louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03522181: Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation
Official title: Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplantation
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lactic acidosis is a common phenomenon occurring during orthotopic liver transplantation (OLT), especially during the anhepatic and early postreperfusion phases. However, little drugs effectively decrease the degree of lactic acidosis when it happens. The aim of this study is to explore whether glucose-Insulin-Potassium(GIK) infusion can relieve metabolic acidosis and improve perioperative outcome in patients undergoing OLT.

Detailed description: Intraoperative metabolic acidosis begins soon after graft reperfusion and persists for several days. The current standard treatment for severe acidosis during OLT is NaHCO3, although it may compromise myocardial performance, exacerbate lactic acid accumulation and cause central nervous system demyelination. Surgical procedure is a primary source of endogenous lactic acid production, especially visceral ischemia originating from anhepatic stage. The present study thus hypothesized that GIK solution may improve metabolic acidosis in OLT patients through its unique effects of metabolic alleviation. Patients for orthotopic liver transplantation was enrolled and received either GIK or placebo. GIK or placebo infusion started after anesthesia induction. Intraoperative measures were mean arterial pressure, HR, arterial blood gases, lactate, glucose, Na, liver and renal function indexes. Outcome measures were time to tracheal extubation, intensive care unit, length of stay, complications, hospital length of stay, requirement for postoperative plasma transfusion, retransplantation, and perioperative mortality.

Eligibility criteria: Inclusion Criteria:

* patients who were to undergo OLT

Exclusion Criteria:

* diabetes mellitus, hyperkalemia on arrival (K+ \> 5.5 mEq/L) and the inability to give informed consent

Primary outcomes:
measure: degree of lactic acidosis
timeFrame: up to 1 weeks
Secondary outcomes:
Other outcomes:
measure: tracheal extubation
timeFrame: up to 3 days
measure: intensive care unit length of stay and hospital length of stay
timeFrame: up to 1 month
measure: The incidence of complications
timeFrame: up to 1 month
measure: The incidence of retransplantation
timeFrame: up to 1 month
measure: The incidence of perioperative mortality
timeFrame: up to 1 month
Locations:
city: Changsha
country: China
facility: Department of Anesthesiology, The Second Xiangya Hospital
state: Hunan
Study officials:
affiliation: Central South University
name: Ru-Ping Dai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01076881: Combined Resistance and Aerobic Exercise is Better Than Resistance Training Alone to Improve Functional Performance of Hemodialysis Patients - Results of a Randomized Trial
Official title: Combined Resistance and Aerobic Exercise is Better Than Resistance Training Alone to Improve Functional Performance of Hemodialysis Patients - Results of a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Universidade Católica de Pelotas
Sponsor class: OTHER
First posted: 2010-02-26
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized trial with participants recruited from one dialysis unit of a Brazilian university hospital. Hemodialysis patients were assigned to receive the resistance exercise combined with an aerobic training or the resistance training alone for a period of 10 weeks. The functional performance of patients was assessed before and after the intervention through the six-minute walk test (6MWT). The difference over time of the 6MWT was compared between the groups through multivariate linear regression.

Thirteen patients were allocated for each group of intervention. The difference in distance walked before and after intervention in the combined training group was of +39.7 (61.4) meters, and this difference in the resistance training group was of -19.2 (53.9) meters, p=0.01. In multivariate analysis with adjustment for age, skin color, gender, hematocrit, time since starting dialysis, Kt/V and baseline values of 6MWT, the type of training remained significantly associated with the amount of increase in walked distance.

Although the best protocol of exercise for patients on dialysis is not yet clear, in the investigators sample of hemodialysis patients the combination of aerobic and resistance training was more effective to improve functional performance.


Eligibility criteria: Inclusion Criteria:

* to be on hemodialysis therapy for longer than 3 months
* to be already included in the resistance training protocol during dialysis
* to receive erythropoietin for the treatment of anemia
* hemoglobin level greater than 9.0 g/dL
* to be able to maintain sitting and standing balance and ambulatory without assistance.

Exclusion Criteria:

* symptomatic ischemic heart disease
* recent myocardial infarction of less than 6 months
* uncontrolled hypertension
* pericardial or pleural friction rub
* aortic stenosis
* active musculoskeletal lower-extremity problem, or history of vertebral fracture caused by osteoporosis
* patients were also excluded if they participated in formal organized exercise programs outside the dialysis unit.

Primary outcomes:
measure: physical performance
timeFrame: 10 weeks
Secondary outcomes:
measure: dialysis adequacy (KtV)
timeFrame: 4/8/10 weeks
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Hospital Universitário São Francisco de Paula
state: RS
Study officials:
References:
Clinical trial NCT03008681: OHRQoL Evaluation After Functional Therapy in JIA Patients
Official title: Oral Health-Related Quality of Life in Patients With Juvenile Idiopathic Arthritis and Temporomandibular Joint Disorders Evaluation After Treatment With a Functional Appliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 93
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to determine the changes in Oral Health-Related Quality of Life (OHRQoL) in patients with juvenile idiopathic arthritis (JIA) and temporomandibular joint (TMJ) disorders who underwent functional therapy for 24 months to assess the age and sex group in which the functional therapy was most effective.

Detailed description: This prospective interventional study included 93 patients with JIA and TMJ disorders at the start of functional orthodontic therapy. Children were prospectively followed in the 24 months of treatment and completed the Oral Health Impact Profile (OHIP-14) before treatment (T0), and at 6 months (T1), 12 months (T2), and 24 months (T3) after the start of therapy.

Eligibility criteria: Inclusion Criteria:

The inclusion criteria were:

* JIA with unilateral or bilateral TMJ arthritis treated with a functional appliance;
* Clear signs or symptoms of TMJ arthritis based on clinical and radiological examination.
* No administration of intra-articular TMJ steroid injections throughout the course of the orthopaedic functional treatment.

Exclusion Criteria:

* previous orthodontic treatment;
* history of maxillofacial surgery;
* genetic diseases, syndromes, other congenital deformities or any concurrent medical condition.

Primary outcomes:
measure: TMJ disorder cessation
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: University of Messina
name: Giovanni Matarese, DDS
role: STUDY_DIRECTOR
References:
citation: Isola G, Perillo L, Migliorati M, Matarese M, Dalessandri D, Grassia V, Alibrandi A, Matarese G. The impact of temporomandibular joint arthritis on functional disability and global health in patients with juvenile idiopathic arthritis. Eur J Orthod. 2019 Mar 29;41(2):117-124. doi: 10.1093/ejo/cjy034.
Clinical trial NCT02544581: Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare
Official title: Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcohol Use Disorder
Lead sponsor: SoberLink, LLC
Sponsor class: INDUSTRY
First posted: 2015-09-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Alcohol abusers enrolled into an aftercare program following residential treatment for alcohol abuse

Brief summary: This is an exempt, retrospective study of a limited set of information obtained from patients' medical records at 10 to 12 substance abuse treatment programs combined with alcohol breath analyzer results during up to 3 years of aftercare monitoring. The study objectives are 1) to compare the compliance rates and likelihood of achieving sustained sobriety for aftercare patients in mandated (eg, impaired professionals) versus non-mandated monitoring programs and 2) identify components within patients' monitoring agreements that are significantly correlated with positive outcomes.


Eligibility criteria: Inclusion Criteria:

* Adults with a diagnosis of alcohol abuse enrolled into an aftercare program following residential treatment

Exclusion Criteria:

-

Primary outcomes:
measure: Compliance rates (negative versus positive versus false positive alcohol test findings)
timeFrame: Test administered 2 to 4 times per day for up to 3 years
measure: Response rates: defined as use of device when prompted-will include several values such as missed, late, excused
timeFrame: Test administered 2 to 4 times per day for up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Juno Beach
country: United States
facility: Ed Pigott
state: Florida
Study officials:
affiliation: Mr. Pigott
name: Ed Pigott, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01348581: Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing
Official title: Chronic Wound Treatment With Extracellular Matrix (ECM) Scaffold Made From Fish Proteins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcers
Venous Ulcers
Diabetic Ulcers
Chronic Ulcer of Foot
Trauma-related Wound
Keywords: Adult
Aged
Aged, 80 and over
Bandages
Biological Dressings
Chronic Disease
Collagen
Epithelium
Extracellular Matrix
Fibroblasts
Granulation Tissue
Humans
Leg Ulcer
Middle Aged
Prospective Studies
Soft Tissue Injuries
Treatment Outcome
Varicose Ulcer
Wound Healing
Wounds and Injuries
Lead sponsor: Kerecis Ltd.
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 37
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 clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds.

The wound dressing is indicated for the management of difficult to heal and chronic wounds. The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary dressing is put on top. Further dressing of the wound depends on the etiology.

The indications for use are:

* partial and full-thickness wounds
* pressure ulcers
* venous ulcers
* diabetic ulcers
* chronic vascular ulcers
* tunneled/undermined wounds
* trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)


Eligibility criteria: Inclusion Criteria:

* Venous leg ulcer
* Arterial leg ulcer
* Rheumatic leg ulcer
* Hydrostatic leg ulcer
* Ulcer where healing is delayed because of drug therapy
* Non-healing ulcer due to known or unknown causes

Exclusion Criteria:

* Active infection

Primary outcomes:
measure: Wound healing
timeFrame: one year
Secondary outcomes:
measure: Wound granulation
timeFrame: one year
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: National University Hospital
Study officials:
References:
Clinical trial NCT05802381: the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition
Official title: the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Malnutrition
Keywords: protein
malnutrition
nutritional risk
cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 100
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: Nutritional risk and malnutrition is common in cancer patients, which is one of the significant factors affecting the overall survival, toxicity during anticancer treatment, and quality of life among patients with cancer. Previous studies have shown that the increased protein intake can stimulate muscle synthesis, and improve muscle mass, strength, function, overall survival, and quality of life. The current study is going to investigate the effectiveness and safety of protein supplements on patients with cancer, in order to provide a reference for further nutrition treatment.

Detailed description: An anticipated total of 100 participants will randomly assigned to receive either a 20-gram protein supplement per day or nutrition counseling to increase the protein intake. there will be a total of 3 study visits, and dietary assessment and blood sample collection will occur at every study visit. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be used in statistical analysis.

Eligibility criteria: Inclusion Criteria:

* • Age\>=18years old;

  * Initial treatment patients with lung/gastrointestinal/esophageal cancer
  * Patients with nutritional risk (NRS-2002≥3) ;
  * Patients are able to provide written informed consent.

Exclusion Criteria:

* • People who are allergic to whey protein.

  * Participants received any drugs or supplements known to influence the outcomes, such as protein powder, anabolic steroids, or glucocorticoids before the 3 months preceding the study.
  * Participants with gastrointestinal bleeding or intestinal obstruction, or any contraindication for oral intake
  * Concurrent severe cardiac disease, liver and renal failure, which may significantly interfere with study compliance.
  * Participants with electronic or mental device.
  * Women in pregnancy or lactation period

Primary outcomes:
measure: blood toxicity
timeFrame: 6 month
measure: nutritional risk
timeFrame: 6 months
measure: malnutrition
timeFrame: 6 months
Secondary outcomes:
measure: phase angle (PA)
timeFrame: 6 month
measure: weight
timeFrame: 6 month
measure: dose limitation
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Kang Yu, MD
role: STUDY_DIRECTOR
affiliation: Peking Union Medical College Hospital
name: Fang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04371081: Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Official title: Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Patent Ductus Arteriosus
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Japanese society of Congenital Interventional Cardiology
First posted: 2020-05-01
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with patent ductus arteriosus (PDA) in whom an Amplatzer™ Piccolo Occluder (Piccolo) implant was attempted will be included in this registry.

Brief summary: The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect safety and efficacy information for evaluating the results of its clinical use.

Detailed description: The Surveillance will be conducted per the standards required by the Ministry of Health, Labour and Welfare (MHLW) and in the standards for post-marketing surveillances and studies \[except for those defined in the Ministerial Ordinance on Good Clinical Practice for Medical Devices (MHLW Ordinance No. 36, 2005)\] based on Paragraph 4, Article 23-2-9 (including application mutatis mutandis per Article 23-2-19 of Revised PAL) of the Law on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, etc. (Law No. 145, 1960, hereinafter referred to as "Revised PAL") by the Marketing Authorization Holder or accredited foreign manufacturer of a medical device defined in Paragraph 1, Article 23-2-5 of Revised PAL.

Eligibility criteria: Inclusion Criteria:

The device is used to percutaneously close the PDA of a patient who meets all of the following:

* PDA ≤4 mm in diameter
* PDA ≥3 mm in length
* Weight ≥700 g

Exclusion Criteria:

* Age \<3 days
* Coarctation of the aorta
* Left pulmonary artery stenosis
* Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension
* Thrombus in the implant site, or sign of venous thrombus in a vessel in which the occluder is inserted and delivered
* Endocarditis, or infection that can cause bacteremia
* Allergic or potentially allergic to nickel

Primary outcomes:
measure: The rate of major complications through 180 days after an attempted Piccolo device implant
timeFrame: Through 180 days after an attempted Piccolo device implant
measure: The rate of effective closure of the ductus arteriosus among subjects with a successful Piccolo implant as assessed by the presence of either a Grade 0 or Grade 1 shunt at the 6-month follow-up by transthoracic echocardiography
timeFrame: At the 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Showa University Hospital
Study officials:
References:
Clinical trial NCT04275310: Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women
Official title: Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hiv
Transgenderism
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-02-19
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to learn more about the economic situations, discrimination experiences, and risk behaviors of transgender women. The ultimate purpose of the study is to test an intervention to improve financial conditions and reduce HIV risk behaviors in transgender women.

Detailed description: The study includes a microeconomic intervention which will provide education on a variety of economic and behavioral topics. Participants will complete questionnaires on multiple occasions during the study.

Eligibility criteria: Inclusion Criteria:

* Transgender woman
* 18-45 years of age

At least one of the following economic vulnerability factors:

unemployment or underemployment \[less than 20 hours/week\], low income \[less than the Medicaid poverty threshold\], housing insecurity in the past year or food insecurity in the past year

• Behavioral vulnerability to HIV transmission (reported at least one episode of unprotected sex in prior 6 months or at least one other behavioral HIV transmission risk factor in the past 6 months: \[transactional sex, multiple sexual partners, 1-time sexual partner, sex under the influence of drugs or alcohol, sex with partner of unknown HIV status).

Exclusion Criteria:

* obvious signs of intoxication or cognitive impairment
* cannot speak English.

Primary outcomes:
measure: Change in Employment Status
timeFrame: Baseline to up to 9 months
measure: Change in Income
timeFrame: Baseline to up to 9 months
measure: Change in Housing Stability
timeFrame: Baseline to up to 9 months
measure: Change in Savings
timeFrame: Baseline to up to 9 months
measure: Change in Self Reported HIV Risk Behavior
timeFrame: Baseline to up to 9 months
measure: Change in Compliance With Recommended Biomedical Prevention or Treatment
timeFrame: Baseline to up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Eric Benotsch, PhD
role: PRINCIPAL_INVESTIGATOR
References: