louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05463653: Comparison of Rehabilitation Intervention, Supported by Telemedicine, With Standard Rehabilitation After Distal Radius Fracture.
Official title: Evaluation of the Efficacy of an Early Rehabilitation Intervention, Supported by Telemedicine, Compared to the Usual Rehabilitation Intervention, in Patients With Distal Radius Fracture. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Rehabilitation
Information technologies
Lead sponsor: Hospital Clinico Mutual de Seguridad
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms parallel design, randomized assignment, outcomes-assessor blind to the assignment
Primary purpose: TREATMENT

Brief summary: This is a randomized clinical trial of two parallel arms, aiming to compare two rehabilitation interventions: an experimental intervention including telemedicine support and remote monitoring of compliance of usual indicated exercises, versus the usual protocol of indicated exercises supported by printed material (triptych) and without remote monitoring

Detailed description: Distal radius fracture is a common pathology. The surgical indication is given by the difficulty in obtaining fracture reduction or by the instability of the fracture. The long-term functional prognosis of the wrist depends largely on patients' adherence to the prescribed indications/exercises in the immediate postoperative phase.

This is a randomized clinical trial of two parallel arms, aiming to compare two rehabilitation interventions: an experimental intervention including telemedicine support and remote monitoring of compliance of usual indicated exercises, versus the usual protocol of indicated exercises supported by printed material (triptych) and without remote monitoring.

Eligibility criteria: Inclusion Criteria:

* distal radial fracture (A2 to C3 type according to the Orthopaedic Trauma Association classification system)
* indication for standard rehabilitation post-surgery

Exclusion Criteria:

* immediate post-surgery complication
* multiple fractures or severe injuries
* history of bone metabolism condition
* illiterate
* non-Spanish speaking
* mental disorder
* not familiar with electronic devices

Primary outcomes:
measure: Change of Patient Related Wrist Evaluation score from Day 28 at Day 56 post ranndomization
timeFrame: Day 56
measure: Adherence to prescribed excercise program
timeFrame: Day 56
Secondary outcomes:
measure: Grip strength
timeFrame: Day 28; Day 56
measure: Wrist flexion and extension
timeFrame: Day 28; Day 56
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Mutual de Seguridad
state: Region Metropolitana
Study officials:
affiliation: Mutual de Seguridad General Manager
name: Ricardo Gamboa
role: STUDY_DIRECTOR
References:
Clinical trial NCT00790153: To Evaluate the Hormonal Response to Low Blood Sugar After a Single Oral Dose of AZD1656 Suspension
Official title: A Randomized, Open, Two-Way Cross-Over, Single-Centre, Phase I Study to Assess the Counter Regulatory Response During Hypoglycaemia in Healthy Male Volunteers After a Single Oral Dose of AZD1656 Suspension in Comparison With Insulin Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes, hormonal response
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656 suspension.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers.
* Clinically normal physical findings (incl. Electrocardiogram (ECG)) and laboratory values as judged by the investigator.
* Have a body mass index (BMI) ≥19 and ≤30

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
* Intake of any prescribed medicine and OTC drugs (including herbals, vitamins and minerals), except for occasional paracetamol or nasal spray for nasal congestion, within two weeks before the first administration of the investigational product.
* Daily use of nicotine containing substances.

Primary outcomes:
measure: Pharmacodynamic variables
timeFrame: Blood samples taken repeatedly up to 6 hours during study days
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
measure: Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)
timeFrame: Taken repeatedly during treatment periods
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Research Site
state: California
Study officials:
affiliation: AstraZeneca R&D Mölndal
name: Klas Malmberg, MD, PhD, Prof
role: STUDY_DIRECTOR
affiliation: Profil Institute for Clinical Research, Inc.
name: Linda Morrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000253: Effects of Nitrous Oxide: A Dose-Response Analysis - 5
Official title: Effects of Nitrous Oxide: A Dose-Response Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
inhalant
subjective effects
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine the subjective, psychomotor, and reinforcing effects of nitrous oxide in healthy volunteers. This is a dose-response analysis.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Choice of N2O vs. placebo
timeFrame: After each pair of sample tests
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Behavioral Pharmacology, 1996, 7: 194-199.
Clinical trial NCT05396053: Mirror Therapy Versus CIMT on Hand Function in Cerebral Palsy
Official title: Mirror Therapy Versus CIMT Improves Hand Strength and Function in Children With Unilateral Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Mirror Hands
Keywords: Mirror therapy
Hand function
Grip strength
Lead sponsor: Batterjee Medical College
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 74
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study (2 groups) and control
Primary purpose: TREATMENT

Brief summary: The aim is to investigate the effect of mirror therapy on hand functions in children with hemiplegic cerebral palsy.

Detailed description: Hemiplegic cerebral palsy (HCP) is a form of paralysis that affects motor performance and muscle tone on one side of the body. Spastic hemiplegia CP is the second form of cerebral palsy in premature infants, affecting one side of the body's limbs. Hand and upper limb dysfunction cause problems in half of the children with cerebral palsy. Mirror therapy is a growingly recognized new treatment option for hemiplegic cerebral palsy. While upper extremity involvement in hemiplegic CP and the residual effects are more severe, there is limited evidence of the efficacy of mirror treatment in children with hemiplegic CP

Eligibility criteria: Inclusion Criteria:

* Spasticity grade 1 or 1+ based on the modified Ashworth scale
* Able to understand and follow instructions

Exclusion Criteria:

* Cognitive impairment
* Orthopedic dysfunction
* Impairment in visual acuity
* Children who are unable to pay attention during the treatment period

Primary outcomes:
measure: Hand grip strength
timeFrame: 12 weeks
measure: Hand function
timeFrame: 12 weeks
measure: Fine Motor skills
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Batterjee Medical College
city: Jeddah
country: Saudi Arabia
facility: Local physical rehabilitation centers
Study officials:
affiliation: Batterjee Medical College
name: Mohamed A Abdel Ghafar, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02776553: A Physical Activity Program in End-state Liver Disease
Official title: A Physical Activity Program in End-stage Liver Disease: Pilot Study Assessing Changes in Physical Fitness, Sarcopenia, and the Metabolic Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Liver Disease (ESLD)
Liver Transplant
Sarcopenia
Poor Physical Fitness
Cirrhosis
Portal Hypertension
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program. Secondary aims will focus on changes in anthropometrics, body composition, quality of life, and metabolic profile. This is a randomized clinical trial including 50 patients, with half allocated to the active group (physical training program) and half to standard of care.


Eligibility criteria: Inclusion Criteria:

* Age 40 to 70.
* Cirrhosis, any cause, defined as:

  * Biopsy-proven.
  * Two or more of the following: albumin \<3.5 g/dL, International Normalized Ration (INR) \>1.3, radiologic or endoscopic evidence of portal hypertension.
* Creatinine \<2.0 mg/dL.
* Physiologic Model for End Stage Liver Disease (MELD) ≥10.
* Decompensated cirrhosis with active or history of variceal bleeding, ascites, hepatic encephalopathy, or jaundice.
* Potential transplant candidate as per UAMS criteria

Exclusion Criteria:

* Large gastric or esophageal varices with contraindication to use beta-blockers.
* Persistent hepatic encephalopathy grades 2-4.
* Prior diagnosis of hepatocellular carcinoma, or hepatic hydrothorax (with prior repeated thoracocentesis).
* Cirrhotic cardiomyopathy or congestive heart failure, pulmonary vascular complications, known active coronary artery disease, syncope, and cardiac dysrhythmias.
* Physical impediment to perform a cardiorespiratory fitness test.
* Use of implantable defibrillator or a pacemaker.

Primary outcomes:
measure: Physical Fitness - VO2
timeFrame: Change from Baseline to 12 weeks after baseline
measure: Physical Fitness - Distance Walked
timeFrame: Change from Baseline to 12 weeks after baseline
measure: Sarcopenia
timeFrame: Change from Baseline to 12 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas Medical Sciences
name: Andres Duarte-Rojo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03211351: Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
Official title: Comparison of the Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Tear Film
Lipid Layer
Liposic
Tears Naturale Forte
Lead sponsor: Huaxia Eye Hospital Group
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 95
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been developed in which phospholipid liposomes are delivered to the tear film via the surface of the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte application on the lipid and stability of the tear film in dry eye patients


Eligibility criteria: Inclusion Criteria:

* Age range from 20 year to 40 years
* The value of OSDI is over 12
* NBUT is less 5 seconds
* Schirmer 1 test is less 10mm
* The basical lipid layer grade is 1-2

Exclusion Criteria:

* Any corneal,conjunctival, or eyelid abnormalities; conjunctivitis; current ocular infection; photophobia that may cause reflex tearing or difficulty in evaluating the patien 's lipid layer;
* Known allergic sensitivity to any of the ingredients in Liposic or Tears Naturale Forte

Primary outcomes:
measure: scale of Schirmer I test
timeFrame: up to 3 months after tear substitutes apply
measure: scale of corneal fluorescein staining
timeFrame: up to 3 months after tear substitutes apply
measure: scale of noninvasive tear breakup time
timeFrame: up to 3 months after tear substitutes apply
measure: scale of tear meniscus height
timeFrame: up to 3 months after tear substitutes apply
measure: lipid layer grade
timeFrame: up to 3 months after tear substitutes apply
measure: questionnaire of ocular surface disease index
timeFrame: up to 3 months after tear substitutes apply
Secondary outcomes:
measure: subjective comfort
timeFrame: up to 3 months after tear substitutes apply
Other outcomes:
Locations:
city: Foshan
country: China
facility: Huaxia Eye Hosptial of Foshan
state: Guangdong
Study officials:
affiliation: Huaxia Eye Hospital of Foshan
name: Chi Zhang, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02714751: Evaluation of an Informative Intervention to the ICU Team About the Presence of Asynchronies in Mechanically Ventilated Patients: Effect Over Incidence Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asynchronies
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Mechanical ventilation (MV) if a life-support treatment for critically ill patients that can develop adverse effects. Patient-ventilator asynchronies can be present from the beginning of MV, it can be associated with poor outcome and it can develop clinical changes. The aim of this study is to evaluate if the knowledge of the presence of asynchronies by the healthcare team can help to reduce its incidence, improving outcomes of critically ill patients.

A prospective, single-center, before and after study will be conducted in the ICU of Hospital de Sabadell. The study will have 2 phases: a first observational period where the incidence of asynchronies will be assessed, and a second period where a daily information of the presence of asynchronies to the healthcare team will be done with the aim to reduce the incidence.

A continous record of asynchronies and clinical variables will be done during ICU stay.


Eligibility criteria: Inclusion Criteria:

* Invasive mechanical ventilation \< 24 hours.
* \> 18 years-old

Exclusion Criteria:

* \> 24 hours of invasive mechanical ventilation at admission.
* \<48 hours of data collected
* Informed consent not obtained

Primary outcomes:
measure: Incidence of asynchronies
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Parc Tauli
Study officials:
References:
Clinical trial NCT05189951: Different Wiping Motions in Phlebotomy
Official title: The Effect of Different Wiping Motions in Phlebotomy on Vein Visibility, Procedural Success and Phlebotomy-related Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study was conducted with 90 patients. The phlebotomy site was wiped with circular motion in the group-I, vertical movement in the group-II, and first vertical and then circular motion in the group-III.

Detailed description: Aim: This study was conducted to evaluate the effects of different wiping motions used in phlebotomy on vein visibility, procedural success, and phlebotomy-related complications.

Background: In phlebotomy practice, many application guidelines or textbooks are used. In these references, it is seen that phlebotomy site is wiped with different motions.

Methods: This study was conducted with 90 patients. The phlebotomy site was wiped with circular motion in the group-I, vertical movement in the group-II, and first vertical and then circular motion in the group-III.

Eligibility criteria: Inclusion Criteria:

* who are over 18 years old,
* without any psychiatric diseases,
* without vision or hearing problems,
* hospitalized in the internal medicine clinic,
* with platelet counts of 200 000 / mm³ and above,
* 8 cc of blood is ordered for lab test and
* individuals who volunteered to participate in the study

Exclusion Criteria:

* having a local or systemic infection,
* having vascular disease,
* having an immunopathological problem,
* scarring, psoriasis, active dermatitis in the phlebotomy site,
* having peripheral nerve disease,
* having peripheral neuropathy,
* patients with coagulation disorder,
* individuals who don't volunteered to participate in the study

Primary outcomes:
measure: Vein Assessment
timeFrame: up to 1 minute after wiping the venipuncture site
measure: Change in complications at 72 hours
timeFrame: 24th, 48th and 72nd hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
affiliation: TC Erciyes University
name: Sevda Korkut
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06037551: System Accuracy of the Blood Glucose Monitor for Personal Use Contour Care
Official title: Evaluierung Des Blutglukose Monitoring Systems Contour Care Der Firma Ascensia Diabetes Care Deutschland GmbH gemäß DIN EN ISO 15197:2015
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Institut fur Diabetes Karlsburg GmbH
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015


Eligibility criteria: Inclusion criteria:

* Male or female patients with hypo-, eu- or hyperglycaemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

* Pregnancy or lactation
* Acute or chronic diseases with the risk of aggravation by the measure
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015

Primary outcomes:
measure: Analysis of system accuracy based on DIN EN ISO 15197
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Institut für Diabetes Karlsburg GmbH
state: Mecklenburg Vorpommern
Study officials:
affiliation: Institut fur Diabetes Karlsburg GmbH
name: Kerstin Rebrin, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01261351: Study of Coagulation Activation Markers and Pre Eclampsia
Official title: Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre Eclampsia
Keywords: Pre eclampsia
Endogenous thrombin potential
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women from two University hospitals in France

Brief summary: The primary purpose of the trial is to evaluate coagulation activator markers in patients with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with the severity of the pathology.

Detailed description: 100 pre-eclamptic patients will be compared to 200 control patients (100 control matched on gestational age at inclusion and 100 control matched on delivery mode (section).

Blood and urine samples will be collected at PE diagnosis, delivery and post partum.

Two axes will be considered:

1. Thrombography, or kinetic measurement of thrombin generation, by studying the coagulant profile according to Hemker's method in CAT System (Calibrated Automated Thrombogram) and by thromboelastogram in ROTEM technique (delocalized coagulation analyzer), in parallel to specific activation markers (thrombin-antithrombin complex, fibrin monomers).
2. The balance of prostacyclin/thromboxane A2 by using ELISA method for urine samples and genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase's promoter CYP8A1).

Eligibility criteria: Inclusion Criteria:

* 18 years old
* diagnosis of pre eclampsia

Exclusion Criteria:

* multiple pregnancy
* less than 18 year old

Primary outcomes:
measure: Endogenous thrombin potential
timeFrame: at preeclampsia diagnosis
Secondary outcomes:
measure: genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1
timeFrame: at pre eclampsia diagnosis
measure: In preeclampsia group : correlation between biological markers and severity of the disease
timeFrame: at the diagnosis of preeclampsia
measure: evolution of endogenous thrombin potential in women with preeclampsia
timeFrame: between the diagnosis of preeclampsia and day 2 of the post partum period
Other outcomes:
Locations:
city: Lille
country: France
facility: University Hospital of Lille
state: Nord
Study officials:
affiliation: Universituy Hospital Of Lille, France
name: Véronique Houfflin Debarge, PHD
role: PRINCIPAL_INVESTIGATOR
References: