louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06439511: Comparison of a Non Contact Vital Signs Application With Traditional Pulse Oximetry for Heart Rate Measurement
Official title: Comparison of a Non Contact Vital Signs Application (Darwin Edge rVSM) on a Smartphone With Traditional Pulse Oximetry for Heart Rate Measurement: a Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart
Lead sponsor: Hôpital du Valais
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2024-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will have heart rate measurement

1. by pulse oxymetry
2. by a smartphone application
Primary purpose: DIAGNOSTIC

Brief summary: The investigators want to test the accuracy of the Smartphone application Darwin Edge rVSM in measuring heart rate, as compared to traditional pulsoxymetry. The intervention is to look at the smartphone camera for approximately 30 seconds, and after that to compare the heart rate value with that obtained with a recording by pulsoxymetry.

Detailed description: Participants undergoing a routine perianesthetic consultation at the preanesthetic clinic will be recruited. as a part of routine clinical assessment their heart rate is measured with pulsoxymetry, a non invasive device worn at the fingertip for about 1 minute. this measurement will be compared to the values for heart rate that can be obtaine with the ''Darwin Edge rVSM'' mobile application. this application can be installed on any smartphone. the participant is required to look into the smartphone camera for about 30 seconds. environmental and lighning conditions will be kept stable.

The investigators will do the measurements in 200 participants in order to obtaine values in a population characterized by a variety of phenotypes, in the perioperative setting.

Eligibility criteria: Inclusion Criteria:

* Men or women older than 18 years old presenting to the preanesthetic assessment clinic of Valais Hospital
* Subjects that have signed the informed consent form

Exclusion criteria:

* subjects with damaged/injured skin at the face
* Subjects unable to remain still for 30 seconds

Primary outcomes:
measure: Heart rate
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Valais Hospital
state: Valais
Study officials:
affiliation: University of Lausanne Hospitals
name: Patrick Schoettker, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04217811: Late Neutropenia in VLBW Preterm Babies
Official title: Late Neutropenia in VLBW Preterm Babies - Characterization and Post Natal Menagement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neutropenia
Keywords: VLBW
Neutropenia
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-01-03
Enrollment: 237
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VLBW infants

Brief summary: There are rare reports regarding late neutropenua in very low birth weight preterm infants.

The investigators wish to characterize it among our population, and assess its consequenses and the postnatal menagement of the infants.

Detailed description: There are rare reports regarding late neutropenua in very low birth weight preterm infants.

The investigators wish to characterize it among our population, and assess its consequenses and the postnatal menagement of the infants.

Eligibility criteria: Inclusion Criteria:

* Preterm infant with birth weight up to 1500 gram

Exclusion Criteria:

* Early neutroenia - neutrophil count \< 1500 at the first week

Primary outcomes:
measure: Length of stay
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: H̱adera
country: Israel
facility: Hillel Yaffe medical center
state: Hadera
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Erez Nadir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Juul SE, Calhoun DA, Christensen RD. "Idiopathic neutropenia" in very low birthweight infants. Acta Paediatr. 1998 Sep;87(9):963-8. doi: 10.1080/080352598750031635.
Clinical trial NCT06661811: A Study of CAR-T Cells Targeting Autoimmune Diseases
Official title: A Study of CAR-T Cells Targeting B Cell Related Autoimmune Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autoimmune Diseases
Lead sponsor: Beijing Boren Hospital
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in patients with autoimmune disease.

Detailed description: Autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs.

Autoreactive B cells can self-activate and differentiate into plasma cells releasing large amounts of autoantibodies, while they can also present their own antigens to autoimmune T cells, thus activating T cells and promoting the release of inflammatory factors.

CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells, allowing immune rebuilding and restoring the patient's normal immune function, achieving drug-free survival, which fully reflects the application prospects of CAR-T therapy in autoimmune disease.

Eligibility criteria: Inclusion Criteria:

1. Male or female, between 18 and 56 years old;
2. Diagnosed with Autoimmune Diseases；
3. Good organ functions;
4. Voluntary participates this trial and can comprehend and sign ICF.

Exclusion Criteria:

1. Had or has active malignancy;
2. Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
3. Combined with other autoimmune disease that needs treatment;
4. Pregnant or lactating women;
5. Has other factors that deemed not suitable by investigator.

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: 0~28 day after treatment
measure: Frequency of AEs, SAEs
timeFrame: 0 day to 24 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Gaobo Boren Hospital
Study officials:
affiliation: Beijing Gaobo Boren Hospital
name: Yajing Zhang, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01100411: Changes in Invitro and ex Vivo Lens Metrology With Daily Wear Contact Lenses
Official title: Changes in Invitro and ex Vivo Lens Metrology With Experienced Daily Wear Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Contact lenses, myopia, lens geometry
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-04-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
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 changes in contact lens geometry after lens wear

Detailed description: The purpose of this study is to evaluate changes invitro and ex vivo in contact lens geometry in daily lens wear

Eligibility criteria: Inclusion Criteria:

* • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;

  * Be at least 18 years old;
  * Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
  * Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;
  * Has vision correctable to at least 6/12 (20/40) or better at distance in each eye with contact lenses;
  * Be experienced at wearing contact lenses.

Exclusion Criteria:

* • Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;

  * Any systemic disease that adversely affects ocular health
  * An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
  * Use of any topical ocular medication during trial with the exception of saline drops ;
  * Use of or a need for any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance
  * Eye surgery within 12 weeks immediately prior to enrolment for this trial;
  * Previous corneal refractive surgery;
  * Contraindications to contact lens wear;
  * Participated or currently enrolled in another clinical trial that may have affected vision or ocular physiology within the previous 2 weeks;
  * Be pregnant (formal testing of pregnancy is not required. A participant's verbal report is sufficient);
  * Worn soft contact lenses 2 calendar days or rigid gas permeable/ orthokeratology lenses 7 calendar days prior.

Primary outcomes:
measure: Lens Geometry
timeFrame: 1 week
Secondary outcomes:
measure: Corneal Shape
timeFrame: 1 week
measure: Conjunctival Staining
timeFrame: 1 week
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Institute for Eye Research
state: New South Wales
Study officials:
affiliation: Alcon Research
name: Alcon Call Center
role: STUDY_CHAIR
References:
Clinical trial NCT01720511: Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation
Official title: Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetic
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a pilot study to demonstrate the effect of purple rice on post-prandial glucose and insulin. The purple color is due, like red wine grapes, mainly to the anthocyanins. The safety and tolerability of purple rice is similar to white or brown rice, but contains the purple elements common to other foods like grapes.

Detailed description: This is a study that will have 1 screening visit and 9 study visits. Subjects will come to the screening visit for blood chemistry, health questionnaire and speak to the coordinator. Each subject passing inclusion/exclusion will go on to eat purple rice for 4 weeks and brown rice for 4 weeks. The 4-week feeding periods will be balanced and assigned randomly. The subjects will report to the metabolic kitchen to pick up their supply of 14 frozen rice dishes each week in a container and return the empty containers as a measure of compliance. At the end of each 4-week feeding period, subjects will come to the inpatient unit fasting from 9pm the prior night except for water. Subjects will have an intravenous line placed and fasting blood will be drawn for chemistry. Subjects will then be given glucose to drink and blood will be drawn from then IV line for glucose and insulin at time listed in the consent.

Eligibility criteria: Inclusion Criteria:

* Generally healthy male or female with a fasting glucose between 100 mg/mL and 126 mg/dL or with type 2 diabetes controlled on diet without diabetes medications.
* Eighteen years of age or older.
* Hemoglobin A1c(HgbA1c) less than 7%.

Exclusion Criteria:

* Pregnant or nursing.
* Taking a medication for diabetes (e.g. Metformin), a medication known to affect blood sugar (e.g. glucocorticoids), an anti-inflammatory medication (e.g. aspiring) or triglycerides (e.g. fibrates).
* Any chronic medication that has not had a stable dose for 1 month or longer.

Primary outcomes:
measure: Glucose Tolerance
timeFrame: 10 weeks
Secondary outcomes:
measure: Serum Lipids
timeFrame: 10 weeks
measure: Inflammation measured by highly sensitive C-reative protein test
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT01753011: Urethral Length and TOT (Transobturator Tape) Positioning
Official title: Prospective, Observational Study: Can Pelvic Floor Ultrasound Help to Optimize TOT (Transobturator Tape) Positioning?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary Incontinence
Transobturator sling
TOT
Lead sponsor: Cantonal Hospital, Frauenfeld
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes women with surgically-corrected stress urinary incontinence who undergo a TOT operative procedure.

Brief summary: This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure.

Detailed description: This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. Outcome data will be collected 1-3 days and 6 months after procedure.

Eligibility criteria: Inclusion Criteria:

1. Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
2. Patient is age 18 or older.
3. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Institutional Review Board (IRB)/Ethic commission (EC)-approved informed consent.
4. Patient is able to fill in all questionnaires (on judgement of investigator)

Exclusion Criteria:

1. Patient has an associated or suspected neurological disease.
2. Patient has an active lesion or present injury to perineum or urethra.
3. Patient has a urethral obstruction.
4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
5. Patient currently has an urinary tract infection.

Primary outcomes:
measure: Cure rate
timeFrame: 6 months postoperative
Secondary outcomes:
measure: Urethral length
timeFrame: Preoperative
measure: Linear urethral dorsocaudal movement (LUDM)
timeFrame: Preoperative
measure: Urethral tape position
timeFrame: 1-3 days and 6 months postoperative
measure: Distance between tape and longitudinal smooth muscle (LSM) complex
timeFrame: 1-3 days and 6 months postoperative
measure: Urodynamic testing
timeFrame: Preoperative
Other outcomes:
Locations:
city: Hagen
country: Germany
facility: Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe
city: Frauenfeld
country: Switzerland
facility: Blasenzentrum, Cantonal Hospital
state: Thurgau
Study officials:
affiliation: Cantonal Hospital, Frauenfeld
name: Volker Viereck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01222611: HCV Evolution in HIV/HCV (Genotype 1) Coinfected Patients Treated With Fosamprenavir
Official title: Randomized, Controlled, Open Label, Pilot Study to Evaluate Fosamprenavir Activity on Genotype 1 Hepatitis C Virus (HCV) Infection Evolution in Human Immunodeficiency Virus (HIV) Co-infected Subjects With Antiretroviral Treatment Including Fosamprenavir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic HIV Infection
HCV Coinfection
Keywords: HIV
HCV
HIV/HCV
Coinfection
Fosamprenavir
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2010-10-18
Enrollment: 42
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: This study examines the impact of fosamprenavir as part of an ART on virological, immunological and clinical parameters of genotype 1 HCV infection in HIV co-infected subjects. Fosamprenavir could have a direct or immune-mediated activity against HCV. If this is shown to be true, changes in HCV viral load or biological characteristics could be demonstrated.


Eligibility criteria: Inclusion Criteria:

* Age \>18 yo
* HIV/HCV co-infected patients with HCV detectable viremia in 2 determinations separated at least by 6 months.
* HCV genotype 1
* Currently receiving ART including 2NRTI+1 PI/r (excluding FPV) or 1 NNRTI, without changes in the last 6 months
* HIV RNA \< 50 copies/mL for the last 6 months

Exclusion Criteria:

* Previous anti HCV treatment
* Foreseeable HCV treatment in the next 12 months
* Acute HCV infection
* Active opportunistic infection
* HIV with FPV resistance mutations
* Current or previous treatment with FPV
* Chronic hepatitis B
* Current alcohol consumption greater than 20 g per day

Primary outcomes:
measure: HCV Viral load and changes in HCV protease gene
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Hospital Príncipe de Asturias
state: Madrid
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: Hospital La Paz, Madrid (Spain)
name: Juan Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02765711: Ticagrelor in Fuwai Hospital
Official title: TIFU: A Non-Interventional, Descriptive Cohort Study to Describe the Use of Ticagrelor in Patients With Acute Coronary Syndrome (TIFU: Ticagrelor in Fuwai Hospital)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: ticagrelor
acute coronary syndrome
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2016-05-09
Enrollment: 1200
Sex: ALL
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: This study will include more than 1200 ACS patients using ticagrelor in Fuwai hospital from May 2016 to May 2017.

Brief summary: This is a single-arm non-interventional cohort study. This study is to describe the contemporary use of ticagrelor in a "real-world" setting, to reflect its acceptance and patients' compliance, and to observe its one-year safety in patients with acute coronary syndrome in Fuwai Hospital.


Eligibility criteria: Inclusion Criteria:

1. ≧18 years
2. Established diagnosis of acute coronary syndrome
3. The use of ticagrelor in hospital
4. agree to join this clinical trial and sign informed consent

Exclusion Criteria:

1. Life-expectancy \<1 year
2. Dialysis required

Primary outcomes:
measure: Number of participants with switching between clopidogrel and ticagrelor
timeFrame: 12 months
measure: Number of participants with switching between clopidogrel and ticagrelor without a reloading dose
timeFrame: 12 months
measure: Number of Participants with discontinuation of P2Y12 receptor antagonist
timeFrame: 12 months
measure: Number of Participants with ticagrelor combined with other anticoagulants
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular Mortality, Myocardial Infarction(MI), Ischemic Stoke
timeFrame: 12 months
measure: Number of bleeding event will be recorded (defined in accordance with PLATO definition)
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Hongbing Yan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05322811: Emotional State Among Patients With Neurological Disorders
Official title: Emotional State Among Patients With Neurological Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emotional Stress
Emotional Depression
Anxiety
Neurologic Disorder
Keywords: stress
anxiety
depression
neurologic disorders
Lead sponsor: International Hellenic University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with neurological disorders

Brief summary: The purpose of the study was to examine the emotional state of the patients with neurological disorders. The evaluation was conducted with DASS-21 scale over 40 patients.

Detailed description: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.The DASS-21 should not be used to replace a face to face clinical interview.

Eligibility criteria: Inclusion Criteria:

* patients with neurological disorders

Exclusion Criteria:

* not given concent
* Incomplete questionaire answers

Primary outcomes:
measure: Emotional state score of the patients
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Stress frequency at the participants
timeFrame: through study completion, an average of 1 year
measure: Depression frequency at the participants
timeFrame: through study completion, an average of 1 year
measure: Anxiety frequency at the participants
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Physical therapy clinic Trevlakis Emmanouil
Study officials:
affiliation: PhD Professor of Physiotherapy at IHU, Head of the Postgraduate Programme, Pediatric Physiotherapy
name: Alexandra-Hristara Papadopoulou
role: STUDY_CHAIR
References: