louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05725252: To Evaluate the Safety and the Pharmacokinetics of NVP-2203
Official title: Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of NVP-2203 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2023-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Detailed description: Phase 1 to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Eligibility criteria: Inclusion Criteria:

* Healthy adult subjects who signed informed consent
* BMI of \>18.0 kg/m2 and \<30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman)

Exclusion Criteria:

* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision

Primary outcomes:
measure: NVP-2203's pharmacokinetics of plasma
timeFrame: 0hours - 72hours
Secondary outcomes:
measure: pharmacokinetics of plasma
timeFrame: 0hours - 72hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
state: Nambusunhwan-ro
Study officials:
affiliation: H Plus Yangji Hospital
name: Jaewoo Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01225432: The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation
Official title: The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elevated Metabolic Cost
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2010-10-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the carryover effect of an innovative new gait training program on physiological and functional gait performance in persons with a traumatic lower extremity amputation. A second objective is to clarify the relationship between gait biomechanics (joint and sgment kinematics and energy cost.


Eligibility criteria: Inclusion Criteria

* Unilateral traumatic trans-tibial or transfemoral amputation
* Independent ambulation without an assistive device for a minimum of three months
* Ability to ambulate continuously for a minimum of 15 minutes
* Trans-femoral participants must use an ischial containment socket
* VAS Pain scores on the involved side of less than 4/10
* Sagittal plane ankle, knee and hip strength of 4 or greater on the uninvolved side as determined by manual muscle test.

Exclusion Criteria:

* Blindness
* TBI-Glascow Coma Scale score of 12 or lower at the time of injury
* Cardiac or pulmonary problems limiting physical activity PTSD or other psychological condition with symptoms that would be exacerbated by participation in the study.

Primary outcomes:
measure: Gait Oxygen Consumption
timeFrame: 3 weeks
measure: Gait Oxygen Consumption
timeFrame: Immediately prior to start of 3 week training.
measure: Gait Oxygen Consumption
timeFrame: Immediately post training
measure: Gait Oxygen Consumption
timeFrame: 3 weeks later from first post training testing
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Center for the Intrepid
state: Texas
Study officials:
affiliation: Director, Military Performance Lab-Center for the Intrepid
name: Jason M Wilken, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02923232: Ocular Adaptation and Visual Performance for Accommodative Contact Lens
Official title: Ocular Adaptation and Visual Performance for Accommodative Contact Lens
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Functionality of Experimental Contact Lens
Keywords: Contact lens; Accommodation; Visual performance
Lead sponsor: Pacific University
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Presbyopes (people who might have a significant loss of their ability to accommodate their crystalline lens in the eye) will be recruited to wear a test lens and perform typical clinical tests of visual acuity with different luminance levels and viewing distances/angles.

Detailed description: In the proposed study we plan to recruit presbyopes (people who might have a significant loss of their ability to accommodate their crystalline lens in the eye) to wear a test lens and perform typical clinical tests of visual acuity with different luminance levels and viewing distances/angles. These are similar to the typical examinations conducted for regular contact lens wearers. Results of this testing will be used to evaluate the efficacy of test lenses and to provide additional information for revision of test lenses. If shown to provide adequate eye comfort and intended vision correction, this lens design has the potential of allowing tens of millions of presbyopes to adapt to contact lenses and significantly improve their vision and well-being.

Eligibility criteria: Inclusion Criteria:

* Be between 40 and 65 years of age.
* Have normal/corrected-to-normal monocular acuity of better than 20/25 for both eyes.
* Have pupil diameter in regular lighting ≥ 2.5 mm.
* Willing and able to wear multifocal contact lenses in both eyes.
* Have a current optical prescription (obtained less than 2 years ago).
* Have spherical equivalent correction equal to or higher than -1.00 Diopter and equal to or less than +0.50 Diopter.
* Have cylindrical correction equal to less than 0.50 Diopter.

Exclusion Criteria:

* Have no prismatic correction.
* Without any eye infection, inflammation, disease, or abnormality that contraindicates contact lens wear within the past 6 months.
* No clinically significant ocular pathology (e.g., cataract, keratoconus, dry eye, diabetic retinopathy, or age-related macular degeneration)
* Have no photosensitive disorders, including migraine and seizure.
* Have no binocular dysfunction, including amblyopia, strabismus, and other binocular diseases.

Primary outcomes:
measure: Monocular Refractive Power
timeFrame: 30 mins of wearing; non-dispensing.
measure: Visual Acuity at 20 Degree Downsize Angles
timeFrame: 30 mins of wearing; non-dispensing.
Secondary outcomes:
Other outcomes:
Locations:
city: Forest Grove
country: United States
facility: Vision Performance Institute
state: Oregon
Study officials:
References:
Clinical trial NCT03919032: Bacterial Infections in Patients with Cirrhosis in Argentina: Clinical and Microbiological Characteristics
Official title: Bacterial Infections in Patients with Cirrhosis in Argentina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infections
Cirrhosis
Resistant Infection
Morality
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older than 17 years with cirrhosis who are hospitalized for bacterial infections, or who develop bacterial infections while hospitalized

Brief summary: In recent years, there has been an increasing prevalence of bacterial infections caused by multiresistant and extremely resistant organisms in patients with cirrhosis. These infections are associated with a worse prognosis, generate difficulties in the management of the patient during hospitalization and increase health costs.

