louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02135146: Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
Official title: Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension
Kidney Injury
Keywords: Hypotension
Kidney injury
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a prospective, randomized, controlled trial comparing a restrictive vs. conservative fluid strategy in thoracic surgery patients. Excessive perioperative fluid has been retrospectively implicated in the development postoperative acute lung injury (PALI) and pulmonary edema following lung resection. However, fluid restriction in these patients is not without risk and may compromise end organ perfusion (i.e. acute kidney injury). The hypothesis is that a conservative fluid approach in thoracic surgery patients will result in better end organ perfusion with fewer occasions of acute kidney injury (AKI) without causing an increase in postoperative acute lung injury or pulmonary edema.


Eligibility criteria: Inclusion Criteria:

* between 18-89 years of age
* undergoing pulmonary lobectomy with open or video assisted thoracotomy

Exclusion Criteria:

* patient refusal
* pregnancy
* cardiac arrhythmia
* pacemaker dependency
* severe aortic insufficiency
* idiopathic hypertrophic subaortic stenosis
* prisoners
* decisionally challenged
* patients that refuse to receive intravenous fluid products made from human plasma (Albumin 5%)
* patients with skin infection or breakdown on their fingers
* severe peripheral vascular disease
* evidence of compromised finger perfusion will be excluded

Primary outcomes:
measure: Development of Renal Injury
timeFrame: Post-op up to 72 hours
measure: Development of Pulmonary Edema
timeFrame: Post-op up to 72 hours
Secondary outcomes:
measure: Length of Surgical Intensive Unit Stay/Hospital Stay
timeFrame: Up to 7 days
measure: Removal of Chest Tubes
timeFrame: Post-op up to 48 hours
measure: Development of Morbidity
timeFrame: Up to 7 days
measure: Death
timeFrame: Assessed up to 30 days Post-op
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Tamas Seres, M.D., PH.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07011446: Usability Evaluation of the Safer Seat
Official title: Usability Evaluation of the Safer Seat
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Impaired Mobility
Impaired Balance
Keywords: Transfers
Mobility Aid
Mobility Support
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is an initial usability assessment of a vehicle Seat Transfer device, the Safer Seat. The study will involve target end users (individuals with mobility impairments) trialing the Safer Seat and providing feedback via the Technology Acceptance Model Survey's Modified from Davis (1985) and brief qualitative interview.

Detailed description: This study investigates the initial usability of the Safer Seat vehicle transfer aid. Participants with impaired mobility, strength, or balance are being asked to transfer onto and off of a vehicle seat with and without the device to trial its usability. In addition, transfers are doing rated by a licensed occupational therapist according to the Physical Mobility Scale to determine if independence level is affected. Usability evaluation is being done both qualitatively and quantitatively using Technology Assessment Surveys and a semi-structured interview. Insight gained through this initial trial will be used to refine the design of the Safer Seat.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Currently living with impaired mobility, strength, or balance
* Self-reported ability to complete transfers at modified independent (independent with the use of an assistive device) or minimal assist (a small amount of assistance from another person) level

Exclusion Criteria:

-

Primary outcomes:
measure: Physical Mobility Scale
timeFrame: Day 1
Secondary outcomes:
measure: Technology Acceptance Model Perceived Ease of Use, Usefulness, and Attitudes Toward Use questionnaires
timeFrame: Day 1
measure: Semi structured interview
timeFrame: Day 1
measure: Demographic Data
timeFrame: Day 1
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Univeristy of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Julie Faieta, PhD, MOT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01196546: Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)
Official title: Multi-center, Open-label, 24-week Study to Demonstrate the Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin 50/500 or 50/1000 mg Twice Daily in Patients With T2DM Inadequately Controlled With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
vildagliptin
metformin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-09-08
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and safety of combination therapy of vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000 mg/day.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months
* The patient is required to have HbA1c 6.5-11.0%
* BMI in the range of 22-48 kg/m2

Exclusion Criteria:

* Severe or uncontrolled Type 2 diabetes mellitus (HbA1c\> 11.0%)
* Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
* Congestive heart failure requiring pharmacologic treatment
* Any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention
* Liver disease such as cirrhosis or chronic active hepatitis

Primary outcomes:
measure: HbA1c reduction
timeFrame: 24 weeks after treatment
Secondary outcomes:
measure: Proportion of patients who achieve target of HbA1c<6.5% at the end of study
timeFrame: 24 weeks after treatment
measure: To evaluate the effect of combination therapy of vildagliptin (50 mg) plus metformin (500 or 1000 mg) twice daily on FPG and BMI, safety and tolerability profiles
timeFrame: 24 weeks after treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: BMA Medical College and Vajira Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Phamongkutklao Hospital
city: Bangkok
country: Thailand
facility: Police General Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Khon Kaen
country: Thailand
facility: Khon Kaen Hospital
city: Nakhon Ratchasima
country: Thailand
facility: Fort Suranaree Hospital
city: Nakhon Ratchasima
country: Thailand
facility: Maharat Nakhon Ratchasima Hospital
Study officials:
References:
Clinical trial NCT00174746: Dose Response Study of Inhaled Ciclesonide (Glucocorticosteroid) to Patients With Persistent Asthma
Official title: A Placebo- and Active-Controlled (Ciclesonide Metered-Dose Inhaler), Randomized, Parallel-Group, Dose-Range Finding Study of Ciclesonide Administered by Dry Powder Inhaler (Ultrahaler) in Adult and Adolescent Patients With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Glucocorticosteroid; Dose response; Bronchospasm
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 1145
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of ciclesonide inhaled into the lungs in a range of doses in a new dry powder inhaler compared to ciclesonide inhaled into the lungs using a metered dose inhaler


Eligibility criteria: Inclusion Criteria:

* Males or females 12 years or older; History of persistent bronchial asthma for at least 6 months; Documented use of an inhaled steroid for at least 1 month before screening; At screening, FEV1 40% or more of predicted normal and at randomization, FEV1 between 40 and 80% predicted normal; Reversibility of FEV1 by at least 12% and 200 ml post-bronchodilator; Be able to use oral inhalers; Non-smokers

Exclusion Criteria:

* History of life-threatening asthma; other pulmonary diseases; URI within 4 weeks before screening; Use of systemic steroids within 1 month before screening or more than 3 times in previous 6 months; beta-adrenergic blocking agent use; More than 2 in-patient hospitalizations or ER visits due to asthma exacerbations in the prior year before screening; Pregnant or breast-feeding females; Females of child-bearing potential not using adequate means of birth control; Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease; Abnormal clinical laboratory parameters that would limit participation in the study or interfere with interpretation of study results; History of drug or alcohol abuse; Treatment with any investigational product within 30 days prior to study entry

Primary outcomes:
measure: Primary endpoint will be the change from baseline to week 6 in FEV1
Secondary outcomes:
measure: PK parameters measured after 4 weeks of treatment. Change from baseline in serum cortisol pre-and post ACTH stimulation, AM and PM peak expiratory flow rates, AM and PM asthma symptoms, and albuterol use after 6 weeks of treatment.
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05062746: Immediate Effect of One-session MRT in Hemiparetics
Official title: Immediate Effect of One-session Matrix Rhythm Therapy on the Functional Status and Treatment Satisfaction of Hemiparetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis;Poststroke/CVA
Satisfaction, Patient
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Immediate effect of one-session Matrix Rhythm Therapy on the functional status and treatment satisfaction of hemiparetic patients will be investigated.


Eligibility criteria: Inclusion Criteria:

* to have single-sided hemiparesis for the first time,
* to have hemiparesis at least four weeks earlier,
* to have Modified Rankin Score of ≤3

Exclusion Criteria:

* to use a cardiac pacemaker,
* to have communication problems,
* to have other neurological, psychiatric and/or orthopedic problems other than hemiparesis.

Primary outcomes:
measure: Motricity Motor Scale
timeFrame: 5 minutes
measure: Trunk Impairment Scale
timeFrame: 10 minutes
measure: The Box and Block Test
timeFrame: 2 minutes
measure: The Nine-Hole Peg Test
timeFrame: 2 minutes
measure: Treatment Satisfaction Scale
timeFrame: 30 sec.
Secondary outcomes:
measure: Global Rating of Change Scale
timeFrame: 30 sec.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT02334046: Remifentanil for Smooth Emergence in Elderly Patients
Official title: Effect-site Concentration of Remifentanil for Preventing Cough During Emergence in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Drug Usage
Keywords: tracheal extubation
remifentanil
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually need smaller doses of anaesthetic drugs than younger patients. The purpose of this study was to investigate the optimal effect-site concentration of remifentanil for preventing cough during emergence in elderly patients under sevoflurane and remifentanil anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II undergoing endoscopic sinus surgery or septoplasty under balanced anesthesia with sevoflurane and remifentanil

Exclusion Criteria:

* predicted difficult airway, body mass index \> 30 kg/m2, history of obstructive sleep apnoea chronic respiratory disease or coughing, current smokers patients angiotensin converting enzyme-inhibitors

Primary outcomes:
measure: Number of cough
timeFrame: from end of surgery to 5 min after tracheal extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeongki-do
Study officials:
affiliation: Ajou University School of Medicine
name: Jong Yeop Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04913246: Triage Score VS Quick-Sofa Score in Septic Patients in the Emergency Department
Official title: Comparison of the Triage Score With the Quick-Sofa Score (qSofa) in Septic Patients in the Emergency Department: Diagnostic and Prognostic Value.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Emergencies
Keywords: Sepsis
severity
prognosis
triage
Mortalty
Lead sponsor: Hôpital Universitaire Sahloul
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: each patient diagnosed as an acute Sepsi consulting the emergencies of CHU Sahloul, Sousse

Brief summary: Sepsis represents by its frequency, its morbidity and mortality and its cost to society a major public health issue with a constantly increasing incidence. It affects millions of people around the world each year and is the 2nd leading cause of death in intensive care units.

The incidence of sepsis has been estimated by the World Health Organization (WHO), based on US data, at 15 to 19 million cases of sepsis per year worldwide.

Detailed description: This is a descriptive, mono-center study aimed at comparing a local triage score with that of qsofa in patients presenting to the Sahloul Emergency Department with sepsis.

A local triage score was calculated for each patient consulting the emergency room; this score makes it possible to classify patients according to severity and to predict the time to treatment.

A form is completed prospectively for each patient admitted to the observation unit whose diagnosis of sepsis is confirmed and validated by a senior during the morning staff.

The validated data were included in the ReSSUS register (Sepsis Register of the Sahloul Emergency Department). This is an observational database on the management of sepsis admitted to the emergency department in Sahloul. It ensures a high level of confidentiality and protection of medical data.

Subsequent follow-up of patients was done by telephone contact to verify mortality at one month and one year.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old
* each patient diagnosed as an acute Sepsi consulting the emergencies of CHU Sahloul, Sousse

Exclusion Criteria:

* no exclusion

Primary outcomes:
measure: Mortality
timeFrame: one month
Secondary outcomes:
measure: Mortality and /or readmission
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: CHU Sahloul, Sousse, Tunisia
name: Riadh Boukef, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00051246: Group Therapy for Postpartum Depression
Official title: Relational Group Intervention for Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-01-08
Enrollment: 147
Sex: FEMALE
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 will compare standard individual treatment to group therapy for the treatment of postpartum depression.

Detailed description: Ten to twenty percent of new mothers experience major depression in the postpartum period or postpartum depression (PPD). This condition poses a risk for disturbances in the mother-infant relationship as well as for developmental delays and subsequent psychopathology in their children. Thus, and investigation of the efficacy of a relational approach that focuses on improving the mother's sense of competence in the parenting role, and reducing depressive symptoms and social isolation through group therapy is warranted.

Patients are randomly assigned to either relational group treatment or to standard individual treatment. Assessments of maternal and infant functioning, mother-infant and father-infant relations, parenting stress, and marital conflict and conducted pre- and post-treatment, at 12 months post-treatment, and when infants are 12 and 24 months of age.

Eligibility criteria: Inclusion Criteria:

* Major depression with an infant under 7 months of age

Exclusion Criteria:

* Bipolar disorder
* Schizophrenia
* Organic brain syndrome
* Antisocial personality disorder
* Current psychosis or mania
* Lifetime history of mental retardation
* Current alcohol or substance abuse
* Cognitive disability
* Infants born more than 6 weeks premature or with major medical conditions or developmental disabilities

Primary outcomes:
measure: Reduction of depression as measured by the Hamilton Rating Scale for Depression (HRSD)
timeFrame: Measured at post-treatment and Month 12 follow-up
Secondary outcomes:
measure: Improvement in parent-infant interactions as measured by the Early Relational Assessment (ERA)
timeFrame: Measured at post-treatment, Month 12 follow-up, and 12 and 24 months of age
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Dept. of Psychiatry
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Roseanne Clark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01156246: Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers
Official title: An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on Fixed Dose Combination Dapagliflozin/Metformin Tablet (5 mg/1000 mg) in Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Dapagliflozin
Diabetes Type 2
Food interaction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-07-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.


Eligibility criteria: Inclusion Criteria:

* Healthy
* BMI 18-30 kg/m2

Exclusion Criteria:

* History of clinically significant illness.
* History of alcohol or drug abuse

Primary outcomes:
measure: To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin.
timeFrame: Serial PK sampling will be done on Days 1-4 at visit 2 and 3.
Secondary outcomes:
measure: To examine the safety and tolerability of the fixed-dose combination tablet of dapagliflozin and metformin.
timeFrame: ECG at screening and follow-up. BP/pulse at screening, once daily during residential period and at follow-up. Clinical chemistry, haematology, and urine analyses at screening, day-1, day 4, and at follow-up.
Other outcomes:
Locations:
city: Lulea
country: Sweden
facility: Research Site
Study officials:
affiliation: Quintiles Hermelinen AB, Varvsgatan 53, SE-972 33 Luleå, Sweden
name: Aslak Rautio
role: PRINCIPAL_INVESTIGATOR
affiliation: Quintiles AB, Global Phase I Services, Strandbodgatan 1, SE-753 23 Uppsala, Sweden
name: Wolfgang Kühn
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Global Clinical Development, Pepparedsleden 1, 431 83 Mölndal, 431 83 Mölndal
name: Mirjana Kujacic
role: STUDY_CHAIR
References: