louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03808428: CUHK Jockey Club HOPE 4 Care Programme - Ankle Robot
Official title: CUHK Jockey Club Tech-Based Stroke Rehabilitation Programme for Elderly Centre - Interactive Exoskeleton Ankle Robot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
First posted: 2019-01-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project 'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres, to benefit the community. The Exoskeleton Ankle Robot is a robot-assisted Ankle-Foot-Orthosis to facilitate gait training of person after stroke with drop foot.


Eligibility criteria: Inclusion Criteria:

* have the ability to walk on the ground independently or with one personal assistance with or without walking aids
* able to understand simple commends

Exclusion Criteria:

* have other neurological, neuromuscular, and orthopedic diseases
* uncontrolled cardiovascular or respiratory disorders
* moderate to severe contractures in the lower extremities

Primary outcomes:
measure: Fugl-Meyer Assessment Lower Extremity (FMA-LE)
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Functional Ambulation Classification (FAC)
timeFrame: 3-month follow-up
measure: Modified Ashworth Scale (MAS)
timeFrame: 3-month follow-up
measure: Berg Balance Scale (BBS)
timeFrame: 3-month follow-up
measure: Timed 10-Meter Walk Test (10MWT)
timeFrame: 3-month follow-up
measure: 6 Minute Walk Test (6MWT)
timeFrame: 3-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Biomedical Engineering, CUHK
name: Raymond Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00150228: 12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation
Official title: A Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) in Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 300
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: The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051019


Eligibility criteria: Inclusion Criteria:

* Subjects must have smoked an average of at least ten cigarettes per day during the past year
* No period of abstinence greater than three months in the past year

Exclusion Criteria:

* Subjects with history of clinically significant cardiovascular disease
* Subjects with uncontrolled hypertension.

Primary outcomes:
measure: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
Secondary outcomes:
measure: Continuous abstinence rate from target quit date to end of treatment (Week 12)
measure: 7-day point prevalence of abstinence at Week 12
measure: Number of cigarettes smoked per day
measure: Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale
measure: Rewarding effects of smoking assessed by Smoking Effects Inventory
measure: weight change from baseline
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Albert Lea
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: La Crosse
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Niaura R, Hays JT, Jorenby DE, Leone FT, Pappas JE, Reeves KR, Williams KE, Billing CB Jr. The efficacy and safety of varenicline for smoking cessation using a flexible dosing strategy in adult smokers: a randomized controlled trial. Curr Med Res Opin. 2008 Jul;24(7):1931-41. doi: 10.1185/03007990802177523. Epub 2008 May 29.
Clinical trial NCT02820428: Evaluation of Behaviour in Parkinson's Disease. Normal Values in Healthy Subjects
Official title: Evaluation Comportementale Dans la Maladie de Parkinson. Normes Chez Des Sujets Sains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behaviour
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 124
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Non-motor symptoms like mood fluctuations and behavioral disorders are frequent in Parkinson's disease. They may be induced by both the pathology and the dopaminergic treatment and must be considered in treatment policies.

Due to their specificity and the absence of an appropriate evaluation tool, behavioral disorders are rarely searched for.

Therefore, investigators developed a scale permitting qualitative and quantitative evaluation of behavior according to the severity of the disorders.

This study aims to define reference values for healthy individuals

Detailed description: The application of the scale includes a semi-structured interview

The ECMP scale consists of 21 items, each of which may be assessed by use of a 5 point scale (not at all - light trouble - moderate trouble - important trouble - severe trouble)

Eligibility criteria: Inclusion Criteria:

* Healthy participants without any neurologic disease
* Men and women from 25 to 75 years old
* French mother tong
* without cognitive troubles (MMS ≥ 24)

Exclusion Criteria:

* Subject under legal guardianship
* Pregnant woman or with childbearing potential without contraceptive device

Primary outcomes:
measure: ECMP score
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Grenoble
name: Anna Castrioto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02930928: Can Habitus Adapted Length Based Body Weight Estimation be Improved by Adding Further Parameters?
Official title: Evaluation of an Algorithm for Gender Specific and Habitus Adapted Length Based Body Weight Estimation in Children - Improvement by Adding Another Parameter?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight-Estimation
Keywords: Anaesthesia
Anthropometry
Body weight and measures
Development
Emergency treatment
Patient safety
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 495
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients planned for elecitve surgery in general anaesthesia

Brief summary: The purpose of this prospective single center study is to investigate if the accuracy of length based body weight estimation by the already investigated algorithm (CLAWAR) can be improved by adding another parameter. For this study 500 patients are required to collect anonymized data (length, weight, age, mid upperarm circumference and patient habitus by visual estimation) for achieving a power of 80% during statistical analysis. The main hypothesis ist that CLAWAR's accuracy can be improved.

Detailed description: This prospective single center study is performed at the university children's Hospital zurich. Patients planned for surgery in general anaesthesia with intubation, aged 0 to 16 years and with a body length suitable for CLAWAR. Patient and parental information is performed during the pre-anaesthetic visit.

After written consent the patient will be included. Patient ́s length and weight will be measures earliest one day before data collection. Data collection during anaesthesia has no influence on the daily anaesthesia routine and has no impact on patient safety and anaesthesia. Patient's data is made anonymous for further inspection. Data is documented in Microsoft Excel and statistical analysis calculated with SPSS.

500 patients are needed for a power of 80%. Primary outcome parameter is the accuracy of length based weight estimation using either patient habitus by visual estimation or an improved version of the algorithm CLAWAR using the mid upperarm circumference.

Eligibility criteria: Inclusion Criteria:

* body length suitable with the investigated algorithm
* all patients aged 0 -16 years

Exclusion Criteria:

* already included in this study once
* missing patient or parental consent

Primary outcomes:
measure: length-based weight-estimation by algorithm
timeFrame: during procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Childrens Hospital
Study officials:
affiliation: University Children's Hospital Zurich, Department of Anaesthesia
name: Alexander R Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01021228: Preconditioning Volatile Anesthesia in Liver Surgery
Official title: Preconditioning is Indeed Protective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: Liver resection
Continuous volatile anesthesia
Continuous intravenous anesthesia
Preconditioning volatile anesthesia
Comparing three groups of anesthesia during the liver surgery according to their benefit on liver and outcome.
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-11-26
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients were included undergoing any type of liver resection with inflow occlusion for benign as well as malign diseases between January first, 2005 and December 31, 2007 in a single tertiary care center

Brief summary: The purpose of this study is to compare the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery.

Detailed description: Comparing the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery.

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* benign and malign disease
* any type of liver surgery
* inflow occlusion during the liver surgery

Exclusion Criteria:

* \< 18 years
* participation on other interventional and treatment randomized controlled trials,
* trauma of the liver
* liver cirrhosis

Primary outcomes:
measure: peak ALT and AST levels representing the ischemia-reperfusion injury
timeFrame: post-operative
Secondary outcomes:
measure: length of hospital stay, length of ICU stay, blood loss and morbidity (post-operative complications)
timeFrame: post-operative
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Universtiy Hospital of Zurich, Department of Visceral and Transplantation Surgery
Study officials:
affiliation: Departement of Visceral and Transplantation
name: Ksenija Slankamenac, med. pract
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03530228: A Phase 1 Study of Tegoprazan on Healthy Male Volunteers
Official title: A Randomized, Open-label, Active-controlled, Single/Multiple-dose Phase 1 Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Tegoprazan After Oral Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pharmacodynamics
Pharmacokinetics
Healthy Male Volunteers
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2018-05-21
Enrollment: 44
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cohort 1: crossover Cohort 2: parallel Cohort 3: single group
Primary purpose: BASIC_SCIENCE

Brief summary: A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects

Detailed description: * To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan between dose groups in healthy H. pylori negative males.
* To evaluate the pharmacokinetics and pharmacodynamics of multiple oral dose of tegoprazan under the fed state in healthy H. pylori negative males.
* To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan in healthy H. pylori positive males.

Eligibility criteria: Inclusion Criteria:

* Healthy adult males aged ≥ 19 years and ≤ 50 years
* Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening

Exclusion Criteria:

* Presence or history of clinically significant diseases
* Presence or history of gastrointestinal disorder (gastric ulcer, GERD, - Crohn's disease, etc.)
* Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
* Serologic test positive
* Abnormal obstacle to insertion and maintenance of pH meter catheter
* History of drug abuse
* Excessive caffeine intake or persistent alcohol intake
* Not use of a medically acceptable method of contraception

Primary outcomes:
measure: AUC(0-24h) of tegoprazan
timeFrame: up to 7 days
measure: Cmax of tegoprazan
timeFrame: up to 7 days
measure: Gastric pH
timeFrame: up to 7 days
measure: Serum gastrin concentration
timeFrame: up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06477328: Evaluating Chronic Obstructive Pulmonary Disease (COPD) Patients' Treatment Compliance and Quality of Life Via Telemedicine
Official title: Treatment Compliance of Patients Diagnosed With Chronic Obstructive Pulmonary Disease And Their Quality of Life After Follow-up: Evaluation Via Telemedicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telehealth
Copd
Keywords: telemedicine
copd
inhaler adherence
inhaler technique
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-27
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a prospective, randomized controlled, method clinical research study. Patients who were hospitalized with COPD exacerbation in the last year were included in the study and were divided into 2 groups.
Primary purpose: SCREENING

Brief summary: The Covid-19 pandemic has disrupted the follow-up and treatment processes for patients, and telemedicine has emerged as an important alternative method. Our aim was to test compare COPD Assessment Test (CAT) scores, inhaler treatment techniques and adherence between telemedicine-mediated healthcare and healthcare provided face-to-face.


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed with COPD according to Global Initiative for Obstructive Lung Disease (GOLD)
* GOLD spirometric grade 3-4
* At least one hospital admission in the past year
* Acceptable score on the Mini-Mental State Examination
* Residing in Ankara
* Patient or caregiver must understand the process and be able to provide clear information
* Medical records and laboratory test results must be accessible to healthcare professionals
* Patient must have access to prescribed medications
* Comorbidities outside of the lungs are included

Exclusion Criteria:

* Patients diagnosed with asthma
* Patients with lung cancer
* Patients with combined pulmonary fibrosis and emphysema
* Patients with active infections such as pneumonia or COVID-19
* Patients being followed for COPD without spirometry
* Patients with low cognitive function as determined by the Mini-Mental State Examination
* Patients who do not consent to participate in the study
* Patients lacking adequate social support
* Patients with COPD grade 1-2
* Patients with no hospital admissions in the past year
* Patients diagnosed with psychotic disorders
* Patients residing outside of Ankara
* Patients enrolled in inpatient or supervised outpatient rehabilitation programs
* Patients unable to use telemedicine devices or without a caregiver to assist
* Patients and caregivers having difficulty providing information
* Patients without internet access or video call capabilities at home

Primary outcomes:
measure: Inhaler adherence
timeFrame: 3 months
Secondary outcomes:
measure: COPD Assesment Test (CAT) score
timeFrame: 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
Clinical trial NCT02429128: 14 Weeks Exercise Training on Lean Women With and Without PCOS
Official title: 14 Weeks Exercise Training on Lean Women With and Without PCOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome (PCOS)
Keywords: Polycystic Ovary Syndrome (PCOS)
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 22
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this project is to investigate the pathophysiology of PCOS in regards to the metabolic profile including defects in insulin sensitivity in skeletal muscle and adipose tissue, and to investigate the effects of exercise training on these parameters.


Eligibility criteria: Inclusion Criteria: Women with PCOS

* Hyperandrogenism and/or hyperandrogenemia
* Regular menstruation
* Age: 20-40
* Inactive or low physical activity level
* Low to moderate fitness status

Inclusion Criteria: Women without PCOS

* Normal levels of plasma androgens
* Polycystic ovary and/or menstrual dysfunction
* Age: 20-40
* Inactive or low physical activity level
* Low to moderate fitness status

Exclusion Criteria: Women with and without PCOS

* Pregnancy or breast feeding
* Smoking
* Use of birth control pills 3 mo before enrolment

Primary outcomes:
measure: Compliance to exercise training program as assessed by number of training sessions completed
timeFrame: 14 weeks
measure: No change in Body Weight
timeFrame: 14 weeks
measure: Component of metabolic syndrome
timeFrame: 14 weeks
measure: Component of metabolic syndrome
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
state: Østerbro
Study officials:
affiliation: NEXS, KU
name: Bente Kiens, Professor
role: STUDY_DIRECTOR
References:
citation: Hansen SL, Svendsen PF, Jeppesen JF, Hoeg LD, Andersen NR, Kristensen JM, Nilas L, Lundsgaard AM, Wojtaszewski JFP, Madsbad S, Kiens B. Molecular Mechanisms in Skeletal Muscle Underlying Insulin Resistance in Women Who Are Lean With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2019 May 1;104(5):1841-1854. doi: 10.1210/jc.2018-01771.
Clinical trial NCT06936228: Evaluation of the Effect of Local Propolis Application on the Healing of Pressure Ulcers
Official title: Evaluation of the Effect of Local Propolis Application on the Healing of Pressure Sores
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Sore
Keywords: Pressure ulcer
Propolis application
Apitherapy
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
Collaborators: name: Karadeniz Technical University
First posted: 2025-04-20
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was conducted to evaluate the effect of local propolis application in patients with pressure ulcers. A total of 62 patients were included in this randomized controlled experimental study, with 31 patients in the propolis group and 31 in the control group. While the control group received the clinic's standard wound care treatment protocol, the propolis group was administered 30% pure propolis extract in addition to the standard wound care treatment protocol. For data collection, the following tools were used: the Introductory Characteristics Form, which includes patients' socio-demographic and medical information; the Propolis Application Follow-up Form; the Pressure Ulcer Healing Assessment Scale; pain assessment tools including the Visual Analog Scale (VAS) for conscious patients and the Face Pain Scale for unconscious patients; Katz's Index of Activities of Daily Living; and the Charlson Comorbidity Index (CCI).


Eligibility criteria: Inclusion Criteria:

The patient or their caregiver is able to communicate verbally, Hospitalized in palliative care or intensive care units for at least one week, Has a Stage 1, 2, or 3 pressure ulcer according to NPUAP (13), The wound has not been closed by a physician, Agrees to participate in the study, Expected to stay in the hospital for at least 21 days.

Exclusion Criteria:

The patient or their caregiver is unable to communicate verbally, Has a Stage 4 or unstageable pressure ulcer according to NPUAP, The wound has been closed by a physician, Does not agree to participate in the study, Expected to stay in the hospital for less than 21 days.

Primary outcomes:
measure: Assessment of Pressure Ulcer Healing: PUSH (Pressure Ulcer Scale for Healing)
timeFrame: 21-day follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Sağlık Bakanlığı Ordu Üniversitesi Eğitim ve Araştırma Hastanei
Study officials:
References: