linjc16/ctgov huggingface dataset:
A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
A non-profit study designed with the aim of analysing the phenotype and molecular characteristics (central review) and evaluating prospectively the role of PET-scans in the management of primary mediastinal lymphoma treated with conventional approaches.

Official Title
-----------------
A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma

Conditions
-----------------
Primary Mediastinal B-Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary mediastinal diffuse large B-cell lymphoma, CD20 positive. Patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum. No prior treatment of lymphoma. Patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms. Any stage of disease. Age at least 18 years. Fit to receive chemotherapy with curative intent. Able and willing to give informed consent, and to undergo staging including PET scanning Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men. Exclusion Criteria: Evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease. Impairment of bone marrow function (WBC <3.0x109/L, ANC <1.5x109/L, PLT <100x109/L), unless due to involvement by lymphoma. Major impairment of renal function (serum creatinine >2x upper normal) or liver function (ASAT/ALAT >2,5 upper normal, total bilirubin >2,5x upper normal), unless due to lymphoma involvement. Known HIV infection. Patients will not be tested routinely. Pregnant or lactating women. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

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 |
| --- | --- | --- |
| response rate on PET scanning following initial chemo-immunotherapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Mediastinal B-Cell Lymphoma, Positron emission tomography
Fit For Kids-Copenhagen

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effect of a 40- week multifactorial intervention against overweight, obesity and physical inactivity in Danish children. The investigators wish to examine 40 children before and after the Fit for Kids intervention with basic anthropometric measures such as body mass indexi (BMI), waist/hip ratio, systolic- and diastolic blood pressure, level of physical fitness and Total Body fat mass. Furthermore the investigators wish to examine the more specific inflammatory, metabolic and hormonal effect of the intervention with a more extensive examination programme. The tests include a DXA-scan, cardio-respiratory fitness, accelerometer monitoring, pedometer monitoring, cognitive testing, Continuous Glucose Monitoring System, different metabolic and inflammatory markers and an oral glucose tolerance test. The study will take place at Centre of Inflammation and Metabolism, Rigshospitalet, Copenhagen. The study is a randomised controlled trial with a gradual rollout. The 40 children will be randomised. Twenty children will start the intervention at baseline and 20 children will start after the first 20 weeks of intervention, thus providing a control group. The investigators expect to find a significant reduction in BMI, total body fat mass and systolic blood pressure after the intervention. As for the more extensive tests, the data approach is explorative, as the investigators look at more statistical dependent variables. The contribution of this project is a further description on the effect of intervention against overweight and physical inactivity on the metabolic and inflammatory response.

Official Title
-----------------
Fit For Kids Copenhagen - an Interventions Study on Obesity and Physical Inactivity in Children.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Physical activity, dietary counseling, coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese children Exclusion Criteria: Other chronic medical conditions Medical intake

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 10 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 |
| --- | --- |
| Other: Lifestyle intervention<br>Lifestyle intervention. | Behavioral: Physical activity, dietary counseling, coaching<br>* Physical activity, dietary counseling, coaching<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Diabetes, Physical activity
Preservation of Ovarian Function Via LOT in Squamous Cell Carcinoma of the Cervix

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic ovarian transposition in women less than 40 years of age with locally advanced cervical squamous cell carcinoma

Official Title
-----------------
Preservation of Ovarian Function Via Laparoscopic Transposition in Patients With Locally Advanced Squamous Cell Carcinoma of the Cervix

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

Intervention / Treatment
-----------------
* Procedure: Laparoscopic ovarian transposition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed Stages iB-iiiB squamous cell carcinoma of the cervix Exclusion Criteria: Evidence of ovarian involvement on MRI Evidence of uterine involvement on MRI Evidence of distant mets on MRI

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Laparoscopic Ovarian Transposition | Procedure: Laparoscopic ovarian transposition<br>* Laparoscopic ovarian transposition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopause |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical Cancer, Squamous Cell, Laparoscopy, Ovarian Function
Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients

Study Overview
=================
Brief Summary
-----------------
Metastatic melanoma is an aggressive and highly malignant cancer. The five-year survival rate of patients with metastatic disease is less than 5% with a median survival of only 6-10 months. Drugs like Dacarbazin (DTIC) as a single agent or in combination with other chemotherapy agents, have a response rate of 15-30%, but the duration of response is usually short, with no impact on survival. Interleukin-2 (IL-2) based immunotherapy has shown more promising results. This form of therapy has a similar response rate with some patients achieving a durable complete response. Recently the National Institute of Health (NIH) reported that by using lympho-depleting chemotherapy, followed by an adoptive transfer of large numbers of anti-tumor specific tumor-infiltrating lymphocytes (TIL), an objective regression was achieved in 51% of patients with metastatic melanoma. Objectives: To introduce the TIL technology to advanced metastatic melanoma patients in Israel.

Official Title
-----------------
Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients

Conditions
-----------------
Metastatic Melanoma

Intervention / Treatment
-----------------
* Procedure: Procedure - Adoptive cell transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic Melanoma patients failing to prior chemo and immunotherapy with good performance status. Exclusion Criteria: Brain mets

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 |
| --- |
|Procedure: Procedure - Adoptive cell transfer|Procedure - Adoptive cell transfer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate and toxicity |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma, metastatic melanoma, adoptive immunotherapy, IL-2
Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Patients who completed the study TVP-1012/232 are eligible to enter the extension study to continue their rasagiline therapy for their Parkinson's disease (PD). During this study the patient's safety, tolerability of rasagiline, and effectiveness of this therapy will be monitored.

Official Title
-----------------
A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: rasagiline mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients who completed evaluations of week 52 of the TVP 1012/232 protocol, where continued rasagiline therapy is warranted, in the opinion of the principal investigator Exclusion Criteria: • Patients having suffered adverse effects that were probably drug-related in the TVP-1012/232 study

Ages Eligible for Study
-----------------
Minimum Age: 35 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: rasagiline mesylate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout) |  | 2.5 years |
Machine leArning Based CT angiograpHy derIved FFR: a Multi-ceNtEr, Registry

Study Overview
=================
Brief Summary
-----------------
Demonstrate in a large multicenter population the diagnostic performance of a pre-commercial on-site, local, CT angiography derived FFR algorithm in comparison to invasive FFR.

Detailed Description
-----------------
To retrospectively evaluate the diagnostic accuracy of FFRCT, in patients with known or suspected CAD. the investigators propose to do technical assessment of the software and evaluate how different parameters effect the outcome. Validate the FFTCT outcome by comparing the FFRCT values with invasive FFR values from retrospective patient data. To analyze the potential of FFRCT on decision making and prognosis.

Official Title
-----------------
Machine leArning Based CT angiograpHy derIved FFR a Multi-ceNtEr, Registry

Conditions
-----------------
Coronary Heart Disease, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Know or suspect coronary artery disease followed within 6 months by an invasive FFR measurement. Exclusion Criteria: Cardiac event between coronary CT angiography and the invasive FFR procedure, noninterpretable coronary CT angiography image quality, or incomplete coronary CT angiography coverage.

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 |
| --- | --- |
| Subject<br>Patients with know or suspected coronary artery disease, who underwent both CT angiography and invasive coronary angiography including invasive FFR measurements. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of local reduced order CFD and machine learning based CT angiography derived FFR, both validated against invasive FFR. Measured at both vessel and patient level. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of calcium on diagnostic accuracy of CT angiography derived FFR. |  | 6 months | 
| Confidence intervals of CT angiography derived FFR |  | 6 months | 
| Direct vessel based comparison between CT angiography derived FFR and QCT stenosis measurements |  | 6 months | 
| Analysis of anatomically mild stenosis (<50% lumen diameter reduction) but functionally significant (invasive FFR ≤ 0.80) |  | 6 months | 
| Long term clinical outcome of CT angiography derived FFR |  | 12 months |
First Trimester Prediction of Preeclampsia and Fetal Growth Restriction

Study Overview
=================
Brief Summary
-----------------
To evaluate the feasibility of screening for preeclampsia and fetal growth restriction between 11-13+6 weeks' gestation utilizing the combination of uterine artery doppler, maternal blood pressure, maternal characteristics, placental volume, and maternal serum factors, including PAPPA-A, PLGF, AFP and free Beta HCG. This is a non interventional study.

Detailed Description
-----------------
Preeclampsia (PE) is a condition which affects approximately 2% of all pregnancies and can be a major cause of maternal and perinatal morbidity/mortality (2). The suspected underlying mechanism of PE is thought to be impaired trophoblastic invasion of the maternal spiral arteries leading to impaired placental perfusion, placental ischemia and subsequent development of endothelial dysfunction (3). There is evidence that PE, which is commonly associated with fetal growth restriction, can be predicted effectively at 11-13 weeks gestational age by combined screening algorithms combining uterine artery pulsatility index (PI), maternal mean arterial pressure (MAP) and maternal serum concentrations of placental products including but not limited to plasma protein A (PAPP-A), and placental growth factor (PLGF) (4-6). Aim of Study/Hypothesis: The aim of this study is to develop an algorithm based on the combination of maternal factors, uterine artery pulsatility index, mean arterial pressure, placental volume and serum biomarkers to estimate patient specific risks for the development of Preeclampsia in a US population.

Official Title
-----------------
First Trimester Prediction of Preeclampsia and Fetal Growth Restriction Using Uterine Artery Doppler, Maternal Blood Pressure, Maternal Characteristics, Placental Volume and Maternal Serum Factors

Conditions
-----------------
Preeclampsia, Fetal Growth Restriction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients during their first trimester visit Exclusion Criteria: Fetal anomalies Pregnancies ending in termination, miscarriage or fetal death prior to 22 weeks and cases with no pregnancy follow up.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Development of Preeclampsia |  | During the first trimester (11-13+6 weeks) |
Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the impact of BOTOX® treatment on anticholinergic drug use in patients with urinary incontinence from Neurogenic Detrusor Overactivity (NDO) due to spinal injury or Multiple Sclerosis (MS) who are prescribed BOTOX® as standard of care in clinical practice.

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Biological: botulinum toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients prescribed BOTOX® for urine incontinence from NDO due to spinal injury or MS as standard of care in clinical practice in Belgium Previous treatment with anticholinergic drugs ineffective Last BOTOX® treatment ≥18 months. Exclusion Criteria: Diagnosis of urinary incontinence less than 9 months. No anticholinergic drug use in the last 9 months.

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 |
| --- | --- |
| BOTOX®<br>Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice. | Biological: botulinum toxin Type A<br>* botulinum toxin Type A (BOTOX®) prescribed as standard of care in clinical practice.<br>* Other names: BOTOX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Anticholinergic Drug Use | Anticholinergic drug use was collected the 9 months before the baseline Botox® treatment and the 9 months following the baseline Botox® treatment. Total anticholinergic drug use in the 9 months following the baseline Botox® treatment is noted. | Baseline, 9 Months |
Comparing Tai Chi Chih and Relaxation Therapy in the Treatment of Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of relaxation therapy and tai chi in treating the symptoms of rheumatoid arthritis (RA).

Detailed Description
-----------------
RA is a debilitating disease characterized by inflammation of the joints, leading to chronic pain, loss of function, and disability. Complementary and alternative medicine (CAM) treatments are being used with increased frequency by patients with chronic pain and rheumatic diseases to relieve their symptoms. While patients find these treatments helpful, there is limited scientific evidence of the effectiveness of these interventions. This study will compare relaxation therapy (a commonly used treatment for RA) to tai chi chih (a combination of slow, deliberate movements and meditation) in treating the symptoms of RA. Participants will be randomly assigned to receive 12 weeks of either relaxation therapy or tai chi chih. At study entry and Weeks 6 and 12, participants will complete questionnaires about their RA symptoms, health functioning, overall quality of life, and complete a brief medical exam.

Official Title
-----------------
Efficacy of CAM Interventions in Rheumatoid Arthritis

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Behavioral: Tai Chi Chih
* Behavioral: Relaxation training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active adult onset rheumatoid arthritis Stable on disease-modifying antirheumatic drugs (DMARDs) or biologic medications Able to walk without use of an assistive device Resides in greater Los Angeles area Willing and able to comply with study requirements Exclusion Criteria: Uncontrolled or untreated medical conditions Frequent or uncontrolled disease flares Use of certain medications any medical condition deemed by the investigators to interfere with either the patient's safe participation or interpretation of the study data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Tai Chi Chih|nan|
|Behavioral: Relaxation training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RA-related disability |  |  | 
| Health functioning |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, Tai Chi, Meditation, Relaxation Techniques