linjc16/ctgov huggingface dataset:
Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation is to determine the effects of Rituxan therapy in individuals with rheumatoid arthritis on endothelial function and other markers of endothelial function

Official Title
-----------------
Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy

Conditions
-----------------
Endothelial Function, Rheumatoid Arthritis, Inflammation

Intervention / Treatment
-----------------
* Drug: Rituxan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to give written informed consent and comply with the requirements of the study protocol Negative serum pregnancy test (for women of child bearing age) Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment. IgG & IgM levels within normal limits Adequate renal function as indicated by serum creatinine measurements. No previous biological use (investigational or approved) except for the three approved anti-TNF alpha therapies Patients who have been treated with anti-TNF alpha therapies must be off of infliximab and adalimumab for two months before study entry and off of etanercept for one month before study entry No use of phosphodiesterase type 5 inhibitors (PDE5) (i.e. Sildenafil, Tadalafil, and Vardenafil) 1 week prior to the study and during the course of the study. SBP ≤ 140/90 for two months prior to study enrollment Exclusion Criteria: Prior history of MI, CVA, CABG, PTCA, or peripheral vascular disease Any serious concomitant medical condition that could interfere with the study. Patients with insulin dependent diabetes Failure to provide written consent. Individuals with HIV infections SBP > 140/90 at two months prior to study enrollment

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: Rituxan<br> | Drug: Rituxan<br>* 1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated Vasodilation (FMD) | endothelial function as assessed by flow-mediated vasodilation of the brachial artery | 12 weeks, 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endothelial function, rheumatoid arthritis, cardiovascular risk, rituxan therapy
Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial

Study Overview
=================
Brief Summary
-----------------
This study investigates the use of post-operative on-Q pain catheters for tissue expander based breast reconstruction, versus conventional ultrasound-guided blocks placed pre-operatively.

Official Title
-----------------
Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial

Conditions
-----------------
Post-operative Pain

Intervention / Treatment
-----------------
* Device: On-Q
* Drug: Ultrasound guided pectoral nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presenting for breast reconstruction w/ planned two-stage, sub muscular tissue expander placement. Exclusion Criteria: pregnant, prisoners, cannot consent, history of chronic pain or pain medication use

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Interventional Model Description: Two groups, conventional treatment versus experimental treatment; blocked randomization scheme
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: On-Q Catheter<br>On-Q catheters placed within the implant pocket; infusion of 0.2% Ropivacaine at 4 mL/h for a total of 400 mL (about 4 days). | Device: On-Q<br>* 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral<br>|
| Active Comparator: Ultrasound Guided Pectoral Nerve Block<br>Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the pecs 2 injection | Drug: Ultrasound guided pectoral nerve block<br>* Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the Pecs 2 injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Narcotic Usage | amount of narcotic used | post operation up to 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Anti-emetic Usage | number and amount of anti-emetic used | post operation up to 2 days | 
| Post-operative Self-reported Pain Scores | Pain scores overall and by breast: 0 (no pain) - 100 (extreme pain) analog scale. | post operation up to 2 days |
Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Rosuvastatin

Study Overview
=================
Brief Summary
-----------------
To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with dyslipidemia with hypertension.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension

Conditions
-----------------
Dyslipidemia With Hypertension

Intervention / Treatment
-----------------
* Drug: Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)
* Drug: Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo)
* Drug: Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dyslipidemia with hypertesion msSBP < 180 mmHg msDBP < 110 mmHg LDL-C ≤ 250 mg/dL Triglycerides < 400 mg/dL Exclusion Criteria: At Visit 3, BP difference SBP ≥20mmHg or DBP ≥10mmHg CK normal range ≥ 2 times Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times) AST or ALT ≥ 2 times Uncontrolled diabetes mellitus (HbA1c≥9%) CLcr < 30 mL/min/1.73m^2 K > 5.5 mEq/L Other exclusion applied

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin 20 mg for 8 weeks | Drug: Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)<br>* Twinstar(80/10 mg) and Rosuvastatin 20 mg for 8 weeks<br>|
| Active Comparator: Group II<br>Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo for 8 weeks | Drug: Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo)<br>* Twinstar(80/10 mg) and Rosuvastatin placebo for 8 weeks<br>|
| Active Comparator: Group III<br>Treatment of Telmisartan 80 mg, Amodipine placebo, Rosuvastatin 20 mg for 8 weeks | Drug: Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)<br>* Twinstar placebo, Amlodipine 10 mg and Rosuvastatin 20 mg for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of LDL-C |  | baseline and 8 weeks | 
| change of msSBP |  | baseline and 8 weeks |
Telemonitoring of Geriatric Cancer Patients Using Handheld Devices

Study Overview
=================
Brief Summary
-----------------
Cancer is becoming a chronic disease, with the requirement of a lifelong intake of cancer-controlling drugs. While young(er) patients may cope with this, geriatric cancer patients may require a more customized and tailored follow up. Most elderly patients have multiple other diseases (comorbidities) and, due to many other factors, may per se not tolerate or simply not follow anticancer therapies. This may not only impair quality of life (QoL), but on the long rung also the therapeutic outcome (survival). Handheld devices provide a new reporting/communication tool for patients and health care providers. TeleGraPH will assess if these devices are a suitable communication modality in a cohort of geriatric cancer patients.

Official Title
-----------------
Telemonitoring of Geriatric Cancer Patients Using Handheld Devices (TeleGraPH)

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: Handheld Device (Smart Phone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 60 years Karnofsky Performance Status ≥ 70 histologically confirmed malignant tumor (cancer) Exclusion Criteria: concurrent severe and/or uncontrolled concomitant medical conditions Patients unwilling or unable to comply with using a handheld device

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring using a handheld device<br>Patients will be euqipped with either an app or a handheld device with a pre-installed app to communicate with the coordinating center. | Device: Handheld Device (Smart Phone)<br>* Handheld device will be used for 3 tasks: 1x per day: status update (how are you today?) 1x per week: 10 questions on general health status 1x per month: EORTC QLQ-C30 questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Adherence/Compliance | Frequency of using the handheld device and of daily/weekly/monthly reportings | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Assessed using the EORTC QLQ-C30 questionnaire | 1 Year | 
| Reliability of reports | Patient-reported status will be compared to physician-rated status | 1 Year |
Chronic Pain After CS in Egypt

Study Overview
=================
Brief Summary
-----------------
This retrospective study will include Women who will attending to Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective CD under spinal anesthesia with horizontal lower abdominal surgical incision within last two years. Exclusion criteria will be refusal to participate, age less than 18 years, recent CD (within 3 months), if the infant had died, and history of chronic pain medications or psychiatric disorder. Data collection Participants will be contacted personally by one of study authors. Data collected are consisted of: Participants' characteristics as Age, parity and ways of delivery, weight, height, residency, husband smoking status, work, previous abdominal surgery, history of diabetes mellitus and hypertension. Last CD related data which include presence of multiple pregnancies, if CD was in private/public facility, presence surgical wound infection. Pain experienced will be assessed by questionnaire described by Nikolajsen et al, 2004

Official Title
-----------------
Prevalence and Risk Factors for Chronic Pain After Cesarean Delivery in Upper Egypt: Retrospective Study

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women attending to Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective ceserean section under spinal anesthesia with horizontal lower abdominal surgical incision within last two years Exclusion Criteria: refusal to participate, age less than 18 years, recent ceserean section (within 3 months), if the infant had died, and history of chronic pain medications or psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Pain experienced assessed by questionnaire described by Nikolajsen et al, 2004|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain | Pain experienced assessed by questionnaire described by Nikolajsen et al, 2004 | Three months after the last ceserean section |
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adults in Gaza

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine whether participation in a mind-body skills program by war-traumatized adults in Gaza will result in improvement of posttraumatic stress symptoms and depression, and will increase posttraumatic growth compared to a control group.

Official Title
-----------------
A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adults in Gaza

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Mind-Body Skills Groups


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having experienced a political violence or war-related criterion A stressor meeting the American Psychiatric Association (DSM-IV TR) criteria for PTSD according to screening scores on the PTSD Checklist- Civilian version Exclusion Criteria: former psychosocial or medical treatment for mental health conditions significant cognitive impairment

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-Body Skills Groups<br> | Behavioral: Mind-Body Skills Groups<br>* Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting<br>|
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist-Civilian Version |  | Change from Baseline (Week 1) at 11 weeks | 
| PTSD Checklist-Civilian Version |  | Change from Week 11 at 23 weeks | 
| PTSD Checklist-Civilian Version |  | Change from Baseline (Week1) at 23 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Epidemiological Studies Depression Scale (CES-D) |  | Change from Baseline (Week 1) at 11 weeks | 
| Center for Epidemiological Studies Depression Scale (CES-D) |  | Change from Week 11 at 23 weeks | 
| Center for Epidemiological Studies Depression Scale (CES-D) |  | Change from Baseline (Week1) at 23 Weeks | 
| Posttraumatic Growth Inventory |  | Change from Baseline (Week 1) at 11 weeks | 
| Posttraumatic Growth Inventory |  | Change from Week 11 at 23 weeks | 
| Posttraumatic Growth Inventory |  | Change from Baseline (Week1) at 23 Weeks |
Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.

Study Overview
=================
Brief Summary
-----------------
The study purpose is to evaluate the safety of T4090.

Official Title
-----------------
Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Kinezodianone R hydrochloride
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent dated and signed. Both eyes diagnosed open-angle glaucoma or ocular hypertension Exclusion Criteria: History of trauma, infection, clinically significant inflammation within the previous 6 months Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s) Pregnancy or breast-feeding

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: T4090<br> | Drug: Kinezodianone R hydrochloride<br>* Eyedrops<br>|
| Placebo Comparator: Placebo<br>named Vehicle in the study protocol. | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular and systemic adverse events | Ocular and systemic treatment-emergent adverse events, serious TEAE, IMP-related TEAE, TEAE leading to premature IMP discontinuation. | up to 22 days |
Treatment of Depression in Nursing Homes

Study Overview
=================
Brief Summary
-----------------
This study will implement a treatment for depression in a nursing home setting.

Detailed Description
-----------------
Depression in long-term care facilities is a significant public health issue. Up to 50% of nursing home residents are affected by significant depressive symptoms. The decreased health and limited cognitive ability of many nursing home residents makes treatment and research extremely challenging. This study will attempt to identify and implement treatments for depressed nursing home residents. Participants are randomly assigned to receive either an active intervention or treatment as usual for 6 weeks. The active intervention is followed by 4 weeks of maintenance. The intervention is implemented primarily by existing nursing facility staff and focuses on increasing opportunities for residents to experience pleasant events through increased levels of activity and positive affect. The maintenance treatment involves incorporation of protocol-based activities into patient care plans. Patients have a follow-up visit 12 weeks after the study. Psychiatric evaluations, depression and mood rating scales, observed affect and activity participation, behavior problems, and staff burden are assessed.

Official Title
-----------------
Behavioral Intervention for Depression in Nursing Homes

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: Pleasant Events-Based Behavioral Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nursing home residents DSM-IV criteria for major depressive disorder or dysthymia or Research Diagnostic Criteria for minor depressive disorder with current Geriatric Depression Scale scores > 11 and Mini Mental State scores >= 14

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This was a pilot feasibility study; the first part was a single group; the second part was a two-group randomized design.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Pleasant Events-Based Behavioral Intervention|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
-----------------
Aging, Nursing homes