louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00813683: Cephalic Version by Acupuncture for Breech Presentation
Official title: Study of Cephalic Version by Acupuncture for Breech Presentation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breech Presentation
Keywords: Acupuncture, moxybustion,
Cephalic version,
Breech presentation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 259
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We want to study the efficiency of acupuncture for cephalic version of breech presentation during pregnancy.

Several randomized studies show that acupuncture may be useful in version of breech presentation, but none with a sham.

Protocol :

* Inclusion of patients with fetus in breech presentation at 32-34 weeks of pregnancy.
* Randomization. First group : acupuncture by stimulation of "67 Bladder" point.Second group : stimulation of "45 Stomach" point (sham).
* Ultrasonographic control of presentation at 35 weeks.


Eligibility criteria: Inclusion criteria:

* Single pregnancy at 32-34 weeks of pregnancy.
* Fetus in breech presentation.

Exclusion criteria:

* Twins.
* Story of preterm birth or any preterm birth risk
* Fetal malformations, abnormal karyotype

Primary outcomes:
measure: Cephalic or breech presentation (ultrasonographic control at 35 weeks of pregnancy)
timeFrame: 35 weeks
Secondary outcomes:
measure: general outcomes about external cephalic version, delivery and neonates
timeFrame: 35 weeks
Other outcomes:
Locations:
city: Schiltigheim
country: France
facility: Service de Gynécologie-Obstétrique, Hôpital SIHCUS - CMCO, 19 rue Louis Pasteur
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Romain FAVRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05059483: Physiotherapy Critical Thinking in Clinical Practice Questionnaire
Official title: Psychometric Evaluation of the Spanish Version of the Physiotherapy Critical Thinking in Clinical Practice Questionnaire: Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Thinking
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health centers

Brief summary: A greater need for user-centered care and an evidence-based clinical practice are factors that emphasize critical thinking as a professional competence. Furthermore, critical thinking is an essential competence that allows clinical reasoning, problem solving and decision-making in the critical clinical practice of all specializations in Physiotherapy. However, no instrument has been found that specifically assesses the critical thinking of physiotherapists in their clinical practice.

Detailed description: Multicenter, descriptive, cross-sectional and correlational study in two phases. Phase 1: adaptation of the N-CT-4P to the population of physiotherapists; Phase 2: analysis of the psychometric properties of the new instrument and levels of critical thinking through a cross-sectional study. Sociodemographic and professional variables and variables referring to the measurement of critical thinking (total score of the questionnaire and of each of its dimensions) will be collected. Its psychometric properties, internal consistency, repeatability analysis, discriminant validity and construct validity will be analyzed through confirmatory factor analysis and a multiple regression analysis will be performed.

Eligibility criteria: Inclusion Criteria:

* Be a Graduate, Diploma or Bachelor of Physiotherapy
* Have an employment contract, as a care physiotherapist at the time of answering the questionnaire.

Exclusion Criteria:

* Have a contractual continuity of less than 15 days.

Primary outcomes:
measure: To validate in the physiotherapist population the instrument Nursing Critical Thinking in Clinical Practice Questionnaire (N-CT-4 Practice) in its version Physiotherapy Critical Thinking in Clinical Practice Questionnaire (PT-CT-4 Practice).
timeFrame: The questionnaire will be self-administered and the estimated response time is less than 15 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: Hospital Universitari Vall d'Hebron Research Institute
name: Beatriz Hernández-Méndez, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron Research Institute
name: Esperanza Zuriguel-Pérez, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00850083: Accuracy of Measurement of Surface Body Temperature Using the Health e Pod Device (Card Guard) Compared to Gold Standard Equipment
Official title: Accuracy of Measurement of Surface Body Temperature Using the Health e Pod Device (Card Guard) Compared to Gold Standard Equipment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: All Children Admitted to the ED
Children With Fever
Keywords: Fever
Children
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-02-24
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children visiting the pediatric emergency unit

Brief summary: Objective To evaluate the accuracy of data acquisition by Health e pod device in measurement of body temperature, to compare it to a standard body temperature measure equipment About 400 consecutive patients admitted to PEU in Assaf Harofeh Medical Center will compile the Study Population.

Basic vital signs will be recorded on admission and during hospitalization as per the PEU policy and not in particular for this study.

As a part of routine check-up all admitted patients undergo body temperature measure (oral or rectal - as per the PEU policy and with PEU devices).

Following an explanation and patient agreement, eligible patients (and their legal guardian) will sign informed consent and enter the study. The health e pod device will be applied to measure body temperature, immediately after the standard temperature measure has been performed by the PEU professional.


Eligibility criteria: Inclusion Criteria:

* Signed an Informed Consent by the patients' legal custodian / guardian (and assent by the patient when applicable).
* Age 0 to 18 years
* Clinically stable patients hospitalized in PEU.

Exclusion Criteria:

* Implanted pacemaker or defibrillator.
* Patients participating in other clinical trail.

Primary outcomes:
measure: Agreament between measurments by Health e pod device and the gold standard reference device.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
References:
Clinical trial NCT03775083: What Happens in Vegas: PEP to PrEP Opportunities
Official title: What Happens in Vegas: Identifying Opportunities to Expand an HIV Prevention Network to Improve PEP and PrEP Delivery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exposure to Human Immunodeficiency Virus (Event)
Keywords: PEP
nPEP
Post Exposure Prophylaxis
non occupational exposure to HIV
Lead sponsor: Huntridge Family Clinic
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 75
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: HIV negative Men, Women, Transgender Men, Transgender Women age who self identify as having had an actual or perceived non-occupational exposure to HIV

HIV negative Men, Women, Transgender Men, Transgender Women age who self identify at risk of acquisition of HIV after having had an actual or perceived non-occupational exposure to HIV

Brief summary: Observational study looking at barriers to care for individuals seeking care, Post Exposure Prophylaxis (PEP) after an actual or perceived exposure to HIV. Following PEP treatment subjects will be asked about there intent to transition to Pre-Exposure Prophylaxis (PrEP) and surveyed about barriers to care or perceptions of care

Detailed description: The primary objective of this study is to assess the rate of engagement in a PEP to PrEP HIV provider network for those patients presenting following a non-occupational HIV exposure.

The development of a referral network and intensive clinical follow up of PEP patients will result in more patients appropriately initiating PEP, being referred to appropriate follow up, and post exposure transition and maintaining on PrEP (if indicated) at completion of the PEP medications.

Eligibility criteria: Inclusion Criteria:

* Actual or perceived non-occupational exposure to HIV, by self report, within 72 hours of enrollment and referred for care
* able and willing to provide informed consent
* available for 12 months of post expoure follow-up Southern Nevada Ryan White defined service area

Exclusion Criteria:

* HIV+ at time of screeing via 4th genderation (Antibody/Antigen) testing
* Current PEP and/or PrEP product condrainidications as listed in the medication product insert.

Primary outcomes:
measure: rate of engagement
timeFrame: from enrollment to day 90
Secondary outcomes:
measure: characteristics
timeFrame: from enrollment through end of study for all participants
measure: barriers
timeFrame: from enrollment through end of study for all participants
measure: Network characteristics
timeFrame: from enrollment through end of study for all participants
measure: transition barriers
timeFrame: from enrollment through end of study for all participants
measure: Retention
timeFrame: from enrollment through end of study for all participants
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Huntridge Family Clinic
state: Nevada
Study officials:
References:
Clinical trial NCT00300183: Evaluation of an HIV Outreach Program
Official title: Evaluation of an Outreach and Intervention Program to Reach HIV- Positive Persons Living in Bronx, NY Single Room Occupancy Hotels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
health services accessibility
health services research
homeless
social support
AIDS
substance abuse
mental health
quality of life
outreach
harm reduction
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: CitiWide Harm Reduction
First posted: 2006-03-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: This study evaluates outreach to HIV-infected people living in unstable housing in New York City who are new to CitiWide Harm Reduction. One hundred and fifty people are interviewed every 6 months, and their medical records are reviewed every 6 months for a total of 18 months. The study examines how outreach, case management, housing, drug use, mental health, and quality of life are related to people's ability to get into and stay in medical care.

Detailed description: The study is a prospective cohort study in which 150 newly enrolled HIV-infected participants of CitiWide Harm Reduction are followed for 18 months to assess HIV-related health outcomes. Data elements include (1) face-to-face interviews focusing on housing, HIV disease severity, utilization of health care services, utilization of non-medical services, substance use, mental health, and quality of life; (2) medical chart information focusing on CD4 count, viral load, and HIV primary care visits; and (3) outreach services. The study hypothesis is that involvement with CitiWide Harm Reduction will improve HIV-related health care utilization and outcomes.

Eligibility criteria: Inclusion Criteria:

* HIV-infected, living in one of 15 single room occupancy hotels served by CitiWide Harm Reduction, new to CitiWide Harm Reduction, at least 18 years of age, English or Spanish speaking

Exclusion Criteria:

* HIV-negative

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Chinazo O Cunningham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02703883: Body Weight Support in Spinal Cord Injury
Official title: Effects of Body Weight-supported Treadmill Training on Center of Mass Control in Spinal Cord Injury, Measured With Inertial Sensors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study was to evaluate the effectiveness of body weight-supported treadmill (BWST) training on static balance impairment in adults with incomplete spinal cord injury (SCI) in chronic stage

Detailed description: The individuals who participated in this study were subjects with SCI with more than twelve months of evolution. All were classified as incomplete injury class C or D according to the American Spinal Injury Association (ASIA). Each received training on a BWST for six weeks. Two measures of stance balance were performed during the training protocol. The first measure was made before entering the training protocol; the final measure was implemented once the gait training on BWST protocol was completed. For instrumented stance balance testing, small wireless inertial motion sensors (OPAL sensors, APDM Inc., Portland, OR) were placed on the subjects' waist. Subjects performed instrumented stance with their eyes opened (iSway). Outcome measures were recorded and automatically generated using Mobility Lab software (APDM Inc., Portland, OR). Measures included the root mean square of sway and jerk (normalized to the range of acceleration amplitude).

Eligibility criteria: Inclusion Criteria:

* SCI with more than twelve months of evolution.
* ASIA C and D

Exclusion Criteria:

* Patients with tracheostomy
* Patients with severe respiratory, cognitive and cardiovascular comorbidities
* Patients with peripheral nerve injury in lower limbs
* Patients with traumatic head injury

Primary outcomes:
measure: Jerk (Derivative of the acceleration of the mass center as marker oscillation of the control the center of mass)
timeFrame: 6 weeks
Secondary outcomes:
measure: Walking Index for Spinal Cord Injury (WISCI) scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clínica Los Coihues
state: Región Metropolitana
Study officials:
affiliation: Clinica Los Coihues
name: Felipe Covarrubias
role: PRINCIPAL_INVESTIGATOR
References:
citation: Covarrubias-Escudero F, Rivera-Lillo G, Torres-Castro R, Varas-Diaz G. Effects of body weight-support treadmill training on postural sway and gait independence in patients with chronic spinal cord injury. J Spinal Cord Med. 2019 Jan;42(1):57-64. doi: 10.1080/10790268.2017.1389676. Epub 2017 Oct 23.
Clinical trial NCT03127683: The Influence of Head and Neck Position on Performance of Ambu AuraGainTM in Children
Official title: The Influence of Head and Neck Position on Performance of Ambu AuraGainTM in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 40
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg.

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.
Primary purpose: OTHER

Brief summary: The influence of different head and neck positions on the effectiveness of ventilation with the Ambu AuraGain airway remains unevaluated.

This study aimed to evaluate the influence of different head and neck positions on ventilation with the AuraGain airway.

An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg.

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.


Eligibility criteria: Inclusion Criteria:

* Children \< 7 years old who scheduled for general anesthesia using supraglottic airway

Exclusion Criteria:

* Children who require tracheal intubation
* Emergency operation without NPO
* History of C-spine surgery or disease
* History of Esophageal disease or surgery

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: 30 seconds after positioning of head and neck
Secondary outcomes:
measure: Peak inspiratory pressure
timeFrame: 30 seconds after positioning of head and neck
measure: Tidal volume
timeFrame: 30 seconds after positioning of head and neck
measure: Fiberopic bronchoscopic view
timeFrame: 30 seconds after positioning of head and neck
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05416983: Developing a Shared Decision Making Tool for Patients With Surgically Removed Non-small Cell Lung Cancer
Official title: The Development of a Shared Decision-Making Encounter Tool for Decisions of Adjuvant Treatment in Patients With Resected Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Non-Small Cell Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with resected non-small cell lung cancer, clinicians, and PAG members.

Brief summary: This study observes conversations between non-small cell lung cancer patients and their doctors to support the development of a decision aid that can be used to inform discussions about treatment options for after surgery. Patients who have undergone surgery for their non-small cell lung cancer may have the option of completing additional treatment. Patients contemplating this additional treatment have been shown to be most satisfied with their choice if they perceive an effort by their doctor to share decision making. Shared decision making tools can help doctors guide conversations, offer tailored recommendations, and support deliberation on whether or not to pursue treatment. This study develops a shared decision making tool for patients with surgically removed non-small cell lung cancer contemplating additional treatment.

Detailed description: PRIMARY OBJECTIVE:

I. To develop, in close collaboration with stakeholders, an evidence-based decision aid to inform discussions regarding options for adjuvant treatment in patients with resected non-small cell lung cancer (NSCL) (NSCL adjuvant choice).

OUTLINE:

Patient and clinician discussions are observed to support refinement of a decision aid. Clinicians may use a prototype of the decision aid in discussions with their patients and may complete a questionnaire.

Eligibility criteria: Inclusion Criteria:

* PATIENTS:
* Adults \>= 18 years with biopsy proven resected non-small cell lung cancer (NSCLC)
* Appointments to discuss adjuvant treatment of resected NSCLC
* CLINICIANS:
* Clinicians who meet with patients to discuss adjuvant treatment of resected NSCLC
* PAG MEMBERS:
* Adults \>= 18 years
* Member of the Knowledge and Evaluation Research (KER) Unit Patient Advisory Group (PAG)

Exclusion Criteria:

* PATIENTS
* Major barriers to providing informed consent (i.e., dementia, severe hearing or visual impairment)

Primary outcomes:
measure: Development of decision aid
timeFrame: Up to study completion, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Konstantinos Leventakos, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01831583: Assessment of PPG & PAT to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea
Official title: Assessment of a New Photoplethysmographic (PPG) Method and a Pulse Arrival Time Method to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in a Sleep Laboratory
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: sleep apnea
Lead sponsor: Sotera Wireless, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-15
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to collect raw waveform data for two separate noninvasive methods, both of which may be useful for the assessment of upper airway obstruction.


Eligibility criteria: Inclusion Criteria:

* Patients twenty-one years of age or older

Exclusion Criteria:

* Patient refusal to participate in study
* Patients under 21 (twenty-one) years of age,
* Referring physician's refusal to have his/her patient participate in the study.
* Patients with cardiac dysrhythmia (arrhythmia), including atrial fibrillation, and frequent premature atrial and/or ventricular contractions.
* Inability to obtain a Sotera cuff pressure and/or PPG signals

Primary outcomes:
measure: Measurement of pulse arrival time in patients with obstructive sleep apnea syndrome.
timeFrame: 4 - 8 hours
Secondary outcomes:
measure: Non-invasive Photoplethysmographic (PPG) measurement in patients with obstructive sleep apnea syndrome.
timeFrame: 4 - 8 hours
Other outcomes:
Locations:
city: Escondido
country: United States
facility: Palomar Hospital
state: California
Study officials:
affiliation: Sotera Wireless
name: James Welch, MS
role: STUDY_DIRECTOR
References: