louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03373578: Earing Protectors Influence on Newborns Preterm Sleep Pattern
Official title: Comparison of the Preterm Newborn Sleep With and Without the Use of Earmuffs During the "Quiet Time" in a Neonatal Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: sleep;
Infant, Premature;
Polysomnography;
Ear Protective Devices
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2017-12-14
Enrollment: 24
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Preterm newborn sleep deprivation due to medical interventions and environmental characteristics of the Neonatal Intermediate Care Unit (NICU) can increase morbidity and developmental deleterious effects. The aim of this study is to test the effect of earmuffs on sleep pattern of preterm neonates. Prospective, randomized, controlled, crossover study conducted in NICU of two teaching hospitals from São Paulo, Brazil. The effect of earmuffs use was analyzed through polysomnography measurement during four "Quiet times" periods. It was also analyzed sleep related variables during 24 hours of the day. Preterm newborns characteristics and clinical characteristics were also analyzed.


Eligibility criteria: Inclusion Criteria:

* Preterm Newborns inside the incubator;
* Preterm Newborns clinically stable;
* Preterm Newborns with no change in hearing screening test;
* Preterm Newborns current weight between 1200 and 2000g.

Exclusion Criteria:

* Preterm Newborns in phototherapy;
* Preterm Newborns in use of invasive mechanical ventilation and noninvasive;
* Preterm Newborns with any type of congenital malformation;
* Preterm Newborns with periventricular hemorrhage grades II, III and IV;
* Preterm Newborns that received Central Nervous System depressant medication and sedative opioid analgesics in the last 24 hours;
* Preterm Newborns using corticoids;
* Preterm Newborn whose mother has a history of illicit drug use during pregnancy

Primary outcomes:
measure: Sleep period
timeFrame: 4 periods of Quiet time (60 minutes)
Secondary outcomes:
measure: sleep pattern according to environmental variables
timeFrame: 4 periods of Quiet time (60 minutes)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal Uiversity of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Eliana M Pinheiro, phD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Mônica H Sato, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Mavilde LG Pedreira, phD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Ariane M Avelar, phD
role: STUDY_CHAIR
References:
Clinical trial NCT02809378: The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of PONV
Official title: The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of Postoperative Nausea and Vomiting in the Women Patients Undergoing Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PONV
Palonosetron
Anesthesia
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: HK inno.N Corporation
First posted: 2016-06-22
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The incidence of postoperative nausea and vomiting (PONV) after thyroidectomy have been shown to be relatively high compared other surgeries, with a reported incidence 65-75 %. PONV may increase patient discomfort, delay patient discharge, and increase the cost of patient care, the risk of postoperative bleeding which may potentially cause airway obstruction.

It is reported that the maintenance of anesthesia with propofol-remifentanil or sevoflurane-propofol-remifentanil decreased the incidence of PONV compared sevoflurane alone, but failed to demonstrate the decreased incidence of PONV in 6-24 hr postoperative period in patients undergoing thyroidectomy. Administration of Palonosetron, newly developed 5-HT3 antagonists with long half life (48 hrs) may decrease the incidence of PONV particularly during this period.

The purpose of this study was to evaluate and compare the incidence of PONV after thyroidectomy with three different anesthetic methods, sevoflurane or sevoflurane-propofol-remifentanil or sevoflurane-propofol-remifentanil-palonosetron in woman patients.


