linjc16/ctgov huggingface dataset:
Resilience and Mentoring in German-speaking Intensive Care Providers and Anesthesiologists

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify factors influencing work engagement and wellbeing in German-speaking intensive-care providers and anesthesiologists.

Official Title
-----------------
Resilience and Mentoring in German-speaking Intensive Care Providers and Anesthesiologists

Conditions
-----------------
Work Engagement, Well-being

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resident or staff anesthetist since more than 6 months working for the same institution Exclusion Criteria: no informed-consent

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| anesthetists<br>German-speaking intensive-care providers and anesthetists | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utrecht Work Engagement Scale |  | 4 weeks | 
| Positive and negative affective scale |  | 4 weeks | 
| Psychological Well-Being questionnaire |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance and Action Questionnaire |  | 4 weeks | 
| Experience Questionnaire |  | 4 weeks | 
| Dutch Workaholism Scale |  | 4 weeks | 
| Multidimensional Perfectionism Scale |  | 4 weeks |
A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function

Study Overview
=================
Brief Summary
-----------------
To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function

Detailed Description
-----------------
This is an 8-day, repeated dose, open label study to investigate the pharmacokinetics and safety of naproxcinod in order to guide initial dosing and achieve the optimal dose of naproxcinod in Renal impaired patients.

Official Title
-----------------
A Phase 1 Repeated Dose Open Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750mg Bid Administered to Patients With Impaired Renal Function Compared to Matching Healthy Subjects

Conditions
-----------------
Renal Failure

Intervention / Treatment
-----------------
* Drug: naproxcinod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 to 75 years with stable mild to moderate renal insufficiency. Male or female aged 18 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health Exclusion Criteria: Any significant acute or chronic disease (except renal impairment) which may interfere with study evaluations. A history of alcohol or drug abuse. Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months Clinically relevant abnormal ECG Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except low dose aspirin (less than or equal to 325mg per day). Participation within 30 days prior to screening in another investigational study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: naproxcinod<br>naproxcinod 750mg(375mg caps x2), administered twice a day. | Drug: naproxcinod<br>* 750mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects. |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects. |  | 8 days | 
| To assess the general safety of naproxcinod in renal impaired patients and in healthy subjects as shown by the biological tolerance and the adverse events (AE) profile. |  | 8 days |
Investigation of Clinical Outcome of ACL Reconstruction Utilizing Two Tibial Fixation Techniques, Concentric Tapered Interference Screws and Interference Screw and Sheath

Study Overview
=================
Brief Summary
-----------------
Tibial fixation is the weak link when using soft tissue grafts and interference screws for fixation in a bony tunnel in ACL reconstruction. The Objective is to study two groups of patients undergoing double loop hamstring autograft ACL reconstruction and compare between the two tibial fixation devices: the tapered Deltascrew and the Intrafix screw and sheath .

Official Title
-----------------
Comparison Between Two Tibial Fixation Techniques in ACL Reconstruction

Conditions
-----------------
Primary ACL Tears

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females between ages 21 and 40 years. Primary ACL tears. Signed Informed consent. Availability during follow up period. Exclusion Criteria: Additional meniscal injury requiring suture. Articular cartilage injury requiring surgical management. Concomitant ligament injuries to the same knee requiring surgery. Bilateral ACL injury. Revision ACL surgery. Concurrent fractures of the lower limbs caused by the same accident. Post operative wound infection. • Post operative nerve injury Cardiovascular compromise. Professional sports people. Soldiers on active military service. Patients actively seeking compensation for injury. Patients on other research protocols. Patients receiving medications which alter bone metabolism: corticosteriods, Calcitonin, Flourides, Biphosphonates, Vitamin D and its derivatives, Cytotoxic drugs. Non compliance. • Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 40 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 |
| --- | --- | --- |
A Study of the GRIP Influenza and SARS-CoV-2 POC Assays

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to determine if the use of a new device can accurately detect a virus infection.

Detailed Description
-----------------
GRIP has developed a novel, graphene-based detection system for potential use in point-of-care settings. This study will compare the performance of the GRIP device to routine PCR testing for detection of COVID-19 and influenza viruses. When patients present for routine testing for COVID-19 and influenza, they will also have a separate nasal swab collected that will be tested by the GRIP point-of-care device.

Official Title
-----------------
Clinical Evaluation of the GRIP Influenza and SARS-CoV-2 Point-of-care Assays Using Fresh Patient Nasal Swab Samples

Conditions
-----------------
COVID-19, Influenza

Intervention / Treatment
-----------------
* Device: GRIP Electronic Diagnostic Chip
* Diagnostic Test: Laboratory-based nucleic acid amplification tests (NAATs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients being tested for COVID 19 or Influenza Exclusion Criteria: Patients < 18 years of age

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel, graphene-based, point-of-care device<br>Subjects will receive one additional nasal swab at the same time as clinical collection. | Device: GRIP Electronic Diagnostic Chip<br>* Graphene-based point-of-care device for detection of respiratory viruses (e.g., COVID-19 and influenza) from a nasal swab<br>Diagnostic Test: Laboratory-based nucleic acid amplification tests (NAATs)<br>* Polymerase Chain Reaction (PCR) analysis for detection of viruses (e.g., Roche cobas SARS-CoV-2 or influenza A/B) from nasal swab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Percent Agreement | Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing | Baseline | 
| Negative Percent Agreement | Percent of nasal swabs to report negative results for respiratory virus for both the GRIP device and NAAT routine clinical testing | Baseline |
Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

Study Overview
=================
Brief Summary
-----------------
In the literature there is conflicting data on administration of local analgesia in addition to the general anesthesia to the trocar sites during laparoscopy, We believe that adding local analgesia to the general anesthesia during laparoscopy is beneficial . the current study will evaluate prospectivly the impact of local analgesia on postoperative pain and recovery in patients undergoing operative laparoscopy

Detailed Description
-----------------
Methods: this is a blinded prospective randomized study. After approval of IRB and informed consent 120 patients undergoing for laparoscopy will be randomized after the induction of general anesthesia into three groups: Group A will receive preemptive analgesia using 3-5 cc of 0,5 % marcaine at the beginning of the procedure. Group 2 will receive a local analgesia using 3-5 cc marcaine at the end of the procedure. Group 3 will be operated under general anesthesia only. The post operative pain and patient recovery will be assessed by the nurses during the hospitalization using a VAS (Visual Analog Scale) the total analgetic drugs will be noted and after the patients discharge the patient status and satisfaction will be evaluated by phone up to 2 wks

Official Title
-----------------
Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: bupivacain 0.5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female older then 18 y/o Exclusion Criteria: Allergy to marcaine

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>preemptive trocar site analgesia | Drug: bupivacain 0.5%<br>* trocar site injection<br>* Other names: marcaine;|
| Experimental: 2<br>trocar site pre skin closure analgesia | Drug: bupivacain 0.5%<br>* trocar site injection<br>* Other names: marcaine;|
| No Intervention: 3<br>control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain measured by VAS |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total analgesics required, patient recovery, patient satisfaction |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopy, preemptive, postoperative, pain, trocar, site
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

Study Overview
=================
Brief Summary
-----------------
This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI).

Official Title
-----------------
An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Biological: ReFacto AF


Participation Criteria
=================
Eligibility Criteria
-----------------
Male, at least 12 years old, with severe hemophilia A undergoing major elective major surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test at screening and no past history of inhibitor. Previously treated with at least 150 exposure days to any Factor VIII product Normal hepatic and renal function tests and no other bleeding disorder

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Biological: ReFacto AF<br> <br> |
| Experimental: B<br> | Biological: ReFacto AF<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Achieved Hemostatic Efficacy After Surgery | Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge | Assessment of hemostatic efficacy by the investigator at the day of discharge from the hospital using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia A, bleeding disorder
Implication of CD35, CD21 and CD55 in Exudative Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine a possible implication of CD21, CD35 and CD55 in the pathogenesis of age-related macular degeneration. The aim is to asses a difference in expression rates of these factors on AMD-patients and a healthy control group.

Official Title
-----------------
Is CD35, CD21 and CD55 Associated With Exudative Age-related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Other: cd 35, cd21, cd55


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man and women over 18 years old Filled out informed consent Diagnosis of non-exudative/ exudative age related macular degeneneration Exclusion Criteria: Inherited retinal diseases Other acquired retinal/ macular Missing informed consent

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cd35<br> | Other: cd 35, cd21, cd55<br>* Blood drawing/ 10ml/ once- duration of 1 day of full examination of the patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine a possible implication of CD21, CD35 and CD55 in the pathogenesis of age-related macular degeneration |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression rates of on AMD-patients and a healthy control group |  | 1 year |
Efficacy and Safety of IBI-10090 in Ocular Surgery Patients

Study Overview
=================
Brief Summary
-----------------
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.

Official Title
-----------------
A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Ocular Surgery

Conditions
-----------------
Inflammation Associated With Cataract Surgery

Intervention / Treatment
-----------------
* Drug: IBI-10090


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for unilateral cataract surgery Exclusion Criteria: Ocular, topical, or oral corticosteroids within 7 days of Day 0

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br> | Drug: IBI-10090<br>* dexamethasone<br>|
| Experimental: Dose 2<br> | Drug: IBI-10090<br>* dexamethasone<br>|
| Experimental: Dose 3<br> | Drug: IBI-10090<br>* dexamethasone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Cell Count at Day 8 Post-Treatment | This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared. | 8 days post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract surgery, ocular inflammation
Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effects of different dietary calcium have on the pregnant teen mother and her newborn. We hypothesize that the higher calcium intake during pregnancy will result in higher bone mass in the newborn.

Detailed Description
-----------------
Osteoporosis in the adult remains a significant public health problem. One of the major causes of osteoporosis is the inadequate calcium intake during the pediatric age range of birth to 20 years of age. We believe that this low calcium may start at birth since the fetus is actively accumulating calcium during the last trimester of pregnancy. Adolescents generally have poor calcium intake. Our study is to compare the newborn bone mass from adolescent mothers who are taking the recommended calcium intake from dairy foods or non-dairy foods such as orange juice during pregnancy.

Official Title
-----------------
Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Dietary Supplement: Orange juice plus calcium
* Dietary Supplement: Dairy products


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant mothers aged 15 to 18 years, term gestation Exclusion Criteria: Chronic disease such as hypertension, diabetes, medications that will affect calcium metabolism

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Usual diet | |
| Active Comparator: 2<br>Orange juice fortified with calcium | Dietary Supplement: Orange juice plus calcium<br>* > 1,200mg Ca (four glasses of orange juice plus calcium)per day<br>|
| Active Comparator: 3<br>Dairy products | Dietary Supplement: Dairy products<br>* > 1,200mg Ca (by consuming milk, yogurt, and cheese)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newborn bone mass |  |  | 
| Maternal dietary intakes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newborn body weight |  |  | 
| Maternal blood pressure |  |  | 
| Newborn blood for calcium, phosphate, vitamin D |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dairy, Calcium, Pregnancy, Fetus, Bone mineralization