linjc16/ctgov huggingface dataset:
A Pilot Study of the Neural Correlates of Treatment Effect on Nicotine Craving

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gather pilot data to determine feasibility of and guide the development of a larger clinical trial investigating the effects of topiramate as an adjunct to nicotine replacement therapy and behavioral counseling in smoking cessation treatment. It is hypothesized that topiramate will decrease nicotine craving and result in improved outcomes for smoking cessation.

Official Title
-----------------
Nicotine Craving: Neural Correlates of Treatment Effect - A Pilot Study

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Drug: Topiramate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, between ages of 18-55 Meets DSM-IV criteria for nicotine dependence Smoke at least 20 cigarettes per day Motivated to quit smoking Exclusion Criteria: Serious or unstable medical conditions Current psychiatric disorder requiring medication or treatment Taking medication that create risk of interaction with study drug Current participation in another smoking cessation treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.

Study Overview
=================
Brief Summary
-----------------
This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.

Official Title
-----------------
Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients. An Open, Randomized Multi-center Study.

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: Meropenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged ≥ 18, requiring intensive care treatment related to secondary nosocomial sepsis, who require potent broad spectrum intravenous antibiotic therapy. Exclusion Criteria: -

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days from randomization to recovery from sepsis among those patients who survived the trial period |  |  | 
| Endpoint considered in conjunction with observed mortality rates to determine whether any reduction in time to recovery from sepsis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days from randomization to ready to discharge from the ICU |  |  | 
| Number of days from randomization until patient is discharged from the ICU |  |  | 
| Number of days on first line antibiotic therapy |  |  | 
| Number of days from randomization until patient is discharged from hospital |  |  | 
| Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy |  |  | 
| Proportion of all patients who are ready to discharge from the ICU following antibiotic therapy |  |  | 
| Mortality rate due to all causes in the meropenem group and the standard antibiotic therapy group |  |  | 
| Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group |  |  | 
| Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic Therapy, sepsis treatment, Meropenem
An Observational Study of CellCept (Mycophenolate Mofetil) in Renal Allograft Recipients

Study Overview
=================
Brief Summary
-----------------
This observational survey study will capture all renal transplant patients in Serbia who are currently receiving CellCept (mycophenolate mofetil) as part of their immunosuppressive protocol.

Official Title
-----------------
Observational, Non-interventional Survey of Renal Allograft Recipients Receiving CellCept as Part of Their Immunosuppressive Protocol

Conditions
-----------------
Kidney Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Recipients of renal allograft Patients receiving CellCept Exclusion Criteria: N/A

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average dose of CellCept used in immunosuppressive protocols in Serbia |  | 9 months | 
| Average dose of concomitant immunosuppressive drugs |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average duration of post-transplant period for patients in Serbia receiving CellCept |  | 9 months |
Pathways of Patients Followed in Palliative Care at the University Hospital of Strasbourg: a Retrospective Pilot Study

Study Overview
=================
Brief Summary
-----------------
In view to develop a study design for a study that would analyze the pathways of palliative care prospectively, this work will identify the individual factors that would be significantly associated with typical pathways of palliative care.

Official Title
-----------------
Pathways of Patients Followed in Palliative Care at the University Hospital of Strasbourg During the Year 2020: a Retrospective Pilot Study

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient met by the palliative care mobile team or admitted in palliative care unit Patient who died between January 2020 and December 2020. Exclusion Criteria: Minors and incapacitated adults, or deprived of liberty Patient who explained their disagreement with the use of medical data for research purposes.

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 |
| --- | --- | --- |
| Retrospective study describing the patient care pathway |  | The files analyzed retrospectively concern the period from January 01, 2020 to December 31, 2020. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliative care, Pathways
Exploring Interactions Between Growth Hormone and the Microbiome

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to characterize the microbiome and metabolomics of children with Growth Hormone (GH) deficiency, prior GH treatment initiation and compare it to healthy children

Official Title
-----------------
Exploring Interactions Between Growth Hormone and the Microbiome

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Other: Non Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with GH deficiency Exclusion Criteria: Turner syndrome End state renal disease (ESRD) Prader-Willi syndrome Systemic illness Antibiotics/Antifungal in the last 3m

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Children who receive Growth hormone treatment. Non Interventional | Other: Non Interventional<br>* Non Interventional<br>|
| Control group<br>Healthy children . Non Interventional | Other: Non Interventional<br>* Non Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the microbiome population following Growth hormone treatment |  | 1 year |
Transcutaneous pO2, Transcutaneous pCO2 and Central Venous SO2 Variations to Define Fluid Responsiveness

Study Overview
=================
Brief Summary
-----------------
Fluid challenge is often carried out in critical ill patients. Its responsiveness usually requires invasive monitoring. To use non-invasive methods is very tempting. Investigators hypothesize that transcutaneous pO2,transcutaneous pCO2 and Central Venous SO2 variations provide feasible estimation on fluid responsiveness in critical ill patients.

Conditions
-----------------
Hypotension, Shock, Fluid Challenge, Fluid Responsiveness

Intervention / Treatment
-----------------
* Other: fluid challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older ICU patients; Septic shock; Monitored with PICCO or Swan-Ganz catheter; The decision of fluid challenge made by the treating physician; Exclusion Criteria: Evidence of fluid overload; Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Septic shock<br>Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation. | Other: fluid challenge<br>* A bag of 500ml of normal saline or 4% gelatin (Gelofusine, B. Braun Medical (Suzhou) Company Limited, Suzhou, China) is infused within 15 minutes using a bag pressurized to 300 mmHg. All other treatments, including maintenance fluids, dose of vasoactive agents and ventilator settings, remain unchanged during the study period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid Responsiveness | Increase in cardiac index ≥ 10% after fluid challenge | Immediately after fluid challenge, average 5 minutes |
Effect of Ulinastatin on Postoperative Renal Function in Patients Undergoing Robot-assisted Laparoscopic Partial Nephrectomy

Study Overview
=================
Brief Summary
-----------------
Ulinastatin reduces systemic inflammatory responses and protects organs from ischemia/reperfusion-induced injury. The aim of this study is to evaluate the effect of ulinastatin on postoperative renal function in patients undergoing robot-assisted laparoscopic partial nephrectomy. Seventy patients, aged 20 to 79 years, scheduled for robot-assisted laparoscopic partial nephrectomy will be divided into ulinastatin (n=35) and control (n=35) groups. Randomly selected patients of the ulinastatin group are given ulinastatin. In contrast, patients in the control group receive an equivalent volume of normal saline as a placebo. The primary endpoints are postoperative renal function measured by serum creatinine, cystatin C, and urine output.

Official Title
-----------------
Effect of Ulinastatin on Postoperative Renal Function in Patients Undergoing Robot-assisted Laparoscopic Partial Nephrectomy

Conditions
-----------------
Renal Mass

Intervention / Treatment
-----------------
* Drug: ulinastatin
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who are scheduled to undergo robot-assisted laparoscopic partial nephrectomy with an American Society of Anesthesiologists (ASA) physical status I-III Exclusion Criteria: Subjects are ineligible if they have severe respiratory or cardiovascular disease, renal insufficiency before operation, cognitive dysfunction, are unable to communicate or speak Korean

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulinastatin group<br>Patients in the ulinastatin group are given ulinastatin during operation. | Drug: ulinastatin<br> <br> |
| Placebo Comparator: control group<br>Patients in the control group receive the same volume of normal saline during operation. | Drug: normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative renal function | Postoperative renal function measured by serum creatinine, cystatin C, and urine output | for 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systemic inflammatory response | the systemic inflammatory response measured by WBC, Neutrophil (%), and CRP | for 3 days after surgery |
Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to evaluate patients' response to neoadjuvant chemotherapy

Detailed Description
-----------------
Neoadjuvant chemotherapy(NAC) is traditionally for locally advanced disease, converting an inoperable to a resectable tumor.In recent years, it has become an option for patients of lower tumor stage to increase the possibility of breast conserving therapy. An effective method to monitor the response to NAC is important.

Official Title
-----------------
Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients undergoing NAC Age: 18-70 yrs Any menopausal status Any hormal receptor status Exclusion Criteria: Failed to retain blood sample before NAC Lost more than 2 blood samples during NAC

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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 |
| --- | --- | --- |
| death of breast cancer | The event is defined as death of breast cancer, which is a separate measure | Follow-up time is estimated to be up to 5 years. The duration is from the date of diagnosis to date of death of breast cancer or date of death of any cause, whichever come first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor recurrence or distant metastasis | The event is defined as breast cancer local recurrence or distant metastasis | Follow-up time is estimated to be up to 5 years.The duration is from diagnosis to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
circulating tumor DNA
The Longevity of Trichuris Trichiura Colonization

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to study the longevity of Trichuris trichiura colonization

Detailed Description
-----------------
The present study investigates the longevity of Trichuris trichiura colonization in a human volunteer as measured by regular fecal sampling.

Official Title
-----------------
The Longevity of Trichuris Trichiura Colonization

Conditions
-----------------
Helminthiasis, Helminth Infection

Intervention / Treatment
-----------------
* Biological: Trichuris trichiura


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The included volunteer is a researcher within parasitology with focus on Trichuris trichiura and Trichiura suis. He planned to infect himself under medical supervision. This was his third self-infection with Trichuris. The only clinical criterion for his inclusion in the study was that he was healthy. Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Trichuris trichiura|Infective eggs from human whipworm, Trichuris trichiura|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faecal egg excretion | Regular monitoring of fecal egg counts by microscopy | 78 weeks |
Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.

Official Title
-----------------
Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy

Conditions
-----------------
Cow Milk Allergy

Intervention / Treatment
-----------------
* Dietary Supplement: Extensively Hydrolyzed formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 1 and 12 months old having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months, whose parent(s) signed the informed consent form Exclusion Criteria: Infants mainly or exclusively breastfed, Infants having a weight at inclusion < 2500g, Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion, Infants fed an amino acid based formula Infants who had an anaphylactic reaction in the past,

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 Months

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: New Thickened Extensively Hydrolyzed formula<br> | Dietary Supplement: Extensively Hydrolyzed formula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients dropped out for intolerance |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cow's milk protein hypersensitivity score |  | 2 weeks | 
| Growth (weight, height, head circumference) |  | 3 months | 
| Growth (weight, height, head circumference) |  | 4 months |
Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections

Study Overview
=================
Brief Summary
-----------------
Carbapenem resistance is a high mortality rate of Klebsiella pneumoniae infection. It has been proved that high-dose carbapenem can reduce mortality and has a certain clinical effect. In this study, a high dose of biapenem was compared to determine whether it had a similar effect than meropenem.

Official Title
-----------------
Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections

Conditions
-----------------
High-dose Biapenem

Intervention / Treatment
-----------------
* Drug: Biapenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU hospitalized for more than 3 days; Biapenem used for more than 3 days Exclusion Criteria: Patients who refuse to be included in the group or pregnant women or under the age of 14 or ICU hospitalized for less than 3 days

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 100 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 |
| --- | --- |
| the death group<br>Through the corresponding treatment, the patients who died within 28 days | Drug: Biapenem<br>* In the course of CRKP treatment, double dose biapenem was selected.<br>|
| the survival group<br>Through the corresponding treatment, the patients who survived within 28 days | Drug: Biapenem<br>* In the course of CRKP treatment, double dose biapenem was selected.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality |  | 2017.01.01-2021.12.31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance rate of pathogenic microorganisms |  | 2017.01.01-2021.12.31 | 
| ICU hospitalization days |  | 2017.01.01-2021.12.31 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High-dose Biapenem, Carbapenem resistance Klebsiella pneumoniae, Clinical Efficacy