louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04444531: Ozone Therapy and Coronavirus Disease of 2019 (COVID-19) Pneumonia
Official title: Ozone Therapy for Patients With COVID-19 Pneumonia: Preliminary Report of a Prospective Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pneumonia
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Adults \>18yo hospitalised patients confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission), with severe pneumonia with baseline chest X-ray abnormalities + oxygen saturation \<94% on room air, and tachypnea with respiratory rate exceeding 30 per minute.

Brief summary: The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement


Eligibility criteria: Inclusion Criteria:

* confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission)
* severe pneumonia with baseline chest X-ray abnormalities;
* Oxygen saturation \<94% on room air, and tachypnea with respiratory rate exceeding 30 per minute.
* Informed consent signed.

Exclusion Criteria:

* Not willing to participate in the study.

Primary outcomes:
measure: Time to clinical improvement
timeFrame: 28 days
Secondary outcomes:
measure: Rate of patients with Clinical improvement at day 14
timeFrame: 14 days
measure: Rate of patients with Clinical improvement at day 28
timeFrame: 28 days
measure: Time to a 2-fold decrease of C-protein reactive from baseline
timeFrame: 28 days
measure: Time to a 2-fold decrease of ferritin from baseline
timeFrame: 28 days
measure: Time to a 2-fold decrease of Lactate Dehydrogenase from baseline
timeFrame: 28 days
measure: Time to a 2-fold decrease of D-dimer from baseline
timeFrame: 28 days
Other outcomes:
Locations:
city: Ibiza
country: Spain
facility: Policlinic Ibiza Hospital
Study officials:
References:
citation: Hernandez A, Vinals M, Pablos A, Vilas F, Papadakos PJ, Wijeysundera DN, Bergese SD, Vives M. Ozone therapy for patients with COVID-19 pneumonia: Preliminary report of a prospective case-control study. Int Immunopharmacol. 2021 Jan;90:107261. doi: 10.1016/j.intimp.2020.107261. Epub 2020 Dec 5.
Clinical trial NCT00374231: Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients
Official title: A Single Center, Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients Utilizing a Tacrolimus/Mycophenolate Mofetil Based Maintenance Immunosuppression Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplantation
Keywords: Liver
Transplant
Corticosteroid withdrawal
Tacrolimus
CellCept
MMF
Mycophenolate mofetil
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2006-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.

Detailed description: To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppression therapy.

Eligibility criteria: Inclusion Criteria:

* Greater than 90 days post transplant.
* Free from rejection within the last 30 days.
* Patient with primary diagnosis of AIH will be evaluated on an individual basis.
* Negative pregnancy test.
* Practicing an acceptable method of birth control.
* Capable of providing written informed consent.

Exclusion Criteria:

* Rejection within the last 30 days.
* Patients with AIH unable to discontinue corticosteroids.
* Patients currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation is contraindicated.
* Known sensitivity or contraindication to tacrolimus or MMF.
* Kidney, pancreas, islet, heart, lung, or small bowel transplant recipient.
* Pregnant or lactating.

Primary outcomes:
measure: Incidence of Biopsy Confirmed Acute Rejection at 12 Months.
timeFrame: 12 months
Secondary outcomes:
measure: Patient Survival.
timeFrame: 12 months
Other outcomes:
measure: Time Post Transplant Corticosteroid Withdrawal
timeFrame: 12 months
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Steve Woodle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02105831: Skeletal Muscle Perfusion With LVAD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: left ventricular assist device
contrast ultrasound
perfusion imaging
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Heart failure patients being referred for LVAD

Brief summary: Advanced heart failure (when the heart pump fails) is associated with symptoms such as shortness of breath and extreme fatigue. Some of these symptoms are simply due to failure of the pump, however abnormal regulation of blood flow to the muscles of the body is also a potential mechanism. Left ventricular assist devices are mechanical pumps used to compensate for patients with failing hearts either as a bridge to heart transplant or as long term therapy. Whether or not these pumps improve muscle flow and whether this is a determinant in the improvement of symptoms is unknown. Understanding how skeletal muscle and heart perfusion is altered in heart failure patients before and after implantation of an LVAD could provide further insight into the beneficial effects of this therapy.

Specific Aims:

1. To evaluate skeletal muscle and heart perfusion studies before and after LVAD implantation
2. To compare functional status with degree of skeletal muscle perfusion.

Detailed description: Methods:

Thirty patients deemed to be candidates for LVAD from either outpatient heart failure clinic or inpatient cardiology service will be studies. Skeletal muscle perfusion imaging using standard of care ultrasound technology will be performed prior to LVAD implant and then 3 months post implant. Functional status by six minute walk test and specialized stress test will be assessed at 3 months post implant.

Eligibility criteria: Inclusion Criteria:

* patients deemed to be candidates for a LVAD

Exclusion Criteria:

* severe peripheral artery disease
* skeletal muscle disorder
* severe congenital heart disease
* pregnancy
* patients \<18 yo

Primary outcomes:
measure: Skeletal muscle perfusion on contrast enhanced ultrasound
timeFrame: 3 months
Secondary outcomes:
measure: 6 minute walk test
timeFrame: 3 month
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT00200031: A Cost Analysis of Interstim Therapy
Official title: Interstim Therapy Retrospective Cost Analysis and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Retention and Symptoms of Overactive Bladder (Urge, Frequency)
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: A study to examine the impact that Interstim Therapy for Urinary Control has on health care utilization and costs within a health care system and the satisfaction with treatment expressed by patients using this therapy.

Detailed description: A retrospective administrative data analysis combined with a prospective health related quality of life/satisfaction with treatment survey designed to examine the impact that Interstim Therapy for Urinary Control has had on health care utilization and costs for the Kaiser Permanente system and the satisfaction with treatment expressed by patients using this therapy.

Eligibility criteria: Patients implanted with an Interstim Therapy for Urinary Control or undergoing test stimulation for potential placement of Interstim Therapy during the period of June 1, 2002 through June 30, 2004 and who are enrolled with Kaiser-Permanente of Southern California.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
Study officials:
affiliation: Kaiser Permanente
name: Sherif Aboseif, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aboseif SR, Kim DH, Rieder JM, Rhee EY, Menefee SA, Kaswick JR, Ree MH. Sacral neuromodulation: cost considerations and clinical benefits. Urology. 2007 Dec;70(6):1069-73; discussion 1073-4. doi: 10.1016/j.urology.2007.07.073.
Clinical trial NCT05853731: The Effect of Light Therapy on Post-Surgical Pain
Official title: The Feasibility of Using Green Light Phototherapy for the Management of Acute Postoperative Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intensive Care Unit
Cardiac Surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers aim to demonstrate that the use of phototherapy is feasible and may reduce acute postoperative pain based on recent literature. The primary objective is to demonstrate that displaying light-emitting diodes \[LED\] can be achieved in the ICU setting in after cardiac surgery.

Detailed description: The primary aim of this study to determine whether or not green light phototherapy is feasible after cardiac surgery.

Patients that will be undergoing heart surgery will be recruited to the study. After surgery they will be exposed to either green or white LEDs for up to 5 hours per day and up to one week after surgery.

After their exposure to light therapy, a survey will be given to the patient which will ask questions regarding tolerance of the therapy. A survey will also be given to the staff which will query whether or not the therapy was an impediment to workflow. In addition, the medical record will be reviewed to assess opiate usage in each group as an exploratory aim which may suggest differences in pain experiences.

Eligibility criteria: Inclusion Criteria:

- Status post heart surgery and are admitted in the ICU at Mayo Clinic, Florida.

Exclusion Criteria:

* Patient with color blindness and/or untreated cataracts.
* Patients who are hemodynamically unstable.
* Patients with dementia/delirium.
* Pregnancy.
* Patient is unwilling to participate or provide informed consent.
* High baseline narcotic baseline requirements that would skew the baseline impact on post-op opiate pain requirements.

Primary outcomes:
measure: Change in postoperative pain
timeFrame: Baseline, 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Sean Kiley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06427031: Comparing Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients
Official title: A Multi-center, Randomized, Double-blinded, Active Control, Parallel, Phase 3 Trial to Evaluate the Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Dry Eye Syndromes
Lead sponsor: Taejoon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-23
Enrollment: 271
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Multicenter, Randomized, Double-blind, Active control for Evaluating the Efficacy and Safety of the test drug(TJO-083) Compared with the control drug in Dry Eye Sydrome
Primary purpose: TREATMENT

Brief summary: In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 20 or over
* Has dry eye symptoms (minimum 3 months)
* Screening both eyes, the corrected visual acuity is 0.2 or more
* Written informed consent to participate in the trial

Exclusion Criteria:

* The patients who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions within 2 weeks of randomized visits.
* The patients with systemic or ocular disorders affecting the test results(ocular surgery, trauma, or disease) within 2 months of screening visits.
* Intraocular pressure(IOP)\> 21 mmHg
* Patients with contact lens

Primary outcomes:
measure: Change From Baseline in Corneal Staining at Week 4
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Change From Baseline in Corneal Staining at Week 8, 12
timeFrame: Baseline and Week 8 and 12
measure: Change From Baseline in Conjunctival Staining at Week 4, 8 and 12
timeFrame: Baseline and Week 4, 8 and 12
measure: Change From Baseline in Non-anesthetic Schirmer Test at Week 4, 8, 12
timeFrame: Baseline and Week 4, 8 and 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Taejoon Pharmaceutical Co., Ltd.
Study officials:
References:
Clinical trial NCT05810831: Efficacy of Massage Versus Massage With Post Isometric Relaxation Exercises in Temporomandibular Disorders
Official title: Efficacy of Massage Versus Massage With Post Isometric Relaxation Exercises in Temporomandibular Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Joint
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine effectiveness of massage versus massage with post isometric relaxation exercises in temporomandibular disorders for pain and limited joint mobility.


Eligibility criteria: Inclusion Criteria:

* patients with clinical features with myofascial pain and limited mouth opening fulfilling the Axis Group I of RDC/TMD criteria,
* absence of temporomandibular disc displacement with or without reduction,
* good general health (absence of chronic diseases which may affect temporomandibular joint or the masticatory muscles),
* full dental arches with natural teeth or missing teeth replaced with fixed dental prostheses

Exclusion Criteria:

* earlier splint therapy,
* pharmacotherapy (e.g., hormone replacement therapy, oral contraception and antidepressants),
* injury of masticatory organ,
* undergoing orthodontic treatment,
* inflammation in oral cavity (e.g., impacted molars and pulp inflammation) and fibromyalgia

Primary outcomes:
measure: Massage exercises , Massage with post isometric relaxation exercises
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03426631: DAW1033B2 in Obstructive Sleep Apnea
Official title: Effect of DAW1033B2 on Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of DAW1033B2 administered before sleep on OSA phenotype traits and OSA severity during sleep.


Eligibility criteria: Inclusion Criterion:

* OSA: AHI \> 15

Exclusion Criteria:

* Any medical condition other than well controlled hypertension, diabetes, hyperlipidemia
* Any medication known to influence breathing, sleep/arousal or muscle physiology.
* Claustrophobia.
* Inability to sleep supine.
* Allergy to lidocaine, Oxymetazoline HCl, DAW1033D.
* Individuals with underlying cardiac disease, such as arrhythmias.
* Individuals taking psychiatric medications, or any of the studied medications for medical care.
* History of seizures
* For women: Pregnancy.
* History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism

Primary outcomes:
measure: Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Sleep Disorders Research Program Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT05020431: Type I Collagen Fragments in the GCF and Saliva During OTM
Official title: Detection of Type I Collagen Fragments in the Gingival Crevicular Fluid and Saliva During Orthodontic Tooth Movement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Collagen Degeneration
Keywords: Orthodontic tooth movement(OTM);
Type I collagen fragments(ICTP, CTX);
Gingival crevicular fluid (GCF);
Saliva.
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 14
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigate the levels of type I Collagen fragments ICTP and CTX in GCF and saliva during initial leveling and alignment of the teeth in a sample of adolescents undergoing orthodontic treatment.

Detailed description: Type I Collagen fragments ICTP (cross-linked carboxyterminal telopeptide of type 1 collagen) and CTX (C-terminal cross-linked telopeptide of type I collagen) are specific bone resorption biomarkers released in the circulation after osteoclastic bone resorption and collagen degradation and were found to be released in gingival crevicular fluid (GCF) and saliva during metabolic bone diseases and active periodontitis. So the aim of the study is to investigate the levels of ICTP and CTX in GCF and saliva during initial leveling and alignment of the teeth in a sample of adolescents undergoing orthodontic treatment.

Eligibility criteria: Inclusion Criteria:

* The age ranges from 13-18 years old.
* Good oral hygiene.
* Clinical gingival health on the intact periodontium.
* Permanent dentition.
* Moderate crowding.
* Non-extraction treatment plan. If extraction of teeth is required, the treatment plan should allow for postponing extraction after sample collection.

Exclusion Criteria:

* Systemic diseases associated with loss of periodontal supporting tissues.
* Metabolic bone diseases and systemic medications affecting bone metabolism.
* Craniofacial anomalies such as cleft lip and/or palate.
* Xerostomia.
* Tobacco-related habits such as smoking, tobacco chewing, etc.

Primary outcomes:
measure: Levels of ICTP in GCF and saliva samples before appliance placement, 24 hours, 3 days, 7 days, 14 days, and 21 days after archwire placement.
timeFrame: 21 days
measure: Levels of CTX in GCF and saliva samples before appliance placement, 24 hours, 3 days, 7 days, 14 days, and 21 days after archwire placement.
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university faculty of dentistry
Study officials:
affiliation: Principal Investigator
name: Omar Tareq
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07006831: A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
Official title: A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Kidney Disease
Kidney Transplant
Transplant Recipient
Renal Function
Cell-free DNA
Lead sponsor: Devyser Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-05
Enrollment: 400
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: Kidney Transplant Recipients

Brief summary: The purpose of this research is to collect blood samples and data from kidney transplant patients. The blood will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to evaluate the status of the transplanted organ.

Detailed description: This is a prospective, multicenter sample collection study within a kidney transplant population.

Whole blood samples and clinical data will be obtained from each participant at the time of indication biopsy (prior to the biopsy procedure).

De-identified leftover retrospective gDNA screening samples from each participant (recipient) and paired donor(s) will be obtained.

Eligibility criteria: Inclusion Criteria:

1. Willing and able to provide written informed consent
2. Is 18 years of age or older at enrollment
3. Had a kidney transplant prior to enrollment
4. Is having an indication biopsy as determined by clinician
5. retrospective leftover samples are available from the recipient and the kidney donor(s).

Exclusion Criteria:

1. Is pregnant
2. Had a blood transfusion within the past 4 weeks
3. Had a transplant from an identical (monozygotic) twin
4. Had transplants of multiple organs from the same donor (eg, kidney and liver transplant).
5. Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant)
6. Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)

Primary outcomes:
measure: Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Pettersson L, Westerling S, Talla V, Sendel A, Wennberg L, Olsson R, Hedrum A, Hauzenberger D. Development and performance of a next generation sequencing (NGS) assay for monitoring of dd-cfDNA post solid organ transplantation. Clin Chim Acta. 2024 Jan 1;552:117647. doi: 10.1016/j.cca.2023.117647. Epub 2023 Nov 10.