louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03646552: A Study to Examine the Efficacy of a Therapeutic THX-110 for Obstructive Sleep Apnea
Official title: Feasibility Study - Whether the Administration of the Dronabinol and PEA May Act as a Therapy for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Lead sponsor: SciSparc
Sponsor class: INDUSTRY
First posted: 2018-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a sponsored proof of concept study with the purpose to examine the safety, tolerability and feasibility of THX-110 (Dronabinol (synthetic Δ9-THC) and PEA) for the treatment of adults with Obstructive Sleep Apnea.

Detailed description: This is a 30-day sponsor-initiated, open-label trial of the therapeutic treatment THX-110 (a combination of Dronabinol and PEA) in 30 adults with Obstructive Sleep Apnea (OSA). Participants will receive THX-110 for the duration of the trial. The goal for this pilot study is to provide initial safety, feasibility and tolerability data on THX-110 in an OSA population.

Eligibility criteria: Inclusion Criteria:

* OSA diagnosis; OSA severity AHI: 15-30
* Population aged 20-65
* Gender: Males and Females
* BMI \< 30
* OSA patients that cannot tolerate CPAP
* OSA patients who use CPAP will not use the device during the entire duration of the study

Exclusion Criteria:

* Minors
* Severity of OSA outside the determined boundaries
* Pregnancy
* BMI \> 30
* Medical history of narcotic dependency

Primary outcomes:
measure: A Significant Change in AHI Index
timeFrame: 30 days
Secondary outcomes:
measure: A Change in Oxygen Desaturation Index (ODI)
timeFrame: 30 days
Other outcomes:
measure: Primary Safety Measurement: Serious Adverse Events (SAEs)
timeFrame: 30 days
measure: Secondary Safety Measurement: Adverse Events (AEs): Anticipated and Unanticipated (uAEs)
timeFrame: 30 days
Locations:
city: Tel Aviv
country: Israel
facility: Assuta HaShalom
Study officials:
References:
Clinical trial NCT04664452: Current Status of Porcine Derived Products in Surgery
Official title: Current Status of Utilization an Surgeons' View of Porcine Derived Medical Products: an International Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ethics, Narrative
Keywords: porcine
ethics
informed consent
biological graft
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Specialist of any branch of surgery excluding pathology and anesthesiology

Brief summary: Porcine derived products are being used as biological grafts in mainly in orthopedic surgery, neurosurgery, cardiovascular surgery and general surgery. It is well known that consuming pork or porcine products are prohibited in some religions or divisions of religions. It may be a tender point for patients undergoing surgery in which porcine derived products are utilized.In this survey study we aimed to determine the level of awareness and perception of surgeons with an international anquette. The study will also reveal the choices of surgeons about this issue both in elective and emergency procedures

Detailed description: In the survey study an online anquette form will be sent through online surgery networks both professional and social media. The questionnaire will not include questions defining the responders individually. The questions are related to frequency of utilization of porcine derived products in surgery, surgeons' level of awareness about utilization of porcine products, surgeons' level of religiousity and surgeons' choices about porcine derived product utilization and consent of patients. After collection of responses the data will be analyzed to discover current status of porcine derived surgical product utilization and surgeons' perception about the issue. The anquette will be distributed worldwide to surgeons in different branches of surgery. Literature seems to be lacking of that kind of study

Eligibility criteria: Inclusion Criteria:

* Being volunteer and responder of at least 80% of the study questionnaire

Exclusion Criteria:

* Responding less than 80% of the questionnaire

Primary outcomes:
measure: Surgeons' awareness of utilization of porcine derived products in surgery
timeFrame: 2 month
measure: Surgeons' choice about utilization of porcine derived products in surgery
timeFrame: 2 month
Secondary outcomes:
measure: Relationship of porcine derived product utilization according to religious/phlosophical belief
timeFrame: 2 month
measure: Surgeons' choice about informing patients about porcine derived products
timeFrame: 2 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02353052: Prospective Cohort Study of the Clinical Applications for the Pathologic Type, Staging, and Grading of GIST
Official title: Prospective Cohort Study of the Clinical Applications for the Pathologic Type, Staging, and Grading of Primary Gastrointestinal Stromal Tumor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Stromal Tumor
Keywords: morphology standards
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with GIST by pathology

Brief summary: Evaluate the reliability of morphology standards for GIST pathologic type, staging and grading by retrospective analyzing clinical data; on this basis, establish a GIST standardized and individualized treatment mode to maximum benefit GIST patients, avoid under- and over-treatment.

Detailed description: 1. Retrospective analysis of GIST cases in the recent five years: the GIST clinical data of Fudan University Zhongshan Hospital from 2007 January to 2012 December were collected. By reviewing the HE slides, GIST was evaluated by 12 indicators, NIH scheme and WHO standard. Accomplish the gene sequencing of KIT, PDGFRA, B-raf, and SDH. Follow up the patients about their treatment and prognosis. Analyze and compare the advantages and disadvantages of the histomorphology indicators, NIH scheme, and WHO standard.
2. Organize the first prospective cohort study of GIST individualized treatment based on the histomorphology. Obtain the evidence of histological assessment for GIST by following up patients for 3 years.
3. Establish an evaluation criteria based on the morphology of GIST. Make objective evaluations about GIST tumor size, tumor location and gene mutation status in the prognosis estimate. Make rules to effectively guide individualized treatment of GIST.

Eligibility criteria: All patients pathologically diagnosed with GIST during the period from 2013 to 2015

Primary outcomes:
measure: Number of participants with tumor recurrence
timeFrame: 3 years
measure: Number of participants with tumor metastasis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Yingyong Hou, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT00656032: Vitamin D, Insulin Resistance and Inflammation in ESRD
Official title: Vitamin D, Insulin Resistance and Inflammation in ESRD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: insulin resistance
end stage renal disease
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-04-10
Enrollment: 12
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: The broad goal of this study is to understand the mechanisms by which Vitamin D receptor activation leads to changes in insulin signaling in advanced uremia. We hypothesize that 1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin resistance and that administration of a vitamin D3 analog will restore insulin sensitivity in End Stage Renal Disease patients.


Eligibility criteria: Inclusion Criteria:

* CKD and receiving hemodialysis for ≥ 3months
* Kt/V ≥ 1.2
* ≥ 18 years of age
* Medically stable
* AVF or PTFE dialysis access
* No acute inflammatory disease within 4 weeks prior to the study
* On stable dose of Paricalcitol for 4 weeks prior to the study
* iPTH value between 150 - 1500 within the past 3 months
* Ca \< 10.5
* PO4 \< 10

Exclusion Criteria:

* Pregnancy
* Intolerance to the study medication
* Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease)
* Type 1 Diabetes mellitus
* Uncontrolled Type 2 Diabetes mellitus (HbA1c \> 10)
* Hospitalization within 1 month prior to the study
* Malfunctioning arterial-venous vascular access (recirculation and/or blood flow \< 250 ml/min)
* Presence of hemodialysis catheter
* Patients receiving steroids and/or other immunosuppressive agents (\> 10 mg prednisone qd)
* BMI \< 25 and \> 45

Primary outcomes:
measure: An improvement in insulin sensitivity
timeFrame: 8 weeks
Secondary outcomes:
measure: A change in insulin signaling
timeFrame: 8 weeks
measure: A decrease in concentration of plasma pro-inflammatory cytokines
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alp Ikizler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02910232: In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration
Official title: In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Fracture of Foot
Keywords: Rice starch
Porous composite
Biomaterial
Bone regeneration
Clinical trial
Hydroxyapatite
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There were 44 volunteers from orthopedic and neurosurgical division.

Brief summary: Biodegradable scaffold is an accepted and commercialized medical alternative choice for bone regeneration. In this project we will used our new invention, porous starch- hydroxyapatite composite, for in vivo clinical trial.

Detailed description: The products were prepared from medical grade Thai rice starch mixed with high purity (\>97%) hydroxyapatite powder from fresh cow bone, and already passed in vivo animal biocompatility test, then processed by freeze-drying. There were 44 volunteers from orthopedic and neurosurgical division, 4 and 40 patients, respectively.

Eligibility criteria: Inclusion Criteria:

* A patient who requires treatment by surgery and product implant in bone.
* Not indicate sex type
* 18-65 years
* Patients accepted participate in the study.
* Type of surgery will be treat for only bone.

Exclusion Criteria:

* Refused to join the study.
* Patients have an allergic history of carbohydrates and bovine bone.

Primary outcomes:
measure: Bone voids repairing
timeFrame: 6 months
Secondary outcomes:
measure: Bone voids repairing
timeFrame: 6 months
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Biomedical Materials and Ceramic Industrial Research Unit
Study officials:
References:
citation: Holzapfel BM, Reichert JC, Schantz JT, Gbureck U, Rackwitz L, Noth U, Jakob F, Rudert M, Groll J, Hutmacher DW. How smart do biomaterials need to be? A translational science and clinical point of view. Adv Drug Deliv Rev. 2013 Apr;65(4):581-603. doi: 10.1016/j.addr.2012.07.009. Epub 2012 Jul 20.
citation: Dimitriou R, Jones E, McGonagle D, Giannoudis PV. Bone regeneration: current concepts and future directions. BMC Med. 2011 May 31;9:66. doi: 10.1186/1741-7015-9-66.
citation: Mendes SC, Reis RL, Bovell YP, Cunha AM, van Blitterswijk CA, de Bruijn JD. Biocompatibility testing of novel starch-based materials with potential application in orthopaedic surgery: a preliminary study. Biomaterials. 2001 Jul;22(14):2057-64. doi: 10.1016/s0142-9612(00)00395-1.
Clinical trial NCT04469452: Validation of a Portable Indirect Calorimeter
Official title: Validation of the Apollo EE Device, Indirect Calorimetry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Human Energy Expenditure
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Only individuals who are enrolled in a separate study using indirect calorimetry to measure RMR within our lab will be eligible to participate in this study.

Brief summary: This study plans to test the accuracy of a new device (the Apollo EE Device) that measures resting energy expenditure (REE) using only oxygen consumed (VO2). Findings from this study will help determine how this new device compares to the gold standard, indirect calorimetry, which measures REE using VO2 and carbon dioxide production (VCO2). Findings may help develop less expensive and more accessible means of measuring energy expenditure.

Detailed description: The gold standard for measuring resting metabolic rate (RMR) is metabolic carts that measure oxygen consumption (VO2) and carbon dioxide production (VCO2). The energy equivalent of VO2 ranges from \~4.7-5.0 kcals/L, depending on the ratio of carbohydrate, fat, and protein oxidized. However, RMR can be measured based solely on VO2, because VCO2 has a relatively small effect on energy expenditure estimation. A device that measures RMR based on VO2 and eliminates the need for measuring VCO2 could provide a simple and less expensive alternative to metabolic carts and may have important clinical applications. The overarching goal of this proposal is to validate such a metabolic system by comparing its ability to accurately measure RMR against a metabolic cart.

Eligibility criteria: Inclusion Criteria:

* Males and females
* 19-99 yrs of age

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Accuracy of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart)
timeFrame: Baseline
measure: Reliability of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart)
timeFrame: Repeated Measure obtained within 1 week of baseline measure
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Edward Melanson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03760432: Collagen Cross-linking in Keratoconus
Official title: Clinical Trial of Laser Custom Corneal Collagen Cross-Linking in Keratoconus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Keratoconus
Keywords: Keratoconus (KCN)
Optical Coherence Tomography (OCT)
Collagen Cross-linking (CXL)
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2018-11-30
Enrollment: 100
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: Optical Coherence Tomography (OCT) devices are non-contact instruments that can measure the depth of scars, other causes of cloudiness of the cornea, and degree of corneal thinning in patients with keratoconus. Laser Custom Corneal Collagen Cross-linking (CXL) significantly decreases corneal aberrations and improves vision. This study will use OCT-guided setting for the lasers used in the corneal smoothing portion of the laser custom CXL procedure to assess the affect on visual outcomes.

Detailed description: In the U.S., CXL and topography-guided laser ablation were approved independently, but not together. Another variation in technique involves the use of mitomycin-C (MMC), which is effective in reducing corneal haze after the laser surface ablation. Use of MMC during the laser custom CXL was associated with better outcomes, but in separate trials that could not be directly compared. This study will use OCT measurements to evaluate the magnitudes of direct and indirect laser actions after the procedure.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of keratoconus
* Minimum corneal thickness of 410 microns

Exclusion Criteria:

* Inability to maintain fixation for OCT imaging
* Inability to commit to required study visits
* Inability to give informed consent
* Eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery
* Mature cataracts if found to limit visual potential to worse than 20/40

Primary outcomes:
measure: Improvement in best spectacle-corrected visual acuity after laser custom CXL
timeFrame: 6 months after the CXL procedure
Secondary outcomes:
measure: Determine CXL demarcation line depth
timeFrame: 1 month after the CXL procedure
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: David Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02123732: Role of DbXell in the Treatment of Subjects With Mildly Uncontrolled Type 2 Diabetes Mellitus
Official title: Role of DbXell in the Treatment of Subjects With Mildly Uncontrolled Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Diabetes Mellitus
Herbal
food supplement
Lead sponsor: Laniado Hospital
Sponsor class: OTHER
Collaborators: name: KGS Research
First posted: 2014-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a 2-arm, single-blind, crossover, placebo-controlled clinical study, with 24 weeks of therapy to evaluate the efficacy and safety of DbXell in improving metabolic control in patients with Type 2 Diabetes that is mildly uncontrolled, defined as HbA1c above target but less than 8.0% on their current conventional therapy.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects with age of 18-70 years Established type 2 diabetes mellitus as defined by the American Diabetes Association, but of duration less than 10 years.
* Suboptimal glycemic control as judged by HbA1c over target but not more than 8.0%.Current medication of not more than 2 oral hypoglycemic agents. No current or past insulin or GLP1 therapy.
* FPG ≤ 180 mg/dL
* Hemoglobin level of ≥ 10.0 g/dL
* Serum ALT ≤ 2.5 times upper limit of normal
* Serum creatinine \< 1.5 times upper limit of normal

Exclusion Criteria:

* Female of childbearing potential
* Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment
* Uncontrolled hypertension (SBP \> 160 mmHg and/or DBP \> 100 mmHg)
* History of renal and/or liver disease
* History of or the presence of any clinical evidence of malignancies
* Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections
* Current treatment with systemic corticosteroids or herbal (alternative) medicines
* Participation in any other intervention trial within 30 days prior to Screening

Primary outcomes:
measure: Change in HbA1C concentrations and fasting glucose levels
timeFrame: 6 months from last patient in
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Laniado Hospital, Diabetes Unit
Study officials:
affiliation: Laniado Hospital
name: Mark J Niven, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05035732: A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)
Official title: A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Prostate Nodule
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To perform both PET scans and MRIs in the same setting using a simultaneous PET/MRI scanner.

Detailed description: Primary Objective:

--To compare the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI and to determine whether 18F- Fluciclovine pelvic PET/MRI is more accurate than a pelvic mpMRI in detecting pelvic RRPC in men with biochemical recurrence with histopathology as reference standard.

Secondary Objective:

--To study inter-reader reliability of 18F- Fluciclovine pelvic PET/MRI and pelvic mpMRI among the readers.

Exploratory Objective:

--To study correlation between SUVmax and ADCmean in the pelvic RRPC.

Eligibility criteria: Inclusion Criteria:

1. Male patients who are 18 years and older
2. Histologically or cytologically proven prostate carcinoma s/p definitive radiation
3. Patients suspected to have BCR based on phoenix criteria (prostate specific antigen value (PSA) of 2 ng/mL above the PSA nadir)
4. Ability to understand and willingness to sign informed consent

Exclusion Criteria:

1. Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
2. Patients with contraindication to undergo MRI
3. Patients with prior allergy to MRI contrast agent.
4. Extreme Claustrophobia

Primary outcomes:
measure: To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Devaki S Surasi
role: PRINCIPAL_INVESTIGATOR
References: