linjc16/ctgov huggingface dataset:
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450) Normal lab parameters Are willing to give informed consent Have previously used and either were intolerant to or lost response to infliximab Exclusion Criteria: History of certain types of cancer Diagnosis of ulcerative colitis Pregnant female or breast feeding subjects Known obstructive strictures Surgical bowel resection in the past 6 months History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis) History of poorly controlled medical conditions Specific doses and durations of Crohn's medications Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction of clinical remission (CDAI score < 150 at Week 4) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response measured as |  |  | 
| Decrease in Baseline CDAI score >= 70 points at Week 4 |  |  | 
| Decrease in Baseline CDAI score >= 100 points at Week 4 |  |  | 
| Changes in IBDQ scores at Week 4 |  |  |
Thromboelastometry in Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Thromboelastometry better assess coagulation than standard coagulation test in patients undergoing ortothopic liver transplantation. In a post-hoc analysis from a randomized study recently conducted by our group, presurgical values of MA10 Extem < 35 mm are highly predictive of RBC administration , with no further improvement over MA10 Extem >40 mm ; suggesting that MA10 Extem between 35-40 would be the optimal range to manage blood product administration. The aim of the study is to validate this result in a prospective cohort of patients submitted to ortothopic liver transplantation.

Official Title
-----------------
Transfusion Prediction Model in Orthotopic Liver Transplantation Based on Thromboelastometry: Prospective Validation Study.

Conditions
-----------------
Liver Transplant Disorder, Coagulopathy

Intervention / Treatment
-----------------
* Other: Fibrinogen and/or platelets administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presurgical hemoglobin < 13 d/L and clot firmness at 10 minutes Extem < 35 mm Exclusion Criteria: Previous thrombosis Antithrombotic treatment No consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Prospective cohort<br>Fibrinogen and/or platelet administration | Other: Fibrinogen and/or platelets administration<br>* Fibrinogen and/or platelets administration to maintain clot amplitude at 10 minutes of the thromboelastometry between 35-40 mm along liver transplant procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red blood cell transfusion |  | until 24h after liver transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis | Thrombosis will be assessed clinically and confirmed by ultrasonographic exam | 28 days after liver transplant |
Reproducibility of a New Practical Newborn Behavioral Observation Scale

Study Overview
=================
Brief Summary
-----------------
Neonatal intensive care is necessary for the survival of preterm baby. Several studies show the deleterious effect on the immature brain due to stimulations caused by the environment and hospital care. However, a specific and individualized support to the development during the first weeks of this preterm patient has a positive effect on newborn development. A new practical newborn behavioral observation scale has been developed by the investigators care unit in order to adapt care and individualized support to the development for each patient. The goal of this study is to estimate the external reproductibility of this scale by experimented nurse in order to implement an individualized care program.

Official Title
-----------------
Evaluation of the Reproducibility of a New Practical Newborn Behavioral Observation Scale in Order to Implement an Individualized Care Program

Conditions
-----------------
Premature Newborn

Intervention / Treatment
-----------------
* Other: quotation of the newborn behavioral observation scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: term of birth between 24 and 33 weeks of amenorrhea weight less than 1500g birth; postnatal age between 1 and 60 days consent form of parent in order to film their baby Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 60 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: quotation of the newborn behavioral observation scale|quotation of the newborn behavioral observation scale by 12 experimented nurses. Patient will be filmed during an usual care and nurses will quote the scale thanks to the video.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of the external reproductibility of a new practical newborn behavioral observation scale |  | up to 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nursing care, observational scale, neonate, premature infant, developmental care
12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension

Study Overview
=================
Brief Summary
-----------------
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).

Detailed Description
-----------------
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.

Official Title
-----------------
A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: RVT-101 35 mg tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed last on-treatment visit of the lead-in study RVT-101-3001 Exclusion Criteria: Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 86 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: RVT-101 35 mg tablets<br>once daily, oral tablets | Drug: RVT-101 35 mg tablets<br>* once daily, oral tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments | The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments | Baseline to 12 months or Early Termination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, RVT-101, donepezil
Joint Consultation Between a Neurologist and a Clinical Psychologist

Study Overview
=================
Brief Summary
-----------------
Joint consultations appeared a few years ago in routine medical practice, but they are still not widely used and rarely evaluated. The primary purpose of the study is to evaluate the impact for the patient of the presence of a clinical psychologist during the joint consultation. The secondary purpose is to evaluate the impact for the patient and for the neurologist of the presence of a clinical psychologist during the joint consultation

Official Title
-----------------
Evaluation of a Joint Consultation Between a Neurologist and a Clinical Psychologist, Dedicated to Neurodegenerative and/or Neurogenetic Disorders

Conditions
-----------------
Neurodegenerative Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with a neurodegenerative and/or neurogenetic disease adult patient Exclusion Criteria: dementia age <18 years

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 |
| --- | --- | --- |
| Patient satisfaction after the consultation assessed by 3 questions on a Likert scale | 5-point Likert scale from which to select a response : Very satisfied. Moderately satisfied. Neither satisfied nor dissatisfied. Moderately dissatisfied. Very dissatisfied. | After consultation et 1 to 3 months later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Joint neurologist, psychologist consultation, neurodegenerative and/or neurogenetic disease
Accuracy of Endoscopists in Predicting Polyp Pathology

Study Overview
=================
Brief Summary
-----------------
The study purpose is to assess the accuracy of experienced endoscopists at a community hospital in predicting histological types of polyps resected at colonoscopy using white light. Patients 50 years or older undergoing first-time screening colonoscopy will be included in this observational study.

Detailed Description
-----------------
The study purpose is to assess the accuracy of experienced endoscopists at a community hospital in predicting histological types of polyps resected at colonoscopy using white light. The study will be conducted at Good Samaritan Hospital and TriHealth Surgery Center West. Study participants include patients 50 years or older undergoing first-time screening colonoscopy. This is an observational study and does not involve any patient interventions. After completing the colonoscopy, the endoscopist will document their prediction of the polyp type. The polyp type predicted by the endoscopist will be compared to the polyp type documented in the pathology report to determine accuracy. It is estimated that study enrollment will take 6 months.

Official Title
-----------------
Accuracy of Endoscopists in Predicting Polyp Pathology

Conditions
-----------------
Resected Polyp

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Exclusion Criteria: first degree relative diagnosed with colorectal carcinoma at age 59 or under New onset of iron deficiency anemia (within past 3 months) Abnormal imaging of colon within past 3 months Pregnant women Inadequate visualization reported by endoscopist

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing screening colonoscopy<br>Patients undergoing first-time colonoscopy using white light with at least 1 polyp resected. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp prediction accuracy | Accuracy of predicting polyp type | up to 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, polyp, endoscopist
Pap Smear Research Study

Study Overview
=================
Brief Summary
-----------------
The principal hypothesis of this study is that HPV testing and/or p16 testing, either alone or in combination or associated with a Pap smear, will demonstrate greater specificity for clinically significant precancerous disease than will a Pap smear alone and that these tests will be of comparable or superior sensitivity than the Pap smear.

Official Title
-----------------
Evaluation of the Role of Human Papillomavirus Testing and p16 Expression in the Management of Patients Undergoing Cervical Cancer Screening

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Other: Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Ability to speak and clearly understand English Female patients Exclusion Criteria: No previous history of Cervical Cancer Treatment(LEEP,Laser,Cone etc.) Women who have had Pap smears within the previous 10 months Women under the age of 18. Women who are pregnant. Inability to give informed consent in English

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Healthy patients screened for cervical cancer | Other: Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)<br>* If positive (Pap smear, HPV and/or p16) patients will be scheduled for 3 colposcopy follow up visits (1,12,18 months)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide cervical cancer screening (Pap smear, HPV test and/or p16 tests) to determine whether further intervention (colposcopy) is required |  | 1st visit, 12 months, 18 months follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pap test, HPV, Healthy patients screened for cervical cancer tests.
Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence.

Official Title
-----------------
Randomized Clinical Trial Comparing TVT SECUR System (TVT S) and Trans Vaginal Obturator Tape (TVT-O) for Surgical Management of Stress Urinary Incontinence

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: transvaginal obturator tape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with symptoms of stress urinary incontinence and a positive cough test who require surgical management. Cough test is positive when leakage of urine is seen from the urethra synchronously with the patient performing a cough or valsalva manuver with a comfortably full bladder in the lying or standing position. Exclusion Criteria: Women with predominantly symptoms of urge urinary incontinence Presence of prolapse greater than Pelvic organ prolapse quantification (POPQ) Stage 1 or prolapse requiring surgery Detrusor overactivity on cystometrogram at urodynamic testing Previous surgery for incontinence Intrinsic sphincter deficiency (MUCP<20 cm H2O or Q -tip <30o) Voiding dysfunction with postvoid residual >100 cc
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TVT SECURE<br>sling | Procedure: transvaginal obturator tape<br> <br> |
| Active Comparator: TVT O<br>sling | Procedure: transvaginal obturator tape<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective cure as defined by the cough test at one year from surgery |  | one year |
Comparison Study Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers

Official Title
-----------------
Unblinded Comparison Study for Relationship and Reproducibility Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring, in Patients With Acid-related Diseases and Healthy Volunteers

Conditions
-----------------
Gastric Acid-related Diseases, Healthy

Intervention / Treatment
-----------------
* Drug: Calcium (13C)Carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Gastric Acid-related diseases like peptic ulcer or gastroesophageal reflux disease in investigator's judgment Healthy subjects who are determined no history of Helicobacter pylori infections Exclusion Criteria: Patients with hypercalcemia Patients with hypothyroidism Patients with hyperparathyroidism History of upper gastrointestinal surgery or resection Any condition would limit the subject's ability to complete 24-hour gastric pH monitoring

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C13-CAC<br> | Drug: Calcium (13C)Carbonate<br>* Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 13CO2 concentration in expired air | 13CO2 concentration in expired air, 13CO2 excretion rate in expired air as well as the pharmacokinetic parameters (Cmax, AUCt, AUC∞, tmax, λz, and t1/2) determined from the 13CO2 concentration in expired air and 13CO2 excretion rate in expired air | 5，10，15，20，25，30，40，50，60，80，100 and 120minutes after C13-CAC administration | 
| 24-hour gastric pH | Gastric pH immediately before taking the C13-CAC and mean gastric pH from a specified time point to the time before C13-CAC administration | from completion of pre-study examination to before C13-CAC adminitration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients, Volunteers