louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02827474: We Experience: Perspectives on a Quality Abortion Care Experience: A Patient Centered Approach
Official title: Perspectives on a Quality Abortion Care Experience: A Patient Centered Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Termination
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient Participants: Women presenting to Center for Reproductive Health (CRH) for induced abortion for an undesired pregnancy in the first trimester \< 14 weeks and age 18-45 years. Woman must have a completed surgical abortion procedure and be able to speak English or Spanish.

Provider Participants: Providers must be performing procedures on the day patient participants are recruited and must be willing to give their perspective on the participating patients' abortion experience.

Brief summary: The purpose of this study is to determine aspects of abortion care most important to the patient in creating a "high quality" abortion experience, to investigate patients' expectations of abortion care, and to explore provider perceptions of patients' abortion experiences and assess concordance with patients' perspectives.

Detailed description: The purpose of this study is to determine aspects of abortion care most important to the patient in creating a "high quality" abortion experience, to investigate patients' expectations of abortion care, and to explore provider perceptions of patients' abortion experiences and assess concordance with patients' perspectives.

The investigators will conduct semi-structured interviews with patient participants and providers separately to determine patients' expectations of abortion care as well as the most important aspects of the abortion experience and to explore providers' perceptions of their patients' abortion experience and assess concordance.

Eligibility criteria: Inclusion Criteria:

* Women presenting to the Center for Reproductive Health (CRH) for induced abortion for an undesired pregnancy in the first trimester \< 14 weeks.
* Women ages 18-45 years.
* Woman must have a completed surgical abortion procedure
* Women must be able to speak English or Spanish.

Exclusion Criteria:

* Women who are unable or unwilling to consent for the study or are unable or unwilling to complete a follow-up interview
* Women who are unable to consent and/or are cognitively impaired.
* Women who are under the age of 18
* Women who are incarcerated.

Primary outcomes:
measure: Patient Experience, semi-structured interviews
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Center for Reproductive Health
state: New Mexico
Study officials:
affiliation: University on New Mexico
name: Brenda Pereda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04599374: the Association Between Thyroid Hormones and Metabolic Components in Patients With Obesity
Official title: the Association Between Thyroid Hormones and Metabolic Components in Patients With Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Euthyroid Condition
Metabolic Syndrome
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We enrolled obese patients with euthyroid function.

Brief summary: This study collected clinical data of obese patients with euthyroid function, including age, gender, height, weight, BMI, waist circumference, blood pressure, fasting blood sugar, blood sugar 2 hours after sugar load, fasting plasma high-density lipoprotein cholesterol, fasting three acyl glycerin, free iodine thyroid hormone (FT3) and free thyroid hormones (FT4), thyroid stimulating hormone (TSH), follow-up information and etc. Via analyzing the data, the investigators want to investigate the association between thyroid hormones (THs) and metabolic components in obese patients with euthyroid function and to present the cutoff values of THs in order to provide new information for the risk stratification of metabolic syndrome in obese patients with euthyroid function.


Eligibility criteria: Inclusion Criteria:

* 1) age ranged from 18-65 years old, 2) BMI over 27.9kg/m2,3)TSH，FT4, and FT3 within the range of 0.38-4.34mIU/L, 10.5-24.4mIU/L, and 2.8-6.3mIU/L, respectively.

Exclusion Criteria:

* secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc.,2)pregnancy or location, 3) severe heart, liver and kidney dysfunction

Primary outcomes:
measure: meet the criteria of metabolism in the 2017 Chinese guideline
timeFrame: 2015-2020
Secondary outcomes:
measure: high uric acid
timeFrame: 2015-2020
measure: FBG≥6.1mmol/L
timeFrame: 2015-2020
measure: BG120≥7.8mmol/L
timeFrame: 2015-2020
measure: FINS≥24.9 pmol/ml
timeFrame: 2015-2020
measure: FCP≥4.4nmol/L
timeFrame: 2015-2020
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06923774: European Real-World Registry for Use of the Ion Endoluminal System
Official title: A European Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pulmonary Nodule
Lung Cancer
Keywords: Biopsy
Bronchoscopy
pulmonary biopsy
pulmonary nodule localization
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2025-04-11
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: Patients planned for an elective lung nodule biopsy and/or localization procedure using the Ion endoluminal system as their standard of care

Brief summary: The objective of this study is to collect collect real-world data for the Ion endoluminal system.

Detailed description: This is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the CE-marked Ion endoluminal system for elective lung nodule biopsies and/or localization procedures. It is a post-market study using the device per the approved indications. All patients will be enrolled per the protocol eligibility criteria. Enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and/or localization procedure attempted or performed.

Eligibility criteria: Inclusion Criteria:

* Patient is aged 18 years or older at time of consent.
* Patient is planned to undergo a lung lesion biopsy(s) and/or localization procedure(s) utilizing the Ion endoluminal system.
* Patient is willing and able to give written informed consent for clinical study participation.

Exclusion Criteria:

* Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.
* Female patient that is pregnant or breast feeding as determined by standard site practices.
* Patient is legally incapacitated or in a legal/court ordered institution or is part of a known vulnerable population, including but not limited to dependency on the sponsor, hospital or study doctor.
* Patient is not willing to comply with post-procedure study participation requirements.
* Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the clinical study.

Primary outcomes:
measure: Diagnostic Yield
timeFrame: Intra-procedure through 24 month post-procedure
Secondary outcomes:
measure: Pneumothorax
timeFrame: Intra-procedure through 30 days post-procedure
measure: Bleeding
timeFrame: Intra-procedure through the 30 day post-procedure
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
References:
Clinical trial NCT00714974: A Prospective, Randomized, Blinded Study of BIS Analysis in ICU Patients Requiring Neuromuscular Blocking Agents
Official title: A Prospective, Randomized, Blinded Study of BIS Analysis in ICU Patients Requiring Neuromuscular Blocking Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ICU Patients
Keywords: Neuromuscular blocking agents
Bispectral analysis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 56
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 is a prospective, randomized, blinded study in which patients will be enrolled into either treated(BIS group) or untreated (non-BIS) group employing bispectral analysis to measure the level of sedation/analgesia in patients receiving neuromuscular blocking agents.

To collect pertinent data on critically ill patients while they are receiving NMBA's. In particular to correlate sedation/analgesic medication needs between a group whose medication use is determined by the values obtained by bispectral analysis to a group who will have medications delivered by the standard of care presently used in the intensive care unit in which they are being treated.

To document that patients who are monitored with bispectral analysis are able to achieve an appropriate level of consciousness in a shorter time and require less manipulation and amounts of sedative or analgesic medications than those who are not monitored.

Detailed description: This is a prospective, randomized and blinded study being done in order to help evaluate the level of consciousness with bispectral analysis (BIS) in ICU patients who are pharmacologically paralyzed with NMBAs (neuromuscular blockade agents) and to assess such things as the amount of time required to achieve the appropriate level of sedation/analgesia. Data will be collected and evaluated via this FDA approved equipment. The intent of this project is to evaluate this technology in those who are requiring "anesthesia" like states (use of NMBAs) for prolonged periods in the critically ill patient population.

Eligibility criteria: Inclusion Criteria:

* Consented ICU patient, receiving neuromuscular blocking agents.

Exclusion Criteria:

* Unable to be consented

Primary outcomes:
measure: Amount of sedation required.
timeFrame: During period of neuromuscular blockade use in ICU
Secondary outcomes:
measure: Time requiring neuromuscular blockade and mechanical ventilation.
timeFrame: Time in ICU
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06663774: Development of a Judo Specific Reactive Agility Test: a Reliability and Validity Study
Official title: Development of a Judo Specific Reactive Agility Test: a Reliability and Validity Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Validation Study
Athletic Performance
Keywords: Reactive
Agility
Performance
Reliability
Validity
Judo
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 34
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: BASIC_SCIENCE

Brief summary: Primary aim of this study is to develop a new reactive agility test spesific for Judokas and evaluate it's validity and reliability. Secondary aim is the investigation of relationship between reactive agility performance score and some of the physical fitness parameter scores related to health and performance.


Eligibility criteria: Inclusion Criteria:

* Active judo training of minimum 300 minutes in a week.
* At least 3 years of Judo experiance
* No acute injury or illness that prevents judo training
* No use of drug or medicine that can/may affect noromusculer control

Exclusion Criteria:

* Major trauma in 6 months prior to study
* Judokas that can't complete the test properly

Primary outcomes:
measure: Validity and reliability
timeFrame: 3-5 days
Secondary outcomes:
measure: Relationship between the IRAT and other physical fitness parameters
timeFrame: 3-5 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Çankaya
Study officials:
References:
Clinical trial NCT06818474: Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
Official title: Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Angioedema
Lead sponsor: Bernstein Clinical Research Center
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all subjects will receive active treatment
Primary purpose: TREATMENT

Brief summary: use of lanadelumab in patients with acquired angioedema


Eligibility criteria: Inclusion Criteria:

* A diagnosis of AAE with recurrent attacks without urticaria (decreased C1INH functional, quantitative levels, decreased C4 and decreased C1q levels, no family history of angioedema), presence of anti-C1INH antibody and/or paraproteinemia (e.g. monoclonal gammopathy of unknown significance)
* historical attack rate of \>= on attack per month prior to starting tranexamic acid (TAA)

Exclusion Criteria:

* History of anaphylaxis or hypersensitivity to biologics
* History of major systemic disease not well controlled in opinion of the PI
* Women who are pregnant or breast feeding
* Concurrent participation in other clinical trials
* HAE Type 1 or 2 and normal complement HAE

Primary outcomes:
measure: Primary Objective
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
Study officials:
affiliation: 5139314181
name: Jonathan Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03169374: Virtual Reality for Anxiety Management in Mechanically Vented Patients
Official title: Virtual Reality for Anxiety Management in Mechanically Vented Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Situational Anxiety
Keywords: Virtual Reality
Mechanical Ventilation
Anxiety
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to investigate the safety and feasibility of virtual reality for anxiety treatment in mechanically ventilated patients.

Detailed description: Mechanically ventilated patients (those on a breathing machine) often experience heightened levels of anxiety and discomfort. This is usually treated by using sedative medications, however these drugs often have unintended side effects. This study will investigate the safety and feasibility of using relaxing virtual reality environments for reduction of anxiety in mechanically ventilated patients.

Eligibility criteria: Inclusion Criteria:

Age: 18 years or older

1. Mechanically ventilated; defined as having an endotracheal tube or tracheostomy and requiring continuous support from a mechanical ventilator.
2. Able to spontaneously maintain a state of wakefulness and alertness and able to follow commands
3. Able to communicate with research staff; defined as writing or head nods/shakes

Exclusion Criteria:

1. Delirious; defined as positive on the Confusion Assessment Method for the ICU (CAM-ICU +)
2. Expected to be liberated from ventilator within 12 hours of potential enrollment
3. Existence of skull injury or recent surgery (craniectomy) which precludes safely wearing VR visor
4. Impaired ability to see or hear, as determined by study investigator
5. Ventilator settings with positive end expiratory pressure (PEEP) greater than 10
6. Inability to be safely removed from physical restraints for VR (virtual reality) sessions
7. Chronic ventilator dependence prior to the present hospitalization
8. Lacking capacity to consent for one's self
9. Known difficult airway; based on review of intubation note
10. Tracheostomy performed within last seven days
11. Pre-existing symptoms overlapping with major symptoms of cyber-sickness: Headache, Vertigo (dizziness), Ataxia (tremor with movement), Nausea, Vomiting.

Primary outcomes:
measure: Incidence of safety events
timeFrame: Immediately following treatment session
Secondary outcomes:
measure: Change in anxiety level during virtual reality treatment
timeFrame: Immediately following treatment session
Other outcomes:
Locations:
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: David Wacker, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00636974: A Randomised Comparison on the Dose Requirement Between, Levobupivacaine, Ropivacaine and Bupivacaine in Intrathecal Anaesthesia
Official title: Minimum Local Anaesthetic Dose for Intrathecal Anaesthesia: a Randomised Comparison Between Levobupivacaine, Ropivacaine and Bupivacaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Conduction
Surgery
Keywords: Patients who are going to have regional anaesthesia for lower limbs surgery.
Leg Surgery.
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2008-03-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine and compare the effective intrathecal dose of levobupivacaine, ropivacaine and bupivacaine for 50% of patients in lower limb surgery


Eligibility criteria: Inclusion Criteria:

* body weight=40-90kg,
* height higher than 145cm

Exclusion Criteria:

* Known hypersensitivity to amide local anaesthetics,
* patients who do not understand English and Chinese,
* Body mass index higher than 35 kg per sq metre

Primary outcomes:
measure: Sensory block at 12th thoracic dermatome or above and successful conduct of the lower limb surgery up to 50 minutes after the intrathecal injection of the study drug
timeFrame: 50 minutes after the intrathecal injection of the study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Kwong Wah Hospital
Study officials:
affiliation: Department of Anaesthesiology, Kwong Wah Hospital
name: Ying Yin Lee, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01197274: Comparison of Simple Blood Lancet(Vitrex®)With DuoTip as Skin Prick Test Devices Among Mite-sensitized Subjects
Official title: Comparison of Simple Blood Lancet(Vitrex®)With DuoTip as Devices for Skin Prick Test Among Mite-sensitized Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Prick Test
Keywords: allergy
skin prick test
mite sensitivity
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have positive skin prick testing to Der p 10,000 AU/ml (wheal size 3 mm at least)

Brief summary: The purpose of this study is to compare the results skin prick tests using simple blood lancet (Vitrex®) with DuoTips among mite-sensitized subjects.

Detailed description: We intend to compare results of skin prick tests by using simple blood lancet(Vitrex®) and DuoTips in terms of wheal size, variability, transfer of allergen and pain level, among mite-sensitive subjects.

Eligibility criteria: Inclusion Criteria:

* Who have positive skin prick testing to Der p 10,000 AU/ml (wheal size 3 mm at least)
* Age 12-60 yrs
* Written informed consent was obtained from all subjects and their parents

Exclusion Criteria:

* Who have positive skin prick testing to Der p 10,000 AU/ml above 15 mm.
* Who have dermographism
* Who have severe disease eg. severe respiratory disease or severe cardiovascular disease
* Who have severe eczema
* Who receive antihistamine, topical steroid within 7 days or ketotifen within 14 days or systemic steroid within 1 month
* Pregnant women

Primary outcomes:
measure: Wheal and flare reaction to Der p results of skin prick test by simple blood lancet (Vitrex®)
timeFrame: 15 minutes
Secondary outcomes:
measure: Determine transfer of allergen by simple blood lancet and Duotips.
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pediatrics, Siriraj hospital, Mahidol University
Study officials:
affiliation: Siriraj Hospital
name: Professor Pakit Vichyanond, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02861274: Electrophysiological Mechanisms and Inhibitory Cardiac Syncope
Official title: ELectrophysiological Mechanisms Underlying the Inhibitory CArdiac Syncope: Therapeutic and Prognostic Implications The ELICA Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Syncope Recurrent
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: OBJECTIVES: To evaluate syncope recurrence at follow up in patients with a positive cardio inhibitory response to the head up tilt testing (HUT) evaluation.

METHODS: 36 consecutive patients affected by cardio inhibitory syncope to HUT without asystolia (2A type) have been enrolled in this study. These patients have been studied by electrophysiological study (ES). After ES patients have been differently treated (interventional treatment group A, v/s drug therapy group), and followed up during 360 days, to evaluate syncope recurrences.


Eligibility criteria: Inclusion Criteria:

* age more than 18, normal heart function, more than 1 syncope event for year.

Exclusion Criteria:

* age inferior 18 years, history of myocardial infarction, heart failure, structural heart disease.

Primary outcomes:
measure: syncope recurrence
timeFrame: 360 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sardu C, Marfella R, Testa G, Santamaria M, Sacra C, Ranauro A, Paolisso G, Rizzo MR, Barbieri M. ELectrophysiological mechanisms underlying the Inhibitory CArdiac syncope without asystolic significant pause: Therapeutic and prognostic implications. The ELICA randomized trial. Medicine (Baltimore). 2018 Aug;97(31):e11757. doi: 10.1097/MD.0000000000011757.