louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00865449: Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis
Official title: Role of Renin Angiotensin Blockade in Peritoneal Fibrosis in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: End Stage Renal Disease
Keywords: spironolactone
peritoneal fibrosis
peritoneal dialysis
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2009-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a double blind randomized controlled study to evaluate the effect of aldactone on peritoneal fibrosis on incident peritoneal dialysis patients. The study would include a total of 40 incident peritoneal dialysis patients. Peritoneal biopsy would be made at randomization and 6 months after the intervention to evaluate the effect of renin angiotensin blockade on peritoneal fibrosis.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Hospitalized for peritoneal catheter placement for peritoneal dialysis

Exclusion Criteria:

* Pregnancy
* Hiperkalemia (K\> 5.5meq/l)
* Intolerance to spironolactone

Primary outcomes:
measure: Peritoneal fibrosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez
state: DF
Study officials:
affiliation: Instituto Nacional de Cardiologia Ignacio Chavez
name: Magdalena Madero, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
Clinical trial NCT02509949: Effects of Dexmedetomidine on Delirium After Living Donor Renal Transplantation in Adult Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Delirium After Living Donor Renal Transplantation
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Delirium, an acute change in mental status, is a serious medical complication among hospitalized patients. Syndrome of delirium involves agitation, sleep disturbance, affective disorders and cognitive disruptions.

One vulnerable period for developing delirium is in the postoperative days. Postoperative delirium often initiates a cascade of adverse consequences including an increase in length of stay and hospital costs, and greater mortality. The investigators have observed that the incidence of postoperative delirium in patients after renal transplantation is about 20-30% in our hospital.

Several studies have revealed that dexmedetomidine, as a widely used sedative during anesthesia, can decrease the incidence of postoperative delirium after cardiac surgery. The investigators aim to examine whether administration of dexmedetomidine can reduce postoperative delirium after living donor renal transplantation in adult patients.


Eligibility criteria: Inclusion Criteria:

* age \> 17 and \< 60 years;
* American Society of Anesthesiology (ASA) I-III;
* admitted for living donor renal transplantation.

Exclusion Criteria:

* Patients with a history of drug abuse;
* preoperative history of schizophrenia, epilepsy, parkinsonism, use of cholinesterase inhibitor, inability to communicate in the preoperative period (coma, profound dementia, or language barrier).

Primary outcomes:
measure: Postoperative Delirium
timeFrame: Postoperative day 1-7.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01562249: Rehabilitative Management of Mastication
Official title: Rehabilitative Management of Mastication After Orthognathic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgery
Malocclusion
Keywords: clinical evaluation
controlled clinical trial
electromyography
exercise program
motor control
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to verify the effectiveness of a systematic rehabilitative program for mastication in patients submitted to orthognathic surgery.

Detailed description: Orthognathic surgery can produce complications during the postoperative period - i.e. situations of acute pain and inflammation - as a consequence of fractures and incisions in the mucosa. The inadequate management of soft tissue and prolonged surgical time could be the causes of acute facial oedema, hematoma and ecchymosis in the face and neck, as well as functional disorders involving swallowing and breathing, which can affect patients' integrity.

Despite the fact that decreased muscular extensibility and strength, increased muscular fatigability, hipomobility, and alteration of the biomechanical efficiency and length of the masticatory muscles are documented clinical consequences, no systematic method of obviating such problems through muscular rehabilitation has yet been published

Eligibility criteria: Inclusion Criteria:

* Skeletal Class III orthognathic surgery patients
* adults (age above 18 years)
* agreement to perform orthognathic surgery
* agreement to undergo all of the necessary procedures determined by the multidisciplinary team

Exclusion Criteria:

* previous orthognathic surgery
* previous head and neck surgery
* neurologic and/or systemic diseases
* facial trauma
* syndromes
* cognitive impairment
* communication and hearing deficits

Primary outcomes:
measure: Evidence of clinical improvement in mastication after oral-motor rehabilitative program
timeFrame: within the first year after surgery (plus or minus 2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clinicas, University of São Paulo
Study officials:
affiliation: School of Medicine, University of São Paulo
name: Claudia RF Andrade, Professor
role: STUDY_CHAIR
affiliation: School of Medicine, University of São Paulo
name: Laura D Mangilli, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000449: Behavior and Naltrexone Treatment for Alcoholics
Official title: Coping, Exposure, and Naltrexone Treatment With Alcoholics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 1999-11-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The study's purpose is to improve alcoholism treatment by investigating the combined effectiveness of a psychotherapy (Coping Skills Training and Cue Exposure Treatment - CSTCET) with naltrexone in a randomized clinical trial. Individuals will receive 2 weeks of CSTCET or a control treatment as inpatients followed by 12 consecutive weeks of receiving either naltrexone or placebo as outpatients. Followups at 24, 48, and 72 weeks after treatment is completed.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for alcohol dependence.

Exclusion Criteria:

* Current diagnosis of dependence on other substances except nicotine.
* A history of psychosis or current psychotic symptoms.
* Current suicidality, homocidality, or psychiatric symptoms that require additional medication.
* Current use of disulfiram (Antabuse).
* Evidence of significant cerebral, renal, thyroid, or cardiac disease.
* History of opioid abuse in the previous year.
* History of cirrhosis, hepatocellular disease, or elevated bilirubin.
* Females who are pregnant, nursing, or not using a reliable method of birth control.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University, Center for Alcohol and Addiction Studies
state: Rhode Island
Study officials:
References:
Clinical trial NCT02694549: CaveoVasc System - a New Femoral Vascular Access and Closure Device
Official title: Prospective, Single Arm Study to Assess the Performance and Safety of CaveoVasc System for Femoral Vascular Access and Closure Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Catheterization Via a Femoral Sheath ≤ 6Fr
Keywords: Vascular Closure Devices
Catheterization Closure Devices
Vascular Access Devices
Lead sponsor: CaveoMed GmbH
Sponsor class: INDUSTRY
Collaborators: name: MedPass International
First posted: 2016-02-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the performance and safety of the CaveoVasc® System for femoral vascular access and for prevention of bleeding from the femoral artery puncture site.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Patients eligible for a non-emergent diagnostic or interventional catheterization via a femoral sheath of less or equal 6Fr
* In the investigator's opinion, the patient is suitable for the CaveoVasc® System , conventional hemostasis techniques and participation in an investigational trial.
* Understand and sign the study specific written informed consent form.

Exclusion Criteria:

* Patients with significant anemia (hemoglobin \<10g/DL, Hct\<30).
* Patients with a baseline INR \> 1.5
* Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance \< 30 mL/min, platelets count \< 100,000 mm3), patients with chronic use of vitamin K antagonists, direct thrombin inhibitors or oral factor Xa antagonists
* Severe concomitant disease with life expectancy below 12 months
* Uncontrolled systemic hypertension
* Patients who are immunocompromised.
* Patients who need a puncture needle longer than 8 cm due to morbidity obesity
* Active systemic or cutaneous infection or inflammation
* Prior arterial surgery in abdomen and/or lower extremities
* Cardiogenic shock
* Patients who are known to be pregnant or lactating.
* Patients having a complication(s) at the femoral artery access site pre-sheath removal including hematoma, pseudoaneurysm, or arterio-venous fistula.
* Prior femoral vascular surgery or vascular graft in region of access site.
* Documented chronic peripheral arterial insufficiency preventing the use of the femoral technique
* Patients who are currently participating in another clinical trial of an investigational drug or device that has not concluded the follow-up period.
* Patients with known allergy to components of the device.
* Patients who cannot adhere to or complete the investigational protocol for any reason

Primary outcomes:
measure: Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE).
timeFrame: 30 days
measure: Primary Performance Endpoint
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Safety Endpoint
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04888949: A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)
Official title: An Phase2 Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: SARS-CoV-2 Infection( COVID-19 )
Lead sponsor: Rohto Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-17
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.

Detailed description: Patients with Severe Pneumonia caused by SARS-CoV-2 infection are enrolled to the study. Adipose-derived mesenchymal stem cells (AD-MSCs) are administered once a week, total four times intravenously. Safety and efficacy of AD-MSCs are evaluated for 12 weeks after first administer.

Eligibility criteria: Inclusion Criteria:

* SARS-CoV-2 infection is confirmed on antigen test or PCR test
* Pulmonary infiltrative shadow is confirmed on chest X-ray test
* PaO2/FiO2 \<=200mmHg at the time of screening

Exclusion Criteria:

* Continue treatment for Pneumonia before SARS-CoV-2 infection
* SOFA score \>= 15
* Infection type on DIC diagnosis criteria \>= 4
* Deep Venous Thrombosis

Primary outcomes:
measure: Ventilator Free Days
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
affiliation: Rohto Pharmaceutical Co., Ltd.
name: Okawa Sumito
role: STUDY_DIRECTOR
References:
Clinical trial NCT00120549: Study of Assisted Hatching of Cleavage Stage Embryos
Official title: Prospective Randomized Trial of Assisted Hatching of Cleavage Stage Embryos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Assisted Hatching
Cleavage Stage, Ovum
Embryo Transfer
Pregnancy
Embryo Implantation
Lead sponsor: Shady Grove Fertility Reproductive Science Center
Sponsor class: OTHER
First posted: 2005-07-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine if assisted embryo hatching can improve pregnancy rates for good prognosis patients undergoing in vitro fertilization (IVF) with day 3 embryo transfer.

Detailed description: Assisted hatching is a procedure in which a hole is made in the hard covering of a developing embryo to allow the embryo to hatch more easily from this shell. This procedure is sometimes used before transferring embryos to patients after in vitro fertilization (IVF) in an attempt to improve resulting pregnancy rates. Assisted hatching has been shown to improve outcomes among certain groups of patients, such as older patients or patients with a history of IVF treatment and embryo transfer without success. Whether this procedure could benefit the broader patient population remains unclear. The purpose of this study was to evaluate potential benefits of assisted hatching for good prognosis patients who would not typically be treated with assisted hatching under current standard protocols. Pregnancy rates were compared between good prognosis patients undergoing IVF with day-3 embryo transfer with or without assisted hatching of the transferred embryos.

Eligibility criteria: Inclusion Criteria:

* IVF patients with day 3 embryo transfer
* Maximum age of 39 years
* Maximum FSH 9 mIU/ml
* Maximum E2 75 pg/ml
* Ovulatory menstrual cycles
* Good embryo quality

Exclusion Criteria:

* Diagnosis of diminished ovarian reserve, polycystic ovarian syndrome, uterine or egg factor infertility
* More than one previous unsuccessful IVF cycle

Primary outcomes:
measure: Clinical pregnancy (with fetal cardiac activity) at 5 to 6 weeks after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Shady Grove Fertility Reproductive Science Center
state: Maryland
Study officials:
affiliation: Shady Grove Fertility Reproductive Science Center
name: Eric A Widra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02610049: Trial of Art Therapy During Cognitive Processing Therapy for PTSD
Official title: Randomized, Controlled Trial of Art Therapy During Cognitive Processing Therapy for PTSD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Stress Disorder, Post-Traumatic
Keywords: PTSD
Lead sponsor: Hampton VA Medical Center
Sponsor class: FED
First posted: 2015-11-20
Enrollment: 31
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: This is a randomized, controlled trial of adjunctive art therapy during cognitive processing therapy for PTSD.

Detailed description: The objective of this study is to examine the effects of art therapy with combat veterans who have PTSD and to measure if it reduces symptoms more than verbal Cognitive Processing Therapy (CPT) alone. This study will incorporate art processes and materials into an already established protocol of CPT in order to create a sense of safety for veterans in beginning therapy, and access the nonverbal parts of the trauma in order to process it. Art-making will be used to help veterans address trauma and integrate who they were before the trauma with who they are currently. It will assist in addressing the grief and loss caused by combat, and will be used as veterans begin building a worldview and self-concept that are not filled with trauma and war. It is hypothesized that the veterans who receive art therapy with CPT will show a significantly greater decrease in PTSD symptoms than those who receive only CPT.

Eligibility criteria: Inclusion Criteria:

* PCL-M initial score \>= 50;
* Both genders,
* All ethnicities,
* Veterans in treatment for PTSD,

Exclusion Criteria:

* No active substance use disorder,
* No active suicidal or homicidal ideation,
* No psychosis

Primary outcomes:
measure: PTSD Symptoms assessed by PCL-M score
timeFrame: 8-12 weeks
measure: Depression Symptoms assessed by Beck Depression Inventory-II
timeFrame: 8-12 weeks
Secondary outcomes:
measure: Treatment Satisfaction assessed by Likert scale
timeFrame: 8-12 weeks
measure: Treatment completion assessed by dropout rate
timeFrame: 8-12 weeks
Other outcomes:
Locations:
city: Hampton
country: United States
facility: Hampton VA Medical Center
state: Virginia
Study officials:
affiliation: IRB Chair
name: Barbara Cross, Ph.D., FNP
role: STUDY_CHAIR
References:
Clinical trial NCT06733506: A Pilot Study to Evaluate Skin Swabbing with Chlorhexidine to Prevent Skin and Soft Tissue Infections Among People Who Inject Drugs
Official title: A Pilot Study to Evaluate the Acceptability and Feasibility of Skin Swabbing with Chlorhexidine Gluconate to Prevent Skin and Soft Tissue Infections Among People Who Inject Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Use Disorder
Infection Control and Prevention
Injection Drug Use
Keywords: opioid use disorder
injection drug use
skin and soft tissue infection
chlorhexidine
people who inject drugs
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: All participants received a brief safer-injection training (Intervention A), which consisted of a one-to-one private discussion with a healthcare provider lasting \~5-10 minutes to encourage skin swabbing prior to drug injection. In addition, participants randomized to a Chlorhexidine swab group received a 2-week supply of chlorhexidine swabs which they were instructed to use for 2 weeks, while those randomized to a usual care condition were supplied with a 2-week supply of standard care isopropyl alcohol swabs.
Primary purpose: PREVENTION

Brief summary: The study examined chlorhexidine gluconate (CHG) swabs as a skin disinfectant in combination with a single-session safer injection training to prevent skin and soft tissue infections (SSTI) in people who inject drugs.

Detailed description: Skin and soft tissue infections (SSTI) are a serious and preventable complication of intravenous drug use, yet few interventions have been developed to reduce SSTI in people who inject drugs (PWID). This study tested two interventions to reduce SSTI in PWID: 1) a single-session behavioral intervention to inculcate skin swabbing behaviors, and 2) chlorhexidine swabs to be used as for cleaning the skin prior to injecting.

Eligibility criteria: Inclusion Criteria:

* Self-report intravenous drug use within past 30 days

Exclusion Criteria:

* None

Primary outcomes:
measure: Skin swabbing frequency
timeFrame: 2 weeks after randomization
Secondary outcomes:
measure: Swab acceptability
timeFrame: 2 weeks after randomization
measure: Safer injection knowledge and behaviors
timeFrame: 2 weeks after randomization
Other outcomes:
measure: Skin and soft tissue infection
timeFrame: 2 weeks after randomization
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT06191406: Five-year Changes in Patients With Chronic Stroke
Official title: Five-year Changes in Physical and Cognitive Function in Patients With Chronic Stroke: a Preliminary Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Stroke
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients whose physical activity was assessed in 2018 - 2019 (Previous research study: Validity and Test-Retest Reliability of a Thai Stroke Physical Activity Questionnaire) which the population was stroke patients, aged ≥ 18 years with onset \> 3 months. The study population is composed of patients who have achieved a compliance rate of more than 70% with the accelerometer within 1 week, total 50 people.

Brief summary: Objective of the study:

* To determine changes in physical and cognitive function in patients with chronic stroke over 5 years
* To determine whether there are differences in physical and cognitive function in chronic stroke patients with different baseline levels of physical activity


Eligibility criteria: Inclusion Criteria:

- Stroke patients whose physical activity was assessed in 2018 - 2019 (Previous research study)

Exclusion Criteria:

- None

Primary outcomes:
measure: 6-minute walk test
timeFrame: 5 years
measure: 10-meter walk test
timeFrame: 5 years
measure: Thai MMSE
timeFrame: 5 years
Secondary outcomes:
measure: Global quality of life
timeFrame: 5 years
measure: Short FES-I
timeFrame: 5 years
measure: Fatigue assessment scale
timeFrame: 5 years
measure: Barthel index
timeFrame: 5 years
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital Khon Kaen University
Study officials:
References: