minimum data set for PE and a minimum of 3-months follow-up for the primary objective and 36-months for the secondary one. Except for patients who died prior to the 3 or 36 months follow-up. Exclusion Criteria: Enrolment of the patient in any treatment trial in a blinded fashion, Lack or withdrawal of patient´s consent.

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 |
| --- | --- | --- |
| Determine Pulmonary Embolism (PE) prevalence in Portugal | Number cases per year | From date of inclusion until the end of the study currently planned (3 to 5 years) | 
| Identification of Pulmonary Embolism (PE) risk factors and comorbidities | Frequency of risk factors and comorbidities | From date of inclusion until the end of the study currently planned (3 to 5 years) | 
| Determine Pulmonary Embolism (PE) clinical management. | Identification of diagnostic of diagnostic and treatment profile | From date of inclusion until the end of the study currently planned (3 to 5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access incidence rate of Chronic Thromboembolic Disease (CTED) with or without pulmonary hypertension after acute PE. | ratio between the number of patients with CTED with or without pulmonary hypertension and total number of patients with PE | From 6 months after date of inclusion until the end of the study currently planned (2 to 5 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Embolism, Venous Thromboembolism, Chronic Thromboembolic Disease