The main objective of this project is to estimate the prevalence of infections by multiresistant bacteria in patients with cirrhosis. Additionally, the prevalence of other antibiotic resistance patterns and morbi-mortality in the study population will be evaluated.

For these purposes, a multicenter prospective cohort study will be carried out, including patients with cirrhosis who present bacterial infections at the time of admission, or during hospitalization.

Performing a study in Argentina on the clinical and microbiological characteristics of bacterial infections in patients with cirrhosis could be very useful to develop new strategies for prevention and treatment of this severe complication.


Eligibility criteria: Inclusion Criteria:

* Patients with cirrhosis
* Patients older than 17 years.
* Patients who are hospitalized for bacterial infections, or who develop bacterial infections while hospitalized

Exclusion Criteria:

• Refusal to participate in the informed consent process

Primary outcomes:
measure: To estimate the prevalence of infections caused by multi-resistant microorganisms in patients with cirrhosis
timeFrame: at the moment of the diagnosis of the bacerial infection
Secondary outcomes:
measure: To evaluate variables associated with infections caused by multi-resistant microorganisms in patients with cirrhosis
timeFrame: at the moment of the diagnosis of the bacerial infection
measure: To evaluate the effect of infections caused by multi-resistant microorganisms on the in-hospital survival of patients with cirrhosis
timeFrame: 30 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Sebastián Marciano
Study officials:
References:
Clinical trial NCT01988532: Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia
Official title: Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Haemophilia A
Haemophilia A With Inhibitors
Haemophilia B
Haemophilia B With Inhibitors
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-11-20
Enrollment: 381
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult PWH in the United States of America (USA) willing to consent to participation who have any history of joint bleeding or joint pain presenting for a comprehensive care visit during which joint range of motion will be assessed.

Brief summary: This study is conducted in the United States of America (USA). The aim of the study is to assess the impact of pain on functional impairment and quality of life in adult persons with hemophilia (PWH) with and without inhibitors with joint bleeding.


Eligibility criteria: Inclusion Criteria:

* Adult males able to provide consent and complete a survey in English
* Congenital hemophilia A or B with or without inhibitors with any history of joint bleeding or joint pain
* Presentation at the treatment center for a comprehensive annual visit where joint range of motion will be obtained
* Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)

Exclusion Criteria:

* Previous participation in this study

Primary outcomes:
measure: Prevalence of acute (bleed-related) pain (percentage)
timeFrame: At the first visit (only one study visit)
measure: Prevalence of chronic (arthritic) pain (percentage)
timeFrame: At the first visit (only one study visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Wang M., Baumann K., Akins S., Funk S., Hernandez G., Kempton C., Buckner T., Cooper D. Pain, Functional Impairment, and Quality of Life (P-FIQ): Reliability of Patient-Reported Outcome (PRO) Instruments Assessing Pain and Function in US Adult People With Hemophilia (PWH). 14th WFH International Musculoskeletal Congress 2015; : Abstract number: P-224 Country: Northern Ireland City: Belfast
citation: Baumann K., Akins S., Funk S., Hernandez G., Kempton C., Wang M., Buckner T., Cooper D. Functional Impairment, Pain, and Pain Management in Adult People with Haemophilia (PWH): Initial Lessons from the Pain Functional Impairment and Quality of Life (P-FIQ) Study. 14th WFH International Musculoskeletal Congress 2015; : Abstract number: MP-209 Country: Northen Ireland City: Belfast
Clinical trial NCT06446232: Influenza Vaccine Effectiveness in Among Young Children in Taiwan
Official title: Influenza Vaccine Effectiveness in Inpatient and Outpatient Settings Among Young Children in Taiwan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Influenza Vaccine Allergy
Keywords: Influenza Vaccine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 1
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Those who have performed a rapid influenza screening test, regardless of whether the result is negative or positive

Brief summary: This project uses questionnaires to statistically analyze whether influenza vaccination is protective for young children.

Detailed description: This plan is expected to admit 350 children who are admitted to the emergency department or hospitalized due to influenza and are aged from 6 months (inclusive) to under 18 years old. Vaccine status, statistical analysis of whether the flu vaccine is protective.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of influenza by Flu A+B rapid antigen test
* Known vaccination status

Exclusion Criteria:

* Unknown vaccination status

Primary outcomes:
measure: Questionnaires
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT05976932: Circulating Tumor DNA Monitoring in Platinum-resistant Ovarian Cancer
Official title: The Utility of Circulating Tumor DNA in Monitoring the Response to Pegylated Liposomal Doxorubicin in Platinum-resistant Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ovarian Cancer
Keywords: ctDNA
pegylated liposomal doxorubicin
ovarian cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 20
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: platinum-resistant ovarian cancer

Brief summary: This observational study is conducted to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer，and evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.

Detailed description: The goal of this study is to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer.This is a single-arm, single-center prospective clinical study.

After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin)and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment，If necessary, Peripheral blood samples also be collected after 2 cycles of treatment.Peripheral blood ctDNA will be tested for genetic variation based on next-generation sequencing (NGS).

Finally, this study will to evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.

Eligibility criteria: Inclusion Criteria:

1. Female, over 18 years of age;
2. Patients with histopathological diagnosis of high-grade serous epithelial ovarian cancer;
3. pathological report:phenotype of p53 mutation；or previous genetic tests of tumor tissue indicated TP53 gene mutations;
4. ECOG≤ 2;
5. Expected survival time ≥3 months;
6. The subjects were able to understand the study process and voluntarily joined the study.

Exclusion Criteria:

1. Pregnant and lactating patients;
2. Patients with severe or uncontrolled infections;
3. Patients who are allergic or intolerant to the investigational drug;
4. Patients who are enrolled in or within a month of another clinical trial.

Primary outcomes:
measure: the consistency of circulating tumor DNA with CT scan
timeFrame: at the beginning of Cycle 1 and 3 weeks after Cycle 1. If necessary, also including 3 weeks after Cycle 2（each cycle is 28 days）
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03318432: Stroke Recovery Initiative - Registry for Stroke Research Studies
Official title: Stroke Recovery Initiative - Stroke Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Acute Stroke
Ischemic Stroke
Hemorrhagic Stroke
Subarachnoid Hemorrhage
Cerebral Ischemia
Cerebral Infarction
Cerebral Stroke
Cerebral Vascular Accident
Keywords: Stroke
Acute Stroke
Ischemic Stroke
Hemorrhagic Stroke
Cerebral Ischemia
Cerebral Infarction
Cerebral Stroke
Cerebral Vascular Accident
Stroke Recovery
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 60000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke survivors

Brief summary: The Stroke Recovery Initiative is a nation-wide participant recruitment registry that connects people who have had a stroke with researchers who are working to develop new approaches to improve recovery after stroke.

Detailed description: The Stroke Recovery Initiative at UCSF is designed to help people who have had a stroke to connect with researchers who are applying the latest science and technology to develop new treatments for stroke recovery. Anyone who is 18 years of age or older and has had a stroke may submit a survey to join. The self-reported information on the survey will be used to match participants to current or future stroke research studies and study personnel for each specific study may contact participants for further screening. Some studies are recruiting participants nationally, not just in the San Francisco Bay Area.

Eligibility criteria: * 18 years of age or older
* Have suffered a stroke
* Have ongoing symptoms as a result of the stroke

Primary outcomes:
measure: Total Enrollment
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Anthony S. Kim, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02349932: The Influence of Histo-blood Group Antigen Polymorphism on the Composition of the Microbiota
Official title: The Influence of Histo-blood Group Antigen Polymorphism on the Composition of the Microbiota
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Microbiota Analysis in Healthy Subjects
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2015-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: A person's blood type is defined by the types of sugars they express on their red blood cells, with antibodies being made to non-self sugars and excluding blood cells expressing these sugars (the basis of blood transfusion reactions). These same sugars can be expressed by commensal bacteria in our gut lumens. The investigators hypothesize that a person's antibodies to non-self sugars also attach to and exclude non-self sugar-expressing bacteria in our guts. Supporting our hypothesis, a person's blood type correlates with the overall composition of their gut flora. Because these sugars are also used by certain pathogens to initiate infection, this information could directly inform our understanding of host susceptibility to various infectious organisms.

Detailed description: A member of the study staff will collect a small volume of blood sample through a finger prick and 2-3 milliliters of saliva from you. Using these samples, we will determine your blood type (defined by your expression of specific sugars on your red blood cells) and your expression pattern of these sugars in body secretions (e.g., saliva). You will provide us with a fecal sample collected the day of your appointment. The fecal sample should be collected in a pre-provided collection container and should be collected within 12 hours of drop-off. Using your fecal sample, we will determine the types of bacteria present in your normal gut flora and whether they express the same sugars expressed on your blood cells. Tests will be done only for research purposes and will not be evaluated or used to diagnose or treat any of your medical problems. Sample collection may need to be repeated if required for your medical care in the future.

Eligibility criteria: Inclusion Criteria:

* healthy,
* adult

Exclusion Criteria:

* younger than 18,
* older than 60,
* pregnant

Primary outcomes:
measure: Blood typing (Blood and saliva will be used to determine overall blood type)
timeFrame: 1 day
measure: Quantitative PCR (PCR will be used to enumerate commensal bacteria in fecal samples)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Stephanie M Karst, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: