linjc16/ctgov huggingface dataset:
Premedication by Clonidine Intranasal in Pediatric Surgery

Study Overview
=================
Brief Summary
-----------------
There are few studies using intra nasal way to dispense premedication in pediatrics. This study will evaluate anxiolysis effect of Intranasal premedication with Clonidine vs Placebo. Two groups, randomized, Total of 150 patients (75 in each group) : Involvement in study for one patient : 7 days Duration of study including inclusion and data analysis : 18 months (inclusion 12 months; data analysis 6 months)

Official Title
-----------------
Premedication by Clonidine Intranasal in Pediatric Surgery

Conditions
-----------------
Child Preschool

Intervention / Treatment
-----------------
* Drug: Clonidine
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child from 1 to 5 years Weight between 10 to 25 kgs Scheduled minor surgery Oral and written information and consent given by main investigator to both of the parents or legal(s) representative(s). ASA score 1 or 2 Patient with social care insurance Exclusion Criteria: Refusal of one of the parental authority or legal representing Concomitant participation to a clinical trial with use of a drug Known hypersensitivity or contraindication to Clonidine or one of its excipients Airway infection within 3 weeks before inclusion Intravenous induction of anesthesia Antecedent of arrhythmia or congenital heart disease Mental disorder or current psychoactive medication

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clonidine<br>This arm will receive intra nasal Clonidine as a premedication before surgery | Drug: Clonidine<br>* clonidine intranasal premedication in preschool infants<br>|
| Placebo Comparator: Placebo<br>This arm will receive intra nasal Placebo as a premedication before surgery | Other: Placebo<br>* Placebo intranasal premedication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiolysis score | Anxiolysis score (1 : Anxious, crying; 2 : Anxious; 3 : Calm, not cooperative; 4 : Calm, cooperative | at 30 minutes after premedication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptation of mask at the induction of anesthesia | Yes / No | 1 hour after premedication | 
| Agitation score after the extubation | Agitation score : 0 : Patient | 15 min after extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paediatric, premedication, clonidine, intranasal
Single-stapled Double Purse-string Technique for Colorectal Anastomosis

Study Overview
=================
Brief Summary
-----------------
A single-arm, single-center prospective study of a novel double purse-string technique for constructing the colorectal anastomosis in robot-assisted laparoscopic resection of the sigmoid colon for cancer.

Detailed Description
-----------------
In all, 30 consecutive patients will be enrolled. The first 5 will be regarded as a pilot series for testing and aligning the study setup. The next 25 patients will form the study group. The clinical outcomes will be compared with historical control patients from our own department. Safety and feasibility will be assessed by short-term clinical outcomes.

Official Title
-----------------
Single-stapled Double Purse-string Anastomotic (SIA) Technique in Robotic Malignant Sigmoid Resections

Conditions
-----------------
Colo-rectal Cancer

Intervention / Treatment
-----------------
* Procedure: SIA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (all must be fulfilled): Verified cancer of the sigmoid colon Planned elective robot-assisted laparoscopic resection of sigmoid colon with primary anastomosis Operation with curative intent Exclusion Criteria: Not legally competent and/or < 18 years old Not able to comprehend information and/or give written consent

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: Study group<br>Robot-assisted laparoscopic resection of sigmoid colon with colorectal anastomosis constructed by the double purse-string technique | Procedure: SIA<br>* As indicated by arm description<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Successful construction of anastomosis by double purse-string technique | 30 days | 
| Complications | Surgical complications graded by Clavien-Dindo | 30 days | 
| Mortality | Postoperative death | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LOS | Length of stay - number of days from day of operation to discharge | 90 days | 
| Readmissions | Unplanned hospital admissions at least 24 hs after discharge | 30 days | 
| Operation time | Duration of operation from incision to last skin stitch | 30 days | 
| Blood loss | Estimated intraoperative blood loss in ml | 30 days | 
| Medical complications | Medical complications graded by Clavien-Dindo and MESS | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Robot
Early Antiviral Therapy for Critically Ill HIV Infected Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to verify the effect of HAART in critically ill HIV infected patients. The current practice is to begin antiviral therapy after ICU discharge, when the condition of the patient is more stable. The investigators hypothesis is that the investigators can improve outcome of these patients with earlier antiviral therapy in the ICU. The investigators just have retrospective studies in this scenario. After admission to ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission) or conventional therapy (initiation of HAART after ICU discharge). The following data will be collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be followed to determine ICU mortality, hospital mortality and 6-month mortality.

Official Title
-----------------
Early Antiretroviral Therapy for Critically Ill HIV Infected Patients

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: early HAART
* Drug: Late HAART


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection CD4 cell count less than 350 cells/mm3 within 3 months prior to study entry OR CD4 cell count between 350 cells/mm3 and 500 cells/mm3 if age > 55 years, coinfection with HBV or HCV, neoplasia, viral load > 100,000 copies/ml or elevated cardiovascular risk OR AIDS-defining illness Exclusion Criteria: Regular use of HAART Pregnant

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early antiviral therapy<br> | Drug: early HAART<br>* Initiation of HAART within 5 days of ICU admission<br>|
| Active Comparator: Conventional therapy<br> | Drug: Late HAART<br>* Initiation of HAART after ICU discharge<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality | It is a estimative of length of hospital stay | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month mortality |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critically ill patients, HIV infection, HAART, mortality
Phase 2 Study of TLK286 in Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of TLK286 in treatment of metastatic breast cancer.

Official Title
-----------------
Phase 2 Study of TLK286 in Metastatic Breast Cancer

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: TLK286


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic diagnosis of breast cancer Metastatic disease Measurable or evaluable disease No prior chemotherapy regimens Age at least 18 years Adequate liver and kidney function Adequate bone marrow function Exclusion Criteria: Pregnant or lactating women Unstable medical conditions Chemotherapy within 14 days of TLK286 Radiation therapy within 14 days of TLK286 Hormonal therapy within 14 days of TLK286 Immunotherapy within 14 days of TLK286 CNS metastasis unless controlled by 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TLK286|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
T2* MRI Analysis for Sarcoma

Study Overview
=================
Brief Summary
-----------------
T2* imaging is a method to identify labile iron pools in tumor cells. These iron pools may be linked to better treatment outcomes for specific types of therapy. This is a small pilot study to see if radiation therapy changes the amount of iron in a sarcoma tumor.

Official Title
-----------------
An Exploratory, Pilot Study Evaluating T2* Imaging for Adult Sarcoma

Conditions
-----------------
Radiotherapy, Magnetic Resonance Imaging, Sarcoma

Intervention / Treatment
-----------------
* Diagnostic Test: T2* Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically confirmed Sarcoma, by biopsy or excision prescribed radiation therapy as per standard of care treatment to begin within 5 weeks after surgery or biopsy ECOG 0, 1, or 2 ability and willingness to provide informed consent Exclusion Criteria: < 18 years of age

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T2* Imaging<br>Participants undergo T2* MRI imaging before beginning their course of radiation therapy and then after completing radiation therapy, about 2 weeks before their surgery. | Diagnostic Test: T2* Imaging<br>* T2* imaging sequences for MRI<br>* Other names: T2* MRI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ferric iron levels detected by T2* MRI | Change from baseline in Fe3+ iron levels | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ferrous iron levels detected by T2* MRI | Change from baseline in Fe2+ iron levels | Baseline and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
soft tissue sarcoma
A Registry Study of Biomarkers in Heart Failure

Study Overview
=================
Brief Summary
-----------------
The registry study aims to discover the prognostic value of bio-markers in heart failure

Detailed Description
-----------------
The purpose of this study is to investigate the prognostic value of biomarkers in Heart Failure.Patients with confirmed diagnosis of heart failure are enrolled.The primary outcome is all-cause mortality based on the death certificates. The secondary outcome is readmission for heart failure and all-cause mortality/readmission for heart failure according to the patients' medical records.

Official Title
-----------------
A Registry Study of Biomarkers in Heart Failure

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years at the time of admission to the hospital With symptoms of new-onset or worsening heart failure Received or is eligible to receive a principal hospital discharge diagnosis of HF With signs and syndromes as follows: dyspnea at rest or with minimal exertion (dyspnea, orthopnea, or edema)；Rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography. Patients who received packed red blood cells, whole blood, or platelets less than 10 days before the blood sample was taken; Exclusion Criteria: Have objective evidence of cardiac dysfunction documented either by plasma concentrations of BNP and/or N-terminal pro-brain natriuretic peptide (NT-proBNP) <35 pg/mL or <125 pg/ml, respectively Current known inability to follow instructions or comply with follow-up procedures. Eligible patients without informed consent form

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of death (all cause) | Number of death within 2 years of discharge | 2 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of rehospitalizations for acute heart failure (HF) | Number of heart failure related hospitalization within 2 years of discharge | 2 years of follow-up | 
| Number of death ( all cause) or readmission for heart failure | Number of Death or heart failure related hospitalization within 2 years of discharge | 2 years of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure
Behavior Addictions Improvement in Parkinson Disease's Patients Treated by Subthalamic Stimulation : Long Term Follow-up

Study Overview
=================
Brief Summary
-----------------
Improvement of behavioral addictions in STN-DBS in PD: Long term follow-up

Detailed Description
-----------------
Whereas subthalamic nucleus (STN) stimulation is considered an established treatment for motor symptoms in advanced Parkinson's disease (PD), its behavioral and psychiatric effects are strongly debated, with some studies showing a worsening or new onset of behavioral and psychiatric issues after STN stimulation and other showing an improvement. However, these data are based mainly on case reports and retrospective series. Recently, the investigators group has conducted a prospective study assessing behavior and psychiatric symptoms in patients undergoing STN stimulation up to one year after surgery. After subthalamic stimulation non-motor fluctuations improved and pathologic hyperdopaminergic syndrome, i.e. behavioral addictions (including pathological gambling, hypersexuality, binge eating, compulsive shopping, …), compulsive use of dopaminergic treatment and dopaminergic dysregulation syndrome (defined as the association of one or more behavioral addictions to compulsive use of dopaminergic treatment), disappeared. These findings represent a milestone because, if confirmed, the indications of STN stimulation might be extended beyond motor complications. To date, there are several long-term studies on motor and cognitive effects of STN stimulation, whereas no long-term longitudinal data on neuropsychiatric effects do exist. Therefore, the investigators designed a long-term prospective study, assessing over 3-8 years behavioral and psychiatric effect in the same cohort of patients included in the one-year study. This study will allow to better evaluate the change in non-motor fluctuations and of behavioral issues in the long-term with a standard management.

Official Title
-----------------
Behavior Addictions Improvement in Parkinson Disease's Patients Treated by

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients included in the protocol 'Apathy' Exclusion Criteria: NA
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
-----------------
Parkinson disease, Deep brain stimulation, behavior and psychiatric symptoms improvement
Effect of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries,

Study Overview
=================
Brief Summary
-----------------
safety and efficacy of intrathecal morphine in post operative pain relief in pediatric patients undergoing major abdominal cancer surgeries using different doses of intrathecal morphine (2 μg/kg , 5 μg/kg ,10 μg/kg).

Detailed Description
-----------------
After obtaining approval of the local ethics committee of faculty of medicine, Assiut University , Assiut , Egypt , and parent's written informed consent, This randomized double -blinded prospective study conducted on ( 45 ) pediatric patients aged 3-12 years , weighting between 10-30 kg , and of American Society of Anesthesiologists (ASA) physical status I and II scheduled for major abdominal surgeries

Official Title
-----------------
Safety and Efficacy of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries, Dose-finding Clinical Study

Conditions
-----------------
Major Abdominal Surgeries

Intervention / Treatment
-----------------
* Drug: Intrathecal Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria weight between 10-30 kg , American Society of Anesthesiologists (ASA) I - II major abdominal surgeries Exclusion Criteria Children with sacral bone abnormalities spina bifida coagulopathy mental delay or retardation

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 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: morphine 2 μg/kg<br>Children will receive intrathecal morphine 2 μg/kg in 2 ml volume normal saline. | Drug: Intrathecal Morphine<br>* Intrathecal administration of Morphine in children undergoing major abdominal surgeries<br>* Other names: morphine sulphate;|
| Active Comparator: morphine 5 μg/kg<br>Children will receive intrathecal morphine 5 μg/kg in 2 ml volume normal saline. | Drug: Intrathecal Morphine<br>* Intrathecal administration of Morphine in children undergoing major abdominal surgeries<br>* Other names: morphine sulphate;|
| Active Comparator: morphine 10 μg/kg<br>Children will receive intrathecal morphine 10 μg/kg in 2 ml volume normal saline. | Drug: Intrathecal Morphine<br>* Intrathecal administration of Morphine in children undergoing major abdominal surgeries<br>* Other names: morphine sulphate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale | 0- 10 in cm score range will be used to assess pain | 24 hours postoperative . | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rams y sedation score | 0-4 score will be used | 24 hours |