linjc16/ctgov huggingface dataset:
Gait Modifications and Cutaneous Stimulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to quantify differences in joint mechanics between different types of walking in healthy individuals and individuals with knee pathology. The investigators will determine how modifying gait through feedback and/or cutaneous stimulation changes joint loading.

Official Title
-----------------
Analysis of Joint Mechanics in Response to Gait Modifications and Cutaneous Stimulation

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: Cutaneous stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI < 35 kg/m^2 For knee pathology subjects: Diagnosis of knee pathology (e.g. knee osteoarthritis, ACL injury, etc) and/or knee pain Full weight-bearing status Exclusion Criteria: Non-ambulatory Use of walking aid For healthy volunteers - history of surgical intervention at any joint of the lower extremity Inability to cooperate with study protocol due to medical or psychiatric reasons Inability to provide informed consent For healthy subjects: Any diagnosis of knee osteoarthritis or knee pain

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

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

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

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: Cutaneous Stimulation<br>Cutaneous stimulation and/or feedback. This stimulation and/or feedback may be visual, auditory, tactile (e.g. vibratory, temperature), or haptic and is completely external. | Device: Cutaneous stimulation<br>* A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peak Knee Flexion Moment (%Bw*Ht) | Within-subject change in peak knee flexion moment (%Bodyweight*Height) with the intervention versus control (without the intervention). | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee Pathology
Evaluating Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens

Study Overview
=================
Brief Summary
-----------------
Multifocal lens allow most patients to be spectacle-free after cataract surgery. Most studies published up-to-date have focused on visual acuity, but not on patient-reported outcomes. Since some patients with very good postoperative visual acuity report being very uncomfortable after surgery, the aim of this study is to evaluate if patient satisfaction is correlated with other outcomes, such as low-contrast visual acuity, contrast sensitivity, photic phenomena and ability to tolerate defocus. Patients who have undergone surgery with bilateral multifocal intraocular lens implantation will be carefully evaluated 3 months after surgery to try to determine the factors that correlate with patient reported outcomes as evaluated with the Catquest SF-9 questionnaire.

Official Title
-----------------
Relationship Between Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens Implantation and Defocus Curves, Contrast Sensitivity and Photic Phenomena

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Cataract surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous bilateral cataract surgery Bilateral implantation of multifocal intraocular lens Exclusion Criteria: Presence of ocular pathologies Intra- or postoperative complications

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cataract surgery|Evaluation of patient satisfaction after bilateral cataract surgery with multifocal intraocular lens implantation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patient satisfaction with visual outcome three months after surgery as evaluated with the Catquest-9 questionnaire | Three months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multifocal intraocular lens, Trifocal intraocular lens, Extended Depth of Focus Lens
CI-AKI in Patients With Stable CAD and Comorbidities. Are we Doing Better?

Study Overview
=================
Brief Summary
-----------------
Patients aged 18-89 with stable CAD and comorbidities receiving optimal medical treatment requiring PCI with iodinated contrast media. The aim of the study is to assess the prevalence of contrast-induced AKI in 2012-2013 and 2017 cohorts and to evaluate the potential risk factors of CI-AKI to better guide the prevention in patients of higher risk.

Official Title
-----------------
The Impact of Comorbidity as a Risk Factor of Acute Kidney Injury (AKI) in Patients With Stable Coronary Artery Disease (CAD)

Conditions
-----------------
Stable Angina, Acute Kidney Injury, Contrast-induced Nephropathy

Intervention / Treatment
-----------------
* Procedure: Iodinated contrast media


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Male and female patients 18 y. o. and older Verified stable coronary artery disease (CAD) Receiving optimal medical treatment and requiring percutaneous coronary intervention (PCI) with iodinated contrast media Exclusion Criteria: Pregnancy, lactation Conditions affecting the prognosis (kidney failure, liver failure, oncology) Acute coronary syndrome (ACS) Stroke Contraindications to PCI Therapy with nephrotoxic drugs during the enrolment which cannot be stopped Refusal to sign the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 (5-year prognosis)<br> | Procedure: Iodinated contrast media<br>* Percutaneous coronary intervention with iodinated contest media<br>|
| Group 2 (1-year prognosis)<br> | Procedure: Iodinated contrast media<br>* Percutaneous coronary intervention with iodinated contest media<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality |  | 5 years | 
| Cardiovascular mortality |  | 5 years | 
| Myocardial infarction |  | 5 years | 
| Stroke |  | 5 years | 
| GI bleeding |  | 5 years | 
| CABG | CABG after PCI at enrolment | 5 years | 
| PCI | Repeat PCI after the enrolment | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute kidney injury, coronary artery disease, contrast-induced acute kidney injury, comorbidity, CI-AKI, stable CAD
Evaluation of the Zilver® Vena™ Venous Stent

Study Overview
=================
Brief Summary
-----------------
This prospective, non-randomized, multi-center study is intended to evaluate the Zilver® Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

Official Title
-----------------
Evaluation of the Zilver® Vena™ Venous Stent

Conditions
-----------------
Iliofemoral Venous Outflow Obstruction

Intervention / Treatment
-----------------
* Device: Zilver Vena Venous Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic venous outflow obstruction in up to two iliofemoral venous segments (one in each limb), demonstrated by: CEAP 'C' ≥ 3, or VCSS pain score ≥ 2 Exclusion Criteria: < 18 years of age Pregnant or planning to become pregnant in the next 12 months Planned surgical or interventional procedures (except thrombolysis and thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or after the study procedure. Lesions with intended treatment lengths extending into the inferior vena cava or below the level of the lesser trochanter Previous stenting of the target vessel Iliofemoral venous segment unsuitable for treatment with available sizes of study devices

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 |
| --- | --- |
| Stent<br>Stent | Device: Zilver Vena Venous Stent<br>* Stenting iliofemoral venous outflow obstruction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events |  | 1 month | 
| Patency | Assessed via ultrasound | 12 months |
Osteoporosis and Dental Implant

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis.

Official Title
-----------------
Evaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: alendronate once weekly 70mg
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women > 2 years after menopause Age between 60 and 75 years Possibility to insert a dental implant Osteoporosis as defined by WHO criteria (intervention group), or women without osteoporosis / osteopenia (non-intervention group) Exclusion Criteria: Pathological findings in the jaw bone Chronic inflammatory rheumatoid disease Bisphosphonate treatments during the last 12 months Inflammatory or metabolic bone disease, excluding osteoporosis Systemic corticosteroid treatments of more than one month within previous 12 months Severe diseases with life expectancy less than one year or expectation of rapid worsening within one year

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant | Drug: alendronate once weekly 70mg<br>* alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant<br>|
| Placebo Comparator: 2<br>placebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant | Drug: placebo<br>* placebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant<br>|
| No Intervention: 3<br>dental implant, calcium 1000mg and Vitamin D 800 IU daily | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental CT |  | baseline, and 3,6,12 months after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis,, bisphosphonate, therapy, dental implant
Feasibility and Efficacy of BACOPP-21 for Patients > 60 Years With Intermediate or Advanced Hodgkins Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2) toxicity, overall response and FFTF.

Conditions
-----------------
Hodgkin´s Lymphoma

Intervention / Treatment
-----------------
* Drug: Cyclophosphamide
* Drug: Adramycin
* Drug: Procarbacine
* Drug: Prednisone
* Drug: Vincristine
* Drug: Bleomycin
* Drug: Erythropoietin beta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hodgkin´s lymphoma (histologically proven) CS (PS) I and II with one of the risk factors a-d bulky mediastinal mass (> 1/3 maximum transverse thorax diameter) extranodal involvement ESR > 50 (A), > 30 (B-symptoms) 3 or more lymph node areas involved CS (PS) III and IV Written informed consent Exclusion Criteria: Leukocytes <3000/microl Platelets <100000/microl Hodgkin´s Disease as composite lymphoma Activity index (WHO) < grade 2

Ages Eligible for Study
-----------------
Minimum Age: 61 Years
Maximum Age: 75 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: Cyclophosphamide|nan|
|Drug: Adramycin|nan|
|Drug: Procarbacine|nan|
|Drug: Prednisone|nan|
|Drug: Vincristine|nan|
|Drug: Bleomycin|nan|
|Drug: Erythropoietin beta|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
-----------------
Hodgkin´s Lymphoma, eldery patients, primary diagnosis
Neural Correlates of PTSD Prevention With Mindfulness Based Stress Reduction (MBSR) in Iraqi Veterans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare Mindfulness Based Stress Reduction to a supportive therapy control group.

Official Title
-----------------
Neural Correlates of PTSD Prevention With MBSR in Iraqi Veterans

Conditions
-----------------
Stress Disorders, Posttraumatic, PTSD

Intervention / Treatment
-----------------
* Behavioral: MBSR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PTSD related to OEF/OIF service Exclusion Criteria: History of brain injury

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

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

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: Arm 1<br>MBSR | Behavioral: MBSR<br>* Mindfulness Based Stress Reduction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptom level measured with the CAPS |  | 3 months |
Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized control trial evaluating the efficacy of iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery.

Conditions
-----------------
Surgical Wound Infection

Intervention / Treatment
-----------------
* Device: iodophor-impregnated adhesive drapes
* Other: No adhesive drapes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary femoroacetabular osteoplasty (FAO) patients Primary Periacetabular Osteotomy (PAO) patients Exclusion Criteria: Total hip arthroplasty (THA) patients Revision FAO surgery Septic or septic arthritis patients Patients with systemic or topical allergy to iodine

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery performed using iodophor-impregnated adhesive drapes<br> | Device: iodophor-impregnated adhesive drapes<br> <br> |
| Other: Surgery performed without iodophor-impregnated adhesive drapes<br> | Other: No adhesive drapes<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bacterial count from skin swabs |  | Immediately post-surgery |
Limbal Stem Cell Deficiency of Genetic Origin: Genotype-phenotype Correlation

Study Overview
=================
Brief Summary
-----------------
The study aims at searching for a genotype-phenotype correlation in patients with a genetic pathology of the ocular surface, in order to identify genetic abnormalities associated with the most severe clinical situations.

Conditions
-----------------
Limbus Corneae

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: genetic pathology of ocular surface Exclusion Criteria: Agonal glaucoma Low vision mostly related to retinal pathology Pregnant or breast feeding patient
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 |
| --- | --- | --- |
| Genotype-phenotype Correlation |  | baseline |
Randomized Clinical Trial in Bellow-the-knee Angioplasty. Treatment of One or More Than One Artery.

Study Overview
=================
Brief Summary
-----------------
It is a randomized study that intend to enroll 80 bellow-the-knee angioplasty procedures in which 40 procedures to treat one artery (standart) or more than one artery in the same procedure. The aim of this study is to know if this strategy increase healing velocity and limb salvage.

Official Title
-----------------
Randomized Clinical Trial in Bellow-the-knee Angioplasty. Treatment of One or More Than One Artery.

Conditions
-----------------
Atherosclerosis of Artery

Intervention / Treatment
-----------------
* Procedure: Angioplasty of distal arteries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Occlusion of the three arteries bellow the knee previously Rutherford 5 - ischemic lesion of the foot Informative Term At least one patente vessel in pedal arch Exclusion Criteria: allergy to aspirin, clopidogrel or contrast media renal impairment Tasc D lesion in femoral or popliteal arteries no undersatnting patients

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
Interventional Model Description: In this study, there is no use of other drugs, biological vaccine or combination product, but it was used two different approaches to the same problem: the renalization of the tibial arteries in patients with tissue loss. The angioplasty, that is the usual method of treatment, is done for one or more than one artery after randomization. It is phase 4 because it is an usual method of treatment (gold standard) for this disease.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One Artery<br>In this arm after obtain the good result after the angioplasty of one artery the procedure stops | Procedure: Angioplasty of distal arteries<br>* angioplasty of the arteries bellow-the-knee<br>|
| Experimental: More than one artery<br>In this arm, after obtain a good result of the angioplasty of one artery, we continue trying one or two more arteries | Procedure: Angioplasty of distal arteries<br>* angioplasty of the arteries bellow-the-knee<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of wound healing | Time in days necessary to the complete healing of the wound | 1 year | 
| Limb Salvage | Time free of major amputation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
angioplasty, infrapopliteal arteries
Study Evaluating Mylotarg (Gemtuzumab Ozogamicin) in Usual Care

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the safety of Mylotarg therapy in routine practice.

Official Title
-----------------
Prospective Observational Study of Mylotarg (Gemtuzumab Ozogamicin) in Usual Care

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Mylotarg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated by Mylotarg Provide ICF

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mylotarg|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
-----------------
Leukemia