Eligibility criteria: Inclusion Criteria:

* patients undergoing thyroidectomy euthyroid status American Society of Anesthesiology Physical status 1,2

Exclusion Criteria:

* Ideal body weight \>130% gastrointestinal disease prior administration of anti-emetics (24hr)

Primary outcomes:
measure: incidence of postoperative nausea and vomiting
timeFrame: 24 hour postoperative
Secondary outcomes:
measure: incidence of postoperative nausea and vomiting
timeFrame: at immediate postoperative
measure: incidence of postoperative nausea and vomiting
timeFrame: 6 hour postoperative
measure: incidence of postoperative nausea and vomiting
timeFrame: 48 hour postoperative
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou universiry hospital
state: Gyeonggi-do
Study officials:
affiliation: Ajou University School of Medicine
name: Dae Hee Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01992978: Radiofrequency-assisted Hepatectomy on the Outcomes of HCC Patients With Cirrhosis
Official title: The Influence of Radiofrequency-assisted Hepatectomy on the Perioperative Outcomes and the Long-term Prognosis of HCC With Cirrhosis：A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Cirrhosis
Keywords: radiofrequency-assisted（RF）
hepatectomy
postoperative liver injury
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality. Recently,radiofrequency-assisted（RFA）hepatectomy has developed rapidly and gained widespread acceptance for the treatment of hepatocellular carcinomas（HCC），but its influence on the prognosis of HCC patients，especially for those with cirrhosis，is still controversial. Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of HCC patients with cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 65 years , no gender restriction.
* Clinical diagnosis of resectable HCC.
* Preoperative liver function test showed Child-Pugh Class A or B.
* Indocyanine green retention at 15 minutes (ICG-15) of \<30%.
* Acceptable clotting profile :platelet count \> 50 x 109/L and a prolonged prothrombin time of \< 5 seconds.
* Enough relative residual liver volume (%RLV) ≥ 40%.
* No tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
* No other anti-tumor therapy received before the treatment.
* No metastasis in lymphnode or other organs.
* Written consent inform assigned.

Exclusion Criteria:

* Pregnancy.
* Intraoperative findings of tumor rupture，extrahepatic tumor or lymphnode metastasis.
* Tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.

Primary outcomes:
measure: Postoperative liver injury
timeFrame: postoperative 90 days
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: postoperative 90 days
measure: Overall survival
timeFrame: 1,3,5-year overall survival
Other outcomes:
measure: Blood parameter change after operation
timeFrame: discharge from hospital (2 weeks)
Locations:
city: Chongqing
country: China
facility: Institute of Hepatobiliry surgery,Southwest Hospital
state: Chongqing
Study officials:
affiliation: Institute of hepatobiliry surgery,Southwest hospital
name: Xiaowu Li, MD-Ph D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06662578: Using Equine Therapy in Dementia Cognitive Stimulation
Official title: Exploring Neurocognitive Stimulation in Dementia Through Equine-Assisted Therapy: A RCT Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Equine therapy
Neurocognitive stimulation
Memory workshop
Quality of life
Alzheimer&#39;s
Depression
Lead sponsor: CESPU University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn if integrating equine therapy in memory workshops in mild to moderate Dementias can improve cognitive function, quality of life and mood. The main question\[s\] it aims to answer is:

Does the mediation of a horse in memory workshops increase its effects ?

Researchers will compare traditional memory workshops, memory workshops using equine therapy and a control group to see if the equine therapy mediation will increase cognitive functions, mood and quality of life in individuals with mild to moderate Dementias.

Participants will participate in 8 weekly sessions of equine therapy memory workshops / traditional memory workshops / a control group will not have any interventions during that period. All subjects will be evaluated pre and post intervention period.


Eligibility criteria: Inclusion Criteria:

* Have been medically diagnosed with Major Neurocognitive Disorders
* Scores between 0.5 and 2 on the Cognitive Dementia Rating scale (CDR) (Berg, 1982)
* Adults of all genders, aged 65 and over; and
* Willingness to participate in a memory workshop; e) willingness to interact with a horse.

Exclusion Criteria:

* Expressed fear, aversion, or has had a negative experience with horses
* Allergy or other medical condition which did not allow contact with horses.

Primary outcomes:
measure: Change in Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline and ten weeks after
Secondary outcomes:
measure: Change in Depression Symptoms as Assessed by the Geriatric Depression Scale (GDS-15)
timeFrame: Baseline and ten weeks after
measure: Change in Quality of Life as Assessed by the Quality of Life in Alzheimer's Disease (QoL-AD NH)
timeFrame: Baseline and ten weeks after
Other outcomes:
Locations:
city: Le Boulou
country: France
facility: CAJOU
Study officials:
References:
Clinical trial NCT00600678: Gastric Emptying Study After Administration of a High Caloric Sip Feed
Official title: Characterisation of Gastric Emptying of a High Caloric Sip Feed Using the Paracetamol Absorption Method: Intraindividual Comparison of Paracetamol Pharmacokinetics After Oral co-Administration With Sip-Feed and After Intravenous Administration in Healthy Volunteers of Both Genders in an Open, Single Centre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition
Keywords: food for special medical purposes
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2008-01-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Measurement of gastric emptying time of an oral nutritional supplement (ProvideXtra DRINK) by using the paracetamol absorption method in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* caucasian origin
* BMI: 22kg/m2 - 27kg/m2;

Exclusion Criteria:

* existing diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of paracetamol (e.g. gastrointestinal or liver disease),
* known allergic reactions to investigational products,
* diseases and/or pathological findings, which could affect absorption, metabolism and/or gastric emptying (e.g. dyspepsia and gastroesophageal reflux),
* regular medication which can influence hepatic biotransformation and/or absorption,
* alcohol dependence, blood donation;

Primary outcomes:
measure: - Gastric emptying after a single oral administration of a nutritional supplement
timeFrame: Time frame gastric emptying: blood samples will be taken at predefined time points, up to 12h after application of test product.
Secondary outcomes:
measure: safety and tolerability
timeFrame: entire study
Other outcomes:
Locations:
city: Erfurt
country: Germany
facility: SocraTec R&D GmbH, Clinical Pharmacology Unit
state: Thueringen
Study officials:
affiliation: SocraTec R&D GmbH, Clinical Pharmacology Unit, Erfurt, Germany
name: Frank Donath, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02975778: Prediction of Pain During Old People Care Measured by Skin Conductance
Official title: Prediction of Pain During Old People Care Measured by Skin Conductance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: 65 years old
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the project is to validate the use of Pain Monitor™ device, not invasive and simple of employment, for old people able to answer to a digital scale of pain intensity.

The main objective is to develop and to validate a model of prediction of the pain in old subject at the time of the care, using the measure of variation of the skin conductance.


Eligibility criteria: Inclusion Criteria:

* hospitalized patient;
* patient over 65 years of age;
* communicating, without cognitive impairment;
* having to undergo an act presumed to be painful during which the patient's mobility is limited: nursing care (removal of a drain, dressing of a chronic wound, urinary catheterization, etc.), medical examination, etc.;
* benefiting from a social security scheme or having rights;
* having given their prior informed written consent;
* person able to read.

Exclusion Criteria:

* cutaneous anomaly on the site of measure;
* pacemaker or internal defibrillator;
* extremities twitching;
* Treated by neostigmine.

Primary outcomes:
measure: Correlation between Number of pics of skin conductance per second measured by Pain Monitor™ device with Numerical visual scale score for pain
timeFrame: 14 days
Secondary outcomes:
measure: Hospital Anxiety and Depression (HAD) score
timeFrame: 14 days
measure: Percentage of efficient poses of Pain Monitor
timeFrame: 14 days
measure: Percentage of patient refusal to use of the Pain monitor
timeFrame: 14 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Maison Médicale Jeanne Garnier
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06952478: A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma
Official title: A Double-Blind, Randomized, Active-Controlled, Parallel-group, Phase 1/3 Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Refractory or Relapsed Multiple Myeloma
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2025-05-01
Enrollment: 486
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 study is a phase 1/3 study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed Multiple Myeloma


Eligibility criteria: \[Main Inclusion Criteria\]

* Male or female with 18 years of age or older.
* Patient must have documented multiple myeloma (MM) according to IMWG criteria
* Patient must have a documented relapsed or refractory disease.
* Patient must have achieved a response (PR or better based on investigator's determination of response by the IMWG criteria) to at least one prior regimen.
* Patient must have a PD as defined by the IMWG criteria on or after their last line of therapy.

\[Main Exclusion Criteria\]

* Patient has received daratumumab or any other drug specifically targeting CD38 previously.
* Patient's disease shows evidence of refractoriness or intolerance to lenalidomide.
* Patient is known or suspected of not being able to comply with the study protocol (e.g., psychological disorder) or the patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Primary outcomes:
measure: PK equivalence of CT-P44 and Darzalex Faspro
timeFrame: Week 0 ~ Week 24
measure: Therapeutic equivalence of CT-P44 and Darzalex Faspro
timeFrame: Week 0 ~ Week 24
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00557778: Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia
Official title: Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Dyslipidemia
Keywords: prevention
dyslipidemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 600
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: Primary Care Clinic

Brief summary: Evaluate the benefit (rate of adherence to the treatment), based on the LDL-C reduction in the group that will be exposed to the program of reinforcement of orientation aimed to the patients, compared to the control group, both in previous use of rosuvastatin.


Eligibility criteria: Inclusion Criteria:

* Subjects eligible for the treatment of dyslipidemia with statins according the current guidelines NCEP ATPIII and IV Brazilian Guidelines of Dyslipidemia and Atherosclerosis Prevention.
* Patients with previous use of rosuvastatin for, at least, 15 days and, for no longer than12 months prior to the inclusion in the study.

Exclusion Criteria:

Pregnancy and childbearing

* History of severe hypersensitivity (including myopathy) to other HMG-CoA reductase inhibitors.
* Subjects with indication of use of cyclosporine and other associations of other lipid lowering drugs.
* Subjects with underlying diseases that may influence lipid levels (i.e. uncontrolled hypothyroidism defined as a Thyroid stimulating hormone (TSH) \> 1.5 times upper level of normality (ULN) at Visit 1, AIDS, transplanted subjects, etc).
* History of drug and alcohol abuse.
* Current active liver disease or hepatic failure or elevations in ALT \>3 times the ULN.
* Elevation of CPK \> 3 times the ULN.
* Elevation in the seric creatinine \> 2,0 mg / dL.
* History of malignancy in the last 5 years, except basal cell or squamous cell carcinoma of the skin (women with a history of Cervical dysplasia must be included, unless they have t3 clear consecutive Papanicolaou (Pap) smears , before the entry in the study).
* Any other known clinical condition that, in the opinion of the investigator, may compromise the subject's safety.

Primary outcomes:
measure: Assess the LDL-C reduction in the group exposed to the educational program compared to the group with routine orientation
Secondary outcomes:
measure: Assess cardiovascular risk through Framingham's score, · · Identify personal characteristics of the study population regarding their health, compile demographic characteristics regarding education, economic and cultural status.
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Research Site
state: Sao Paulo
Study officials:
affiliation: AstraZeneca Brazil Ltda
name: Jose Eduardo Neves, MD
role: STUDY_DIRECTOR
affiliation: PUC-Campinas
name: Francisco Jose Saraiva, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00041678: Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer Disease
Keywords: Psychosis Associated with Dementia of the Alzheimer's Type
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2002-07-15
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn if aripiprazole is safe and effective in the treatment of psychosis associated with dementia of the Alzheimer's type.


Eligibility criteria: Inclusion Criteria:

* Institutionalized patients with Alzheimer's Disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rosemead
country: United States
facility: Local Institution
state: California
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: Bennington
country: United States
facility: Local Institution
state: Vermont
city: Burlington
country: United States
facility: Local Institution
state: Vermont
city: Milwaukee
country: United States
facility: Local Institution
state: Wisconsin
Study officials:
References: