linjc16/ctgov huggingface dataset:
The Investigation of the EtCO₂- PaCO₂ Relation During Laparoscopic Colon Surgery

Study Overview
=================
Brief Summary
-----------------
Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery. Patient and surgical characteristics, mechanical ventilation adjustments, and intraabdominal pressure values and the corelation between these parameters and EtCO₂ - PaCO₂ difference were also investigated.

Detailed Description
-----------------
Patient records from patients underwent colorectal surgery between 2010-2011 will be studied. It was planned to include patients undergoing laparoscopic colorectal surgery with a predetermined anaesthesia protocol. Patients will receive a standardized general anesthetic and thoracal epidural anaesthesia. Ventilatory parameters will be adjusted to maintain ETCO2 35 mmHg, Paw 25 cmH2O.Patient age, gen-der, BMI, ASA classification, the duration of surgery, anesthesia, Trendelenburg position and pneumoperitoneum. Hemodynamic parameters, blood gas analyzes, ventilation parameters and EtCO₂ values will be recorded. We determined 6 timelines to compare the difference between PaCO₂ and EtCO₂. These timelines were the times where we could collect the most data regarding blood gas analyzes. Preoperative period: to, 10th minute after the first insuflation and trendelendburg position: t₁,the first hour after the first insuflation and trendelendburg position: t₂, 10th minute after desuflation and supine position: t₃, 10th minute after the second insuflation and trendelendburg position: t₄, and 10th minute after the second desuflation and supine position:t₅. Primary outcome measure is the difference between PaCO₂ and EtCO₂ a difference greater than 5 mmHg was assumed to be important.

Official Title
-----------------
Cohort Study on Patients Underwent Colorectal Surgery

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III patients underwent laparoscopic colorectal resection Exclusion Criteria: convertion to the open surgery
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arterial carbondioxide pressure, Colon surgery, End-tidal carbondioxide, Laparoscopic Trendelenburg
A Trial of Skeletal Targeted Radiotherapy Using Holmium-166-DOTMP in Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
Multiple myeloma is a disease that resides primarily in the bone and has shown to be sensitive to radiation. Administration of a radiotherapy agent that targets the bone, such as Holmium-166-DOTMP, in conjunction with melphalan and an autologous stem cell transplant, may improve the patient's chance of responding to treatment. The purpose of this study is to determine the amount of Holmium-166-DOTMP that localizes in the bone and in normal organs, and to evaluate the safety and efficacy of Holmium-166-DOTMP in the treatment of patients with multiple myeloma.

Detailed Description
-----------------
The purpose of this study is to estimate the radiation absorbed dose to the bone marrow and kidneys based on whole-body gamma camera image data for comparison with that obtained using mathematical models based on whole body counting from a small gamma detection device called a thyroid probe; to obtain pharmacokinetic data following administration of 166Ho-DOTMP; and to evaluate safety and efficacy in patients who receive 25 Gy targeted therapy of 166Ho-DOTMP and 200 mg/m2 melphalan followed by autologous peripheral blood stem cell transplant (PBSCT).

Official Title
-----------------
A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Holmium-166-DOTMP


Participation Criteria
=================

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: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Holmium-166-DOTMP|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
-----------------
Multiple myeloma, Transplant, Skeletal Targeted Radiotherapy, Holmium
Long Term Evaluation of Function and Quality of Life After Pollicisation

Study Overview
=================
Brief Summary
-----------------
The study aims at describing long term functional outcome of patients that underwent pollicisation surgery. The hypothesis of the study is that there are prognostic factors of good function results of pollicisation (based on T-GAP classification for function) that will be searched on univariate and multivariate analysis.

Official Title
-----------------
Long Term Evaluation of Function and Quality of Life After Pollicisation

Conditions
-----------------
Patients That Had Pollicization Surgery

Intervention / Treatment
-----------------
* Other: Functional evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 7 years and less than 50 years Underwent unilateral or bilateral pollicisation surgery For children : non opposition of the parents For adults : non opposition Exclusion Criteria: - Patients able to understand the research and to answer to forms

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Functional evaluation|Patients will complete these forms and tests : Box and block test, Purdue peg board, Percival, Nine hole peg, T-GAP, EGF, MAHVIE, DASH, RAND36, CHQ-PF28, CHQ-CF45, CGI-S|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-GAP score | The Thumb Grasp and Pinch assessment (T-GAP) is a new outcome measure that classifies grasp and pinch styles to quantify use of the new thumb. Scoring is based on principles of hand development and skill using a 7-point hierarchical scale including abnormal (scores of 1e3) and normal (scores of 4e7) grasp patterns, with more mature patterns receiving higher points. | At baseline, Day 0 (>5 years post-surgery) |
Epidemiological Description of the Kaposi's Disease in France's Southeast

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the prevalence of the Kaposi's disease in France's southeast on 10 years (from 2007 to 2017)

Detailed Description
-----------------
Kaposi's disease is a multifocal disease with cutaneous expression in more than 95% of cases. There are 4 forms : Mediterranean, Endemic (Sub-Saharan Africa), iatrogenic and epidemic (HIV) The physiological hypotheses to explain the disease are not clear. A proliferation of immunity cells in blood vessels and also an undetermined role of the human herpes virus 8 (HHV-8) could be involved. The treatment is complex and not standardized. There are a lot of different treatments. The purpose of this study is to evaluate the prevalence and described the characteristics and the treatment of the Kaposi's disease in the France's southeast on 10 years, from 2007 to 2017.

Official Title
-----------------
Epidemiological Description of the Kaposi's Disease in France's Southeast

Conditions
-----------------
Kaposi's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed patients with a Kaposi's disease by biopsy from January 2007 to December 2017 Exclusion Criteria: Opposition to the use of personal data

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Prevalence of Kaposi's disease | Diagnosed patients with biopsy, in France's southeast | 10 years (2007-2017) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive analysis of the different form of the Kaposi's disease in the population | Mediterranean form, endemic form, iatrogenic form and epidemic form | 10 years (2007-2017) | 
| Descriptive analysis of the population : sociodemographic | sociodemographic characteristics | 10 years (2007-2017) | 
| Descriptive analysis of the population : paraclinical | paraclinical characteristics | 10 years (2007-2017) | 
| Descriptive analysis of the population : clinical | clinical characteristics | 10 years (2007-2017) | 
| Descriptive analysis of the population : therapeutic | therapeutic care | 10 years (2007-2017) | 
| Survival analysis | mortality rate | 10 years (2007-2017) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kaposi's disease, HHV8, Prevalence
Distortion Product After Stapedotomy Surgery

Study Overview
=================
Brief Summary
-----------------
This study aims at capturing for the first time at which frequencies and sound intensities hearing distortions are perceived after successful stapedotomy surgery. Also, the portion of patients perceiving these sound distortions and the length of time over which the distortions occur are assessed.

Detailed Description
-----------------
If the stapes footplate is fixed in position, e.g. by otosclerosis, rather than being normally mobile, a conductive hearing loss results. This conductive hearing loss is usually compensated with hearing aids or through stapedotomy. During stapedotomy, the diseased stapes bone is removed and is replaced with a piston prosthesis that conveys the sound stimulus from the incus to the footplate of the removed stapes. After surgery subjects sometimes state that the quality of sound is suboptimal, even though their hearing ability has improved significantly. Some subjects subjectively hear distorted sounds, which often disappear several weeks after surgery. This study aims at capturing for the first time at which frequencies and sound intensities these distortions are perceived. Additionally, the portion of patients perceiving these sound distortions and the length of time over which the distortions occur are assessed.

Official Title
-----------------
Subjektiv Verzerrter Höreindruck Nach Stapedotomie

Conditions
-----------------
Distorted Sound Perception

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for stapedotomy written consent given Exclusion Criteria: not mentally able to give written consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>No indication for stapedotomy | |
| Distortion positive<br>Subjects after stapedotomy perceiving sound distortions | |
| Distortion negative<br>Subjects after stapedotomy not perceiving sound distortions. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of distorted sound perception after stapedotomy surgery | A psychoacoustic audiometric tests is performed; subjects are asked to press a button if the sound they hear is distorted, and this is tested at different frequencies and different level of loudness. | 7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire on quality of hearing after Stapedotomy (APOSE) |  | 7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery |
Correlation Between Femoral Head and Cup Size and Postoperative Pain in Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
We want to investigate the correlation between the native femoral head and the implanted cup in Total hip arthroplasty. As second parameter to investigate we believe an oversized cup will cause groin pain. We want to find a cutoff value to predict groin pain after cup implementation in THA.

Official Title
-----------------
Correlation Between Femoral Head and Cup Size and Postoperative Pain in Total Hip Arthroplasty

Conditions
-----------------
Femoral Head Size, Cup Size THP, Postoperatie Groin Pain

Intervention / Treatment
-----------------
* Device: THA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all primary THA Exclusion Criteria: DDH-LCP Acetabulum/femoral neck fracture
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pain<br>THA | Device: THA<br>* Total hip arthroplasty<br>|
| no pain<br>THA | Device: THA<br>* Total hip arthroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between femoral head and cup size and postoperative pain in Total Hip arthroplasty |  | 1 year |
Ultrasound-guided Femoral Arterial Puncture for Interventional Neuro-radiology in Children

Study Overview
=================
Brief Summary
-----------------
Using ultrasound to guide vascular catheterism in children is highly recommended for central venous access. It has been proven that central venous line is inserted faster, with fewer attempts and complications. Its interest in central arterial line insertion is less obvious. It seems to have benefits in adults, both for radial and femoral arterial insertion. But there is no study assessing the interest of ultrasound guided arterial puncture in children,.

Official Title
-----------------
Assessing the Interest of Ultrasound-guided Femoral Arterial Puncture for Interventional Neuro-radiology in Children

Conditions
-----------------
Retrograde Femoral Catheterism

Intervention / Treatment
-----------------
* Device: Ultrasound guided femoral puncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: requirement of retrograde femoral arterial catheterism Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 15 Years

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

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

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: Ultrasound guided femoral puncture<br> | Device: Ultrasound guided femoral puncture<br> <br> |
| No Intervention: palpation guided femoral puncture<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate at first attempt |  | immediate |
Health Effects of Early-Life Exposure to Urban Pollutants in Minority Children

Study Overview
=================
Brief Summary
-----------------
A molecular epidemiologic study of African American and Hispanic mothers and newborns to investigate the role of common urban pollutants on procarcinogenic and developmental damage.

Detailed Description
-----------------
The major objective of the proposed research is to study the impact of early-life exposures to common urban pollutants on neurobehavioral development and asthma in a sample of children living in three low-income, minority communities of New York City (Central Harlem, Washington Heights and the South Bronx). Using a molecular epidemiologic approach with monitoring, biomarkers, and clinical assessments at serial time points, we will extend our study of African-American and Latina urban mothers and children in order to follow the cohort through child age 11 years to assess the longer-term impact of exposures on child health and developmental outcomes.

Official Title
-----------------
Health Effects of Early-Life Exposure to Urban Pollutants in Minority Children

Conditions
-----------------
Asthma, Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Enrollment eligibility was restricted to nonsmoking pregnant women 18-35 years of age who self-identified as either African American or Dominican and who had resided in northern Manhattan or the South Bronx in New York City for at least 1 year before pregnancy. Women were excluded if they used illicit drugs, had diabetes, hypertension, or known HIV, or had their first prenatal visit after the 20th week of pregnancy.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurobehavioral development |  | 1 to 12 years | 
| Asthma |  | 2-12 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pollutants
Balance and Mild Traumatic Brain Injury (TBI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot project is to determine whether using one inertial sensor on the waist during routine clinical balance testing (i.e. Balance Error Scoring System (BESS)), will be a more immediate, objective, reliable and sensitive way to measure and quantify balance deficits in individuals with mild Traumatic Brain Injury (mTBI).

Detailed Description
-----------------
The purpose of this pilot project is to gather preliminary data to determine whether using one inertial sensor at the waist during the BESS could provide the examiner with a more immediate, objective, reliable and sensitive way to quantify deficits in postural control in the post-concussive population. The investigators hypothesize that the metrics obtained from the iSWAY will be better able to distinguish mTBI subjects from control subjects than the standard clinical assessment. The specific aims are: To determine test-retest and inter-rater reliability of the clinical BESS compared to the instrumented BESS test. To determine if an instrumented BESS can distinguish mTBI from age-matched control subjects better than the commonly used BESS and to determine the best metrics of sway to separate groups.

Official Title
-----------------
Wearable Sensor to Detect Postural Instability in People After Mild Traumatic Brain Injury (mTBI)

Conditions
-----------------
Brain Concussion, Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a mild Traumatic Brain Injury or Concussion Between the ages 12-40 years Exclusion Criteria: Out of age range

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 40 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mTBI, concussion, mild Traumatic Brain Injury, balance, sensors
A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric population.

Official Title
-----------------
A Pediatric Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation

Conditions
-----------------
Head Lice Infestation

Intervention / Treatment
-----------------
* Drug: Ha44 Gel 0.74% w/w


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 6months < 3years of age Good health Active head lice infestation defined as the presence of at least 3 live lice Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation) Parent/guardian agrees to allow PK samples collected Signed Informed Consent Form Exclusion Criteria: Condition or illness that in the opinion of the investigator may interfere with the study results. Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled. Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract. Receiving systemic or topical medication that may interfere the study results. Received an investigational agent within 30 days prior to Day 0.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 2 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: Ha44 Gel 0.74% w/w<br>Open label, one arm | Drug: Ha44 Gel 0.74% w/w<br>* HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.<br>* Other names: Benzyl Alcohol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of Ha44 Gel | Clinically significant changes in Physical Examinations, vital signs, safety laboratory tests and assessments of scalp and eye irritation and Electrocardiogram. The frequency and severity of Adverse Events. | 8 months |