linjc16/ctgov huggingface dataset:
Milrinone During Living Donor Hepatectomy

Study Overview
=================
Brief Summary
-----------------
Maintaining a low central venous pressure during living donor hepatectomy is routine practice. The investigators tried to test the hypothesis that using milrinone to maintain a low central venous pressure (CVP) during is associated with a superior surgical field and less blood loss.

Official Title
-----------------
Effect of Milrinone During Living Donor Hepatectomy Using a Low Central Venous Pressure Technique

Conditions
-----------------
Hepatectomy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living liver donors Exclusion Criteria: Donors with concurrent cardiac, pulmonary, and urologic disease Hepatectomy performed laparoscopically

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: milrinone<br>milrinone infusion | Drug: milrinone<br> <br> |
| Placebo Comparator: placebo<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| condition of surgical field |  | intraoperative period (from the start of surgery to end of living donor hepatectomy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the use of vasopressor and diuretics to maintain hemodynamic stability and low CVP status, respectively |  | intraoperative period (from the start of surgery to end of living donor hepatectomy) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical field condition
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to describe the real-world profile of patients treated with adalimumab FK in gastroenterology, dermatology or rheumatology in order to evaluate in this population the predictive factors of therapeutic response (in particular nutritional status) and generate hypothesis between nutritional status and therapeutic response.

Official Title
-----------------
A Prospective Observational Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response

Conditions
-----------------
Crohn Disease, Ulcerative Colitis, Psoriasis, Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 18 years old who agree to participate in the study and do not object to the use of their health data A disorder treated with anti-TNF therapy Whose physician made the decision to initiate adalimumab treatment prior to the study Exclusion Criteria: Patients participating in an interventional therapeutic trial at the time of inclusion Patients who are unwilling or unable to fulfil follow-up requirements (patients who cannot be reached by phone or complete the self-administered questionnaire or not fluent in French

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 |
| --- | --- | --- |
| Clinical Global Impression (CGI) | The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutrition
Role of Drain in Decreasing Postoperative Complications

Study Overview
=================
Brief Summary
-----------------
postoperative complications are common after cesarean section

Detailed Description
-----------------
wound infection can occur after cesarean section

Official Title
-----------------
Role of Drain in Decreasing Postoperative Complications After Cesarean Section

Conditions
-----------------
Cesarean Section Complications

Intervention / Treatment
-----------------
* Device: Drain insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing cesarean section Exclusion Criteria: Women who deliver by normal vaginal delivery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drain<br> | Device: Drain insertion<br>* insertion of a drain<br>|
| No Intervention: No drain<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women who will have complications | How many women who will have complications postoperative | within 2 weeks |
World Bleeding Disorders Registry

Study Overview
=================
Brief Summary
-----------------
The WBDR is an international observational disease registry of patients with hemophilia. It will provide a platform for a network of hemophilia treatment centres (HTCs) around the world to collect uniform and standardized patient data and guide clinical practice. With informed consent from the patient, the WBDR stores anonymous data about the person's disease, such as hemophilia type and severity, symptoms, and treatment.

Detailed Description
-----------------
The WBDR is a prospective, global registry of patients diagnosed with hemophilia A and B. Following the success of a pilot study, implementation of the full scale WBDR is underway. The goals are to enroll at least 200 HTCs from more than 50 countries, and at least 10,000 people with hemophilia, during the first five years, aiming for representation of patients from around the world and from all levels of access to care. Minimal criteria for participation of HTCs include access to reliable internet, human resources for data entry and commitment to long-term enrolment and follow-up of patients. The WBDR database is being developed through a collaboration between the WFH, Karolinska Institute and Health Solutions. By combining data from countries around the world, the WBDR will provide a large amount of real world data, on which researchers can address important scientific and clinical issues. The World Bleeding Disorders Registry (WBDR) is intended to fill existing gaps in knowledge by collecting real world data on the patient clinical experience around the globe.

Official Title
-----------------
World Bleeding Disorders Registry

Conditions
-----------------
Hemophilia A, Hemophilia B, Von Willebrand Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of participating Hemophilia Treatment Centres with Hemophilia A or B, or von Willebrand Disease Exclusion Criteria: none
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 |
| --- | --- | --- |
| Number of participants recruited |  | 5 years | 
| Number of participating Hemophilia Treatment Centres |  | 5 years | 
| Number of participating countries |  | 5 years |
Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study aims to investigate the utility of Pivotal Response Treatment (PRT), a behaviorally derived intervention, to improve the quality and frequency of communication and social engagement of toddlers with siblings who have an autism spectrum disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social interaction between 12 and 15 months of age.

Official Title
-----------------
Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder

Conditions
-----------------
Autism Spectrum Disorders

Intervention / Treatment
-----------------
* Behavioral: Infant Toddler Years PRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: toddlers, age 12 - 15 months, who have an older sibling with ASD delays of at least 1.5 standard deviations in communication (receptive/expressive language) based on developmental testing scores that exceed the ASD cutoff on standardized measures of social-communicative behavior Exclusion Criteria: physical or neurological disorder (e.g., seizures, cerebral palsy)

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 15 Months

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: Infant Toddler Years PRT<br>Infant Toddler PRT in an evidence-based, manualized treatment for children with autism spectrum disorder that involves specific motivational behavioral procedures adapted to be developmentally appropriate for 12-15 month old infants who present with developmental delays. | Behavioral: Infant Toddler Years PRT<br> <br> * Other names: Pivotal Response Treatment;|
| No Intervention: Community Treatment<br>Community Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a novel behavioral treatment | Assessment of Outcome: Attendance. Attendance to parent education sessions will be recorded by the therapist. Parent utilization. To assess the acceptability of the PRT approach, parents will be asked to keep a weekly log of procedure use, including overall estimated duration and choice of activities. | 24 months | 
| Acceptability of a novel behavioral treatment | Assessment of Outcome: Parent satisfaction. At post-treatment, parents will be asked to complete a Likert-scale and short response questionnaire rating their satisfaction with various aspects of the program | 24 months |
Retrospective of Children With ADHD and Cardiac Symptoms

Study Overview
=================
Brief Summary
-----------------
There is some evidence suggesting ADHD medication interaction could result in mild myocardial ischemia/infarct.

Detailed Description
-----------------
Children with no previous cardiac history who have been on Adderall for ADHD, have developed acute cardiac symptoms after the addition of Straterra for the treatment of ADHD. We wish to do a study of the medication interactions of Straterra and other ADHD medications focusing on the cardiac manifestations. We will collect the following information on each patient: Medical Record Number, Account number, Dates of Admission, Discharge, Treatment or Death, Information Regarding Cardiac Signs and Symptoms, Medication Information, Age, Weight, Diagnoses

Official Title
-----------------
A Retrospective Study of Children With ADHD and Cardiac Symptoms

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADHD myocardial ischemia/infarct no previous cardiac history added Straterra already taking Adderall Exclusion Criteria: those who do not meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum 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
-----------------
pediatric, cardiac, ADHD, Adderall, Straterra
Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

Study Overview
=================
Brief Summary
-----------------
The improvement of conventional imaging techniques has led to an increased detection rate of different adrenal tumors. Since those tumors can belong to a variety of entities the therapeutic consequences also show considerable variation. In order to definitely determine the type of tumor, invasive procedures like CT guided biopsies are often required, which could be avoided by a tumor specific imaging method. The presently available scintigraphic procedures are either time consuming and lead to high radiation exposure or are technically demanding. The steroidogenic enzymes CYP11B1 (11ß-hydroxylase)and CYP11B2 (aldosterone synthase)are expressed exclusively in the adrenal cortex and therefore represent suitable targets for a specific imaging technique. In our project we evaluate 123I-Iodometomidate which binds to both CYP11B enzymes as radiotracer for adrenal scintigraphy.

Conditions
-----------------
Adrenal Tumor, Adrenocortical Carcinoma

Intervention / Treatment
-----------------
* Drug: 123I-Iodometomidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adrenal tumor seen by CT or MRT-scan with diameter of at least 2 cm or patient with adrenocortical carcinoma and suspected metastasis or local recurrence or patients with primary hyperaldosteronismus and adrenal tumour > 1 cm Hormonal work up of of the adrenal tumor according to ENS@T (European network for the study of adrenal tumours)-criteria Age ≥ 30 Jahre Effective contraception (pearl index <1%) Written informed consent Exclusion Criteria: Pregnancy or breast feeding Renal insufficiency (serum creatinine > 2,0 mg/dl or MDRD < 60 ml/min) Known allergy to etomidate or constituents of the test drug

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 123I-Iodometomidate|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
-----------------
adrenocortical carcinoma (ACC), adrenal tumor, metastastic adrenocortical carcinoma
Prevalence of Lactose Intolerance Following Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
It is currently assumed that all patients are lactose intolerant post bone marrow transplantation. This pilot study is to assess what the incidence of lactose intolerance is after bone marrow transplantation in children. This will be done using a lactose breath test.

Detailed Description
-----------------
All pediatric patients over the age of 4 years who are scheduled for a stem cell transplant will be approached to assess whether what the incidence of lactose intolerance is in the post transplant period and how quickly recovery occurs. A baseline lactose and lactulose breath test will be performed followed by repeat lactose breath tests starting 2 weeks after day 0 and repeated every fortnight for 10 weeks. Stool pH and reducing substances will be checked at the time of the breath tests to see if there is any correlation.

Official Title
-----------------
Prevalence of Lactose Intolerance Following Stem Cell Transplantation in Pediatric Patients.

Conditions
-----------------
Lactose Intolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients planned to undergo a stem cell transplant. Exclusion Criteria: Refusal to participate Unable to perform breath tests on request (generally under the age of 4 years.)

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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
-----------------
Pilot, pediatric, stem cell transplant, lactose intolerance
Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals

Study Overview
=================
Brief Summary
-----------------
Vaccination remains the main promising measure to fight against the COVID-19 pandemic. The presumed efficacy of the vaccines is quite remarkable since it varies between 62 and 95%. There is increasing evidence that sex-specific effects may lead to different outcomes of vaccine safety and efficacy. However, sex-disaggregated data after COVID-19 vaccine are lacking. The first purpose of the study is to determine antibody titers against SARS-CoV-2 spike after COVID-19 vaccination. The secondary purpose is to identify predictor factors of immune response including age, gender and biological factors.

Official Title
-----------------
Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals

Conditions
-----------------
COVID-19 Vaccines

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Any person, male or female, over 18 years of age who underwent vaccination and anti-SARS-CoV-2 serological test after vaccination having already given their consent for their biological resources to be: stored in a biocollection of the Microbiology Technical Platform (PTM) having received an approval from the CPP Est-IV and declared to the Ministry of Education and Research under reference No. DC2009-1002; subsequently reused, as well as the anonymized associated data, for research purposes Exclusion Criteria: Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.) Person under safeguard of justice Person under guardianship or curatorship-

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 |
| --- | --- | --- |
| Study of the relationship between the serological response to the COVID-19 vaccine and the demographic characteristics of the patient |  | up to 1 month post-vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, SARS-CoV-2, Vaccine, Humoral response, Anti-spike antibodies, Neutralizing antibodies, Gender
Drug Interaction Oral Contraceptive Pill (OCP)

Study Overview
=================
Brief Summary
-----------------
To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects

Official Title
-----------------
Effect of BMS-650032 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri- Cyclen (R)) in Healthy Female Subjects

Conditions
-----------------
Hepatitis C Virus

Intervention / Treatment
-----------------
* Drug: Ortho Tri-Cyclen®
* Drug: BMS-650032


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Females, 18-40 years, BMI 18 - 32kg/m². Must use an acceptable method of contraception to avoid pregnancy throughout the study and 8 weeks after last dose of study drug Exclusion Criteria: Abnormal pap smear within 1 year prior to day 1 Any significant or chronic uncontrolled medical illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A - Ortho Tri-Cyclen®<br>1 to 28 days | Drug: Ortho Tri-Cyclen®<br>* Tablets, Oral, 1 Tablet, once daily<br>|
| Active Comparator: Arm B - Ortho Tri-Cyclen®<br>29 to 56 days | Drug: Ortho Tri-Cyclen®<br>* Tablets, Oral, 1 Tablet, once daily<br>|
| Active Comparator: Arm C - Ortho Tri-Cyclen® + BMS-650032<br>Ortho Tri-Cyclen®: 57 to 77 days BMS-650032: 68 to 77 days | Drug: Ortho Tri-Cyclen®<br>* Tablets, Oral, 1 Tablet, once daily<br>Drug: BMS-650032<br>* Tablets, Oral, 600 mg, BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU) |  | 24 hours of dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered |  | Safety will be assessed through day 78 | 
| To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination |  | PK assessments will be done on Day 49, 50, 77 and 78 |