linjc16/ctgov huggingface dataset:
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX-4430)

Study Overview
=================
Brief Summary
-----------------
This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enroll and dose 6 subjects. Subjects will be admitted to the clinical unit on the evening of Day 1 prior to investigational medicinal product (IMP) administration. Subjects will be dosed on the morning of Day 1 and it is planned that they will remain resident in the clinic until up to 168 hour after dosing (up to Day 8). It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% or if <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 hour periods.

Official Title
-----------------
An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX-4430) in Healthy Male Subjects

Conditions
-----------------
Heathy Volunteers

Intervention / Treatment
-----------------
* Drug: [14C]-acebilustat solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Body mass index of 18.0 to 35.0 kg/m2 Exclusion Criteria: Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type) Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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

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: 100 mg [14C]-acebilustat<br>a single oral dose of 100 mg [14C]-acebilustat | Drug: [14C]-acebilustat solution<br>* Acebilustat is a novel synthetic small molecule leukotriene A4 hydrolase (LTA4H) inhibitor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance recovery of total radioactivity in all excreta: amount excreted (Ae) and Ae as a percentage of the administered dose (%Ae), cumulative recovery (CumAe), and cumulative recovery expressed as a percentage of the administered dose (Cum%Ae) |  | Day 10 |
a Case-control Study of the Association Between Heavy Mental and Children With Attention Deficit Hyperactivity Disorder in Korea

Study Overview
=================
Brief Summary
-----------------
Heavy metal has been reported that it can cause attention deficit and behavioral disturbance. The investigators hypothesis is that heavy metal is associated with children with attention deficit/hyperactivity disorder(ADHD).

Official Title
-----------------
a Case-control Study of the Association Between Heavy Mental and Children With Attention Deficit Hyperactivity Disorder in Korea

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K) interview Subjects signed a written consent form voluntarily. Patient 's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates, or legal guardian. Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time Exclusion Criteria: Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder. Subjects who have significant suicidal ideation or homicidal ideation Subjects with mental retardation Subjects with Tourette's syndrome requiring drug therapy. Subjects who currently have a significant medical conditions (e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma). Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results, including serum chemistries and hematology. Subjects who have been administrated alpha-2 adrenergic receptor agonist,antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant within recent 2 months. Subjects who dyed their hair within 8 weeks

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- | --- |
The Use of rFVIIa in Trauma Patients: A Multi-Center Case Registry

Study Overview
=================
Brief Summary
-----------------
Trauma surgeons throughout the US have begun using recombinant activated factor VII (rFVIIa) to control severe hemorrhage following injury when traditional measures have failed. Despite promising results from several small studies, there remain several unanswered questions regarding the use of this relatively expensive product in injured patients including: The timing of administration Selection of appropriate patients who are most likely to benefit The effective dose in injured patients The potential need for repeated dosing The need for administration of platelets and correction of acidosis prior to administering the first dose The risks associated with the use of rFVIIa including venous and/or arterial thrombosis The potential for rFVIIa to cause or aggravate post-injury organ failure and/or infectious complications An analysis of cost versus benefit The purpose of this study is to collect a large sample of patients from multiple institutions in order to address the issues listed above. To this end, the Western Trauma Association Foundation is sponsoring a multi-center case registry for patients receiving rFVIIa for treatment of uncontrolled hemorrhage.

Detailed Description
-----------------
This is a prospective, multi-center case registry that seeks to combine the collective experience with the use of rFVIIa at UCSF/SFGH with other trauma centers. The study is being conducted under the auspices of the Western Trauma Association and the American Association of the Surgery of Trauma. Both organizations have a long history of successfully completing multi-center studies. The outcomes to be used in this study are: 1) survival, 2) amount of blood products infused before and after rFVIIa, 3) coagulation factors (PTT, INR) before and after, and 4) the surgeon's assessment of hemostasis. Data will also be analyzed to determine the cost effectiveness of rFVIIa when compared with other methods of treating severe hemorrhage, primarily administration of blood products. Finally, the incidence of complications and thrombotic events after drug administration will be evaluated.

Official Title
-----------------
The Use of rFVIIa in Trauma Patients: A WTA/AAST Multi-Center Case Registry

Conditions
-----------------
Traumatic Hemorrhage, Hemorrhagic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coagulopathy treated with rFVIIa 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?
-----------------
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
-----------------
recombinant Factor VIIa, traumatic hemorrhage, hemorrhagic shock, coagulopathy
Epidemiology of Pediatric Traumatology

Study Overview
=================
Brief Summary
-----------------
Fractures have been shown to account for 10-25% of injuries in children and the consequences of pediatric fractures are significant and result in significant restriction of activity. Despite this, the epidemiology of pediatric fractures remains poorly detailed. Investigators seek to establish the incidence of pediatric trauma and fractures and determine patient, trauma and injury characteristics.

Official Title
-----------------
Epidemiology of Pediatric Traumatology

Conditions
-----------------
Fractures in Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Children treated in the pediatric emergency department of the Strasbourg University Hospitals between January 2014 and December 2020 for skeletal trauma. Child and Holders of parental authority who have been informed of the use of their child's data for the purposes of this research and who have not expressed any opposition Exclusion criteria: Patient or legal representative who expressed their opposition to participating in the study Impossibility of giving informed information to the subject

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 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 |
| --- | --- | --- |
| Incidence of pediatric trauma and fractures and to determine the characteristics of patients, traumas and lesions | This study focuses on retrospective analysis of patients' medical records | Files analysed retrospectively from January 01, 2014 to December 31, 2012 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fractures in Children, pediatric fractures
Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC

Study Overview
=================
Brief Summary
-----------------
This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.

Official Title
-----------------
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer

Conditions
-----------------
CRC

Intervention / Treatment
-----------------
* Drug: HLX07
* Drug: HLX10
* Drug: mFOLFOX6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>=18Y and ≤75Y Good Organ Function Expected survival time ≥ 3 months mCRC that have been diagnosed histologically KRAS/NRAS/BRAF WT verified by PCR or NGS of tumor tissue ECOG score 0-1; Exclusion Criteria: HIV infection Active clinical severe infection; A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A：1L treatment<br>HLX07 * 1000 mg+HLX10* 200mg +mFOLFOX6, IV, Q2W | Drug: HLX07<br>* 1000mg<br>Drug: HLX10<br>* 200mg<br>Drug: mFOLFOX6<br>* OXA：85 mg/m2;LV:400 mg/m2；5-FU：400 mg/m2<br>|
| Experimental: B：≥2L treatment<br>HLX07 *1000 mg monotherapy,IV, Q2W | Drug: HLX07<br>* 1000mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate (assessed by investigator per RECIST V1.1) | up to 3 years | 
| PFS | Progression-free survival (PFS) (assessed by the investigator per RECIST v1.1 ) | : from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall Survival | up to 5 years |
Can We Improve the Comfort of Pelvic Exams?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate patients self-reported comfort levels during each section of the pelvic exam.

Detailed Description
-----------------
The purpose of this randomized controlled trial is to investigate the sequence in which physicians perform the pelvic exam, describe and compare the self-reported comfort during each section of the pelvic exam and how comfort during the exam relates to quality of life, self-esteem, and sexual function in English speaking females at least 18 years of age in an outpatient setting.

Official Title
-----------------
Can We Improve the Comfort of Pelvic Exams?

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: External Exam
* Other: Bimanual Exam
* Other: Speculum Exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking, female patients Are able to can read and write English Are utilizing outpatient services at an OBGYN outpatient office Are scheduled for a well-woman exam Exclusion Criteria: Non-English speaking patients Patients who cannot read or write Those who are pregnant Have an active vaginal infection Patients who, otherwise, do not require a speculum exam during their appointment

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

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observational<br>ARM: Normal Pelvic Exam Exposures: External Exam followed by speculum exam, followed by bimanual exam | |
| Active Comparator: Experimental Pelvic Exam<br>Arm: Changing the order of Pelvic Exam Intervention: External exam, Bimanual Exam, Speculum Exam | Other: External Exam<br>* The pelvic exam will be completed in the following order: external, speculum, bimanual exam in the Standard group. In the Experimental group the pelvic exam will be done with external exam, bimanual exam, then speculum exam.<br>Other: Bimanual Exam<br> <br> Other: Speculum Exam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score: A change of 13mm |  | Within 1 hour of the exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellbeing quality of life score: Range 0-4. | High wellbeing 2.5-4.0, Low wellbeing 1.5-2.4, and very low wellbeing 0-1.4 | Within 1 hour of the exam | 
| Rosenberg Self-Esteem Score: Scale 10-40 | Higher numbers indicate higher self-esteem | Within 1 hour of the exam | 
| Female Sexual Function Index-19 | Score of less than 26.55 indicates sexual dysfunction | Within 1 hour of the exam |
Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain in Potentiel Organ Donors.

Study Overview
=================
Brief Summary
-----------------
Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous breathing is established the apnea test (according to the American Academy of Neurology's Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some data suggest modifying the apnea test : replace the ventilator switching off with continuous positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP) increased the level of lung harvest but they were not sufficient because these studies were monocentric with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter,cluster trial; each center will use the method of apnea test which it uses usually.

Conditions
-----------------
Alternative Method of Apnea Test

Intervention / Treatment
-----------------
* Procedure: Apnea test - Standard
* Procedure: Apnea test - CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : from 18 to 75 years Neurological signs evoking cerebral ischemia Exclusion Criteria: Severe hypoxemia (PaO2/FiO2 < 200) with controlled ventilation (FiO2: 100%) Hypothermia < 36°C Obesity (BMI ≥ 40) with documented hypopnoea Intractable hypotension despite optimal filling and catecholamine doses > 1µg.Kg.min Patients with contraindication for organs harvesting. Documented chronic respiratory failure Progressive infectious acute respiratory disease Family opposition to subject's participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Standard group<br>Apnea test according to the recommendation | Procedure: Apnea test - Standard<br> <br> |
| CPAP group<br>Apnea test with CPAP connection | Procedure: Apnea test - CPAP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eligibility to lung harvest |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of hypoxemia |  | 2 years | 
| Arterial blood gas after apnea test |  | 2 years | 
| Rate of ventilatory impairment |  | 2 years | 
| Rate of cardiocirculatory impairment |  | 2 years | 
| Rate of apnea test interruption |  | 2 years | 
| Number of lung transplantation realization |  | 2 years |
Safety and Effectiveness of Two Different Formulations of an HIV Vaccine in Infants Born to HIV-Infected Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the safety and effectiveness of two different formulations of an HIV vaccine in infants born to HIV-infected women.

Official Title
-----------------
A Phase I Trial of the Safety and Immunogenicity of MN rsgp120/HIV-1 With the Adjuvants QS-21 and Alum Compared to MN rsgp120/HIV-1 and QS-21 in Infants Born to HIV-Infected Women

Conditions
-----------------
HIV Infections, HIV Seronegativity

Intervention / Treatment
-----------------
* Biological: Aluminum hydroxide
* Biological: QS-21
* Biological: MN rsgp120/HIV-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Infants may be eligible for this study if they: Are 1 to 3 days old.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Days

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Aluminum hydroxide|nan|
|Biological: QS-21|nan|
|Biological: MN rsgp120/HIV-1|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
-----------------
HIV Preventive Vaccine, HIV Therapeutic Vaccine