linjc16/ctgov huggingface dataset:
Using Sugar Water to Relieve Pain in Infants

Study Overview
=================
Brief Summary
-----------------
This study will examine the safety and effectiveness of sugar water to relieve pain in newborn infants during painful blood tests and injections. Infants of diabetic mothers who receive repeated blood tests will be compared to infants of healthy mothers who receive routine painful procedures. We believe that administration of sucrose analgesia for every painful cutaneous procedure performed after delivery will result in less pain during the newborn infant screening test.

Official Title
-----------------
Effectiveness of Sucrose Analgesia in Reducing Pain Responses in Infants Born to Diabetic and Non-diabetic Mothers: A Randomized Controlled Trial

Conditions
-----------------
Pain, Infant, Newborn, Diabetes

Intervention / Treatment
-----------------
* Drug: Sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy newborn infants ≥36 weeks gestation infants born to mothers with diabetes (type 1, type 2, or gestational diabetes that is diet-controlled or insulin-dependent)and infants born to mothers without diabetes Exclusion Criteria: Admission to the neonatal intensive care unit plan to undergo circumcision during the study period major congenital or neurological anomalies clinical diagnosis of birth asphyxia or seizures receiving analgesics or sedatives

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (effectiveness): |  |  | 
| - Effectiveness of sucrose for repeated heel lances |  |  | 
| - Effectiveness of sucrose in decreasing anticipatory pain responses during venipuncture |  |  | 
| - Effectiveness of sucrose in decreasing pain response during Vitamin K injection |  |  | 
| - Determination of relationship between painful procedures and infant response during routine care procedures |  |  | 
| (safety): |  |  | 
| - Incidence of vomiting during administration of sucrose |  |  | 
| - Oxygen saturation during administration of sucrose |  |  | 
| - Serum Glucose concentrations in infants of diabetic mothers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sucrose, analgesia, pain, neonates, diabetes
Evaluating the Influence of Apnea on Cardiac Function Using Cardiac Magnetic Resonance Imaging.

Study Overview
=================
Brief Summary
-----------------
Former studies revealed a distinct pattern of changes in circulation during deliberate apnea. Blood pressure rises significantly often accompanied by bradycardia. Further studies confirmed a massive increase of total vascular resistance as it also happens in shock to maintain perfusion of heart, lung and brain. This study is to determine the exact alterations of the cardiac function during this reaction, show the redistribution of blood volume in apnea and evaluate possible longterm effects on the central nervous system caused by repeated apnea via magnetic resonance imaging.

Official Title
-----------------
Evaluating the Influence of Apnea on Heart Function With Strain Analysis and Measurement of Fibrosis Derived From T1-mapping Using Cardiac Magnetic Resonance Imaging (MRI).

Conditions
-----------------
Physiological Changes in Deliberate Apnea

Intervention / Treatment
-----------------
* Device: magnetic resonance imaging (MRI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being able to hold breath deliberately at least 4,5 minutes Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deliberate Apnea Group<br>Subjects undergo maximum apnea. | Device: magnetic resonance imaging (MRI)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Function: Duration of Apnea | Alteration of cardiac function in subjects undergoing maximum apnea. | every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements | 
| Mean Blood Flow Measurement Under Apnea Using MRI | Blood flow pattern in subjects undergoing maximum apnea. | Every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements |
ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer

Official Title
-----------------
A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer

Conditions
-----------------
Metastatic Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: ACP-196
* Drug: ACP-196 in combination with pembrolizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women ≥ 18 years of age ECOG performance status of 0 or 1 Histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma that is unresectable or metastatic Prior therapy with ≥ 1 systemic chemotherapy regimen for unresectable or metastatic pancreatic cancer or unwilling/unable to receive systemic chemotherapy Exclusion Criteria: Prior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years. Known central nervous system (CNS) metastases and/or carcinomatous meningitis Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction Breastfeeding or 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: Experimental: Arm 1<br>ACP-196 alone | Drug: ACP-196<br> <br> |
| Experimental: Experimental: Arm 2<br>ACP-196 in combination with pembrolizumab | Drug: ACP-196 in combination with pembrolizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | Every 12 weeks for up to 2 years. |
Detection of Colorectal Adenomas in Côte-d'Or

Study Overview
=================
Brief Summary
-----------------
Previous studies have shown geographic disparities in the detection of colorectal adenomas in Côte-d'Or, with an impact of the distance from the general practitioner and an ecological deprivation index (EDI). On the other hand, the extremely low detection rates for these lesions in everyday practice before the implementation of organized screening for colorectal cancer in the Côte-d'Or were shown. One of the aims of this screening is to reduce socio-geographic inequalities in access to care and prevention. Yet, participation in screening also varies depending on the socio-economic level. In this context, the Côte-d'Or Polyps Registry, the only body to have data for the pre-screening period (before 2003), will make it possible to determine whether the implementation of organized screening led to the elimination of socio-geographic disparities concerning the detection of adenomas.

Official Title
-----------------
Detection of Colorectal Adenomas in Côte-d'Or: Impact of Organized Screening on Socio-geographic Disparities

Conditions
-----------------
Colorectal Adenoma

Intervention / Treatment
-----------------
* Other: screening data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study population will include all patients residing in Côte d'Or with a first colorectal adenoma (including in situ carcinomas) diagnosed between 01/01/1997 and 31/12/2008 Exclusion Criteria: Absence of address history (or suspected history) of previously resected adenoma personal history of colorectal cancer or colorectal cancer discovered in the year following resection of the adenoma (because the cancer was probably not seen at the initial colonoscopy) familial polyposis or known HNPCC chronic inflammatory bowel disease

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 74 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 |
| --- | --- |
| colorectal adenoma<br> | Other: screening data<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rates for colorectal adenomas |  | through the study completion up to 2 years |
HT-0712 vs. Placebo in Subjects With Age-Associated Memory Impairment (AAMI)

Study Overview
=================
Brief Summary
-----------------
This is a Phase 2 randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy of HT-0712 in improving memory and cognitive performance in subjects with Age-Associated Memory Impairment (AAMI)

Official Title
-----------------
A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing HT-0712 With Placebo in Subjects With Age-Associated Memory Impairment (AAMI)

Conditions
-----------------
Age-Associated Memory Impairment (AAMI)

Intervention / Treatment
-----------------
* Drug: HT-0712
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Complaints of memory loss in everyday life Performance at least one standard deviation below the mean established for young adults on standardized memory tests Absence of dementia Intact global intellectual function Main Exclusion Criteria: Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease Evidence of dementia Evidence of psychiatric or neurological disorder that could influence cognition or contributed to the subject's memory loss Use of any drugs that could influence cognition

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: HT-0712 (50mg)<br>HT-0712 capsules administered once daily. | Drug: HT-0712<br> <br> |
| Placebo Comparator: Placebo<br>Placebo capsules administered once daily. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Drug Research™ (CDR) Study Specific Test Battery |  | Weekly over the course of 6-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paired Associated Learning and Memory Test |  | Weekly over the course of 6-weeks | 
| Subject Global Impression Scale of Cognition (SGI-Cog) |  | Weekly over the course of 6-weeks |
Topical Penlac Nail Lacquer for Onychomycosis in Children

Study Overview
=================
Brief Summary
-----------------
Five months of therapy is sufficient to treat onychomycosis in children. Topical therapy of onychomycosis in children with Penlac nail lacquer has comparable efficacy and a superior cost and safety profile compared to systemic therapy.

Detailed Description
-----------------
Therapeutic trials for the treatment of onychomycosis have been conducted in the adult population, but there is limited data available in the pediatric population.

Official Title
-----------------
A Prospective, Double-blind, Placebo-controlled Trial of Topical Penlac Nail Lacquer for Therapy of Onychomycosis in Children

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Drug: Ciclopirox
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between the ages of two and sixteen years Clinical diagnosis of toenail onychomycosis involving at least 20% of one nail plate Positive DTM reading or fungal culture for onychomycosis-either dermatophytes or non-dermatophyte mold Consent to participate in the study Women of child-bearing potential must have a negative urine pregnancy test at the baseline visit and be willing to practice effective contraception for the duration of the study. Exclusion Criteria: Children with allergy to Penlac or one of its ingredients Structural deformity of target nail plate Presence of active psoriasis or severe foot eczema Presence of immunodeficiency disorder Concurrent immune suppressive therapy or immune suppressive therapy within the last 3 months Previous systemic antifungal therapy within the last 6 months Previous topical antifungal therapy within the last 14 days Female subjects who are pregnant, nursing mothers, those planning a pregnancy during the course of the study, or who become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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: topical Penlac nail lacquer<br>3-1 randomization of active to placebo | Drug: Ciclopirox<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycological cure or global evaluation of 2 or less Mycological Cure |  | Week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated cost of therapy |  |  |
Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS

Study Overview
=================
Brief Summary
-----------------
Multiple Sclerosis (MS) is a chronic, autoimmune, neurodegenerative disease; clinical events are mainly attributed to myelin destruction and inflammatory of the central nervous system. The diagnosis resides in clinical and radiological criteria according to 2017 McDonald criteria. Once the diagnosis of MS has been made, treatment should be initiated promptly, in order to delay the onset of severe disability in the long-term, even more ocrelizumab are a treatment of high efficacy. Ocrelizumab is used as a first-line or second-line treatment in Relapsing Remitting MS (RRMS) It is an anti-CD20 monoclonal antibody that provides rapid depletion of circulating CD20+ B lymphocytes by complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity. The main objective is the retrospective evaluation of the impact of ocrelizumab on the outcome of MS. The secondary objective is the search of predictive factors of response to treatment.

Official Title
-----------------
Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Suffering from relapsing-remitting MS (RRMS) Supported in a neurology department at Strasbourg or Nancy University Hospital between 10/01/2018 and 11/31/2020. Treated with ocrelizumab 600mg every 6 months during the period from 01/10/2018 to 01/05/2020. Have had an M0, M3 / M6 and M12 MRI after initiation of treatment. Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research Exclusion criteria: Subject having expressed opposition to participating in the study Primary progressive multiple sclerosis (MS-PP), secondarily progressive (MS-SP) Subject not meeting all the inclusion criteria Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.) Subjects under safeguard of justice Subject under guardianship or guardianship

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 of the impact of ocrelizumab used in patients with multiple sclerosis |  | Files analysed retrospectively from October 01, 2018 to November 31, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MS-RR, Ocrelizumab, Switch
Anemia and Red Blood Cells Transfusion in Oncological Surgery

Study Overview
=================
Brief Summary
-----------------
Oncologic patients experience anemia and anemia is associated with poor prognosis. Transfusion is associated with adverse events, and equipoise remains on the optimal transfusion strategy in oncologic patients in surgical setting. The primary objective of this study is to determine the impact of anemia and red blood cells (RBC) transfusion on post-operative complications and mortality.

Detailed Description
-----------------
Between 36 and 75% of oncologic patients experience anemia and anemia is associated with poor prognosis. Up to 40% of surgical oncologic patients receive red blood cells (RBC). However, transfusion is associated with adverse events, and equipoise remains on the optimal transfusion strategy in oncologic patients in surgical setting. The primary objective of this study is to determine the impact of anemia and red blood cells (RBC) transfusion on post-operative complications and mortality. This is a retrospective, single center study. All adults admitted to the intensive care unit (ICU) after oncologic surgery within the study period are eligible.

Official Title
-----------------
Impact of Perioperative Anemia and Red Blood Cells Transfusion on Post-operative Complications After Oncological Surgery

Conditions
-----------------
Anemia, Surgery, Oncology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgery for cancer Admission to intensive care Exclusion Criteria: no 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mortality or any respiratory, cardiac, renal, thromboembolic, infectious and/or hemorrhagic post operative complications | mortality or any respiratory, cardiac, renal, thromboembolic, infectious and/or hemorrhagic post operative complications | 30 DAYS (hospital discharge) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
red blood cells transfusion