louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01180686: Comparison of a Multiple Thrust Instrument to a Single Thrust Instrument in Treating the Low Back
Official title: Comparative Effectiveness of the Multiple Thrust Impulse Instrument and the Activator IV Single Thrust Instrument in Correcting a Lumbar Spinal Manipulable Lesion and Improving Lumbar Erector Spinae Flexion-relaxation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Low Back Pain
Keywords: low back pain
chiropractic
manipulation
Lead sponsor: Anglo-European College of Chiropractic
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to determine if there is a difference between two treatment methods of spine joints that are not moving as they should as determined by tenderness over the spine and activity of the muscles along side the spine with movement.

The hypothesis is that there will be no difference between the two types of treatment.

Detailed description: Two specialised instruments used for treating manipulable lesions of the spine will be compared using muscle relaxation response of the erector spinae muscles and correction of the spinal manipulable lesion.

Eligibility criteria: Inclusion Criteria:

* Between 18-64 years of age
* Fluent in English
* With non-specific low back pain
* No lumbar manipulation within the prior 24 hours
* Not involved in strenuous back exercise on the day preceding the study
* Have not taken pain medication for two days prior to the study

Exclusion Criteria:

* Absolute contraindications to manipulation
* Specific causes for the low back pain
* Involved in or pending litigation for low back pain
* Lumbar related leg pain

Primary outcomes:
measure: Correction of the spinal manipulable lesion
timeFrame: An average of 5 minutes from the the end of first treatment
Secondary outcomes:
measure: Pressure pain threshold over the spinous process
timeFrame: An average of 5 minutes from the end of the first treatment
measure: Surface EMG (electromyography) of the lumbar erector spinae flexion-relaxation response
timeFrame: An average of 5 minutes from the end of treatment.
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Anglo-European College of Chiropractic
state: Dorset
Study officials:
affiliation: Anglo-European College of Chiropractic
name: Hugh Gemmell, DC, EdD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01227486: Verification of Endotracheal Tube Placement by Ultrasound in the Obese Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation, Intratracheal
Obesity
Keywords: Intubation, intratracheal
Ultrasonography
Auscultation
Capnography
Obesity
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2010-10-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese patients admitted for planned bariatric surgery on Glostrup Hospital, Denmark

Brief summary: The purpose of this study is to determine whether verification of correct tube placement after endotracheal intubation in the obese patient can be conducted as fast with ultrasound as with the conventional method of combined auscultation and capnography.

The investigators hypothesize that ultrasound is a faster method for verifying correct endotracheal tube placement in the obese patient than combined auscultation and capnography.

Detailed description: Both verification methods are conducted in all patients and patients act as their own control

Eligibility criteria: Inclusion Criteria:

* Planned for bariatric surgery in general anaesthesia
* Planned for endotracheal intubation
* BMI above 30

Exclusion Criteria:

* Predicted difficult airway in the pre-anaesthesia airway evaluation.
* Unpredicted difficult airway during induction of anaesthesia where assistance is needed by the investigators.

Primary outcomes:
measure: Difference in time to correct verification of endotracheal tube placement between ultrasound and combined auscultation and capnography
timeFrame: 0 to 1 hour
Secondary outcomes:
measure: Difference in time to correct verification of endotracheal tube placement between ultrasound and auscultation alone
timeFrame: 0 to 1 hour
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Anaesthesiology, Bariatric section. Copenhagen University Hospital Glostrup
Study officials:
affiliation: Department of Anaesthesiology, Copenhagen University Hospital Bispbjerg
name: Dan Isbye, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01383486: Self Selection Trial of Naproxen Sodium
Official title: A Pilot Self Selection Trial of an Extended-Release Over-the-Counter Analgesic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Self Selection Tria
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-06-28
Enrollment: 253
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.


Eligibility criteria: Inclusion Criteria:

* At least 12 years of age
* Report taking at least one dose of Over-the-counter (OTC) analgesic for pain in the past month
* Able to read and understand English
* Provide written informed consent (subjects 12-17 years of age provide written assent and/or parent or legal guardian provide written consent)
* Provide contact information

Exclusion Criteria:

* Have participated in a trial involving OTC analgesics in the last 6 months
* They or someone else in the household work for a market research company, an advertising agency, a public relations firm, a pharmaceutical company, as a healthcare professional, or as part of a health care practice (eliminated for reasons of confidentiality or increased awareness of drugs and their labels)
* Have a history of known allergies to Nonsteroidal Antiinflammatory Drugs (NSAIDs) (i.e., naproxen, ibuprofen, acetaminophen, aspirin, etc.)
* Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days
* Female subjects who have a positive urine pregnancy test or who are breastfeeding.

Primary outcomes:
measure: The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours
timeFrame: up to 14 days
Secondary outcomes:
measure: The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours
timeFrame: Within 24 hours of their selection decision taken up to 14 days
measure: The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Yorba Linda
country: United States
state: California
city: Pembroke Pines
country: United States
state: Florida
city: Griffin
country: United States
state: Georgia
city: Andover
country: United States
state: Minnesota
city: Roseville
country: United States
state: Minnesota
city: Bountiful
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Bellevue
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03125486: Compassionate Use for Subcutaneous (SC) Belimumab
Official title: Compassionate Use for Subcutaneous (SC) Belimumab
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Systemic Lupus Erythematosus
Keywords: subcutaneous Belimumab
Individual Patient Compassionate Use
SLE
GSK1550188
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-04-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: GlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the subcutaneous formulation of belimumab which is currently under review by the Food and Drug Administration (FDA). The goal of this individual patient compassionate use supply is to provide a patient with subcutaneous belimumab for the period of 1 year or until the subcutaneous formulation of belimumab becomes approved for use by the FDA and is commercially available to this patient, whichever is sooner. You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.


Eligibility criteria: This is a protocol to support an emergency IND for compassionate use in one patient requiring use of belimumab subcutaneous for SLE treatment (lacks venous access and cannot receive IV belimumab).

Eligibility criteria is based on the following, as provided within GSK's policy on compassionate use:

* The illness being treated is life threatening or seriously debilitating.
* There are no satisfactory alternative treatments (confirmed by the HCP).
* There is sufficient evidence to believe the benefit to the patient justifies the risk You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02765386: Optimisation of Hybrid Fittings for Cochlear Implant Recipients
Official title: Optimisation of Hybrid Fittings for Newly Implanted Cochlear Implant Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
Keywords: Cochlear implants
Hybrid fittings
Cross-over frequency
Lead sponsor: The Hearing Cooperative Research Centre
Sponsor class: OTHER
Collaborators: name: Royal Victoria Eye and Ear Hospital
name: Cochlear
name: University of Melbourne
First posted: 2016-05-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: When providing amplification post-implantation to residual acoustic hearing in the implanted ear, the lower frequency boundary can be modified to minimize or avoid overlap between the frequencies coded through acoustic hearing and those presented through electrical stimulation. This boundary is termed the cross-over frequency (Fc) and the effect of modifying this parameter will be investigated in this study. To avoid the research being confounded by prior bias for a particular frequency allocation, the study will be conducted with newly implanted recipients.

This study will also investigate whether tests which measure the ability to use low frequency hearing and objective measures can predict the preferred Fc and speech performance benefit.


Eligibility criteria: Inclusion Criteria:

1. Adult (≥18 years of age)
2. Post-operative residual hearing in the implanted ear (defined as having an unaided threshold better than or equal to 80 dB HL at the 500 Hz frequency).
3. Implanted with the CI500 or CI24RE-series cochlear implants
4. User of the commercially available Nucleus 6 sound processor
5. User of the ACE strategy
6. Native speaker in the language used to assess speech perception performance
7. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

1. Additional handicaps that would prevent participation in evaluations
2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device

Primary outcomes:
measure: Speech, Spatial and Qualities of Hearing (SSQ) scale
timeFrame: Testing at 18, 19, 22 and 25 weeks post-activation of cochlear implant
measure: Word recognition scores in quiet
timeFrame: Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
measure: Speech recognition in noise
timeFrame: Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The HEARing CRC
state: Victoria
Study officials:
References:
Clinical trial NCT03485586: Comparison of the Visual Quality of Traditional Ultrasound Biometrics and Lenstar on the Cataract After Pars Plana Vitrectomy
Official title: Comparison of the Visual Quality of Traditional Ultrasound Biometrics and Lenstar on the Cataract After Pars Plana Vitrectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Retinopathy Patients After Vitrectomy
Keywords: cataract, higher order aberration,vitrectomy,diabetic retinopathy
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cataract after vitrectomy because of diabetic retinopathy.

Brief summary: Comparison of the visual quality of traditional ultrasound biometrics and lenstar on the cataract patients with diabetic retinopathy after vitrectomy in the 3 months later.To evaluate the clinical value of lenstar in post-vitrectomy patients.


Eligibility criteria: Inclusion Criteria:

1. Patients with cataract after vitrectomy because of diabetic retinopathy.
2. Patients with good fixation in order to cooperate with various examination.

Exclusion Criteria:

1. Myopia of \>6 diopters
2. Ocular trauma and other eye disease accepted vitrectomy,such as branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO).
3. Vision acuity \<0.1
4. Silicone oil eye

Primary outcomes:
measure: the visual quality of the eye after surgery
timeFrame: one month
measure: the visual quality of the eye after surgery
timeFrame: three month
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Eye Hospital
name: bojie Hu, docter
role: STUDY_DIRECTOR
References:
Clinical trial NCT01136486: Pain in Traumatic Brain Injury - Basile, MD
Official title: The Role of Persistent Pain on Neuro Psychological Functioning and Community Integration in Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head Trauma
Keywords: head trauma; traumatic brain injury
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: history of traumatic brain injury

Brief summary: The observation through a chart review of persistent pain on neuro psychological functioning and how it applies to the community integration with patients that had suffered traumatic brain injury.

Detailed description: This pilot study is designed and conducted over a one year period by the PI, who then solely carried out this study from recruitment, to patient testing, to data entry. Pain was assessed with the Visual Analog Scale and patients underwent a brief battery of tests that included assessment of neuropsychological functions, mood, anxiety and community functions.

Eligibility criteria: Inclusion Criteria:

* documented history of traumatic brain injury
* 18 years or older

Exclusion Criteria:

* younger than 18 years old
* cannot read and write English

Primary outcomes:
measure: Assessment of Pain Severity
timeFrame: Referral
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
References:
Clinical trial NCT01259986: Treatment of Vitiligo With Low-energy Visible Light Laser
Official title: Treatment of Recalcitrant Forms of Vitiligo With a Low-energy 635 nm Visible Light Laser
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vitiligo
Keywords: Vitiligo
Laser
Segmental vitiligo
Acral vitiligo
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
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 the evaluate the efficacy of using a low-energy 635 nm visible light laser in the treatment of various recalcitrant forms of vitiligo.

Detailed description: Vitiligo is a pigmentary disorder characterized by depigmented and hypopigmented macules and patches. There are forms of vitiligo which are more resistant to treatment, including segmental vitiligo and acral vitiligo. Previous studies have shown that a low energy helium-neon (633 nm) laser can cause increased proliferation of melanocytes and repigmentation in segmental-type vitiligo. The goal of this study is to verify these results and show efficacy in other recalcitrant forms of vitiligo including acral vitiligo and post melanocyte-keratinocyte transplantation vitiligo.

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old
* Have active or stable segmental vitiligo on the neck or face, acral vitiligo, or have undergone recent melanocyte-keratinocyte transplantation procedure (MKTP)
* Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection
* Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
* Agree to follow and undergo all study-related procedures

Exclusion Criteria:

* Women who are lactating, pregnant, or planning to become pregnant
* Patients with a recent history of melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
* Patients with a known history of photosensitivity disorders
* Photosensitizing medications may be continued throughout of the study at the discretion of the investigator
* Patients with a known history of melanoma or non-melanoma skin cancers
* Concomitant use of tanning beds
* Any reason the investigator feels the patient should not participate in the study

Primary outcomes:
measure: Percent repigmentation
timeFrame: 24 clinic visits over 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Henry Ford Health System
name: Iltefat H. Hamzavi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05718986: Familial B-cell Lymphoproliferative Disorders
Official title: Epidemiology of Familial B-cell Lymphoproliferative Disorders
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lymphoproliferative Disorders
Premalignant
Monoclonal B-Cell Lymphocytosis
Chronic Lymphocytic Leukemia
Keywords: lymphoproliferative disorders
Chronic Lymphocytic Leukemia
Monoclonal B-cell Lymphocytosis
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Bnai Zion Medical Center
First posted: 2023-02-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Jewish and Arab LPD families with at least 2 family members with LPD.

Brief summary: This study investigates families with at least two cases of B-cell lymphoproliferative disorders (LPD), and evaluates the prevalence of LPD in families, the relationship between medical history, genetic factors, and the risk of familial LPD, and various clinical outcomes for these families in a multiethnic population of Jews and Arabs in Israel.


Eligibility criteria: Inclusion Criteria:

* Patient inclusion criteria:

Patients must have LPD and must have a family history of LPD. LPD patients who signed an informed consent to participate in the study.

Criteria for the inclusion of relatives of patients:

Relatives must be related by blood to LPD patients or unrelated (for control group).

Relatives who signed an informed consent to participate in the study.

Exclusion Criteria:

* Pregnant women, special populations and those lacking judgment will not be included

Primary outcomes:
measure: Prevalence of familial LPD in Israel
timeFrame: 5 years
measure: Association between medical history and genetic variants and the risk of familial LPD
timeFrame: 5 years
measure: Risk of clinical outcomes among familial LPD and family members
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Haifa
name: Geffen Kleinstern, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06037486: System Accuracy of BGM GL60
Official title: Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GL60 gemäß DIN EN ISO 15197:2015
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Institut fur Diabetes Karlsburg GmbH
Sponsor class: OTHER
Collaborators: name: Beurer GmbH
First posted: 2023-09-14
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

Detailed description: This study assesses the system accuracy ofthe blood glucose monitoring systems for personal use GL60 as outlined in DIN EN ISO 15197:2015.

Eligibility criteria: Inclusion criteria:

* Male or female patients with hypo-, eu- or hyperglycaemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

* Pregnancy or lactation
* Acute or chronic diseases with the risk of aggravation by the measure
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015

Primary outcomes:
measure: Analysis of system accuracy based on DIN EN ISO 15197
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Institut für Diabetes Karlsburg GmbH
state: Mecklenburg Vorpommern
Study officials:
References: