linjc16/ctgov huggingface dataset:
A Study to Monitor the Use of an Amino Acid-Based Infant Formula

Study Overview
=================
Brief Summary
-----------------
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.

Detailed Description
-----------------
Prospective, post-market surveillance program to be conducted in the United States (US). Infant will be invited to enroll by their healthcare provider who recommends the use of a free amino acid based infant formula

Official Title
-----------------
A Study to Monitor the Use of an Amino Acid-Based Infant Formula

Conditions
-----------------
Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders, Malabsorption/Maldigestion, Short Bowel Syndrome, Multiple Food Allergies

Intervention / Treatment
-----------------
* Other: Free amino acid infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants who use a free amino acid based Infant formula during their first year of life including: Those that are currently consuming the formula at the time of enrollment Those for whom consumption of the formula is planned At least one parent/guardian is willing to provide written informed consent form (ICF) for participation in the surveillance program Exclusion Criteria: - Infants <37 weeks of corrected gestation age (CGA) at time of enrollment

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Free amino acid infant formula|Patients who will be fed a free amino acid based infant formula|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | To assess the frequency and nature of adverse events in infants consuming a free amino acid based infant formula | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical characteristics | To describe the demographic and clinical characteristics of infants fed a free amino acid based infant formula | 4 months |
A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to document the long-term safety and tolerability after intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who participated in study sNN0031-001

Official Title
-----------------
A Follow-up Study on Safety and Tolerability and Pharmacodynamic Effect, of Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Who Have Previously Been Treated With sNN0031, Using an Implanted Catheter and a SynchroMed® II Pump

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous participation in study sNN0031-001 with completion of 12 study weeks without development of clinically significant safety concerns, defined as being any drug-related or device related serious adverse event that resulted in premature termination of treatment or a medical device incident that could not be resolved during the conduct of study sNN0031-001 The patient has a diagnosis of idiopathic PD The patient has been given written and verbal information about the follow-up study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments The patient has provided written informed consent to participate in the follow-up study Exclusion Criteria: The patient has been included or participates in another clinical study after participation in Study sNN0031-001 The patient has, since participation in study sNN0031-001, had functional neurosurgical treatment for PD (e.g., deep brain stimulation). Patients will only be excluded from participation in the event of a laboratory test abnormality that is indicative of a medical condition requiring treatment which, in the opinion of the investigator, is not compatible with participation in the present study

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| saline<br>Saline administration to patients with idiopathic Parkinson's disease (PD) of moderate severity, who have previously been treated with sNN0031 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | up to 3 years |
Prevention of Hip Fractures With Soft and Hard Hip Protectors

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compliance with and effect of soft and hard hip protectors in Norwegian nursing homes.

Detailed Description
-----------------
Hip fractures are a major cause of disability and functional limitation. Hip protectors have shown to have the potential to lower the risk of a fracture by reducing the impact on the hip region during falls, but low uptake and adherence have been a problem. Changing the hip protector's design might give a higher uptake and adherence. The aim of this study is to compare uptake, adherence and effect of soft and hard hip protectors in Norwegian nursing homes. Because a soft hip protector seems to be more comfortable, we expect a higher uptake and adherence with the soft hip protector, specially when it comes to 24 hour use. If the soft hip protector has the same protective quality as the hard hip protector, the soft hip protector will be a better alternative than the hard one. This cluster randomized study is performed in 18 Norwegian nursing homes in 2 municipalities. The study started May 15. 2006 and will end November 30. 2006. All permanent residents are invited to participate in the study either as a user of hip protector or as a non user.

Official Title
-----------------
Compliance With and Effect of Soft and Hard Hip Protectors in Norwegian Nursing Homes

Conditions
-----------------
Hip Fractures, Prevention

Intervention / Treatment
-----------------
* Device: Hip protectors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all permanent residents in the the participating nursing homes
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hip protectors|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake and adherence with soft and hard hip protectors |  |  | 
| Effect of soft and hard hip protectors in protected and unprotected falls |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip protectors, uptake and adherence, Nursing home residents, efficacy, prevention
Validation of Gene Expression Markers of Renal Allograft Functional Decline

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if certain genes found in a kidney biopsy performed at one-year post transplant can predict which transplanted kidneys will have decreased kidney function within five years post-transplant.

Detailed Description
-----------------
Gene expression profiling is used to study the activity of genes. Each gene has an on/off switch that controls how they are expressed in a cell, as well as a volume control that increases or decreases the level of expression of a particular gene as necessary. Researchers want to see if the presence and abundance of certain transcripts in a kidney biopsy at one year after transplant can predict which kidneys will have reduced function over time.

Official Title
-----------------
Multicenter Validation of Gene Expression Markers of Renal Allograft Functional Decline (GEN-04)

Conditions
-----------------
Kidney Transplant Recipients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (≥18 years) conventional renal transplant recipient. Patients who have given informed consent and are willing to comply with the protocol. Exclusion Criteria: ABO incompatible kidney transplants. Positive crossmatch kidney transplants (T cell crossmatch >100, B flow cytometric crossmatch >150). Simultaneous kidney and extra-renal organ transplants including pancreas, liver, heart, lung, etc. Subjects who had previous extra renal transplants may be included in the study. Patients taking chronic anticoagulation, which includes Coumadin, Plavix and any type of heparin. Aspirin is acceptable but must be stopped 5 days prior to the renal biopsy. An inability to have the 1-year renal biopsy performed within the acceptable protocol window (Months 11-14 [Days 301-420] post-transplant).

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 |
| --- | --- | --- |
| Renal Function Decline | The primary endpoint for this study is defined as a progressive decline in renal function in participants with good function at 1 year. These Progressors are defined by all of the following criteria: 1 year estimated GFR (eGFR) by MDRD equation of >40 ml/min. Decline in eGFR beyond 1 year during the time frame of this study (minimum 2.6 years after transplant and up to 5 years after transplant) with a slope of <-6.1% (i.e. slope of decline of renal function is >6.1%). >20% decline in eGFR from 1 year post-transplant to latest follow-up point. At least one eGFR (MDRD) interval < 60 ml/min. | Baseline to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney transplant, gene expression markers, renal allograft function
Effectiveness and Safety of Nivolumab in Participants That Have Head and Neck Cancer That Has Come Back or Has Spread

Study Overview
=================
Brief Summary
-----------------
Non-interventional study in Japan of participants with HNC recurring or that has spread and who are treated with nivolumab

Official Title
-----------------
Efficacy and Safety of Nivolumab in Recurrent or Metastatic Head and Neck Cancer (HNC) Patients - Japanese Real-world Data Through Clinical Chart Review

Conditions
-----------------
Cancer of Head and Neck, Cancer of the Head, Cancer of the Neck

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent/metastatic HNC patients with disease progression on or after a platinum-based therapy treated with nivolumab at least once from 01-Jul-2017 through 31-Dec-2017 Exclusion Criteria: History of participation in any clinical trials prior- or post-nivolumab treatment Other protocol defined inclusion/exclusion criteria could apply
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metastatic head and neck participants in Japan<br>Study in Japan targeting recurrent/metastatic HNC patients who are treated with nivolumab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of drug therapy treatment information |  | 6 months | 
| Distribution of non-drug therapy treatment information |  | 6 months | 
| Distribution of clinical laboratory testing |  | 6 months | 
| Distribution of participant information |  | 6 months | 
| Distribution of non-medication therapy treatment history |  | 12 months | 
| Distribution of therapeutic history |  | 12 months | 
| Overall survival |  | 12 months | 
| Progression free survival |  | 12 months | 
| Objective response rate |  | 12 months | 
| Duration of response |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AE's |  | Up to 12 months | 
| Incidence of serious AE's |  | Up to 12 months |
Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta

Study Overview
=================
Brief Summary
-----------------
40 pregnant females at term diagnosed with morbidly adherent placenta and planned for elective cesarean section were recruited and randomized to 2 groups. Group A: Internal iliac ligation followed by cesarean hysterectomy. Group B: cesarean hysterectomy.

Official Title
-----------------
Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta: A Randomized Clinical Trial

Conditions
-----------------
Blood Loss

Intervention / Treatment
-----------------
* Procedure: Internal iliac artery ligation
* Procedure: cesarean hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Placenta previa accreta Previous 2 cesarean section completed her family Hemoglobin > 11 gm/dl Elective cesarean hysterectomy Exclusion Criteria: Anemia ( Hemoglobin < 11 gm/dl) Not completed her family BMI > 35 Kg/m2 Bleeding tendency Emergengy cesarean section Thrombophilia

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: internal iliac artery ligation + cesarean hysterectomy<br> | Procedure: Internal iliac artery ligation<br>* Internal iliac artery ligation and cesarean hysterectomy<br>* Other names: cesarean hysterectomy;Procedure: cesarean hysterectomy<br>* cesarean hysterectomy<br>|
| Active Comparator: cesarean hysterectomy<br> | Procedure: cesarean hysterectomy<br>* cesarean hysterectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of blood loss |  | intraoperative | 
| Amount of Blood transfusion needed in mililiters |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of hemoglobin |  | 24 hours | 
| change of hematocrit |  | 24 hours | 
| operative time |  | intraoperative | 
| incidence of injury of important structures during operation | incidence of injury of important structures during operation as urinary bladder, ureteric, intestinal or great vessels injury | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Internal iliac artery, Internal iliac artery ligation, Placenta previa, Placenta accreta, cesarean hysterectomy
A Pilot Study of the Envision® Surface

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the clinical safety and effectiveness of the Envision® surface.

Detailed Description
-----------------
This study is to evaluate the clinical safety and effectiveness of the Envision® surface placed on the TotalCare® frame in pressure ulcer prevention and management, patient comfort, and staff acceptance in the critical care environment

Official Title
-----------------
A Pilot Study of the Envision® Surface in a Patient Population at High Risk for or Who Have Pressure Ulcers: Evaluation of Pressure Ulcer Incidence, Changes in Existing Pressure Ulcers, Clinical Staff Satisfaction and Patient Comfort

Conditions
-----------------
Pressure Ulcers

Intervention / Treatment
-----------------
* Device: Envision® Patient Support System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject weighs between 70 and 400 pounds Subject to remain on Envision Surface for at least 3 days Subject at risk for pressure ulcers (Braden Score < 14) or has existing ulcer of any stage Subject is able to provide voluntary consent Exclusion Criteria: Subject requires pulmonary treatment surface Subject declines consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Envision® Patient Support System|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
-----------------
Pressure Ulcers
VI-1121 for the Treatment Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and effective as a daily treatment for Alzheimer's disease that is worsening despite current treatment.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Safety, Tolerability and Efficacy of VI-1121 in Subjects With Alzheimer's Disease

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

Intervention / Treatment
-----------------
* Drug: VI-1121
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of Alzheimer's disease CT or MRI within 2 years prior to study stable dose of current Alzheimer's treatment for at least 3 months Exclusion Criteria: advanced, severe, progressive or unstable disease history of cerebrovascular disease or myocardial infarction within 6 months

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo/VI-1121<br>Subjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period. | Drug: VI-1121<br> <br> Drug: Placebo<br> <br> |
| Experimental: VI-1121/Placebo<br>Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period. | Drug: VI-1121<br> <br> Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable is the change in Alzheimer's Disease Assessment-Cognitive Subscale (ADAS-Cog) score from baseline to Week 12 of each treatment period. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary efficacy endpoint is the mean change in Mini-Mental State Examination (MMSE) score from baseline to Week 12 of each treatment period. |  | 12 weeks | 
| Percentage of subjects who achieve 3-point improvement in ADAS-Cog score from baseline to Week 12 of each treatment period. |  | 12 Weeks | 
| Change in Clinician's Interview Based Impression of Change Plus Caregiver's Input (CIBIC-plus) score from baseline to Week 12 of each treatment period |  | 12 Weeks | 
| Mean change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score from baseline to Weeks 4, 8, and 12 of each treatment period |  | 4, 8, and 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
donepezil, VI-1121
A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects

Study Overview
=================
Brief Summary
-----------------
Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2), and exit procedures.

Official Title
-----------------
A Crossover Study to Assess the Bioequivalence of the Phase III and Commercial Risedronate 35 mg Delayed Release Formulations.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: risedronate DR (Phase III clinical supply)
* Drug: risedronate 35 mg DR (Commercial Tablet)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female, 18 to 65 years of age if female, non-lactating and either surgically sterile or postmenopausal body mass index less than or equal to 32 kg/m2 at screening Exclusion Criteria: no use of a bisphosphonate within 1 month no history of GI disease no use of any medications within 7-14 days prior to scheduled dosing day

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>one commercial risedronate 35 mg DR tablet | Drug: risedronate 35 mg DR (Commercial Tablet)<br>* Test - (Commercial tablets) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast<br>* Other names: Commercial Tablet;|
| Active Comparator: 1<br>one Phase III risedronate 35 mg DR tablet | Drug: risedronate DR (Phase III clinical supply)<br>* Reference - (Phase III clinical supply) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast<br>* Other names: Phase III clinical supply;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the bioequivalence (BE) between the commercial and the Phase III risedronate 35 mg DR formulations. |  | 72 hours post-dose |