linjc16/ctgov huggingface dataset:
Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if MDX-1342 given in combination with Methotrexate is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in the severity patients' arthritis will also be analysed.

Official Title
-----------------
A Phase 1, Multicenter, Single-dose, Dose-escalation, Safety and Tolerability Study of MDX-1342 (Anti-CD19 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Biological: MDX-1342


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have met ACR criteria for the diagnosis of rheumatoid arthritis (RA) Must have active RA Must be treated with Methotrexate (MTX) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug administration date. All other DMARDs or biologics must be discontinued at least 28 days prior to study drug administration and: 1) Leflunomide, which must be discontinued at least 60 days before study drug administration, 2) infliximab, adalimumab, and abatacept must be discontinued at least 56 days prior to study drug administration Exclusion Criteria: Both Rheumatoid factor and anti-CCP negative Prior treatment with any B-cell depleting therapy Any other mAb or Ig-based fusion proteins 56 days or less prior to Visit History of or current inflammatory joint disease other than RA Neuropathies or neurovasculopathies that might interfere with pain evaluation Complications of RA or other disease Any other autoimmune disease other than RA Acute or chronic infection Clinically significant disease requiring

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Active MDX-1342 given in combination with Methotrexate | Biological: MDX-1342<br>* One dose of active MDX-1342 (anti-CD19 fully human monoclonal antibody) will be administered to patients as an i.v. infusion. Patients will receive one dose of MDX-1342 given in combination with Methotrexate treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence and severity of treatment-emergent adverse events |  | all adverse events will be followed to resolution | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid, arthritis, RA, joint inflammation, autoimmune, Medarex, Rheumatology
Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation

Official Title
-----------------
Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated With Cataract Surgery: European Study

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Drug: Nepafenac 1mg/ml eye drops, suspension
* Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution
* Other: Nepafenac vehicle eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 18. Other protocol-defined exclusion criteria may apply.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nepafenac<br>One drop in the study eye 3 times daily for 23 days | Drug: Nepafenac 1mg/ml eye drops, suspension<br>* One drop in the study eye 3 times daily for 23 days<br>|
| Active Comparator: Ketorolac Trometamol<br>One drop in the study eye 3 times daily for 23 days | Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution<br>* One drop in the study eye 3 times daily for 23 days<br>|
| Placebo Comparator: Nepafenac Vehicle<br>One drop in the study eye 3 times daily for 23 days | Other: Nepafenac vehicle eye drops<br>* One drop in the study eye 3 times daily for 23 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients with Day 14 Cure | Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14. | Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataracts
Strength Training Following Gastric Bypass for Obesity

Study Overview
=================
Brief Summary
-----------------
We will assess whether undesirable loss of lean tissue following gastric bypass surgery for obesity can be minimized by protein supplementation and exercise training.

Official Title
-----------------
Strength Training Following Gastric Bypass for Obesity

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

Intervention / Treatment
-----------------
* Behavioral: strength training


Participation Criteria
=================
Eligibility Criteria
-----------------
clinically severe obesity candidate for bypass surgery new york city local address willing to visit hospital weekly

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 52 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: strength training|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
-----------------
obesity, gastric bypass, obesity surgery, bariatric surgery, exercise
Diabetes Prevention in Prediabetic Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the feasibility and efficacy of two interventions of lifestyle ( intensive and less intensive) to prevent diabetes in patients from Ethiopian origin, aged 25 to 55 years old with prediabetes living in Israel and insured by Clalit Health Services in the Central district, using resources existing in this Health Care system (HMO).

Official Title
-----------------
Diabetes Prevention in Patients Aged 25-55 From Ethiopian Origin With Prediabetes: Evaluation of Feasibility and Efficacy of Intensive or Less Intensive Lifestyle Intervention

Conditions
-----------------
Ethnic Group, Young Adults, Prediabetes, Community Health Services

Intervention / Treatment
-----------------
* Behavioral: intensive lifestyle counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prediabetes age 25-55 ethiopian origin Exclusion Criteria: diabetes age under 25 or above 55 non ethiopian origin

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 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 |
| --- | --- |
| Intensive Lifestyle counseling<br> | Behavioral: intensive lifestyle counseling<br>* Intensive lifestyle counseling will include a bi annual visit of the primary physician and nurse, a group intervention about use of medical resources, healthy lifestyle a one to one intervention with a dietician about diet and a one to one intervention with a physiotherapist about exercise<br>|
| usual lifestyle counseling<br> | Behavioral: intensive lifestyle counseling<br>* Intensive lifestyle counseling will include a bi annual visit of the primary physician and nurse, a group intervention about use of medical resources, healthy lifestyle a one to one intervention with a dietician about diet and a one to one intervention with a physiotherapist about exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurence of diabetes | Patients included in the study will have a one year lifestyle intervention ( two arms: intensive, less intensive) and will be followed for two years for the occurence of diabetes | two years period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Body Mass index and Physical activity |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes prevention, BMI, physical activity, lifestyle
Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included.

Official Title
-----------------
Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus

Conditions
-----------------
Nystagmus, Congenital, Nystagmus, Acquired, Multiple Sclerosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who has succesfully completed the lead-in study MRZ 92579-0707/1 Exclusion Criteria: Occurence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579-0707/1)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 81 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

| Intervention/Treatment |
| --- |
|Drug: Neramexane mesylate|open-label treatment of 36 months Neramexane mesylate up to 75 mg per day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety, Visual acuity |  | Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nystagmus, congenital idiopathic
Study to Evaluate Real-world Pharmacoeconomics of Panitumumab in Metastatic Colorectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This is a phase IV multicenter trial to evaluate real-world health outcomes and economic impact of panitumumab versus standard-of-care (SOC) in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). The study will enable real-life health economics and outcome research (HEOR) to assess the impact of panitumumab in the Quebec population. The primary objective is to evaluate real-world health outcomes and economic impact of panitumumab in the treatment of patients with chemotherapy-refractory mCRC in comparison with SOC. The secondary objectives are to confirm survival data, to assess the quality of life of patients and to assess the health care resource utilization of patients. Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and patients with a non-mutated (wild type) KRAS gene will be treated with panitumumab. During the course of the study, data will be collected on quality of life and work productivity. Patients will be asked to fill a set of questionnaires at their recruitment in the study and at every 3 months after treatment initiation.

Official Title
-----------------
A Phase IV Multicenter Trial to Evaluate Real-world Health Outcomes and Economic Impact of Panitumumab Versus Standard-of-care in the Treatment of Patients With Chemotherapy-refractory Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer Metastatic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a histologically confirmed diagnosis of mCRC. Immunohistochemical evidence of EGFR expression. ECOG performance status of 0, 1 or 2. Patients refractory to fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens Patients with a wt KRAS scheduled to receive panitumumab as a single agent for the third-line treatment of mCRC or patients with a mt KRAS scheduled to receive SOC for third-line treatment of mCRC. Signed and dated IRB-approved informed consent document. Ability to read and understand English or French. 18 years of age or older.

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 |
| --- | --- | --- |
| The pharmacoeconomic impact of panitumumab for the treatment of metastatic colorectal cancer in a real-life setting | Pharmacoeconomic impact (cost-effectiveness and cost-utility) will be evaluated by questionnaires completed by the patient and caregiver. These include quality of life, health resource utilization, work productivity and activity impairment, and health questionnaires. | From the date of registration until date of death from any cause, assessed up to 38 months |
Active Over 45: A Step-up Jogging Program in Inactive Female Hospital Staff Aged 45+

Study Overview
=================
Brief Summary
-----------------
Background: Inactive individuals face motivational obstacles for becoming and staying physically active. Therefore, sustainable physical activity promotion programs tailored to reach inactive individuals are needed. Purpose: to test the effect (long and short-term) and feasibility of a training program and to evaluate the association between the baseline motivation to become physical activity and the change in physical activity and performance. Design: uncontrolled trail Setting/participants: inactive, female hospital staff aged 45 and older from the University Hospital Zurich Intervention: 3-month step-up jogging program Main outcome measures: physical performance and level of physical activity

