louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02138968: Clinical and Economic Assessment of a Pre-frail Screening Program
Official title: Clinical and Economic Assessment of an Opportunistic Screening Program for Pre-frailty State in Elderly Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-frail
Elderly
Keywords: Pre-frailty
Frail
Exercise
Nutritional assessment
Functional capacity
Lead sponsor: Consorci Sanitari del Maresme
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 170
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study intervention improves functional capacity and delays frailty status in pre-frail elderly subjects.


Eligibility criteria: Inclusion Criteria:

* More than 70 years consulting in primary care
* Non institutionalized
* Pre-frailty according to L.Fried criteria (1 or 2 criteria)
* Signed informed consent

Exclusion Criteria:

* Patient not able to stand by himself/herself
* Dementia
* Palliative care or life expectancy less than 6 months
* Blind patient
* unstable clinical situation
* Participation in other programs, studies or trials for elderly people

Primary outcomes:
measure: Frailty according to L.Fried criteria (questionnaire).
timeFrame: One year
measure: Functional capacity according to Barthel score and Timed up and go test.
timeFrame: One year
Secondary outcomes:
measure: Nutritional status according to MNA-sf.
timeFrame: One year
measure: Quality of live according to EuroQoL.
timeFrame: One year
measure: Mortality
timeFrame: One year
measure: Health resource consumption (composite measure)
timeFrame: One year
Other outcomes:
measure: Pain according Visual Analog Scale.
timeFrame: One year
Locations:
city: Mataró
country: Spain
facility: Consorci Sanitari del Maresme
state: Barcelona
Study officials:
affiliation: Fundació Salut del Consorci Sanitari del Maresme
name: Mateu Serra-Prat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serra-Prat M, Sist X, Domenich R, Jurado L, Saiz A, Roces A, Palomera E, Tarradelles M, Papiol M. Effectiveness of an intervention to prevent frailty in pre-frail community-dwelling older people consulting in primary care: a randomised controlled trial. Age Ageing. 2017 May 1;46(3):401-407. doi: 10.1093/ageing/afw242.
Clinical trial NCT00055068: Family Based Treatment of Early Childhood Obsessive Compulsive Disorder
Official title: Family Based Treatment of Early Childhood OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-02-20
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate a treatment program for young children with Obsessive Compulsive Disorder (OCD) and their families.

Detailed description: Childhood onset OCD is a serious condition that may be a predictor of illness in adulthood. To date, no OCD psychotherapy trials have specifically focused on early childhood. Development of interventions for childhood onset OCD that address both developmental considerations and familial relationships is necessary.

Participants are randomly assigned to receive 12 sessions of either Cognitive Behavioral Therapy (CBT) or Relaxation Training (RT) over the course of 14 weeks. The CBT treatment is designed to lessen anxiety by addressing specific OCD symptoms. The relaxation intervention addresses generalized feelings of anxiety with the expectation that OCD symptoms may benefit indirectly. The clarity, completeness, acceptability, and feasibility of both interventions is assessed. A 3-month post-treatment follow-up is also conducted.

Eligibility criteria: Inclusion Criteria:

* Obsessive Compulsive Disorder (OCD)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital/Brown University
state: Rhode Island
Study officials:
References:
citation: Freeman JB, Garcia AM, Coyne L, Ale C, Przeworski A, Himle M, Compton S, Leonard HL. Early childhood OCD: preliminary findings from a family-based cognitive-behavioral approach. J Am Acad Child Adolesc Psychiatry. 2008 May;47(5):593-602. doi: 10.1097/CHI.0b013e31816765f9.
Clinical trial NCT04330768: Platelet Rich Fibrin(PRF) Injection for Treatment of Dental Pulp Exposure:Randomized Clinical Trial
Official title: Platelet Rich Fibrin(PRF) Versus Pulp Capping in Treatment of Dental Pulp Exposure:Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Pulp Exposure
Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: platelet rich fibrin(PRF) obtained from patient from patient blood sample (before start of treatment)is injected in the site of exposure of exposure(intervention group) control group will receive normal pulp capping procedure by MTA follow up will be one year

Detailed description: intervention group:patient with deep caries lesion ,free from sign and symptoms of irreversible pulpitis the blood sample will be taken before the beginning of dental treatment..PRF will be obtained by blood centrifugal and injected in the site of exposure covered by glass ionomer restoration control group: patient with same condition will receive pulp capping procedure by MTA followed by glass ionomer restoration

Eligibility criteria: Inclusion Criteria:

* deep carious lesion- no sign of irreversible pulpitis

Exclusion Criteria:

* old age- periapical lesion-

Primary outcomes:
measure: pulp vitality
timeFrame: After 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02639468: Electric Impedance Tomography
Official title: Electric Impedance Tomography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke Volume
Lead sponsor: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Sponsor class: INDUSTRY
Collaborators: name: Centre Hospitalier Universitaire Vaudois
First posted: 2015-12-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when compared to reference measurements performed via right heart thermodilution


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery which requires placement of pulmonary catheter
* Patients with right heart catheterization for diagnostic or therapeutic reasons

Exclusion Criteria:

* Patient unable to understand the study
* Patient unable to provide written consent or refusing his/her participation
* Patient suffering from a severe valvular insufficiency
* Patient allergic to ECG electrodes

Primary outcomes:
measure: Correlation of stroke volume values measured via pulmonary catheter compared to EIT-derived stroke volume estimates.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
References:
Clinical trial NCT01148368: A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers
Official title: A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: fimasartan
renal impairment
hypertension
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Hospital
First posted: 2010-06-22
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal impairment patients and healthy volunteers.


Eligibility criteria: Inclusion Criteria:

\<Renal impairment patient\>

* age: 20-65 years
* eGFR: \< 30ml/min/1.73m\^2
* not on dialysis
* body weight: greater than 55kg
* written informed consent

\<Healthy volunteer\>

* age: 20-65 years
* body weight: greater than 55kg
* written informed consent

Exclusion Criteria:

* AST, ALT \> 1.5 times of upper normal range
* positive drug or alcohol screening

Primary outcomes:
measure: pharmacokinetic characteristic of fimasartan
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine
name: Yon Su Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00854568: Comparison Study of Doxorubicin Versus Epirubicin-induced Cardiotoxicity in Patients With DLBCL
Official title: A Randomized Phase III Study Comparing CHOP Versus CEOP-induced Cardiotoxicity in Patients With Aggressive B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphoma
Keywords: B-cell lymphoma
CHOP
CEOP
Cardiotoxicity
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-03-03
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare CHOP versus CEOP-induced cardiotoxicity in patients with aggressive B-cell lymphoma. The hypothesis is epirubicin is associated with less cardiotoxicity without compromising the efficacy.

Detailed description: The doxorucin-containing regimen (CHOP) and epirubicin-containing regimen (CEOP) are both frequently used in patients with aggress B-cell lymphoma in out institution. According to a Cochrane meta-analysis, epirubicin is less cardiotoxic than doxorubicin on a mg per mg basis. However, compared with 50mg/m2 of doxorubicin in CHOP, epirubicin was usually used at a higher dose (70mg/m2) to treat non-Hodgkin's lymphoma (NHL). Because of the correlation between cumulative dose and risk of cardiotoxicity, it is reasonable to speculate that CEOP (70mg/m2) has less cardiotoxicity than CHOP (50mg/m2) when both regimens are administered with similar cycles.

Eligibility criteria: Inclusion Criteria:

* Previously untreated aggressive B-cell lymphoma
* Age range 18-75 years old
* ECOG performance status 0-2
* Life expectancy of more than 3 months
* Adequate organ function

Exclusion Criteria:

* Previous serious cardiac disease
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection

Primary outcomes:
measure: Cardiotoxicity (Class III or IV cardiotoxicity according to New York Heart Association (NYHA) Classification or LVEF abnormality [< 50% or a decrease in absolute LVEF ≥ 10%) by post-treatment RNA])
timeFrame: 18 weeks
Secondary outcomes:
measure: Objective response rate
timeFrame: Six weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05500768: Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices
Official title: Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices: A RAndomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pocket Hematoma
Keywords: cardiac devices
surgical wound
oral anticoagulation therapy
oral antiplatelet therapy
compression bandage
hypothermic therapy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the efficacy of hypothermic compression bandaging versus conventional compression bandaging, for the prevention of surgical wound hematoma of cardiac implementable electronic devices in patients undergoing chronic oral anticoagulant therapy and/or oral antiplatelet therapy.


Eligibility criteria: Inclusion Criteria:

* patients under oral anticoagulation and/or antiplatelet treatment who were going to undergo implantation of an implanted device cardiac stimulation or generator replacement due to battery depletion

Exclusion Criteria:

* insertion of drainage in the wound,
* non-compliance with the pre-surgical antithrombotic protocol
* INR in a high therapeutic range (\>3.5)
* Do not follow-up in the same hospital
* Coagulation and hemostasis disorders
* Replacement of devices due to alterations in the operation unrelated to the battery.

Primary outcomes:
measure: Appearance of hematoma
timeFrame: 10 days
Secondary outcomes:
measure: Appearance of severe hematoma
timeFrame: 10 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic
Study officials:
References:
Clinical trial NCT01050868: Comparison of the Management of Post-prandial Hyperglycemia by Multiple Bolus Calculators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This prospective, non-randomized, non-controlled, interventional study will determine whether the Roche automated bolus caclulator (ABC) reduces post-meal hyperglycemia better than the competitor's ABC without causing significant hypoglycemia.


Eligibility criteria: Inclusion Criteria:

* Subjects \>/= 18 years at screening
* Type 1 diabetics currently using an insulin pump for management of their diabetes and have been on a pump for at least at least 6 months prior to the screening visit
* Subjects have to use a fast acting analog insulin
* HbA1c = 9% (measured with DCA 2000)
* Willing to perform periods of intensive blood glucose (BG) monitoring for up to 21 days prior to the study (\~10 tests per day) with skipped meals and testmeals
* Willing to use the 3 different bolus calculators during the course of the study
* Willing to undergo planned hyperglycemia
* Willing to perform high frequency BG monitoring (\> 20 / day) during the experiment

Exclusion Criteria:

* Type 2 Diabetes
* Manifest severe late complications of diabetes (e.g. severe macro- or microangiopathy, severe neuropathy, severe retinopathy and/or severe nephropathy)
* Current addiction to alcohol or substances of abuse
* Pregnant or lactating women
* Any known life-threatening disease

Primary outcomes:
measure: To compare the difference between the self-monitoring blood glucose (SMBG) value achieved at 6 hours after meals with induced post-prandial hyperglycemia and the mean target value of 110 mg/dL. Target post-prandial range is 80-140 mg/dL.
timeFrame: 6 hours after meal
Secondary outcomes:
measure: To compare the absolute difference between the SMBG value and the target value between the calculators
timeFrame: 6 hours after meal
measure: To compare theto compare the relative difference (multiplied by 100) between the SMBG value and the target value between the calculators
timeFrame: 6 hours after meal
measure: To compare the absolute relative difference (RAD, multiplied by 100) between the SMBG value and the target value between the calculators
timeFrame: 6 hours after meal
Other outcomes:
Locations:
city: Ulm
country: Germany
Study officials:
affiliation: Roche Diagnostics GmbH / Diabetes Care
name: Bettina Petersen
role: STUDY_DIRECTOR
References:
Clinical trial NCT00168168: ACB A Randomized Study of 2.5ug/kg/Day vs. 5ug/kg/Day Dose of G-CSF After High Dose Chemotherapy Followed by Autologous Peripheral Blood Stem Cell/Marrow Transplant Recipients FILE#17159
Official title: ACB A Randomized Study of 2.5ug/kg/Day vs. 5ug/kg/Day Dose of G-CSF After High Dose Chemotherapy Followed by Autologous Peripheral Blood Stem Cell/Marrow Transplant Recipients FILE#17159
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Stem Cell/Marrow Transplant
Keywords: G-CSF
Filgrastim
Engraftment time
Autologus transplant
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate recovery time on 2.5 mg/Kg/day dose of G-CSF versus 5 mg/Kg/day dose.


Eligibility criteria: Inclusion Criteria:

* over age 18
* autologous stem cell/marrow transplant candidate in MM, lymphoma, AMG and testicular

Exclusion Criteria:

* age below 18 years
* sensitive to G-CSF

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Meluka Game, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01092468: Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap Elevation for Head and Neck Reconstruction
Official title: Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Keywords: cancer
reconstruction
free flap
surgery
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 20
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: This study is to compare the efficacy of Harmonic Scalpel with conventional diathermy technique in terms of reducing elevation time and perioperative complications of perforator flaps for head and neck reconstruction.


Eligibility criteria: Inclusion Criteria:

* head and neck reconstruction with perforator flap
* informed consent from the patient

Exclusion Criteria:

* coagulation problem
* refused to participate

Primary outcomes:
measure: flap elevation time: from identification of skin perforator to completion of dissection to main pedicle
timeFrame: 1 hour after completion of flap elevation
Secondary outcomes:
measure: intraoperative complications: bleeding, perforator injury (thermal, mechanical)
timeFrame: 1 hour after completion of flap elevation
measure: postoperative drainage amount
timeFrame: 1 week after flap inset
measure: postoperative pain measured by visual analogue scale (VAS)
timeFrame: 1 week after completion of flap elevation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
References:
Clinical trial NCT04690868: A Study to Compare PK, PD and Safety of the AD-213-A and AD-2131
Official title: A Randomized, Open Label, Multi Dose, Cross Over Design Clinical Study to Evaluate the Pharmacokinetic Pharmacodynamic Characteristics and Safety of AD-213-A and AD-2131 After Oral Administration in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastroesophagus Reflux Disease
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-31
Enrollment: 43
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-A to AD-2131 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adults over 19 years of age.
* Weight is more than 50kg and BMI is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2.
* Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials.
* Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing.

Exclusion Criteria:

* A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug.
* As a result of laboratory tests, the following figures: ALT or AST or total bilirubin \> 1.5 times upper limit of normal range.
* As a result of laboratory tests, the following figures: Creatinine clearance \< 80mL/min.
* Subjects who judged ineligible by the investigator.

Primary outcomes:
measure: AUCtau
timeFrame: From Day 1 up to Day 17
measure: Integrated gastric acidity(%Decrease form baseline)
timeFrame: 4 times from Day -1 to Day 17
Secondary outcomes:
measure: Cmax
timeFrame: Day 1
measure: AUClast
timeFrame: Day 1
measure: AUCinf
timeFrame: Day 1
measure: Tmax
timeFrame: Day 1
measure: t1/2
timeFrame: Day 1
measure: CL/F
timeFrame: Day 1
measure: Vd/F
timeFrame: Day 1
measure: Cmax,ss
timeFrame: From Day 1 up to Day 17
measure: Cmin,ss
timeFrame: From Day 1 up to Day 17
measure: AUCinf
timeFrame: From Day 1 up to Day 17
measure: Tmax,ss
timeFrame: From Day 1 up to Day 17
measure: t1/2
timeFrame: From Day 1 up to Day 17
measure: CLss/F
timeFrame: From Day 1 up to Day 17
measure: Vdss/F
timeFrame: From Day 1 up to Day 17
measure: Integrated gastric acidity(Variations form baseline)
timeFrame: 4 times from Day -1 to Day 17
measure: Percentage of time to maintain gastric pH 4.0 or higher
timeFrame: 4 times from Day -1 to Day 17
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
References: