linjc16/ctgov huggingface dataset:
Robotic Urogynecological Surgery: Hospital Stay and Perioperative Complications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery.

Official Title
-----------------
Recovery After Robotic Urogynecological Surgery: Hospital Stay and Perioperative Complications of Patients Who Did Not Complete Questionnaires

Conditions
-----------------
Urogynecology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The first 21 women who underwent DaVinci-assisted robotic sacrocolpopexy and who did not complete postoperative QA questionnaires from 09/01/2007 through 09/01/2008. Exclusion Criteria: Any women not meeting inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| To assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery. |  | 09/01/07 - 09/01/08 |
Written Self-disclosure for Youth Abdominal Pain

Study Overview
=================
Brief Summary
-----------------
The aims are to evaluate: (1) the effectiveness of written self-disclosure (WSD) on health status of youth ages 12-18 with functional recurrent abdominal pain (RAP); (2) whether effectiveness of WSD is similar for younger (12-14) and older (15-18) youth with functional RAP; and (3) the feasibility and acceptability of WSD when extended to the pediatric health care setting.We will implement a randomized, controlled trial (RCT) designed to compare health status in 140 youths (ages 12-18) with functional RAP assigned either to standard medical care (SMC) or WSD provided in the health care setting in addition to SMC. Health status will be measured at Baseline and 3- and 6-months thereafter. Primary measures of health status are symptom severity and episode frequency, consistent with the definition of RAP. Secondary measures of health are functional health, psychological distress, health-related quality of life, and health care utilization. Total use and diagnostic tests will index health care utilization, collected for the 6-mos prior to and following Baseline. Mixed model ANOVA or MANOVA will be used to test directional hypotheses corresponding to the specific aims.

Official Title
-----------------
RCT of Written Self-disclosure for Youth Abdominal Pain

Conditions
-----------------
Abdominal Pain

Intervention / Treatment
-----------------
* Behavioral: Written self-disclosure


Participation Criteria
=================
Eligibility Criteria
-----------------
Ages 12-18. Diagnosis of RAP by the examining pediatric gastroenterologist using Apley's (1975) criteria: (a) 3 episodes of abdominal pain, (b) severe enough to interrupt activities and occurring, (c) over a period of at least 3 months, (d) without an identifiable organic cause (If an organic cause is identified during participation in protocol, then participant is withdrawn from database prior to analysis). Free of a known chronic health condition. Physical and mental ability to complete the procedures, as judged by Dr. Madan-Swain. Consents to complete the protocol over the next 6 months. Parent(s) consents to participate and agrees to support the youth in completing the protocol. Access to a phone on the days writing sessions are to be completed at home.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Written self-disclosure|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
-----------------
Abdominal
Feasibility Study of the Vedera KXS for Treatment of Keratoconus

Study Overview
=================
Brief Summary
-----------------
The objective of this investigation is to evaluate the feasibility, safety and efficacy of the Vedera KXS for the reduction or elimination of myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or glasses.

Official Title
-----------------
Feasibility Study of the Vedera KXS for Treatment of Keratoconus

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Device: Vedera KXS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14 years of age or older Presence of central or inferior steepening on the Pentacam map Axial topography consistent with keratoconus I-S ratio > 1.5 on the Pentacam map or topography map BSCVA worse than 20/20 (<53 letters on ETDRS chart) Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction Signed written informed consent Willingness and ability to comply with schedule for follow-up visits Exclusion Criteria: Eyes classified as either normal or atypical normal on the keratoconus severity grading scheme. A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated. Corneal pachymetry <400 microns at diameter to be treated. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring in the treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the treatment. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated. Diagnosed with autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications likely to affect wound healing. Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 100 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: Vedera KXS<br> | Device: Vedera KXS<br>* One treatment session with Vedera KXS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reduction in Kmax (by keratometry) of >1 D |  | 3 months |
Light Filters in Intraocular Lenses (IOLs) and Its Influence on Colour and Contrast Vision.

Study Overview
=================
Brief Summary
-----------------
Visible-light-filtering IOLs are implanted increasingly often in cataract surgery. Several studies examined the effect of light-filters on contrast and colour vision. However, the study outcomes were varying. The present study investigated the effect of two light-filtering IOL on colour perception and contrast acuity using highly sensitive measurement methods.

Detailed Description
-----------------
Prospective, randomized, double-masked study with intraindividual comparison. Implantation of a Polylens Y30 IOL in one eye and an Orange Series Model PC 440 Y in the contralateral eye.

Official Title
-----------------
Influence of Light-filters in IOLs on Color Perception and Contrast Acuity. A Randomized, Double-masked Study With Intraindividual Comparison.

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

Intervention / Treatment
-----------------
* Procedure: Polylens Y30 intraocular lens
* Procedure: Orange Series Model PC 440 Y intraocular lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bilateral age-related cataract age 55 to 80 years expected postoperative visual acuity of at least 1.0 Exclusion Criteria: amblyopia corneal scars diabetes arterial hypertonia pseudoexfoliation-syndrome earlier ocular surgeries or laser treatments intraocular tumors color abnormalities expected postoperative visual acuity lower 1.0

Ages Eligible for Study
-----------------
Minimum Age: 55 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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Polylens Y30 intraocular lens|cataract surgery|
|Procedure: Orange Series Model PC 440 Y intraocular lens|cataract surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contrast acuity |  | 3 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity and color vision |  | 3 month after surgery | 
| colour perception |  | 3 month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraocular lens, light filtering intraocular lens, contrast acuity, color vision
Changes in Cerebral Oxygenation During Laparoscopy in Patients With Single Ventricle Anatomy

Study Overview
=================
Brief Summary
-----------------
Patients with single ventricle physiology (hypoplastic left heart syndrome, tricuspid atresia) frequently have feeding difficulties necessitating procedures such as Nissen fundoplication and G-tube placement. With advances in minimally invasive surgery, these are frequently performed using laparoscopic techniques. Although generally safe and effective, the increase in IAP during laparoscopy may increase systemic and pulmonary vascular resistance and decrease cardiac output. This prospective study will include 50 patients with single ventricle physiology presenting for laparoscopic procedures. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS).

Conditions
-----------------
Congenital Heart Disease, Single Ventricle

Intervention / Treatment
-----------------
* Device: NIRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with single ventricle physiology presenting for laparoscopic procedures. Exclusion Criteria: None
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 ventricle<br>Patients with single ventricle physiology presenting for laparoscopic procedures. | Device: NIRS<br>* Cerebral oxygenation monitor which is standard of care for this surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cerebral oxygenation values | Measured on the NIRS cerebral oxygenation monitor attached to the patient. | From baseline to insufflation (average time frame of 30 mins. - 2 hrs.) |
Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

Study Overview
=================
Brief Summary
-----------------
Ovarian cryopreservation is one of the available option for preserving fertility prior to potentially sterilizing treatments. In the absence of other techniques such as in vitro folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used by autograft. In France, the first live birth after orthotopic ovarian transplantation, was obtained by Roux et al. in 2009. This clinical trial aims to collect data on the efficiency of the graft in terms of restoration of ovarian function and live births. It will also allow us to carry out the patient follow-up after ovarian tissue cryopreservation and after autograft when achieved. In cases of neoplastic malignancies, minimal residual disease detection will be performed on ovarian tissue, to avoid any risk of cancer re-seeding.

Official Title
-----------------
Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

Conditions
-----------------
Ovarian Function Insufficiency

Intervention / Treatment
-----------------
* Procedure: Autograft of cryopreserved ovarian tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent Ovarian tissue cryopreservation Premature ovarian failure Patients cured of their primary disease Women between 18 and 43 years of age Patients who have already benefited from ovarian tissue autograft Exclusion Criteria: Patients under trusteeship Patients placed in receivers Patients under the protection of a conservator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ovarian tissue cryopreservation<br> | Procedure: Autograft of cryopreserved ovarian tissue<br>* Orthotopic transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration of ovarian function by using autograft |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of live births after ovarian tissue autograft |  | 5 years | 
| Number of complications that could result from a surgery with anesthesia or depending on graft quality |  | 5 years | 
| Number of graft recovery |  | 5 years | 
| Number of residual disease development. |  | 5 years |
Diabetic Foot Ulcer Prevention System

Study Overview
=================
Brief Summary
-----------------
To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.

Official Title
-----------------
An Innovative System for the Early Identification, Monitoring, Evaluation and Diagnosis of Diabetic Foot Ulcers

Conditions
-----------------
Diabetic Foot

Intervention / Treatment
-----------------
* Device: DFUPS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older Has no history of diabetes Has no previous history of foot ulceration Has no previous history of foot surgery Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both) Has no history of peripheral neuropathy Has no history of peripheral arterial disease Must be able to provide meaningful written informed consent for the study Exclusion Criteria: Has active foot ulceration and infection Has foot deformity which in the opinion of the Investigator, would interfere with interpreting the results of the study Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study Has an implantable electronic device Is aged <18

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Other: Study in healthy volunteers<br>Skin foot temperature measurement by DFUPS device | Device: DFUPS<br>* The DFUPS device is a two-camera instrument for capturing images of feet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of hot spots on a foot thermal map image |  | 9 months |
Dysfunctional Hemoglobin Pulse Oximetry

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess device performance in the presence of carbon monoxide.

Official Title
-----------------
Dysfunctional Hemoglobin Pulse Oximeter

Conditions
-----------------
Carbon Monoxide Poisoning

Intervention / Treatment
-----------------
* Device: Pulse Oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is male or female. The subject is of any racial or ethnic group. The subject is between 18 years and 50 years of age (self-reported). The subject does not have significant medical problems (self-reported). The subject is willing to provide written informed consent and is willing and able to comply with study procedures. Exclusion Criteria: Has a BMI greater than 30.0 (calculated from self-reported weight and height). Has had any relevant injury at the sensor location site (self-reported). Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection). Has a known respiratory condition (self-reported). Is currently a smoker (self-reported). Has a known heart or cardiovascular condition (self-reported). Is currently pregnant (positive serum pregnancy test at screening visit or positive urine POC test on day of study). Is female and actively trying to get pregnant (self-reported). Has a clotting disorder (self-reported). Has Raynaud's Disease (self-reported). Is known to have anemia (hemoglobin value below lower range of normal for gender) Is known to have a hemoglobinopathy such as sickle-cell anemia or thalassemia (abnormal hemoglobin electrophoresis). Is known to have a inherited or congenital methemoglobinemia (self-reported). Has unacceptable collateral circulation from the ulnar artery (based on exam). Is unwilling or unable to provide written informed consent to participate in the study. Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pulse Oximeter|Comparison of pulse oximetry to blood gas analyzer.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carboxyhemoglobin accuracy | Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device. | Through study completion, an average of 3 months. |
Population Pharmacokinetics of Propafenone and Propranolol in Children Patients

Study Overview
=================
Brief Summary
-----------------
The use of propafenone and propranolol in children during clinical treatment was depending mostly on experience. Besides, there was no recommended dose for children in drug instruction. Therefore, the investigators' aim is to study the pharmacokinetics and pharmacodynamics in children.

Official Title
-----------------
Population Pharmacokinetics of Propafenone and Propranolol in Children Patients

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Drug: Propafenone and Propranolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged ≤18years. Parental written consent to participate in the study. Patients treat with Propafenone and Propranolol Exclusion Criteria: Patients can not complete the research; Abnormal hepatic and renal function; Patient is allergic to propafenone; There are conditions that researchers do not consider it appropriate to join the research.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Propafenone and Propranolol|Propafenone Hydrochloride Tablets, 100-200mg, 1 or 2 times per day; Propranolol Hydrochloride Sustained-Release Capsules, 40mg, 1 times per day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular premature beats of 24 hours | frequency of Ventricular premature beats of 24 hours | From date of randomization until the date of discharge, assessed up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P-R interval | P-R interval time | From date of randomization until the date of discharge, assessed up to 12 months | 
| QT interval | QT interval time | From date of randomization until the date of discharge, assessed up to 12 months |