linjc16/ctgov huggingface dataset:
Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the risk of venous thromboembolism (VTE) of oral contraceptives with non-use, focusing specifically on Valette® compared to other users of low estrogen dose combined oral contraceptives.

Detailed Description
-----------------
This is a population-based case-control study in Germany. Cases are women who are between 15 and 49 years old with a diagnosis of venous thromboembolism (VTE). The VTE is diagnosed in Germany between January 2002 und December 2007. Controls are women who are between 15 and 49 years old without a VTE diagnosis. About 4 controls matched by year of birth and region will be allocated to each case. Both cases and controls will receive a similar self-administered questionnaire except of some case-specific questions which are not applicable for the controls. Study participants will be asked for their informed consent. Data confidentiality will be ensured by the Berlin Center for Epidemiology and Health Research.

Official Title
-----------------
Use of OCs Containing Dienogest and Risk of Venous Thromboembolism

Conditions
-----------------
Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cases: women with a venous thromboembolism who are between 15 and 49 years old control: women without a venous thromboembolism diagnosis who are between 15 and 49 years old Exclusion Criteria: women outside the defined age range women with severe language problems women who are not willing to participate

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 49 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 |
| --- | --- |
| 1: Cases<br> | |
| 2: Controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC) | The time frame is the time when venous thromboembolism (VTE) was diagnosed in the cases group. VTE includes deep venous thrombosis and pulmonary embolism. These clinical endpoints were established by magnetic resonance imaging, spiral computer tomography, duplex sonography, and lung scintigraphy. | 01/2002 - 01/2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
venous thromboembolism
Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases

Study Overview
=================
Brief Summary
-----------------
The intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of intransit metastases the overall survival rate is still 20-30%. However, the management of intransit metastases is sometimes difficult because of frequent recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies indicate. In this study the safety and efficacy of IL-2 are evaluated.

Official Title
-----------------
Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: Interleukin-2 (Proleukin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18+ Informed consent Histologically proven melanoma Have confirmed stage IIIB or stage IV disease (AJCC 2002) with skin or soft-tissue metastases Exclusion Criteria: Pregnant or lactating women Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina) Patients with severe liver disease or severe renal disease Simultaneous immunosuppressive treatment (e.g. steroids) Simultaneous chemotherapy Pretreated soft-tissue or skin metastases (e.g. cryo-, radiotherapy)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interleukin-2 (Proleukin)|6-12 MIE/d 3times a week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy in regard to complete and partial response |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | every 6 months | 
| Side-effects |  | during treament and 4 weeks afterwards | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanoma, Soft tissue metastases, Interleukin-2
Geriatric COVID-19 Serology

Study Overview
=================
Brief Summary
-----------------
Coronaviruses are important human and animal pathogens. At the end of 2019, a new coronavirus was identified as the cause of a cluster of pneumonia cases in Wuhan, a city in China's Hubei province. It quickly spread, leading to an epidemic across China, followed by an increasing number of cases in other countries around the world. In February 2020, the World Health Organization designated the disease COVID-19, which stands for coronavirus disease 2019. The virus that causes COVID-19 is SARS-CoV-2. The duration of protection during which a patient after infection and / or vaccination remains clinically protected and the evolution of their serology as well as their titre remains unknown

Official Title
-----------------
Geriatric COVID-19 Serology

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age> 75 years old Patient hospitalized or resident in the geriatrics center from July 1, 2020 to November 30, 2021 having presented with COVID or having benefited from a COVID vaccination. Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research Exclusion criteria: Subject having expressed opposition to participating in the study Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.) Subject under guardianship, curatorship or safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 76 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective study of COVID serologies in a geriatric population after infection or vaccination |  | Files analysed retrospectively from July 1, 2020 to November 30, 2021 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, SARS-COV-2, Elderly people, Geriatric, RT-PCR SARS-CoV-2
The Correlation Between Fasicitis Plantaris and Hallux Rigidus

Study Overview
=================
Brief Summary
-----------------
Comparison between 3 groups: group I has hallux rigidus. Is fasicitis plantaris present? group II has fasicitis plantaris. Does the hallux have limited mobility? group III does not have hallux rigidus or fasicitis plantaris

Official Title
-----------------
The Correlation Between Fasicitis Plantaris and Hallux Rigidus

Conditions
-----------------
Hallux Rigidus, Fasicitis Plantaris

Intervention / Treatment
-----------------
* Procedure: Clinical examination and radiological evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hallux rigidus or fasicitis plantaris or healthy volunteer Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Clinical examination and radiological evaluation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective evidence of hallux rigidus being a cause of fasicitis plantaris. |  |  |
Dose-ranging Study of Tranexamic Acid in Valve Surgery

Study Overview
=================
Brief Summary
-----------------
Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has shown that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no randomized study focus on TA in primary valve surgery. The aim of this prospective, double-blinded, randomized trial is to compare two dosing regimens of TA during primary valve surgery on perioperative blood loss and allogeneic blood transfusion.

Official Title
-----------------
Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery

Conditions
-----------------
Hemorrhage, Valvular Heart Surgery

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass (CPB) Exclusion Criteria: a history of bleeding disorders active chronic hepatitis or cirrhosis chronic renal insufficiency (serum creatinine > 2 mg/dl) preoperative anemia (Hb < 10 g/dl) previous cardiac surgery urgent and emergency surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: High dosage<br>A loading dose of 30 mg/kg and a maintenance infusion of 16 mg/kg through out the operation, and 2 mg/kg into the cardiopulmonary bypass (CPB) prime volume. | Drug: Tranexamic Acid<br>* High and low dosage. Loading dose followed by continuous infusion in operation.<br>|
| Experimental: Low dosage<br>A loading dose of 10 mg/kg and a maintenance infusion of 1 mg/kg through out the operation, and 1 mg/kg into the cardiopulmonary bypass (CPB) prime volume. | Drug: Tranexamic Acid<br>* High and low dosage. Loading dose followed by continuous infusion in operation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of allogeneic red blood cells transfused |  | 7 days post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest tube drainage |  | 6 hours post-operation | 
| Chest tube drainage |  | 24 hours post-operation |
A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection

Study Overview
=================
Brief Summary
-----------------
This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the drug causes.

Detailed Description
-----------------
HIV-1-infected patients who are currently receiving stable antiretroviral therapy add tenofovir DF to their regimen. Study participation lasts for approximately 48 weeks. Interested patients should contact their physicians.

Official Title
-----------------
An Open-Label, Multicenter, Compassionate Access Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Tenofovir disoproxil fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have a viral load greater than or equal to 10,000 copies/ml. Have a CD4 count less than or equal to 50 cells/mm3, or have a CD4 count greater than 50 and no more than 200 cells/mm3 with an opportunistic (AIDS-related) infection within 90 days of study entry. (Patients with a CD4 count above 200 cells/mm3 may be considered depending on drug supply.) Are at least 18 years old. Agree to use barrier methods of birth control (such as condoms) while on the study and for 30 days afterward. Have a life expectancy of at least one year. Exclusion Criteria You will not be eligible for this study if you: Have a history of a serious kidney or bone disease. Have severe nausea, vomiting, or trouble taking medications by mouth. Are pregnant or breast-feeding. Abuse alcohol or other substances that your doctor thinks would interfere with taking this medicine. Are taking any medicines that interfere with kidney functions.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tenofovir disoproxil fumarate|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
-----------------
HIV-1, Drug Therapy, Combination, Disease Progression, Anti-HIV Agents
NLP Headache Speech (NLPH-SPEECH): a Cross-sectional Study on Natural Language Processing Analysing Spoken Monologues by Headache Patients

Study Overview
=================
Brief Summary
-----------------
The research collects spoken descriptions of headache disorders by participants with headache disorders. The speech recordings are analyzed by natural language processing (NLP) tools to analyse linguistic properties of the texts and to obtain insight into the potential of NLP machine learning models for the recognition of headache syndromes of the participants.

Official Title
-----------------
NLP Headache Speech (NLPH-SPEECH): a Cross-sectional Study on Natural Language Processing Analysing Spoken Monologues by Headache Patients

Conditions
-----------------
Headache Disorders

Intervention / Treatment
-----------------
* Other: Digital Analysis of Speech


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: is a patient of the tertiary headache clinic at Ghent University Hospital is 18 years or older has Dutch as native speaking language Exclusion Criteria: has difficulties in producing spoken language has limited or no knowledge of Dutch

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>Participants will provide spoken narratives on their headache disorder | Other: Digital Analysis of Speech<br>* Recordings will be transcribed manually to written digital text formats, on which NLP tools such as tokenisation and lexical analysis will be performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linguistic analysis of texts | Descriptive linguistic analysis of lexical choices, sentence formation and thematic content within the texts | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Machine learning modelling for classification of headache disorders | To investigate the potential and learn insights of machine learning modelling to classify headache disorders based on the descriptions by participants | through study completion, an average of 1 year | 
| Machine learning modelling for estimation of headache impact scores | To investigate the potential and learn insights of machine learning modelling to estimate headache impact scores from different validated questionnaires investigating burden of disease and quality of life | through study completion, an average of 1 year |
Analysis Of Sensory Recovery Of Donor Size And Quality Life In Oral Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate post-surgery sensory impairment and life quality changes in oral cancer patients who underwent free flap (Free Flap) on post-operative 6 months, 12 months, and 24 months, respectively

Official Title
-----------------
Retrospective Analysis Of Sensory Recovery Of Donor Size And Related Quality Life In Oral Cancer Patients Receiving Free Flap Reconstruction

Conditions
-----------------
Oral Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with American Society of Anesthesiologists physical status I-III Older than 20 patients Diagnosis of oral canaer ,requiring free flap reconstruction Exclusion Criteria: Diagnosis of a serious mental illness involving formal thought disorder (e.g., schizophrenia) documented in medical record Cognitive with dementia, delirium

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral Cancer Patients underwent Free Flap Reconstruction<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensory impairment on Donor site | comparison the contra-lateral side and donor site; measurement of thermal hyperalgesia with thermal roller temperatures measurement of allodynia with brush and cotton swab measurment of mechanical hyperalgesia with Von Frey filaments sensory impairments with roller wheel | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative life quality using EORTC QLQ C-30 questionnaire . |  | postoperative 6 months to one year, postoperative 1 to 2 years, and over postoperative 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral cancer,Quality of life,Sensory
PTA-Registry, a Prospective, Multicenter Study With 24-Month Follow-up

Study Overview
=================
Brief Summary
-----------------
The PTA-Registry (PTA-REG) is a prospective health services research registry to monitor and follow-up patients with peripheral arterial disease undergoing endovascular peripheral intervention. The PTA-REG has an interdisciplinary approach: cardiologists, angiologists, and radiologists contributed actively to this registry.

Detailed Description
-----------------
The registry was created for the following purposes: evaluation of the clinical effectiveness, safety and quality of the endovascular therapy, and history of the disease after endovascular therapy. The resulting specific research questions were determination of the technical and clinical success of the procedure, monitoring of periinterventional complications, evaluation of vessel patency, amputation rate, mortality, and major adverse cardiac events during the follow-up. In addition, the quality of life after endovascular peripheral intervention over a period of two years was evaluated.

Official Title
-----------------
Endovascular Treatment in Patients With Peripheral Artery Disease: Real Life Effectiveness Off the Road of Studies PTA-Registry, a Prospective, Multicenter Study With 24-Month Follow-up

Conditions
-----------------
Efficacy/Long-term Effectiveness Endovascular Therapy in PAD

Intervention / Treatment
-----------------
* Device: PTA, balloon angioplasty, stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: peripheral arterial disease of the iliac and lower extremity arteries and appropriate clinical indication for treatment with PTA according to current guidelines Exclusion Criteria: no exclusion criteria and no age restriction

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 |
| --- |
|Device: PTA, balloon angioplasty, stent|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death of any cause |  | 2 years | 
| revascularization (TLR, TVR) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| minor or major amputation |  | 2 years | 
| major adverse cardiac events and stroke |  | 2 years | 
| quality of life | The follow-up was performed at months 6, 12, 18, and 24. The follow-up consisted of a quality of life questionnaire (EQ-5D) | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAD, PTA, mortality, morbidity, amputation rate, quality of life, Percutaneous transluminal angioplasty (PTA), Stenting, balloon angioplasty