linjc16/ctgov huggingface dataset:
Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate

Study Overview
=================
Brief Summary
-----------------
Longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline treatment with Methotrexate.

Detailed Description
-----------------
Objective. 30-year follow-up of rheumatoid arthritis (RA) patients treated with methotrexate (MTX) in the 1980s to analyze the association of the degree of response to MTX with long-term mortality. Methods. In this observational cohort study, 271 RA patients who had started treatment with MTX between 1980 and 1987 were included (mean age 58 years, mean disease duration 8.5 years). One year after baseline, the treatment response to MTX was evaluated. Responders were defined as patients with at least 20% improvement. Thereafter, assessments were performed at 10 and 18 years after baseline. This re-evaluation was done to provide the data after 30 years of follow-up. Standardized mortality ratios (SMR) are calculated, Cox regression and logistic regression are performed.

Official Title
-----------------
Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate Enroled in the Ratingener Rheuma-Kohorte

Conditions
-----------------
External Causes of Morbidity and Mortality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rheumatoid arthritis treatment with methotrexate active disease Exclusion Criteria: low disease activity previous treatment with methotrexate
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 |
| --- | --- | --- |
| mortality |  | 30 years |
Glucocorticoids and Bone in Graves' Ophthalmopathy

Study Overview
=================
Brief Summary
-----------------
Continuous use of systemic glucocorticoids decreases bone mineral density and increases fracture risk. Graves' orbitopathy is treated with weekly infusion of high-dose intravenous glucocorticoid. The investigators aim at investigating whether this treatment regimen also affects bone metabolism.

Detailed Description
-----------------
Systemic glucocorticoid increases bone resorption and decreases bone formation and thereby decreases bone mineral density and increases fracture risk. This effect is evident with a daily dose of 5 mg for three months or an accumulated dose of 450mg. There is, however, less evidence that intermittent use of glucocorticoids is harmful to bone. Graves orbitopathy is treated with a weekly infusion of the glucocorticoid methylprednisolone and the accumulated dose over a 12-week course sums up to 4,500mg. The investigators therefore want to investigate if that treatment regimen affects bone turnover, bone mineral density, or bone structure in 30 patients with Graves' orbitopathy.

Official Title
-----------------
The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy

Conditions
-----------------
Graves Ophthalmopathy

Intervention / Treatment
-----------------
* Drug: Methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Graves Ophthalmopathy that requires treatment with intra-venous methylprednisolone Exclusion Criteria: Treatment with osteoporosis medication Primary hyperparathyroidism Hypoparathyroidism Vitamin D < 20mmol/L eGFR < 30 Liver disease Peroral treatment with glucocorticoids within last three months prior to inclusion

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 |
| --- | --- |
| Patients<br>30 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated | Drug: Methylprednisolone<br>* Intravenous methylprednisolone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar spine bone mineral density | Change in lumbar spine bone mineral density from baseline to week 12 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral neck bone mineral density | Change in femoral neck bone mineral density from baseline to week 12 | 12 weeks | 
| Total hip bone mineral density | Change in total hip bone mineral density from baseline to week 12 | 12 weeks | 
| Bone turnover | Change in bone turnover measured by the biochemical markers CTx and P1NP | 12 weeks | 
| Bone structure | Change in bone structure measured by high-resolution peripheral quantitative computed tomography | 12 weeks |
Institut Paoli Calmettes Cardia Cancer Database

Study Overview
=================
Brief Summary
-----------------
Database of Institut Paoli-Calmettes patients diagnosed with cardia cancer

Official Title
-----------------
Institut Paoli Calmettes Cardia Cancer Database

Conditions
-----------------
Stomach Neoplasms, Cardia

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cardia cancer Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 cardia cancer diagnosis<br> | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients | Overall survival of all patients who come in the center | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patients characteristics | Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies | 10 years |
Glutamine and Intestinal Protein Metabolism

Study Overview
=================
Brief Summary
-----------------
Gut barrier plays a major role in defence of the organism. During catabolic states, like major surgery or inflammation, gut barrier could be altered. It has been reported that preoperative nutritional support may have beneficial effects on clinical outcome in patients with surgery on gastrointestinal tract. Glutamine, which is a conditionally essential amino, have been reported to modulate inflammatory, antioxidant responses and protein metabolism in intestine. In addition, glutamine supply improves clinical outcome in critically ill patients. Antioxidant micronutrients may also have some beneficial effects in intestine by improving antioxidant response and might also regulate protein expression. Nevertheless, effects of glutamine combined to antioxidant micronutrients have not been evaluated. Thus, the aim of this study will be to assess the influence of glutamine and glutamine-antioxidant micronutrients-containing solutions on intestinal response in humans.

Official Title
-----------------
Comparative Effects of Glutamine and Glucose on Intestinal Protein Metabolism in Healthy Humans

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Glutamine
* Drug: Glucose
* Drug: glutamine-antioxidants containing solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers, male and female, aged between 18 and 50 years, negatives for HIV1, 2 and for HVC and HVB BMI between 20 and 24 kg/m², giving their written informed consent no-smokers no allergic and digestive antecedents Exclusion Criteria: smokers Allergic and digestive antecedents, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Glutamine|nan|
|Drug: Glucose|nan|
|Drug: glutamine-antioxidants containing solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on protein synthesis rate and proteolytic activities in intestine. |  | at the end of infusion (hour 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of protein expression pattern and glutathione synthesis. |  | at the end of infusion (hour 5) |
Geko Venous Leg Ulcer Study

Study Overview
=================
Brief Summary
-----------------
This study is designed to look at the effect of the geko device on the circulation in lower limbs of participants with venous leg ulcers.

Official Title
-----------------
A Single Centre Open Label Pilot Study Measuring Lower Limb Blood Flow in Patients With Venous Leg Ulcers Using the Geko™ T-2 or gekoTM Plus [R-2] Neuromuscular Electro Stimulation Device

Conditions
-----------------
Venous Leg Ulcer

Intervention / Treatment
-----------------
* Device: geko


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Intact healthy skin at the site of device application Able to understand the Patient Information Sheet Willing to give informed consent Willing to follow the requirements of the protocol Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 2 cm2 and less than 10 cm in maximum diameter, ABPI of 0.8 or greater Exclusion Criteria: History of significant haematological disorders or DVT with the preceding six months Pregnant Pacemakers or implantable defibrillators Use of any other neuro-modulation device Current use of TENS in pelvic region, back or legs Use of investigational drug or device within the past 4 weeks that may interfere with this study Recent surgery (such as abdominal, gynaecological, hip or knee replacement) Recent trauma to the lower limbs Size of leg incompatible with the geko™ device. Chronic obesity (BMI > 34) Any medication deemed to be significant by the Investigator Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension Diabetic subjects with advanced small vessel disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: geko device<br> | Device: geko<br>* neuromuscular electrostimulator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultra sound measurements of haemodynamics |  | 10mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event rate |  | 2 hrs | 
| patient rated tolerability | A questionnaire has been designed to record the opinion of the patient with regard to the device, in particular how comfortable the device was to wear. The patient will be asked to rate how comfortable the devices are to wear on a scale of 1-5, 1 being very comfortable and 5 being extremely uncomfortable | 2 hrs |
Non-hypovascular Solid Pancreatic Lesions: Role of EUS

Study Overview
=================
Brief Summary
-----------------
Vascular pattern of solid pancreatic lesions (SPLs) has been investigated by different abdominal imaging modalities and by contrast-enhanced endoscopic ultrasonography (CE-EUS). Compared with surrounding pancreatic parenchyma three different patterns have been described: hypo-, iso-, and hypervascular. The majority of SPLs are hypovascular, and the diagnostic relevance of hypoenhanced pattern to predict pancreatic adenocarcinoma (PDAC) is well established. Differently, iso- and hypervascular pattern is not specific and can be expressed by several SPLs, with different clinical behavior and management. To date, poor is know about the role of EUS in differential diagnosis of non-hypovascular SPLs and features associated with malignancy.

Official Title
-----------------
Role of EUS in Differential Diagnosis and Malignancy Prediction of Non-hypovascular Solid Pancreatic Lesions: A Prospective Observational Study

Conditions
-----------------
Solid Pancreatic Neoplasms, Endoscopic Ultrasound

Intervention / Treatment
-----------------
* Diagnostic Test: Endoscopic ultrasound-fine needle biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of one or more solid pancreatic lesions preliminary evaluated by contrast-enhanced computed tomography (CE-CT) and/or contrast enhanced magnetic resonance imaging (CE-MRI) reporting a non-hypovascular contrast pattern (e.g., iso- or hypervascular). Exclusion Criteria: Patients with associated chronic pancreatitis features (e.g., pancreatic calcifications) Lesion with hypovascular pattern at CE-EUS. Lesion not found or non pancreatic at EUS. Patients refusing to be included in the study

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 |
| --- |
|Diagnostic Test: Endoscopic ultrasound-fine needle biopsy|Patients with non-hypovascular solid pancreatic lesion undergo endoscopic ultrasound-fine needle biopsy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upstream dilation of the main pancreatic duct | Percentage of cases with upstream dilation of main pancreatic duct will be recorded. | 6 months | 
| Vascular pattern (iso or hypervascular) | Percentage of cases with iso-vascular or hyper-vascular pattern will be recorded. | 6 months | 
| Lesion borders (smooth or irregular) | Percentage of cases with smooth or irregular borders will be recorded. | 6 months |
An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Factorial Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia

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

Intervention / Treatment
-----------------
* Drug: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 14 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High cholesterol Exclusion Criteria: Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 14 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma LDL-C. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma TG and HDL-C; proportion of patients achieving LDL-C targets; tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary hypercholesterolemia
Prospective Clinical Evaluation of Three Prosthesis Re-cap, M2a-Magnum and C2a-taper.

Study Overview
=================
Brief Summary
-----------------
This evaluation is being conducted to evaluate the performance of thee prosthesis.

Conditions
-----------------
Patients Undergoing a THR

Intervention / Treatment
-----------------
* Device: Hip prosthesis (re-cap, m2a-magnum and C2a-taper)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health of age (ASA I-II) DEXA-scanning: lower limit for a 55 years old man MRI normal vitality in caput Willing to return for follow-up evaluations Exclusion Criteria: Subjects displaying any of the following contra-indications shall be excluded from this evaluation: Inability to co-operate with and complete the study Collum < 2 cm Large cysts in caput Mismatch between caput acetabulum Caput necrosis

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hip prosthesis (re-cap, m2a-magnum and C2a-taper)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Labor and Delivery Teamwork Intervention Trial

Study Overview
=================
Brief Summary
-----------------
A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals to evaluate the effect of teamwork training on the occurrence of adverse outcomes and processes of care in labor and delivery.

Detailed Description
-----------------
A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals to evaluate the effect of teamwork training on the occurrence of adverse outcomes and processes of care in labor and delivery. The intervention, called the Labor & Delivery Team Coordination Course, was a standardized teamwork training curriculum based on crew resource management that emphasized communication and team structure. The primary outcome was the proportion of deliveries at greater than or equal to 20 weeks gestation in which one or more adverse maternal and/or neonatal outcomes occurred (Adverse Outcome Index, AOI). Additional outcomes included 11 clinical process measures.

Official Title
-----------------
The Labor and Delivery Teamwork Intervention Trial

Conditions
-----------------
Adverse Maternal and Neonatal Outcomes

Intervention / Treatment
-----------------
* Behavioral: Labor and Delivery Team Coordination Course


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: delivery at a participating hospital between 12/31/02-03/31/04 pregnancy of 20-43 weeks gestation Exclusion Criteria: delivery at less than 20 weeks or greater than 43 weeks

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Labor and Delivery Team Coordination Course|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was the proportion of deliveries at greater than or equal to 20 weeks gestation in which one or more adverse maternal and/or neonatal outcomes occurred (Adverse Outcome Index). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional outcomes were eleven process measures that recorded length of care or delay to action. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor and delivery care, teamwork training, crew resource management, cluster-randomized trial
Ghrelin and Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
Ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines immediately after weight loss surgery. Some studies suggest that ghrelin may worsen an individual's ability to respond to insulin. The purpose of this study is to determine if the decline in ghrelin levels after weight loss surgery contributes to the improvement of insulin sensitivity.

Official Title
-----------------
Role of Ghrelin in the Improvement of Insulin Resistance After Roux-en-Y Gastric Bypass Surgery

Conditions
-----------------
Obesity, Insulin Resistance, Normal Weight,Healthy Controls

Intervention / Treatment
-----------------
* Drug: Ghrelin infusion to assess effects on insulin sensitivity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for RYGB group: Age 18-65 BMI > 35 kg/m2 Scheduled for bariatric surgery at Vanderbilt University Medical Center Inclusion Criteria for Lean group: Age 18-65 BMI < 30kg/m2 Exclusion Criteria: Prior bariatric surgery Serum creatinine > 1.5 mg/dl Hepatic enzyme elevations > 2x upper limits of normal Current use of warfarin or clopidogrel Intercurrent infections Females with positive pregnancy test Abnormal ECG

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Roux-en-Y gastric bypass<br> | Drug: Ghrelin infusion to assess effects on insulin sensitivity<br> <br> |
| Experimental: Lean<br> | Drug: Ghrelin infusion to assess effects on insulin sensitivity<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of ghrelin on insulin resistance in obese subject, as well as subjects in the immediate post-RYGB period. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Insulin resistance, Ghrelin