linjc16/ctgov huggingface dataset:
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.

Conditions
-----------------
Breast Reconstruction

Intervention / Treatment
-----------------
* Device: Biodegradable (purified) surgical silk scaffold


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be willing to undergo immediate breast reconstruction following a skin-sparing or nipple sparing mastectomy with healthy, sufficiently thick, well-vascularized skin flaps, and the implantation of SERI® Surgical Scaffold and breast implant Be female, between 18 and 65 years of age at the time of enrollment Exclusion Criteria: Have undergone prior radiation treatment on the study breast(s) and/or is preoperatively evaluated to require radiation treatment to the study breast(s) during the course of the study Have undergone a skin reducing mastectomy Have a BMI that is <17 or ≥ 30 Predicted implant weight more than 500 grams Have a known allergy to silk Have an abscess or active infection at any location within one month prior to surgery Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study

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

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

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: SERI® Surgical Scaffold<br> | Device: Biodegradable (purified) surgical silk scaffold<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of implant loss (SERI® and breast implant) |  | 52 weeks |
Change of Neutrophil Gelatinase-Associated Lipocalin(NGAL) Following Sodium Phosphate Bowel Preparation(Pilot Study)

Study Overview
=================
Brief Summary
-----------------
Oral phosphate purgative is the preferred bowel regimen on the basis of better tolerability, cost effectiveness, and efficacy. There are also numerous reports of patients with even previously normal renal function developing acute and chronic kidney disease after use of oral phosphate purgative. Several uncontrolled case reports and case series suggest a potential link between oral phosphate and acute kidney injury and/or chronic kidney disease1. Its use is contraindicated in patients with preexisting renal disease because of the risk for developing acute renal failure, so called acute phosphate nephropathy, or electrolyte disturbance. Since most of the outpatients who are going to undergo a colonoscopy are exposed to this agent, it is important to detect or prevent vulnerable patients. We would seek a sensitive and rapid diagnosis method of acute kidney injury following sodium phosphate bowel preparation. Within a few hours, NGAL mRNA is highly upregulated after kidney injury, such as renal ischemia-reperfusion and cisplatin nephropathy, NGAL induction precedes the elevation of classical markers for kidney damage such as serum creatinine. The investigators will investigate the change of NGAL following sodium phosphate bowel preparation.

Official Title
-----------------
Change of Neutrophil Gelatinase-Associated Lipocalin(NGAL) Following Sodium Phosphate Bowel Preparation(Pilot Study)

Conditions
-----------------
Acute Kidney Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Who takes ACE-inhibitor, ARB Has a renal or heart disease Has a serum electrolyte disturbance

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

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

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 |
| --- | --- | --- |
| NGAL |  | Baseline, colonoscopy day, post 1day, post 2 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute kidney failure, Colonoscopy, Neutrophil gelatinase-associated lipocalin
Effects of Single-task Versus Dual-task Training on balancePERFORMANCE

Study Overview
=================
Brief Summary
-----------------
Background: Impairment in the control of balance is a common problem among elderly patients especially whom with osteoarthritis (OA). Aim: The aim of this study was to compare the effects of single-task and dual-task training on balance performance in the elderly osteoarthritic patients with balance impairment.

Detailed Description
-----------------
Fifty elderly osteoarthritic patients with balance impairment were included into this study. Patients were randomly assigned to single task balance training (Group 1) or dual-task balance training (Group 2) groups. Balance activities were given to both groups for 3 times a week for 4 weeks. Patients in group 2 also performed cognitive tasks simultaneously with these exercises. Patients were evaluated with Berg balance scale (BBS), kinesthetic ability trainer (KAT 2000) static and dynamic scores, timed up and go test (TUTG) and walking speed for single and dual tasks, number of stopping and Activities Specific Balance Confidence (ABC) Scale at the baseline and at the end of 4 weeks.

Official Title
-----------------
Effects of Single-task Versus Dual-task Training on Balance Performance in Elderly Osteoarthritic Patients With Balance Impairment

Conditions
-----------------
Balance Impairment

Intervention / Treatment
-----------------
* Other: single task balance training
* Other: dual task balance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: included age ≥65, able to walk 10 m, no neurological or musculoskeletal diagnosis, met the criteria of balance impairment, and scored >19 on the mini mental state examination. Exclusion Criteria: neurologic or musculoskeletal diagnosis such as stroke, orthopedic involvement, significant visual and auditory impairments, severe vitamin B12 deficiency and sedative drug use.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Comparator: single task balance training<br> | Other: single task balance training<br>* single task balance training<br>Other: dual task balance training<br>* dual task balance training<br>|
| Active Comparator: dual task balance training<br> | Other: single task balance training<br>* single task balance training<br>Other: dual task balance training<br>* dual task balance training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg balance scale |  | 1 month |
Understanding Ketamine's Dissociative Effects (KD Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand how ketamine brings about dissociative symptoms.

Detailed Description
-----------------
The goal of this proposed research is to record the effects of ketamine on brain activity to understand the changes that occur during dissociation in epilepsy patients with stereoEEG.

Official Title
-----------------
Understanding Ketamine's Dissociative Effects in Epilepsy (KD Study)

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient in Stanford Epilepsy Monitoring Unit Age >18 years old. Exclusion Criteria: Lifetime psychotic or bipolar disorder Inability to speak, read or understand English Pregnant or nursing females Prior adverse ketamine response

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ketamine<br>Study participants will receive 0.5mg/kg of ketamine - one single infusion | Drug: Ketamine<br>* Study participants will receive 0.5mg/kg of ketamine - one single infusion<br>* Other names: Ketalar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale) | The CADSS is an instrument for the measurement of dissociative symptoms. The CADSS comprises 23 subjective items and participant's responses are coded on a 5-point scale (0 = Not at all; 4 = Extreme). The higher the number on the CADSS, the more severe the symptoms. | up to 1 week |
Botulinum Toxin Injection in the Treatment of Open Abdomen

Study Overview
=================
Brief Summary
-----------------
Botulinum toxin has been widely approved and utilized in the treatment of complex abdominal wall hernias. Botulinum toxin has been only randomly studied in the treatment of open abdomen.

Detailed Description
-----------------
30 consecutive patients who have open abdomen for any indication, will have 300 IU botulinum toxin injected in three spots in either sides of the abdomen within 72 hours of the start of open abdomen. The hypothesis is botulinum toxin relaxes abdominal wall musculature to ensure better and faster closure of the open abdomen.

Official Title
-----------------
Botulinum Toxin Injection in the Treatment of Open Abdomen

Conditions
-----------------
Open Abdomen, Botulinum Toxin Injection

Intervention / Treatment
-----------------
* Drug: Botulinum Toxins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open abdomen Exclusion Criteria: Previous incisional hernia in midline Patient is not in active treatment

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 |
| --- | --- |
| Botox injection<br>30 consecutive patients will have 300 IU of botulinum toxin injected to six spots in abdominal wall to gain abdominal wall musculature relaxation. | Drug: Botulinum Toxins<br>* Botulinum toxin injection to abdominal wall<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal wall closure | Duration of open abdomen treatment | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive care time | Treatment time in the intensive care unit | 30 days | 
| Hospitalization | Time spent in the hospital | 30 days | 
| Hernia | Incisional hernia incidence | 2 years | 
| Re-laparotomies | Number of abdominal explorations | 30 days | 
| Enterocutaneus fistula | Enterocutaneus fistula incidence | 30 days | 
| Abdominal wall closure success rate | the rate of complite abdominal wall closure | 30 days |
Desensitization Protocol for Deceased Donor List

Study Overview
=================
Brief Summary
-----------------
Purpose of the study: The specific aims of this study are to evaluate overall efficacy and safety of the pre-transplant IVIG treatment in our transplant center since 2007 and to identify factors affecting treatment outcomes in order to improve patient selection and treatment protocols for future patients.

Detailed Description
-----------------
Background: Intravenous immunoglobulin (IVIG) infusion is one of several novel approaches to decrease antibody levels for highly sensitized kidney transplant candidates [1, 2]. This approach can potentially give a chance of kidney transplantation to end-stage renal failure patients who could never receive transplantation because of high levels of antibodies and persistent positive crossmatches to all potential kidney donors. Many transplant centers have used this strategy in order to increase transplant rates of highly sensitized patients with various levels of anti-HLA antibodies. However, the responses to the treatment seem to be different in each patient and factors affecting treatment outcome have yet to be determined.

Official Title
-----------------
Desensitization Protocol for Deceased Donor List

Conditions
-----------------
Transplant; Failure, Kidney

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent (< 3 months) high levels of anti-HLA antibodies (at least one cPRA ≥ 40%). Waiting time greater than 1 year for blood type AB, 2 years for blood types A, B, or O. Exclusion Criteria: Female subject is pregnant or lactating. Subject has an uncontrolled concomitant infection or any other unstable medical condition (e.g., uncontrolled cardiovascular disease) that could interfere with the study objectives. Subject has an uncontrolled active hepatitis B, hepatitis C, or HIV infection. Subject has a current malignancy or a recent history of any malignancy that is deemed to be contraindicated to kidney transplantation. Subject has a psychiatric illness that, in the judgment of caring physicians, may interfere with study participation.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Anti HLA antibody level |  | after IVIG infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients transplanted |  | at the end of study |
Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion.

Detailed Description
-----------------
With the widespread use of routine sonography during pregnancy, the incidence of fetal ovarian cysts detected in utero has increased in the past decades. However

Official Title
-----------------
Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion

Conditions
-----------------
Ovarian Cyst, Ultrasonography Prenatal

Intervention / Treatment
-----------------
* Procedure: Fetal ovarian cyst aspiration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women having an uneventful single pregnancy and a female fetus diagnosed with anechoic ovarian cyst (diameter at least 30mm) Exclusion Criteria: Multiple pregnancy Complicated pregnancy (PE, diabetes, PROM, fetal malformation) Echoic cyst (fluid debris level, septated, retracting clot, globally echoic) Unability to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fetal ovarian cyst aspiration performed as soon as possible | Procedure: Fetal ovarian cyst aspiration<br>* Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia<br>|
| No Intervention: 2<br>Expectative | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To avoid neonatal surgery |  | 3 months after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound pattern of neonatal ovarian cyst |  | 3 months after birth | 
| Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration |  | 3 months after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspiration, Fetal ovarian cyst, Ovarian torsion
Celecoxib Japan Observational Study for the Patients With Acute Pain

Study Overview
=================
Brief Summary
-----------------
This study is to assess the safety and efficacy of celecoxib on the pain relief from acute pain.

Detailed Description
-----------------
Patients with traumatic pain, post-surgical and tooth extract pain will be included in this study. Patients will receive Celecoxib for 2 weeks and the efficacy on pain relief and the safety will be evaluated.

Official Title
-----------------
Celecoxib Japan Observational Study for the Patients With Acute Pain

Conditions
-----------------
Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract Pain

Intervention / Treatment
-----------------
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with traumatic pain, post-surgical pain and tooth extract pain Exclusion Criteria: Hyperreactive to sulfonamide Aspirin asthma patients Peptidic ulcer patients Serious liver disease patients Serious kidney disease patients Serious heart failure patients End of pregnancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Celecox group<br> | Drug: Celecoxib<br>* oral<br>* Other names: Celecox;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the incidence of adverse events and lab-tests |  | For 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall pain improvement assessed by visual analogue scale (VAS) |  | Baseline and week-2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSAIDs, Acute pain
Absolute Bioavailability of Lu AE58054 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady state

Official Title
-----------------
Interventional, Open-label Study Investigating the Absolute Bioavailability of Lu AE58054 After Multiple Oral Dosing and a Single Radio-labelled Intravenous Micro-dose as Well as the Contribution of Cytochrome P450 2D6 to the Exposure of Lu AE58054 in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Lu AE58054


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women). The subjects CYP2D6 genotype must be determined before inclusion into the study. Women must not be pregnant or lactating. Exclusion Criteria: The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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: Lu AE58054<br> | Drug: Lu AE58054<br>* Oral dosing: 90 mg Lu AE58054 as a single dose once and after a 3 days washout period, once daily for 7 days. Intravenous dosing: 90 μg/not more than (NMT) 1000 nCi/37 kBq 14C-Lu AE58054 for intravenous infusion once on Day 10.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV | Intravenous (IV) | Day 10 | 
| Ratio of (AUC0-24(PM)/AUC0-24(EM)) | Poor Metaboliser (PM); Extensive Metaboliser (EM) | Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and frequency of adverse events | Standard clinical safety assessments | Up to Day 16 | 
| Number of subjects with adverse events | Adverse event monitoring | Up to Day 16 | 
| Risk of Suicidality | Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions | Up to Day 16 |