linjc16/ctgov huggingface dataset:
Split-Thickness Skin Graft Donor Site Wound Healing Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to discover whether instruments widely used in skin research can be used to measure wound healing in split thickness skin graft donor sites and whether these instruments can detect differences in healing when two different dressing products are used.

Detailed Description
-----------------
Currently there is no standard treatment to promote wound healing for split thickness skin graft donor sites and healing is determined based on clinical observation of the graft donor site and clinical judgement. Here we propose to use two instruments commonly used in skin research to measure wound healing. This study will validate the use of these two instruments, one that measures transepidermal water loss and the other that measures skin pigmentation to determine healing. To further validate the use of these instruments we will determine if these instruments can detect differences between two different wound dressing products that have been previously reported to heal skin graft donor sites at different rates.

Official Title
-----------------
Split-Thickness Skin Graft Donor Site Wound Healing Study

Conditions
-----------------
Split-thickness Skin Graft Donor Sites

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants 18 years of age and over who have a split-thickness skin graft donor site. Exclusion Criteria: Individuals under 18 years of age. Individuals who do not have a split thickness skin graft donor site.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wound healing, skin, graft donor site, donor site, transepidermal water loss
Fertility in Untreated Rectosigmoid Endometriosis

Study Overview
=================
Brief Summary
-----------------
Several studies investigated the reproductive outcomes after surgical treatment of colorectal endometriosis, mainly segmental colorectal resection. Little information is available on the spontaneous fertility of patients with bowel endometriosis. This study aims to evaluate the fertility of patients affected by rectosigmoid endometriosis who did not undergo previous surgical treatment.

Official Title
-----------------
Fertility in Patients With Untreated Rectosigmoid Endometriosis

Conditions
-----------------
Endometriosis, Bowel Endometriosis, Endometriosis, Rectum, Endometriosis Colon

Intervention / Treatment
-----------------
* Behavioral: Expectant management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Desire of conception Diagnosis of rectosigmoid endometriosis by transvaginal ultrasonography (TVS) and magnetic resonance imaging enema (MR-e) Exclusion Criteria: Previous surgery for endometriosis Diagnosis of hydrosalpinx at imaging Previous conception Abnormal semen parameters of male partners

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with rectosigmoid endometriosis<br> | Behavioral: Expectant management<br>* Patients did not undergo surgical treatment for endometriosis and medical consultations were done every 6 months from the beginning of the attempts to conceive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Ultrasonographic evidence of intrauterine gestational sac | 4-9 weeks after conception | 
| Live birth rate | Complete expulsion or extraction from a woman of a product of fertilization after 22 completed weeks of gestational age, which, after such separation, breathes or shows any other evidence of life | 22 weeks after conception | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (%) of patients conceiving spontaneously/by Assisted Reproductive Technology | Modality of conception | Immediately after diagnosis of clinical pregnancy | 
| Number (%) of patients undergoing vaginal delivery/delivering by cesarean section | Modality of delivery | 22-42 weeks after conception |
Studies of Neurological Paraneoplastic Syndromes

Study Overview
=================
Brief Summary
-----------------
This study is for patients with cancer, a known paraneoplastic syndrome, or neurological problems that suggest a paraneoplastic syndrome.

Detailed Description
-----------------
Patients usually go to their doctors with neurological complaints and later find they have cancer, a known paraneoplastic syndrome, or neurological problems that suggest a paraneoplastic syndrome. Paraneoplastic syndromes are rare conditions in which the immune system is involved in causing brain damage and fighting cancer. Such patients with paraneoplastic neurologic degenerations(PNDs) may have autoantibodies, an antibody or protein the immune system creates that is directed against his or her own proteins. This study aims to better understand PNDS by: analyzing for autoantibodies in serum and cerebral spinal fluid analyzing for antigen specificity and for antigens in cancer tissue comparing PND autoantibodies with those in cancer patients but no PND comparing PND autoantibodies with those in PND patients but no cancer studying the immune performance of patients with PNDs As this study is not a treatment study, tissues for this study will only come from procedures necessary for the patient's treatment.

Official Title
-----------------
Studies of Neurological Paraneoplastic Syndromes

Conditions
-----------------
Paraneoplastic Neurologic Degenerations (PNDs)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults are potentially eligible. Exclusion Criteria: None.

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 |
| --- | --- |
| 1<br>One cohort group of patient with PNDS or suspected PNDS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase understanding of PNDS |  | Ongoing |
An Open-label, Rollover Study Providing Continued Dosing of Gevokizumab in Order to Assess Long-term Gevokizumab Safety Data

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide continued dosing of gevokizumab in order to obtain and assess long-term gevokizumab safety data.

Official Title
-----------------
An Open-Label, Non-Randomized, Single-Arm, Rollover Study to Continue Dosing of Gevokizumab in Subjects With Non Infectious Intermediate-, Posterior-, or Pan-Uveitis Patients Who Each Successfully Completed Either the X052130/CL3-78989-005 (EYEGUARD™-A) or the X052131/CL3-78989-006 (EYEGUARD™-C) Study or Who Have Controlled Ocular Inflammation After Receiving Study Drug in Study X052133 (EYEGUARD™-US)

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Drug: Dose 2 gevokizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed either the X052130/CL3-78989-005 or the X052131/CL3-78989-006 study's masked D392 or OL-224 completion day visits or had controlled ocular inflammation after having received study drug in Part 2 of study X052133 Exclusion Criteria: Discontinued from the previous study Other protocol-defined inclusion/exclusion criteria may apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 2 gevokizumab<br> | Drug: Dose 2 gevokizumab<br>* Solution for subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent Adverse Events |  | 108 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis, Behçet's disease uveitis
Evaluation of Mirus™ for Sedation in Resuscitation

Study Overview
=================
Brief Summary
-----------------
Current recommendations for the conduct of sédationanalgésie ICU encourage the use of the lightest possible sedation strategies, avoiding the administration of benzodiazepines source of longer durations of ventilation and ICU stay of syndrome cessation, mental confusion. Among the proposed alternatives, administration of halogenated volatile agents (sevoflurane) in resuscitation is interesting because their favorable pharmacokinetic even after prolonged administration: no tachyphylaxis, rapid clearance, no withdrawal syndrome. There are two suitable delivery devices sevoflurane in intensive care, both with CE marking. The device Mirus ™ (Pall Medical, Fribourg, Switzerland) is the newest and it is easy to use and reliable. The objective of this study was to evaluate the use of Mirus ™ device in trauma resuscitation and cardiovascular resuscitation. Specifically, it will use this modality in case of failure with conventional sedation products (propofol, midazolam): maximum permissible doses, sedation weaning failure due to severe agitation.

Official Title
-----------------
Evaluation of Mirus™ for Sedation in Resuscitation

Conditions
-----------------
Patient Requiring Mechanical Ventilation

Intervention / Treatment
-----------------
* Device: patient requiring the MIRUS (mechanical ventilation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged over 18 years In mechanical ventilation for more than 48 hours No intracranial hypertension In severe state of agitation measured by a sedation scale score greater than 2 RASS Agitation observed in two circumstances: receiving maximal doses of propofol (≥ 5 mg / kg / h) and / or midazolam (≥ 0.2 mg / kg / h), or weaning failure to stop the sedation agitation. Exclusion Criteria: Presence of a severe head injury (Glasgow initial score between 3 and 8) requiring monitoring intracranial pressure and / or treatment of intracranial hypertension Sedation with dexmedetomidine Personal or family antecedent of anesthetic malignant hyperthermia Pregnant woman

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

| Intervention/Treatment |
| --- |
|Device: patient requiring the MIRUS (mechanical ventilation)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ead-time (in minutes) of sevoflurane sedation for obtaining a target RASS score between 1 (anxious) and 2 (mild sedation). |  | 24 hours |
Fast-track Surgery in the Treatment of Hirschsprung's Disease

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of Hirschsprung's disease

Detailed Description
-----------------
The patients are divided into two groups：fast-track surgery combined with laparoscope group and laparoscope with traditional managements group.Postoperative recovery,hospital stay,hospital cost and complcations were compared.

Official Title
-----------------
Fast-track Surgery in the Treatment of Hirschsprung's Disease

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Drug: probiotics
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgical treatment for Hirschsprung's disease The first procedure for Hirschsprung's disease Age<14 years Exclusion Criteria: conservative treatment for Hirschsprung's disease The reoperation for Hirschsprung's disease Age>14 years

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fast-track Surgery<br>probiotics,oral,b.i.d. | Drug: probiotics<br>* probiotics<br>* Other names: Bifico;|
| Active Comparator: Traditional Group<br>placebo,oral,b.i.d. | Drug: placebo<br>* placebo<br>* Other names: Bifico;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with recovery of boewl movements |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the hospital stay |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fast-track surgery
Interventional Research in Schools - Second Part

Study Overview
=================
Brief Summary
-----------------
The main objective this project is the development of a measurement tool. This consists of construct and validate a questionnaire to conduct a quantitative assessment of knowledge and individual conceptions of cancer enrolled in CM1 and CM2 (9-11 years).

Detailed Description
-----------------
exper judges by DELPHI method for content validity pre-testing for appearence validity testing for construct validity

Official Title
-----------------
Interventional Research in Schools - Second Part

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

Intervention / Treatment
-----------------
* Other: Questionnaire and focus group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children enrolled in classes CM1 and CM2 of the departments of Loire, Essonne, Rhone and Ain Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 11 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Questionnaire and Focus group<br>The children complete the questionnaire to better know their knowledge and cancer individual conceptions. Then, they will be interviewed during one hour in groups for the pre-testing phase. And after, for the testing phase, they just complete the questionnaire. | Other: Questionnaire and focus group<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire validity |  | 1 hour |
A Communication Strategy for Families of Patients Dying in the ICU

Study Overview
=================
Brief Summary
-----------------
Decisions to limit life sustaining treatments are made for most patients dying in the ICU, usually with input from the family. The well-being of the family may be jeopardized by involvement in the decision-making process and bereavement. We evaluated the ability of a proactive communication strategy (family conference and providing family members with a bereavement information leaflet) designed to improve family well-being.

Official Title
-----------------
A Proactive Communication Strategy for Family Members of Patients Dying in the ICU: A Multicenter Randomized Controlled Trial

Conditions
-----------------
Family of Dying Patient in the ICU

Intervention / Treatment
-----------------
* Procedure: family conference with bereavement information leaflet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: family of dying patient Exclusion Criteria: family having no enough knowledge of French to respond to telephone interview patient alive on day 90

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: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: family conference with bereavement information leaflet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms related to posttraumatic stress disorder |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms of anxiety and depression |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
family, end-of-life, intensive care unit
Outcome of Symptoms in Patients Undergoing a Heller Myotomy

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to review studies and patient symptoms before and after laparoscopic Heller myotomy to assess outcomes following laparoscopic surgery for achalasia.

Detailed Description
-----------------
Patients will answer questionnaires before and after surgery to evaluate their symptoms of achalasia and will also have their charts reviewed for relevant medical information.

Official Title
-----------------
Short and Long Term Outcomes of Heller Myotomy

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Other: Symptom questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with achalasia who have had laparoscopic Heller myotomies for the treatment of achalasia Exclusion Criteria: No patients under the age of 18 will be included

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 |
| --- | --- |
| I<br>Patients will answer symptom questionnaires and have their charts reviewed for relevant medical information. | Other: Symptom questionnaire<br>* Patients will answer questionnaires evaluating their symptoms of achalasia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this study is to review pre-operative and post-operative studies and patient evaluation reports to evaluate patient outcomes following laparoscopic surgery for achalasia |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
achalasia, Heller myotomy
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

Study Overview
=================
Brief Summary
-----------------
Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenzae type b.

Official Title
-----------------
To Assess Safety, Reactogenicity and Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Co-administered With DTPa-combined Vaccines and MenC or Hib-MenC Vaccines During the First 6 Months of Age.

Conditions
-----------------
Infections, Streptococcal

Intervention / Treatment
-----------------
* Biological: Pneumococcal (vaccine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female between, and including, 6-16 weeks (42 to 118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. Exclusion Criteria: use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3. Previous vaccinations against diseases which are targeted by the vaccines used in the study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 16 Weeks

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

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

| Intervention/Treatment |
| --- |
|Biological: Pneumococcal (vaccine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post at least 1 dose: rectal fever >39°C |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post each dose: solicited/unsolicited AEs (4/31 days), SAEs (whole study); post dose 2 & 3: Ab conc to vaccine antigens |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Streptococcus pneumonia, vaccine