linjc16/ctgov huggingface dataset:
Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis

Study Overview
=================
Brief Summary
-----------------
Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful conditions. There have been a few attempts to use RF current for the treatment of painful conditions of joints of the extremities. It was also used for the treatment of painful conditions of the hip joint.

Official Title
-----------------
Efficacy of Genicular Nerve Radiofrequency Ablation Versus Intra-Articular Platelet Rich Plasma in Chronic Knee Osteoarthritis; a Randomized Clinical Trial

Conditions
-----------------
Osteo Arthritis Knee, Pain, Chronic

Intervention / Treatment
-----------------
* Procedure: radiofrequency
* Procedure: platelet rich plasma injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteoarthritis knee Exclusion Criteria: coaguloapthy patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Parallel Assignment
Interventional Model Description: patients with chronic knee osteoarthritis non res ponders to conventional medical treatment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: radiofrequency<br>genicular nerves pulsed radiofrequency | Procedure: radiofrequency<br>* radiofrequency of the genicular nerves<br>|
| Active Comparator: intra-articular platelet rich plasma<br>injection of platelet rich plasma in the affected joint | Procedure: platelet rich plasma injection<br>* intra articular injection of platelet rich plasma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain visual analog scale | assessment of visual analog scale (VAS) VAS of zero means no pain, and 10 means sever pain | 12 months |
plasmApuane CoV-2 : Efficacy and Safety of Immune Covid-19 Plasma in Covid-19 Pneumonia in Non ITU Patients

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to verify the efficacy and safety of convalescent hyperimmune plasma infusion in hospitalized covid-19 patients non in ITU with pneumonia and respiratory symptoms within seven days from the beginning of symptoms. Efficacy is evaluated by the number of patients who will improve their clinical condition and will not be admitted to ITU. .Safety is considered in relation to adverse reactions to plasma infusion.

Official Title
-----------------
Studio in Aperto Sulla Somministrazione di Plasma di Paziente Convalescente da COVID- 19 a Paziente Con Polmonite COVID-19 Ospedalizzato, Non in Terapia Intensiva

Conditions
-----------------
Covid-19 Pneumonia

Intervention / Treatment
-----------------
* Biological: immune plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years hospitalized patients with positive covid-19 swab with respiratory symptoms and CT confirmation of covid-19 chest disease admitted to non ITU recovery area. informed consent for plasma infusion informed consent to blood samples storing for future studies. Exclusion Criteria: pregnant or breastfeeding female patient or planning for a pregnancy in the period of the study immunoglobulin infusion in the last month contraindication to transfusion or previous adverse reaction

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: Prevention
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sequential immune plasma infused patients<br>immune covid 19 plasma infusion | Biological: immune plasma<br>* immune covid 19 plasma infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ITU admission | number of patients admitted to ITU after immune plasma transfusion | up to 30 days | 
| administration of O2 | O2 support will be monitored and reported in its various modes of administration (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, mechanical ventilation) | up to 30 days | 
| hospital mortality | number of subject deaths | up to 90 days | 
| immune plasma infusion adverse reaction | number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | in the first 24-48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
covid-19 pneumonia, convalescent plasma, hyperimmune plasma
A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).

Detailed Description
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)

Conditions
-----------------
Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Drug: GW685698X


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of perennial allergic rhinitis (PAR). Must comply with study procedures and be literate. Exclusion criteria: Significant concomitant medical conditions. Use of corticosteroids. Use of allergy medications and some other medications during the study. Current tobacco use. Clinically significant abnormal ECG or laboratory abnormality.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Arm 1<br> | Drug: GW685698X<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergic rhinitis, GW685698X, Perennial Allergic Rhinitis
Early Use of Raw Milk and Breastfeeding Continuation

Study Overview
=================
Brief Summary
-----------------
BACKGROUND: Despite the critical importance of breast milk for preterm and sick neonates, there is no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. OBJECTIVES: This study aimed to describe the use of raw MOM in hospitalised neonates before day 7 (early use), and to investigate: (i) related factors, (ii) maternal satisfaction, and (iii) the association with breastfeeding continuation. METHODS: This prospective cohort included 516 neonates intended to be breastfed in 2 French neonatal units. Neonates receiving raw MOM before day 7 were compared to those who did not. The association between early use of MOM and breastfeeding continuation at hospital discharge, and up to 6 months later, was measured by logistic regression.

Official Title
-----------------
Early Use of Mother's Own Raw Milk, Maternal Satisfaction, and Breastfeeding Continuation in Hospitalised Neonates: A Prospective Cohort Study

Conditions
-----------------
Breastfeeding Continuation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible neonates were those admitted between April 2012 and June 2013, who were intended to be breastfed and remained hospitalized for 7 days or more. Exclusion Criteria: Neonates with parents not fluent in French were excluded.

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Raw maternal own milk before day 7<br>Without any intervention, investigators observed whether neonates received raw MOM during the first week of life. Accordingly, the neonates were grouped as exposed when they received any raw MOM before day 7, versus unexposed when they did not receive any raw MOM before day 7. | |
| No Raw maternal own milk before day 7<br>Without any intervention, investigators observed whether neonates received raw MOM during the first week of life. Accordingly, the neonates were grouped as exposed when they received any raw MOM before day 7, versus unexposed when they did not receive any raw MOM before day 7. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in breastfeeding after hospital discharge | Breastfeeding was defined as the consumption of any mother's own milk (MOM), provided either directly at the breast or after having been expressed. Information on breastfeeding continuation was extracted from the electronic chart during the last 2 days preceding hospital discharge. It was classed as exclusive when all the fed milk was MOM, or partial when it was completed by other milk and/or food. | On Day 60 and Day 180 after hospital discharge |
MR-Guided Cryoablation of Prostate Bed Recurrences

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences.

Official Title
-----------------
Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences

Conditions
-----------------
Prostate Tumors

Intervention / Treatment
-----------------
* Procedure: MR-guided cryoablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with biopsy proven soft tissue tumor recurrences of prostate fossa Surgery is not a desirable alternative therapy at the time of enrollment Radiation therapy has failed or not indicated or can be safely postponed Tumor size is < 5 cm at its largest diameter Tumor does not encompass the rectal wall or external urethral sphincter Patient is able to undergo MRI Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MR-guided cryoablation (freezing of tissue and/or tumors)<br> | Procedure: MR-guided cryoablation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of target lesion at 3-6, 12, 24, and 36 month imaging follow-up |  | 3 years |
A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction

Study Overview
=================
Brief Summary
-----------------
To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.

Detailed Description
-----------------
OBJECTIVE The objective of the study is to actively gather additional information on the use of CorMatrix ECM for vascular repair in the reconstruction of the femoral artery. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.

Official Title
-----------------
A Post Market Observational Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Device: CorMatrix ECM for Vascular Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be undergoing femoral arterial reconstruction with patch angioplasty closure Surgeon intends to use CorMatrix ECM per FDA cleared Indications for Use Subject possesses ability to provide informed consent Subject expresses understanding and willingness to fulfill all expected requirements of protocol Exclusion Criteria: 1. Known sensitivity to porcine material
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Arm<br>Subjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair. | Device: CorMatrix ECM for Vascular Repair<br>* Standard femoral arterial interventional procedure using CorMatrix ECM for vascular repair.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-Related Adverse Events | Proportion of patients experiencing device related adverse events. | Up to 12 months follow-up |
Risk Factors for Pulmonary Hypertension of the Newborn

Study Overview
=================
Brief Summary
-----------------
To conduct a multicenter case-control study of persistent pulmonary hypertension of the newborn (PPHN) in relation to maternal exposure to smoking and non-steroidal anti-inflammatory drugs (NSAIDs). Also, to assess other potential antenatal risk factors and collect and store buccal cell specimens for future analyses.

Detailed Description
-----------------
BACKGROUND: Persistent pulmonary hypertension of the newborn (PPHN), previously called persistent fetal circulation, is a birth defect affecting approximately 1 in 1250 liveborn term infants; even with complex and high-risk interventions, PPHN results in substantial mortality and morbidity. This defect results from the inappropriate muscularization of fetal pulmonary vessels, and experimental and human evidence consistently suggests that maternal cigarette smoking and antenatal exposure to NSAIDs, particularly aspirin or ibuprofen, may play a role in the etiology of this condition. Because these exposures are quite prevalent (e.g., ibuprofen is currently taken in the first trimester or later in pregnancy by 15 percent and 3.2 percent of women, respectively), testing these hypotheses is of considerable public health importance. DESIGN NARRATIVE: The multicenter study had a case-control design. There were 560 case infants with PPHN and four controls per case (2240). All controls were drawn from the birth hospitals of cases; half the controls had malformations other than PPHN, and half had normal formations. Cases and controls were identified within five months of birth at 88 birth and tertiary hospitals in the areas surrounding Boston, Philadelphia, and Toronto. Mothers of subjects were interviewed by telephone within six months of delivery; a standardized questionnaire inquired in detail about demographic factors; reproductive, medical, and pregnancy illness histories; medication use (including a detailed focus on use of over-the-counter analgesic/antipyretic medications), smoking, and nutrition. Because of emerging genetic research suggesting an effect of NSAIDs on pathways possibly related to the etiology of PPHN, buccal swabs were also collected and stored for future analyses. Exposure prevalences were compared between mothers of cases and controls and relative risks were estimated, controlling for potential confounding factors. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Persistent Fetal Circulation Syndrome, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Endoleak Repair Guided by Navigation Technology

Study Overview
=================
Brief Summary
-----------------
The study is aimed at investigating whether repair of endoleak type II can be improved by adding navigation technology. Can this technology increase precision by guiding the needle that punctures through the skin as used during the repair procedure? Can the procedure logistics be improved by using navigation technology instead of computed tomography (CT) guidance of the needle puncture? Parameters logged during the procedure: was the needle placement successful? number of needle punctures? time used on guidance procedure X-ray exposure dose

Official Title
-----------------
Endoleak Repair Guided by Navigation Technology

Conditions
-----------------
Aortic Aneurysm, Endoleak

Intervention / Treatment
-----------------
* Procedure: endoleak repair procedure (navigation technology )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: detected endoleak Exclusion Criteria: n/a

Ages Eligible for Study
-----------------
Minimum Age: 20 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: navigation technology<br>custom made navigation technology integrated in a Siemens angiography suite for feasibility evaluation in endoleak repair procedure | Procedure: endoleak repair procedure (navigation technology )<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detected leakage | number of patients with persistent leakage | within 1 hour after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Image guided therapy, Endovascular procedures, Angiography, Vascular surgical procedures
Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this week long study is to describe sleep and problems with sleep in women diagnosed with Fibromyalgia syndrome.

Detailed Description
-----------------
At least 50 women over 18 years of age are invited to volunteer in this study. Sleep quality and problems with sleep will be described using several kinds of measures. Questionnaires on sleep and Fibromyalgia will be completed by the volunteer. In addition, the volunteer will complete a sleep diary for at least 7 days and wear an Actiwatch (a wrist watch like device that measures sleep). At completion of the study, participants will be provided a print out of their sleep obtained from the Actiwatch. Participants may not be in the study if they work night shift (11 pm - 7 am) or have been diagnosed with a condition called sleep apnea. Participants need not live in Kentucky to participate in this study.

Official Title
-----------------
Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome

Conditions
-----------------
Fibromyalgia Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18 years old; diagnosed with Fibromyalgia; Exclusion Criteria: Volunteer works night shift (11PM - 7AM); Volunteer has been diagnosed with sleep apnea.

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?
-----------------
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
-----------------
Fibromyalgia Syndrome