Official Title
-----------------
Active Over 45: A Step-up Jogging Program in Inactive Female Hospital Staff Aged 45+: Feasability, Role of Motivation and Sustained Benefit

Conditions
-----------------
Physical Activity

Intervention / Treatment
-----------------
* Behavioral: step-up jogging program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: female hospital stuff no regular physical activity older than 45 years Exclusion criteria: osteoporotic fracture in the last three month significant musculoskeletal, cardiac or respiratory disorder

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: training<br>step up jogging program | Behavioral: step-up jogging program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity | Coopertest | 3 and 12 month |
Induction of Labor in Intrahepatic Cholestasis of Pregnancy

Study Overview
=================
Brief Summary
-----------------
Induction of Labour in Intrahepatic Cholestasis of Pregnancy (ICP) has become a common procedure in management of ICP to avoid fetal complications. Surprisingly, this empirical approach has not been evaluated as to delivery complications and fetal outcome as yet. The investigators now examine weather ICP affects (i) delivery procedures chosen, in particular the incidence of caesarian section, (ii)fetal and maternal outcome in induced labor, and (iii)possible impact of bile acids and UDCA treatment in a retrospective cohort study based on approximately 5000 induced deliveries at Danderyd Hospital, Karolinska Institutet, Stockholm. The investigators analyze data on on previous deliveries, BMI, medical history and medical book data. Primary endpoint is the risk of caesarian section.

Official Title
-----------------
Induction of Labor in Intrahepatic Cholestasis of Pregnancy

Conditions
-----------------
Intrahepatic Cholestasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICP during pregnancy and induction of labor ICP and spontaneous delivery No ICP but induction of labor Exclusion Criteria: No ICP spontaneous delivery Elective caesarian section
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Induction of labor in ICP<br>Induction of laborin women with ICP | |
| Induction of labor in women with no ICP<br>No ICP | |
| ICP and spontanius delivery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean section |  | 32 to 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding |  | 32 to 40 weeks | 
| Abruptio placentae |  | 32 to 40 weeks | 
| APGAR |  | 32 to 40 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intrahepatic Cholestasis of Pregnancy, Induction of labor, Pregnancy, Caesarian section, Pruritus, IUFD
Zinc Supplement Before or With Food in Generally Healthy Men

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the influence of food consumption timing on the body's response to a zinc supplement

Detailed Description
-----------------
This research is a dietary intervention study designed to evaluate the effect of the food consumption timing on the absorption of zinc supplement. The main objective is to measure plasma zinc in generally healthy male subjects, who will consume zinc supplement with food or 30-min before food for 2-weeks. In addition to the primary objectives, correlations in enzyme activity with changes in fat metabolism, namely circulating triglyceride and cholesterol, will be determined. This will enable the determination of the effect of a low Zn intake on various aspects of dyslipidemia.

Official Title
-----------------
Evaluation of Zinc Supplementation Taken Prior or With Food

Conditions
-----------------
Zinc Deficiency, Dyslipidemias, Zinc Excess, Inflammation

Intervention / Treatment
-----------------
* Dietary Supplement: Zinc supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing to stop supplementation 4 weeks prior to start of the study has an operative understanding of English no plans to move from the area during the study period regularly eat breakfast Exclusion Criteria: Chronic or acute metabolic disease smoker or user of nicotine products history of alcohol abuse, or use of illicit drugs (incl marijuana) Is underweight or overweight, body mass index (BMI) < 18 or > 30 kg/m2

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplement with food<br>Zinc supplement to be taken at time of breakfast consumption | Dietary Supplement: Zinc supplement<br>* 25 mg<br>|
| Experimental: supplement prior to food<br>Zinc supplement to be taken 30-min before breakfast consumption | Dietary Supplement: Zinc supplement<br>* 25 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Zinc changes | Change in plasma zinc | Day 0, Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight changes | Body weight changes | Day 0, Day 15 | 
| Essential Fatty acid changes | Essential Fatty acid changes | Day 0, Day 15 | 
| Blood glucose changes | Blood glucose changes | Day 0, Day 15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
zinc, nutrition, supplement, food