louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05256680: Gardening Activities for the Elderly Psychological Well-Being and Depression
Official title: The Effect of Gardening Activities Applied to The Elderly in Nursing Home on Psychological Wellness and Depression: A Single Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Person
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose of the Study: This research will be conducted to determine the effects of gardening activities applied to the elderly in nursing homes on psychological well-being and depression.

Research Hypotheses H0: Gardening activities applied to the elderly in the nursing home do not affect the psychological well-being of the elderly.

H1: Gardening activities applied to the elderly in nursing homes increase the psychological well-being of the elderly.

H0: Gardening activities applied to the elderly in the nursing home do not affect the depression level of the elderly.

H1: Gardening activities applied to the elderly in nursing homes reduce the depression level of the elderly.

Detailed description: This study was planned as a single-blind randomized controlled experimental study.

Eligibility criteria: Inclusion Criteria:

* Staying in a nursing home for at least 3 months,
* Does not have a physical disability that may hinder gardening activities,
* No vision or hearing loss that may hinder gardening activities,
* Open to communication and cooperation,
* The elderly who volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Having a serious medical disability (such as paralysis, Parkinson's),
* Having a serious psychiatric diagnosis,
* Severely demented and
* The elderly who do not want to continue the research will be excluded from the research.

Primary outcomes:
measure: Psychological Well-Being Scale
timeFrame: 12 weeks
measure: Geriatric Depression Scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Hacer GOK UGUR
state: Altınordu
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Hacer GÖK UĞUR, Assoc. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Şeyma ŞENGÜR, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05196880: Biofilm Correlation and Validation
Official title: A Prospective, Single-blind, Clinical Evaluation of the MolecuLight DX in Combination With Biofilm Based Wound Care for the Identification of Biofilm Containing Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Infection
Lead sponsor: MolecuLight Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female subjects presenting with acute or chronic wounds

Brief summary: This is a prospective, single-blind, controlled trial. There are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (CSB+/CSB-) are allocated in each arm. The primary objective is to evaluate the diagnostic accuracy of MolecuLight fluorescence in identifying biofilm as validated by gold standard SEM imaging.


Eligibility criteria: Inclusion Criteria:

1. Patients presenting with acute or chronic wounds
2. 18 years or older
3. Willing to consent

Exclusion Criteria:

1. Treatment with an investigational drug within 1 month of enrolment
2. Any contra-indication to regular wound care
3. Inability or unwillingness to consent

Primary outcomes:
measure: Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: The Mayer Institute
state: Ontario
Study officials:
References:
Clinical trial NCT00156780: Phase 1 Safety and Pharmacokinetic Study of AI-700 in Patients With Diminished DLCO and COPD and/or CHF
Official title: A Phase 1, Double Blind, Crossover, Placebo-Controlled, Dual-Injection, Safety and Pharmacokinetic Study of AI-700 in Patients With Diminished DLCO and Chronic Obstructive Pulmonary Disease (COPD) and/or Congestive Heart Failure (CHF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Keywords: ultrasound contrast agent
pharmacokinetics
congestive heart failure
chronic obstructive pulmonary disease
safety
Lead sponsor: Acusphere
Sponsor class: INDUSTRY
First posted: 2005-09-12
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: ECT

Brief summary: This study was conducted to evaluate the safety and pharmacokinetics of an echocardiographic contrast agent, AI-700, in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and/or congestive heart failure (CHF).

Detailed description: In ongoing clinical trials, AI-700 is currently being evaluated for its value to provide enhanced echocardiography to detect CAD. The patient population is comprised of those patients who have chest pain and are being evaluated for inducible ischemia. This population may include patients with compromised pulmonary function due to COPD or CHF. This study was to evaluate the safety of AI-700 in these patients.


Primary outcomes:
measure: To determine the safety of AI-700 in patients with diminished pulmonary diffusing capacity (DLCO) and moderate or severe COPD and/or CHF
measure: To determine the pharmacokinetics of perfluorocarbon gas in blood following an intravenous injection of AI-700 in this patient population
Secondary outcomes:
Other outcomes:
Locations:
city: Watertown
country: United States
facility: Acusphere, Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT04136080: The Effect of Increasing the Mean Arterial Pressure on the Microcirculation and the Prognosis of Patients With Septic Shock
Official title: The Effect of Increasing the Mean Arterial Pressure on the Microcirculation and the Prognosis of Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 752
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: Background： The mean arterial pressure（ MAP） is a key pressure index to improve tissue perfusion. At present, there are no surprising results of large-scale clinical studies on sublingual microcirculation. The changes of sublingual microcirculation were more severe in septic shock non-survivors than survivors. Purpose： This study is mean to increase the MAP in septic shock patients whether with chronic hypertension or not, so as to observe the change of the microcirculation and prognosis. Method： This is a single-center, randomized, prospective cohort study. Eligible patients will be allocated into chronic hypertension or denying chronic hypertension group. These patients will be treat with vasopressors to maintain MAP at 90±5 mmHg and 70±5 mmHg. Outcome： The 28-day all-cause mortality, the 90-day all-cause mortality, the 28-day without organ dysfunction days, the Changes of sublingual microcirculation, SOFA， APACHE-Ⅱ score Will be recorded.


Eligibility criteria: Adult patients (≥18 years) admitted to The Critical Medicine Departments Three of Fujian Provincial Hospital will be considered eligible，who are presence of infection or suspected infection，requiring mechanical ventilation. At the same time, without the vasopressors the MAP would be less than 65mmHg, and the blood lactic acid level is higher than 2mmol/l.

Primary outcomes:
measure: the 28-day all-cause mortality and Changes of sublingual microcirculation
timeFrame: 28 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03639480: Study to Evaluate the Safety and Efficacy of CJ-30061 in Hypertensive Patients With Hyperlipidemia
Official title: A Double-blind, Randomized, Multi-center Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of CJ-30061 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Atorvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-21
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of CJ-30061 compared with amlodipine/valsartan combination therapy and valsartan/atorvastatin combination therapy in hypertensive patients with hyperlipidemia


Eligibility criteria: Inclusion Criteria:

* Aged between 19 and 74 years
* Diagnosed with essintial hypertension(average siSBP ≥ 140mmHg) accompanying hyperlipidemia(LDL-C ≥ 100mg/dL) and were on or off treatment at Visit 1(screening)
* Decided to participate in the study and provided signed informed consent form voluntarily after receiving explanation of the objectives, methods, and effects of the study

Exclusion Criteria:

* Severe hypertension defined as average siDBP ≥ 120mmHg or average siSBP ≥ 200mmHg at Visit 1(screening)
* The difference in BPs between those measured at the reference arm at Visit 1(screening) was ≥ 10mmHg for siDBP or ≥ 20mmHg for siSBP
* LDL-C \> 250mg/dL or TG ≥ 400mg/dL at Visit 1(screening)
* Secondary hypertension
* Diagnosis of type 1 diabetes mellitus(DM) or uncontrolled DM(patients on insulin therapy or patients with HbA1c ≥ 9%)

Primary outcomes:
measure: Change in siSBP
timeFrame: baseline and 8 weeks
measure: Change in LDL-C
timeFrame: baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Duk-Hyun Kang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02765880: Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders
Official title: Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Fondation pour la Recherche Médicale (FRM)
First posted: 2016-05-09
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main purpose of the study is to examine to which extent abnormalities in the dynamics of neural activities observed in patients with psychosis is related to difficulties at ordering simple visual stimuli and/or personal events.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60 years
* Affiliation to a social security insurance
* Written consent given
* Only for patient : DSM criteria for schizophrenia or bipolar disorder

Exclusion Criteria:

* Addiction problem
* Invalidating visual sensory problems
* Neurological history
* Pregnancy or breastfeeding
* Legal safeguard
* Participation in another clinical trial
* Contraindication to MRI

Primary outcomes:
measure: Abnormalities in connectivity during order judgement tasks will be taken as seeds to check whether they account for abnormalities in connectivity at rest, by means of mathematic modelization
timeFrame: After study completion (2 years)
Secondary outcomes:
measure: Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during rest.
timeFrame: After study completion (2 years)
measure: - Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during time ordering.
timeFrame: After study completion (2 years)
measure: Comparison of patients with schizophrenia vs. bipolar disorder
timeFrame: During fMRI and EEG sessions
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de psychiatrie
Study officials:
affiliation: Strasbourg's University Hospitals - INSERM 1114 Unit
name: Anne GIERSCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01519180: Antro-pyloro-duodenal Motility in Idiopathic Gastroparesis
Official title: Study of the Antro-pyloro-duodenal Motor Dysfunction in Idiopathic Gastroparesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroparesis
Keywords: gastroparesis
gastric emptying
antro-duodenal manometry
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Idiopathic gastroparesis and healthy volunteers

Brief summary: Impaired gastric emptying may cause dyspeptic symptoms including nausea, vomiting and even nutritionnal impairment. Delay in gastric emptying may result from antro-pyloro-duodenal motility impairement.

Detailed description: The aim of this study is therefore to measure antro-pyloro-duodenal motor activity in patients with idiopathic gastroparesis.

Eligibility criteria: Inclusion Criteria:

* Idiopathic gastroparesis or healthy volunteers
* Idiopathic gastroparesis must have delayed gastric emptying shown using C13 breath test

Exclusion Criteria:

* Diabetic or post-surgical gastroparesis
* Treatment modifying GI motility (prokinetics, opioids...)
* Parkinson or neurologic disease
* Evoluting inflammatory process or neoplasia
* Treatment modifying coagulation
* Patients not affiliated to the French healthcare insurance

Primary outcomes:
measure: antro-pyloro-duodenal pressure
timeFrame: 3h
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Service de Physiologie
state: Haute normandie
Study officials:
affiliation: University Hospital, Rouen
name: Guillaume Gourcerol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04240080: Impact of Near-Infrared Vein Mapping on Outcomes and Satisfaction After Botox/Filler Treatment
Official title: The Impact of Near-Infrared Vein Mapping on Outcomes and Satisfaction After Botox/Filler Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wrinkle
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers are studying how vein mapping impacts patient outcomes and satisfaction after facial injection procedures.

Detailed description: Facial Botox/filler injections carry risk of puncturing superficial veins, leading to bruising and pain. Our study will investigate the utility of non-invasive vein imaging (specifically near-infrared light reflection) on the incidence of pain/bruising/hematoma and patient satisfaction after facial injections.

The current standard of care for facial injection procedures does not involve any modality of facial venous mapping. Vein mapping is a non-invasive, simple task that takes very little time to conduct. One risk is patient time, however maximum extra time needed will be 5 minutes during the clinical visit. This potential extra time in mind, the benefits far outweigh the risks.

Two cohorts of patients will be prospectively compared following randomization, those who did have pre-procedure venous mapping prior to injection versus those who did not. Data will be analyzed with regard to bruising and swelling following injection, as well as other potential complications such as hematoma or infection, along with patient satisfaction survey information.

Eligibility criteria: Inclusion Criteria:

* Patients pursuing aesthetic/therapeutic facial injection procedures (botox/filler)

Exclusion Criteria:

* Patients undergoing aesthetic facial procedures not requiring needle injection

Primary outcomes:
measure: Patient satisfaction
timeFrame: Approximately 7-10 days following the procedure
Secondary outcomes:
measure: Rate of Bruising/Hematoma
timeFrame: Approximately 7-10 days following the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: William Casey III, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05605080: Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery
Official title: Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Anal Fistula
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 292
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery.

Detailed description: Hemorrhoidectomy and fistulotomy these two types of anal surgery are common surgeries in colon and rectal surgery division in Shuang Ho hospital. For these patients underwent surgical treatment, some surgeons used gauze with Bosmin for hemostasis and analgesia after surgery, and other surgeons used Gelfoam. These choices were often determined by surgeon's personal preference according to their experiences. Shuang Ho hospital has top three quantity of hemorrhoidectomy in Taiwan. So, a randomized controlled trial is conducted to evaluate the difference between hemostatic agents use after anal surgery.

Eligibility criteria: Inclusion Criteria:

* Patients who undergo conventional hemorrhoidectomy or stapled hemorrhonidpexy are include.
* Patients who undergo fistulectomy or fistulotomy are include.

Exclusion Criteria:

* Emergency operation
* Patients with colorectal cancer
* Liver cirrhosis
* Patients with coagulopathy
* Patients with HIV infection

Primary outcomes:
measure: Post-operative pain
timeFrame: 0-7 days
measure: Analgesic agent use
timeFrame: 0-7days
Secondary outcomes:
measure: Incidence of post-operative bleeding
timeFrame: 0-30 days
measure: Incidence of urinary retention
timeFrame: 0-7 days
measure: Incidence of surgical site infection
timeFrame: 0-30 days
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang-Ho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Tung-Cheng Chang, MD, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04431180: Recruit Blood Donors Via SMS During Epidemic of COVID-19 #Second Repeat Trial#
Official title: Recruit Blood Donors Via SMS With Different Contents During Epidemic of COVID-19#Second Repeat Trial#
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Donation
Lead sponsor: Guangzhou Blood Center
Sponsor class: OTHER_GOV
First posted: 2020-06-16
Enrollment: 403535
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The fight against the spread of the 2019-nCoV epidemic has achieved some success in China, but the epidemic is far from over. A key factor making the epidemic under control in China is the government's call for social distance, which has led to few people going out for donation. As a result, the number of blood donors on the streets has been continuing to decline. The first urgent recruitment of blood donors had been implemented during the period from 30 April to 10 May via emergency recruitment SMS . This second repeat trial has been designed to further confirm the results from the the first recruitment by comparing which information extraction frameworks would be more sensitive to blood donors in emergency situations.

Detailed description: Researches has showed that that the information extraction and processing in emergency was different from the normal situation. To understand what information the blood donors are more sensitive to in an environment that may pose a potential threat to themselves, the first urgent recruitment of blood donors had been implemented during the period from 30 April to 10 . This interventional study is the second repeat trail of the first trail. The same with first trail, eligible blood donors in Guangzhou Blood Center has been randomly divided into four groups according to their sociological variables, their interval since last blood donation , their history donation times and the location of their last blood donation. Three groups of donors has been randomly selected as interventional groups, and will receive three kindly of emergency blood donor recruitment SMS respectively. The placebo group donors will only receive a thank-you SMS. One recruitment SMS will emphasize what blood services will do to ensure the safety of blood donors during their donation in 2019-nCoV epidemic,one will shows information about a loss-based framework, while the third one will show information about a benefit-based framework .

Eligibility criteria: Inclusion Criteria:

* Blood donors whose last turning up were between December 10, 2016 to December 10, 2019

Exclusion Criteria:

* Blood donors who were deferral by blood screening result and other situations. Blood donors who have indicated that they would not accept urgent recruitment.

Primary outcomes:
measure: Blood donation rate
timeFrame: 18days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Blood Center
state: Guangdong
Study officials:
References: