linjc16/ctgov huggingface dataset:
Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity).

Detailed Description
-----------------
The purpose of this study is to evaluate the clinical performance of the Contamac lens in comparison with a currently marketed silicone hydrogel: Biofinity® (CooperVision). This is a 3-month, open-label, bilateral, parallel group, randomised, daily wear study. Approx. two-thirds of the subjects will wear the Contamac Silicone Hydrogel lens in both eyes while the other third will wear control lenses.

Official Title
-----------------
Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens

Conditions
-----------------
Vision Correction

Intervention / Treatment
-----------------
* Device: Definitive Contact Lens
* Device: Biofinity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: existing contact lens wearer read and signed statement of informed consent has clear central cornea requires spherical distance correction Exclusion Criteria: has worn RGP contact lenses within the last 30 days is using any ocular medication has had refractive surgery has an infectious disease is pregnant or lactating is participating in another clinical research study

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Contamac 74% silicone hydrogel contact lens<br>Definitive Contact Lens | Device: Definitive Contact Lens<br>* Daily wear contact lens<br>|
| Placebo Comparator: Cooper Vision Biofinity<br>Biofinity Contact Lens | Device: Biofinity<br>* Daily wear contact lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy. | The clinical study will assess the following performance variables as compared to the predicate device during 5 follow-up visits over a 3 month period to demonstrate safety and efficacy: Sphere-cyl Refraction and VA, Keratometry, Comfort, Handling, Symptoms, Over-Refraction and VA, Lens Fit, Lens Deposits, and Slit Lamp Findings. | 3 months |
Characteristics of Long COVID-19 Syndrome

Study Overview
=================
Brief Summary
-----------------
Characterization of patients with long COVID syndrome including symptoms, medical history and persistent organ damage.

Detailed Description
-----------------
Some people are very hesitant to recover from a COVID-19 infection and present persistent symptoms. The participants still suffer after the acute phase of the infection from shortness of breath, coughing, chest pain or fatigue. Therefore, a special interdisciplinary consultation was built. The consulatation is not only addressed to people who have been hospitalized due to COVID-19, but also to those with mild symptoms during infection. During the consultation hours, personal health data are collected that serves as the basis for this research project.

Official Title
-----------------
Long COVID Syndrom: Charakterisierung Eines Neuen Krankheitsbildes

Conditions
-----------------
Long COVID Syndrome

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Long COVID syndrome age >= 18 years Informed consent Exclusion Criteria: none

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Long COVID<br>Patients with long COVID syndrome | Other: No intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | modified medical research council (scale from 0 to 4). The higher the score the worse the symptoms. | once through study completion, an average of 6 months. | 
| self-addressed Quality of life | Short form health 36 questionnaire with 8 domains, each rated from 0-100. The higher the score the better subjective quality of life. | once through study completion, an average of 6 months | 
| Thoracic pain | assessed by medical interview (reported as yes or no) | once through study completion, an average of 6 months | 
| Medical history | List of relevant morbidities assessed as present/not present by medical interview (e.g. respiratory, cardial, neurological, psychiatric diseases by interview and medical records) | once through study completion, an average of 6 months | 
| Fibrosis | Assessed by chest CT, rated as present/not present | once through study completion, an average of 6 months | 
| Myocardial damage | Assessed by myocardial damage, rated as present/not present | once through study completion, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
long COVID, post COVID
Study on Wood-plastic Composite for Circumferential Casting

Study Overview
=================
Brief Summary
-----------------
The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.

Detailed Description
-----------------
An ecologically friendly and biodegradable wood-plastic composite-cast is studied. The purpose of the study is to verify that WOODCAST Circular system performs safely and effectively in its intended use. Patients, who need immobilization of extremity (including for example scaphoid fracture of the wrist or ankle fracture) will be participating in the study. Various casting techniques with novel WOODCAST material will be studied.

Official Title
-----------------
Study on Circumferential Casting Techniques With WOODCAST

Conditions
-----------------
Bone Fracture, Radius Fracture, Ankle Fracture

Intervention / Treatment
-----------------
* Other: limb casting/splinting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient treatment involves circular casting; age 0-90 years; mother tongue finnish or swedish Exclusion Criteria: open fracture; other fractures or a previous fracture; a previous or simultaneous tendon-, nerve-, or vascular injury to the extremity yo be treated; a multiple injured extremity; decreased co-operation of the patient; malignancy; an illness affecting the general health.

Ages Eligible for Study
-----------------
Maximum Age: 90 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 |
| --- | --- |
| Other: limb casting/splinting<br>Patient age 0-90 years. Patient treatment requires extremity immobilization | Other: limb casting/splinting<br>* ankle and arm cast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficient Casting With Woodcast Circular System | Efficient casting conduc ted with Novel Woodcast material | 1 - 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cast, splint, circumferential casting, casting techniques, fracture in extremity
Analysis of the Pharmaceutical Validation of Picc Line Installation Requests at the Nîmes University Hospital

Study Overview
=================
Brief Summary
-----------------
The picc line is a central venous catheter inserted peripherally into a deep vein in the arm (cephalic, basilic or axillary) whose distal end is located at the junction of the superior vena cava / atrium. It is installed for a minimum of 7 days (1), and can be stored for up to 6 months or more if it is functional. For treatments with an indication of more than 3 months, it is common practice to place an implantable catheter chamber. The main indications for picc line placement are: long-term antibiotic therapy, parenteral nutrition, chemotherapy or long-term venous approach when difficulties are encountered in applying a peripheral venous route to the patient. Quickly adopted by medical teams, picc lines are not without risk, however, and three complications are mainly reported: catheter obstruction, deep vein thrombosis and infections. In order to avoid any risk of unnecessary complications, it therefore seems appropriate to target the most appropriate device upstream of the procedure according to the provisional indication. An inventory of pharmaceutical interventions carried out during picc line requests would make it possible to lay the foundations for considering actions to be implemented with the various services requesting picc line and proposals for improvement for the follow-up of patients with picc line to reduce the risk of complications.

Official Title
-----------------
Analysis of the Pharmaceutical Validation of Picc Line Installation Requests at the Nîmes University Hospital

Conditions
-----------------
Parenteral Nutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 or over, hospitalized at the University Hospital of Nîmes Benefiting from a pharmaceutical validation of the demand for picc line connected Exclusion Criteria: The patient is opposed to participating in 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimate the prevalence of requesting pharmaceutical interventions with a criticality greater than or equal to 2 accepted. |  | 2018 |
Tumor Registry of Advanced Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to record information of therapy reality of metastatic or locally advanced Renal Cell Carcinoma by office-based medical oncologists in Germany.

Detailed Description
-----------------
The RCC Registry is a prospective, longitudinal, nation wide cohort study that collects data on the treatment reality of patients with mRCC. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Patients are followed until death or for a maximum of 3 years.

Official Title
-----------------
Clinical Registry Describing Treatment Reality and Therapy Modality of Patients With Metastatic or Locally Advanced Renal Cell Carcinoma Requiring Therapy

Conditions
-----------------
Renal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metastatic or locally advanced Renal Cell Carcinoma requiring therapy Start of first palliative therapy within 1 year before enrollment of patient to registry; since enrollment of 1000 Patients: start of first palliative therapy within 4 weeks before enrollment Exclusion Criteria: -

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 |
| --- | --- | --- |
| Documentation of therapies |  | 9 years, 3 years per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of response rate and adverse reactions; development of a numeric prognostic score |  | 9 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Renal Cell Carcinoma, MRCC, Therapy-reality, Observation, Registry, RCC, ARCC, Germany, Metastatic Renal Cell Carcinoma, Renal Cell Carcinoma, Renal Cell Cancer, Sorafenib, Sunitinib, Interferon, Interleukin, Temsirolimus, Pazopanib, Cytokines, VEGF
A Post Marketing Safety Study of Sitagliptin (JANUVIA®) (MK-0431-234)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to obtain safety information on the use of sitagliptin (JANUVIA®) from endocrinologists, diabetologists, internists, and general practitioners.

Official Title
-----------------
Sitagliptin (JANUVIA®) Post Marketing Surveillance Protocol

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Sitagliptin (JANUVIA®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Must be taking sitagliptin (JANUVIA™) for the treatment of type 2 diabetes mellitus - Treating physician must agree to provide information regarding the participants treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants treated with sitagliptin<br> | Drug: Sitagliptin (JANUVIA®)<br>* Participants prescribed Sitagliptin (JANUVIA®) in routine clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an Adverse Event |  | Up to approximately 28 months | 
| Age of Participants Prescribed Sitagliptin |  | Up to approximately 28 months | 
| Number of Participants With Concomitant Therapies |  | Up to approximately 28 months | 
| Number of Participants With Concomitant Conditions |  | Up to approximately 28 months |
Efficacy of PLEM100(Inbody®) in Children

Study Overview
=================
Brief Summary
-----------------
Evaluation of efficacy of PLEM100(Inbody®) in measuring the sedation level in pediatric patients

Detailed Description
-----------------
The investigators plan to gather the basic data relevant to measurement of the level of consciousness/sedation in pediatric patients with developing brain by using PLEM100(Inbody®) PLEM100 (Inbody®) is a medical equipment to measure, based on phase lag entropy algorithm, the level of patient consciousness, which is expressed by PLE score ranging from 0 (burst suppression or deep sedated) to 100 (awake). In this study, pediatric patients aged from 3 to 6 years old who undergo total intravenous general anesthesia are chosen as target subjects. The investigators measure how PLE score changes during 1) anesthesia induction, 2) anesthesia maintenance, 3) emergence from anesthesia. Then, the PLE score would be validated by analyzing the correlation with the consciousness level expressed in University of Michigan Sedation Scale (UMSS).

Official Title
-----------------
Efficacy of PLEM100(Inbody®) to Measure the the Sedation Level in Pediatric Patients

Conditions
-----------------
Development, Child

Intervention / Treatment
-----------------
* Device: PLE100(Inbody®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients to be operated under general anesthesia, aged from 3 to 6 years Written Consent is available from a parent who has been explained about the study Elective surgery Exclusion Criteria: Patients who cannot be attached by PLEM100 (Inbody®) sensors to the forehead or the side of the head Patients Having Cerebral Vascular Diseases in the past or present Patients with Developmental delay Patients to be admitted to intensive care unit or sedated after receiving operation Patients who researchers decide are not eligible to be enrolled in the study because of various factors including clinical test results.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PLE100(Inbody®)|PLE100(Inbody®) monitoring in children to be operated under the total intravenous anesthesia (Propofol)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PLE100 score (0 to 100) | Changes of PLE100 score | baseline and end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of consciousness measured in University of Michigan Sedation Scale (UMSS) | correlation with the PLE100 scores and concentraion of propofol | baseline and end of surgery | 
| pharmacodynamic model | UMSS with propofol concentration | baseline and end of surgery |
Tranexamic Acid in Major Orthopedic Surgery: Comparison of 3 Dosage Regimen

Study Overview
=================
Brief Summary
-----------------
Tranexamic acid has been shown to be effective in reducing blood loss and transfusion in orthopedic surgery. It remains unknown the ideal therapeutic regimen. The goal of this study is to compare 3 dosage regimen of tranexamic acid in patients submitted to major orthopedic surgery.

Detailed Description
-----------------
There is ongoing debate, however, around optimal perioperative tranexamic acid dosing, which varies widely. A large number of studies comparing tranexamic acid to placebo, overall blood loss and transfusion requirements are both reduced by ≈30%. A well designed tranexamic acid trial will provide answers to the best regimen dosage for perioperative tranexamic acid use. It will benefit patients by reducing allogeneic transfusions and their associated risks and costs, thus adding value to the care delivered.

Official Title
-----------------
Tranexamic Acid in Major Orthopedic Surgery: Comparison of 3 Dosage Regimen

Conditions
-----------------
Tranexamic Acid, Knee Osteoarthritis, Ankle Osteoarthritis, Bleeding

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 anos Total ankle arthroplasty Total knee arthroplasty Weight >50 kilogram Exclusion Criteria: Allergy and Hypersensitivity to tranexamic acid Thromboembolic events history Epilepsy Acute kidney injury, Glomerular Filtration Rate < 50 ml/min Coagulation disorders Surgical reintervention Blood transfusion refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| intra-op single dose<br>intra-operative single dose of tranexamic acid | Drug: Tranexamic Acid<br>* Tranexamic acid effect on perioperative bleeding in orthopedic surgery<br>|
| intra-op dose and additional dose<br>intra-operative dose of tranexamic acid and additional dose 3 hours after | Drug: Tranexamic Acid<br>* Tranexamic acid effect on perioperative bleeding in orthopedic surgery<br>|
| intra-op dose and perfusion<br>intra-operative dose of tranexamic acid followed by a continuous infusion during 6 hours. | Drug: Tranexamic Acid<br>* Tranexamic acid effect on perioperative bleeding in orthopedic surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative bleeding | perioperative blood loss measured in mililiters (mL) | postoperative day 2 |
A Single-Center Study of RO5508887 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time on study treatment is 14 days.

Official Title
-----------------
A Single-Center, Randomized, Investigator/Subject-Blind, Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RO5508887


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult healthy volunteers, >/=18 years of age Body mass index (BMI) between 18 and 30 kg/m2 inclusive Use of adequate contraception methods or surgically sterile Exclusion Criteria: Evidence of active or chronic disease Regular consumption of drugs of abuse Regular smoker (>5 cigarettes per day) Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) History of significant allergic reactions Abnormal blood pressure Clinical significant abnormalities (e.g., cardiovascular, laboratory values)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Multiple doses of placebo<br>|
| Experimental: RO5508887<br> | Drug: RO5508887<br>* Multiple doses of RO5508887<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: incidence of adverse events |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the age on pharmacokinetics of RO5508887 |  | 30 days | 
| Correlation of the age on pharmacodynamics of RO5508887 |  | 30 days | 
| Pharmacokinetics: plasma levels of RO5508887 |  | Predose and up to 144 hours post last dose, and at follow-up | 
| Pharmacodynamics: Plasma levels of amyloid deposition markers |  | Predose and up to 144 hours post last dose | 
| Correlation of the age on safety of RO5508887 |  | 30 days |