linjc16/ctgov huggingface dataset:
NPD Measurement in Infants

Study Overview
=================
Brief Summary
-----------------
Nasal Potential Difference measurements (NPD) have been performed in Israel since 1996. NPD measurements are used to assess the voltage across nasal epithelium, which correlates with the transport of sodium and chloride across cell membranes. NPD was first demonstrated to be abnormal in Cystic Fibrosis (CF) in 1981 and the technique has since been used to increase our understanding of this condition. It is now established as an important diagnostic tool and more recently has been used to assess the effectiveness of new treatments such as gene and alternative therapy (Knowles 1995; Wilschanski 2003). The nasal cavity is accessible which makes it a good site to examine the ion transport characteristics of airway epithelia. Less than a centimetre into the nose the squamous (skin type) epithelium becomes ciliated pseudocolumnar epithelium, characteristic of the proximal airways. The change in NPD with the perfusion of different solutions is demonstrated. By employing NPD protocols with perfusion of different solutions and drugs, different aspects of the nasal ion transport characteristics can be examined. In CF, this ion transport profile is abnormal and the NPD measurement has a number of features that differentiate CF from non-CF. This methodology is well established for measurements in subjects over 6 years of age. Measurements on smaller children and infants have been very difficult to perform. We propose a new method using smaller, single lumen catheters with much lower perfusion rates (0.2 ml/min compared to up to 5 ml/min with the adult method) .Perfusion measurements will be possible in newly born infants. Obviously this opens up the potential for using NPD as a diagnostic test in babies. This is important as the diagnosis of CF is often difficult to make or refute in babies because of the problems in collecting enough sweat. This may be the ideal diagnostic test for CF in the neonatal nursery in infants with meconium plug syndrome.

Official Title
-----------------
Nasal Potential Difference Measurement in Infants

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Age below 6 years Patients who suspected for CF due to pulmonary and/or gastrointestinal symptoms Exclusion Criteria: Age over 6 years

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 6 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasal Potential Difference
A Study of Isoprinosine in Patients With Severe AIDS

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to: Laboratory (immunologic defects): Comparison of total helper and suppressor T-cell numbers among the groups. Comparison of changes in natural killer cell activity. Comparison of other laboratory findings among the groups. Clinical changes: Comparison of the frequency of opportunistic infections among the groups. Comparison of the frequency of the development of AIDS-related malignancies. Comparison of other clinical manifestations relative to severity and time of onset.

Official Title
-----------------
A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Inosine pranobex


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer are excluded. Concurrent Medication: Excluded: Steroids. Cytotoxic immunosuppressive agents. Radiotherapy. The following are excluded: Critically ill patients. Patients receiving steroids, cytotoxic immunosuppressive agents, radiotherapy. Patients who have received any other immunotherapy. Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer. Prior Medication: Excluded: Any other immunotherapy. Patients with severe AIDS and specified laboratory immunologic defects.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inosine pranobex|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
-----------------
Infusions, Intravenous, Drug Evaluation, Administration, Oral, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Biological Availability
Lanadelumab for Treatment of COVID-19 Disease

Study Overview
=================
Brief Summary
-----------------
So far little is very few drugs have demonstrated positive results for treatment of COVID19. Recently the researchers have shown that the use of icatibant in COVID-19 results in a potent decrease in oxygen use. Yet the effect of the three dosages as according to the label dose was insufficient to maintain the clinical improvement in a small group of patients. The researchers argue that with the use of lanadelumab a more lasting effect can be reached due to its longer half life.

Official Title
-----------------
Lanadelumab for Treatment of COVID-19 Disease

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: lanadelumab
* Other: regular care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is SARS-COV2 positive (PCR) Without oxygen a saturation below 90% At least 3L/min oxygen dependent Patient is 16 years and older Exclusion Criteria: Has previously participated in this study Acute myocardial or cerebral ischemic event at time of enrolment Receiving ACE or ARB inhibitor or comparable drugs that is specified as an intervention in this domain as a usual medication prior to this hospitalization will exclude a patient from receiving that agent A baseline alanine aminotransferase or an aspartate aminotransferase that is more than five times the upper limit of normal Patient is known hypersensitive to full human monoclonal antibodies Patient is pregnant or breast feeding

Ages Eligible for Study
-----------------
Minimum 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
Interventional Model Description: controls will get standard of care and historical controls will be matched to the patients included
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lanadelumab<br>20 Patients will receive an intravenous dose of 300 mg lanadelumab on day 1, followed by a second dose of lanadelumab 300mg iv on day 4 (if needed). | Biological: lanadelumab<br>* single dose, or two doses administered iv<br>|
| Other: controls<br>20 patients will received standard of care In additiona, for every index patient we will match one historical controls. Controls will be matched based on age, bodyweight and gender. | Other: regular care<br>* no lanadelumab administration, treated according to regular care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen | oxygen use in L/min | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | adverse events after lanadelumab administration | 2 weeks |
Sternal Wound Infection in Patients Undergone Sternal Fixation Using Locking Compression Plates

Study Overview
=================
Brief Summary
-----------------
Sternal Wound Infection (SWI) in open heart surgery is one of the most annoying and avoidable complications that one encounters during work. Investigators investigate the rates of sternal wound infection (SWI) in patients in whom were used locking compression plates (LCP) versus in patients in whom were used wires to fixate the sternum for variable causes. SWI increases the overall cost and burden in the medical service and increases the patients suffering and disability. investigators aim to provide our patients with the most suitable means for sternal fixation.

Official Title
-----------------
Sternal Wound Infection in Patients Undergone Sternal Fixation Using Locking Compression Plates

Conditions
-----------------
Sternal Fracture, Sternal Wound Infection, Surgical Site Infection

Intervention / Treatment
-----------------
* Other: Locking Compression Plates
* Other: Sternal Wires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All genders are accepted Ages from 18 to 80 years old Patients undergoing Open heart surgery for any reasons and trauma patients who suffer sternal fractures of any type. Exclusion Criteria: Ages less than 18 years old and older than 80 years old Patients undergoing minimally invasive surgeries utilizing access sites other than the sternum. Trauma patients with multiple complex injuries.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Case-Control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Locking Compression Plates<br>Patients in whom we used Locking compression plates for sternal fixation | Other: Locking Compression Plates<br>* Plates and screws for sternal fixation<br>|
| Other: Wires<br>Patients in whom we used Sternal Wires for sternal fixation | Other: Sternal Wires<br>* sternal wires used for fixation of sternum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sternal Wound Infection rate | sternal wound infection in the form of redness, hotness, swelling and discharge | 3 weeks post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sternum, wound infection, locking compression plates, sternal wires
M-CPP and Fenfluramine in Cocaine Addicts - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate predictive value of M-CPP and fenfluramine challenges for outcome.

Official Title
-----------------
To Study Predictive Values of M-CPP and Fenfluramine in Cocaine Addicts

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: M-CPP


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: M-CPP|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Hospitalization, arrests, jail, employment, psychiataric symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed by monitoring of inflammatory parameters.

Official Title
-----------------
Double-blind, Prospective, Randomized Comparison of a Medium Chain Triglycerides (MCT)/Long Chain Triglycerides (LCT)/Fish Oil (FO) Containing 20% Lipid Emulsion With a MCT/LCT Emulsion (20%) for Parenteral Nutrition in Preterm Infants

Conditions
-----------------
Preterm Infants, Parenteral Nutrition n-3 Fatty Acids

Intervention / Treatment
-----------------
* Drug: Lipofundin MCT/LCT 20 %
* Drug: Lipidem 20%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prematurity (birth weight 500 - 1500 g) postnatal age <= 72 h need for cumulative parenteral energy supply of at least 70% during study duration signed informed consent form Exclusion Criteria: simultaneous participation in another clinical study platelet count below 50000 /ml cumulative enteral energy supply of > 30 % during study duration serious congenital infections and/or diseases serious metabolic disturbances severe cranial bleeding (Papile III, IV) need for administration of blood products contra-indication for iv lipid administration withdrawal of consent

Ages Eligible for Study
-----------------
Minimum Age: 5 Hours
Maximum Age: 3 Days

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: 1<br>Lipidem 20 % | Drug: Lipidem 20%<br>* daily i.v. infusion for up to 5 days<br>|
| Active Comparator: 2<br>Lipofundin MCT/LCT 20% | Drug: Lipofundin MCT/LCT 20 %<br>* daily i.v. infusion for up to 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Alanine Transaminase (ALT) | Change in ALT between pre/post treatment | on Study day -1 & 6 | 
| Efficacy: Interleukin-6 (IL-6) | Change of IL-6 Measurement pre/post treatment | on Study day -1 & 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
n-3 Polyunsaturated Fatty Acids (PUFA), parenteral nutrition, preterm infant
Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon

Study Overview
=================
Brief Summary
-----------------
It is unclear whether individual treatment of scabies is similarly effective compared to household treatment. This study therefore compares these two treatment strategies with topical benzyl benzoate for treating scabies in Lambaréné and surroundings in Gabon. Subjects presenting with uncomplicated scabies are randomized into either the Individual Treatment group, where only the affected subjects receive treatment, or the Household Treatment group, where all family members are treated in parallel to the affected subjects regardless of signs and symptoms. The primary endpoint is clinical cure after 28 days; the secondary endpoint is the proportion of affected household members per household after 28 days.

Official Title
-----------------
A Randomized Controlled Trial Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon

Conditions
-----------------
Scabies, Households

Intervention / Treatment
-----------------
* Drug: Benzyl Benzoate 25% Topical Application Lotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with active, uncomplicated scabies no known hypersensitivity or allergy against benzyl benzoate Exclusion Criteria: hypersensitivity or allergy against benzyl benzoate severe superinfection of scabies lesions
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 |
| --- | --- |
| Active Comparator: Individual Treatment<br> | Drug: Benzyl Benzoate 25% Topical Application Lotion<br>* Applied to skin for the treatment of scabies<br>|
| Active Comparator: Household Treatment<br> | Drug: Benzyl Benzoate 25% Topical Application Lotion<br>* Applied to skin for the treatment of scabies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Cure | clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination | after 28 days from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Affected Household Members Per Household | proportion of scabies cases per household after 4 weeks | after 28 days from baseline |
Revascularisation of Autotransplanted Teeth

Study Overview
=================
Brief Summary
-----------------
Retrospective Analysis of a Study cohort that experienced autotransplantation of mature teeth with simultaneous root end resection Note: The study was registered on Clinicaltrials.gov after termination of study.

Official Title
-----------------
Revascularisation of Autotransplanted Teeth - Retrospective Analysis of a Novel Technique

Conditions
-----------------
Endodontic Disease, Pulp Canal Obliteration

Intervention / Treatment
-----------------
* Procedure: Autotransplantation and Apicoectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female consenting and judicious young people and adults Written consent of the participant and, if applicable, of the legal guardian after education Planned tooth transplantation with advanced or completed root growth Exclusion Criteria: Contraindications for magnetic resonance imaging (MRI): (pronounced metal restorations, running orthodontics with metal, fixed appliance in the target jaw) Current or past antiresorptive therapy with bisphosphonates Further anamnestic general or local risk situation, among others: Anti-angiogenic therapy, History of local radiation therapy, severe coagulation disorder, unadjusted diabetes mellitus, malignant diseases Acute gingivitis or advanced periodontitis Participation in an ongoing drug trial (various drugs may distort the result, such as bisphosphonates, cortisone, chemotherapeutics, angiogenesis inhibitors) heavy smokers (> 10 per day) Acute or chronic infections (osteomyelitis) at the surgical site metabolic diseases (diabetes, hyperparathyroidism, osteomalacia) Severe kidney dysfunction, severe liver disease Patients with high-dose corticosteroid therapy prolonged corticosteroid or radiotherapy in the oral cavity autoimmune diseases Pregnant or breastfeeding women

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 Years

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: Autotransplantation<br>Autotransplantation and apicoectomy of mature teeth | Procedure: Autotransplantation and Apicoectomy<br>* Autotransplantation of a mature teeth with simultaneous extra-oral root-end resectoin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Tooth survival | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revascularisation | Occurrence of Revascularisation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autotransplantation, Apicoectomy, Revascularisation