louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05453344: DEXCOM ONE: Continuous Glucose Monitoring in the Real World, Utility of Sustained High Alerts
Official title: DEXCOM ONE: Continuous Glucose Monitoring in the Real World, Utility of Sustained High Alerts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Insulin-dependent
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
First posted: 2022-07-12
Enrollment: 112
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 to gather feedback on a new continuous glucose monitor (CGM), called DEXCOM One. Unlike some other CGMs which allow a low (hypoglycaemic) and a high (hyperglycaemic) glucose alarm to be set, the DEXCOM One sensor has the unique feature of the 'Sustained Hyperglycaemic Alert', where the alarm is only activated if the glucose is above a certain threshold for a pre-specified amount of time.

International consensus guidance states that people with diabetes should aim for 70% time in the range 3.9-10 mmol/L. After meals there is usually a rise in blood glucose, so it is not unexpected for the glucose to go above 10 mmol/L for a short time even if the insulin dose already given before a meal is correct. Therefore, people with a high glucose alarm set at 10 mmol/L on their GCM may unnecessarily inject extra insulin and risk a low blood glucose. However, DEXCOM One's Sustained Hyperglycaemic Alert would only notify patients if their blood sugar was high for a prolonged period, and so may reflect a time when it would be genuinely advantageous to inject more insulin.

The aim of this single-centre, non-randomised, observational study is to gather experience from a range of users to assess the utility of this unique attribute, and the optimal settings. We aim to recruit 80-100 patients, and each participant's involvement is in 2 phases; for the first 3 months DEXCOM One sensors will be used, and for months 4-6 there will be the option of continuing to use the DEXCOM One sensors with the addition of a FitBit to track physical activity.


Eligibility criteria: Inclusion Criteria:

* Aged 18+ years
* A patient registered in the diabetes service at Sheffield Teaching Hospitals NHS Foundation Trust
* HbA1c within the last 3 months of \>70 mmol/mol

Exclusion Criteria:

* Unable to provide informed consent
* Unable to communicate in written and verbal English

Primary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: rtCGM measurements
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospital NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: University of Sheffield
name: Jackie Elliott, PhD, MbChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06315244: Perforating Cutaneous Nerve Injection Efficacy in Chronic Coccydynia: A Randomized, Double-Blind Study
Official title: Effectiveness of Perforating Cutaneous Nerve Injection in Patients With Chronic Coccydynia: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Coccyx Disorder
Coccyx Injury
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interventions targeting the perforating cutaneous nerve are relatively new to the literature, with a safe side-effect profile but lacking high-quality studies. Their effectiveness remains at the level of case presentations. According to the hypothesis expressed in these publications, coccydynia might be an overlooked cause due to the compression of the perforating cutaneous nerve where it pierces the sacrotuberous ligament and becomes superficial. Ultimately, it is hypothesized that injection of dextrose into this ligament and the sensory area of this nerve will resolve these symptoms due to nerve entrapment, similar to other entrapment neuropathies treated with 5% dextrose, like carpal tunnel syndrome.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 50 years.
2. Chronic coccyx pain (≥3 months).
3. Pain Visual Analogue Scale (VAS) score ≥4.
4. Pain not alleviated by first-line treatment (physical therapy/oral analgesic therapy + sitting cushion).

Exclusion Criteria:

1. Injection to the area in the last 3 months.
2. Concurrent mechanical or inflammatory low back pain.
3. Coccyx pain that started during pregnancy or postpartum.
4. History of myelomeningocele or spina bifida.
5. History of sacrococcygeal luxation or subluxation (confirmed by radiography).
6. History of coccyx fracture.
7. Concurrent neurological deficit.
8. Skin disease affecting the injection area.
9. History of malignancy.
10. Pregnancy or breastfeeding.
11. Severe coagulopathy.
12. Infection at the injection site.
13. Neurological or psychiatric diseases, including ongoing depression (Beck Depression Inventory Score \>14).

Primary outcomes:
measure: Effectiveness of Perforating Cutaneous Nerve Injection
timeFrame: Baseline, 2 weeks, 1 month, and 3 months post-treatment
Secondary outcomes:
measure: Change in Pressure Pain Threshold
timeFrame: Baseline, 2 weeks, 1 month, and 3 months post-treatment
measure: Change in Quality of Life
timeFrame: Baseline, 2 weeks, 1 month, and 3 months post-treatment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Training and Research Hospital
Study officials:
affiliation: Sisli Hamidiye Training and Research Hospital
name: Julide Oncu Alptekin, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03284944: Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS)
Official title: Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS): A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss Anemia
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 369
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: All adult patients admitted to the participating intensive care unit at the investigative site.

Brief summary: STRATUS will evaluate the use of small-volume ("soft-draw") blood collection tubes for laboratory testing in reducing anemia and transfusion in intensive care unit patients without significant adverse consequences. This is a simple, cost-neutral intervention that could improve the quality of patient care and reduce the harms of frequent laboratory testing.

Detailed description: The STRATUS Pilot Study is a prospective observational study (before-after design) to assess the feasibility of implementing a full-scale randomized trial powered for clinical outcomes (RBC transfusion, incidence and severity of anemia). Identification of barriers and facilitators of implementation will enhance the conduct of the full-scale trial and facilitate incorporation of the intervention into routine practice.

Eligibility criteria: Investigative Site Eligibility:

* Intensive care unit with at least 15 beds with capacity for mechanical ventilation
* Current standard to use standard-draw blood collection tubes
* Availability of hospital administrative data and electronic patient information

Primary outcomes:
measure: Successful crossover from standard-volume to small-volume tubes
timeFrame: 2 week washout period
measure: Adherence to the correct tube size during the intervention period
timeFrame: 6 week intervention period
measure: Sufficient volume for testing with small-volume tubes
timeFrame: 6 week intervention period
measure: Acceptability of the intervention by end-users
timeFrame: 6 week intervention period
measure: Complete primary data collection
timeFrame: 14 weeks
Secondary outcomes:
measure: Reduction in blood loss
timeFrame: 12 weeks
measure: RBC units transfused
timeFrame: 12 weeks
measure: Change in hemoglobin
timeFrame: 12 weeks
measure: ICU and hospital length of stay
timeFrame: 12 weeks
measure: ICU and hospital mortality
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Population Health Research Institute, McMaster University, Hamilton Health Sciences
name: Deborah Siegal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute, McMaster University, Hamilton Health Sciences
name: Stuart Connolly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05210244: Acute Beetroot Juice Supplementation in Amateur Climbers
Official title: Acute Effects of Beetroot Juice Supplementation Among Neuromuscular Performance in Amateur Climbers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Supplement
Sport Performance
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Whereas beetroot juice (BJ) supplementation is shown to increase physical performance in endurance activities, its benefits in neuromuscular function and strength performance has been barely studied. In this cross-over randomized placebo-controlled study, we investigated the effects of BJ acute supplementation in improving neuromuscular performance in amateur climbers


Eligibility criteria: Inclusion Criteria:

* more than 18 years
* active climbing for, at least, last 6 months

Exclusion Criteria:

* smoking
* contraindications to BJ diet
* physical limitations, health problems, or musculoskeletal injuries

Primary outcomes:
measure: Changes in rate of force development (N/s) at 50, 100 and 200 ms; and at 95% of maximal force
timeFrame: 1 week
Secondary outcomes:
measure: Changes in nitrites and nitrates levels in saliva (μmol/L)
timeFrame: 1 week
measure: Changes in maximal number of pull-ups
timeFrame: 1 week
measure: Changes in maximal isometric handgrip strength (kg)
timeFrame: 1 week
measure: Changes in maximal jump height (cm)
timeFrame: 1 week
Other outcomes:
Locations:
city: Pozuelo De Alarcón
country: Spain
facility: Universidad Francisco de Vitoria
state: Madrid
Study officials:
affiliation: Universidad Francisco de Vitoria
name: Luis Berlanga
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06672744: Superior Cluneal Nerve Entrapment Syndrome, Kinesiotaping and Myofascial Release Techniques
Official title: Comparison of the Efficacy of Kinesiotaping and Myofascial Release Techniques in the Treatment of Superior Cluneal Nerve Entrapment Syndrome: A Randomised Single Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Superior Cluneal Nerve Entrapment
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-11-04
Enrollment: 75
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: Myofascial release techniques and/or kinesiotaping may be effective in the treatment of superior cluneal nerve impingement syndrome ?


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with superior cluneal nerve entrapment syndrome

Exclusion Criteria:

* those with communication problems
* those who also described pain in the mid-lumbar region

Primary outcomes:
measure: Visual Analoque Scale
timeFrame: Before treatment, immediately after treatment, 1 month after the end of treatment
measure: The Roland-Morris Disability Questionnaire
timeFrame: Before treatment, immediately after treatment, 1 month after the end of treatment
Secondary outcomes:
measure: SF-36 Quality of Life Scale
timeFrame: Before treatment, immediately after treatment, 1 month after the end of treatment
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Beyhekim Training and Research Hospital
state: Selçuklu
Study officials:
References:
citation: Draghici NC, Bolchis R, Popa LL, Vacaras V, Ilut S, Bashimov A, Domnita DM, Dragos HM, Vlad I, Muresanu DF. Rare entrapment neuropathies of the lower extremity: A narrative review. Medicine (Baltimore). 2024 Aug 30;103(35):e39486. doi: 10.1097/MD.0000000000039486.
Clinical trial NCT03751540: Retrospective Evaluation of Plane Blocks in Laparoscopic Cholecystectomy
Official title: Ultrasound-guided Oblique Subcostal Transversus Abdominis Plane Block Versus Serratus Intercostal Plane Block Plus Rectus Sheath Block; in Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients undergoing laparoscopic cholecystectomy, ASA I-II-III patients.

Brief summary: the investigators use usually a plane block for postoperative analgesia; if it suitable. İn laparoscopic patients; investigators used oblique subcostal transversus abdominis plane block; formerly. But in the last few months, the investigators have performed serratus intercostal (BRILMA) block with bilateral rectus sheath block. in this retrospective evaluation, the aim of the retrospective evaluation is to determine the effects of two block on postoperative opioid consumption.


Eligibility criteria: Inclusion Criteria:

* patients undergoed laparoscopic cholecystectomy ASA I-II-III

Exclusion Criteria:

* patients used another block or block combination
* no block performed patients
* procedure converted to open procedure

Primary outcomes:
measure: opioid consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Pain assessed by NRS
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University faculty of medicine
Study officials:
affiliation: Maltepe University
name: serkan tulgar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen Y, Shi K, Xia Y, Zhang X, Papadimos TJ, Xu X, Wang Q. Sensory Assessment and Regression Rate of Bilateral Oblique Subcostal Transversus Abdominis Plane Block in Volunteers. Reg Anesth Pain Med. 2018 Feb;43(2):174-179. doi: 10.1097/AAP.0000000000000715.
citation: Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.
Clinical trial NCT00000344: Buprenorphine/Naloxone for Treatment of Opiate Dependence - 9
Official title: Trial of Buprenorphine/Naloxone for Treatment of Opiate Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Keywords: opioid dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.


Eligibility criteria: Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02826044: The Pharmacokinetics Study of Single and Multiple Dose of SP2086 in Healthy Volunteers
Official title: Pharmacokinetics,Safety and Tolerability Study Following Single and Multiple Dose of SP2086 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose study the investigators evaluated the safety, tolerability and Pharmacokinetics profiles of SP2086 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* BMI(a measure of a person's weight in relation to height)is between 19 and 26 kg/m2,and the weight is equal or less than 100kg.
* without the history of cardiovascular diseases,liver diseases,kidney diseases,gastrointestinal tract diseases,mental nerve diseases and drug allergy.
* Be willing to accept physical contraception.
* Sign the informed consents voluntarily and ensure to completed the study.

Exclusion Criteria:

* Known allergy to SP2086 or any of the excipients of the formulation of SP2086;
* ever occured myocardial infarction,acute coronary syndrome, transient ischemic attack.
* the B hepatitis surface antigen or hepatitis C antibody or syphilis antibody or HIV antibody was positive.
* had participated three or more clinical trial in one year or had participated one time clinical medicine in one month of screening.
* have the history of blood donation in 3 months of screening or received the blood transfusion in 1 months of screening.
* have the history of tobacco,alcohol or drug abuse.
* History of or current clinically significant medical illness as determined by the Investigator.

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SP2086
timeFrame: up to Day 13
measure: The steady-state plasma concentration (Css) of SP2086
timeFrame: up to Day 13
measure: The maximum plasma concentration (Cmax) of SP2086 acid
timeFrame: up to Day 13
measure: The steady-state plasma concentration (Css) of SP2086 acid
timeFrame: up to Day 13
measure: The maximum urine concentration (Cmax) of SP2086
timeFrame: up to Day 13
measure: The steady-state urine concentration (Css) of SP2086
timeFrame: up to Day 13
measure: The maximum urine concentration (Cmax) of SP2086 acid
timeFrame: up to Day 13
measure: The steady-state urine concentration (Css) of SP2086 acid
timeFrame: up to Day 13
measure: Cumulative excretion of SP2086
timeFrame: up to Day 13
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to Day 13
Other outcomes:
Locations:
city: Changchun
country: China
facility: the First Hosital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT01609244: Bilevel Versus Servoventilation in Complex Sleep Apnea
Official title: Bilevel Versus Servoventilation in Complex Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Sleep Apnea
CPAP Induced Central Sleep Apnea
Keywords: Sleep apnea
central sleep apnea
bilevel
servoventilation
CPAP
Lead sponsor: Krankenhaus Kloster Grafschaft
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with complex sleep apnea during continuous positive airway pressure (CPAP) treatment.

Detailed description: Patients with primary obstructive sleep apnea, who develop complex sleep apnea after CPAP treatment of 4-6 weeks duration were randomized to either receive Bilevel of Servoventilation treatment. Parameters of sleep as well as apnea-hypopnea indices are to be compared.

Eligibility criteria: Inclusion Criteria:

Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment

Exclusion Criteria:

primary central sleep apnea non-compliance to CPAP therapy

Primary outcomes:
measure: apnea-hypopnea index
timeFrame: at 6 weeks
Secondary outcomes:
measure: Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy
timeFrame: at 6 weeks
Other outcomes:
Locations:
city: Schmallenberg
country: Germany
facility: Kloster Grafschaft
state: NRW
Study officials:
affiliation: FKKG
name: Dominic Dellweg, MD
role: STUDY_CHAIR
References:
citation: Kuzniar TJ, Pusalavidyasagar S, Gay PC, Morgenthaler TI. Natural course of complex sleep apnea--a retrospective study. Sleep Breath. 2008 May;12(2):135-9. doi: 10.1007/s11325-007-0140-z.
citation: Dellweg D, Kerl J, Hoehn E, Wenzel M, Koehler D. Randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus servoventilation in patients with CPAP-induced central sleep apnea (complex sleep apnea). Sleep. 2013 Aug 1;36(8):1163-71. doi: 10.5665/sleep.2878.