linjc16/ctgov huggingface dataset:
Genetic Modifiers of Cystic Fibrosis Related Diabetes

Study Overview
=================
Brief Summary
-----------------
This research is being done to find the genes and other factors that are responsible for differences among persons with cystic fibrosis. We are particularly interested in the factors that relate to the development of Cystic Fibrosis Related Diabetes (CFRD).

Detailed Description
-----------------
The study is recruiting people with cystic fibrosis (CF). The medical record is being extracted, and a blood sample is taken for DNA. The DNA samples are tested for variation both at the cystic fibrosis transmembrane conductance regulator (CFTR) gene (the CF gene) and over the entire rest of the genome. Using large numbers of people with CF, and knowing who does and does not have CFRD, we identify genetic variations that associate with CFRD. Knowing these variations allows us to better understand the causes of CFRD, and with enough information, better to predict CFRD and identify people at particularly high or low risk of CFRD. People participating in this study also have the option to participate in related studies of other metabolic traits in CF such as over- and underweight.

Official Title
-----------------
Genetic Modifiers of Cystic Fibrosis Related Diabetes

Conditions
-----------------
Cystic Fibrosis Related Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any person with Cystic Fibrosis and his/her parents. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 99 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of Genes or other factors that influence the development of CFRD |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CF, CFRD, Diabetes, Genetic Modifiers
Fatty Acids and Attention Deficit and Hyperactivity Disorder Symptoms

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the longitudinal association between n-6:n-3 LCPUFAs ratio in cord blood and child ADHD symptoms at 4 and 7 years old. This study was based on the INMA project, a population-based birth cohort in Spain. Higher cord blood n-6:n-3 ratio was associated with higher subclinical ADHD symptoms during early and mid-childhood.

Official Title
-----------------
Prenatal Omega-6/Omega-3 Ratio and Attention Deficit and Hyperactivity Disorder Symptoms in Children: a Population-based Longitudinal Study

Conditions
-----------------
Child Behavior Problem, Attention Deficit Hyperactivity Disorder, Fatty Acid Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age 16 years or older Singleton pregnancy No use of assisted reproductive techniques Intention to deliver at the reference hospital Ability to speak and understand Spanish or a local language
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatty acid ratio in cord blood |  | 2004-2008 | 
| ADHD 4 years old |  | 2008-2012 | 
| ADHD 7 years old |  | 2012-2016 |
Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and tolerability of QAT370 compared to tiotropium in patients with COPD.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Efficacious Dose of QAT370 Compared to Open-label Tiotropium Bromide Following Once Daily Dosing for 7 Days in COPD Patients

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: QAT370
* Drug: Placebo
* Drug: Tiotropium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 40 and 80 years of age with controlled COPD. Women must be surgically sterilized or postmenopausal. Additional birth control and post-menopausal information will be available at time of enrollment. Body mass index (BMI) must be within the range of 18 to 32 kg/m2 Exclusion Criteria: Participation in any interventional clinical investigation with 4 weeks of study start Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start Past medical personal or close family history of clinically significant ECG abnormalities Any medical condition that may interfere with exercise testing or that may make spirometry unsafe A known hypersensitivity to the drug. History of immunocompromise, including a positive HIV test result. History of drug or alcohol abuse within 12 months of study start Any condition that may compromise patient safety

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>QAT370 | Drug: QAT370<br> <br> |
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <br> |
| Active Comparator: 3<br>Tiotropium | Drug: Tiotropium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1 second |  | Days 1 and 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity. |  | Days 1 and 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, pharmacokinetics, plethysmography, cycle ergometry, exercise testing, spirometry
Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX

Study Overview
=================
Brief Summary
-----------------
This study is conducted in the United States of America (USA). The aim of this study is to investigate the at-home-administration of bypassing agents for treatment of bleeding episodes in patients with congenital haemophilia with inhibitors to factors VIII and IX. We are further investigating how bleeding episodes affect the quality of life of the patient and their family or caregivers.

Official Title
-----------------
Dosing Observational Study in Hemophilia Subjects With Inhibitors: A Phase IV Diary Study in Subjects Prescribed NovoSeven® as First Line on Demand Therapy for Acute Bleeding Episodes

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII
* Drug: Feiba VH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects with congenital haemophilia A or B and inhibitors with spontaneous bleeds which require on-demand treatment Subjects prescribed NovoSeven® as the first line or recommended bypass agent History of on average at least 4 bleeds of any type over a 3 month period Subject or caregiver able and willing to complete daily journal for 3 months Informed consent obtained from all subjects or legal representative
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: activated recombinant human factor VII<br>* This is an observation of how patients/caregivers dose bypassing agents at home for haemophilia with inhibitors<br>Drug: Feiba VH<br>* This is an observation of how patients/caregivers dose bypassing agents at home for hemophilia with inhibitors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterisation of dose and dosing intervals for each bleeding episode |  | after 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of type of bleed on initial dose, dosing interval and total dose |  | after 3-6 months | 
| Effect of initial dose and dosing interval on total dose, time to first perceived improvement, time to perceived bleed resolution |  | after 3-6 months | 
| Effect of time to first dose on dosing interval and total dose |  | after 3-6 months | 
| Effect of bleeds and drug administration time on planned daily activities |  | after 3-6 months | 
| Relationship of dose and dosing intervals to reported SAEs |  | after 3-6 months |
Spironolactone Safety in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
Cardiovascular disease is the leading cause of death and disproportionately prevalent in patients with kidney disease. Spironolactone has been shown to improve survival in the general population with heart failure by up to 30%. We wish to study the safety and tolerability of aldosterone blockade with spironolactone on cardiac function in a high risk population of patients on hemodialysis. We will study and closely monitor subjects over a period of 12 months, during which they will be receiving spironolactone for a period of 6 months.

Official Title
-----------------
Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone

Conditions
-----------------
End Stage Renal Disease, Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: spironolactone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They must be at least 18 years of age. They must understand the study purpose and give their written informed consent. They must have been stable on chronic hemodialysis for at least three months before enrollment into the study. Hemodialysis subjects will be included if they have had a left ventricular ejection fraction measured within the past six months with a value no more than 45 percent. A repeat, standardized echocardiogram will be used to confirm left ventricular ejection fraction. Exclusion Criteria: Subjects with primary operable valvular heart disease. Subjects with a congenital heart disease. Subjects with unstable angina. Subjects with primary hepatic failure. Subjects with active cancer or any life-threatening disease (other than heart failure or end-stage renal disease). Subjects who have undergone heart transplantation or who are awaiting heart transplantation are also ineligible. Subjects on a renal transplant list will be accepted into the study until the time of successful renal transplantation and termination of dialysis. Subjects with habitually difficult to control hyperkalemia (serum potassium >6.0 meq/L) in the previous month while on dialysis will be excluded. The inability to complete the 6-minute walk test will not be a reason to exclude subjects from this study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spirnolactone<br> | Drug: spironolactone<br>* spironolactone administered to ESRD patients at low dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk of hyperkalemia |  | 6 months |
Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

Study Overview
=================
Brief Summary
-----------------
A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

Conditions
-----------------
Myopia, Hyperopia, Astigmatism

Intervention / Treatment
-----------------
* Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: were at least 18 years old; were experienced contact lens wearers; were correctable to at least 20/40 or better in both eyes with contact lenses; were in good general health, with healthy eyes (other than requiring vision correction); had not worn lenses for at least 12 hours before each baseline visit; had a corneal staining score no greater than Grade 1 in either eye at time of enrollment; had previously used an MPS or hydrogen peroxide solution successfully. Exclusion Criteria: had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition; required concurrent ocular medication or have used ocular medication within 24 hours of entering the study; had a known sensitivity or intolerance to any MPS, study products or ingredient(s); were currently participating in any other clinical study; had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RevitaLens OcuTec Multipurpose Solution (Investigational MPS)<br> | Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)<br>* multi-purpose lens care solution<br>|
| Active Comparator: Opti-Free RepleniSH Multipurpose Solution (MPS, Control)<br> | Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)<br>* multi-purpose lens care solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With No Change in Corneal Staining | Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe. | Change from baseline after 1, 2, 4 and 6+ hours of wear |
TB-LAM in the Diagnosis of TB

Study Overview
=================
Brief Summary
-----------------
Tuberculosis (TB) is still the leading cause of death in HIV-infected patients. Early diagnosis of TB substantially improves the survival of HIV-infected patients. Urine based detection of lipoarabinomannan (LAM) provides promising methods for quick diagnosis of TB in HIV-infected patients. However, the sensitivity and specificity of TB-LAM is still not well established, especially in area where non-tuberculosis mycobacterium is also prevalence. Here we aimed to evaluate the clinical utility of TB-LAM in diagnosis of active TB in hospitalized HIV-infected patients.

Official Title
-----------------
Clinical Utility of TB-LAM in the Diagnosis of Active TB in Hospitalized HIV-infected Patients

Conditions
-----------------
HIV Infections, Tuberculosis, Non-Tuberculous Mycobacterial Pneumonia

Intervention / Treatment
-----------------
* Diagnostic Test: Alere TB-LAM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized HIV-infected patients. Willing to participate into the study. Exclusion Criteria: Already diagnosed with active TB Received any anti-tuberculosis drugs and/or quinolone for more than 7 days.
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Experimental: Diagnosis arm<br>Urine TB-LAM, sputum smear, Gene Xpert, mycobacterial culture | Diagnostic Test: Alere TB-LAM<br>* Subjects also undergo clinical evaluation including CT, sputum smear, Gene Xpert and mycobacterial culture.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity against microbiological reference standard | Number of TB-LAM positive/Number of positive by culture or Gene Xpert | 2 months | 
| Specificity against microbiological reference standard | 1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity against composite reference standard | Number of TB-LAM positive/Number of active TB diagnosed clinically | 2 months | 
| Specificity against composite reference standard | 1-Number of TB-LAM negative/Number of TB excluded | 2 months |
Minimal Residual Disease Evaluation on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
Cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation. This pilot study aims to evaluate the minimal residual disease on ovarian fragments harvested before allogeneic stem cell transplantation at the time of complete remission.

Official Title
-----------------
Pilot Study to Assess Minimal Residual Disease on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient diagnosed with AML At least one molecular marker identified at AML diagnosis Patients who undergo ovarian tissue cryopreservation for fertility preservation in complete remission, before hematopoietic stem cell transplantation. Exclusion Criteria: Other diagnostic No marker available at AML diagnosis No bone marrow/ovarian fragment available at the time of complete remission

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 25 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 |
| --- | --- | --- |
| Percentage of patients without detectable MRD in ovarian tissue |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with MRD detected in ovarian tissue and bone marrow. |  | Up to 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myeloid leukemia, Fertility preservation, Ovarian cryopreservation, Minimal residual disease
Abdominal Binder Study to Decrease Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
We conducted a controlled randomized trial examining the ability of the Mott abdominal Compression Binder to decrease postoperative pain in gynecologic abdominal laparotomy patients

Official Title
-----------------
A Controlled Randomized Trial Examining the Ability of the Mott Compression Bonder to Decrease Postoperative Pain in Gynecologic Abdominal Laparotomy Patients.

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Device: abdominal binder
* Other: no binder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gynecologic abdominal laparotomy patients Exclusion Criteria: non gynecologic abdominal laparotomy patients

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: regular bandage<br>no abdominal binder | Other: no binder<br> <br> |
| Experimental: abdominal binder<br>binder | Device: abdominal binder<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | linear pain scale | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ambulations in 24 hours postoperatively | number ambulations | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdominal binder