louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04903171: Effects of Enriched Gardens in Nursing Home Residents With Dementia
Official title: Effects of Enriched Gardens on Cognition and Independence of Nursing Home Residents With Dementia: a Cluster-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer
Enriched garden
Enriched environment
Dementia
Cognitive impairment
Functional autonomy
Lead sponsor: RIVAGES
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 130
Sex: ALL
Minimum age (years): 75
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparing the effect of the frequentation of an enriched garden vs sensory conventional garden by nursing home residents with Alzheimer disease. The effects will be evaluated as regards to cognitive impairment (MMSE), autonomy (ADL) and prevention of falls (Unipodal stance and UpandGo Test)

Detailed description: The cluster controlled trial is conducted over a six months period after recruitment of residents from 4 different nursing homes in France. The participants are distributed into 3 groups. One group does not receive incentive from carers to visit any garden, the second group receives incentives to visit regularly a conventional sensory garden and the third group receive incentives from carers to visit regularly an enriched garden. The study is conducted over a period of 6 months. All participants are giving consent to the study. They will be evaluated before and after over 4 different tests. MMSE (Mini Mental Status Examination) for cognitive impairment, ADL (Activity for day Living) for functional autonomy, TUG (Test up and Go) and Unipodal Stance for prevention of falls.

Eligibility criteria: Inclusion Criteria:

* Give consent
* Ability walking alone
* Alzheimer's disease

Exclusion Criteria:

* No dementia
* Severe dementia
* Severe behavioural disorder
* Inability to walk alone

Primary outcomes:
measure: Change in global cognitive function
timeFrame: 6 MONTHS
measure: Change in functional independence
timeFrame: 6 MONTHS
Secondary outcomes:
measure: Change in gait ability
timeFrame: 6 MONTHS
measure: Change in balance
timeFrame: 6 MONTHS
Other outcomes:
Locations:
city: Ivry-sur-Seine
country: France
facility: Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université
state: Val De Marne
Study officials:
References:
Clinical trial NCT04033471: Combined Epidural Morphine and Midazolam on Postoperative Pain
Official title: Effect of Epidural Morphine and Midazolam on Postoperative Painin Patients Undergoing Major Abdominal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Postoperative Pain
Keywords: epidural, morphine, midazolam, acute postoperative pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: epidural bupiviacain
Primary purpose: TREATMENT

Brief summary: this study aim to Compare the effect of preoperative Epidural Midazolam, Morphine and their combination in postoperative pain relief and total morphine consumption.

Detailed description: Major abdominal surgeries with abdominal incisions lead to severe abdominal pain, which if treated inadequately, can cause shallow breathing, atelectasis, retention of secretions and lack of cooperation in physiotherapy. This increases the incidence of post-operative morbidity and leads to delayed recovery.Epidural anesthesia is safe and inexpensive technique with the advantage of providing surgical anesthesia and prolonged postoperative pain relief. It also an effective treatment of operative pain blunts autonomic, somatic and endocrine responses. Morphine and midazolam can be used as adjuvant to bupivicain to reduced the postoperative pain

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients scheduled for major abdominal cancer surgeries

Exclusion Criteria:

* patients with known allergy to the study drugs,
* significant cardiac, respiratory, renal or hepatic disease,
* drug or alcohol abuse,
* psychiatric illness that would interfere with perception and assessment of pain.

Primary outcomes:
measure: time to first request of analgesia
timeFrame: 1st 48 hours postoperative
Secondary outcomes:
measure: the cumulative consumption of morphine in the 1st 48h postoperatively
timeFrame: 1st 48 hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT04346771: The Effect of Emotional Working Memory Training on Reducing Depressive Symptoms
Official title: The Effect of Emotional Working Memory Training on Reducing Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Keywords: Depression
Cognitive control
Emotion
Working memory
Cognitive bias
Emotional regulation
Lead sponsor: Hunan Normal University
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 31
Sex: ALL
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether emotional working memory training and attention bias modification training are an effective neurobehavioral therapy to improve depressive symptoms.That is whether emotional working memory training is superior to attention bias modification training or not in reducing depressive symptoms over 1 year after training.

Detailed description: Attentional bias has been theorized to play a critical role in the onset and maintenance of depression. Attentional bias modification training (ABMT), an experimental paradigm that uses training to induce adaptive attentional bias, was developed to test the causal model and this has therapeutic implications in depression.To test the effect of ABMT on treatment of depressive symptoms, a randomized, double-blind, placebo and blank controlled trial is conducted in college students who are experiencing mild-to-severe symptoms of depression.

Eligibility criteria: Inclusion Criteria:

Meet the major and mild depression disorder's criteria

Exclusion Criteria:

bipolar disorder, schizophrenia or organic mental disorder; any concurrent psychotherapy; any concurrent psychotropic medication.

Primary outcomes:
measure: Changes of depressive symptoms
timeFrame: pre-training, post-training(2 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month( booster pre-training), 4-month (booster post-training), 5-month,6-month,12-month after post-training)
Secondary outcomes:
measure: Changes of self-reported depressive symptoms
timeFrame: pre-training, post-training(2 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month( booster pre-training), 4-month (booster post-training), 5-month,6-month,12-month after post-training)
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Psychology, Hunan Normal University
state: Hunan
Study officials:
affiliation: Department of Psychology, Hunan Normal University
name: Wenhui Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06153771: Description of Changes in NIRS as a Function of Ductus Arteriosus Status in Very Premature Babies Born Before 32 WG at the DIJON University Hospital
Official title: Description of Changes in NIRS as a Function of Ductus Arteriosus Status in Very Premature Babies Born Before 32 WG at the DIJON University Hospital: Exploratory Prospective, Monocentric, Observational, Descriptive Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extremely Premature Newborn (Born Before 32 Weeks' Gestation)
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 140
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Extremely premature newborn (born before 32 weeks' gestation)

Brief summary: Monitoring patent ductus arteriosus is currently performed using echocardiography, an operator-dependent examination which requires holding the child on their back and which is potentially time-consuming. This test is usually carried out on days 2, 4 and 7 after birth.

NIRS (near-infrared spectroscopy) is a non-invasive method of monitoring tissue oxygen saturation using infrared light.

The aim of the study was to investigate an association between cerebral and renal NIRS data and ductus arteriosus status obtained by echocardiography.


Eligibility criteria: Inclusion Criteria:

* Parent who has agreed to participate in the study
* Very premature newborn (born before 32 weeks' gestation)
* Hospitalised in the Neonatal Intensive Care Unit at Dijon University Hospital
* Before 48 hours of life

Exclusion Criteria:

* Newborn with congenital heart disease
* Newborn with a congenital renal anomaly
* Newborn with polymalformative syndrome
* Newborn with a skin anomaly
* Newborn with severe circulatory failure unrelated to the ductus arteriosus

Primary outcomes:
measure: The ultrasound status of the ductus arteriosus
timeFrame: On day 2, day 4 and day 7 of life
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01341171: The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Proteins
Official title: Platelet Modulation in the Control of Angiogenesis: The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Activation and Angiogenic Proteins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: tamoxifen
aromatase inhibitors
breast cancer
platelets
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2011-04-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women using tamoxifen or aromatase inhibitor therapy for greater than 6 months

Brief summary: Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy.


Eligibility criteria: Inclusion Criteria:

* women routinely taking tamoxifen or aromatase inhibitor therapy as prescribed by their oncologist

Exclusion Criteria:

* Use of heparin, warfarin

Primary outcomes:
measure: Angiogenic Protein levels
timeFrame: following 6 months of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Chris E Holmes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04307771: Effectiveness of Smart Phone Application in Improving Oral Health Behaviours of Adolescents
Official title: Effectiveness of Smart-phone App in Improving Oral-Health Knowledge & Practices Among School Going Adolescents: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Hygiene
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 152
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study would be a first step towards mobile-health associated Sustainable Development Goals by World Health Organization, as there are no mobile-health driven oral health activities in Karachi, Pakistan. Concurrently, it will help in improving knowledge and practices of adolescents towards general dental hygiene as this age is crucial for the prognosis of newly erupted permanent teeth. This would help in preventing chronic problems of adulthood. This will also help in reducing the number of days missed from school, increasing self-confidence of individuals as bad breath has a negative impact on one's self-esteem and confidence, giving a positive sense of aesthetics and will also keep in check over-all body health.Persistent unmaintained dental hygiene also overburdens families due to its high-maintenance outcomes like caries and early tooth loss. Dental treatment is considered as fourth most expensive treatment in developing countries . According to recent studies, households of low and middle income countries are at a higher risk of falling below the poverty line due to expenditure on dental problems. Such a simple intervention making use of modern-day technology would enable adolescents to keep their oral health in check and would prevent them from facing consequences of poor oral health.


Eligibility criteria: Inclusion Criteria:

* Adolescent of age between 14-19 years
* Having access to an android device at home; either personal or parents'
* Would be able to use the app twice every day- Having access to Wi-Fi at home- for downloading the app.
* Willing to give consent
* participate in the study till the follow-up period.

Exclusion Criteria:

* - Having mixed dentition
* Undergoing orthodontic treatment
* Should have no serious existing gingival or dental problems\* that could hinder calculation of plaque or gingival scores
* Should have no serious existing gingival or dental problems\* that could hinder routine brushing.
* Taking medications that have effect on gingival/dental health
* Having intrinsic or extrinsic enamel defects/ tooth malformations
* Having more than 1/3rd of the tooth stained due to areca nut chewing, smokeless tobacco (gutkha) chewing or cigarette smoking.

Primary outcomes:
measure: Knowledge scores
timeFrame: 6 weeks
measure: Practice scores
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Aga Khan University
name: Shafquat Rozi, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01593371: Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients
Official title: Comparing Effects of Metformin and Pioglitazone on Regulation of Serum Adipokines in Newly Diagnosed Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Adipokines
leptin
chemerin
omentin
metformin
type 2 diabetes mellitus
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 98
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Oral hypoglycemic agents encompass the mainstay of treatment in the majority of patients with type 2 diabetes. Thiazolidinediones (such a pioglitazone) and Biguanides (such as metformin), are two major groups of hypoglycemic medications that while function via different pathways, are both effective in short- and long-term glycemic control . These medications diminish or at least delay long term micro- and macrovascular complications associated with prolonged insulin resistance although at different rates. The mechanisms by which this aim is achieved, nevertheless, remains largely unclear. With adipokines playing a key role in development of both insulin resistance and atherosclerosis, oral hypoglycemic agents might regulate these substances by direct and indirect routes.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria (2011) for diagnosis of diabetes

Exclusion Criteria:

* previous intake of oral hypoglycemic agents for treatment of diabetes or other hyperglycemia associated conditions
* intake of glucocorticoids in the past one year
* major illnesses of heart, lung, kidney, and liver.

Primary outcomes:
measure: Serum concentrations of omentin
timeFrame: 12 weeks
measure: Serum concentrations of leptin
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Alireza Esteghamati, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esteghamati A, Ghasemiesfe M, Mousavizadeh M, Noshad S, Nakhjavani M. Pioglitazone and metformin are equally effective in reduction of chemerin in patients with type 2 diabetes. J Diabetes Investig. 2014 May 4;5(3):327-32. doi: 10.1111/jdi.12157. Epub 2013 Oct 22.
Clinical trial NCT00787371: Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)
Official title: Study to Confirm Dose Response With PegIntron (SCH 54031) Monotherapy in Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Hepatitis C
Keywords: alanine transaminase
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-11-07
Enrollment: 69
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: In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore, the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW) PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese patients with chronic hepatitis C.


Eligibility criteria: Inclusion Criteria:

Patients with chronic hepatitis C patients (CHC) who met all of the following criteria:

* At least 20 years of age and willing to sign an informed consent
* Patients who can practice contraception
* Patients who are classified either as relapsers or non-responders.
* Weight between 45 and 100 kg
* Patients willing to be hospitalized for 3 days after the start of treatment
* Patients with positive HCV-RNA
* Serum ALT level: Over 60 IU/L, equal to or less than 150 IU/L
* Neutrophil count: equal to or more than 1,200 /mm\^3
* Platelet count：equal to or more than 100,000/mm\^3

Exclusion Criteria:

* Patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.

Primary outcomes:
measure: Percentage of patients who achieve normalization of ALT in each treatment group
timeFrame: Measured at the end of 12 weeks of treatment or at discontinuation.
Secondary outcomes:
measure: Safety: adverse events, adverse reactions, laboratory test result (hematology, blood biochemistry and thyroid function test)
timeFrame: Measured between when the patient signs the informed consent form and the end of post-treatment follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00520871: The Water-Blueberry Study
Official title: The Effect of Blueberry Juice on Cardiovascular Risk Factors, and Markers of Antioxidant Status, Oxidative Stress Status and Inflammation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cardiovascular Disease
Keywords: Cardiovascular disease
Blueberruy
Antioxidants
Oxidative stress
Inflammation
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Ullevaal University Hospital
First posted: 2007-08-27
Enrollment: 62
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We will study the effect of supplementation of 1 L blueberry juice to participants with at least one elevated cardiovasculat risk factor.

Detailed description: Participants with at leat one elevated cardiovacsular risk factor, as defined as systolic blood pressure between 140 and 165 mmHg, diastolic blood pressure between 90 and 105 mmHg, low density lipoprotein (LDL) cholesterol ≥3.4 mmol/L, total/high density lipoprotein (HDL) cholesterol ratio \>4 or smoking a minimum of 3 cigarettes daily.

Subjects were randomized to two groups, where the blueberry group were supplemented with 1 L blueberry juice per day for four weeks. The control group consumed an equal amount of water.

Clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation were measured in blood samples before amd after the intervention period.

Eligibility criteria: Inclusion Criteria:

* 30-70 years for men and 45-70 years or at least 12 months postmenopausal for women
* at least one elevated cardiovascular risk factor, defined as systolic blood pressure between 140 and 165 mmHg, diastolic blood pressure between 90 and 105 mmHg, low density lipoprotein (LDL) cholesterol ≥3.4 mmol/L, total/high density lipoprotein (HDL) cholesterol ratio \>4 or smoking a minimum of 3 cigarettes daily.

Exclusion Criteria:

* clinically recognized chronic diseases as impaired renal function, diabetes mellitus, cardiovascular disease, liver or gastrointestinal disease or cancer within the last 5 years
* use of lipid-lowering drugs, diuretics or hormone replacement therapy for women
* Subjects with a body-mass index ≥31
* with a alcohol consumption above 3 units/day for men and 1 unit/day for women
* blood donation within the last six months

Primary outcomes:
measure: Primary endpoints are cardiovascular risk factors
timeFrame: 4 weeks
Secondary outcomes:
measure: Secondary endpoints are additional clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Oslo
name: Rune Blomhoff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ullevaal University Hospital
name: Serena Tonstad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Anette Karlsen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03265171: A Single-patient Study of Repeat-dose Administration of Prometic Plasminogen (Human) Intravenous
Official title: A Single-patient Study of Repeat-dose Administration of ProMetic Plasminogen (Human) Intravenous Infusion in an Adult With Hypoplasminogenemia
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Hypoplasminogenemia
Lead sponsor: Prometic Biotherapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cedars-Sinai Medical Center
name: Vanderbilt University Medical Center
name: Indiana Hemophilia &Thrombosis Center, Inc.
First posted: 2017-08-29
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: These are single-patient studies with repeat-dose administration of ProMetic Plasminogen IV infusion in one adult and one child with hypoplasminogenemia. These patients are under treatment to address wound healing and obstructions.


Eligibility criteria: Inclusion Criteria:

* Patient has provided informed consent.
* Patient has a diagnosis of compound homozygous Type 1 plasminogen deficiency as evidence by ligneous conjunctivitis since birth as well as involvement of the conjunctiva, nasopharynx, gingiva, tracheobronchial tree, gastrointestinal tract, and urinary tract.

Exclusion Criteria:

* Not applicable

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: