louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01404299: Effects of a Nutritional Supplementation on the Functional Status of Frail Elders With Low Socioeconomic Status (SES)
Official title: Effects of a Protein-Energy Nutritional Supplementation on the Functional Status of Frail Older Adults With Low Socioeconomic Status: A Community-based Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail
Keywords: Frailty,
nutritional supplementation,
functional status
Lead sponsor: Gangbuk-gu Community Health Center
Sponsor class: OTHER_GOV
First posted: 2011-07-28
Enrollment: 87
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether protein-energy nutritional supplementation improves geriatric function in community-dwelling frail older adults of low socioeconomic status.

Detailed description: Chronic undernutrition is a common condition in older people, and is clearly an important component of frailty. However, the effect of protein-energy nutritional supplementation on the functional status of frail older people is controversial. Some investigators suggested that, if nutritional or functional status has deteriorated too far, it could be very difficult for single nutritional supplementation to reverse malnutrition progression or functional decline.

The investigators believe one of the reasons for these ineffective results, especially for the community-dwelling frail elderly, may be due to a lack of regard to the socioeconomic status of the study population. For this reason, the investigators recruited a study sample with low socioeconomic status and evaluated the effect of protein-energy nutritional supplementation on their disability scores and physical performance.

Eligibility criteria: Inclusion Criteria:

* Older adults over 65 years of age, registered in the National Home Healthcare Service database
* Require more than 5 seconds to perform 3m walking test (Usual Gait Speed \<0.6 m/sec)
* Get less than 24 points on Mini Nutritional Assessment (Mini Nutritional Assessment \<24)

Exclusion Criteria:

* Unable to walk or are too functionally deteriorated to receive home health care services
* Who were participating in any kind of exercise program or clinical nutrition program
* who were restricted to a high-protein diet by an internist (i.e., for liver failure or severe renal failure)

Primary outcomes:
measure: Functional Status
timeFrame: 12 weeks
Secondary outcomes:
measure: Nutritional Status, Other Functionality Test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangbuk-gu Community Health Center
Study officials:
affiliation: Department of District Health Care Service, Gangbuk-gu Community Health Center, Republic of Korea
name: Chang-O Kim, M.D, MSW
role: STUDY_DIRECTOR
References:
Clinical trial NCT02186899: Peripheral Nerve Block (Femoral - Sciatic - Obturator) Versus General Anesthesia for Arthroscopic ACL Repair
Official title: Comparison of Femoral - Sciatic - Obturator Nerve Block vs General Anesthesia in Combination With Continuous or Bolus Femoral Nerve Block for Arthroscopic ACL Repair Regarding the Time of Patient Mobilasation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroscopic ACL Rerpair
Surgery
Anesthesia Care
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Arthroscopic ACL repair can be performed under different types of anesthesia. In the last few years peripheral nerve blocks have increased their popularity for this kind of operation. The investigators want to see how the type of anesthesia and postoperative analgesia effects the time required for patient mobilisation.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 80 yrs
* ASA I - III
* ACL surgery

Exclusion Criteria:

* Coagulopathy disorders
* Infection at the puncture site for the interscalene block
* Neurologic deficit in the arm that is going to be operated
* Allergy to local anesthetics
* BMI \> 35
* Psychiatric disorders
* Patient's refusal
* Problems with patient communication

Primary outcomes:
measure: Surgery completed without pain for the patient
timeFrame: Completion of the surgery
measure: Postoperative pain
timeFrame: 1st postoperative day
Secondary outcomes:
measure: Mobilization of the knee
timeFrame: 24 weeks postoperatively
Other outcomes:
measure: Chronic pain development
timeFrame: 24 weeks postoperatively
Locations:
city: Larissa
country: Greece
facility: Private Clinic of Larissa "Asklipeiio"
Study officials:
affiliation: Private Clinic of Larissa "Asklipeiio"
name: Marina Simaioforidou, Medicine
role: STUDY_DIRECTOR
affiliation: Private Clinic of Larissa "Asklipeiio"
name: George Basdekis, Medicine
role: STUDY_CHAIR
affiliation: Larissa University Hospital
name: Konstantinos Bargiotas, Medicine
role: STUDY_CHAIR
affiliation: Private Clinic of Larissa "Askipeiio"
name: Aristeidis Zibis, Medicine
role: STUDY_CHAIR
affiliation: Larissa University Hospital
name: Athanasios Drakos, Medicine
role: STUDY_CHAIR
affiliation: Larissa University Hospital
name: Metaxia Bareka, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01894399: Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects
Official title: Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic Characteristics of HM61713 Tablet in Healthy Korean, Japanese and Caucasian
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: HM61713
pharmacokinetics
Phase I
healthy
olmutinib
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 59
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study Design

* Open, escalating single-dose design.
* 7 ascending dose cohorts
* In each cohorts, subjects will receive a single dose of HM61713.
* Main objective of this study is to evaluate the pharmacokinetics of HM61713 tablet.

Detailed description: Primary objectives

• To assess the PK characteristics of HM61713 and metabolites in healthy male volunteers

Secondary objectives

* To assess the safety and tolerability of HM61713 tablet in healthy male subjects.
* To assess the food effect on PK characteristics of HM61713 tablet in healthy male subjects.
* To assess the ethnic differences of PK characteristics of HM61713 (Korean, Japanese, Caucasian)
* To investigate genotype of drug metabolism.transport that affect PK characteristics of HM61713
* To investigate the change of endogenous metabolic markers after administration of HM61713

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, age between 20 and 45
* Informed of the investigational nature of this study and voluntarily agree to participate in this study
* BMI of \>18.5kg/m2 and \<28kg/m2 subject

Exclusion Criteria:

* Use of any prescription medication within 2 weeks prior to Day 1
* Use of any medication within 1 weeks prior to Day 1
* Has a severe medical history of hypersensitivity to drug
* Participation in another clinical study within 8 weeks days prior to start of study drug administration

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of HM61713 and metabolites
timeFrame: 0-48 hrs
measure: Area under the plasma concentration time curve from zero to infinity (AUC) of HM61713 and metabolites
timeFrame: 0-48 hrs
measure: Tmax of HM61713 and metabolites
timeFrame: 0-48 hrs
measure: Terminal half life (t1/2) of HM61713 and metabolites
timeFrame: 0-48 hrs
measure: The apparent plasma clearance (CL/F) of HM61713 and metabolites
timeFrame: 0-48 hrs
measure: Mean residence time (MRT) of HM61713 and metabolites
timeFrame: 0-48 hrs
Secondary outcomes:
measure: Safety data, including physical examinations, laboratory evaluation, ECGs, ICGs, vital signs, and adverse events.
timeFrame: 7 days after the investigational drug administration.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05299099: Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Inj. Compared With RCN301
Official title: A Randomized, Open-label, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Inj. Compared With RCN301 in Postoperative Patients Requiring Central Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parenteral Nutrition
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2022-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to evaluate the safety and efficacy of IN-C006 inj. and RCN301 in postoperative patients requiring central parenteral nutrition.

Detailed description: This study is a randomized, open-label, phase 3 design. The subject will be assigned to one of the two treatment groups (IN-C006 inj. or RCN301)

Eligibility criteria: Inclusion Criteria:

* Age over 19 at the time of obtaining the informed consent form
* Requiring over 3 days of parenteral nutrition via a central vein after an operation
* BMI 16 \~ 30 kg/㎡

Exclusion Criteria:

* Has received parenteral nutrition within 7 days of screening
* Severe dyslipidemia
* Uncontrolled diabetes
* Clinically significant liver disease
* Clinically significant kidney disease

Primary outcomes:
measure: Adverse drug reaction rate
timeFrame: Day 1 to Day 4
Secondary outcomes:
measure: Change in nutritional management parameters
timeFrame: Day 1 to Day 4
measure: Change in inflammation parameters
timeFrame: Day 1 to Day 4
measure: Change in fatty acid profile
timeFrame: Day 1 to Day 4
measure: Incidence of Adverse event
timeFrame: Day 1 to Day 4
measure: Change in laboratory parameters
timeFrame: Day 1 to Day 4
measure: Change in vital sign
timeFrame: Day 1 to Day 4
measure: Normal and abnormal change in physical examination
timeFrame: Day 1 to Day 4
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National Univerity Hospital
name: Do Joong PARK
role: STUDY_CHAIR
References:
Clinical trial NCT05274399: Hopelessness and Self-care Power in Hemodialysis Patients
Official title: The Correlation Between The Hopelessness Level and Self-Care Agency In Patients Receiving Hemodialysis Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodialysis
Despondency
Relational Problems
Keywords: hemodialysis
hopelessness
self-care agency
nurse
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the study consisted of 75 patients registered in the hemodialysis unit of this university hospital, and the sample of the study consisted of 69 patients who were treated in this hospital and voluntarily accepted to participate in the study.

Brief summary: The purpose of this study is to investigate the correlation between hopelessness level and self-care agency in patient receiving hemodialysis treatment.

Detailed description: While the symptoms and signs that occur as a result of renal failure can be controlled with hemodialysis treatment, the reasons such as the nature of the disease, disease-related symptoms, treatment period and patients' dependency on the hemodialysis machine due to this treatment lead to many physical and psychological problems in the patients. Patients undergoing hemodialysis face physical problems such as becoming dependent, impairment of the socio-economic status, inability to fulfill their role in the society, and changes in work life and various psychological problems such as anxiety, depression, isolation, rejection of the disease, delusions, and hallucinations. it is hoped that this study aiming to determine whether or not there is a correlation between hopelessness level and self-care agency of hemodialysis patients would make a great contribution to the limited available literature.

Eligibility criteria: Inclusion Criteria:

* Being 18 years or older,
* To be receiving hemodialysis treatment for at least three months,
* Not having mental confusion or having any psychiatric problems,
* Hearing-sight (except for those who use glasses)-speech problem
* Volunteering to participate in the research

Exclusion Criteria:

* Being 18 years or younger,
* have cognitive impairments,
* not being able to complete the questionnaires,
* not wanting to participate in the study,
* having decided to leave the job

Primary outcomes:
measure: Patient Information Form
timeFrame: one week after obtaining permission from the institution
measure: Beck Hopelessness Scale (BHS)
timeFrame: one week after obtaining permission from the institution
measure: Self-Care Agency Scale
timeFrame: one week after obtaining permission from the institution
Secondary outcomes:
Other outcomes:
Locations:
city: Muş
country: Turkey
facility: Muş Alparslan University
Study officials:
References:
Clinical trial NCT06272799: Tolerability and Efficacy of Adjuvant T-DM1 in Patients with HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents.
Official title: Tolerability and Efficacy of Adjuvant T-DM1 in Patients with HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents. Real-world Multicenter Retrospective-prospective Study. ATD-Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 160
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HER2 positive breast cancer

Brief summary: Multicenter, retrospective-prospective, real-world observational study, with the aim of evaluating tolerability and efficacy in a population of patients treated according to clinical practice outside of studies randomized.

Detailed description: Patients affected by will be included in the study and analyzed HER2 positive breast cancer with residual invasive disease after neoadjuvant chemotherapy, treated consecutively with adjuvant T-DM1 at the various Italian oncology centers.

Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of HER2 positive breast cancer;
* Presence of invasive residual disease on T or N after neoadjuvant chemotherapy including anti-HER2 agents
* Treatment with T-DM1 in the adjuvant post-neoadjuvant setting, in case of positive hormone receptors in combination with adjuvant hormone therapy. Complementary radiotherapy will be allowed as per lines guide;
* Availability of adequate information regarding treatment with adjuvant T-DM1 in accordance with the objectives of the study;
* Written informed consent for the prospective part and, if possible, for the recruited patients retrospectively

Exclusion Criteria:

* Concomitant treatments with other biological agents;
* Absence of clinical data that allow the correct analysis of the primary and secondary objectives;
* Patients with a history of other malignant neoplasms;
* Contraindications to the use of T-DM

Primary outcomes:
measure: Evaluate the tolerability.
timeFrame: 24 months
Secondary outcomes:
measure: Evaluate the effectiveness of treatment.
timeFrame: 24 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: &#34;Regina Elena&#34; National Cancer Institute
Study officials:
References:
Clinical trial NCT04391699: Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy
Official title: Humidifier Study: Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osa Syndrome
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: DOM AIR
First posted: 2020-05-18
Enrollment: 0
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: To compare two different clinical strategies in order to evaluate the impact of prophylactic heated humidification on OSA patients' compliance to CPAP therapy.

Detailed description: To compare two different clinical strategies in order to evaluate the impact of prophylactic heated humidification on OSA patients' compliance to CPAP therapy.

Eligibility criteria: Inclusion Criteria:

* Adult Patient
* Newly diagnosed OSA Patients eligible to CPAP therapy
* Signed informed consent

Exclusion Criteria:

* CPAP therapy contraindications
* Pregnancy
* Patient unable to come to study follow up visits or unable to finish the study.
* Informed consent not signed
* Adults who are subject to a legal protection measure or are unable to express their consent (such as patients under guardianship and patients deprived of judicial or administrative freedom)

Primary outcomes:
measure: CPAP mean usage (hours/night) at the 3 month follow up
timeFrame: 3 months
Secondary outcomes:
measure: Sleep quality
timeFrame: 3 months
measure: sleepiness
timeFrame: 3 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Bel Air
Study officials:
affiliation: clinique Bel Air
name: Nathalie Raymond, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05418699: Real-life Data from Diabetic Patients on Closed-loop Pumps
Official title: Real-life Data from Diabetic Patients on Closed-loop Pumps
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Type 1 Diabetes
Lead sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 439
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type I diabetic patients with a closed-loop insulin pump between April 2020 and August 2023

Brief summary: To evaluate, in real life, the effect of closed-loop devices on the improvement of glycemic control in diabetic patients managed in the endocrinology departments of secondary care hospitals.

Detailed description: In recent years, closed-loop insulin delivery have been developed to deliver real-time glucose-responsive insulin to people with type 1 diabetes. Their use has been validated in clinical trials, but international investigative centers participating in clinical trials are not always representative of secondary care centers, and the patients they manage are also different. The eligibility criteria for participants in clinical trials are more stringent and restrictive than those of the usual patient population of diabetes/endocrinology centers. The socio-demographic characteristics of patients in clinical trials, in particular the ratio of males to females, age or ethnicity, do not necessarily reflect those observed in patients actually using the device.

Eligibility criteria: Inclusion Criteria:

* type I diabetic
* with a closed-loop insulin pump

Exclusion Criteria:

* under legal protection order
* patient or legal guardian objecting to the use of the data in the research

Primary outcomes:
measure: HbA1c level
timeFrame: At 3 months
Secondary outcomes:
measure: HbA1c level
timeFrame: At 6 months
measure: HbA1c level
timeFrame: At 12 months
measure: Time in range
timeFrame: At 3 months
measure: Time in range
timeFrame: At 6 months
measure: Time in range
timeFrame: At 12 months
measure: Time below range
timeFrame: At 3 months
measure: Time below range
timeFrame: At 6 months
measure: Time below range
timeFrame: At 12 months
measure: Time above range
timeFrame: At 3 months
measure: Time above range
timeFrame: At 6 months
measure: Time above range
timeFrame: At 12 months
measure: Coefficient of variation
timeFrame: At 3 months
measure: Coefficient of variation
timeFrame: At 6 months
measure: Coefficient of variation
timeFrame: At 12 months
Other outcomes:
Locations:
city: Boulogne-sur-Mer
country: France
facility: CH Boulogne-sur-Mer
city: Béthune
country: France
facility: CH Béthune-Beuvry
city: Dax
country: France
facility: CH Dax
city: Mont-de-Marsan
country: France
facility: CHI Mont de Marsan et du Pays des Sources
city: Périgueux
country: France
facility: CH Périgueux
Study officials:
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
name: Didier GOUET, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03391999: Health-Related Quality of Life in Upper Secondary Schools in Denmark
Official title: (Danish): Sundhed, Trivsel og Læring på HHX og HTX, Erhvervsskolerne i Aars
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Keywords: Mental Health, Physical Health
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adults enrolled at the Technical College in Aars

Brief summary: Measuring Quality of Life in an upper secondary school in Denmark

Detailed description: The Child Health Utility 9 Dimension (CHU9D) is a relatively new health-related quality of life (HRQoL) instrument for use in children and young people. CHU9D has recently been translated and linguistic validated into Danish.

The objective of this study is twofold. Firstly, the investigators wants to examine the feasibility of using the Danish version of CHU9D to assess the HRQoL in young adults. Secondly, the investigators wants to analyse the association of wellbeing, happiness with the school and the learning environment with the students HRQoL in the Northern Danish Region of Denmark.

Eligibility criteria: Inclusion Criteria:

* Students at the Higher Commercial Examination (HHX) and Higher Technical Examination (HTX) at the Technical College in Aars.

Exclusion Criteria:

* There will be no exclusion criteria concerning diseases or conditions for these school students.

Primary outcomes:
measure: QALY
timeFrame: 3-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
affiliation: Aalborg University
name: Birgitte Gregersen, PhD
role: STUDY_DIRECTOR
References:
citation: Petersen KD, Ratcliffe J, Chen G, Serles D, Frosig CS, Olesen AV. The construct validity of the Child Health Utility 9D-DK instrument. Health Qual Life Outcomes. 2019 Dec 23;17(1):187. doi: 10.1186/s12955-019-1256-0.