linjc16/ctgov huggingface dataset:
AeriSeal System for Lung Volume Reduction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.

Detailed Description
-----------------
The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced homogeneous and heterogeneous emphysema.

Official Title
-----------------
A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema

Conditions
-----------------
Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Emphysema, Lung Diseases

Intervention / Treatment
-----------------
* Device: AeriSeal System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC<70% predicted, FEV1 of <50% predicted, TLC > 100% predicted, and RV > 135% predicted. Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS. Patients must be > 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- |
|Device: AeriSeal System|AeriSeal System for Lung Volume Reduction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio |  | 12 Weeks following final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in RV/TLC ratio |  | 24 and 48 weeks following treatment | 
| Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator) |  | 12, 24, 48 weeks following treatment | 
| Change from baseline in MRC dyspnea score |  | 12, 24, 48 weeks following treatment | 
| Change from baseline in 6 minute walk test (MWT) |  | 12, 24, 48 weeks following treatment | 
| Change from baseline in disease-specific health related quality of life assessment (SGRQ) |  | 12, 24, 48 weeks following treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polymeric Lung Volume Reduction (PLVR), Biologic Lung Volume Reduction (BLVR), AeriSeal, treatment, device, breathing, COPD, emphysema, heterogeneous, homogeneous, Pathologic Processes, Respiratory Tract Diseases, Lung Diseases, Pulmonary Disease, Chronic Obstructive
Acute Kidney Injury in Patients Hospitalized With COVID-19

Study Overview
=================
Brief Summary
-----------------
The kidney may be affected in coronavirus-2019 disease (COVID-19). This study assessed the predictors and outcomes of acute kidney injury (AKI) among individuals with COVID-19.

Official Title
-----------------
Acute Kidney Injury in Patients Hospitalized With COVID-19 in Wuhan, China: a Single-center Retrospective Observational Study

Conditions
-----------------
COVID-19, Acute Kidney Injury, Kidney Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 pneumonia patients diagnosed by WHO criteria Exclusion Criteria: Patients who were younger than 18 years, Patients who had undergone renal replacement therapy (RRT) before admission, Patients whose entire stay lasted for less than 48 hours.

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 |
| --- | --- |
| AKI<br>COVID-19 patients with acute kidney injury | |
| non-AKI<br>COVID-19 patients without acute kidney injury | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Acute Kidney Injury | the incidence of Acute Kidney Injury | From date of admission until the date of discharge or death from any cause, up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Death | death from any cause in the hospital | From date of admission until the date of death from any cause, up to 60 days | 
| the length of hospital stay | days from admission to discharge or death | From date of admission until the date of discharge or death from any cause, up to 60 days |
New, Previously Unknown, Uses of Optical Coherence Tomography Angiography (OCTA)

Study Overview
=================
Brief Summary
-----------------
Sickle cell maculopathy was sparingly mentioned in the literature before despite the fact that sickle cell disease or sickle cell trait is common in people of many areas of the world. This study shows that OCTA is a very valuable, non invasive, office procedure that may well be used in diagnosing this disease.

Detailed Description
-----------------
this is a clinical study of two African Canadian patients that were diagnosed with sickle cell trait. I used OCTA to show macular vascular occlusions that usually happen with this disease.

Official Title
-----------------
New, Previously Unknown, Uses of Optical Coherence Tomography Angiography (OCTA): Sickle Cell Maculopathy

Conditions
-----------------
Sickle Cell Retinopathy

Intervention / Treatment
-----------------
* Device: Optical Coherence Tomography Angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: people with sickle cell trait or sickle cell disease - Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| African Canadians<br>African Canadians with sickle cell disease maculopathy diagnosed by OCTA. | Device: Optical Coherence Tomography Angiography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular changes seen in the macular vasculature of people with sickle cell disease/ trait as compared to macular vasculature of normal macula. | in this angiography the delicate vasculature of the macula can be clearly visualized and documented. | through study completion, an average of one year |
Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

Study Overview
=================
Brief Summary
-----------------
Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. It has ani-fibrotic properties. Previous studies have shown that relaxin is safe at concentrations upto 60 times higher than achieved in pregnancy. Study is designed to see if skin improvement and improvement in functional ability can be achieved.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse Scleroderma

Conditions
-----------------
Systemic Sclerosis

Intervention / Treatment
-----------------
* Drug: Relaxin
* Drug: Relaxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 to 70 years of age with diffuse SSc Disease duration 5 years since the onset of the first non-Raynaud sign or symptom A baseline modified Rodnan skin score (MRSS) of 20 or greater, or at least 16 if truncal involvement was present. Recombinant human relaxin (10 or 25 ug/kg/day), or placebo was administered for 24 weeks as a continuous subcutaneous infusion and there was a follow-up safety visit at week 28.

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Placebo | Drug: Relaxin<br>* Placebo<br>|
| Experimental: A<br>10ug/kg/day or 25/ug/kg/day | Drug: Relaxin<br>* 10 ug/kg/day or 25 ug/kg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRSS |  | baseline, weeks 4,12, and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAQ-DI |  | baseline, weeks 4, 12, and 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diffuse Scleroderma, Skin score
Effect of Sevelamer on P-cresol Levels in CKD

Study Overview
=================
Brief Summary
-----------------
The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly demanded. It has been reported that the phosphate binder sevelamer sequesters p-cresol in vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our study was to evaluate the effect of sevelamer on p-cresol levels in CKD patients.

Conditions
-----------------
Chronic Kidney Disease Stage 3-5

Intervention / Treatment
-----------------
* Drug: Sevelamer
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years, CKD stage 3-5 Exclusion Criteria: Existing or previous treatment within the last 1 year with a phosphate binder; hyperphosphatemia (>5.6 mg/dL); hypophosphatemia (<2.5 mg/dL); malnutrition, malignant neoplasms, current history of gastrointestinal and/or endocrine diseases.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevelamer<br>The dose of Sev was 2400 mg (800 mg three times a day) in all patients. | Drug: Sevelamer<br>* The dose of Sev was 2400 mg (800 mg three times a day) in all patients.<br>|
| Placebo Comparator: Placebo<br>The patients received placebo three times a day | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on p-creol levels | The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy. | 3 months |
Subconjunctival Bupivacaine in Strabismus Surgery

Study Overview
=================
Brief Summary
-----------------
This study aimed to assess the effectiveness of the Subconjunctival bupivacaine on postoperative pain in Strabismus surgery under general anaesthesia.

Detailed Description
-----------------
40 patients will schedule for elective Strabismus surgery under general anaesthesia and randomly allocated into two groups to receive Subconjunctival 0.5%Bupivacaine group(B) or Subconjunctival placebo 0.9% normal saline group at the end of the surgery and assess the postoperative pain at 0th,30th, 60th,2nd h, 4h,6h,12h,24h.and post operative nausea and vomiting.

Official Title
-----------------
The Effect of Subconjunctival Bupivacaine Injection in Squint Surgery for Postoperative Analgesia

Conditions
-----------------
Anesthesia, Local

Intervention / Treatment
-----------------
* Drug: Iocal anaesthetic bupivacaine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients aged 14 _30 years old with body mass index 18_28kg/m. American Anaesthesiologist Association physical states I,II. singed informed consent to participate in the study and were scheduled for strabismus operations under general anaesthesia. Exclusion Criteria: were patients with chronic pain. ocular hypertension. inability to communicate. history of hematological disease. allergy to local anesthetic drugs.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 20 patients receive Subconjunctival bupivacaine of the end of the surgery<br>20 patients receive Subconjunctival bupivacaine in the end of operation and monitoring postoperative pain score | Drug: Iocal anaesthetic bupivacaine<br>* Local anaesthetic Subconjunctival bupivacaine<br>* Other names: Group (p);|
| Placebo Comparator: 20 patients receive Subconjunctival placebo in the end of operation<br>20 patients receive Subconjunctival placebo in the end of operation and monitoring postoperative pain score | Drug: Placebo<br>* 0.9 saline<br>* Other names: Group (s);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) pain score | Range, 0_10;0,no pain ;10,worst pain | 5 minutes after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and vomiting | Operation related side effect | 24 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subconjunctival bupivacaine., Strabismus surgery., Postoperative analgesia.
Prolapse and Pregnancy Assessment

Study Overview
=================
Brief Summary
-----------------
Pelvic organ prolapse (POP) is one of the most common indications for gynaecological surgery. In 1997, more than 225000 inpatient surgical procedures for POP were undertaken in USA (22.7 per 10000 women) at an estimated cost of more than one billion dollars. In the UK, the disorder accounts for 20% of the women on the waiting list for major gynaecological surgery. Vaginal birth, advancing age and increasing body mass are the most consistent risk factors. Furthermore a racial and congenital predisposition has been reported. The cause of this disorder is likely to be multifactorial and attributable to a combination of factors, varying from patient to patient. Controversy exists as to whether the pregnancy per se rather than the mode of delivery alters the risk of POP. Caesarean section appears to protect against the development of prolapse. However, when a caesarean section is undertaken during the active stage of labour it may not be completely protective. Ideally prospective longitudinal studies are needed to study the impact of pregnancy and childbirth on pelvic organ prolapse. Unfortunately, studies to date, are small with poor follow-up and have only assessed objective outcome rendering it difficult to draw conclusions. The primary objective of our study was to objectively assess the impact of pregnancy and childbirth on pelvic organ support using the Pelvic Organ Prolapse Quantification (POPQ)System.

Official Title
-----------------
Effect of Pregnancy and Childbirth on the Pelvic Floor

Conditions
-----------------
Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton Pregnancy Exclusion Criteria: Multiple pregnancies Previous prolapse surgery Medical disorders including diabetes mellitus Inflammatory bowel disease Collagen disorders

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Pregnant Women with singleton pregnancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective assessment of Prolapse using Pelvic organ prolapse Quantification System | Prospective evaluation of the impact of mode of delivery on pelvic organ support using the International Continence Society recommended Pelvic Organ Prolapse Quantification system (POPQ). | 2nd trimester, 3rd trimester, 14 weeks, 12 months and 5 years after childbirth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prolapse, Childbirth, Pregnancy
Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.

Official Title
-----------------
Open, Randomized, Parallel Multi-center Comparison of Cycle Control and Safety of the Oral Contraceptive Yasmin 20 in a 24-day Regimen vs. Mercilon for 7 Cycles in 440 Healthy Female Volunteers

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Yasmin 20
* Drug: Mercilon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female volunteer aged 18-35, Smokers 18-30 Exclusion Criteria: Contraindications for using hormonal contraceptives

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Yasmin 20<br>* Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)<br>|
| Active Comparator: Arm 2<br> | Drug: Mercilon<br>* Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycle control and bleeding pattern |  | 7 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pearl index |  | 7 cycles | 
| Laboratory tests |  | Screening | 
| Adverse Events |  | 7 cycles | 
| General Physical and gynecological examinations |  | Screening | 
| Vital signs |  | Screening, admission | 
| Body weight |  | Screening, admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contraception,, Cycle control,, Bleeding pattern
TAP Block Alone Versus TAPblock With Rectus Sheath Block in Liposuction Surgery

Study Overview
=================
Brief Summary
-----------------
The transversus abdominis plane (TAP) block is an effective regional nerve block for the anterior abdominal wall. An anesthesiologist typically administers the TAP block preoperatively with ultrasound guidance. It is not yet commonly used during anterior abdominal wall liposuction, where postprocedural pain remains a major concern for patients and surgeons.

Detailed Description
-----------------
The author investigated the feasibility of administering the TAP block under direct vision and compared postoperative narcotic use in patients who received analgesia by TAP block vs with TAP block i addition to rectus sheath block, both performed under direct vision during anterior abdominal wall liposuction.

Official Title
-----------------
Transversus Abdominis Plane Block Alone Versus Transversus Abdominis Plane Block With Rectus Sheath Block as a Postoperative Analgesia in Anterior Abdominal Wall Liposuction Surgery

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: Transversus abdominis plane block
* Procedure: rectus sheath block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II, consent, Exclusion Criteria: allergy, coagulopathy, refusal, mentally unstable

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP<br>Transversus abdominis plane block | Procedure: Transversus abdominis plane block<br>* ultra sound guides Transversus abdominis plane block<br>|
| Experimental: TAP and rectus sheath block<br>Transversus abdominis plane block with rectus sheath block | Procedure: Transversus abdominis plane block<br>* ultra sound guides Transversus abdominis plane block<br>Procedure: rectus sheath block<br>* ultrasound guided rectus sheath block<br>|
| No Intervention: control<br>no truncal blocks, conventional analgesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | visual analogue scale for pain assessment | Three days |