louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01304550: Evaluation of the Accuracy of the Masimo Pulse-Hemoglobin-Meter Monitor in Surgical Patients
Official title: Evaluation of the Accuracy of the Masimo Pulse-Hemoglobin-Meter Monitor in Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accuracy of Non-invasive Hemoglobin Monitor
Keywords: non-invasive
hemoglobin
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patience undergoing elect cardiac surgery.

Brief summary: This is a retrospective comparison of hemoglobin measurements obtained by arterial blood gas analysis and the Masimo Continuous Hemoglobin Monitor

Detailed description: The chief objective of this study is to internally validate the accuracy of the Masimo SpHb (TM) technology as compared to our laboratory measurement of Hb. We have been using the Masimo SpHb monitor on patients who underwent open heart surgery, hepatic resection, kidney transplant and aortic aneurysm repair since January 2009. These patients also had hemoglobin concentration measurements as part of the arterial blood gas analysis performed by our laboratory to evaluate intraoperative ventilation and electrolyte changes. We will collate the laboratory measurements with the Masimo SpHb values documented in the anesthetic records.

Eligibility criteria: Inclusion Criteria:

* Patients who had indwelling arterial catheters placed for surgeries that involved major blood loss and who had serial hemoglobin concentration measurements for their surgeries, since January 2009. This will represent approximately 50 patients.

Exclusion Criteria:

* Inclusion criteria are patients undergoing major surgery from January 2009 - April 2009, who had continuous hemoglobin pulse oximetry readings form the Masimo SpHb monitor and serial hemoglobin concentration measurement from the lab. Patient who did not have these studies will be excluded.

Primary outcomes:
measure: Accuracy of Masimo Monitor
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
name: Neal W. Fleming, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Faculty, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
name: Aubrey Yao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
name: Gudrun Kungys, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05946850: Caudal Analgesia & Anticoagulated Patient
Official title: Caudal Analgesia in Anticoagulated Chronic Pain Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Pain Syndrome
Anticoagulants and Bleeding Disorders
Keywords: Caudal analgesia
Lead sponsor: Salem Anaesthesia Pain Clinic
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult chronic pain clinic patients who have lumbosacral pain, and undergo caudal analgesia

Brief summary: Caudal analgesia is an effective intervention for lumbosacral pain. Some chronic pain patients take anticoagulants for vasculopathy treatment. Anticoagulation limits the use of caudal analgesia because of the risk of epidural bleeding. Caudal analgesia may be safe and effective in anticoagulated chronic pain patients.

Quantitative analysis of prospective clinical data. Evaluation of caudal analgesia efficacy and safety in anticoagulated chronic pain patients. Analysis of outcome, and complications.

Detailed description: Caudal analgesia is an effective interventional therapy for chronic lumbosacral pain. Some chronic pain patients take anticoagulants for vasculopathy treatment. Anticoagulation limits the use of caudal analgesia because of the risk of epidural bleeding. Anticoagulation may be discontinued briefly, to allow caudal injection. Interruption of anticoagulation may be difficult and dangerous for some high-risk patients. Caudal analgesia may be safe and effective in anticoagulated chronic pain patients.

Quantitative analysis of prospective clinical data. An evaluation of caudal analgesia safety in anticoagulated chronic pain patients. An analysis of treatment outcome, and complications.

Eligibility criteria: Inclusion Criteria:

* adult chronic pain patients who undergo caudal analgesia

Exclusion Criteria:

* chronic pain patients who refuse caudal analgesia

Primary outcomes:
measure: Pain score, objective measurement using the validated Numeric Pain Rating scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Salem Anaesthesia Pain Clinic
state: British Columbia
Study officials:
affiliation: Salem Anaesthesia Pain Clinic
name: Olu Bamgbade, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manchikanti L, Boswell MV, Singh V, Benyamin RM, Fellows B, Abdi S, Buenaventura RM, Conn A, Datta S, Derby R, Falco FJ, Erhart S, Diwan S, Hayek SM, Helm S, Parr AT, Schultz DM, Smith HS, Wolfer LR, Hirsch JA; ASIPP-IPM. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):699-802.
Clinical trial NCT03658850: Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients
Official title: Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypernatremia
Critical Illness
Keywords: hypernatremia
Critical care
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 184
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: HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia


Eligibility criteria: Inclusion Criteria:

* hospitalized for intensive care,
* Over 18 years of age,
* Two serum sodium measurements above 145 mEq / L (with no pre-determined interval between them),
* Mean arterial pressure greater than 65mmHg

Exclusion Criteria:

* Absence of consent to participate in the study
* Cardiac index below 2.5L / min / m2 OR signs of ineffective circulation (capillary filling time greater than 2 seconds, cold or sticky skin) OR arterial lactate\> 4mMol / L.
* Use of vasopressors at doses greater than 0.1 mcg / kg / min of noradrenaline or with initiation or increase of dose within less than one hour before inclusion in the study.
* Unavailable enteral route.
* Use of hydrochlorothiazide in the last 7 days of ICU admission.
* History of allergy or intolerance to hydrochlorothiazide or other thiazides.
* Nephrogenic Diabetes Insipidus.
* Renal impairment KDIGO 3
* Indication of renal replacement therapy.
* Acute neurological insult.
* Heart failure American Heart Association classification (AHA), class D.
* Liver cirrhosis Child-Pugh C.
* Pregnant women
* Exclusive palliative care
* Dying, with expected survival less than 48 hours

Primary outcomes:
measure: hypernatremia correction
timeFrame: DAY 3
Secondary outcomes:
measure: renal replacement therapy
timeFrame: 6 months
measure: mechanical ventilation
timeFrame: 6 months
measure: vasoactive drugs
timeFrame: 6 months
measure: mortality
timeFrame: 6 months
measure: serious adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: André LN Gobatto, p.h.d
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06639555: Initial Clinical and CBCT Outcomes of Enamel Matrix Derivative-Based Regenerative Therapy in Vertical Bone Defects
Official title: Initial Clinical and CBCT Outcomes of Enamel Matrix Derivative-Based Regenerative Therapy in Vertical Bone Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertical Alveolar Bone Loss
Lead sponsor: Medical University of Varna
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of the effectiveness of the application of regenerative therapy with autogenous, platelet-rich plasma in vertical defects Investigation of the effectiveness of the application of regenerative therapy with enamel matrix derivatives in vertical bone defects Study of the effectiveness of the application of guided tissue regeneration in vertical bone defects with Barrier membrane and Barrier membrane and autogenous platelet-rich plasma


Eligibility criteria: Inclusion Criteria:

* good oral hygiene
* written informed consent
* age
* no systemic diseases

Exclusion Criteria:

* smokers
* horizontal bone loss
* untreated periodontium disease

Primary outcomes:
measure: Probing depth in mm
timeFrame: 6 months
measure: Level of Margo Gingivalis in mm
timeFrame: 6 months
measure: Clinical attachment level in mm
timeFrame: 6 months
measure: The distance from the ECJ to the base of the bone defect in mm
timeFrame: 6 months
measure: The distance from the ECJ to the apex of the bone defect in mm
timeFrame: 6 months
measure: The width of the bone defect in mm
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Varna
country: Bulgaria
facility: Medical University - Varna
Study officials:
References:
Clinical trial NCT02050555: Anti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: Marukome Co., Ltd.
First posted: 2014-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate the effect of koji-extracted beverage fermented with Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.


Eligibility criteria: Inclusion Criteria:

* BMI 25-30 kg/m2

Exclusion Criteria:

* Taking drugs or functional food that may affect body weight or body fat
* Pregnant or nursing a child
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease
* History of severe disease and/or major surgery

Primary outcomes:
measure: Change in BMI from baseline
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Change in body fat mass (percentage) from baseline
timeFrame: Every 4 weeks (Overall 12 weeks)
Secondary outcomes:
measure: Change in abdominal circumference from baseline
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Change in visceral fat area by CT scan from baseline
timeFrame: Weeks 0 and 12
measure: Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
timeFrame: Weeks 0 and 12
measure: Change in fasting plasma glucose from baseline
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Change in serum triglyceride from baseline
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Change in serum total cholesterol from baseline
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Change in serum LDL cholesterol from baseline
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Change in serum HDL cholesterol from baseline
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Change in fasting insulin from baseline
timeFrame: Weeks 0 and 12
measure: Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline
timeFrame: Weeks 0 and 12
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
affiliation: Hiroshima University
name: Fumiko Higashikawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00884455: Alpha-1 Foundation DNA and Tissue Bank
Official title: Alpha-1 Foundation DNA and Tissue Bank
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Alpha 1 Antitrypsin Deficiency
Keywords: tissue banking, research
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Alpha-1 Foundation
First posted: 2009-04-20
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with alpha-1-antitrypsin deficiency, carriers of deficient alleles and interested individuals

Brief summary: This is a long-term follow-up banking protocol that collects medical information and tissue (blood, liver and lung) samples for future research; use of data and samples for research purposes is overseen by the Tissue Bank Advisory Committee; the purpose of the Bank is to further research on alpha-1 antitrypsin deficiency.

Detailed description: Subject participation includes completion of informed consent, medical questionnaire, and email authorization. Subjects may provide a blood sample for alpha-1 antitrypsin genotype, phenotype and level. Lung and liver tissue may also be provided if available. Subjects may be contacted no more often than annually for updated information.

This project has a certificate of confidentiality from NIH.

Eligibility criteria: Inclusion Criteria:

* all interested individuals may enroll

Exclusion Criteria:

* there are no exclusion criteria

Primary outcomes:
measure: Data and tissue samples
timeFrame: The total number of tissue samples received and used for research are tracked annually.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Mark L Brantly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tonelli AR, Rouhani F, Li N, Schreck P, Brantly ML. Alpha-1-antitrypsin augmentation therapy in deficient individuals enrolled in the Alpha-1 Foundation DNA and Tissue Bank. Int J Chron Obstruct Pulmon Dis. 2009;4:443-52. doi: 10.2147/copd.s8577. Epub 2009 Dec 29.
citation: Clark VC, Dhanasekaran R, Brantly M, Rouhani F, Schreck P, Nelson DR. Liver test results do not identify liver disease in adults with alpha(1)-antitrypsin deficiency. Clin Gastroenterol Hepatol. 2012 Nov;10(11):1278-83. doi: 10.1016/j.cgh.2012.07.007. Epub 2012 Jul 24.
Clinical trial NCT05027555: Multisensory Training in PD
Official title: Effect of Multisensory Training on Gait Variability in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Multisensory training
Gait variability
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People with Parkinson's disease (PD) were characterized by many motor symptoms, including rigidity, postural instability, bradykinesia, and resting tremor. These motor symptoms might cause gait dysfunction. Gait dysfunction represented a common sign of PD, including reduced gait velocity, reduced stride length, reduced arm swing, and increased gait variability. Poor postural control in people with PD might result to increase gait variability and then increase fall risk. Previous studies reported that proprioceptive-vestibular multisensory training improved postural stability in people with PD. However, no literature investigated the effects of proprioceptive-vestibular multisensory training on gait variability. Therefore, the purpose of this study is to examine the effect of proprioceptive-vestibular multisensory training on gait variability in people with PD.


Eligibility criteria: Inclusion Criteria:

* Idiopathic PD
* Hoehn and Yahr stage I to III
* Age 60\~80 y/o
* Mini-Mental State Examination (MMSE) ≥24
* Ability to ambulate independently (with or without walking aid)

Exclusion Criteria:

* Affecting the peripheral vestibular system
* Medical condition that substantially influenced their gait and balance performance
* People had joined any rehabilitation past 1 month

Primary outcomes:
measure: Gait variability
timeFrame: Change from baseline at 6 weeks
Secondary outcomes:
measure: Gait performance
timeFrame: Change from baseline at 6 weeks
measure: Sensory organization test
timeFrame: Change from baseline at 6 weeks
measure: Timed up and go test
timeFrame: Change from baseline at 6 weeks
measure: Dynamic Gait Index
timeFrame: Change from baseline at 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04070950: Sexuality of Women With Pelvic Cancer
Official title: Longitudinal Study of the Couple Relationship of Women With Pelvic Cancer: Impact on Sexuality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Behavior
Pelvic Cancer
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 40
Sex: FEMALE
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: Women with cancer of the cervix or uterine body, or ovarian

Brief summary: This study aims to study in patients with cancer of the cervix or the body of the uterus, or the ovary between the time of diagnosis and 3 months after the end of the last treatment: the evolution of the relationship of couple, and more particularly of communication (verbal and non-verbal) concerning sexuality, before and during cancer.

Detailed description: The representations associated with sexuality and cancer seem antinomic: wellbeing / death, and yet combine in the experience of cancer. The latter has an impact on sexuality in terms of satisfaction or sexual activity and on the relationship in terms of support.

In addition, various studies show the psychological impact of treatments on the couple's relationship or the body image of women with cancer. Their abilities to seduce are affected and explain the decrease of their sexual activity during the treatments: a communication, valuing the femininity, would it then facilitate the relations of couple? There is no work that considers sexuality in a systematic way (sexual act and verbal and non-verbal communication) and apprehends its link with the evolution of the relationship, from the diagnosis of cancer to the end of treatments.

This study aims to study in patients with cancer of the cervix or the body of the uterus, or the ovary between the time of diagnosis and 3 months after the end of the last treatment: the evolution of the relationship of couple, and more particularly of communication (verbal and non-verbal) concerning sexuality, before and during cancer.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Life in a couple or single with a regular partner for at least 3 months
* Cancer of the cervix or uterine body or ovarian cancer, in first diagnosis and treatment
* Whatever the stage of cancer
* Curative treatment
* Support in one of the participating centers
* Possible follow-up of all stages of the research

Exclusion Criteria:

* Presence of metastases
* History of other cancer
* History of severe psychiatric illness

Primary outcomes:
measure: Evaluation of sexual activity
timeFrame: 3 months after the end of therapeutic treatment (not the object of the study)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Alain RAVAUD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01125150: Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acanthosis Nigricans
Hyperinsulinemia
Spectroscopic Analysis
Keywords: diffuse reflectance spectroscopy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 9
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with both hyperinsulinemia and acanthosis nigricans.

Brief summary: Acanthosis Nigricans is skin disease that associated with hyperinsulinemia. Clinical is velvety hyperpigmented plaques on neck, axilla, groin. If hyperinsulinemia is improved by treated with oral metformin and/ or diet control, acanthosis nigricans would be improved as well. Hyperpigmented plaques will be changed. We assess objective measurement by using spectroscopic and colorimetric analysis.


Eligibility criteria: Inclusion Criteria:

1. Subjects must have an elevated fasting insulin level, suggesting they are in an insulin resistant state.
2. Subjects must carry a diagnosis of acanthosis nigricans, which will be verified by a Dermatologist before entry into the study. If necessary, a small 4mm punch biopsy may be taken to document dermatopathology consistent with acanthosis nigricans.
3. Subjects must be willing and able to undergo treatment with Metformin, including initial referral and follow up.
4. Agree to abide by the investigator's guidelines
5. Be able to understand the requirements of the study, the risks involved and are able to sign the informed consent form
6. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

1. Subjects with Type 1 Diabetes are excluded because of their naturally insulin-deficient, rather than hyper-insulinemic, states.
2. Women who are lactating, pregnant, or planning to become pregnant.
3. Any reason the investigator feels the patient should not participate in the study.

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Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Department of Dermatology, NEW CENTER ONE
state: Michigan
Study officials:
affiliation: Department of Dermatology, Henry Ford Hospital
name: Iltefat Hamzavi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: