louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02996890: Zika-Vaccine Dose Finding Study Regarding Safety, Immunogenicity and Tolerability (V186-001)
Official title: Double Blinded, Randomized, Placebo Controlled, Dose Finding Trial to Evaluate the Optimal Dose of MV-ZIKA, a New Vaccine Against Zika Virus, in Regard to Immunogenicity, Safety, and Tolerability in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Zika Virus
Lead sponsor: Themis Bioscience GmbH
Sponsor class: INDUSTRY
First posted: 2016-12-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects.

After completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) All subjects will receive study treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with two vaccinations will receive a second treatment at day 28.

Subjects will return on day 56 for the final visit.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers aged 18 to 55
* subjects of child bearing potential must perform reliable method of contraception

Exclusion Criteria:

* immune deficiency, history of HIV, HBV, HCV
* drug addiction
* vaccination within 4 weeks prior to study or planned vaccination during study
* prior receipt of any Zika vaccine
* recent infection 1 week prior to screening
* relevant medical history interfering with aim of study
* neoplastic disease, hematological malignancy
* history of autoimmune disease
* psychological condition that affects ability to participate in the study
* history of severe adverse reactions to vaccine administration
* history of anaphylaxis
* allergic reactions, abnormal lab values, or concomitant medication per decision of the investigator
* use of immunosuppressive drugs within 30 days before screening or planned use during study
* receipt of blood products within 120 days before screening or planned use during study
* pregnancy, unreliable contraception method
* decision of the investigator
* regular blood plasma donor

Primary outcomes:
measure: Immunogenicity: Functional anti-Zika antibodies as measured by PRNT
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Center for Pathophysiology, Infectiology and Immunology
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Clinical Pharmacology
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02326090: Phase 2 Study With Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye
Official title: A Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1.0% and 2.5% Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndrome
Lead sponsor: Herantis Pharma Plc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2014-12-25
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the Phase 2 study is to compare the safety and efficacy of cis-UCA Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility criteria: Key Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a subject reported history of dry eye;
* Have a history of use or desire to use eye drops.

Key Exclusion Criteria:

* Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Have used Restasis® within 30 days of Visit 1;
* Have any planned ocular and/or lid surgeries over the study period;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential;
* Have a known allergy and/or sensitivity to the study drug or its components;
* Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
* Be unable or unwilling to follow instructions, including participation in all study assessments and visits.

Primary outcomes:
measure: Corneal Fluorescein Staining
timeFrame: Day 29
measure: Symptom Score
timeFrame: Day 22 to 28
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
state: Massachusetts
Study officials:
References:
Clinical trial NCT06670690: Comparison Between Atenolol,Propnalol and Ivabradine
Official title: Comparison Between Atenolol , Propnalol and Ivabradine as a Premedication for Bloodless Field Anesthesia in Lumbar Spine Surgery ,a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Bleeding
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery.

Detailed description: This study will investigate the effect of atenolol, propranolol, and ivabradine as oral premedication in adult patients undergoing LUMBAR SPINE SURGERY to achieve bloodless field anesthesia.

AIM OF THE WORK

* The primary aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery.
* The secondary aims are to assess field visibility and measure the amount of blood loss in patients, and surgeon satisfaction and also to asses if there are any associated undesirable side effects of atenolol, propranolol, or Ivabradine will appear.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I and II,

  * aged from 18 to 50 years old
  * scheduled for elective lumber spine surgeries will be included in this study.

Exclusion Criteria:

* Hypertension.
* Hepatic or renal disease.
* Diabetes Mellitus.
* Pregnancy.
* Coagulation disorders.
* Anemia (Hb \< 10 g/dL).
* Ischemic heart disease
* Drug or alcohol abuse.
* Allergy to any of atenolol, propranolol, and ivabradine.
* History of beta-blockers, calcium channel blockers, Tricyclic antidepressants, anticoagulant or clonidine intake.

Primary outcomes:
measure: Perioperative Heamodynamic Effect of the drugs
timeFrame: every 5 minutes for 15 minutes and then every 10 minutes till end of surgery, then every 15 minutes for 1hour in the recovery room
Secondary outcomes:
measure: Blood loss & surgical field visibility score
timeFrame: Intraoperative time
measure: Anesthetic consumption
timeFrame: Intraoperative time
measure: Incidence of complication
timeFrame: Intraoperative time
measure: The need for blood transfusion
timeFrame: Intraoperative time
Other outcomes:
Locations:
city: Shepien El Kom
country: Egypt
facility: Menoufia University
state: Menoufia Government
Study officials:
References:
Clinical trial NCT04316390: Influence of Hesperidin and Vitamin C on Uric Acid Concentration
Official title: Influence of Hesperidin and Vitamin C on Uric Acid Concentration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Higher Uric Acid Concentrations (>5,5 mg/dl)
Healthy
Keywords: hesperidin
vitamin C
uric acid concentration
Lead sponsor: University of Kiel
Sponsor class: OTHER
Collaborators: name: Hochschule Geisenheim University
First posted: 2020-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Aim of the study is to investigate the impact of hesperidin and/or vitamin C on elevated uric acid concentrations.

Detailed description: Duration of the study is 9 weeks. 1) a washout week, 2) two intervention weeks, 3) four weeks washout period, 4) two intervention weeks.

The study is conducted under free living conditions. During washout weeks consumption of orange juice or citrus fruits or vitamin C containing supplements is restricted.

During intervention weeks 200 mL of study drink is consumed daily. And participants are asked to maintain their normal physical activity and habitual diet. Additional citrus or vitamin C containing beverages are not allowed.

At the beginning and the end of each intervention phase uric acid, insulin sensitivity, blood pressure, pulse wave velocity and bioavailability of hesperidin are assessed.

Eligibility criteria: Inclusion Criteria:

* healthy
* higher uric acid concentration (≥5.5 mg/dL)
* Informed written consent

Exclusion Criteria:

* pregnancy
* fructose intolerance
* smoking
* gout or medicated hyperuricemia
* diabetes mellitus
* antidiabetic or cytostatic medication
* weight loss (≥5% in the past 3 months)
* consumption of vitamin C-containing supplements
* parallel participation in a clinical trial
* anemia and / or iron deficiency

Primary outcomes:
measure: Changes in uric acid serum concentrations
timeFrame: Baseline (pre) and post two weeks of intervention
Secondary outcomes:
measure: changes in uric acid excretion
timeFrame: Baseline (pre) and post two weeks of intervention
measure: changes in pulse wave velocity
timeFrame: Baseline (pre) and post two weeks of intervention
measure: insulin sensitivity
timeFrame: Baseline (pre) intervention periods
Other outcomes:
measure: bioavailability of hesperidin in blood
timeFrame: Baseline (pre) and post two weeks of intervention
measure: bioavailability of hesperidin in urine
timeFrame: Baseline (pre) and post two weeks of intervention
Locations:
city: Kiel
country: Germany
facility: Institute of Human Nutrition
Study officials:
affiliation: Institute of Human Nutrition, Kiel University
name: Anja Bosy-Westphal, Prof, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04606290: Automated Oxygen Titration with O2matic Home Oxygen Therapy (O2matic HOT) Phase 1
Official title: Automated Oxygen Titration to Patients with COPD and Domiciliary Long-term Oxygen Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD
Chronic Hypoxemic Respiratory Failure
Keywords: O2matic
Closed-loop
Pulse oximetry
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Innovation Fund Denmark
name: Naestved Hospital
First posted: 2020-10-28
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: O2matic HOT is a further development of O2matic and is intended for home oxygen use with patients in need of long-term oxygen treatment (LTOT). O2matic HOT is a closed-loop system which on basis of signals from pulse oximetry titrates the oxygen flow to the patient. In this crossover trial patients are admitted for 24 hours twice. Once with usual fixed dose oxygen and once with oxygen titration by O2matic HOT.

Detailed description: The purpose of this study is to examine if automated oxygen control based on pulse oximetry to patients with domiciliary long-term oxygen treatment (LTOT) is better than manually controlled oxygen treatment in keeping SpO2 within intended target interval. In manually controlled oxygen treatment flow is usually kept constant for months between visits from specialist nurse, whereas in automated control the patient can titrate oxygen flow several times a day based on pulse oximetry in a closed-loop system.

Eligibility criteria: Inclusion Criteria:

* Verified COPD with FEV1/FVC \< 0.70
* Need of LTOT (PaO2 \<= 7.3 kPa or SpO2 \< 88 % on ambient air)
* Cognitively able to participate
* Willing to provide informed consent

Exclusion Criteria:

* Moderate or severe exacerbation in COPD within 4 weeks from study start
* Major comorbidities (cancer, uncontrolled chronic disease)
* Asthma or other disease with need of higher SpO2
* Pregnancy
* Fall in pH below 7.35 or increase in PaCO2 \> 1 kPa on 5 liters of oxygen
* Active smoking
* LTOT use less than 1 hours/day

Primary outcomes:
measure: Percentage of time in intended SpO2-interval
timeFrame: 24 hours
Secondary outcomes:
measure: Percentage of time with SpO2 below 85 %
timeFrame: 24 hours
measure: Percentage of time with SpO2 below target but not below 85 %
timeFrame: 24 hours
measure: Percentage of time with SpO2 above target
timeFrame: 24 hours
measure: Change in PaCO2 from baseline
timeFrame: 8 hours
measure: Change in PaCO2 from baseline
timeFrame: 24 hours
measure: Accumulated oxygen usage
timeFrame: 24 hours
measure: Adverse and serious adverse events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
city: Næstved
country: Denmark
facility: Næstved University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Thomas Ringbaek, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03730090: Hypothermia in Cesarean Sectio Patients in Regional Anaesthesia
Official title: Hypothermia in Cesarean Sectio Patients in Regional Anaesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Section
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive, elective cesarean sectio

Brief summary: To study the core temperature perioperatively in patients due for elective cesarean sectio in spinal anaesthesia.

Core temperature will be registered by a zero-flux (SpotOn. 3m) probe on the forehead, starting in the holding area and continued until normotemperature post-operatively.


Eligibility criteria: Inclusion Criteria:

* Elective patients
* planned spinal anaesthesia

Exclusion Criteria:

* Conversion of procedure to general anaesthesia
* allergy to temperature probe (adhesive)

Primary outcomes:
measure: incidence of perioperative hypothermia, less than 36.0 degrees
timeFrame: perioperatively
Secondary outcomes:
measure: patient satisfaction: Patient will be asked to grade
timeFrame: perioperatively, repeated
measure: duration of perioperative hypothermia
timeFrame: perioperatively, continously
measure: shivering
timeFrame: perioperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03102203: Differentiation of Progression From Treatment Effects in High-Grade Gliomas: A Clinical Trial With Multimodality MR Imaging
Official title: Differentiation of Progression From Treatment Effects in High-Grade Gliomas: A Prospective Multicenter Clinical Trial With Multimodality MR Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Eligibility module specifies the criteria for determining which people are (or are not) eligible to participate in the study

Brief summary: To evaluate the efficacy of multi-modality magnetic resonance quantitative parameters in evaluating the treatment effects of high-grade gliomas, and to provide new biomarkers for the establishment of new diagnostic criteria for the identification of true and pseudoprogression of high-grade gliomas.


Eligibility criteria: Inclusion Criteria:

1. Patients with high-grade gliomas confirmed by pathology and have not been treated with concurrent chemoradiotherapy;
2. Written informed consent is obtained.

Exclusion Criteria:

1. Patients not suitable for enhanced MRI scanning of patients;
2. Patients who have not finished follow-up concurrent chemoradiotherapy or MR scanning.

Primary outcomes:
measure: Ktrans
timeFrame: baseline
measure: Ktrans
timeFrame: 3 months
measure: Ktrans
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Guang Ming Lu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00764803: 3DKnee™ System vs. the MJS Knee System
Official title: Post-Market Study: The Efficacy of the 3DKnee™ System vs. the MJS Knee System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Traumatic Arthritis
Joint Disease Secondary to Osteoarthritis
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who meet either the indications for use of the 3DKnee or the MJS knee system. Subjects must also meet the inclusion/exclusion criteria.

Brief summary: The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way.

Detailed description: The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way. Approximately 300 patients have already received the MJS™ knee system and data, as described below, has been collected for these patients over a period of two years. A second group of 300 patients will receive the Encore 3DKnee™ system over the next two years, and equivalent data will be collected for these individuals. A portion of the data has been collected over the past year, and now we would like to obtain permission from the patients to analyze these data as well as collect an additional year of data.

Eligibility criteria: Inclusion Criteria:

* This must be a primary knee replacement on this knee.
* Patient is over 18 years of age or older
* Patients must have one of the following

  * rheumatoid or traumatic arthritis OR
  * joint disease secondary to osteoarthritis
* Patient is likely to be available for evaluation for the duration of the study
* Able and willing to sign the informed consent and follow study procedures
* Patient is not pregnant

Exclusion Criteria:

* Is younger than 18 years of age
* If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
* Overt infection
* Alcoholism or other addictions
* Muscular, neurological or vascular deficiencies which compromise the affected extremity
* Obesity
* Marked bone loss
* Materials sensitivity
* Prisoner
* Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
* Patient is pregnant

Primary outcomes:
measure: The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Center for Excellence
state: California
Study officials:
affiliation: Center for Excellence
name: D. Kevin Lester, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03554603: Modified Reporting of Positive Urine Cultures Collected From Long Term Care
Official title: Modified Reporting of Positive Urine Cultures Collected From Long Term Care, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Asymptomatic Bacteriuria
Keywords: Long term care
Urine culture
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB is difficult, since the microbiology laboratory cannot distinguish patients with AB. The investigators study will use a restricted laboratory report requesting the physician to call the laboratory for culture results. The restricted report may reduce the rate of inappropriate treatment of AB.

Detailed description: Positive urine cultures during the study period will be randomized to restricted microbiology laboratory reporting or standard microbiology laboratory reporting. Physician or patient consent will not be collected. Patient records will be assessed by the investigator to determine if patients have AB or urinary tract infection. Physician antibiotic treatment decision in both groups will be collected.

Eligibility criteria: Inclusion Criteria:

1. Consecutive positive urine cultures collected from patients admitted to Long term care facilities will be included. All methods of urine collection will be included (midstream, in-and-out catheterization, indwelling catheter).

Exclusion Criteria:

1. Positive urine cultures not collected from Long term care facility patients
2. Pregnancy
3. Antibiotic treatment at the time of collection
4. Patients known to have blood neutrophils \<1.0 within 7 days of urine collection

Primary outcomes:
measure: Proportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint John's
country: Canada
facility: Health Sciences Center
state: Newfoundland and Labrador
Study officials:
References: